Abstract
Background
The watch-and-wait (WW) strategy is a potential option for patients with rectal cancer who obtain a complete clinic response after neoadjuvant therapy. The aim of this study is to analyze the long-term oncological outcomes and perform a cost-effectiveness analysis in patients undergoing this strategy for rectal cancer.
Material and methods
The data of patients treated with the WW strategy were prospectively collected from January 2015 to January 2020. A control group was created, matched 1:1 from a pool of 480 patients undergoing total mesorectal excision. An independent company carried out the financial analysis. Clinical and oncological outcomes were analyzed in both groups. Outcome parameters included surgical and follow-up costs, quality-adjusted life years (QALYs), and the incremental cost per QALY gained or the incremental cost-effectiveness ratio (ICER).
Results
Forty patients were included in the WW group, with 40 patients in the surgical group. During a median follow-up period of 36 months, metastasis-free survival (MFS) and overall survival (OS) were similar in the two groups. In the WW group, nine (22%) local regrowths were detected in the first 2 years. The permanent stoma rate was slightly higher after salvage surgery in the WW group compared to the surgical group (48.5% vs 20%, p < 0.01). The cost-effectiveness analysis was slightly better for the WW group, especially for low rectal cancer compared to medium–high rectal cancer (ICER = − 108,642.1 vs ICER = − 42,423).
Conclusions
The WW strategy in locally advanced rectal cancer offers similar oncological outcomes with respect to the surgical group and excellent results in quality of life and cost outcomes, especially for low rectal cancer. Nonetheless, the complex surgical field during salvage surgery can lead to a high permanent stoma rate; therefore, the careful selection of patients is mandatory.
Similar content being viewed by others
Data availability
Because of the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject confidentiality protocols may be sent to Valentina Ferri at valenpeglio@gmail.com. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
References
Pucciarelli S, Del Bianco P, Efficace F et al (2011) Patient-reported outcomes after neoadjuvant chemoradiotherapy for rectal cancer: a multicenter prospective observational study. Ann Surg 253(1):71–77
Chow OS, Smith JJ, Gollub MJ, Garcia-Aguilar J (2014) Can we predict response and/or resistance to neoadjuvant chemoradiotherapy in patients with rectal cancer? Curr Colorectal Cancer Rep 10(2):164–172. https://doi.org/10.1007/s11888-014-0210-0
Park IJ, You YN, Agarwal A et al (2012) Neoadjuvant treatment response as an early response indicator for patients with rectal cancer. J Clin Oncol 30(15):1770–1776. https://doi.org/10.1200/JCO.2011.39.7901
Habr-Gama A, Perez RO, Nadalin W et al (2004) Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results. Ann Surg 240(4):711–718
Dossa F, Chesney TR, Acuna SA, Baxter NN (2017) 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 2(7):501–513. https://doi.org/10.1016/S2468-1253(17)30074-2
van der Valk MJM, Hilling DE, Bastiaannet E et al (2018) IWWD Consortium . 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 391(10139):2537–2545
Smith JJ, Strombom P, Chow OS, Roxburgh CS, Lynn P, Eaton A, Widmar M, Ganesh K, Yaeger R, Cercek A, Weiser MR, Nash GM, Guillem JG, Temple LKF, Chalasani SB, Fuqua JL, Petkovska I, Wu AJ, Reyngold M, Vakiani E, Shia J, Segal NH, Smith JD, Crane C, Gollub MJ, Gonen M, Saltz LB, Garcia-Aguilar J, Paty PB (2019) The risk of distant metastases in patients with clinical complete response managed by watch and wait after neoadjuvant therapy for rectal cancer: the influence of local regrowth in the International Watch and Wait Database. Evaluation of a watch and wait strategy for rectal cancer in patients with a complete response after neoadjuvant therapy. JAMA Oncol 5(4):e185896
