Watch-and-wait Therapeutic Approach in Locally Advanced Rectal Cancer: An Innovative or Inevitable Option for Rectal Preservation

Document Type : Review Article

Authors

1 School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

2 Department of Radiation Oncology, Howard University Hospital, 2401 Georgia Avenue, NW Suite BA-07, Washington, DC 20060, USA

3 Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

Abstract

Neoadjuvant chemoradiation followed by total mesorectal excision through a low anterior resection (LAR) or abdominoperineal resection (APR) is considered the standard treatment approach in most patients with locally advanced rectal cancer. While LAR allows for anatomic rectal preservation, APR leads to significant morbidity and compromised quality of life in rectal cancer patients. Approximately 10-40% of patients achieve clinical complete response (cCR) following neoadjuvant chemoradiation. Meanwhile, the pathologic complete response (pCR) rate is usually less than the cCR rate. The complete response rate may be improved by escalating the radiation dose and optimizing (total) neoadjuvant chemotherapy. Therefore, at least one-fifth of patients will have the chance of rectal preservation using the watch-and-wait strategy. In this therapeutic strategy, patients should be followed up by an active surveillance protocol to detect early tumor regrowth and undergo salvage radical surgery and will, therefore, provide comparable oncologic outcomes to those achieved in patients who undergo initial radical surgery. This study aimed to review the most recent evidence and guidelines regarding the watch-and-wait therapeutic strategy in patients with rectal cancer.

