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  • 101.
    Niederle, B.
    et al.
    Med Univ Vienna, Dept Surg, Vienna, Austria..
    Pape, U. -F
    Costa, F.
    Hosp Sirio Libanes, Ctr Oncol, Sao Paulo, Brazil..
    Gross, D.
    Hadassah Univ Hosp, Dept Endocrinol & Metab, Mevasseret Tsion, Israel..
    Kelestimur, F.
    Erciyes Univ, Sch Med, Dept Endocrinol, Kayseri, Turkey..
    Knigge, U.
    Copenhagen Univ Hosp, Rigshosp, Neuroendocrine Tumor Ctr Excellence, Copenhagen, Denmark..
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology.
    Pavel, M.
    Charite, Dept Gastroenterol & Hepatol, Campus Virchow Klinikum, D-13353 Berlin, Germany..
    Perren, A.
    Univ Bern, Inst Pathol, Bern, Switzerland..
    Toumpanakis, C.
    Royal Free Hosp, Neuroendocrine Tumour Unit, Pond St, London NW3 2QG, England..
    O'Connor, J.
    Inst Alexander Fleming, Dept Clin Oncol, Buenos Aires, DF, Argentina..
    O'Toole, D.
    St Vincents Univ, Natl NET Ctr, Dublin, Ireland.;St James Hosp, Dept Clin Med, Dublin 8, Ireland.;Univ Dublin Trinity Coll, Dublin 2, Ireland..
    Krenning, E.
    Erasmus MC, Div Nucl Med, Dept Internal Med, Rotterdam, Netherlands..
    Reed, N.
    Gartnavel Royal Hosp, Beatson Oncol Ctr, Glasgow, Lanark, Scotland..
    Kianmanesh, R.
    CHU Robert Debre, Dept Surg, Reims, France..
    ENETS Consensus Guidelines Update for Neuroendocrine Neoplasms of the Jejunum and Ileum2016In: Neuroendocrinology, ISSN 0028-3835, E-ISSN 1423-0194, Vol. 103, no 2, p. 125-138Article in journal (Refereed)
  • 102.
    Norlén, Olov
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Daskalakis, Kosmas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology.
    Åkerström, Göran
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Stålberg, Peter
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Hellman, Per
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Indication for Liver Transplantation in Young Patients with Small Intestinal NETs Is Rare?2014In: World Journal of Surgery, ISSN 0364-2313, E-ISSN 1432-2323, Vol. 38, no 3, p. 742-747Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:

    A majority of patients with small intestinal neuroendocrine tumors (SI-NETs) present with or develop liver metastases (LM). A number of treatments for LM are used clinically, including liver transplantation (LTx). Indications for LTx are under debate; young age (<65 years), absence of extrahepatic disease, resected primary tumor and limited extent of LM have been suggested as inclusion criteria for LTx with the aim to optimize outcome.

    MATERIALS AND METHODS:

    From our series of 672 patients with SI-NET treated at the University Hospital in Uppsala between 1985 and 2012, we identified 78 patients according to the following criteria: <65 years of age, locoregional surgery (LRS) of the primary tumor and mesenteric metastases successfully performed, LM present but no extrahepatic disease. Baseline was chosen as the first date the following points were met: First visit to our center, LRS performed, LM present. The patients underwent treatment according to the standard clinical protocols at our center, and during this time period we did not perform or refer any SI-NET patients for LTx. Kaplan-Meier survival analyses were performed in three different groups based on hypothetical criteria for LTx.

    RESULTS:

    Five-year overall survival rates for patients <65 years (n = 78) and <55 years (n = 36) of age were 84 ± 8 and 92 ± 9 %, respectively. For patients fulfilling the Milan criteria (n = 33) the 5-year survival was 97 ± 6 %.

    CONCLUSIONS:

    Most young patients (<65 years) with SI-NET and LM have a favorable survival with standardized multimodality treatment. Indeed, most survival figures reported after LTx of NET do not surpass these figures.

  • 103.
    Norlén, Olov
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Stålberg, Peter
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Eriksson, John
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Hedberg, Jakob
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Upper Abdominal Surgery.
    Hessman, Ola
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Tiensuu Janson, Eva
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Hellman, Per
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Åkerström, Göran
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Long-Term Results of Surgery for Small Intestinal Neuroendocrine Tumors at a Tertiary Referral Center2012In: World Journal of Surgery, ISSN 0364-2313, E-ISSN 1432-2323, Vol. 36, no 6, p. 1419-1431Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:

    Small intestinal neuroendocrine tumors (SI-NETs) are uncommon, with an annual incidence of about 1 per 100,000 individuals. The primary tumor (PT) is generally small, but nevertheless the majority of patients have mesenteric lymph node metastases and liver metastases at diagnosis. Our aim was to identify prognostic factors for survival and to evaluate outcome after surgery in SI-NET patients.

    MATERIAL AND METHODS:

    We included 603 consecutive patients (325 men; age at diagnosis 63 ± 11 years [mean ± SD]) with histopathologically verified SI-NET, who were diagnosed between 1985 and 2010. Hospital charts were reviewed and were scrutinized for carcinoid heart disease (CHD), flush and/or diarrhea, proliferation by Ki-67 index, mesenteric lymph node metastases (m.lgllm), distant abdominal lymph node metastases (da.lgllm), liver tumor load (LTL), extra-abdominal metastases (EAM), locoregional resective surgery, as well as debulking of LTL, and adverse events after surgery.

    RESULTS:

    Median overall survival (OS) was 8.4 years; 5-year OS was 67%, and 5-year relative survival was 74%. Independent prognostic factors by univariate and multivariate analysis were age at diagnosis, CHD, m.lgllm, da.lgllm, LTL, EAM, peritoneal carcinomatosis (PC), and proliferation. Locoregional resective surgery was associated with increased survival on crude and multivariate analysis. The 30-day mortality in our institution after initial locoregional resective surgery was 0.5% (1/205).

    CONCLUSIONS:

    For the first time, m.lgllm and da.lgllm, LTL, PC, and EAM are demonstrated to be independent prognostic factors by multivariate analysis. Locoregional removal of the PT/m.lgllm. was a positive prognostic factor by crude and adjusted analysis and may influence survival.

