Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors a subgroup analysis of the phase III RADIANT-3 trial

Pancreas

Volumn 44, Issue 2, 2015, Pages 181-189

  Lombard Bohas, Catherine ^a   Yao, James C ^b   Hobday, Timothy ^c   Van Cutsem, Eric ^d   Wolin, Edward M ^e   Panneerselvam, Ashok ^f   Stergiopoulos, Sotirios ^g   Shah, Manisha H ^h   Capdevila, Jaume ⁱ   Pommier, Rodney ^j  

^a EDOUARD HERRIOT HOSPITAL   (France)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^c Mayo Clinic   (United States)

^d UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^e CEDARS SINAI MEDICAL CENTER   (United States)

^f Department of Oncology Biometrics and Data ^*  (United States)

^g NOVARTIS PHARMA AG   (Switzerland)

^h OHIO STATE UNIVERSITY   (United States)

ⁱ HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^j OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

more..

Author keywords

Chemotherapy; Everolimus; First line therapy; Mammalian target of rapamycin inhibition

Indexed keywords

EVEROLIMUS; PLACEBO; ANTINEOPLASTIC AGENT;

ADULT; ADVANCED CANCER; ARTICLE; ASTHENIA; CANCER FATIGUE; CANCER GROWTH; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG SAFETY; DRY SKIN; DYSGEUSIA; EPISTAXIS; FEMALE; HEADACHE; HUMAN; HYPERGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAIL DISEASE; PANCREATIC NEUROENDOCRINE TUMOR; PATIENT HISTORY OF CHEMOTHERAPY; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; PRURITUS; RANDOMIZED CONTROLLED TRIAL; STOMATITIS; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; AGED; CLINICAL TRIAL; DISEASE COURSE; DISEASE FREE SURVIVAL; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; NEUROENDOCRINE TUMORS; PANCREATIC NEOPLASMS; PATHOLOGY; PATIENT SELECTION; PROPORTIONAL HAZARDS MODEL; TIME; UNITED STATES; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; EVEROLIMUS; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEUROENDOCRINE TUMORS; PANCREATIC NEOPLASMS; PATIENT SELECTION; PROPORTIONAL HAZARDS MODELS; PROSPECTIVE STUDIES; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES;

EID: 84925851377     PISSN: 08853177     EISSN: 15364828     Source Type: Journal    
DOI: 10.1097/MPA.0000000000000262     Document Type: Article

References (29)

