Quality of life in rectal cancer patients with or without oxaliplatin in the randomised CAO/ARO/AIO-04 phase 3 trial.

Background: The CAO/ARO/AIO trial has shown that oxaliplatin added to preoperative chemoradiotherapy and postoperative chemotherapy significantly improved disease-free survival in locally advanced rectal cancer (LARC). Here, we present a post-hoc analysis of quality of life (QoL) in disease-free patients.
Patients and Methods: Between 2006 and 2010, 1236 patients with LARC were randomly assigned either to preoperative chemoradiotherapy followed by total mesorectal excision and postoperative chemotherapy (N = 623) or combined with oxaliplatin (N = 613). QoL questionnaires (EORTC QLQ-C30, colorectal module CR38) were completed at baseline, after postoperative chemotherapy and during follow-up. Analysis was performed according intent-to-treat.
Results: Available questionnaires (baseline) were 82% (N = 512) in the control and 84% (N = 513) in the investigational group. Response rates were 49% (533 of 1086) at 1 year and 43% (403 of 928) at 3 years. Global health status (GHS) for disease-free patients was stable in both groups (range 0-100). At baseline: standard arm 62.0 (mean, SD 21.6; N = 491) versus oxaliplatin arm 63.2 (mean, SD 22; N = 503); at 3 years: 69.4 (SD 19.3; N = 187) versus 65.4 (SD 22.2; N = 202). After treatment and at 3 years, no significant differences (≥10 points) between groups were found in QoL subscales. Disease-free patients experiencing neurotoxic side-effects (grade 1-4) showed reduced GHS at 3 years versus patients without neurotoxicity (mean 59.2 versus 69.3; P < 0.001), while grade 3-4 rate was low.
Conclusion: The addition of oxaliplatin was not associated with worse overall QoL. This information is of interest to patients in many ongoing rectal cancer trials.
Trial Registration Information: NCT00349076.
Competing Interests: Conflict of interest statement CR received grants from German Cancer Aid (Deutsche Krebshilfe), during the conduct of the study and reports personal fees from Roche, grants and personal fees from Sanofi-Aventis, grants from Merck-KGaA, outside the submitted work. UG received grants from German Cancer Aid (Deutsche Krebshilfe) and reports personal fees from Sirtex Medical, Boehringer Ingelheim, personal fees and non-financial support from Merck KGaA, personal fees and non-financial support from Amgen GmbH, personal fees from Hexal AG, Bristol-Meyers Squibb, Daiichi Sankyo and Servier, outside the submitted work. RF reports personal fees from Sanofi-Aventis, outside the submitted work. DA received grants and personal fess from Roche, grants and personal fees from Sanofi-Aventis, grants and personal fees from Merck KGaA, personal fees from Amgen, outside the submitted work. GGG reports grants from Fresenius-AG, outside the submitted work. GF received grants and personal fees from Merck KGaA, personal fees from Roche, personal fees from Sanofi -Aventis, personal fees from Amgen, personal fees from Lilly, outside the submitted work. MG reports grants from the University of Erlangen, Germany. SK, TL, RH, RS, RK, BP, MF report grants from German Cancer Aid (Deutsche Krebshilfe). All other authors declare no competing interests.
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