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

Abstract

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.

• Authors: Rebekka Kosmala, Emmanouil Fokas, Michael Flentje, Rolf Sauer, Torsten Liersch, Ullrich Graeven, Rainer Fietkau, Werner Hohenberger, Dirk Arnold, Ralf-Dieter Hofheinz, Michael Ghadimi, Philipp Ströbel, Ludger Staib, Gerhard G Grabenbauer, Gunnar Folprecht, Simon Kirste, Wolfgang Uter, Christine Gall, Claus Rödel, Bülent Polat, of the German Rectal Cancer Study Group
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 144 Pg. 281-290 (02 2021) ISSN: 1879-0852 [Electronic] England
• PMID: 33383348 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 Elsevier Ltd. All rights reserved.

Chemical References

• Oxaliplatin
• Fluorouracil

Topics

• Adenocarcinoma, Mucinous (pathology, psychology, therapy)
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Signet Ring Cell (pathology, psychology, therapy)
• Chemoradiotherapy (mortality)
• Chemotherapy, Adjuvant (mortality)
• Female
• Fluorouracil (administration & dosage)
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Neoadjuvant Therapy (mortality)
• Oxaliplatin (administration & dosage)
• Prognosis
• Quality of Life
• Rectal Neoplasms (pathology, psychology, therapy)
• Survival Rate