Annals of Surgical Oncology

, Volume 24, Issue 7, pp 1904–1915 | Cite as

Nonoperative Management or ‘Watch and Wait’ for Rectal Cancer with Complete Clinical Response After Neoadjuvant Chemoradiotherapy: A Critical Appraisal

  • Tarik Sammour
  • Brandee A. Price
  • Kate J. Krause
  • George J. Chang
Colorectal Cancer



There is increasing interest in nonoperative management (NOM) for rectal cancer with complete clinical response (cCR) after neoadjuvant chemoradiation (nCRT).


The aim of this systematic review was to summarize the available data on NOM, with the intention of formulating standardized protocols on which to base future investigations.


A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted. A highly sensitive literature search identified all relevant studies published between January 2004 and December 2016. Data extraction and quality assessment was performed independently by two authors, and resolved by consensus with a third reviewer.


In total, 15 studies, including 920 patients, met the inclusion criteria; 575 (62.5%) of these patients underwent NOM after cCR, with the remaining patients forming a surgical control group. The weighted mean follow-up was 39.4 (12.7) months in the NOM group and 39.8 (5.1) months in the surgery group. The pooled regrowth rate in the NOM group was 21.3% at a mean of 15.6 (7.0) months. Surgical salvage was possible and was undertaken in 93.2% of these patients. Overall survival in the NOM group was 91.7%, while disease-free survival was 82.7%. For the comparison proctectomy group, pooled rates of local recurrence, overall survival, and disease-free survival were 8.4, 92.4, and 87.5%, respectively.


NOM may be a feasible option for surgically eligible rectal cancer patients with cCR after nCRT. Before such a strategy can be widely implemented, further prospective data are required with standardized definitions, diagnostic criteria, and management protocols, with an emphasis on shared patient–provider decision making and patient-centered outcomes.



This work was supported in part by the MD Anderson Cancer Center (MDACC) Cancer Center Support Grant (CCSG; P30 CA016672) and the Aman Trust for Colorectal Cancer Research and Education (GJC) and the Andrews Family Fund for Colorectal Cancer Research (GJC).

Conflicts of interest

Tarik Sammour, Brandee A. Price, Kate J. Krause, and George J. Chang declare that they have no relevant conflicts of interest.

Supplementary material

10434_2017_5841_MOESM1_ESM.docx (18 kb)
Supplementary material 1 (DOCX 19 kb)


