Quality of clinical trials in gastroenteropancreatic neuroendocrine tumours

Neuroendocrinology

Volumn 96, Issue 3, 2012, Pages 238-248

  Walter, Thomas ^a,c   Krzyzanowska, Monika K ^a,b  

^a PRINCESS MARGARET HOSPITAL   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c EDOUARD HERRIOT HOSPITAL   (France)

Author keywords

Clinical trials; Neuroendocrine tumours; Quality; Reporting

Indexed keywords

ANTINEOPLASTIC AGENT; KI 67 ANTIGEN;

FUNCTIONAL STATUS; HUMAN; PANCREATIC NEUROENDOCRINE TUMOR; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; REVIEW; SAMPLE SIZE; SYSTEMATIC REVIEW; TUMOR DIFFERENTIATION; TUMOR GROWTH;

CLINICAL TRIALS AS TOPIC; GASTROINTESTINAL NEOPLASMS; HUMANS; NEUROENDOCRINE TUMORS; PANCREATIC NEOPLASMS; PATIENT SELECTION; TREATMENT OUTCOME;

EID: 84870251333     PISSN: 00283835     EISSN: 14230194     Source Type: Journal    
DOI: 10.1159/000337662     Document Type: Review

References (29)

1. Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB: One hundred years after 'carcinoid': Epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol 2008; 26: 3063-3072.
2. Modlin IM, Oberg K, Chung DC, Jensen RT, de Herder WW, Thakker RV, Caplin M, Delle Fave G, Kaltsas GA, Krenning EP, Moss SF, Nilsson O, Rindi G, Salazar R, Ruszniewski P, Sundin A: Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol 2008; 9: 61-72.
3. Steinmuller T, Kianmanesh R, Falconi M, Scarpa A, Taal B, Kwekkeboom DJ, Lopes JM, Perren A, Nikou G, Yao J, Delle Fave GF, O'Toole D: Consensus guidelines for the management of patients with liver metastases from digestive (neuro)endocrine tumors: Foregut, midgut, hindgut, and unknown primary. Neuroendocrinology 2008; 87: 47-62. (Pubitemid 350308294)
4. Clark OH, Benson AB 3rd, Berlin JD, Choti MA, Doherty GM, Engstrom PF, Gibbs JF, Heslin MJ, Kessinger A, Kulke MH, Kvols L, Salem R, Saltz L, Shah MH, Shibata S, Strosberg JR, Yao JC: NCCN Clinical Practice Guidelines in Oncology: Neuroendocrine tumors. J Natl Compr Canc Netw 2009; 7: 712-747.
5. Kulke MH, Anthony LB, Bushnell DL, de Herder WW, Goldsmith SJ, Klimstra DS, Marx SJ, Pasieka JL, Pommier RF, Yao JC, Jensen RT: NANETS treatment guidelines: Well-differentiated neuroendocrine tumors of the stomach and pancreas. Pancreas 2010; 39: 735-752.
6. Boudreaux JP, Klimstra DS, Hassan MM, Woltering EA, Jensen RT, Goldsmith SJ, Nutting C, Bushnell DL, Caplin ME, Yao JC: The NANETS consensus guideline for the diagnosis and management of neuroendocrine tumors: Well-differentiated neuroendocrine tumors of the jejunum, ileum, appendix, and cecum. Pancreas 2010; 39: 753-766.
7. Anthony LB, Strosberg JR, Klimstra DS, Maples WJ, O'Dorisio TM, Warner RR, Wiseman GA, Benson AB 3rd, Pommier RF: The NANETS consensus guidelines for the diagnosis and management of gastrointestinal neuroendocrine tumors (NETs): Well-differentiated NETs of the distal colon and rectum. Pancreas 2010; 39: 767-774.
8. Strosberg JR, Coppola D, Klimstra DS, Phan AT, Kulke MH, Wiseman GA, Kvols LK: The NANETS consensus guidelines for the diagnosis and management of poorly differentiated (high-Grade) extrapulmonary neuroendocrine carcinomas. Pancreas 2010; 39: 799-800.
9. Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Oberg K: Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 2011; 364: 514-523.
10. Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Horsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P: Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med 2011; 364: 501-513.
11. Rinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R: Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: A report from the PROMID Study Group. J Clin Oncol 2009; 27: 4656-4663.
12. Pavel ME, Hainsworth JD, Baudin E, Peeters M, Horsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van-Custem E, Yao JC. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): A randomized study, placebo-controlled, phase 3 study. Lancet 2011; 378: 2005-2012.
