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Carboplatin + Gemcitabine Equivalent to Vinorelbine + Gemcitabine in NSCLC: Presented at ESMO

By Adrian Burton

NICE, FRANCE -- October 22, 2002 -- A Portuguese study has found no difference between combined carboplatin + gemcitabine or vinorelbine + gemcitabine in the treatment of advanced non-small cell lung cancer (NSCLC), according to results presented here October 21^st at the 27^th Congress of the European Society for Medical Oncology.

"Standard therapy for this disease has been the use of carboplatin and gemcitabine. We wanted to know whether there would be any toxicity or response advantages to using a non-platin agent -- which could be less toxic in theory -- in combination therapy," said Dr. Fernando Jose Barata, from the Centro Hospitalar Coimbra in Coimbra, Portugal.

The researchers investigated the use of these two combinations in 90 chemotherapy-naive patients. All had histologically or cytologically confirmed stage IIIB (with pleural effusion) or stage IV NSCLC, and all had bidimensionally measurable disease and European Cooperative Oncology Group performance status less than 2. All had normal liver and kidney function and none had brain metastases.

After randomisation, 44 patients received intravenous carboplatin area under the curve 5 on day 1 + gemcitabine 1250 mg/m² on days 1 and 8 every 3 weeks, and 46 received vinorelbine 25 mg/m² + gemcitabine 1000 mg/m² on days 1 and 8 every 3 weeks. Median age was 67 years in the carboplatin arm and 68 years in the vinorelbine arm. In the carboplatin arm, 50 percent of patients had adenocarcinoma and 43.2 percent had squamous cell carcinoma; in the vinorelbine arm, 54.3 percent had adenocarcinoma and 32.6 percent had squamous cell carcinoma.

No grade IV toxicities were seen in either arm, and grade II and III toxicities were mild and manageable in both treatment arms. Neutropenia occurred in 14.4 percent of cycles in the carboplatin arm compared with 13.3 percent in the vinorelbine arm, and anaemia occurred in 19.6 percent and 12.6 percent of cycles, respectively (no statistical difference). No differences were seen in survival figures.

"Neither of these drugs is more expensive than the other. Both regimens are effective and both toxicity profiles are quite manageable. The only choice to make depends on what you have in the pharmacy," concluded Dr. Barata.

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