Paclitaxel in combination with carboplatin as salvage treatment in refractory small-cell lung cancer (SCLC): a multicenter phase II study.
OBJECTIVE
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.


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/m2 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.
Kakolyris
S
S
Department of Clinical Oncology, University General Hospital of Heraklion, Crete, Greece.
Mavroudis
D
D
Tsavaris
N
N
Souglakos
J
J
Tsiafaki
P
P
Kalbakis
K
K
Agelaki
S
S
Androulakis
N
N
Georgoulias
V
V
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016879:Salvage Therapy; D015996:Survival Rate
D016190:Carboplatin; D017239:Paclitaxel