Randomized phase II study of cetuximab in combination with cisplatin (C) and vinorelbine (V) vs. CV alone in the first-line treatment of patients (pts) with epidermal growth factor receptor (EGFR)-expressing advanced non-small-cell lung cancer (NSCLC)

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Abstract
7012 Background: NSCLC is a tumor with high EGFR-expression in the majority of cases. Since there is still a need for improvement in the outcome of patients with NSCLC, we evaluated the addition of cetuximab (Erbitux), an IgG1 monoclonal antibody targeting the EGFR, to CV, a standard chemotherapy in NSCLC, in first-line treatment of patients with NSCLC. Combinations of cetuximab and chemotherapy have shown to be effective and safe in several EGFR-expressing tumors such as colorectal cancer and head and neck cancer. Methods: Neither of the patients had received prior chemotherapy. All patients were treated with C 80 mg/m2 d1 and V 25 mg/m2 d1 and 8, q3 and were randomized to either receive additional cetuximab 400 mg/m2 week 1 and 250 mg/m2 weekly thereafter (arm A) or no additional treatment (arm B). Results: 101/112 (90%) of pts screened had EGFR-expressing tumors. Enrollment was completed with a total of 86 pts: 43 (10 f, 33 m) in arm A and 43 (12 f, 31 m) in arm B. The following patient/tumor characteristics were similar in both treatment arms: median age of 58 y (34–75), median KPS of 90, 92% of patients had stage IV NSCLC, 42% had adenocarcinoma and 42% had squamous cell carcinoma. Relevant grade 3/4 adverse events in arm A (B) were: leucopenia 64.3% (51.2), nausea/vomiting 16.7% (14.0), asthenia/fatigue 16.7% (2.3), infection 11.9% (4.7), fever/chills 9.5% (7.0), thrombocytopenia 7.1% (4.7), acne-like rash 4.8% (0), diarrhea 2.4% (0). Confirmed response rates based on preliminary assesment of 41 pts in arm A were 31.7% (C.I.: 17.5 - 46.0) [13 PR, 18 SD, 3 PD], and of 40 pts in arm B: 20.0% (C.I.: 7.6 –32.4) [8 PR, 17 SD, 13 PD], TTP based on 79% of events is 4.7 months in arm A and 4.2 months in arm B. Conclusions: Cetuximab can safely be added to the regimen of cisplatin and vinorelbine, with evidence suggesting enhancement of activity. No significant financial relationships to disclose.

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