Efficacy of RAD001 (everolimus) and octreotide LAR in advanced low- to intermediate-grade neuroendocrine tumors: Results of a phase II study

Journal of Clinical Oncology

Volumn 26, Issue 26, 2008, Pages 4311-4318

  Yao, James C ^a   Phan, Alexandria T ^a   Chang, David Z ^a   Wolff, Robert A ^a   Hess, Kenneth ^a   Gupta, Sanjay ^a   Jacobs, Carmen ^a   Mares, Jeannette E ^a   Landgraf, Andrea N ^a   Rashid, Asif ^a   Meric Bernstam, Funda ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

CHROMOGRANIN A; EVEROLIMUS; KI 67 ANTIGEN; OCTREOTIDE; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; RAPAMYCIN;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; APHTHOUS ULCER; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER SURVIVAL; CARCINOID; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG TOLERABILITY; DYSGEUSIA; FATIGUE; FEMALE; HUMAN; HUMAN TISSUE; HYPERBILIRUBINEMIA; HYPERGLYCEMIA; HYPERTRIGLYCERIDEMIA; HYPOGLYCEMIA; HYPOKALEMIA; HYPOPHOSPHATEMIA; LEUKOCYTOSIS; LEUKOPENIA; MALE; NAIL DISEASE; NAUSEA; NEUROENDOCRINE TUMOR; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; RASH; SIDE EFFECT; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT RESPONSE; AGED; DELAYED RELEASE FORMULATION; MIDDLE AGED; PANCREAS ISLET CELL CARCINOMA; PANCREAS TUMOR;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOID TUMOR; CARCINOMA, ISLET CELL; DELAYED-ACTION PREPARATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEUROENDOCRINE TUMORS; OCTREOTIDE; PANCREATIC NEOPLASMS; SIROLIMUS;

EID: 52049125970     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.16.7858     Document Type: Article

References (34)

