دورية أكاديمية
Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy.
| العنوان: | Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy. |
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| المؤلفون: | Garcia-Aguilar J; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Patil S; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY., Gollub MJ; Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY., Kim JK; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Yuval JB; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Thompson HM; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Verheij FS; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Omer DM; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Lee M; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Dunne RF; Department of Medicine, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY., Marcet J; Division of Colon and Rectal Surgery, Department of Surgery, University of South Florida, Tampa, FL., Cataldo P; Division of General Surgery, Department of Surgery, University of Vermont, Burlington, VT., Polite B; Department of Medicine, Comprehensive Cancer Center, University of Chicago, Chicago, IL., Herzig DO; Division of Gastrointestinal and General Surgery, Oregon Health and Science University, Portland, OR., Liska D; Department of Colorectal Surgery, Cleveland Clinic, Cleveland, OH., Oommen S; Division of Gastrointestinal Oncology, John Muir Cancer Institute, John Muir Health, Walnut Creek, CA., Friel CM; Division of General Surgery, Department of Surgery, University of Virginia, Charlottesville, VA., Ternent C; Department of Surgery, Colorectal Service at Bergan Mercy Medical Center, Omaha, NE., Coveler AL; Department of Medicine, Fred Hutch Cancer Center, University of Washington, Seattle, WA., Hunt S; Department of Surgery, Washington University School of Medicine, St Louis, MO., Gregory A; Department of Surgery, St Joseph Hospital Orange County, Orange, CA., Varma MG; Section of Colon and Rectal Surgery, Department of Surgery, University of California, San Francisco, San Francisco, CA., Bello BL; Division of Colorectal Surgery, Department of Surgery, Medstar Washington Hospital Center, Washington, DC., Carmichael JC; Division of Colon and Rectal Surgery, Department of Surgery, University of California, Irvine, Irvine, CA., Krauss J; Department of Medicine, Rogel Cancer Center at the University of Michigan, Ann Arbor, MI., Gleisner A; Division of Surgical Oncology, Department of Surgery, University of Colorado, Denver, CO., Paty PB; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Weiser MR; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Nash GM; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Pappou E; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Guillem JG; Division of Gastrointestinal Surgery, Department of Surgery, University of North Carolina, Chapel Hill, NC., Temple L; Division of Colorectal Surgery, Department of Surgery, University of Rochester Medical Center, Rochester, NY., Wei IH; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Widmar M; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Lin S; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY., Segal NH; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY., Cercek A; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY., Yaeger R; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY., Smith JJ; Department of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, NY., Goodman KA; Department of Radiation Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY., Wu AJ; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY., Saltz LB; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY. |
| المصدر: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2022 Aug 10; Vol. 40 (23), pp. 2546-2556. Date of Electronic Publication: 2022 Apr 28. |
| نوع المنشور: | Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology Original Publication: New York, N.Y. : Grune & Stratton, c1983- |
| مواضيع طبية MeSH: | Adenocarcinoma*/drug therapy , Rectal Neoplasms*/drug therapy , Rectal Neoplasms*/pathology, Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Capecitabine ; Chemoradiotherapy ; Disease-Free Survival ; Fluorouracil ; Humans ; Neoadjuvant Therapy/adverse effects ; Neoplasm Staging ; Organ Preservation ; Oxaliplatin ; Prospective Studies |
| مستخلص: | Purpose: Prospective data on the efficacy of a watch-and-wait strategy to achieve organ preservation in patients with locally advanced rectal cancer treated with total neoadjuvant therapy are limited. Methods: In this prospective, randomized phase II trial, we assessed the outcomes of 324 patients with stage II or III rectal adenocarcinoma treated with induction chemotherapy followed by chemoradiotherapy (INCT-CRT) or chemoradiotherapy followed by consolidation chemotherapy (CRT-CNCT) and either total mesorectal excision (TME) or watch-and-wait on the basis of tumor response. Patients in both groups received 4 months of infusional fluorouracil-leucovorin-oxaliplatin or capecitabine-oxaliplatin and 5,000 to 5,600 cGy of radiation combined with either continuous infusion fluorouracil or capecitabine during radiotherapy. The trial was designed as two stand-alone studies with disease-free survival (DFS) as the primary end point for both groups, with a comparison to a null hypothesis on the basis of historical data. The secondary end point was TME-free survival. Results: Median follow-up was 3 years. Three-year DFS was 76% (95% CI, 69 to 84) for the INCT-CRT group and 76% (95% CI, 69 to 83) for the CRT-CNCT group, in line with the 3-year DFS rate (75%) observed historically. Three-year TME-free survival was 41% (95% CI, 33 to 50) in the INCT-CRT group and 53% (95% CI, 45 to 62) in the CRT-CNCT group. No differences were found between groups in local recurrence-free survival, distant metastasis-free survival, or overall survival. Patients who underwent TME after restaging and patients who underwent TME after regrowth had similar DFS rates. Conclusion: Organ preservation is achievable in half of the patients with rectal cancer treated with total neoadjuvant therapy, without an apparent detriment in survival, compared with historical controls treated with chemoradiotherapy, TME, and postoperative chemotherapy. |
| التعليقات: | Comment in: J Clin Oncol. 2022 Aug 10;40(23):2515-2519. (PMID: 35724356) Comment in: J Clin Oncol. 2023 Jan 10;41(2):416-417. (PMID: 36126234) Comment in: J Clin Oncol. 2023 Jan 10;41(2):415-416. (PMID: 36126238) Comment in: J Clin Oncol. 2023 Jan 10;41(2):417. (PMID: 36126242) Comment in: Int J Radiat Oncol Biol Phys. 2023 Mar 1;115(3):545-552. (PMID: 36725162) |
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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 |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02008656 |
| المشرفين على المادة: | 04ZR38536J (Oxaliplatin) 6804DJ8Z9U (Capecitabine) U3P01618RT (Fluorouracil) |
| تواريخ الأحداث: | Date Created: 20220428 Date Completed: 20220809 Latest Revision: 20240207 |
| رمز التحديث: | 20240207 |
| مُعرف محوري في PubMed: | PMC9362876 |
| DOI: | 10.1200/JCO.22.00032 |
| PMID: | 35483010 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1527-7755 |
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| DOI: | 10.1200/JCO.22.00032 |