Background
Cancer and Leukemia Group B (CALGB) trial 9430 was a randomized phase II trial which investigated the safety and activity of four novel doublets in untreated extensive stage small cell lung cancer (ES-SCLC). The results of the paclitaxel and cisplatin arm have not been reported.
Patients and Methods
Patients received paclitaxel 230 mg/m2 followed by cisplatin 75 mg/m2 on day 1 every 21 days. All patients received granulocyte colony stimulating factor (G-CSF) 5 μg/kg/day beginning on day 3 of each cycle.
Results
The patient characteristics of the 34 patients assigned to this treatment arm were: median age 61.5 years (range 41 to 82), male (76%), performance status 0 (41%), 1 (32%), and 2 (26%). An objective response was observed in 23 patients (68%; 95% confidence interval (CI): 49% to 83%); 2 complete responses (6%) and 21 partial responses (62%). Median progression-free survival time was 5.6 months (95% CI: 4.8 to 7.1 months), and median overall survival time was 7.7 months (95% CI: 7.2 to 12.6 months). The one year survival rate observed was 29% (95% CI: 15 to 45%). Grade 3/4 neutropenia and thrombocytopenia was observed in 5 (15%) and 4 (12%) patients, respectively. Two patients developed febrile neutropenia including one patient who died from neutropenic sepsis. Grade 3/4 non-hematologic observed were: sensory neuropathy in 8 patients (24%); and hyperglycemia, malaise and nausea were all observed in 4 patients (12%).
Conclusions
CALGB will not pursue further investigation of paclitaxel and cisplatin due to the modest activity and the toxicity observed on this trial.