CALGB 30704 (Alliance): A randomized phase II study to assess the efficacy of pemetrexed or sunitinib or pemetrexed plus sunitinib in the second-line treatment of advanced non-small-cell lung cancer.
Abstract | BACKGROUND: METHODS: Patients with stage IIIB/IV NSCLC with performance status 0 to 1 progressive after first-line chemotherapy were eligible for randomization to pemetrexed, sunitinib, or the combination. Patients were stratified by performance status, stage, and sex. Primary objective was 18-week progression-free survival (PFS) rate; secondary objectives included response, overall survival (OS), and toxicity. Target accrual was 225. The study was terminated early because of decreasing accrual rates. RESULTS: Between April 2008 and September 2011, 130 patients were registered and randomized; of this, 125 patients were treated. Baseline characteristics in the three arms were well balanced. Toxicity was higher in the sunitinib-containing arms. The 18-week PFS rate in the pemetrexed, sunitinib, and combination arms was 54% (95% confidence interval [CI], 40-71), 37% (95% CI, 25-54), and 48% (95% CI, 35-66), respectively (p = 0.25). Median PFS in the pemetrexed, sunitinib, and combination arms in months was 4.9 (2.1-8.8), 3.3 (2.3-4.2), and 3.7 (2.5-5.8), respectively (p = 0.18). There was an overall statistically significant difference in OS between the three arms: median OS in months was 10.5 (8.3-20.2) for pemetrexed, 8.0 (6.8-13.5) for sunitinib, and 6.7 (4.1-10.1) for the combination (p = 0.03). CONCLUSION:
Pemetrexed had a superior toxicity profile to either sunitinib or the combination of pemetrexed and sunitinib. The 18-week PFS rate was not significantly different between the arms. OS was significantly better with pemetrexed alone compared with the two sunitinib-containing arms, with the doublet performing worst for OS.
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Authors | Rebecca S Heist, Xiaofei Wang, Lydia Hodgson, Gregory A Otterson, Thomas E Stinchcombe, Leena Gandhi, Miguel A Villalona-Calero, Peter Watson, Everett E Vokes, Mark A Socinski, Alliance for Clinical Trials in Oncology |
Journal | Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
(J Thorac Oncol)
Vol. 9
Issue 2
Pg. 214-21
(Feb 2014)
ISSN: 1556-1380 [Electronic] United States |
PMID | 24419419
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Glutamates
- Indoles
- Pyrroles
- Pemetrexed
- Guanine
- Sunitinib
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Topics |
- Adenocarcinoma
(drug therapy, mortality, pathology)
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carcinoma, Large Cell
(drug therapy, mortality, pathology)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, mortality, pathology)
- Carcinoma, Squamous Cell
(drug therapy, mortality, pathology)
- Female
- Follow-Up Studies
- Glutamates
(administration & dosage)
- Guanine
(administration & dosage, analogs & derivatives)
- Humans
- Indoles
(administration & dosage)
- Lung Neoplasms
(drug therapy, mortality, pathology)
- Male
- Middle Aged
- Neoplasm Staging
- Pemetrexed
- Prognosis
- Pyrroles
(administration & dosage)
- Remission Induction
- Salvage Therapy
- Sunitinib
- Survival Rate
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