  • 104.
    Oberg, K
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Onkologisk endokrinologi.
    Chemotherapy and biotherapy in the treatment of neuroendocrine tumours.2001In: Ann Oncol, ISSN 0923-7534, Vol. 12 Suppl 2, p. S111-4Article in journal (Refereed)
  • 105.
    Oberg, K
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Management of neuroendocrine tumours.2004In: Ann Oncol, ISSN 0923-7534, Vol. 15 Suppl 4, p. iv293-8Article in journal (Refereed)
  • 106.
    Oberg, K
    et al.
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Kvols, L
    Caplin, M
    Delle Fave, G
    de Herder, W
    Rindi, G
    Ruszniewski, P
    Woltering, E A
    Wiedenmann, B
    Consensus report on the use of somatostatin analogs for the management of neuroendocrine tumors of the gastroenteropancreatic system.2004In: Ann Oncol, ISSN 0923-7534, Vol. 15, no 6, p. 966-73Article in journal (Other scientific)
  • 107.
    Oberg, K
    et al.
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Onkologisk endokrinologi.
    Skogseid, B
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Endokrin tumörbiologi.
    The ultimate biochemical diagnosis of endocrine pancreatic tumours in MEN-1.1998In: J Intern Med, ISSN 0954-6820, Vol. 243, no 6, p. 471-6Article, review/survey (Other (popular scientific, debate etc.))
  • 108.
    Oberg, Kjell
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Onkologisk endokrinologi.
    Carcinoid tumors: molecular genetics, tumor biology, and update of diagnosis and treatment.2002In: Curr Opin Oncol, ISSN 1040-8746, Vol. 14, no 1, p. 38-45Article in journal (Refereed)
  • 109.
    Oberg, Kjell
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Onkologisk endokrinologi.
    Future aspects of somatostatin-receptor-mediated therapy.2004In: Neuroendocrinology, ISSN 0028-3835, Vol. 80 Suppl 1, p. 57-61Article in journal (Refereed)
  • 110.
    Oberg, Kjell
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Onkologisk endokrinologi.
    Major Coverage of the advances in an expanding field2006In: Expert Review of Endocrinology & Metabolism, ISSN 1744-6651, Vol. 1, no 1, p. 1-2Article in journal (Refereed)
  • 111.
    Oberg, Kjell
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Onkologisk endokrinologi.
    Molecular imaging in diagnosis of neuroendocrine tumours.2006In: Lancet Oncol, ISSN 1470-2045, Vol. 7, no 10, p. 790-2Article in journal (Refereed)
  • 112.
    Oberg, Kjell
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Onkologisk endokrinologi.
    Neuroendocrine GEP Tumors-Recent update on diagnosis and treatment2005Other (Other (popular scientific, debate etc.))
  • 113.
    Oberg, Kjell
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Onkologisk endokrinologi.
    Neuroendocrine tumors of the gastrointestinal tract: recent advances in molecular genetics, diagnosis, and treatment.2005In: Curr Opin Oncol, ISSN 1040-8746, Vol. 17, no 4, p. 386-91Article in journal (Refereed)
  • 114.
    Oberg, Kjell
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Onkologisk endokrinologi.
    Somatostatin-receptor mediated diagnosis and treatment in gastrointestinal neuroendocrine tumours (GEP-NET's).2005In: Rocz Akad Med Bialymst, Vol. 50, p. 62-8Article in journal (Refereed)
  • 115.
    Oberg, Kjell
    et al.
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Endokrin onkologi.
    Astrup, Lone
    Eriksson, Barbro
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Endokrin onkologi.
    Falkmer, Sture E
    Falkmer, Ursula G
    Gustafsen, Jens
    Haglund, Caj
    Knigge, Ulrich
    Vatn, Morten H
    Välimäki, Matti
    Guidelines for the management of gastroenteropancreatic neuroendocrine tumours (including bronchopulmonary and thymic neoplasms). Part II-specific NE tumour types.2004In: Acta Oncol, ISSN 0284-186X, Vol. 43, no 7, p. 626-36Article in journal (Refereed)
  • 116.
    Oberg, Kjell
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology.
    Leyden, J.
    Unicorn Fdn, Mosman, Australia..
    Sissons, M.
    NET Patient Fdn, Hockley Heath, W Midlands, England..
    Kolarova, T.
    APOZ & Friends, Sofia, Bulgaria..
    Goldstein, G.
    Carcinoid Canc Fdn, White Plains, NY USA..
    Multidisciplinary Team (MDT) in Neuroendocrine Tumor (NET) Management: Results from the First Global NET Patient (pt) Survey - A Collaboration between the International Neuroendocrine Cancer Alliance (INCA) and Novartis Pharmaceuticals2015In: Neuroendocrinology, ISSN 0028-3835, E-ISSN 1423-0194, Vol. 102, no 1-2, p. 159-160Article in journal (Other academic)
  • 117.
    Oberg, Kjell
    et al.
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Tiensuu Janson, E
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Eriksson,
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Tumour markers in neuroendocrine tumours1999In: Ital J Gastroenterol Hepatol, Vol. 31, p. 160-Article in journal (Refereed)
  • 118. Pape, U. -F
    et al.
    Niederle, B.
    Med Univ Vienna, Dept Surg, Vienna, Austria..
    Costa, F.
    Hosp Sirio Libanes, Ctr Oncol, Sao Paulo, Brazil..
    Gross, D.
    Hadassah Univ Hosp, Dept Endocrinol & Metab, Mevasseret Tsion, Israel..
    Kelestimur, F.
    Erciyes Univ, Sch Med, Dept Endocrinol, Kayseri, Turkey..
    Kianmanesh, R.
    CHU Robert Debre, Dept Surg, Reims, France..
    Knigge, U.
    Copenhagen Univ Hosp, Rigshosp, Neuroendocrine Tumor Ctr Excellence, Copenhagen, Denmark..
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology.
    Pavel, M.
    Charite, Dept Gastroenterol & Hepatol, Campus Virchow Klinikum, D-13353 Berlin, Germany..
    Perren, A.
    Univ Bern, Inst Pathol, Bern, Switzerland..
    Toumpanakis, C.
    Royal Free Hosp, Neuroendocrine Tumour Unit, Pond St, London NW3 2QG, England..
    O'Connor, J.
    Inst Alexander Fleming, Dept Clin Oncol, Buenos Aires, DF, Argentina..
    Krenning, E.
    Erasmus MC, Div Nucl Med, Dept Internal Med, Rotterdam, Netherlands..
    Reed, N.
    Gartnavel Royal Hosp, Beatson Oncol Ctr, Glasgow, Lanark, Scotland..
    O'Toole, D.
    St Vincents Univ, Natl NET Ctr, Dublin, Ireland.;St James Hosp, Dublin 8, Ireland.;Univ Dublin Trinity Coll, Dublin 2, Ireland..
    ENETS Consensus Guidelines for Neuroendocrine Neoplasms of the Appendix (Excluding Goblet Cell Carcinomas)2016In: Neuroendocrinology, ISSN 0028-3835, E-ISSN 1423-0194, Vol. 103, no 2, p. 144-152Article in journal (Refereed)
  • 119.
    Pavel, M. E.
    et al.
    Charite, Dept Hepatol & Gastroenterol, Campus Virchow Klinikum, D-13353 Berlin, Germany..
    Baudin, E.
    Inst Gustave Roussy, Dept Nucl Med & Endocrine Oncol, Villejuif, France..
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Tumor Biology.
    Hainsworth, J. D.
    Sarah Cannon Res Inst, Nashville, TN USA..
    Voi, M.
    Novartis Pharmaceut, E Hanover, NJ USA..
    Rouyrre, N.
    Novartis Int AG, Basel, Switzerland..
    Peeters, M.
    Antwerp Univ Hosp, Dept Oncol, Edegem, Belgium..
    Gross, D. J.
    Hadassah Hebrew Univ, Med Ctr, Neuroendocrine Tumor Unit, Jerusalem, Israel..
    Yao, J. C.
    Univ Texas MD Anderson Canc Ctr, Dept Gastrointestinal Med Oncol, Div Canc Med, Houston, TX 77030 USA..
    Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study2017In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 28, no 7, p. 1569-1575Article in journal (Refereed)
    Abstract [en]