Keywords


  1. Xi Y, Xu P. Global colorectal cancer burden in 2020 and projections to 2040. Translational Oncology. 2021;14(10):101174.
  2. Roshandel G, Ferlay J, Ghanbari- Motlagh A, Partovipour E, Salavati F, Aryan K, et al. Cancer in Iran 2008 to 2025: Recent incidence trends and short-term predictions of the future burden. International Journal of Cancer. 2021;149(3):594-605.
  3. Mohammadianpanah M. Colorectal cancer incidence: does Iran follow the West? Iranian Journal of Colorectal Research. 2015;3(1):0-.
  4. Keller DS, Berho M, Perez RO, Wexner SD, Chand M. The multidisciplinary management of rectal cancer. Nature Reviews Gastroenterology & Hepatology. 2020;17(7):414-29.
  5. Bananzadeh A, Hafezi AA, Nguyen N, Omidvari S, Mosalaei A, Ahmadloo N, et al. Efficacy and safety of sequential
    neoadjuvant chemotherapy and shortcourse radiation therapy followed by delayed surgery in locally advanced
    rectal cancer: a single-arm phase II clinical trial with subgroup analysis between the older and young patients.
    Radiat Oncol J. 2021;39(4):270-8.
  6. Alves A, Panis Y, Mathieu P, Mantion G, Kwiatkowski F, Slim K, et al. Postoperative Mortality and Morbidity in French Patients Undergoing Colorectal Surgery: Results of a Prospective Multicenter
    Study. Archives of Surgery. 2005;140(3):278-83.
  7. van der Valk MJM, Hilling DE, Bastiaannet E, Meershoek-Klein Kranenbarg E, Beets GL, Figueiredo NL, et al. Long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer in the International Watch & Wait Database (IWWD): an international multicentre registry study. Lancet. 2018;391(10139):2537-45.
  8. van der Pas MH, Haglind E, Cuesta MA, Fürst A, Lacy AM, Hop WC, et al. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013;14(3):210-8.
  9. Vennix S, Pelzers L, Bouvy N, Beets GL, Pierie JP, Wiggers T, et al. Laparoscopic versus open total mesorectal excision for rectal cancer. Cochrane Database Syst Rev. 2014(4):Cd005200.
  10. Podda M, Sylla P, Baiocchi G, Adamina M, Agnoletti V, Agresta F, et al. Multidisciplinary management of elderly patients with rectal cancer: recommendations from the SICG (Italian Society of Geriatric Surgery), SIFIPAC (Italian Society of Surgical Pathophysiology), SICE (Italian Society of Endoscopic Surgery and new technologies), and the WSES (World Society of Emergency Surgery) International Consensus Project. World J Emerg Surg. 2021;16(1):35.
  11. Teo MTW, McParland L, Appelt AL, Sebag-Montefiore D. Phase 2 Neoadjuvant Treatment Intensification Trials in Rectal Cancer: A Systematic Review. Int J Radiat Oncol Biol Phys. 2018;100(1):146-58.
  12. De Caluwé L, Van Nieuwenhove Y, Ceelen WP. Preoperative chemoradiation versus radiation alone for stage II and III resectable rectal cancer. Cochrane Database Syst Rev. 2013(2):Cd006041.
  13. Bitterman DS, Resende Salgado L, Moore HG, Sanfilippo NJ, Gu P, Hatzaras I, et al. Predictors of Complete Response and Disease Recurrence Following Chemoradiation for Rectal Cancer. Front Oncol. 2015;5:286.
  14. Ngan SY, Burmeister B, Fisher RJ, Solomon M, Goldstein D, Joseph D, et al. Randomized Trial of Short-Course
    Radiotherapy Versus Long-Course Chemoradiation Comparing Rates of Local Recurrence in Patients With T3 Rectal Cancer: Trans-Tasman Radiation Oncology Group Trial 01.04. Journal of Clinical Oncology. 2012;30(31):3827-33.
  15. Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, et al. Shortcourse radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, openlabel, phase 3 trial. Lancet Oncol. 2021;22(1):29-42.
  16. Appelt AL, Pløen J, Harling H, Jensen FS, Jensen LH, Jørgensen JC, et al. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015;16(8):919-27.
  17. Garcia-Aguilar J, Patil S, Gollub MJ, Kim JK, Yuval JB, Thompson HM, et al. Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy. Journal of Clinical Oncology. 2022;40(23):2546-56.
  18. Aref A, Abdalla A. Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: Induction or Consolidation
    Chemotherapy? Journal of Clinical Oncology. 2022;40(23):2515-9.
  19. Hearn N, Atwell D, Cahill K, Elks J, Vignarajah D, Lagopoulos J, et al. Neoadjuvant Radiotherapy Dose Escalation in Locally Advanced Rectal Cancer: a Systematic Review and Meta-analysis of Modern Treatment Approaches and Outcomes. Clin Oncol (R Coll Radiol). 2021;33(1):e1-e14.
  20. Omidvari S, Zohourinia S, Ansari M, Ghahramani L, Zare-Bandamiri M, Mosalaei A, et al. Efficacy and Safety of Low-Dose-Rate Endorectal Brachytherapy as a Boost to Neoadjuvant Chemoradiation in the Treatment of Locally Advanced Distal Rectal Cancer: A Phase-II Clinical Trial. Ann Coloproctol. 2015;31(4):123-30.