1. Yao JC, Hassan M, Phan A, et al. 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. Phan AT, Yao JC. Neuroendocrine tumors: novel approaches in the age of targeted therapy. Oncology. 2008; 22: 1617-1623; discussion 1623-1624, 1629.
3. Halfdanarson TR, Rabe KG, Rubin J, et al. Pancreatic neuroendocrine tumors (PNETs): incidence, prognosis and recent trend toward improved survival. Ann Oncol. 2008; 19: 1727-1733.
4. Yao JC, Eisner MP, Leary C, et al. Population-based study of islet cell carcinoma. Ann Surg Oncol. 2007; 14: 3492-3500.
5. Yao J, Phan AT. Optimising therapeutic options for patients with advanced pancreatic neuroendocrine tumours. Eur Oncol Haematol. 2012; 8: 217-223.
6. US Food and Drug Administration: drugs @ FDA. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm? CFID=13046159&CFTOKEN=abbfa5d19ccad0bf-447320C8-ACB5- 57ED-A00D66F05198D399#apphist. Accessed July 22, 2013.
7. Moertel CG, Lefkopoulo M, Lipsitz S, et al. Streptozocin-doxorubicin, streptozocin-fluorouracil or chlorozotocin in the treatment of advanced islet-cell carcinoma. N Engl J Med. 1992; 326: 519-523.
8. Pavel M, Baudin E, Couvelard A, et al. Barcelona Consensus Conference participants: ENETS consensus guidelines for the management of patients with liver and other distant metastases from neuroendocrine neoplasms of foregut, midgut, hindgut, and unknown primary. Neuroendocrinology. 2012; 95: 157-176.
9. Yao JC, Phan AT, Chang DZ, et al. 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.
10. Yao JC, Lombard-Bohas C, Baudin E, et al. 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.
11. Yao JC, Shah MH, Ito T, et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011; 364: 514-523.
12. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000; 92: 205-216.
13. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Available at: http://ctep.cancer.gov/protocolDevelopment/electronic-applications/docs/ctcaev3.pdf. Accessed July 22, 2013.
14. Moertel CG, Hanley JA, Johnson LA. Streptozocin alone compared with streptozocin plus fluorouracil in the treatment of advanced islet-cell carcinoma. N Engl JMed. 1980; 303: 1189-1194.
15. Eriksson B, Skogseid B, Lundqvist G, et al. Medical treatment and long-term survival in a prospective study of 84 patients with endocrine pancreatic tumors. Cancer. 1990; 65: 1883-1890.
16. Cheng PN, Saltz LB. Failure to confirm major objective antitumor activity for streptozocin and doxorubicin in the treatment of patients with advanced islet cell carcinoma. Cancer. 1999; 86: 944-948.
17. McCollumAD, KulkeMH, Ryan DP, et al. Lack of efficacy of streptozocin and doxorubicin in patients with advanced pancreatic endocrine tumors. Am J Clin Oncol. 2004; 27: 485-488.
18. Kouvaraki MA, Ajani JA, Hoff P, et al. Fluorouracil, doxorubicin, and streptozocin in the treatment of patients with locally advanced and metastatic pancreatic endocrine carcinomas. J Clin Oncol. 2004; 22: 4762-4771.
19. Delaunoit T, Ducreux M, Boige V, et al. The doxorubicin-streptozotocin combination for the treatment of advanced well-differentiated pancreatic endocrine carcinoma: a judicious option? Eur J Cancer. 2004; 40: 515-520.
20. Strosberg JR, Fine RL, Choi J, et al. First-line chemotherapy with capecitabine and temozolomide in patients with metastatic pancreatic endocrine carcinomas. Cancer. 2011; 117: 268-275.
21. Kulke MH, Stuart K, Enzinger PC, et al. Phase II study of temozolomide and thalidomide in patients with metastatic neuroendocrine tumors. J Clin Oncol. 2006; 24: 401-406.
22. Kulke MH, Hornick JL, Frauenhoffer C, et al. O6-Methylguanine DNA methyltransferase deficiency and response to temozolomide-based therapy in patients with neuroendocrine tumors. Clin Cancer Res. 2009; 15: 338-345.
23. Chan JA, Stuart K, Earle CC, et al. Prospective study of bevacizumab plus temozolomide in patients with advanced neuroendocrine tumors. J Clin Oncol. 2012; 30: 2963-2968.
24. Kulke MH, Siu LL, Tepper JE, et al. 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.
25. Hadoux J, Ducreux M. Bevacizumab and subtype-adapted chemotherapy backbone in neuroendocrine tumors. J Clin Oncol. 2013; 31: 976-977.
26. Kulke MH. Systemic therapy for advanced pancreatic neuroendocrine tumors. Semin Oncol. 2013; 40: 75-83.
27. Raymond E, Dahan L, Raoul JL, et al. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011; 364: 501-513.
28. Wolin EM. Long-term, open-label everolimus in patients with pancreatic neuroendocrine tumors: two case presentations from RADIANT-3 [abstract]. International Society of Gastrointestinal Oncology 2012 Gastrointestinal Oncology Conference. Available at: http://www.isgio.org/isgio2012/abstracts/2012Poster16.pdf. Accessed July 22, 2013.
29. Pavel ME, Hainsworth JD, Baudin E, et al. 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 study. Lancet. 2011; 378: 2005-2012.