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Everolimus plus octreotide long-acting repeatable in patients with colorectal neuroendocrine tumors: a subgroup analysis of the phase III RADIANT-2 study.
- Source :
-
The oncologist [Oncologist] 2013; Vol. 18 (1), pp. 46-53. Date of Electronic Publication: 2012 Dec 21. - Publication Year :
- 2013
-
Abstract
- Introduction: The incidence of colorectal neuroendocrine tumors (NETs) is increasing, and patients with this disease have particularly poor prognoses. Treatment options are limited, and survival times have not improved in the past decade.<br />Methods: A post hoc analysis of the efficacy and tolerability of everolimus plus octreotide long-acting repeatable (LAR) was conducted in patients with colorectal NETs enrolled in the phase III RAD001 in Advanced Neuroendocrine Tumors, Second Trial (RADIANT-2) study. The primary endpoint (progression-free survival [PFS]), secondary endpoints (including objective response rate), and safety were assessed.<br />Results: Patients with colorectal NETs receiving everolimus plus octreotide LAR had a significantly longer median PFS (29.9 months; n = 19) than did those receiving placebo plus octreotide LAR (6.6 months; n = 20). Everolimus plus octreotide LAR treatment also significantly reduced the risk for disease progression (hazard ratio: 0.34; 95% confidence interval: 0.13-0.89; p = .011). Although no objective responses were observed, tumor shrinkage was more frequently noted in the everolimus plus octreotide LAR arm than in the placebo plus octreotide LAR arm (67% vs. 37%, respectively). The combination of everolimus plus octreotide LAR was generally well tolerated by patients with colorectal NETs; rash and stomatitis were the most commonly reported adverse events.<br />Conclusions: Everolimus plus octreotide LAR treatment had significant benefits and improved outcomes for patients with advanced colorectal NETs compared with placebo plus octreotide LAR treatment. Results of this exploratory analysis are consistent with those reported from the RADIANT-2 primary analysis. These findings support additional investigations of everolimus plus octreotide LAR in patients with colorectal NETs.
- Subjects :
- Adult
Antineoplastic Agents, Hormonal administration & dosage
Antineoplastic Agents, Hormonal adverse effects
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Antineoplastic Combined Chemotherapy Protocols adverse effects
Clinical Trials, Phase III as Topic
Colorectal Neoplasms epidemiology
Colorectal Neoplasms pathology
Disease-Free Survival
Everolimus
Female
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Neoplasm Staging
Neuroendocrine Tumors epidemiology
Neuroendocrine Tumors pathology
Octreotide adverse effects
Sirolimus administration & dosage
Sirolimus adverse effects
Colorectal Neoplasms drug therapy
Neuroendocrine Tumors drug therapy
Octreotide administration & dosage
Sirolimus analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1549-490X
- Volume :
- 18
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The oncologist
- Publication Type :
- Academic Journal
- Accession number :
- 23263288
- Full Text :
- https://doi.org/10.1634/theoncologist.2012-0263