Paclitaxel and carboplatin in inoperable non-small cell lung cancer

Based on the activity of single-agent paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and the significant 1-year survival rates of patients with non-small cell lung cancer treated with carboplatin, the Hellenic Cooperative Oncology Group initiated a phase II trial using both agents in patients with inoperable stage III or IV disease to investigate the efficacy and toxicity of the combination. Since July 1995, 31 patients fulfilling all eligibility criteria entered this study. All patients received paclitaxel 175 mg/m2 as a 3-hour infusion and carboplatin dosed to an area under the concentration-time curve of 7, every 3 weeks. No granulocyte colony-stimulating factor was given. Among the 29 male and two female patients, the median age was 55 years (age range, 29 to 73 years) and the median Eastern Cooperative Oncology Group performance status was 1. Most of the patients had stage IV adenocarcinoma (19) with low differentiation (15). The median number of chemotherapy cycles was two, with a range of one to six. Among 21 patients evaluable, seven achieved a partial response, 10 had stable disease, and four had progressive disease. It is too early to evaluate nine patients. Grade 2/3 nonhematologic toxicity included alopecia (48%), neurotoxicity (3.7%), and myalgia/arthralgia (7.4%). Grade 2/3 neutropenia occurred in 11.1% of patients, whereas grade 2 thrombocytopenia was seen in only 3.7%. One patient died following complications of severe allergic reaction. In conclusion, although this study is ongoing, combination treatment using paclitaxel and carboplatin is both effective and well tolerated in patients with inoperable non-small cell lung cancer.