13. Kulke MH, Siu LL, Tepper JE, Fisher G, Jaffe D, Haller DG, Ellis LM, Benedetti JK, Bergsland EK, Hobday TJ, Van Cutsem E, Pingpank J, Oberg K, Cohen SJ, Posner MC, Yao JC: Future directions in the treatment of neuroendocrine tumors: Consensus report of the National Cancer Institute Neuroendocrine Tumor Clinical Trials Planning Meeting. J Clin Oncol 2011; 29: 934-943.
14. Kulke MH, Lenz HJ, Meropol NJ, Posey J, Ryan DP, Picus J, Bergsland E, Stuart K, Tye L, Huang X, Li JZ, Baum CM, Fuchs CS: Activity of sunitinib in patients with advanced neuroendocrine tumors. J Clin Oncol 2008; 26: 3403-3410.
15. Yao JC, Phan AT, Chang DZ, Wolff RA, Hess K, Gupta S, Jacobs C, Mares JE, Landgraf AN, Rashid A, Meric-Bernstam F: Efficacy of RAD001 (everolimus) and octreotide LAR in advanced low- To intermediate-Grade neuroendocrine tumors: Results of a phase II study. J Clin Oncol 2008; 26: 4311-4318.
16. Kulke MH, Hornick JL, Frauenhoffer C, Hooshmand S, Ryan DP, Enzinger PC, Meyerhardt JA, Clark JW, Stuart K, Fuchs CS, Redston MS: O 6-methylguanine DNA methyltransferase deficiency and response to temozolomide-based therapy in patients with neuroendocrine tumors. Clin Cancer Res 2009; 15: 338-345.
17. Mitry E, Baudin E, Ducreux M, Sabourin JC, Rufie P, Aparicio T, Aparicio T, Lasser P, Elias D, Duvillard P, Schlumberger M, Rougier P: Treatment of poorly differentiated neuroendocrine tumours with etoposide and cisplatin. Br J Cancer 1999; 81: 1351-1355.
18. Kwekkeboom DJ, de Herder WW, Kam BL, van Eijck CH, van Essen M, Kooij PP, Feelders RA, van Aken MO, Krenning EP: Treatment with the radiolabeled somatostatin analog [ 177 Lu-DOTA 0,Tyr 3 ]octreotate: Toxicity, efficacy, and survival. J Clin Oncol 2008; 26: 2124-2130.
19. Cwikla JB, Sankowski A, Seklecka N, Buscombe JR, Nasierowska-Guttmejer A, Jeziorski KG, Mikolajczak R, Pawlak D, Stepien K, Walecki J: Efficacy of radionuclide treatment DOTATATE Y-90 in patients with progressive metastatic gastroenteropancreatic neuroendocrine carcinomas (GEP-NETs): A phase II study. Ann Oncol 2010; 21: 787-794.
20. Lebwohl D, Kay A, Berg W, Baladi JF, Zheng J: Progression-free survival: Gaining on overall survival as a gold standard and accelerating drug development. Cancer J 2009; 15: 386-394.
21. Yao JC, Lombard-Bohas C, Baudin E, Kvols LK, Rougier P, Ruszniewski P, Hoosen S, St Peter J, Haas T, Lebwohl D, Van Cutsem E, Kulke MH, Hobday TJ, O'Dorisio TM, Shah MH, Cadiot G, Luppi G, Posey JA, Wiedenmann B: Daily oral everolimus activity in patients with metastatic pancreatic neuroendocrine tumors after failure of cytotoxic chemotherapy: A phase II trial. J Clin Oncol 2010; 28: 69-76.
22. Toulmonde M, Bellera C, Mathoulin-Pelissier S, Debled M, Bui B, Italiano A: Quality of randomized controlled trials reporting in the treatment of sarcomas. J Clin Oncol 2011; 29: 1204-1209.
23. Lai R, Chu R, Fraumeni M, Thabane L: Quality of randomized controlled trials reporting in the primary treatment of brain tumors. J Clin Oncol 2006; 24: 1136-1144. (Pubitemid 46638811)
24. Kober T, Trelle S, Engert A: Reporting of randomized controlled trials in Hodgkin lymphoma in biomedical journals. J Natl Cancer Inst 2006; 98: 620-625. (Pubitemid 43904845)
25. Rindi G, Kloppel G, Alhman H, Caplin M, Couvelard A, de Herder WW, Erikssson B, Falchetti A, Falconi M, Komminoth P, Korner M, Lopes JM, McNicol AM, Nilsson O, Perren A, Scarpa A, Scoazec JY, Wiedenmann B: TNM staging of foregut (neuro)endocrine tumors: A consensus proposal including a grading system. Virchows Arch 2006; 449: 395-401. (Pubitemid 44451313)
26. Rindi G, Kloppel G, Couvelard A, Komminoth P, Korner M, Lopes JM, McNicol AM, Nilsson O, Perren A, Scarpa A, Scoazec JY, Wiedenmann B: TNM staging of midgut and hindgut (neuro)endocrine tumors: A consensus proposal including a grading system. Virchows Arch 2007; 451: 757-762. (Pubitemid 47497934)
27. Sobin L, Gospodarowicz M, Wittekind C: TNM Classification Malignant Tumours. International Union Against Cancer, ed 7. Hoboken/NJ, Wiley-Blackwell 2009.
28. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D: The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: Explanation and elaboration. J Clin Epidemiol 2009; 62:e1-E34.
29. Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother 2010; 1: 100-107.