METHODS: A total of 185 patients [119 men, median age 65 years, median ECOG performance status (PS) 1] were identified. One hundred and sixty-eight patients had extensive disease (ED) at the time of
paclitaxel therapy.
Paclitaxel was mainly given as third- or fourth-line
therapy (93%). The response rate (RR) was 17% and disease control rate (DCR) 28%. Patients reached a median progression-free survival (PFS) of 1.6 (95% CI: 1.4-1.8) months and median overall survival (OS) of 3.3 (95% CI: 2.8-3.9) months. Main toxicities were
fatigue (25%) and
polyneuropathy (17%).
Dose reduction of ≥25% was associated with shorter PFS [1.9 (95% CI: 1.5-2.3) vs. 1.4 (95% CI: 1.3-1.5) months; P=0.004]. Further independent predictive factors for PFS were gender, age, and hepatic/
brain metastases (P<0.05).
Tumor response to
paclitaxel, PS, number and location of
metastases,
dose reduction, and smoking history were significant factors for OS in univariable analyses (P<0.05), while PS,
dose reduction, status of cerebral/hepatic
metastases,
tumor response, and smoking history were retained as independent prognostic factors in multivariable testing. Notably, ECOG PS 2 patients had toxicity rates similar to ECOG PS 0-1 patients (63% vs. 62%), as well as a comparable DCR (29% vs. 28%), which was associated with prolonged survival (4.5 vs. 3.2 months for refractory cases, P=0.034).
CONCLUSIONS:
Paclitaxel has clinically relevant activity in heavily pretreated SCLC. While patients with good PS and no cerebral/hepatic
metastases derive the greatest benefit, ECOG PS 2 per se should not be used as a criterion to exclude patients.