دورية أكاديمية
Compliance and Toxicity of Total Neoadjuvant Therapy for Rectal Cancer: A Secondary Analysis of the OPRA Trial.
العنوان: | Compliance and Toxicity of Total Neoadjuvant Therapy for Rectal Cancer: A Secondary Analysis of the OPRA Trial. |
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المؤلفون: | Verheij FS; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York., Omer DM; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York., Lin ST; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York., Yuval JB; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York., Thompson HM; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York., Kim JK; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York., Valdivieso SC; Columbia University College of Physicians and Surgeons at Harlem Hospital, New York, New York., Qin LX; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York., Wu AJ; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Saltz LB; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York., Garcia-Aguilar J; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: garciaaj@mskcc.org. |
المصدر: | International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2024 Jan 01; Vol. 118 (1), pp. 115-123. Date of Electronic Publication: 2023 Aug 05. |
نوع المنشور: | Randomized Controlled Trial; Journal Article |
اللغة: | English |
بيانات الدورية: | Publisher: Elsevier, Inc Country of Publication: United States NLM ID: 7603616 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-355X (Electronic) Linking ISSN: 03603016 NLM ISO Abbreviation: Int J Radiat Oncol Biol Phys Subsets: MEDLINE |
أسماء مطبوعة: | Publication: New York, NY : Elsevier, Inc Original Publication: Elmsford, N. Y., Pergamon Press. |
مواضيع طبية MeSH: | Neoadjuvant Therapy*/adverse effects , Neoadjuvant Therapy*/methods , Rectal Neoplasms*/pathology, Humans ; Capecitabine ; Oxaliplatin/adverse effects ; Fluorouracil ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Chemoradiotherapy/adverse effects ; Chemoradiotherapy/methods ; Leucovorin/adverse effects ; Patient Compliance ; Neoplasm Staging ; Treatment Outcome |
مستخلص: | Purpose: Patients with locally advanced rectal cancer treated with total neoadjuvant therapy (TNT) may achieve organ preservation without a compromise to oncologic outcomes. However, reports on patient compliance with TNT and with treatment-related toxicities are limited. Methods and Materials: The OPRA trial assessed organ preservation rates and oncologic outcomes in patients with clinical stage II/III rectal adenocarcinoma randomized to induction chemotherapy followed by chemoradiation (INCT-CRT) or chemoradiation followed by consolidation chemotherapy (CRT-CNCT). Systemic chemotherapy consisted of 8 cycles (16 weeks) of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or 5 cycles (15 weeks) of capecitabine and oxaliplatin (CAPEOX). Patients received >4500 cGy of radiation with sensitizing capecitabine or fluorouracil. In this report, we compare compliance and treatment-related toxicity in patients receiving INCT-CRT versus CRT-CNCT. Additionally, we evaluate the association of compliance to chemotherapy, compliance to chemoradiation, and toxicity with organ preservation and disease-free survival (DFS). Results: Of the 324 patients randomized, fewer patients started chemoradiation in the INCT-CRT group compared with the CRT-CNCT group (93% vs 98%, P = .03), and fewer patients started systemic chemotherapy in the CRT-CNCT group compared with the INCT-CRT group (94% vs 99%, P = .04). Order of TNT did not affect the ability to complete all intended cycles of FOLFOX (86% INCT-CRT vs 83% CRT-CNCT, P = .60) or CAPEOX (74% INCT-CRT vs 77% CRT-CNCT, P = .80). A total of 97% of INCT and 98% of CRT-CNCT patients received >4500 cGy radiation (P = .93). Sixty-four patients (41%) treated with INCT-CRT and 57 CRT-CNCT patients (34%) experienced a grade 3+ adverse event (P = .30). Compliance and toxicity were not associated with organ preservation or DFS. Conclusions: We identified only minor differences in treatment compliance between patients treated with INCT-CRT and CRT-CNCT. No difference in adverse events was observed between groups. Treatment compliance and toxicity did not correlate with organ preservation rates or DFS. (Copyright © 2023 Elsevier Inc. All rights reserved.) |
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معلومات مُعتمدة: | P30 CA008748 United States CA NCI NIH HHS; R01 CA182551 United States CA NCI NIH HHS; T32 CA009501 United States CA NCI NIH HHS |
المشرفين على المادة: | 6804DJ8Z9U (Capecitabine) 04ZR38536J (Oxaliplatin) U3P01618RT (Fluorouracil) Q573I9DVLP (Leucovorin) |
تواريخ الأحداث: | Date Created: 20230806 Date Completed: 20231206 Latest Revision: 20240426 |
رمز التحديث: | 20240426 |
مُعرف محوري في PubMed: | PMC11027192 |
DOI: | 10.1016/j.ijrobp.2023.07.043 |
PMID: | 37544412 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1879-355X |
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DOI: | 10.1016/j.ijrobp.2023.07.043 |