Chemotherapy With or Without Maintenance Sunitinib for Untreated Extensive-Stage Small-Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase II Study-CALGB 30504 (Alliance)

To evaluate the efficacy of maintenance sunitinib after chemotherapy for small-cell lung cancer (SCLC). The Cancer and Leukemia Group B 30504 trial was a randomized, placebo-controlled, phase II study that enrolled patients before chemotherapy (cisplatin 80 mg/m(2) or carboplatin area under the curv...

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Vydáno v:Journal of clinical oncology Ročník 33; číslo 15; s. 1660
Hlavní autoři: Ready, Neal E, Pang, Herbert H, Gu, Lin, Otterson, Gregory A, Thomas, Sachdev P, Miller, Antonius A, Baggstrom, Maria, Masters, Gregory A, Graziano, Stephen L, Crawford, Jeffrey, Bogart, Jeffrey, Vokes, Everett E
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 20.05.2015
Témata:
Adult
Aged
Antineoplastic Agents - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Carboplatin - administration & dosage
Cisplatin - administration & dosage
Disease Progression
Disease-Free Survival
Double-Blind Method
Etoposide - administration & dosage
Female
Humans
Indoles - administration & dosage
Kaplan-Meier Estimate
Lung Neoplasms - drug therapy
Lung Neoplasms - mortality
Male
Middle Aged
Proportional Hazards Models
Pyrroles - administration & dosage
Small Cell Lung Carcinoma - drug therapy
Small Cell Lung Carcinoma - mortality
Treatment Outcome
ISSN:1527-7755, 1527-7755
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Shrnutí:To evaluate the efficacy of maintenance sunitinib after chemotherapy for small-cell lung cancer (SCLC). The Cancer and Leukemia Group B 30504 trial was a randomized, placebo-controlled, phase II study that enrolled patients before chemotherapy (cisplatin 80 mg/m(2) or carboplatin area under the curve of 5 on day 1 plus etoposide 100 mg/m(2) per day on days 1 to 3 every 21 days for four to six cycles). Patients without progression were randomly assigned 1:1 to placebo or sunitinib 37.5 mg per day until progression. Cross-over after progression was allowed. The primary end point was progression-free survival (PFS) from random assignment for maintenance placebo versus sunitinib using a one-sided log-rank test with α = .15; 80 randomly assigned patients provided 89% power to detect a hazard ratio (HR) of 1.67. One hundred forty-four patients were enrolled; 138 patients received chemotherapy. Ninety-five patients were randomly assigned; 10 patients did not receive maintenance therapy (five on each arm). Eighty-five patients received maintenance therapy (placebo, n = 41; sunitinib, n = 44). Grade 3 adverse events with more than 5% incidence were fatigue (19%), decreased neutrophils (14%), decreased leukocytes (7%), and decreased platelets (7%) for sunitinib and fatigue (10%) for placebo; grade 4 adverse events were GI hemorrhage (n = 1) and pancreatitis, hypocalcemia, and elevated lipase (n = 1; all in same patient) for sunitinib and thrombocytopenia (n = 1) and hypernatremia (n = 1) for placebo. Median PFS on maintenance was 2.1 months for placebo and 3.7 months for sunitinib (HR, 1.62; 70% CI, 1.27 to 2.08; 95% CI, 1.02 to 2.60; one-sided P = .02). Median overall survival from random assignment was 6.9 months for placebo and 9.0 months for sunitinib (HR, 1.28; 95% CI, 0.79 to 2.10; one-sided P = .16). Three sunitinib and no placebo patients achieved complete response during maintenance. Ten (77%) of 13 patients evaluable after cross-over had stable disease on sunitinib (6 to 27 weeks). Maintenance sunitinib was safe and improved PFS in extensive-stage SCLC.
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ISSN:1527-7755
1527-7755
DOI:10.1200/JCO.2014.57.3105