“Quality of Life (QoL) in the Randomised HD10-12 Trials of the German Hodgkin Study Group (GHSG): Sexual Functions (SX) in Hodgkin Lymphoma (HL) Patients Decrease by Disease Stage and Improve After Therapy Depending On Stage and Treatment Modality.”.

Abstract 896 Purpose: Current research in HL is focusing on long-term consequences of therapy. Among these, especially health related quality of life (HRQoL) needs thorough investigation since it becomes increasingly important for HL survivors. HRQoL is complex and incorporates different aspects such as general QoL, fatigue, emotional, physical, role, social, cognitive, and sexual functions. In this analysis, we focus on sexual functions (SX) in the HD10-12 trials of the GHSG and the influence of stage, treatment modality, social relationships (SF), and fatigue (FA). Methods: Between 1998 and 2002, the GHSG has conducted the fourth generation of clinical trials for the treatment of early favourable, early unfavourable and advanced stage HL (HD 10-12) involving a total of 4610 patients. Patients completed the QLQ-C30, the MFI20 and additional items for SX at the time of diagnosis, after chemotherapy, after radiotherapy, and at follow-up examinations. We describe SX with means and 95%-CI for each measurement point and compare them with t-tests when appropriate. In multiple regressions, we analysed the role of the following prespecified set of predictors on SX at baseline: sex, age, stage, FA, and SF. These predictors were also included in the analyses on SX 2 years after treatment and further supplemented with SX baseline score and treatment modality. Full information maximum likelihood estimations (FIML) were used to account for missing data. Results: QoL data from 919 patients in early favourable (HD10), 1065 patients in early unfavourable (HD11), and 1126 patients in advanced stages (HD12) were analysed. For patients included in HD10, mean SX before and after therapy were equally high in both treatment arms. Initial SX scores for patients enrolled into HD11 and HD12 were significantly lower than in the HD10 trial (p<.001). In HD11, the SX scores after 2 years remarkably improved compared to the initial values (p<.001) and, interestingly, reached the same level as in HD10. In contrast, SX scores in HD12 also significantly improved after two years (p<.05) but improvement was lower and did not reach the same level as in HD10 and HD11. With regard to the randomly assigned treatment modalities in HD10 (4xABVD vs. 2xABVD) and HD12 (8xBEACOPPescalated vs. 4xBEACOPPescalated + 4xBEACOPPbaseline), SX scores did not differ after 2 years. However, in HD11, the SX scores 2 years after 4xBEACOPPbaseline were significantly lower (p<.05) compared with 4xABVD after adjustment for sex, age, and initial SX scores. At baseline, SX was significantly related to age, sex and stage, as well as to FA and SF. For SX after 2 years, the initial SX scores, age, FA, and SF were the strongest, significant predictors. Conclusion: This large prospective study shows that sexual functions are influenced by the lymphoma itself, treatment modality, age, fatigue, and social relationships. Sexual functions significantly improved after 2 years compared to baseline. Thus, patients with HL can expect that their sexual life after therapy will at least be as satisfying as before. ABVD led to more favourable sexual functioning than BEACOPP, probably due to less therapy-induced gonadal toxicity. In further studies, we will investigate the impact of chemotherapy on sex hormon levels and their influence on sexual life. Disclosures: No relevant conflicts of interest to declare.