    Background: In the phase 3 RADIANT-2 study, everolimus plus octreotide long-acting repeatable (LAR) showed improvement of 5.1 months in median progression-free survival versus placebo plus octreotide LAR among patients with advanced neuroendocrine tumors associated with carcinoid syndrome. The progression-free survival P-value was marginally above the pre-specified threshold for statistical significance. Here, we report final overall survival (OS) and key safety update from RADIANT-2.

    Patients and methods: The RADIANT-2 trial compared everolimus (10 mg/day, orally; n = 216) versus placebo (n = 213), both in conjunction with octreotide LAR (30 mg, intramuscularly, every 28 days). Patients, unblinded at the time of progression or after end of double-blind core phase following primary analysis, were offered open-label everolimus with octreotide LAR (open-label phase). In the open-label phase, patients had similar safety and efficacy assessments as those in the core phase. For OS, hazard ratios (HRs) with 95% CIs using unadjusted Cox model and a Cox model adjusted for prespecified baseline covariates were calculated.

    Results: A total of 170 patients received open-label everolimus (143 crossed over from the placebo arm; 27 in the everolimus arm continued to receive the same treatment after unblinding). The median OS (95% CI) after 271 events was 29.2 months (23.8-35.9) for the everolimus arm and 35.2 months (30.0-44.7) for the placebo arm (HR, 1.17; 95% CI, 0.92-1.49). HR adjusted for baseline covariates was 1.08 (95% CI, 0.84-1.38). The most frequent drug-related grade 3 or 4 AEs reported during the open-label phase were diarrhea (5.3%), fatigue (4.7%), and stomatitis (4.1%). Deaths related to pulmonary or cardiac failure were observed more frequently in the everolimus arm.

    Conclusion: No significant difference in OS was observed for the everolimus plus octreotide LAR and placebo plus octreotide LAR arms of the RADIANT-2 study, even after adjusting for imbalances in the baseline covariates. Clinical Trial Number: NCT00412061, www.clinicaltrials.gov

  • 120.
    Pavel, M. E.
    et al.
    Univ Klinikum Erlangen, Erlangen, Germany..
    Gable, J.
    Clin Outcomes Solut, Tucson, AZ USA..
    Kulke, M. H.
    Dana Farber Canc Inst, Boston, MA 02115 USA..
    Bergsland, E.
    UCSF Helen Diller Family Comprehens Canc Ctr, San Francisco, CA USA..
    Anthony, L. B.
    Univ Kentucky, Lexington, KY 40506 USA..
    Caplin, M. E.
    Royal Free Hosp, London, England..
    Öberg, Kjell E.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Tumor Biology.
    Banks, P.
    Lexicon Pharmaceut Inc, The Woodlands, TX USA..
    Yang, Q. M.
    Lexicon Pharmaceut Inc, The Woodlands, TX USA..
    Lapuerta, P.
    Lexicon Pharmaceut Inc, The Woodlands, TX USA..
    Hudgens, S.
    Clin Outcomes Solut, Tucson, AZ USA..
    Evaluation of meaningful change in bowel move frequency for patients with carcinoid syndrome2017In: ONCOLOGY RESEARCH AND TREATMENT, ISSN 2296-5270, Vol. 40, p. 238-238Article in journal (Other academic)
  • 121.
    Pavel, M.
    et al.
    Charite, Berlin, Germany..
    Hoersch, D.
    Zent Klin Bad Berka, Bad Berka, Germany..
    Anthony, L.
    Univ Kentucky, Lexington, KY 40506 USA..
    Ervin, C.
    RTI Hlth Solut, Res Triangle Pk, NC USA..
    Kulke, M.
    Dana Farber Canc Inst, Boston, MA 02115 USA..
    Bergsland, E.
    UCSF Helen Diller Family Comprehens Canc Ctr, San Francisco, CA USA..
    Caplin, M.
    Royal Free Hosp, London, England..
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Tumor Biology.
    Warner, R.
    Icahn Sch Med Mt Sinai, New York, NY 10029 USA..
    Kunz, P.
    Stanford Univ, Palo Alto, CA 94304 USA..
    Metz, D.
    Univ Penn, Perelman Sch Med, Philadelphia, PA 19104 USA..
    Pasieka, J.
    Tom Baker Canc Ctr Calgary, Calgary, AB, Canada..
    Pavlakis, N.
    Royal North Shore Hosp, St Leonards, NSW, Australia..
    DiBenedetti, D.
    RTI Hlth Solut, Res Triangle Pk, NC USA..
    Lapuerta, P.
    Lexicon Pharmaceut Inc, The Woodlands, TX USA..
    Patient Interviews in TELESTAR, a Phase 3 Study of Telotristat Etiprate, Report Meaningful Improvement in Carcinoid Syndrome2016In: Neuroendocrinology, ISSN 0028-3835, E-ISSN 1423-0194, Vol. 103, p. 89-89Article in journal (Refereed)
  • 122.
    Pavel, M.
    et al.
    Charite, Campus Virchow Klinikum, Dept Gastroenterol & Hepatol, Augustenburger Pl 1, DE-13353 Berlin, Germany..
    O'Toole, D.
    St Vincents Univ, NET Ctr, Dublin, Ireland.;St James Hosp, Dept Clin Med, Dublin 8, Ireland.;Univ Dublin Trinity Coll, Dublin 2, Ireland..
    Costa, F.
    Oncoclin Med Associados SS Ltda, Sao Paulo, Brazil..
    Capdevila, J.
    Vall dHebron Univ Hosp, Inst Oncol, Barcelona, Spain..
    Gross, D.
    Hadassah Univ Hosp, Dept Endocrinol & Metab, Mevasseret Tsion, Israel..
    Kianmanesh, R.
    CHU Robert Debre, Dept Surg, Reims, France..
    Krenning, E.
    Erasmus MC, Dept Internal Med, Rotterdam, Netherlands..
    Knigge, U.
    Copenhagen Univ Hosp, Rigshosp, Neuroendocrine Tumor Ctr Excellence, Copenhagen, Denmark..
    Salazar, R.
    Pape, U. -F
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology. Inst Catala Oncol, Barcelona, Spain.;Univ Uppsala Hosp, Dept Med Sci, Endocrine Oncol Unit, Uppsala, Sweden..
    ENETS Consensus Guidelines Update for the Management of Distant Metastatic Disease of Intestinal, Pancreatic, Bronchial Neuroendocrine Neoplasms (NEN) and NEN of Unknown Primary Site2016In: Neuroendocrinology, ISSN 0028-3835, E-ISSN 1423-0194, Vol. 103, no 2, p. 172-185Article in journal (Refereed)
    Abstract [en]

