Journal
JOURNAL OF THORACIC ONCOLOGY
Volume 4, Issue 1, Pages 87-92Publisher
ELSEVIER SCIENCE INC
DOI: 10.1097/JTO.0b013e3181915052
Keywords
Advanced NSCLC; Bortezomib; Carboplatin; Gemcitabine; Proteasome; Stage IV
Categories
Funding
- NATIONAL CANCER INSTITUTE [U10CA046282, U10CA038926, U10CA045808, U10CA086780, U10CA035281, U10CA027057, U10CA035128, U10CA058882, U10CA035431, U10CA045807, U10CA046441, U10CA063844, U10CA035178, U10CA067575, U10CA032102, U10CA180846, U10CA063850, U10CA046368, U10CA045560, U10CA035090, U10CA035119, U10CA020319, U10CA042777] Funding Source: NIH RePORTER
- NCI NIH HHS [U10 CA045807, N01 CA045560, N01 CA035119, U10 CA046441, N01 CA032102, U10 CA058882, U10 CA032102-32, U10 CA063850, CA45808, CA46282, N01 CA027057, CA20319, U10 CA180846, U10 CA067575, CA58882, U10 CA035281, N01 CA045807, N01 CA038926, U10 CA045808, U10 CA020319, N01 CA035178, U10 CA038926, CA35281, N01 CA046441, CA63850, U10 CA042777, U10 CA035178, U10 CA035431, U10 CA032102, U10 CA035119, U10 CA086780, CA42777, U10 CA046368, N01 CA067575, U10 CA035090, CA46368, CA35090, U10 CA063844, CA86780, U10 CA027057, CA35128, N01 CA035431, U10 CA045560, N01 CA063844, U10 CA046282, U10 CA035128] Funding Source: Medline
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Introduction: Bortezomib is a small-molecule proteasome inhibitor with single-agent activity in patients with non-small cell lung carcinoma (NSCLC) and synergy with gemcitabine in preclinical studies. This phase II study of bortezomib in combination with gemcitabine/carboplatin was conducted in chemotherapy-naive advanced NSCLC patients to assess efficacy and safety. Methods: Patients with selected stage IIIB/IV NSCLC, performance status 0-1, and no history of brain metastasis received up to six 21-day cycles of gemcitabine 1000 mg/m(2), days I and 8, carboplatin area under curve 5.0, day 1, and bortezomib 1.0 mg/m(2), days 1, 4, 8, and 11. Results: One-hundred-fourteen patients (52% adenocarcinoma, 85% stage IV) received a median of 3.6 treatment cycles, Median follow-up was >3 years. Median overall survival was 11 months; 1-year and 2-year survival rates were 47% and 19%, respectively. Median progression-free survival was 5 months; 1-year progression-free survival rate was 7%. Response rate was 23%, and disease control rate (responses + stable disease) was 68%. The most common grade 3/4 toxicities were thrombocytopenia (63%) and neutropenia (52%). One patient experienced febrile neutropenia. Grade 3/4 neuropathy occurred in 4%, and a further 6% experienced grade 2 sensory neuropathy. Conclusions: Bortezomib plus gemcitabine/carboplatin resulted in a notable Survival benefit in patients with advanced NSCLC, with the anticipated primary toxicity of myelosuppression. Further studies designed to investigate the role of bortezomib in advanced NSCLC are warranted.
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