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This study was designed to determine the efficacy and safety of the paclitaxel and carboplatin combination in second-line chemotherapy treatment of patients with non-small-cell lung cancer. Treatment consisted of 175 mg/m 2 paclitaxel infused in 1 hour and carboplatin AUC 5 infused in 30 minutes, administered each 3 weeks for a maximum of 6 cycles. The following patient groups were included in the study: those who were stage IV at diagnosis; with progression during or after the administration of previous first-line chemotherapy; PS ≤ 2 and with normal hepatic, renal and bone marrow function. Twenty-two patients were included between January 2000 and December 2002. Their clinical characteristics were: male 81% / female 19%; adenocarcinoma histology in 12 patients (55%) / squamous carcinoma in 6 patients (27%) / large cell carcinoma in 2 patients (9%), and other-types in 2 patients (9%). The Performance Status (ECOG Scale) was 0 in 5 patients (22%), 1 in 5 patients (22%) and 2 in 12 patients (55%). Previously administered treatments were: combinations with cisplatin in 11 patients (50%) and combinations without cisplatin (ifosfamide, gemcitabine, vinorelbine) in 11 patients (50%). The mean number of first-line chemotherapies received was 1 to 4 cycles in 50% patients. The mean number of second-line treatments was 1 to 3 cycles in 50% and 3 to 6 cycles in the others. The doses administered were 100% of that planned in 20 patients, with 2 patients requiring dose reductions due to neutropenia and grade 3 neurotoxicity. The treatment was well tolerated with presentation of the following grade 3-4 toxicities: neutropenia in 2 patients (9%), peripheral neuropathy in 2 patients (9%). The overall response rate was 23% (CI 95%, 8-45): 5 patients (23%) with partial response, 9 (36%) with stable disease and 8 (31%) with progression. The median time to progression with second-line treatment was 16 weeks, reaching a median overall survival of 79 weeks. From the initiation of second-line treatment median survival was 24.1 weeks (CI 95%, 13.7-34.5). In this study it was observed that the combination of paclitaxel with carboplatin as second-line chemotherapy in patients with non-small-cell lung cancer presented moderate/restrained activity without severe toxicity.

Phase II study: combination of carboplatin and paclitaxel as second-line treatment in metastatic non-small-cell lung cancer