    The goal of this paper is to update a more extensive review and guidelines paper published in 2012 [1] . Gen-erally, any pertinent update pertaining to the diagnosis and staging of individual primary tumors is provided in the relevant papers published elsewhere in this issue of updated guideline reviews. More specific issues with re-spect to therapy of stage IV neuroendocrine neoplasms (NEN) (focusing on grade1/2 tumors) are given below. A separate guideline is provided for poorly differentiated neoplasms (grade 3 NEN). As some new large phase III trials have been published since the previous guidelines, this has indeed led to specific modifications in our ap-proach to therapy.

  • 123. Pavel, M.
    et al.
    Wiedenmann, B.
    Capdevila, J.
    Valle, J. W.
    De Herder, W. W.
    Metzer, C.
    Salazar, R.
    Horsch, D.
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology.
    Ramsete: a single-arm, multicenter, single-stage phase ii trial of rad001 (everolimus) in advanced and metastatic silent neuro-endocrine tumours in europe: analysis by tumor origin2012In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 23, no S9, p. 377-377Article in journal (Other academic)
  • 124. Pavel, M.
    et al.
    Öberg, Kjell E.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology.
    Hainsworth, J. D.
    Lam, D.
    Stergiopolos, S. G.
    Rouyrre, N.
    Peeters, M.
    Baudin, E.
    Gross, D.
    Yao, J. C.
    Everolimus plus octreotide long-acting release (LAR) for the treatment of advanced neuroendocrine tumors (NET) associated with carcinoid syndrome (RADIANT-2): Updated overall survival results2013In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 49, no Suppl. 2, p. S577-S577Article in journal (Other academic)
  • 125. Pavel, Marianne
    et al.
    Baudin, Eric
    Couvelard, Anne
    Krenning, Eric
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Internal Medicine.
    Steinmüller, Thomas
    Anlauf, Martin
    Wiedenmann, Bertram
    Salazar, Ramon
    ENETS Consensus Guidelines for the Management of Patients with Liver and Other Distant Metastases from Neuroendocrine Neoplasms of Foregut, Midgut, Hindgut, and Unknown Primary2012In: Neuroendocrinology, ISSN 0028-3835, E-ISSN 1423-0194, Vol. 95, no 2, p. 157-176Article in journal (Refereed)
  • 126. Pavel, Marianne E
    et al.
    Hainsworth, John D
    Baudin, Eric
    Peeters, Marc
    Hörsch, Dieter
    Winkler, Robert E
    Klimovsky, Judith
    Lebwohl, David
    Jehl, Valentine
    Wolin, Edward M
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Internal Medicine.
    van Cutsem, Eric
    Yao, James C
    Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study2011In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 378, no 9808, p. 2005-2012Article in journal (Refereed)
    Abstract [en]

    Background

    Everolimus, an oral inhibitor of the mammalian target of rapamycin (mTOR), has shown antitumour activity in patients with advanced pancreatic neuroendocrine tumours. We aimed to assess the combination of everolimus plus octreotide long-acting repeatable (LAR) in patients with low-grade or intermediate-grade neuroendocrine tumours (carcinoid).

    Methods

    We did a randomised, double-blind, placebo-controlled, phase 3 study comparing 10 mg per day oral everolimus with placebo, both in conjunction with 30 mg intramuscular octreotide LAR every 28 days. Randomisation was by interactive voice response systems. Participants were aged 18 years or older, with low-grade or intermediate-grade advanced (unresectable locally advanced or distant metastatic) neuroendocrine tumours, and disease progression established by radiological assessment within the past 12 months. Our primary endpoint was progression-free survival. Adjusted for two interim analyses, the prespecified boundary at final analysis was p <= 0.0246. This study is registered at ClinicalTrials.gov, number NCT00412061.

    Findings

    429 individuals were randomly assigned to study groups; 357 participants discontinued study treatment and one was lost to follow-up. Median progression-free survival by central review was 16.4 (95% CI 13.7-21.2) months in the everolimus plus octreotide LAR group and 11.3 (8.4-14.6) months in the placebo plus octreotide LAR group (hazard ratio 0.77, 95% CI 0.59-1.00; one-sided log-rank test p=0.026). Drug-related adverse events (everolimus plus octreotide LAR vs placebo plus octreotide LAR) were mostly grade 1 or 2, and adverse events of all grades included stomatitis (62% vs 14%), rash (37% vs 12%), fatigue (31% vs 23%), and diarrhoea (27% vs 16%).

    Interpretation

    Everolimus plus octreotide LAR, compared with placebo plus octreotide LAR, improved progression-free survival in patients with advanced neuroendocrine tumours associated with carcinoid syndrome.

