Quality of life in rectal cancer patients with or without oxaliplatin in the randomised CAO/ARO/AIO-04 phase 3 trial
Publikation: Beitrag in Fachzeitschrift › Forschungsartikel › Beigetragen › Begutachtung
Beitragende
- Arbeitsbereich Medizinische Biologie
- Universitäts KrebsCentrum Dresden
- Medizinische Klinik und Poliklinik I
- Universitätsklinikum Würzburg
- Universitätsklinikum Frankfurt
- Staatliche Berufsfachschulen am Universitätsklinikum Erlangen
- Universitätsmedizin Göttingen
- Kliniken Maria Hilf GmbH
- Asklepios Klinik Altona
- SRH Hochschule Heidelberg
- Klinikum Esslingen
- Universitätsklinikum Carl Gustav Carus Dresden
- Universitätsklinikum Freiburg
- Friedrich-Alexander-Universität Erlangen-Nürnberg
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.
Details
Originalsprache | Englisch |
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Seiten (von - bis) | 281-290 |
Seitenumfang | 10 |
Fachzeitschrift | European journal of cancer |
Jahrgang | 144 |
Publikationsstatus | Veröffentlicht - Feb. 2021 |
Peer-Review-Status | Ja |
Externe IDs
Scopus | 85098184174 |
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ORCID | /0000-0002-9321-9911/work/142251958 |
Schlagworte
Ziele für nachhaltige Entwicklung
Schlagwörter
- Adenocarcinoma, Mucinous/pathology, Aged, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Carcinoma, Signet Ring Cell/pathology, 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, Survival Rate