1. Obendorfer S: Carcinoid of the small intestine [In German]. Frankf Z Pathol 1:425-129, 1907
2. Kim do H, Nagano Y, Choi IS, et al: Allelic alterations In well-differentiated neuroendocrine tumors (carcinoid tumors) identified by genome-wide single nucleotide polymorphism analysis and comparison with pancreatic endocrine tumors. Genes Chromosomes Cancer 47:84-92, 2008
3. Choi IS, Estecio MR, Nagano Y, et al: Hypom-ethylation of LINE-1 and Alu In well-differentiated neuroendocrine tumors (pancreatic endocrine tumors and carcinoid tumors). Mod Pathol 20:802-810, 2007
4. Wang GG, Yao JC, Worah S, et al: Comparison of genetic alterations in neuroendocrine tumors: Frequent loss of chromosome 18 In ileal carcinoid tumors. Mod Pathol 18:1079-1087, 2005
5. Modlin IM, Lye KD, Kidd M: A 5-decade analysis of 13,715 carcinoid tumors. Cancer 97:934-959, 2003
6. 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 22: 4762-4771, 2004
7. Kulke MH, Stuart K, Enzinger PC, et al: Phase II study of temozolomide and thalidomide In patients with metastatic neuroendocrine tumors. J Clin Oncol 24:401-406, 2006
8. Plank TL, Logginidou H, Klein-Szanto A, et al: The expression of hamartin, the product of the TSC1 gene, in normal human tissues and in TSC1- and TSC2-llnked angiomyolipomas. Mod Pathol 12:539-545, 1999
9. Verhoef S, van Diemen-Steenvoorde R, Akkersdijk WL, et al: Malignant pancreatic tumour within the spectrum of tuberous sclerosis complex in childhood. Eur J Pediatr 158:284-287, 1999
10. Eledrisi MS, Stuart CA, Alshanti M: Insulinoma in a patient with tuberous sclerosis: Is there an association? Endocr Pract 8:109-112, 2002
11. Johannessen CM, Reczek EE, James MF, et al: The NF1 tumor suppressor critically regulates TSC2 and mTOR. Proc Natl Acad Sci U S A 102: 8573-8578, 2005
12. Tan CC, Hall Rl, Semeraro D, et al: Ampullary somatostatinoma associated with von Reckling-hausen's neurofibromatosis presenting as obstructive jaundice. Eur J Surg Oncol 22:298-301, 1996
13. van Basten JP, van Hoek B, de Bruine A, et al: Ampullary carcinoid and neurofibromatosis: Case report and review of the literature. Neth J Med 44:202-206, 1994
14. Yoshida A, Hatanaka S, Ohi Y, et al: Von Recklinghausen's disease associated with somatostatin-rich duodenal carcinoid (somatostatinoma), medullary thyroid carcinoma and diffuse adrenal medullary hyperplasia. Acta Pathol Jpn 41: 847-856, 1991
15. von Wichert G, Jehle PM, Hoeflich A, et al: Insulin-Iike growth factor-l Is an autocrine regulator of chromogranin A secretion and growth in human neuroendocrine tumor cells. Cancer Res 60:4573-4581, 2000
16. Moreno A, Akcakanat A, Munsell MF, et al: Antitumor activity of rapamycin and octreotide as single agents or in combination In neuroendocrine tumors, Endocr Relat Cancer 15:257-266, 2008
17. O'Reilly KE, Rojo F, She QB, et al: MTOR Inhibition induces upstream receptor tyrosine kinase signaling and activates Akt. Cancer Res 66:1500-1508, 2006
18. Pollak MN, Polychronakos C, Guyda H: Soma-tostatin analogue SMS 201-995 reduces serum IGF-I levels In patients with neoplasms potentially dependent on IGF-I. Anticancer Res 9:889-891, 1989
19. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment In solid tumors: European Organisation for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216, 2000
20. Rivera VM, Tang H, Metcalf CA III, et at: Anti-proliferative activity of the mTOR inhibitor AP23573 in combination with cytotoxic and targeted agents. AACR Meeting 45:896a, 2004 (abstr 3887)
21. Shah MH, Young D, Kindler HL, et al: Phase II study of the proteasome inhibitor bortezomib (PS-341) in patients with metastatic neuroendocrine tumors. Clin Cancer Res 10:6111-6118, 2004
22. Yao JC, Zhang Jx, Rashid A, et al: Clinical and In vitro studies of imatinib in advanced carcinoid tumors. Clin Cancer Res 13:234-240, 2007
23. Hobday TJ, Rubin J, Holen K, et al: MC044h, a phase II trial of sorafenib in patients (pts) with metastatic neuroendocrine tumors (NET): A phase II consortium (P2C) study. J Clin Oncol 25:4504, 2007
24. Kulke MH, Lenz HJ, Meropol NJ, et al: A phase 2 study to evaluate the efficacy and safety of SU11248 in patients (pts) with unresectable neuroendocrine tumors (NETs). J Clin Oncol 23:310s, 2005
25. Yao JC, Phan A, Hoff PM, et al: Targeting vascular endothelial growth factor in advanced car cinoid tumor: A random assignment phase II study of depot octreotide with bevacizumab and pegylated interferon alpha-2b. J Clin Oncol 26:1316-1323, 2008
26. Jensen EH, Kvols L, McLoughlin JM, et al: Biomarkers predict outcomes following cytoreduc tive surgery for hepatic metastases from functional carcinoid tumors. Ann Surg Oncol 14:780-785, 2007
27. Janson ET, Holmberg L, Stridsberg M, et al: Carcinoid tumors: Analysis of prognostic factors and survival in 301 patients from a referral center. Ann Oncol 8:685-690, 1997
28. Rindi G, Kloppel G, Couvelard A, et al: TNM staging of midgut and hindgut (neuro) endocrine tumors: A consensus proposal including a grading system. Virchows Arch 451:757-762, 2007
29. Azuma M, Shi M, Danenberg KD, et al: Serum lactate dehydrogenase levels and glycolysis signifi cantly correlate with tumor VEGFA and VEGFR expression in metastatic CRC patients. Pharmacog-enomics 8:1705-1713, 2007
30. Lukacova S, Sorensen BS, Alsner J, et al: The impact of hypoxia on the activity of lactate dehydrogenase in two different pre-clinical tumour models. Acta Oncol: 1-7, 2007
31. van der Poel HG, Hanrahan C, Zhong H, et al: Rapamycin induces Smad activity in prostate cancer cell lines. Urol Res 30:380-386, 2003
32. Lang SA, Klein D, Koehl G, et al: Blocking mTOR by rapamycin reduces HIF-1{alpha} function in human gastric cancer cells in vitro and inhibits angiogenesis and tumor growth in vivo. AACR Meeting 46:265, 2005 (abstr 1136)
33. Del Bufalo D, Ciuffreda L, Trisciuoglio D, et al: Antiangiogenic potential of the mammalian target of rapamycin inhibitor temsirolimus. Cancer Res 66: 5549-5554, 2006
34. Schnirer II, Yao JC, Ajani JA: Carcinoid: A comprehensive review. Acta Oncol 42:672-692,2003