  • 127.
    Pavel, Marianne
    et al.
    Charite Univ Med Berlin, CVK, Med Klin Schwerpunkt, Berlin, Germany..
    Gross, David
    Hadassah Hebrew Univ, Med Ctr, Jerusalem, Israel..
    Benavent, Marta
    Hosp Univ Virgen Rocio, Seville, Spain..
    Caplin, Martyn
    Royal Free Hosp, Hampstead, England..
    Perros, Petros
    Royal Victoria Infirm, Newcastle Upon Tyne, Tyne & Wear, England..
    Srirajaskanthan, Raj
    Kings Coll Hosp London, London, England..
    Valle, Juan
    Christie NHS Fdn Trust, Manchester, Lancs, England..
    Warner, Richard
    Mt Sinai Sch Med, New York, NY USA..
    Kulke, Matthew
    Dana Farber Canc Inst, Boston, MA USA..
    Anthony, Lowell
    Univ Kentucky, Lexington, KY 40506 USA..
    Kunz, Pamela
    Stanford Univ, Stanford, CA 94305 USA..
    Hoersch, Dieter
    Klin Innere Med, Bad Berka, Germany..
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Tumor Biology.
    Lapuerta, Pablo
    Lexicon Pharmaceut Inc, The Woodlands, TX USA..
    Jackson, Shanna
    Lexicon Pharmaceut Inc, The Woodlands, TX USA..
    Banks, Phillip
    Lexicon Pharmaceut Inc, The Woodlands, TX USA..
    Biran, Talia
    Lexicon Pharmaceut Inc, The Woodlands, TX USA..
    Garcia-Carbonero, Rocio
    Hosp Univ Doce Octubre, Madrid, Spain..
    Efficacy and Safety Results of Telotristat Ethyl in Patients With Carcinoid Syndrome During the Double-blind Treatment Period of the TELECAST Phase 3 Clinical Trial2017In: Pancreas, ISSN 0885-3177, E-ISSN 1536-4828, Vol. 46, no 3, p. 434-435Article in journal (Other academic)
  • 128. Ricke, J
    et al.
    Klose, K J
    Mignon, M
    Oberg, K
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Wiedenmann, B
    Standardisation of imaging in neuroendocrine tumours: results of a European delphi process.2001In: Eur J Radiol, ISSN 0720-048X, Vol. 37, no 1, p. 8-17Article in journal (Refereed)
  • 129.
    Saras, Jan
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology.
    Grönberg, Malin
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology.
    Stridsberg, Mats
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Biochemical endocrinology.
    Öberg, Kjell E.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology.
    Janson, Eva Tiensuu
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Oncology.
    Somatostatin induces rapid contraction of neuroendocrine cells2007In: FEBS Letters, ISSN 0014-5793, E-ISSN 1873-3468, Vol. 581, no 10, p. 1957-1962Article in journal (Refereed)
    Abstract [en]

    The peptide hormone somatostatin, as well as the somatostatin analog octreotide, induces rapid morphological changes in neuroendocrine cells. The effect can be detected in less than 2min: retraction fibers are formed, cells round up and cell–cell contacts are broken. Somatostatin-dependent cell contraction is inhibited by Y-27632, indicating that this effect is dependent on Rho kinase. In BON1 cells, the somatostatin-induced inhibition of forskolin-induced secretion of chromogranin A is not blocked by Y-27632. It is therefore concluded that the inhibitory effect of somatostatin in forskolin-stimulated cells is not dependent on cell contraction.

  • 130.
    Shi, Hao
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine oncology.
    Li, Su-Chen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine oncology.
    Khan, Mohid
    Royal Free Hosp, London NW3 2QG, England.
    Caplin, Martyn
    Royal Free Hosp, London NW3 2QG, England.
    Meyer, Tim
    UCL, Inst Canc, London, England.
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine oncology.
    Giandomenico, Valeria
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine oncology.
    Functional role of miR-196a in neuroendocrine tumor cells2015In: Neuroendocrinology, ISSN 0028-3835, E-ISSN 1423-0194, Vol. 102, no 1-2, p. 87-87Article in journal (Refereed)
  • 131.
    Skogseid, B
    et al.
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Endokrin tumörbiologi.
    Rastad, J
    Department of Surgical Sciences.
    Oberg, K
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Onkologisk endokrinologi.
    Multiple endocrine neoplasia type 1. Clinical features and screening.1994In: Endocrinol Metab Clin North Am, ISSN 0889-8529, Vol. 23, no 1, p. 1-18Article in journal (Refereed)
  • 132.
    Skogseid, Britt
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Åkerström, Göran
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences.
    Eriksson, Barbro
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Westlin, Jan-Erik
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Oncology, Radiology and Clinical Immunology.
    Tiensuu Janson, Eva
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Eklöf, Hampus
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Oncology, Radiology and Clinical Immunology.
    Elvin, Anders
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Oncology, Radiology and Clinical Immunology.
    Juhlin, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences.
    Rastad, Jonas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences.
    Limited tumor involvement found at multiple endocrine neoplasia type I pancreatic exploration: can it be predicted by preoperative tumor localization?1998In: World Journal of Surgery, ISSN 0364-2313, E-ISSN 1432-2323, Vol. 22, no 7, p. 673-677; discussion 667-668Article in journal (Refereed)
    Abstract [en]

    Radiologically demonstrable pancreatic endocrine tumors are a frequent requirement for exploration in patients with multiple endocrine neoplasia type I (MEN-I). Such delayed intervention is accompanied by a 30% to 50% incidence of pancreatic endocrine metastases. This study explores biochemical tumor markers and operative findings in relation to preoperative pancreatic radiology in 25 MEN-I patients. They underwent pancreatic surgery with (n = 19) or without (n = 6) radiologic signs of primary tumor and absence of metastases upon conventional examination, including OctreoScan testing (n = 10). Biochemical diagnosis required an increasing elevation of at least two independent pancreatic tumor markers. Tumor diameters averaged 1.1 cm (0-5 cm) and 0.9 cm (0.2-1.5 cm) in the patients with and without positive preoperative radiology, respectively. These investigations never displayed more than one of the consistently multiple tumors, and the results were falsely positive in 26%. Preoperatively unidentified regional or hepatic metastases were found at surgical exploration in 26% of patients with radiologic localization and in none of the others. Limited pancreatic tumor involvement necessitated intraoperative absence of metastases and pancreatic lesions </= 1 cm in diameter on palpation, intraoperative ultrasonography, and microscopy. It occurred in 37% and 50% of the patients with and without radiologic tumor localization, respectively. The number of positive tumor markers was similar for patients with limited and major disease (2.3 vs. 2.7), whereas four or more such markers were found in all those with malignancies. The mean marker level was higher in patients with radiologically demonstrable tumors and lower in those with limited disease, but with a substantial overlap. OctreoScan testing was negative in all cases with limited disease and was the single most sensitive method (75%) in the others. Limited pancreatic disease could not be identified preoperatively, and the present means of biochemical pancreatic tumor identification invariably involved the presence of at least one lesion >/= 7 mm in diameter. Conventional pancreatic imaging is insensitive and nonspecific for recognizing even substantial pancreatic tumors associated with MEN-I.

