Cited by 447Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

Cetuximab and First-Line Taxane/Carboplatin Chemotherapy in Advanced Non–Small-Cell Lung Cancer: Results of the Randomized Multicenter Phase III Trial BMS099

Lynch, Thomas J., Patel, Taral, Dreisbach, Luke, McCleod, Michael, Heim, William J., Hermann, Robert C., Paschold, Eugene, Iannotti, Nicholas O. +5 more·2010·Journal of Clinical Oncology

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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Crossref · 10.1200/jco.2009.21.9618

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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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