D1-07: Cochrane systematic review of platinum vs non-platinum chemotherapy regimes for small cell lung cancer

Abstract

plus best supportive care (OT+ BSC) versus best supportive care (BSC) alone using the EQ-5D assessment in a clinical trial in SCLC. Information from ongoing studies supports that a minimal important difference (MID) in lung cancer of 0.08 can be used to further interpret results obtained for EQ-5D Index. Methods: Data were analyzed from a randomized, open-label, multicenter trial in 141 SCLC patients receiving either OT+BSC or BSC alone where health status was assessed by patient self-report using the EQ-5D Index and the EQ-5D Visual Analogue Scale (VAS). EQ-5D is a questionnaire that covers multi-attribute health outcomes, including mobility, self-care, usual activity, pain/discomfort, and anxiety/depression, as an overall measurement of patient health status. The Index is scored on a scale from 0 (dead) to 1 (perfect health), and the VAS scores range from 0 (worst health) to 100 (best health). The EQ-5D measures were administered at baseline and at 3-week intervals at subsequent four visits. Change from baseline in EQ-5D Index and EQ-5D-VAS was assessed using a pooled analysis (change from baseline to averaged on-treatment assessments) and also considering only change from baseline to last evaluation. Rate of change in EQ-5D Index scores (rate at which symptoms improved or deteriorated) across treatment groups was analyzed using a mixed model to account for repeated measurements over the treatment course. Results: A significantly smaller decline in EQ-5D Index and VAS change scores were observed for the OT+BSC than BSC groups in both pooled and last evaluation analyses (Table ). The rate of change from baseline per 3-month interval for EQ-5D Index score was -0.05 (95% CI: -0.11, 0.02) for OT+BSC and -.20 (95% CI, -0.27, -0.12) for BSC, indicating a decline for both groups, but a significantly slower decline for OT+BSC.