  • 133.
    Stridsberg, M
    et al.
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Berne, C
    Sandler, S
    Wilander, E
    Oberg, K
    Inhibition of insulin secretion, but normal peripheral insulin sensitivity, in a patient with a malignant endocrine pancreatic tumour producing high amounts of an islet amyloid polypeptide-like molecule.1993In: Diabetologia, ISSN 0012-186X, Vol. 36, no 9, p. 843-9Article in journal (Other scientific)
  • 134.
    Stridsberg, M
    et al.
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Hellman, U
    Wilander, E
    Lundqvist, G
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Hellsing, K
    Oberg, K
    Fragments of chromogranin A are present in the urine of patients with carcinoid: development of a specific radioimmunoassay for chromogranin A and its fragments.1993In: J Endocrinol, ISSN 0022-0795, Vol. 139, no 2, p. 329-37Article in journal (Other scientific)
  • 135.
    Stridsberg, M
    et al.
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Wilander, E
    Öberg, K
    Lundqvist, G
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Eriksson, B
    Islet amyloid polypeptide-producing pancreatic islet cell tumour: A clinical and biochemical characterization1992In: Scand. J. Gastroenterol, Vol. 27, p. 155-159Article in journal (Refereed)
  • 136.
    Stridsberg, Mats
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Chemistry. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Biochemical endocrinology.
    Eriksson, Barbro
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Internal Medicine.
    Lundqvist, Gudmar
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Chemistry.
    Skogseid, Britt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Internal Medicine.
    Wilander, Erik
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Genetics and Pathology, Molecular and Morphological Pathology.
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Internal Medicine. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Ludwig Institute for Cancer Research.
    Islet amyloid polypeptide (IAPP) in patients with neuroendocrine tumours1995In: Regulatory Peptides, ISSN 0167-0115, E-ISSN 1873-1686, Vol. 55, no 2, p. 119-131Article in journal (Refereed)
    Abstract [en]

    Although IAPP was first discovered and isolated from amyloid deposits in an endocrine pancreatic tumour (EPT), surprisingly few reports have investigated the potential use of IAPP as a marker for neuroendocrine tumour growth. In this study we present results from plasma measurements of IAPP in 102 patients with neuroendocrine tumours. Four of 35 patients (11%) with midgut carcinoid tumours, but none of the patients (4 and 5, respectively) with lung carcinoids or with rectal carcinoids displayed elevated plasma levels of IAPP. Five of 31 patients (16%) with sporadic EPT and 3 of 27 patients (11%) with EPT and multiple endocrine neoplasia type 1 syndrome disclosed elevated IAPP levels. Within the different syndromes, 1/11 individuals with insulinoma, 2/16 with gastrinoma, 0/2 with glucagonoma, 0/3 with VIPoma and 5/26 with non-functioning tumours showed elevated plasma levels of IAPP. In two patients, the plasma IAPP levels were extremely elevated. These patients also exhibited altered glucose homeostasis. In response to a standardised mixed meal test, IAPP increased in parallel to the insulin, pancreatic polypeptide, gastrin and glucose responses. In MEN1 patients with hypercalcaemia due to increased secretion of parathyroid hormone, the plasma levels of IAPP were significantly higher before than after surgical removal of the parathyroid adenomas. However in normocalcaemic patients, no correlation between the blood calcium and plasma IAPP levels was found. Immunocytochemical staining of tumour tissue showed that 9/13 (69%) of insulin producing tumours, 4/14 (29%) of non-functioning tumours and 1/9 (11%) of gastrin producing tumours were IAPP immunoreactive. Amyloid deposits were always IAPP immunoreactive. In conclusion, increased circulating levels of IAPP occurred in 12% of 102 patients with neuroendocrine tumours. In 2 patients with extremely elevated plasma levels of IAPP, effects on glucose homeostasis were recorded. Thus, IAPP may be useful as an additional marker for neuroendocrine tumour growth in selected cases.

  • 137.
    Stridsberg, Mats
    et al.
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences.
    Eriksson, Barbro
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Dept of Endocrine Oncology.
    Oberg, Kjell
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Dept of Endocrine Oncology.
    Tiensuu Janson, Eva
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Dept of Endocrine Oncology.
    A panel of 11 region-specific radioimmunoassays for measurements of human chromogranin A.2004In: Regul Pept, ISSN 0167-0115, Vol. 117, no 3, p. 219-27Article in journal (Refereed)
  • 138.
    Stridsberg, Mats
    et al.
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. clincal chemistry.
    Eriksson, Barbro
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Endocrine Oncology.
    Oberg, Kjell
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Endocrine Oncology.
    Tiensuu Janson, Eva
    Uppsala University, Medicinska vetenskapsområdet, Faculty of Medicine, Department of Medical Sciences. Endocrine Oncology.
    A panel of 13 region-specific radioimmunoassays for measurements of human chromogranin B.2005In: Regul Pept, ISSN 0167-0115, Vol. 125, no 1-3, p. 193-9Article in journal (Refereed)
  • 139.
    Strosberg, J.
    et al.
    H Lee Moffitt Canc Ctr & Res Inst, 12902 Magnolia Dr, Tampa, FL 33612 USA..
    El-Haddad, G.
    H Lee Moffitt Canc Ctr & Res Inst, 12902 Magnolia Dr, Tampa, FL 33612 USA..
    Wolin, E.
    Univ Kentucky, Markey Canc Ctr, Lexington, KY USA..
    Hendifar, A.
    Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA..
    Yao, J.
    Univ Texas Hlth Sci Ctr Houston, Houston, TX 77030 USA..
    Chasen, B.
    Univ Texas Hlth Sci Ctr Houston, Houston, TX 77030 USA..
    Mittra, E.
    Stanford Univ, Sch Med, Stanford, CA 94305 USA..
    Kunz, P. L.
    Stanford Univ, Sch Med, Stanford, CA 94305 USA..
    Kulke, M. H.
    Dana Farber Canc Inst, Boston, MA 02115 USA..
    Jacene, H.
    Dana Farber Canc Inst, Boston, MA 02115 USA..
    Bushnell, D.
    Univ Iowa, Iowa City, IA USA..
    O'Dorisio, T. M.
    Univ Iowa, Iowa City, IA USA..
    Baum, R. P.
    Zentralklin, Bad Berka, Germany..
    Kulkarni, H. R.
    Zentralklin, Bad Berka, Germany..
    Caplin, M.
    Royal Free Hosp, London, England..
    Lebtahi, R.
    Hop Beaujon, Clichy, France..
    Hobday, T.
    Mayo Clin Coll Med, Rochester, MN USA..
    Delpassand, E.
    Excel Diagnost Imaging Clin, Houston, TX USA..
    Van Cutsem, E.
    Univ Hosp, Leuven, Belgium.;Katholieke Univ Leuven, Leuven, Belgium..
    Benson, A.
    Robert H Lurie Comprehens Canc Ctr, Chicago, IL USA..
    Srirajaskanthan, R.
    Kings Coll Hosp NHS FDN Trust, London, England..
    Pavel, M.
    Charite, Berlin, Germany..
    Mora, J.
    Hosp Univ Bellvitge, Barcelona, Spain..
    Berlin, J.
    Vanderbilt Univ, Med Ctr, Nashville, TN USA..
    Grande, E.
    Hosp Univ Ramon & Cajal, Madrid, Spain..
    Reed, N.
    Beatson Oncol Ctr, Glasgow, Lanark, Scotland..
    Seregni, E.
    Ist Nazl Tumori, Fdn Ist Ricovero & Cura Carattere Sci, Milan, Italy..
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Tumor Biology.
    Sierra, M. Lopera
    Adv Accelerator Applicat USA, New York, NY USA..
    Santoro, P.
    Adv Accelerator Applicat USA, New York, NY USA..
    Thevenet, T.
    Adv Accelerator Applicat, St Genis Pouilly, France..
    Erion, J. L.
    Adv Accelerator Applicat USA, New York, NY USA..
    Ruszniewski, P.
    Hop Beaujon, Clichy, France..
    Kwekkeboom, D.
    Erasmus MC, Rotterdam, Netherlands..
    Krenning, E.
    Erasmus MC, Rotterdam, Netherlands..
    Phase 3 Trial of Lu-177-Dotatate for Midgut Neuroendocrine Tumors2017In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 376, no 2, p. 125-135Article in journal (Refereed)
    Abstract [en]

