Pilot phase II study of weekly chemotherapy with paclitaxel and carboplatin for refractory or relapsed small-cell lung cancer.

PURPOSE: The safety and efficacy of weekly chemotherapy with paclitaxel and carboplatin for the treatment of patients with refractory or relapsed small-cell lung cancer (SCLC) were evaluated.

PATIENTS AND METHODS: Paclitaxel (100 mg/m(2)) and carboplatin (with a target area under the concentration versus time curve of 2 mg min/ml using the Calvert formula) were administered to patients with previously- treated SCLC on days 1 and 8 at every 3-4 weeks.

RESULTS: A total of 29 patients (pts) [male/female, 26/3 pts; median age 62.7 years (43-74); performance status 0/1/2, 9/10/10 pts] were enrolled between March 2000 and June 2002. The mean number of cycles administered per pt was 3 (1-7). The overall response rate was 69% (95% confidence interval 52-86%), and 83% (15/18) in sensitive pts and 45% (5/11) in refractory pts (P<0.01). The overall median survival time was 29.6 weeks with a 1-year survival rate of 37% [34.1 weeks in sensitive pts and 23.1 weeks in refractory pts (P=0.085), 46.9 weeks in PS 0-1 and 16.3 weeks in PS 2 (P<0.001)]. The median time to progressive disease was 16.4 weeks [21.7 weeks in sensitive pts and 15.3 weeks in refractory pts (P=0.32)]. Hematologic toxicities observed included grade >or=3 neutropenia in 55%, grade >or=3 anemia in 36%, and grade >or=3 thrombocytopenia in 3%. Non-hematologic toxicities were mild except for grade 3 diarrhea in three pts and grade 3 pneumonitis in one pt.

CONCLUSION: Weekly chemotherapy with paclitaxel and carboplatin was well- tolerated and gave a high-response rate in pts with refractory or relapsed small-cell lung cancer.