Abstract
The present study examined the therapeutic effects of preoperative neoadjuvant chemoradiation therapy (NACRT) and predictive factors for complete clinical remission, compared the prognosis and costs of abdominoperineal resection (APR) and the “watch and wait” method (WW), and evaluated the usefulness of WW. In our department, patients with stage II–III lower rectal cancer requiring APR receive NACRT. NACRT was performed as a preoperative treatment (52 Gy + S-1: 80–120 mg/day × 25 days). Eight weeks after the completion of NACRT, rectal examination, endoscopic, computed tomography, and magnetic resonance imaging findings were evaluated to assess its therapeutic effects. APR was indicated for patients in whom endoscopic findings suggested a residual tumor in which a deep ulcer or marginal swelling remained or lymph node metastasis. However, WW was selected for patients who refused APR after informed consent was obtained. In the APR and WW groups, 5- and 20-year treatment costs after CRT were calculated using the Medical Fee Points of Japan in 2020. No significant differences were observed in 3-year disease-free survival rates for either parameter between the two groups. Regarding expenses, treatment costs were lower in the WW group than in the APR group. Organ preservation using active surveillance with CRT for rectal cancer requiring APR is feasible with the achievement of endoluminal complete remission.
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References
Gérard JP, Conroy T, Bonnetain F, Bouché O, Chapet O, Closon-Dejardin MT, Untereiner M, Leduc B, Francois E, Maurel J, Seitz JF, Buecher B, Mackiewicz R, Ducreux M, Bedenne L (2006) Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3–4 rectal cancers: results of FFCD 9203. J Clin Oncol 24(28):4620–4625. https://doi.org/10.1200/JCO.2006.06.7629
Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC (2006) Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med 355(11):1114–1123. https://doi.org/10.1056/NEJMoa060829
Habr-Gama A, Perez RO, Nadalin W, Sabbaga J, Ribeiro U Jr, e SilvaSousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J (2004) Operative versus nonoperative treatment for stage 0 distal cancer following chemoradiation therapy: long-term results. Ann Surg 240(7):711–717. https://doi.org/10.1097/01.sla.0000141194.27992.32
Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewé KW, Buijsen J, Beets GL (2011) Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol 29(35):4633–4640. https://doi.org/10.1200/JCO.2011.37.7176
van der Valk MJM, Hilling DE, Bastiaannet E, Meershoek-KleinKranenbarg E, Beets GL, Figueiredo NL, Habr-Gama A, Perez RO, Renehan AG, van de Velde CJH, IWWD Consortium (2018) 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. https://doi.org/10.1016/S0140-6736(18)31078-X
Bryant CL, Lunniss PJ, Knowles CH, Thaha MA, Chan CL (2012) Anterior resection syndrome. Lancet Oncol 13(9):e403–e408. https://doi.org/10.1007/s10147-019-01485-z
Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T et al (2020) Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol 25(1):1–42. https://doi.org/10.1007/s10147-019-01485-z
Glynne-Jones R, Wyrwicz L, Tiret E, Brown G, Rödel C, Cervantes A, Arnold D, ESMO Guidelines Committee (2017) Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 28(4):iv22–iv40. https://doi.org/10.1093/annonc/mdx224
