Phase II study of a biweekly schedule of docetaxel and cisplatin in patients with metastatic non-small cell lung cancer.

PURPOSE

We investigated the efficacy and toxicity of a biweekly schedule of docetaxel and cisplatin in patients with metastatic non-small cell lung cancer (NSCLC).

METHODS

In this study, 48 patients with previously untreated metastatic NSCLC were given combination chemotherapy consisting of docetaxel 40 mg/m(2) and cisplatin 40 mg/m(2); both drugs were given biweekly, on days 1 and 15, every 4 weeks.

RESULTS

A partial response and stable disease were observed in 25 patients (52.1%, 95% CI: 38.7-66.9%) and ten patients (20.8%), respectively. The overall median survival was 14.0 months (95% CI: 7.10-20.9 months). There was no treatment-related mortality. The major toxicity was grade 2 asthenia (35.4%). Grade 4 neutropenia was observed in two patients (4.2%), as was grade 3 infection (4.2%).

CONCLUSIONS

As a front-line chemotherapy in an outpatient setting for patients with metastatic NSCLC, the biweekly schedule of docetaxel and cisplatin showed effective antitumor activity with a marked reduction in hematologic toxicity, comparable to the results of previous studies using 3-week or weekly schedules. Further randomized studies are needed before this can be accepted as a standard schedule.