Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-smallcell lung cancer - a randomized trial with quality of life as the primary outcome

Three hundred patients with symptomatic, locally advanced or metastatic NSC LC not requiring immediate radiotherapy were enrolled into this randomized multicentre trial comparing gemcitabine + BSC vs BSC alone. Patients alloca ted gemcitabine received 1000 mg/m(2) on days 1, 8 and 15 of a 28-day cycle , for a maximum of six cycles. The main aim of this trial was to compare pa tient assessment of a predefined subset of commonly reported symptoms (SS14 ) from the EORTC QLQ-C30 and LC13 scales. The primary end-points were defin ed as (1) the percentage change in mean SS14 score between baseline and 2 m onths and (2) the proportion of patients with a marked (greater than or equ al to 25%) improvement in SS14 score between baseline and 2 months sustaine d for greater than or equal to 4 weeks. The secondary objectives were to co mpare treatments with respect to overall survival, and multidimensional QL parameters. The treatment groups were balanced with regard to age, gender, Karnofsky performance status (KPS) and disease stage (40% had metastatic di sease). The percentage change in mean SS14 score from baseline to 2 months was a 10% decrease (i.e. improvement) for gemcitabine plus BSC and a 1% inc rease (i.e. deterioration) for BSC alone (P = 0.113, two-sample t-test), A sustained (greater than or equal to 4 weeks) improvement (greater than or e qual to 25%) on SS14 was recorded in a significantly higher proportion of g emcitabine + BSC patients (22%) than in BSC alone patients (9%) (P = 0.0014 , Pearson's chi-squared test). The QLQ-C30 and L13 subscales showed greater improvement in the gemcitabine plus BSC arm (in 11 domains) than in the BS C arm (one symptom item). There was greater deterioration in the BSC alone arm (six domains/items) than in the gemcitabine + BSC arm (three QL domains ). Tumour response occurred in 19% (95% CI 13-27) of gemcitabine patients. There was no difference in overall survival: median 5.7 months (95% CI 4.6- 7.6) for gemcitabine + BSC patients and 5.9 months (95% CI 5.0-7.9) (log-ra nk, P = 0.84) for BSC patients, and I-year survival was 25% for gemcitabine + BSC and 22% for BSC. Overall, 74 (49%) gemcitabine + BSC patients and 11 9 (79%) BSC patients received palliative radiotherapy. The median time to r adiotherapy was 29 weeks for gemcitabine + BSC patients and 3.8 weeks for B SC. Patients treated with gemcitabine + BSC reported better QL and reduced disease-related symptoms compared with those receiving BSC alone. These imp rovements in patient-assessed QL were significant in magnitude and were sus tained. (C) 2000 Cancer Research Campaign.