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Showing content from http://www.ncbi.nlm.nih.gov/pubmed/24022527 below:

Watch and wait approach following extended neoadjuvant chemoradiation for distal rectal cancer: are we getting closer to anal cancer management?

Clinical Trial

Affiliations

• ¹ 1 Angelita & Joaquim Gama Institute, Sao Paulo, Brazil 2 Clinical Oncology Division, Instituto do Cancer do Estado de São Paulo (ICESP), Sao Paulo, Brazil 3 Department of Gastroenterology, Colorectal Surgery Division, University of São Paulo School of Medicine, Sao Paulo, Brazil 4 Department of Radiology, Radiation Oncology Division, University of São Paulo School of Medicine, Sao Paulo, Brazil 5 Radiation Oncology Division, Hospital Alemão Oswaldo Cruz, Sao Paulo, Brazil 6 Ludwig Institute for Cancer Research, São Paulo Branch, Sao Paulo, Brazil.

• PMID: 24022527
• DOI: 10.1097/DCR.0b013e3182a25c4e

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Clinical Trial

Angelita Habr-Gama et al. Dis Colon Rectum. 2013 Oct.

• ¹ 1 Angelita & Joaquim Gama Institute, Sao Paulo, Brazil 2 Clinical Oncology Division, Instituto do Cancer do Estado de São Paulo (ICESP), Sao Paulo, Brazil 3 Department of Gastroenterology, Colorectal Surgery Division, University of São Paulo School of Medicine, Sao Paulo, Brazil 4 Department of Radiology, Radiation Oncology Division, University of São Paulo School of Medicine, Sao Paulo, Brazil 5 Radiation Oncology Division, Hospital Alemão Oswaldo Cruz, Sao Paulo, Brazil 6 Ludwig Institute for Cancer Research, São Paulo Branch, Sao Paulo, Brazil.

• PMID: 24022527
• DOI: 10.1097/DCR.0b013e3182a25c4e

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Background: No immediate surgery (Watch and Wait) has been considered in select patients with complete clinical response after neoadjuvant chemoradiation to avoid postoperative morbidity and functional disorders after radical surgery.

Objective: The purpose of this study was to demonstrate the long-term results of patients who had a complete clinical response following an alternative chemoradiation regimen and were managed nonoperatively.

Design: This is a prospective study.

Settings: This study was conducted at a single center.

Patients: Seventy consecutive patients with T2-4N0-2M0 distal rectal cancer were studied. Neoadjuvant chemoradiotherapy included 54 Gy and 5-fluorouracil/leucovorin delivered in 6 cycles every 21 days. Patients were assessed for tumor response at 10 weeks from radiation completion. Patients with incomplete clinical response were referred to immediate surgery. Patients with complete clinical response were not immediately operated on and were monitored.

Main outcome measures: The primary outcomes measured were the initial complete clinical response rates after 10 weeks and the sustained complete clinical response rates after 12 months from chemoradiotherapy.

Results: One patient died during chemoradiotherapy because of cardiac complications. Forty-seven (68%) patients had initial complete clinical response. Of these, 8 developed local regrowth within the first 12 months of follow-up (17%). Thirty-nine sustained complete clinical response at a median follow-up of 56 months (57%). An additional 4 patients (10%) developed late local recurrences (>12 months of follow-up). Overall, 35 patients never underwent surgery (50%).

Limitations: This study is limited by the short follow-up and small sample size.

Conclusion: Extended chemoradiation therapy with additional chemotherapy cycles and 54 Gy of radiation may result in over 50% of sustained (>12 months) complete clinical response rates that may ultimately avoid radical rectal resection. Local failures occur more frequently during the initial 12 months of follow-up in up to 17% of cases, whereas late recurrences are less common but still possible, leading to 50% of patients who never required surgery. Strict follow-up may allow salvage therapy in the majority of these patients (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A113.).

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• Transanal local excision for distal rectal cancer and incomplete response to neoadjuvant chemoradiation - does baseline staging matter?

  Perez RO, Habr-Gama A, São Julião GP, Proscurshim I, Coelho AQ, Figueiredo MN, Fernandez LM, Gama-Rodrigues J. Perez RO, et al. Dis Colon Rectum. 2014 Nov;57(11):1253-9. doi: 10.1097/DCR.0000000000000215. Dis Colon Rectum. 2014. PMID: 25285691

• Increasing the rates of complete response to neoadjuvant chemoradiotherapy for distal rectal cancer: results of a prospective study using additional chemotherapy during the resting period.