    BACKGROUND Patients with advanced midgut neuroendocrine tumors who have had disease progression during first-line somatostatin analogue therapy have limited therapeutic options. This randomized, controlled trial evaluated the efficacy and safety of lutetium-177 (Lu-177)-Dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors. METHODS We randomly assigned 229 patients who had well-differentiated, metastatic midgut neuroendocrine tumors to receive either Lu-177-Dotatate (116 patients) at a dose of 7.4 GBq every 8 weeks (four intravenous infusions, plus best supportive care including octreotide long-acting repeatable [LAR] administered intramuscularly at a dose of 30 mg) (Lu-177-Dotatate group) or octreotide LAR alone (113 patients) administered intramuscularly at a dose of 60 mg every 4 weeks (control group). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, safety, and the side-effect profile. The final analysis of overall survival will be conducted in the future as specified in the protocol; a prespecified interim analysis of overall survival was conducted and is reported here. RESULTS At the data-cutoff date for the primary analysis, the estimated rate of progression-free survival at month 20 was 65.2% (95% confidence interval [CI], 50.0 to 76.8) in the Lu-177-Dotatate group and 10.8% (95% CI, 3.5 to 23.0) in the control group. The response rate was 18% in the Lu-177-Dotatate group versus 3% in the control group (P<0.001). In the planned interim analysis of overall survival, 14 deaths occurred in the Lu-177-Dotatate group and 26 in the control group (P = 0.004). Grade 3 or 4 neutropenia, thrombocytopenia, and lymphopenia occurred in 1%, 2%, and 9%, respectively, of patients in the Lu-177-Dotatate group as compared with no patients in the control group, with no evidence of renal toxic effects during the observed time frame. CONCLUSIONS Treatment with Lu-177-Dotatate resulted in markedly longer progression-free survival and a significantly higher response rate than high-dose octreotide LAR among patients with advanced midgut neuroendocrine tumors. Preliminary evidence of an overall survival benefit was seen in an interim analysis; confirmation will be required in the planned final analysis. Clinically significant myelosuppression occurred in less than 10% of patients in the Lu-177-Dotatate group. (Funded by Advanced Accelerator Applications; NETTER-1 ClinicalTrials. gov number, NCT01578239; EudraCT number 2011-005049-11.)

