Carboplatin and weekly paclitaxel in locally advanced [stage IIIB] and metastatic non-small-cell cancer [NSCLC]: a phase II pilot study

ABSTRACT

A phase II pilot study was conducted to determine the response, toxicity and survival rates of lung cancer patients treated with the combination carboplatin and weekly paclitaxel in stage IIIB and IV non-small-cell lung cancer [NSCLC]. A total of 19 cases were included in the current study. Paclitaxel was administered in a dose of 70 mg/m2 over 1 hour infusion weekly for 3 weeks, followed by 1 week of rest for each 4-week cycle for a total of four cycles. Carboplatin was administered in a dose of [area under the curve] AUC 6 day 1 each cycle following the paclitaxel. Assessment of treatment outcome was carried out following. An overall response rate was achieved in 36.8% of the cases [7/19], all of them were partial remissions and none of the patients achieved complete remission. Seven [36.8%] patients showed stationary disease and the remaining 5 [26.4%] patients showed disease progression. Treatment related toxicities encountered were mainly mild to moderate. Grade 3-4 neutropenia was reported in 3 [18.8%] patients, grade 3 anemia and thrombocytopenia were reported in two [10.5%] patients each. Neutropenic fever was encountered only in one [5.3%] patient. Grade 3 peripheral neuropathy and arthralgia/myalgia was reported in three [15.8%] patients. In general, treatment was well tolerated. Overall median survival was 10 months and 1-year overall survival was 42.5%. The median and 1-year progression free survival results were 8 months and 6.7%, respectively. Cox regression multivariate analysis of various prognostic factors revealed that response to treatment and presence of pleural effusion were significant and independent predictors of overall survival. The combination of carboplatin and weekly paclitaxel is an active and well tolerated regimen. The role of weekly paclitaxel in NSCLC should he better defined in future randomized studies