Abstract |
Somatostatin analogues (SSA) have demonstrated antiproliferative activity in addition to efficacy for carcinoid symptom control in functional neuroendocrine tumors (NET). A post hoc analysis of the placebo arm of the RAD001 In Advanced Neuroendocrine Tumors-2 (RADIANT-2) study was conducted to assess the efficacy of octreotide long-acting repeatable (LAR) on progression-free survival (PFS) and overall survival (OS) estimated using the Kaplan-Meier method. Out of 213 patients randomized to placebo plus octreotide LAR in RADIANT-2, 196 patients with foregut, midgut, or hindgut NET were considered for present analysis. Of these, 41 patients were SSA-treatment naïve and 155 had received SSA therapy before study entry. For SSA-naïve patients, median PFS by adjudicated central review was 13.6 (95% CI 8.2-22.7) months. For SSA-naïve patients with midgut NET (n=24), median PFS was 22.2 (95% CI 8.3-29.5) months. For patients who had received SSA previously, the median PFS was 11.1 (95% CI 8.4-14.3) months. Among the SSA-pretreated patients who had midgut NET (n=119), the median PFS was 12.0 (95% CI 8.4-19.3) months. Median OS was 35.8 (95% CI 32.5-48.9) months for patients in the placebo plus octreotide LAR arm; 50.6 (36.4 - not reached) months for SSA-naïve patients and 33.5 (95% CI 27.5-44.7) months for those who had received prior SSA. This post hoc analysis of the placebo arm of the large phase 3 RADIANT-2 study provides data on PFS and OS among patients with progressive NET treated with octreotide therapy.
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Authors | Jonathan R Strosberg, James C Yao, Emilio Bajetta, Mounir Aout, Bert Bakker, John D Hainsworth, Philippe B Ruszniewski, Eric Van Cutsem, Kjell Öberg, Marianne E Pavel |
Journal | Endocrine-related cancer
(Endocr Relat Cancer)
Vol. 22
Issue 6
Pg. 933-40
(Dec 2015)
ISSN: 1479-6821 [Electronic] England |
PMID | 26373569
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 The authors. |
Chemical References |
- Antineoplastic Agents, Hormonal
- Delayed-Action Preparations
- Placebos
- Everolimus
- Octreotide
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Hormonal
(administration & dosage, therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Delayed-Action Preparations
- Disease-Free Survival
- Double-Blind Method
- Everolimus
(administration & dosage)
- Female
- Gastrointestinal Neoplasms
(drug therapy, mortality)
- Humans
- Kaplan-Meier Estimate
- Male
- Malignant Carcinoid Syndrome
(drug therapy)
- Middle Aged
- Neuroendocrine Tumors
(drug therapy, mortality)
- Octreotide
(administration & dosage, therapeutic use)
- Placebos
- Treatment Outcome
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