Purpose: The activity and toxicity of paclitaxel plus carboplatin
combination in patients with disease progression after initial
chemotherapy for small-cell lung cancer (SCLC) was investigated in a
multicenter phase II study.
Patients and methods: Thirty-two patients (twenty-seven men) with
extensive stage refractory SCLC after EP or CAV front-line chemotherapy
were treated with paclitaxel 200 mg/m(2) on day 1 and carboplatin 6 AUC
on day 2 in a four-week schedule. The patients’ median age was 60 years
and the performance status (WHO) was 0 for 9, 1 for 20 and 2 for 3
patients. All patients were evaluable for toxicity and 29 for response.
Results: Complete response was observed in one (3%) and partial
response in seven (22%) for an overall response rate of 25% (95%
confidence interval (CI): 10%-40%). Seven (22%) patients had stable
disease and seventeen (53%) progressive disease. All but one of the
responders had been previously treated with EP combination and three of
them had failed to respond. The median duration of response and the
median TTP were 3 and 5.5 months, respectively. The median overall
survival was seven months. Grade 3-4 neutropenia was observed in 12
(37%) patients and in 2 of these it was associated with infection.
There were no toxic deaths. Grade 4 anaemia was observed in one (3%)
patient and grade 3 thrombocytopenia in three (9.4%). Non-hematologic
toxicity was very mild with grade 2-3 asthenia occurring in 10 (25%)
patients; asthenia was the reason for treatment discontinuation in 3
patients.
Conclusions: The combination of paclitaxel and carboplatin is a
relatively active and well-tolerated regimen as salvage treatment in
patients with refractory SCLC
