Cetuximab and First-Line Taxane/Carboplatin Chemotherapy in Advanced Non–Small-Cell Lung Cancer: Results of the Randomized Multicenter Phase III Trial BMS099
Abstract
Purpose: To evaluate the efficacy of cetuximab plus taxane/carboplatin (TC) as first-line treatment of advanced non–small-cell lung cancer (NSCLC). Patients and Methods: This multicenter, open-label, phase III study enrolled 676 chemotherapy-naïve patients with stage IIIB (pleural effusion) or IV NSCLC, without restrictions by histology or epidermal growth factor receptor expression. Patients were randomly assigned to cetuximab/TC or TC. TC consisted of paclitaxel (225 mg/m 2) or docetaxel (75 mg/m 2), at the investigator's discretion, and carboplatin (area under the curve = 6) on day 1 every 3 weeks for ≤ six cycles; cetuximab (400 mg/m 2 on day 1, 250 mg/m 2 weekly) was administered until progression or unacceptable toxicity. The primary end point was progression-free survival assessed by independent radiologic review committee (PFS-IRRC); overall response rate (ORR), overall survival (OS), quality of life (QoL), and safety were key secondary end points. PFS and ORR assessed by investigators were also evaluated. Results: Median PFS-IRRC was 4.40 months with cetuximab/TC versus 4.24 months with TC (hazard ratio [HR] = 0.902; 95% CI, 0.761 to 1.069; P = .236). Median OS was 9.69 months with cetuximab/TC versus 8.38 months with TC (HR = 0.890; 95% CI, 0.754 to 1.051; P = .169). ORR-IRRC was 25.7% with cetuximab/TC versus 17.2% with TC (P = .007). The safety profile of this combination was manageable and consistent with its individual components. Conclusion: The addition of cetuximab to TC did not significantly improve the primary end point, PFS-IRRC. There was significant improvement in ORR by IRRC. The difference in OS favored cetuximab but did not reach statistical significance.
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The cetuximab trial that used carboplatin plus paclitaxel in both arms lacked the power to determine an OS difference.
“it lacked the power to determine an OS difference.71”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [71]
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- Authors
- Lynch, T. J., Patel, T., Dreisbach, L., McCleod, M., Heim, W. J., Hermann, R. C., Paschold, E., Iannotti, N. O., Dakhil, S., Gorton, S., Pautret, V., Weber, M. R., & Woytowitz, D.
- Affiliations
- Yale University (US)
- Venue
- Journal of Clinical Oncology
- Published
- 2010-02-20
- Volume
- 28
- Issue
- 6
- Pages
- 911-917
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2112660136
- Cited by
- 447
- References
- 54
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 4 · 2023: 4 · 2022: 11 · 2021: 8 · 2020: 9 · 2019: 10 · 2018: 19 · 2017: 25 · 2016: 28 · 2015: 37 · 2014: 44 · 2013: 60 · 2012: 65
- FWCI
- 64.28
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- cetuximab, non-small cell lung cancer, first-line therapy, paclitaxel, docetaxel, carboplatin, EGFR, progression-free survival, overall survival, objective response rate, quality of life, drug safety, pleural effusion, stage IIIB/IV NSCLC
- MeSH terms
- Cetuximab, Docetaxel, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Prognosis, Survival Rate, Carboplatin, Treatment Outcome, Paclitaxel, Taxoids, Antibodies, Monoclonal, Humanized
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