Background: Cisplatin and etoposide (PE) has been a standard treatment for patients with poor prognosis small cell lung cancer (SCLC). This non-inferiority design trial (registered as ISRCTN 39679215) aimed to determine whether gemcitabine and carboplatin (GC) has a similar survival but is less toxic with better quality of life (QoL).
Methods: Previously untreated SCLC patients with extensive disease or limited-stage with poor prognostic factors were randomly assigned to six, 3-weekly cycles of GC, or PE.
Results: 241 patients (121 GC and 120 PE) were recruited of which 216 (90%) had died. There was no difference in overall survival (HR 1.01, 95% CI 0.77 to 1.32). Median survival was 8.0 months and 8.1 months with GC and PE respectively.. Median progression-free survival was 5.9 months with GC and 6.3 months with PE. Grade 3 or 4 myelosuppressions were more frequent with GC (anaemia, 14% GC v 2% PE; leucopenia, 32% GC v 13% PE; thrombocytopenia, 22% GC v 4% PE) but these were not associated with increased hospital admissions, infections, or fatalities. More frequent grade 2-3 alopecia (68% PE v 17% GC) and nausea (43% PE v 26% GC) were seen with PE. GC patients received more chemotherapy as out-patients (89% GC vs 66% PE of treatment cycles). In QoL questionaires, more PE patients reported upset by hair loss (P=.004) and impaired cognitive functioning (P=0.04).
Conclusions: GC is as effective as PE in terms of overall survival and progression-free survival, and has a toxicity profile more acceptable to patients.
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