  21. Nguyen NP, Ceizyk M, Vock J, Vos P, Chi A, Vinh-Hung V, et al. Feasibility of image-guided radiotherapy for elderly patients with locally advanced rectal cancer. PLoS One. 2013;8(8):e71250-e.
  22. Vuong T, Garant A, Vendrely V, Nout R, Martin AG, Enger SA, et al. Image- Guided Brachytherapy for Rectal Cancer: Reviewing the Past Two Decades of Clinical Investigation. Cancers (Basel). 2022;14(19).
  23. Huang Y, Lee D, Young C. Predictors for complete pathological response for stage II and III rectal cancer following
    neoadjuvant therapy - A systematic review and meta-analysis. Am J Surg. 2020;220(2):300-8.
  24. Hosseini S, Nguyen N, Mohammadianpanah M, Mirzaei S, Bananzadeh AM. Predictive Significance of Mucinous Histology on Pathologic Complete Response Rate Following Capecitabine-Based Neoadjuvant Chemoradiation in
    Rectal Cancer: a Comparative Study. Journal of Gastrointestinal Cancer. 2019;50(4):716-22.
  25. Zhang J, Xie X, Wu Z, Hu H, Cai Y, Li J, et al. Mucinous Adenocarcinoma Predicts Poor Response and Prognosis in Patients With Locally Advanced Rectal Cancer: A Pooled Analysis of Individual Participant Data From 3 Prospective Studies. Clin Colorectal Cancer. 2021;20(4):e240-e8.
  26. Sun Z, Adam MA, Kim J, Shenoi M, Migaly J, Mantyh CR. Optimal Timing to Surgery after Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer. J Am Coll Surg. 2016;222(4):367-74 .
  27. Benson AB, Venook AP, Al-Hawary MM, Azad N, Chen YJ, Ciombor KK, et al. Rectal Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022;20(10):1139-67.
  28. Akgun E, Caliskan C, Bozbiyik O, Yoldas T, Doganavsargil B, Ozkok S, et al. Effect of interval between neoadjuvant chemoradiotherapy and surgery on disease recurrence and survival in rectal cancer: long-term results of a randomized clinical trial. BJS Open. 2022;6(5).
  29. Terzi C, Bingul M, Arslan NC, Ozturk E, Canda AE, Isik O, et al. Randomized controlled trial of 8 weeks’ vs 12 weeks’ interval between neoadjuvant chemoradiotherapy and surgery for locally advanced rectal cancer.                        Colorectal Dis. 2020;22(3):279-88.
  30. Ma B, Gao P, Song Y, Huang X, Wang H, Xu Q, et al. Short-Course Radiotherapy in Neoadjuvant Treatment for Rectal Cancer: A Systematic Review and Metaanalysis. Clinical Colorectal Cancer. 2018;17(4):320-30.e5.
  31. Perez RO, Habr-Gama A, São Julião GP, Lynn PB, Sabbagh C, Proscurshim I, et al. Predicting complete response to neoadjuvant CRT for distal rectal cancer using sequential PET/CT imaging. Tech Coloproctol. 2014;18(8):699-708.
  32. Kalff V, Duong C, Drummond EG, Matthews JP, Hicks RJ. Findings on 18F-FDG PET scans after neoadjuvant chemoradiation provides prognostic stratification in patients with locally advanced rectal carcinoma subsequently treated by radical surgery. J Nucl Med. 2006;47(1):14-22.
  33. Pyo DH, Choi JY, Lee WY, Yun SH, Kim HC, Huh JW, et al. A Nomogram for Predicting Pathological Complete Response to Neoadjuvant Chemoradiotherapy Using Semiquantitative Parameters Derived From Sequential PET/CT
    in Locally Advanced Rectal Cancer. Front Oncol. 2021;11:742728.
  34. Beets-Tan RGH, Lambregts DMJ, Maas M, Bipat S, Barbaro B, Curvo-Semedo L, et al. Magnetic resonance imaging for clinical management of rectal cancer: Updated recommendations from the 2016 European Society of Gastrointestinal and Abdominal Radiology (ESGAR) consensus meeting. Eur Radiol. 2018;28(4):1465-75.
  35. Gollub MJ, Arya S, Beets-Tan RG, dePrisco G, Gonen M, Jhaveri K, et al. Use of magnetic resonance imaging
    in rectal cancer patients: Society of Abdominal Radiology (SAR) rectal cancer disease-focused panel (DFP)
    recommendations 2017. Abdom Radiol (NY). 2018;43(11):2893-902.
  36. Marincaş AM, Prunoiu VM, Brătucu E, Cirimbei C, Ionescu S, Buzatu R, et al. Clinical and Paraclinical Criteria of Patient Selection for the Nonoperative Treatment in Completely Responsive Rectal Cancer (after Neoadjuvant Radiochemotherapy). Chirurgia (Bucur). 2015;110(4):351-5.
  37. Memon S, Lynch AC, Bressel M, Wise AG, Heriot AG. Systematic review and meta-analysis of the accuracy of MRI and endorectal ultrasound in the restaging and response assessment of rectal cancer following neoadjuvant therapy. Colorectal Dis. 2015;17(9):748-61.
  38. Cote A, Florin FG, Mois E, Elisei R, Badea R, Mare C, et al. The accuracy of endorectal ultrasonography and high-resolution magnetic resonance imaging for restaging rectal cancer after neoadjuvant chemoradiotherapy.
    Ann Ital Chir. 2018;89:168-76.
  39. de Jong EA, ten Berge JC, Dwarkasing RS, Rijkers AP, van Eijck CH. The accuracy of MRI, endorectal ultrasonography, and computed tomography in predicting the response of locally advanced rectal cancer after preoperative therapy: A metaanalysis. Surgery. 2016;159(3):688-99.
