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| |  ICACT: Medium Dose Cisplatin-Gemcitabine-Carboplatin Triplet as Effective as Standard Doublet in Stage IV Non-Small Cell Lung Cancer By Adrian Burton Special to DG News PARIS, FRANCE -- February 2, 2003 -- A phase II study has shown that although a medium dose cisplatin-gemcitabine-carboplatin regimen is as effective as a standard platinum-based doublet, it does not reduce toxicity at the doses tested. The findings were presented here February 1st at the International Congress on Anti-Cancer Therapy. Cisplatin-based regimens are standard treatment for stage IV non-small cell lung cancer (NSCLC) but they cannot be given for long periods of time because of their associated toxicity. However, moderate doses of cisplatin in combination with carboplatin have been shown to be as effective as high dose cisplatin alone -- and to be much less toxic. In an attempt to improve toxicity profiles further, French researchers tested a reduced dose regimen combining gemcitabine, cisplatin and carboplatin. "The idea of our study was to see if we could maintain the efficacy of the gemcitabine-cisplatin doublet, but further lower its toxicity," explained David Zylberait, a medical oncologist at the Centre Hospitalier Compiegne, in Compiegne, France. His team enrolled 25 patients with stage IV NSCLC and a median age of 63 years. All patients received gemcitabine 800 mg/m2 on days 1 and 8, carboplatin 200mg/m2 on day 1, and cisplatin 25 mg/m2 on days 2 and 3 every 4 weeks. Median survival was 14 months, with 8% of patients alive at 21 months. Two patients achieved a complete response, 10 had a partial response, and the overall response rate was 48% (CI 95%=28-68). Median time to progression was 4 months. Toxicity was evaluated after 6 cycles. Grade 3-4 haemorrhage was seen in 8% of patients, vomiting in 16%, diarrhoea in 4%, alopecia in 8%, neurological problems in 4%, and renal problems in 4%. Platelets counts were <50,000/mm3 in 48% of patients and <25,000 in 44%. Polymorphonucleocyte counts were <1000/mm3 in 72% and <500 in 52%. "The efficacy was exactly the same as that achieved by the reference protocol," said Dr. Zylberait. "The overall toxicity is, in fact, a little lower than what is achieved with the combination of gemcitabine and either cisplatin or carboplatin." Although his team did not achieve their goal of decreasing the haematological toxicity rate from that seen with the doublet regimen, Dr. Zylberait said, "this is almost certainly due to the carboplatin." He suggested that haematological toxicity might be reduced by maintaining an area under the curve below 3 or 4.
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