  1. 1.
    Tural D, Selcukbiricik F, Ozturk MA, et al. The relation between pathological complete response and clinical outcome in patients with rectal cancer. Hepatogastroenterology. 2013;60(126):1365–70.PubMedGoogle Scholar
  2. 2.
    Park IJ, You YN, Agarwal A, et al. Neoadjuvant treatment response as an early response indicator for patients with rectal cancer. J Clin Oncol. 2012;30(15):1770–76.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Perez RO. Complete clinical response in rectal cancer: a turning tide. Lancet Oncol. 2016;17(2):125–6.CrossRefPubMedGoogle Scholar
  4. 4.
    Hiotis SP, Weber SM, Cohen AM, et al. Assessing the predictive value of clinical complete response to neoadjuvant therapy for rectal cancer: an analysis of 488 patients. J Am Coll Surg. 2002;194(2):131–5; discussion 135–136.Google Scholar
  5. 5.
    Neuman HB, Elkin EB, Guillem JG, et al. Treatment for patients with rectal cancer and a clinical complete response to neoadjuvant therapy: a decision analysis. Dis Colon Rectum. 2009;52(5):863–71.CrossRefPubMedGoogle Scholar
  6. 6.
    Minsky BD. Rectal cancer: is ‘watch and wait’ a safe option for rectal cancer? Nat Rev Gastroenterol Hepatol. 2013;10(12):698–700.CrossRefPubMedGoogle Scholar
  7. 7.
    Glynne-Jones R, Wallace M, Livingstone JI, Meyrick-Thomas J. Complete clinical response after preoperative chemoradiation in rectal cancer: is a “wait and see” policy justified? Dis Colon Rectum. 2008;51(1):10–19; discussion 19-20.Google Scholar
  8. 8.
    Singh-Ranger G, Kumar D. Current concepts in the non-operative management of rectal cancer after neoadjuvant chemoradiation. Anticancer Res. 2011;31(5):1795–1800.PubMedGoogle Scholar
  9. 9.
    Glynne-Jones R, Hughes R. Complete response after chemoradiotherapy in rectal cancer (watch-and-wait): have we cracked the code? Clin Oncol. 2016;28(2):152–160.CrossRefGoogle Scholar
  10. 10.
    Chang GJ. Simulating watch and wait for rectal cancer. Dis Colon Rectum. 2015;58(2):155–56.CrossRefPubMedGoogle Scholar
  11. 11.
    Smith FM, Rao C, Oliva Perez R, et al. Avoiding radical surgery improves early survival in elderly patients with rectal cancer, demonstrating complete clinical response after neoadjuvant therapy: results of a decision-analytic model. Dis Colon Rectum. 2015;58(2):159–71.CrossRefPubMedGoogle Scholar
  12. 12.
    Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Appelt AL, Ploen J, Harling H, et al. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015;16(8):919–27.CrossRefPubMedGoogle Scholar
  14. 14.
    Araujo RO, Valadao M, Borges D, et al. Nonoperative management of rectal cancer after chemoradiation opposed to resection after complete clinical response. A comparative study. Eur J Surg Oncol. 2015;41(11):1456–63.CrossRefPubMedGoogle Scholar
  15. 15.
    Creavin B, Ryan E, Martin ST, et al. Organ preservation with local excision or active surveillance following chemoradiotherapy for rectal cancer. Br J Cancer. 2017;116(2):169–74.CrossRefPubMedGoogle Scholar
  16. 16.
    Dalton RS, Velineni R, Osborne ME, et al. A single-centre experience of chemoradiotherapy for rectal cancer: is there potential for nonoperative management? Colorectal Dis. 2012;14(5):567–71.CrossRefPubMedGoogle Scholar
  17. 17.
    Habr-Gama A, Gama-Rodrigues J, Sao Juliao GP, et al. Local recurrence after complete clinical response and watch and wait in rectal cancer after neoadjuvant chemoradiation: impact of salvage therapy on local disease control. Int J Radiat Oncol Biol Phys. 2014;88(4):822–28.CrossRefPubMedGoogle Scholar
  18. 18.
    Habr-Gama A, Perez RO, Sabbaga J, Nadalin W, Sao Juliao GP, Gama-Rodrigues J. 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. Dis Colon Rectum. 2009;52(12):1927–34.CrossRefPubMedGoogle Scholar
  19. 19.
    Lai CL, Lai MJ, Wu CC, Jao SW, Hsiao CW. Rectal cancer with complete clinical response after neoadjuvant chemoradiotherapy, surgery, or “watch and wait”. Int J Colorectal Dis. 2016;31(2):413–19.CrossRefPubMedGoogle Scholar
  20. 20.
    Lee SY, Kim CH, Kim YJ, Kim HR. Oncologic outcomes according to the treatment strategy in radiologic complete responders after neoadjuvant chemoradiation for rectal cancer. Oncology. 2015;89(6):311–18.CrossRefPubMedGoogle Scholar
  21. 21.
    Martens MH, Maas M, Heijnen LA, et al. Long-term outcome of an organ preservation program after neoadjuvant treatment for rectal cancer. J Natl Cancer Inst. 2016;108(12).Google Scholar
  22. 22.
    Nahas SC, Rizkallah Nahas CS, Sparapan Marques CF, et al. 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. Dis Colon Rectum. 2016;59(4):255–63.CrossRefPubMedGoogle Scholar
  23. 23.
    Renehan AG, Malcomson L, Emsley R, et al. Watch-and-wait approach versus surgical resection after chemoradiotherapy for patients with rectal cancer (the OnCoRe project): a propensity-score matched cohort analysis. Lancet Oncol. 2016;17(2):174–83.CrossRefPubMedGoogle Scholar
  24. 24.
    Sanchez Loria F, Iseas S, O’Connor JM, et al. Non-surgical management of rectal cancer. Series of 68 cases, long follow up in two leading centres in Argentina. Dig Liver Dis. 2016;48(11):1372–77.CrossRefPubMedGoogle Scholar
  25. 25.
    Smith JD, Ruby JA, Goodman KA, et al. Nonoperative management of rectal cancer with complete clinical response after neoadjuvant therapy. Ann Surg. 2012;256(6):965–72.CrossRefPubMedGoogle Scholar
  26. 26.
    Smith RK, Fry RD, Mahmoud NN, Paulson EC. Surveillance after neoadjuvant therapy in advanced rectal cancer with complete clinical response can have comparable outcomes to total mesorectal excision. Int J Colorectal Dis. 2015;30(6):769–74.CrossRefPubMedGoogle Scholar
  27. 27.
    Vaccaro CA, Yazyi FJ, Ojra Quintana G, et al. Locally advanced rectal cancer: Preliminary results of rectal preservation after neoadjuvant chemoradiotherapy. Cir Esp. 2016;94(5):274–79.CrossRefPubMedGoogle Scholar
  28. 28.
    Das P, Minsky BD. A watch-and-wait approach to the management of rectal cancer. Oncology (Williston Park). 2013;27(10):962–68.PubMedGoogle Scholar
  29. 29.
    Smith FM, Chang KH, Sheahan K, Hyland J, O’Connell PR, Winter DC. The surgical significance of residual mucosal abnormalities in rectal cancer following neoadjuvant chemoradiotherapy. Br J Surg. 2012;99(7):993–1001.CrossRefPubMedGoogle Scholar
  30. 30.
    Smith FM, Wiland H, Mace A, Pai RK, Kalady MF. Clinical criteria underestimate complete pathological response in rectal cancer treated with neoadjuvant chemoradiotherapy. Dis Colon Rectum. 2014;57(3):311–15.CrossRefPubMedGoogle Scholar

Copyright information

© Society of Surgical Oncology 2017

Authors and Affiliations

  • Tarik Sammour
    • 1
  • Brandee A. Price
    • 1
  • Kate J. Krause
    • 2
  • George J. Chang
    • 1
    • 3
  1. 1.Department of Surgical OncologyThe University of Texas MD Anderson Cancer CenterHoustonUSA
  2. 2.Research Medical LibraryThe University of Texas MD Anderson Cancer CenterHoustonUSA
  3. 3.Department of Health Services ResearchThe University of Texas MD Anderson Cancer CenterHoustonUSA

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