Pieniowski EHA, Nordenvall C, Palmer G, Johar A, Tumlin Ekelund S, Lagergren P, Abraham-Nordling M (2020) Prevalence of low anterior resection syndrome and impact on quality of life after rectal cancer surgery: population-based study. BJS open 4(5):935–942. https://doi.org/10.1002/bjs5.50312
Herrera MA, Chu TM, Holyoke ED (1976) Carcinoembryonic antigen (CEA) as a prognostic and monitoring test in clinically complete resection of colorectal carcinoma. Ann Surg 183(1):5–9. https://doi.org/10.1097/00000658-197601000-00002
Trial SRC, Cedermark B, Dahlberg M, Glimelius B, Påhlman L, Rutqvist LE, Wilking N (1997) Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med 336(14):980–987. https://doi.org/10.1056/NEJM199704033361402
Shrotriya S, Walsh D, Bennani-Baiti N, Thomas S, Lorton C (2015) C-reactive protein is an important biomarker for prognosis tumor recurrence and treatment response in adult solid tumors: a systematic review. PLoS ONE 10(12):E0143080. https://doi.org/10.1371/journal.pone.0143080
Folkesson J, Birgisson H, Pahlman L, Cedermark B, Glimelius B, Gunnarsson U (2005) Swedish Rectal Cancer Trial: long lasting benefits from radiotherapy on survival and local recurrence rate. J Clin Oncol 23(24):5644–5650. https://doi.org/10.1200/JCO.2005.08.144
Sato T, Kokuba Y, Koizumi W, Hayakawa K, Okayasu I, Watanabe M (2007) Phase I trial of neoadjuvant preoperative chemotherapy with S-1 and irinotecan plus radiation in patients with locally advanced rectal cancer. Int J Radiat Oncol Biol Phys 69(5):1442–1447. https://doi.org/10.1016/j.ijrobp.2007.05.081
Nakamura T, Yamashita K, Sato T, Ema A, Naito M, Watanabe M (2014) Neoadjuvant chemoradiation therapy using concurrent S-1 and irinotecan in rectal cancer; impact on long-term clinical outcomes and prognostic factors. Int J Radiat Oncol Biol Phys 89(3):547–555. https://doi.org/10.1016/j.ijrobp.2014.03.007
Fietkau R, Rödel C, Hohenberger W, Raab R, Hess C, Liersch T, Becker H, Wittekind C, Hutter M, Hager E, Karstens J, Ewald H, Christen N, Jagoditsch M, Martus P, Sauer R, German, Rectal, Cancer, Study, Group (2007) Rectal cancer delivery of radiotherapy in adequate time and with adequate dose is influenced by treatment center, treatment schedule, and gender and is prognostic parameter for local control; results of study CAO/ARO/AIO-94. Int J Radiat Oncol Biol Phys 67(4):1008–1019. https://doi.org/10.1016/j.ijrobp.2006.10.020
Kawai K, Ishihara S, Nozawa H, Hata K, Kiyomatsu T, Morikawa T, Fukayama M, Watanabe T (2017) Prediction pf pathological complete response using endoscopic findings and outcomes of patients who underwent watchful waiting after chemo-radiotherapy for rectal cancer. Dis Colon Rectum 60(4):368–375. https://doi.org/10.1097/DCR.0000000000000742
Smith JJ, Chow OS, Gollub MJ, Nash GM, Temple LK, Weiser MR, Guillem JG, Paty PB, Avila K, Garcia-Aguilar J, Rectal Cancer Consortium (2015) 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 15:767. https://doi.org/10.1186/s12885-015-1632-z
Gérard JP, Azria D, Gourgou-Bourgade S, Martel-Laffay I, Hennequin C, Etienne PL, Vendrely V, François E, de La Roche G, Bouché O, Mirabel X, Denis B, Mineur L, Berdah JF, Mahé MA, Bécouarn Y, Dupuis O, Lledo G, Montoto-Grillot C, Conroy T (2010) Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: results of the phase III trial ACCORD 12/0405-Prodige 2. J Clin Oncol 28(10):1638–1644. https://doi.org/10.1200/JCO.2009.25.8376