  Habr-Gama A, Perez RO, Sabbaga J, Nadalin W, São Julião GP, Gama-Rodrigues J. Habr-Gama A, et al. Dis Colon Rectum. 2009 Dec;52(12):1927-34. doi: 10.1007/DCR.0b013e3181ba14ed. Dis Colon Rectum. 2009. PMID: 19934911 Clinical Trial.

• Pathologic Complete Response in Rectal Cancer: Can We Detect It? Lessons Learned From a Proposed Randomized Trial of Watch-and-Wait Treatment of Rectal Cancer.

  Nahas SC, Rizkallah Nahas CS, Sparapan Marques CF, Ribeiro U Jr, Cotti GC, Imperiale AR, Capareli FC, Chih Chen AT, Hoff PM, Cecconello I. Nahas SC, et al. Dis Colon Rectum. 2016 Apr;59(4):255-63. doi: 10.1097/DCR.0000000000000558. Dis Colon Rectum. 2016. PMID: 26953983 Clinical Trial.

• A watch-and-wait approach for locally advanced rectal cancer after a clinical complete response following neoadjuvant chemoradiation: a systematic review and meta-analysis.

  Dossa F, Chesney TR, Acuna SA, Baxter NN. Dossa F, et al. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):501-513. doi: 10.1016/S2468-1253(17)30074-2. Epub 2017 May 4. Lancet Gastroenterol Hepatol. 2017. PMID: 28479372 Review.

• Critical appraisal of the 'wait and see' approach in rectal cancer for clinical complete responders after chemoradiation.

  Glynne-Jones R, Hughes R. Glynne-Jones R, et al. Br J Surg. 2012 Jul;99(7):897-909. doi: 10.1002/bjs.8732. Epub 2012 Apr 27. Br J Surg. 2012. PMID: 22539154 Review.

• Early MRI predictors of disease-free survival in locally advanced rectal cancer from the GRECCAR 4 trial.

  Nougaret S, Castan F, de Forges H, Vargas HA, Gallix B, Gourgou S, Rouanet P; GRECCAR Study Group. Nougaret S, et al. Br J Surg. 2019 Oct;106(11):1530-1541. doi: 10.1002/bjs.11233. Epub 2019 Aug 22. Br J Surg. 2019. PMID: 31436325 Free PMC article. Clinical Trial.

• Clinical Outcomes of Patients With Locally Advanced Rectal Cancer With Persistent Circumferential Resection Margin Invasion After Preoperative Chemoradiotherapy.

  Kim CH, Yeom SS, Kwak HD, Lee SY, Ju JK, Kim YJ, Kim HR. Kim CH, et al. Ann Coloproctol. 2019 Apr;35(2):72-82. doi: 10.3393/ac.2019.04.22. Epub 2019 Apr 30. Ann Coloproctol. 2019. PMID: 31113172 Free PMC article.

• Role of magnetic resonance imaging in organ-preserving strategies for the management of patients with rectal cancer.

  Ortega CD, Perez RO. Ortega CD, et al. Insights Imaging. 2019 May 30;10(1):59. doi: 10.1186/s13244-019-0742-6. Insights Imaging. 2019. PMID: 31147789 Free PMC article. Review.

• Organ preservation strategy: new therapeutic alternative in rectal cancer.

  Safini F, Amaoui B, Semghouli S, Aqodad N. Safini F, et al. J Egypt Natl Canc Inst. 2023 Apr 24;35(1):10. doi: 10.1186/s43046-023-00169-0. J Egypt Natl Canc Inst. 2023. PMID: 37093327 Free PMC article. Review.

• Consolidation chemotherapy during neoadjuvant chemoradiation (CRT) for distal rectal cancer leads to sustained decrease in tumor metabolism when compared to standard CRT regimen.

  Habr-Gama A, Perez RO, São Julião GP, Proscurshim I, Fernandez LM, Figueiredo MN, Gama-Rodrigues J, Buchpiguel CA. Habr-Gama A, et al. Radiat Oncol. 2016 Feb 24;11:24. doi: 10.1186/s13014-016-0598-6. Radiat Oncol. 2016. PMID: 26911200 Free PMC article. Clinical Trial.

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