Fernandez LM, São Julião GP, Figueiredo NL, Beets GL, van der Valk MJM, Bahadoer RR, Hilling DE, Meershoek-Klein Kranenbarg E, Roodvoets AGH, Renehan AG, van de Velde CJH, Habr-Gama A, Perez RO (2021) International Watch & Wait Database Consortium. Conditional recurrence-free survival of clinical complete responders managed by watch and wait after neoadjuvant chemoradiotherapy for rectal cancer in the International Watch & Wait Database: a retrospective, international, multicentre registry study. Lancet Oncol 22(1):43–50. https://doi.org/10.1016/S1470-2045(20)30557-X. Epub 2020 Dec 11
Miller JA, Wang H, Chang DT, Pollom EL (2020) Cost-effectiveness and quality-adjusted survival of watch and wait after complete response to chemoradiotherapy for rectal cancer. J Natl Cancer Inst 112(8):792–801. https://doi.org/10.1093/jnci/djaa003
Gemma Vilagut et al (2005) The Spanish SF-36 Health Questionnaire: a decade of experience and new developments. Gaceta Sanitaria. https://doi.org/10.1157/13074369
Renehan AG, Malcomson L, Emsley R, Gollins S, Maw A, Myint AS, Rooney PS, Susnerwala S, Blower A, Saunders MP, Wilson MS, Scott N, O’Dwyer ST (2016) 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 17(2):174–183
Habr-Gama A, Gama-Rodrigues J, São Julião GP, Proscurshim I, Sabbagh C, Lynn PB, Perez RO (2014) 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 88(4):822–8. https://doi.org/10.1016/j.ijrobp.2013.12.012. Epub 2014 Feb 1
Cotti GC, Pandini RV, Braghiroli OFM, Nahas CSR, Bustamante-Lopez LA, Marques CFS, Imperiale AR, Ribeiro U Jr, Salvajoli B, Hoff PM, Nahas SC (2022) Outcomes of patients with local regrowth after nonoperative management of rectal cancer after neoadjuvant chemoradiotherapy. Dis Colon Rectum 65(3):333–339. https://doi.org/10.1097/DCR.0000000000002197
van der Sande ME, Figueiredo N, Beets GL (2021) Management and outcome of local regrowths in a watch-and-wait prospective cohort for complete responses in rectal cancer. Ann Surg 274(6):e1056–e1062. https://doi.org/10.1097/SLA.0000000000003738
Kong JC, Guerra GR, Warrier SK, Ramsay RG, Heriot AG (2017) Outcome and salvage surgery following “watch and wait” for rectal cancer after neoadjuvant therapy: a systematic review. Dis Colon Rectum 60(3):335–345
Cui CL, Luo WY, Cosman BC, Eisenstein S, Simpson D, Ramamoorthy S, Murphy J, Lopez N (2022) Cost effectiveness of watch and wait versus resection in rectal cancer patients with complete clinical response to neoadjuvant chemoradiation. Ann Surg Oncol 29(3):1894–1907. https://doi.org/10.1245/s10434-021-10576-z. Epub 2021 Sep 16
Rodríguez-Pascual J, Núñez-Alfonsel J, Ielpo B, López M, Quijano Y, de Vicente E, Cubillo A, Saborido CM (2022) Surveillance and wait-and-see policy versus robotic surgery for locally advanced rectal cancer: a cost-effectiveness study (RECCOSTE). Surg Oncol 41:101710
Funding
This study was supported by the Foundation for Development and Investigation in Surgical Oncology of Madrid and by the International Investigation Department in General and Digestive Surgery of the Catholic University of Murcia.
Author information
Authors and Affiliations
Contributions
Emilio Vicente and Yolanda Quijano proposed the study. Valentina Ferri and Riccardo Caruso performed research and wrote the first draft. Hipolito Duran, Eduardo Diaz, and Isabel Fabra collected and analyzed the data. All authors contributed to the design and interpretation of the study and to further drafts. Valentina Ferri is the guarantor.
Corresponding author
Ethics declarations
Ethical approval
This study was approved by the Ethics Committee of the Sanchinarro Hospital, San Pablo University, Madrid, Spain.
Competing interests
No benefits in any form have been received or will be received from a commercial party.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Ferri, V., Vicente, E., Quijano, Y. et al. Light and shadow of watch-and-wait strategy in rectal cancer: oncological result, clinical outcomes, and cost-effectiveness analysis. Int J Colorectal Dis 38, 277 (2023). https://doi.org/10.1007/s00384-023-04573-9
Accepted:
Published:
DOI: https://doi.org/10.1007/s00384-023-04573-9