Health-related quality of life (QoL) in patients with seminoma stage I treated with either adjuvant radiotherapy (RT) or two cycles of carboplatinum chemotherapy (CT): Results of a randomized phase III trial of the German Interdisciplinary Working Party on Testicular Cancer

Abstract

5050 Background: RT and CT are efficient adjuvant therapies in seminoma stage I and were compared in this trial. Clinical results will be reported elsewhere. Secondary endpoint was to assess QoL. Materials and Methods: Pts were randomized to receive RT (5x2 Gy/wk, 26–30 Gy total dose) or carboplatinum (300–460 mg/m2, 1 h iv d 1, 29). The QLQ C30 vs. 2.0 (15 QoL dimensions) and the Testicular Tumour Questionnaire (TTQ, 16 domains) were completed at randomization (0) and 1, 4, and 12 months (m) after trial entry. QoL was compared over time within the two arms (Wilcoxon) and between treatments (Mann-Whitney) by intent-to-treat. Results: 807 pts were randomized. Questionnaire compliance was 72% at 0, 75% at 1, 69% at 4 and 70% at 12m. Sign. variation (p<0.05) in QoL over time in both treatment arms (no. of Qol domains with deterioration over time): QLQ C30: RT: m1 vs 0 9, m4 vs 0 2, m12 vs 0 0 , CT: m1 vs 0 6, m4 vs 0 3, m12 vs 0 1; TTQ: RT: m1 vs 0 4, m4 vs 0 2, m12 vs 0 3, CT: m1 vs 0 1, m4 vs 0 2, m12 vs 0 1. (¼ improvement over time): QLQ C30: RT: m1 vs 0 0, m4 vs 0 6, m12 vs 0 8, CT: m1 vs 0 2, m4 vs 0 6, m12 vs 0 10; TTQ: RT: m1 vs 0 1, m4 vs 0 2, m12 vs 0 3, CT: m1 vs 0 2, m4 vs 0 4, m12 vs 0 6. Sign. variation in QoL comparing treatment modalities: QLQ C30: Better QoL in RT: at m1 in 0, at m4 in 0 and at m12 in 0 domains, Better QoL in CT: at m1 in 11, at m4 in 2 and at m12 in 5 domains; TTQ: Better QoL in RT: at m1 in 4, at m4 in 1 and at m12 in 0 domains, Better QoL in CT: at m1 in 3, at m4 in 0 and at m12 in 2 domains. Discussion and Conclusions: Adjuvant RT has a more negative impact on self-reported QoL of seminoma pts than CT, as determined by two instruments over a period of one year. RT negatively affects more dimensions of QoL as compared to CT, especially during the early phase. Pts rapidly adapt to QoL impairment, with little change persisting at m12. Not all observed differences are clinically relevant. Potential bias and methodological limitations will be discussed. Given the presumed clinical equivalence of both modalities, pts should be aware of the more negative impact of RT on the well-being. Treatment recommendation should be based on objective outcome parameters, toxicity, logistics and QoL considerations. No significant financial relationships to disclose.