Overall side effect assessment of oxaliplatin toxicity in rectal cancer patients in NRG oncology/NSABP R04.

Autor: Peipert JD; Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 625 Michigan Ave, 22nd Floor, Chicago, IL, 60611, USA. john.peipert@northwestern.edu., Roydhouse J; Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia., Tighiouart M; Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA., Henry NL; University of Michigan Medical School, Ann Arbor, MI, USA., Kim S; Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA., Hays RD; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, CA, USA., Rogatko A; Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA., Yothers G; University of Pittsburgh and NRG Oncology, Pittsburgh, PA, USA., Ganz PA; Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, CA, USA.; Department of Medicine (Hematology/Oncology), David Geffen School of Medicine at University of California, Los Angeles, CA, USA.
Jazyk: angličtina
Zdroj: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation [Qual Life Res] 2024 Nov; Vol. 33 (11), pp. 3069-3079. Date of Electronic Publication: 2024 Jul 30.
DOI: 10.1007/s11136-024-03746-5
Abstrakt: Purpose: Regulatory guidance suggests capturing patient-reported overall side effect impact in cancer trials. We examined whether the Functional Assessment of Cancer Therapy (FACT) GP5 item ("I am bothered by side effects of treatment") post-neoadjuvant chemotherapy/radiotherapy differed between oxaliplatin vs. non- oxaliplatin arms in the National Surgical Adjuvant Breast and Bowel Project (NSABP) R-04 trial of stage II-III rectal cancer patients.
Methods: The R-04 neoadjuvant trial compared local-regional tumor control between patients randomized to receive 5-fluorouracil or capecitabine with radiation, with or without oxaliplatin (4 treatment arms). Participants completed surveys at baseline and immediately after chemoradiotherapy. GP5 has a 5-point response scale: "Not at all" (0), "A little bit" (1), "Somewhat" (2), "Quite a bit" (3), and "Very much" (4). Logistic regression compared the odds of reporting moderate-high side effect impact (GP5 2-4) between patients receiving oxaliplatin or not after chemoradiotherapy, controlling for relevant patient characteristics. We examined associations between GP5 and other patient-reported outcomes reflecting side effects.
Results: Analyses were performed among 1132 study participants. Participants receiving oxaliplatin were 1.58 times (95% CI: 1.22-2.05) more likely to report moderate-high side effect bother at post-chemotherapy/radiation. In both arms, worse overall side effect impact was associated with patient-reported diarrhea, nausea, vomiting, and peripheral sensory neuropathy (p < 0.01 for all).
Conclusion: This secondary analysis of R-04 found that GP5 distinguished between patients receiving oxaliplatin or not as part of their post-neoadjuvant chemoradiotherapy, adding patient-centric evidence on the reduced tolerability of oxaliplatin and demonstrating that GP5 is sensitive to known toxicity differences between treatments.
Clinicaltrials: GOV: NCT00058474.
(© 2024. The Author(s).)
Databáze: MEDLINE
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