{"doi":"10.1007/s11136-024-03746-5","title":"Overall side effect assessment of oxaliplatin toxicity in rectal cancer patients in NRG oncology/NSABP R04","abstract":"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.","journal":"Quality of Life Research","year":2024,"id":468713,"datarank":0.2252608912005024,"base_score":1.3862943611198906,"endowment":1.3862943611198906,"self_citation_contribution":0.20794415416798362,"citation_network_contribution":0.0173167370325188,"self_endowment_contribution":0.20794415416798362,"citer_contribution":0.0173167370325188,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":2,"citers_with_citation_signal":1,"citers_with_endowment":1,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9618,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT00058474"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":516539,"name":"Jessica Roydhouse","orcid":"0000-0002-8025-5841","position":1,"is_corresponding":false},{"id":465524,"name":"Mourad Tighiouart","orcid":"0000-0001-8021-5690","position":2,"is_corresponding":false},{"id":420450,"name":"N. Lynn Henry","orcid":"0000-0002-4771-5930","position":3,"is_corresponding":false},{"id":465523,"name":"Sungjin Kim","orcid":"0000-0002-1150-703X","position":4,"is_corresponding":false},{"id":453463,"name":"Ron D. Hays","orcid":"0000-0001-6697-907X","position":5,"is_corresponding":false},{"id":465526,"name":"André Rogatko","orcid":"0000-0001-8935-8890","position":6,"is_corresponding":false},{"id":465525,"name":"Greg Yothers","orcid":"0000-0002-7965-7333","position":7,"is_corresponding":false},{"id":514402,"name":"Peter Ganz","orcid":"0000-0002-0437-8882","position":8,"is_corresponding":false},{"id":445512,"name":"John Devin Peipert","orcid":"0000-0001-5762-7881","position":0,"is_corresponding":true}],"reference_count":36,"raw_metadata":null,"created_at":"2026-07-19T02:05:23.500722Z","pmid":"39080091","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}