Quality of life (QOL) impact of adjuvant chemotherapy for early stage non-small cell lung cancer (NSCLC): Final analysis of JBR.10 randomized trial

Abstract

7585 Background: Adjuvant chemotherapy for early stage NSCLC is now standard of care, but its impact on QOL is not known. We report the final QOL analysis of JBR.10, a North American intergroup randomized trial of adjuvant cisplatin/vinorelbine compared to observation in patients (pts) with completely resected stage IB/II NSCLC (n=482). Methods: QOL, a secondary endpoint of JBR.10, was assessed using the EORTC QLQ-C30 and a trial-specific checklist at baseline, weeks 5 and 9 for those on chemotherapy, and at 3, 6, 9, 12, 18, 24, 30 and 36 months of follow up. A 10-point change in QOL scores from baseline was considered clinically significant. Results: QOL assessment was not mandatory for all pts; 186/242 (76.9%) pts randomized to chemotherapy completed the baseline QOL assessment, compared to 173/240 (72.1%) pts on the observation arm. The overall survival of pts contributing QOL data, and the effect of adjuvant chemotherapy, was not different from the entire study population. Baseline QOL in the two study arms was comparable, with low global QOL scores and a significant symptom burden, especially pain and fatigue, following thoracotomy. A significantly greater proportion of chemotherapy pts experienced worsening symptoms including fatigue (p=0.02), appetite, hair loss, nausea and vomiting. At 6 months, a higher proportion of pts on the observation arm reported improved QOL in the global (p = 0.002), physical (p=0.02) and functional domains, compared to pts on the chemotherapy arm. However, by the 9 month time-point, global QOL of patients on chemotherapy was comparable to QOL of patients on observation, as were the five functional domains. Numbness (change scores: 22 vs 6, p<0.01) and pins & needles in fingers/toes (change scores: 21 vs 5, p<0.01) were the only symptoms that persisted, up to 24 months. Conclusion: Patients on adjuvant chemotherapy experience an initial slower recovery of QOL after thoracotomy, but following completion of treatment reach levels comparable to patients treated with surgery alone, in most aspects of QOL. [Table: see text]