Cetuximab Plus Chemotherapy Effective as First-Line Trtment

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Title: Cetuximab Plus Chemotherapy Effective as First-Line Treatment for Advanced NSCLC: Presented at WCLC

"Cetuximab Plus Chemotherapy Effective as First-Line Treatment for Advanced NSCLC: Presented at WCLC"

By Fred Gebhart SAN FRANCISCO -- August 3, 2009 -- Cetuximab, in combination with cisplatin and gemcitabine, appears to be effective and tolerable in the first-line treatment of advanced non-small-cell lung cancer (NSCLC), researchers reported on here at the 13th World Conference on Lung Cancer (WCLC). Several phase 2 and phase 3 studies have shown that cetuximab can improve survival and overall response rates when combined with standard first-line regimens such as cisplatin plus vinorelbine and carboplatin plus paclitaxel or docetaxel. "Our objective was to assess the efficacy of cetuximab in combination with cisplatin and gemcitabine and we succeeded," said Fernando Barata, MD, Centro Hospitalar de Coimbra, Coimbra, Portugal, on August 1. "Our primary overall response rate in the trial was more than 38%. We also found that any rash during the first cycle is associated with longer survival on this regimen." The single-arm, open-label, multicentre, phase 2 study recruited 48 patients between December 2006 and March 2008. Patients had metastatic NSCLC of any histological subtype, measurable disease, and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients with brain metastases were excluded from the trial. The 48 patients received an initial dose of cetuximab 400 mg/m[2 followed by 250 mg/m2 weekly in combination with cisplatin 40 mg/m2 on days 1 and 8 and gemcitabine 1,200 mg/m2 on days 1 and 8, every 21 days for up to 6 cycles.

The number of cycles depended on how well patients tolerated the regimen and any evidence of objective response. Of the 48 patients who began the trial, 42 were treated with at least 4 cycles. All 48 patients were included in the intent-to-treat analysis.

The overall response rate was 35.4% in the intent-to-treat analysis and 38.1% in the treated group. The median time to progression was 5 months while the median overall survival was 12 months in the intent-to-treat group. Dr. Barata noted that the overall response rate and the median time to progression were better than those typically seen with chemotherapy alone.

Dr. Barata also conduced a post hoc analysis that included all of the patients who were alive on day 21. He found that the median overall survival of patients who had any grade of rash during the first cycle was 16 months compared with an overall survival of 6 months for patients who did not have a rash during the first cycle of treatment (P = .007). There was also an improvement in overall response from patients who were epidermal growth factor receptor (EGFR) positive (26.9%) compared with patients who were EGFR negative (53.8%), but the difference was not statistically significant (P = .5).

During treatment, 77% of patients reported grade 3 to 5 adverse events. Of the 96 grade 3 to 5 adverse events, 36 were evaluated as probably or highly probably related to the combination of chemotherapy and cetuximab. The most common serious events were neutropenia and thrombocytopenia.

[Presentation title: Open-Label, Single Arm, Multicenter Phase II Study on the Efficacy and Safety of Cetuximab in Combination With Cisplatin and Gemcitabine as 1st-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer. Abstract A2.3]

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