Phase II Study of Pemetrexed and Carboplatin Plus Bevacizumab With Maintenance Pemetrexed and Bevacizumab As First-Line Therapy for Nonsquamous Non–Small-Cell Lung Cancer

This study evaluated the efficacy and safety of pemetrexed, carboplatin, and bevacizumab followed by maintenance pemetrexed and bevacizumab in patients with chemotherapy-naive stage IIIB (effusion) or stage IV nonsquamous non-small-cell lung cancer (NSCLC). Patients received pemetrexed 500 mg/m(2),...

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Published inJournal of clinical oncology Vol. 27; no. 20; pp. 3284 - 3289
Main Authors Patel, Jyoti D., Hensing, Thomas A., Rademaker, Alfred, Hart, Eric M., Blum, Matthew G., Milton, Daniel T., Bonomi, Philip D.
Format Journal Article
LanguageEnglish
Published Alexandria, VA American Society of Clinical Oncology 10.07.2009
Subjects
Online AccessGet full text
ISSN0732-183X
1527-7755
DOI10.1200/JCO.2008.20.8181

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Abstract This study evaluated the efficacy and safety of pemetrexed, carboplatin, and bevacizumab followed by maintenance pemetrexed and bevacizumab in patients with chemotherapy-naive stage IIIB (effusion) or stage IV nonsquamous non-small-cell lung cancer (NSCLC). Patients received pemetrexed 500 mg/m(2), carboplatin area under the concentration-time curve of 6, and bevacizumab 15 mg/kg every 3 weeks for six cycles. For patients with response or stable disease, pemetrexed and bevacizumab were continued until disease progression or unacceptable toxicity. Fifty patients were enrolled and received treatment. The median follow-up was 13.0 months, and the median number of treatment cycles was seven (range, one to 51). Thirty patients (60%) completed > or = six treatment cycles, and nine (18%) completed > or = 18 treatment cycles. Among the 49 patients assessable for response, the objective response rate was 55% (95% CI, 41% to 69%). Median progression-free and overall survival rates were 7.8 months (95% CI, 5.2 to 11.5 months) and 14.1 months (95% CI, 10.8 to 19.6 months), respectively. Grade 3/4 hematologic toxicity was modest-anemia (6%; 0), neutropenia (4%; 0), and thrombocytopenia (0; 8%). Grade 3/4 nonhematologic toxicities were proteinuria (2%; 0), venous thrombosis (4%; 2%), arterial thrombosis (2%; 0), fatigue (8%; 0), infection (8%; 2%), nephrotoxicity (2%; 0), and diverticulitis (6%; 2%). There were no grade 3 or greater hemorrhagic events or hypertension cases. This regimen, involving a maintenance component, was associated with acceptable toxicity and relatively long survival in patients with advanced nonsquamous NSCLC. These results justify a phase III comparison against the standard-of-care in this patient population.
AbstractList This study evaluated the efficacy and safety of pemetrexed, carboplatin, and bevacizumab followed by maintenance pemetrexed and bevacizumab in patients with chemotherapy-naive stage IIIB (effusion) or stage IV nonsquamous non-small-cell lung cancer (NSCLC). Patients received pemetrexed 500 mg/m(2), carboplatin area under the concentration-time curve of 6, and bevacizumab 15 mg/kg every 3 weeks for six cycles. For patients with response or stable disease, pemetrexed and bevacizumab were continued until disease progression or unacceptable toxicity. Fifty patients were enrolled and received treatment. The median follow-up was 13.0 months, and the median number of treatment cycles was seven (range, one to 51). Thirty patients (60%) completed > or = six treatment cycles, and nine (18%) completed > or = 18 treatment cycles. Among the 49 patients assessable for response, the objective response rate was 55% (95% CI, 41% to 69%). Median progression-free and overall survival rates were 7.8 months (95% CI, 5.2 to 11.5 months) and 14.1 months (95% CI, 10.8 to 19.6 months), respectively. Grade 3/4 hematologic toxicity was modest-anemia (6%; 0), neutropenia (4%; 0), and thrombocytopenia (0; 8%). Grade 3/4 nonhematologic toxicities were proteinuria (2%; 0), venous thrombosis (4%; 2%), arterial thrombosis (2%; 0), fatigue (8%; 0), infection (8%; 2%), nephrotoxicity (2%; 0), and diverticulitis (6%; 2%). There were no grade 3 or greater hemorrhagic events or hypertension cases. This regimen, involving a maintenance component, was associated with acceptable toxicity and relatively long survival in patients with advanced nonsquamous NSCLC. These results justify a phase III comparison against the standard-of-care in this patient population.
Author Jyoti D. Patel
Alfred Rademaker
Daniel T. Milton
Thomas A. Hensing
Matthew G. Blum
Philip D. Bonomi
Eric M. Hart
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Keywords Antineoplastic agent
Lung disease
Respiratory disease
Lung cancer
Monoclonal antibody
Malignant tumor
non-small cell lung carcinoma
Pemetrexed
Bevacizumab
First line treatment
Antifolate
Cancerology
Vascular endothelium growth factor
Phase II trial
Carboplatin
Bronchus disease
Antiangiogenic agent
Cancer
Platinum II Complexes
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Snippet This study evaluated the efficacy and safety of pemetrexed, carboplatin, and bevacizumab followed by maintenance pemetrexed and bevacizumab in patients with...
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SubjectTerms Adult
Aged
Aged, 80 and over
Anemia - chemically induced
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Bevacizumab
Biological and medical sciences
Carboplatin - administration & dosage
Carboplatin - adverse effects
Carcinoma, Non-Small-Cell Lung - drug therapy
Carcinoma, Non-Small-Cell Lung - pathology
Disease-Free Survival
Drug Administration Schedule
Fatigue - chemically induced
Female
Follow-Up Studies
Glutamates - administration & dosage
Glutamates - adverse effects
Guanine - administration & dosage
Guanine - adverse effects
Guanine - analogs & derivatives
Humans
Kaplan-Meier Estimate
Lung Neoplasms - drug therapy
Lung Neoplasms - pathology
Male
Medical sciences
Middle Aged
Neoplasm Staging
Neutropenia - chemically induced
Pemetrexed
Pneumology
Thrombocytopenia - chemically induced
Treatment Outcome
Tumors
Tumors of the respiratory system and mediastinum
Title Phase II Study of Pemetrexed and Carboplatin Plus Bevacizumab With Maintenance Pemetrexed and Bevacizumab As First-Line Therapy for Nonsquamous Non–Small-Cell Lung Cancer
URI http://jco.ascopubs.org/content/27/20/3284.abstract
https://www.ncbi.nlm.nih.gov/pubmed/19433684
Volume 27
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