Everolimus for advanced pancreatic neuroendocrine tumours: A subgroup analysis evaluating japanese patients in the radiant-3 trial

Japanese Journal of Clinical Oncology

Volumn 42, Issue 10, 2012, Pages 903-911

  Ito, Tetsuhide ^a   Okusaka, Takuji ^b   Ikeda, Masafumi ^c   Igarashi, Hisato ^a   Morizane, Chigusa ^b   Nakachi, Kohei ^c   Tajima, Takeshi ^d   Kasuga, Akio ^d   Fujita, Yoshie ^d   Furuse, Junji ^e  

^a KYUSHU UNIVERSITY   (Japan)

^b NATIONAL CANCER CENTER HOSPITAL   (Japan)

^c NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^d NOVARTIS PHARMA K K   (Japan)

^e KYORIN UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Everolimus; Japanese population; MTOR inhibitors; Pancreatic neuroendocrine tumours

Indexed keywords

EVEROLIMUS; PLACEBO;

ABDOMINAL PAIN; ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; ADVANCED CANCER; ANEMIA; APLASIA; ARTICLE; CANCER GROWTH; CANCER RISK; CANCER SURVIVAL; CELLULITIS; CONTROLLED STUDY; DECREASED APPETITE; DIABETES MELLITUS; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSGEUSIA; EPISTAXIS; FATIGUE; FEMALE; FEVER; GINGIVITIS; GLOSSITIS; HEADACHE; HUMAN; HYPERGLYCEMIA; HYPERLIPIDEMIA; HYPERTENSION; HYPOPHOSPHATEMIA; ILEUS; INFECTION; JAPANESE; LEUKOPENIA; LIVER ABSCESS; LIVER FUNCTION; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAIL DISEASE; NAUSEA; NEUTROPENIA; PANCREATIC NEUROENDOCRINE TUMOR; PHASE 3 CLINICAL TRIAL; PHOSPHATE BLOOD LEVEL; PNEUMONIA; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RASH; RISK REDUCTION; SIDE EFFECT; STAPHYLOCOCCAL BACTEREMIA; STOMATITIS; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; CLINICAL TRIALS, PHASE III AS TOPIC; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; NEOPLASM STAGING; NEUROENDOCRINE TUMORS; PANCREATIC NEOPLASMS; PROGNOSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SIROLIMUS; SURVIVAL RATE; YOUNG ADULT;

EID: 84866751750     PISSN: 03682811     EISSN: 14653621     Source Type: Journal    
DOI: 10.1093/jjco/hys123     Document Type: Article

References (27)

1. Yao JC, Eisner MP, Leary C, et al. Population-based study of islet cell carcinoma. Ann Surg Oncol 2007;14:3492-500.
2. 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;26:3063-723
3. Ito T, Sasano H, Tanaka M, et al. Epidemiological study of gastroenteropancreatic neuroendocrine tumors in Japan. J Gastroenterol 2010;45:234-43.
4. Capurso G, Fazio N, Festa S, Panzuto F, de Braud F, Delle Fave G. Molecular target therapy for gastroenteropancreatic endocrine tumours: biological rationale and clinical perspectives. Crit Rev Oncol Hematol 2009;72:110-24.
5. Basu B, Sirohi B, Corrie P. Systemic therapy for neuroendocrine tumours of gastroenteropancreatic origin. Endocr Relat Cancer 2010;17:R75-90.
6. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in OncologyTM Neuroendocrine Tumors. National Comprehensive Cancer Network Web site. http://www.nccn.org/ professionals/physician_gls/pdf/neuroendocrine.pdf (11 April 2012, date last accessed).
7. Moertel CG, Lefkopoulo M, Lipsitz S, Hahn RG, Klaassen D. Streptozocin-doxorubicin, streptozocin-fluorouracil or chlorozotocin in the treatment of advanced islet-cell carcinoma. N Engl J Med 1992;326:519-23.
8. 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;86:944-8.
9. 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: 4762-71.
10. Kulke MH. Gastrointestinal neuroendocrine tumors: a role for targeted therapies? Endocr Relat Cancer 2007;14:207-19.
11. Pavel M, Baudin E, Couvelard A, et al. 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;95:157-76.
12. Dudeck O, Ricke J. Advances in regional chemotherapy of the liver. Expert Opin Drug Deliv 2011;8:1057-69.
13. Kress O, Wagner HJ, Wied M, Klose KJ, Arnold R, Alfke H. Transarterial chemoembolization of advanced liver metastases of neuroendocrine tumors-a retrospective single-center analysis. Digestion 2003;68:94-101.
14. Berber E, Flesher N, Siperstein AE. Laparoscopic radiofrequency ablation of neuroendocrine liver metastases. World J Surg 2002;26:985-90.
15. Eriksson J, Stalberg P, Nilsson A, et al. Surgery and radiofrequency ablation for treatment of liver metastases from midgut and foregut carcinoids and endocrine pancreatic tumors. World J Surg 2008;32:930-8.
16. Guenette JP, Dupuy DE. Radiofrequency ablation of colorectal hepatic metastases. J Surg Oncol 2010;102:978-87.
17. Mazzaglia PJ, Berber E, Milas M, Siperstein AE. Laparoscopic radiofrequency ablation of neuroendocrine liver metastases: a 10-year experience evaluating predictors of survival. Surgery 2007;142:10-9.
18. Chan JA, Kulke MH. New treatment options for patients with advanced neuroendocrine tumors. Curr Treat Options Oncol 2011;12:136-48.
19. Faivre S, Kroemer G, Raymond E. Current development of mTOR inhibitors as anticancer agents. Nat Rev Drug Discov 2006;5:671-88.
20. Wullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism. Cell 2006;124:471-84.
21. Missiaglia E, Dalai I, Barbi S, et al. Pancreatic endocrine tumors: expression profiling evidences a role for AKT-mTOR pathway. J Clin Oncol 2010;28:245-55.
22. 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.
23. 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 trial. J Clin Oncol 2008;26:4311-8.
24. Yao JC, Shah MH, Ito T, et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 2011;364:514-23.
25. Tsukamoto T, Shinohara N, Tsuchiya N, et al. Phase III trial of everolimus in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from RECORD-1. Jpn J Clin Oncol 2011;41:17-24.
26. Motzer RJ, Escudier B, Oudard S, et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010;116:4256-65.
27. Okamoto I, Doi T, Ohtsu A, et al. Phase I clinical and pharmacokinetic study of RAD001 (everolimus) administered daily to Japanese patients with advanced solid tumors. Jpn J Clin Oncol 2010;40:17-23.