Randomized Phase II Study of Cetuximab and Bevacizumab in Combination with Two Regimens of Paclitaxel and Carboplatin in Chemonaive Patients with Stage IIIB/IV Non–Small-Cell Lung Cancer
Autor: | Mark R. Olsen, Philip Bonomi, Joseph Mace, Hagop Youssoufian, Romeo A. Mandanas, Terry L. Katz, Myo Min, Hyun Jung Lee, Grishma Sheth |
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Rok vydání: | 2013 |
Předmět: |
Adult
Male Pulmonary and Respiratory Medicine medicine.medical_specialty Lung Neoplasms Paclitaxel Bevacizumab medicine.medical_treatment Cetuximab Phases of clinical research Adenocarcinoma Antibodies Monoclonal Humanized Gastroenterology Carboplatin chemistry.chemical_compound Carcinoma Non-Small-Cell Lung Internal medicine Antineoplastic Combined Chemotherapy Protocols Humans Medicine Lung cancer Survival rate Aged Neoplasm Staging Aged 80 and over Chemotherapy business.industry Non–small-cell lung cancer Area under the curve Middle Aged Prognosis medicine.disease Surgery Survival Rate Clinical Trials Phase III as Topic Oncology chemistry Carcinoma Squamous Cell Carcinoma Large Cell Female Neoplasm Recurrence Local business Follow-Up Studies medicine.drug |
Zdroj: | Journal of Thoracic Oncology. 8:338-345 |
ISSN: | 1556-0864 |
Popis: | Introduction We conducted a phase II study of dual-agent monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with paclitaxel and carboplatin chemotherapy in non–small-cell lung cancer. Methods Patients with stage IIIB/IV nonsquamous non–small-cell lung cancer randomly received cetuximab (400 mg/m 2 initially, 250 mg/m 2 weekly thereafter) plus bevacizumab (15 mg/kg) for six cycles combined with paclitaxel (200 mg/m 2 ) and carboplatin (area under the curve 6) for either six cycles (six-cycle arm) or the first three cycles (three-cycle arm) (one cycle=3 weeks). The primary objective was progression-free survival (PFS), estimated separately for each treatment arm. Results In 121 patients, the median PFS was 6.05 months (95% confidence interval [CI]: 5.65, 7.03) in the six-cycle arm and 4.50 months (95% CI: 4.01, 5.42) in the three-cycle arm. Respective median overall survival times were 12.06 months (95% CI: 9.40, 19.25) and 11.63 months (95% CI: 6.64, 17.61). The tumor response rate was 51.7% (95% CI: 39.0%, 64.3%) and 44.3% (95% CI: 31.8%, 56.7%) in the six-cycle and three-cycle arms, respectively, with corresponding median response durations of 4.86 months (95% CI: 4.30, 7.16) and 3.94 months (95% CI: 2.92, 4.47). Quality of life was consistent across arms. Cetuximab-related grade 3/4 events in greater than 5% of patients (six-cycle arm, three-cycle arm) were dermatitis acneiform (6.9%; 8.6%) and fatigue (13.8%; 5.2%). Three patients died during the study from drug-related adverse events (one in the six-cycle arm and two in the three-cycle arm). Conclusions Both the regimens showed expected PFS and numerically comparable overall survival. Quality of life was similar in the two arms, and both the regimens were well tolerated. |
Databáze: | OpenAIRE |
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