  • 140. Strosberg, J. R.
    et al.
    Yao, J. C.
    Bajetta, E.
    Aout, M.
    Bakker, B.
    Hainsworth, J. D.
    Ruszniewski, P.
    Cutsem, E. V.
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Pavel, M.
    Efficacy of Octreotide LAR (OCT) in Patients (pts) with Advanced Neuroendocrine Tumors (NET): A Subgroup Analysis of Phase III RADIANT-2 Study with Updated Overall Survival (OS)2014In: Neuroendocrinology, ISSN 0028-3835, E-ISSN 1423-0194, Vol. 99, no 3-4, p. 274-274Article in journal (Other academic)
  • 141.
    Strosberg, J.
    et al.
    H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA..
    Wolin, E.
    Markey Canc Ctr, Lexington, KY USA..
    Chasen, B.
    Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA..
    Kulke, M.
    Dana Farber Canc Inst, Boston, MA 02115 USA..
    Bushnell, D.
    Univ Iowa, Med Ctr, Iowa City, IA USA..
    Caplin, M.
    Royal Free Hosp, London, England..
    Baum, R.
    Zent Klin, Bad Berka, Germany..
    Kunz, P.
    Stanford Univ, Med Ctr, Stanford, CA 94305 USA..
    Hobday, T.
    Mayo Clin, Coll Med, Rochester, MI USA..
    Hendifar, A.
    Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA..
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Tumor Biology.
    Sierra, Lopera M.
    Adv Accelerator Applicat, New York, NY USA..
    Kwekkeboom, D.
    Erasmus MC, Rotterdam, Netherlands..
    Ruszniewski, P.
    Hop Beaujon, Clichy, France..
    Krenning, E.
    Erasmus MC, Rotterdam, Netherlands..
    NETTER-1 Phase III in Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-DOTATATE: Efficacy and Safety Results2016In: Neuroendocrinology, ISSN 0028-3835, E-ISSN 1423-0194, Vol. 103, p. 95-95Article in journal (Refereed)
  • 142.
    Strosberg, J.
    et al.
    Univ S Florida, H Lee Moffitt Canc Ctr, Oncol, Tampa, FL USA..
    Wolin, E.
    Univ Kentucky, Oncol, Lexington, KY USA..
    Chasen, B.
    Univ Texas Hlth Sci Ctr Houston, Nucl Med, Houston, TX 77030 USA..
    Kulke, M.
    Dana Farber Canc Inst, Med Oncol, Boston, MA 02115 USA..
    Bushnell, D.
    Univ Iowa, Div Nucl Med, Iowa City, IA USA..
    Caplin, M.
    Royal Free Hosp, Sch Med, Neuroendocrine Tumour Unit, Gastroenterol, London, England..
    Baum, R.
    Zent Klin Bad Berka GmbH, Nucl Med, Bad Berka, Germany..
    Kunz, P. L.
    Stanford Univ, Med Ctr, Oncol, Stanford, CA 94305 USA..
    Hobday, T.
    Mayo Clin, Oncol, Rochester, NY USA..
    Hendifar, A.
    Cedars Sinai Med Ctr, Oncol, Los Angeles, CA 90048 USA..
    Öberg, Kjell E.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Tumor Biology.
    Sierra, M. Lopera
    Adv Accelerator Applicat, New York, NY USA..
    Kwekkeboom, D.
    Erasmus Univ, Med Ctr, Nucl Med Dept, Rotterdam, Netherlands..
    Ruszniewski, P.
    Hop Beaujon, Gastroenterol, Clichy, France..
    Krenning, E.
    Erasmus Univ, Med Ctr, Oncol, Rotterdam, Netherlands..
    NETTER-1 phase III in patients with midgut neuroendocrine tumors treated with 177Lu-dotatate: Efficacy, safety, QoL results and subgroup analysis2016In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 27, no 6, article id 420PDArticle in journal (Refereed)
  • 143.
    Strosberg, J.
    et al.
    H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA.
    Wolin, E.
    Montefiore Einstein Ctr Canc Care, Bronx, NY USA.
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    Mayo Clin, Coll Med, Rochester, NY USA.
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    Hop Beaujon, Clichy, France; Paris Diderot Univ, Clichy, France.
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    Erasmus MC, Rotterdam, Netherlands.
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    Dana Farber Canc Inst, Boston, MA 02115 USA..
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    Univ Iowa, Iowa City, IA USA..
    Caplin, M.
    Royal Free Hosp, London, England..
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    Zent Klin, Bad Berska, Germany..
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    Mayo Clin, Coll Med, Rochester, MN USA..
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    Univ Hosp, Uppsala, Sweden..
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    Adv Accelerator Applicat, New York, NY USA..
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    Erasmus MC, Rotterdam, Netherlands..
    Ruszniewski, P.
    Hop Beaujon, Clichy, France..
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    NETTER-1 Phase III in Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-Dotatate: Efficacy and Safety Results2016In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 43, p. S121-S121Article in journal (Refereed)
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    Dana Farber Canc Inst, Boston, MA 02115 USA.
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    Univ Iowa, Iowa City, IA USA.
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    Royal Free Hosp, London, England.
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    Zent Klin Bad Berska, Bad Berska, Germany.
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    Stanford Univ, Med Ctr, Stanford, CA 94305 USA.
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    Mayo Clin, Coll Med, Rochester, MN USA.
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    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Tumor Biology.
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    Univ Texas MD Anderson Canc Ctr, Dept Nucl Med, Houston, TX 77030 USA..
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    Dana Farber Canc Inst, Neuroendocrine & Carcinoid Tumors, Boston, MA 02115 USA..
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    Univ Iowa, Carver Coll Med, Div Nucl Med, Iowa City, IA USA..
    Caplin, M.
    Royal Free Hosp, Gastroenterol & Gastrointestinal Neuroendocrinol, London NW3 2QG, England..
    Baum, R. P.
    Ctr Neuroendocrine Tumors, Zent Klin, Bad Berka, Germany..
    Mittra, E.
    Stanford Univ, Med Ctr, Radiol & Nucl Med, Stanford, CA 94305 USA..
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    Mayo Clin, Coll Med, Hematol & Oncol, Rochester, MN USA..
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    Cedars Sinai Med Ctr, Gastrointestinal Oncol, Los Angeles, CA 90048 USA..
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    Adv Accelerator Applicat, Clin Dev, New York, NY USA..
    Ruszniewski, P.
    Hop Beaujon, Gastroenterol & Pancreatol, Clichy, France..
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    Erasmus MC, Nucl Med, Rotterdam, Netherlands..
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    Univ Kentucky, Markey Canc Ctr, Lexington, KY USA..
    Kulke, M.
    Dana Farber Canc Inst, Boston, MA 02115 USA..
    Bushnell, D.
    Univ Iowa, Iowa City, IA USA..
    Chaplin, M.
    Royal Free Hosp, London, England..
    Baum, R.
    Zent Klin Bad Berka, Bad Berka, Germany..
    Kunz, P.
    Stanford Univ, Med Ctr, Stanford, CA 94305 USA..
    Hobday, T.
    Mayo Clin, Coll Med, Rochester, MN USA..
    Öberg, Kjell
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrine Tumor Biology.
    Sierra, M. Lopera
    Adv Accelerator Applicat, New York, NY USA..
    Kwekkeboom, D.
    Erasmus MC, Rotterdam, Netherlands..
    Ruszniewski, P.
    Hop Beaujon, Clichy, France..
    Krenning, E.
    Erasmus MC, Rotterdam, Netherlands..
    Hendifar, A.
    Cedars Sinai Med Ctr, Samuel Oschin Canc Ctr, Los Angeles, CA 90048 USA..
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    Dana Farber Canc Inst, Boston, MA 02115 USA..
    Bushnell, D.
    Univ Iowa, Iowa City, IA USA..
    Caplin, M.
    Royal Free Hosp, London, England..
    Baum, R.
    Zent Klin, Bad Berska, Bad Berska, Germany..
    Kunz, P.
    Stanford Univ, Med Ctr, Stanford, CA 94305 USA..
    Hobday, T.
    Mayo Clin, Coll Med, Rochester, NY USA..
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    Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA..
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    Erasmus MC, Rotterdam, Netherlands..
    Ruszniewski, P.
    Hop Beaujon, Clichy, France..
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    Erasmus MC, Rotterdam, Netherlands..
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    Dana Farber Canc Inst, Gastrointestinal Canc, Boston, MA 02115 USA..
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    Univ Iowa, Nucl Med, Iowa City, IA 52242 USA..
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    Royal Free Hosp, Neuroendocrine Tumour Unit, London, England..
    Baum, R. P.
    Zentralklin Bad Berka GmbH, Nucl Med, Bad Berka, Germany..
    Kunz, P.
    Stanford Univ, Med Ctr, Oncol, Stanford, CA 94305 USA..
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    Mayo Clin, Oncol, Rochester, MN USA..
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    Cedars Sinai Med Ctr, Oncol, Los Angeles, CA 90048 USA..
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    4 Boston Med Ctr, Boston, MA USA.
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    Univ Iowa, Iowa City, IA USA.
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    Royal Free Hosp, London, England.
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    Zentralklinik, Bad Berka, Bad Berka, Germany.
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