  40. Smith JJ, Chow OS, Gollub MJ, Nash GM, Temple LK, Weiser MR, et al. Organ Preservation in Rectal Adenocarcinoma: a phase II randomized controlled trial evaluating 3-year disease-free survival in patients with locally advanced rectal
    cancer treated with chemoradiation plus induction or consolidation chemotherapy, and total mesorectal excision or nonoperative management. BMC Cancer. 2015;15:767.
  41. Glynne-Jones R, Wyrwicz L, Tiret E, Brown G, Rödel C, Cervantes A, et al. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(suppl_4):iv22-iv40.
  42. Wei IH, Garcia-Aguilar J. Nonoperative management of rectal cancer: understanding tumor biology.               Minerva Chir. 2018;73(6):601-18.
  43. Pianka K, Zhao B, Lee K, Liu S, Eisenstein S, Ramamoorthy S, et al. Factors associated with refusing surgery versus planned nonoperative management for rectal cancer. Surgery. 2022;172(5):1309-14.
  44. Dattani M, Heald RJ, Goussous G, Broadhurst J, São Julião GP, Habr- Gama A, et al. Oncological and Survival Outcomes in Watch and Wait Patients With a Clinical Complete Response After Neoadjuvant Chemoradiotherapy for Rectal Cancer: A Systematic Review and Pooled Analysis. Ann Surg. 2018;268(6):955-67.
  45. Nasir I, Fernandez L, Vieira P, Parés O, Santiago I, Castillo-Martin M, et al. Salvage surgery for local regrowths in Watch & Wait - Are we harming our patients by deferring the surgery? Eur J Surg Oncol. 2019;45(9):1559-66.
  46. Habr-Gama A, Gama-Rodrigues J, São Julião GP, Proscurshim I, Sabbagh C, Lynn PB, 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):822-8.
  47. Kong JC, Guerra GR, Warrier SK, Ramsay RG, Heriot AG. Outcome and Salvage Surgery Following “Watch and Wait” for Rectal Cancer after Neoadjuvant Therapy: A Systematic Review. Dis Colon Rectum. 2017;60(3):335-45.
  48. On J, Shim J, Aly EH. Systematic review and meta-analysis on outcomes of salvage therapy in patients with tumour recurrence during ‘watch and wait’ in rectal cancer. Ann R Coll Surg Engl. 2019;101(7):441-52.
  49. Chadi SA, Malcomson L, Ensor J, Riley RD, Vaccaro CA, Rossi GL, et al. Factors affecting local regrowth after watch and wait for patients with a clinical complete response following chemoradiotherapy in rectal cancer (InterCoRe consortium): an individual participant data metaanalysis. Lancet Gastroenterol Hepatol. 2018;3(12):825-36.
  50. Habr-Gama A, Sabbaga J, Gama- Rodrigues J, São Julião GP, Proscurshim I, Bailão Aguilar P, et al. Watch and wait approach following extended neoadjuvant chemoradiation for distal rectal cancer: are we getting closer to anal cancer management? Dis Colon Rectum. 2013;56(10):1109-17.
  51. López-Campos F, Martín-Martín M, Fornell-Pérez R, García-Pérez JC, Die- Trill J, Fuentes-Mateos R, et al. Watch
    and wait approach in rectal cancer: Current controversies and future directions.                                                      World J Gastroenterol. 2020;26(29):4218-39.
  52. Dossa F, Chesney TR, Acuna SA, Baxter NN. A watch-and-wait approach for locally advanced rectal cancer after a clinical complete response following neoadjuvant chemoradiation: a systematic review and meta-analysis.
    Lancet Gastroenterol Hepatol. 2017;2(7):501-13.
  53. Bibi S, Edilbe MW, Rao C. The Costeffectiveness of Watch and Wait for Rectal Cancer. Clin Oncol (R Coll Radiol).2022.
  54. Rodriguez-Pascual J, Nuñez-Alfonsel J, Ielpo B, Lopez M, Quijano Y, de Vicente E, et al. Watch-and-Wait policy versus robotic surgery for locally advanced rectal cancer: A costeffectiveness study (RECCOSTE).                                  Surg Oncol. 2022;41:101710.
  55. Dossa F, Chesney TR, Acuna SA, Baxter NN. A watch-and-wait approach for locally advanced rectal cancer after a clinical complete response following neoadjuvant chemoradiation: a systematic review and meta-analysis. The Lancet Gastroenterology & Hepatology. 2017;2(7):501-13.
  56. Cercek A, Lumish M, Sinopoli J, Weiss J, Shia J, Lamendola-Essel M, et al. PD-1 Blockade in Mismatch Repair-Deficient, Locally Advanced Rectal Cancer. N Engl J Med. 2022;386(25):2363-76.
  57. Mi M, Ye C, Yuan Y. Neoadjuvant PD-1 blockade: a promising nonoperative strategy for mismatch repair-deficient, locally advanced rectal cancer. Signal Transduct Target Ther. 2022;7(1):361.
  58. Fleischmann M, Diefenhardt M, Trommel M, Scherf C, Ramm U, Chatzikonstantinou G, et al. Imageguided high-dose-rate brachytherapy for rectal cancer: technical note and first clinical experience on an organpreserving
    approach. Strahlenther Onkol. 2022;198(7):654-62.