AB 42. Paclitaxel and carboplatin in the treatment of small-cell lung cancer patients

Background: To compare the combination of paclitaxel and carboplatin (PC) versus other anticancer regimens in previously untreated, smallcell lung cancer (SCLC) patients.

Patients and methods: A total of 763 SCLC patients (ECOG PS =0-2) were enrolled, 476 on arm A (carboplatin AUC 6 mg/mL and paclitaxel 175 mg/m² i.v every 28 days) and 287 on arm B (3.5 mg/m² ifosphamide, carboplatin AUC 6 mg/mL, 200 mg/m² etoposide on days 1 to 3, every 28 days), each regimen for a maximum of eight cycles. Primary end points were overall survival and time to progression and secondary end points were objective response rate and toxicity. The vast majority of responding limited disease (LD) pts and complete responders (CR) with extensive disease (ED) also received prophylactic cranial irradiation (PCI).

Results: Overall survival was 274 days for arm A (95% CI, 250-297) and 295 for arm B (95% CI, 274-315), statistically non significant. Arm A experienced significantly earlier progression in 196 days (95% CI, 179-213) versus 225 days (95% CI, 210-240) in group B (P=0.013, Breslow test). Objective response rate was 50% for limited disease and 21% for extensive disease in arm A and 42% and 32% respectively in arm B. Also patients in group B experienced significantly more toxicity, mainly neutropenia and thrombocytopenia, compared with group A.

Conclusions: There was no statistically significant survival advantage for carboplatin-paclitaxel compared with other than taxanes regimens in SCLC, but there was a better toxicity profile.