Rödel C, Liersch T, Becker H, Fietkau R, Hohenberger W, Hothorn T, Graeven U, Arnold D, Lang-Welzenbach M, Raab HR, Sülberg H, Wittekind C, Potapov S, Staib L, Hess C, Weigang-Köhler K, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R, German Rectal Cancer Study Group (2012) Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer; initial results of the German CAO/ARO/AIO-04 randomized phase 3 trial. Lancet Oncol 13(7):679–687. https://doi.org/10.1016/S1470-2045(12)70187-0
Bryant CL, Lunniss PJ, Knowles CH, Thaha MA, Chan CL (2012) Anterior resection syndrome. Lancet Oncol 13:e403–e408. https://doi.org/10.1016/S1470-2045(12)70236-X
Huh JW, Jung EJ, Park YA, Lee KY, Sohn SK (2008) Preoperative chemoradiation followed by transanal excision for rectal cancer. J Surg Res 148(2):244–250. https://doi.org/10.1016/j.jss.2007.08.010
Bonnen M, Crane C, Vauthey JN, Skibber J, Delclos ME, Rodriguez-Bigas M, Hoff PM, Lin E, Eng C, Wong A, Janjan NA, Feig BW (2004) Long-term results using local excision after preoperative chemoradiation among selected T3 rectal cancer patients. Int J Radiat Oncol Biol Phys 60(4):1098–1105. https://doi.org/10.1016/j.ijrobp.2004.04.062
Kim CJ, Yeatman TJ, Coppola D, Trotti A, Williams B, Barthel JS, Dinwoodie W, Karl RC, Marcet J (2001) Local excision of T2 and T3 rectal cancers after downstaging chemoradiation. Ann Surg 234(3):352–358. https://doi.org/10.1097/00000658-200109000-00009
Hupkens BJP, Martens MH, Stoot JH, Berbee M, Melenhorst J, Beets-Tan RG, Beets GL, Breukink SO (2017) Quality of life in rectal cancer patients after chemoradiation: Watch-and-Wait policy versus standard resection-a matched-controlled study. Dis Colon Rectum 60(10):1032–1040. https://doi.org/10.1097/DCR.0000000000000862
López-Campos F, Martín-Martín M, Fornell-Pérez R, García-Pérez JC, Die-Trill J, Fuentes-Mateos R, López-Durán S, Domínguez-Rullán J, Ferreiro R, Riquelme-Oliveira A, Hervás-Morón A, Couñago F (2020) Watch and wait approach in rectal cancer: current controversies and future directions. World J Gastroenterol 26(29):4218–4239. https://doi.org/10.3748/wjg.v26.i29.4218
Quezada-Diaz FF, Smith JJ, Jimenez-Rodriguez RM, Wasserman I, Pappou EP, Patil S, Wei IH, Nash GM, Guillem JG, Weiser MR, Paty PB, Garcia-Aguilar J (2020) Patient-reported bowel function in patients with rectal cancer managed by a watch-and-wait strategy after neoadjuvant therapy: a case-control study. Dis Colon Rectum 63(7):897–902. https://doi.org/10.1097/DCR.0000000000001646
Bulens PP, Smets L, Debucquoy A, Joye I, D’Hoore A, Wolthuis A, Debrun L, Dekervel J, Van Cutsem E, Dresen R, Vandecaveye V, Deroose CM, Sagaert X, Haustermans K (2022) Nonoperative versus operative approach according to the response to neoadjuvant chemoradiotherapy for rectal cancer: a prospective cohort study. Clin Transl Radiat Oncol 36:113–120. https://doi.org/10.1016/j.ctro.2022.07.009
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 17:174–183. https://doi.org/10.1016/S1470-2045(15)00467-2
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):822–828. https://doi.org/10.1016/j.ijrobp.2013.12.012
Kundel Y, Brenner R, Purim O, Peled N, Idelevich E, Fenig E, Sulkes A, Brenner B (2010) Is local excision after complete pathological response to neoadjuvant chemoradiation for rectal cancer an acceptable treatment option? Dis Colon Rectum 53(12):1624–1631. https://doi.org/10.1007/DCR.0b013e3181f5b64d
Ryan JE, Warrier SK, Lynch AC, Ramsay RG, Phillips WA, Heriot AG (2016) Predicting pathological complete response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer: a systematic review. Colorectal Dis 18(3):234–246. https://doi.org/10.1111/codi.13207
Probst CP, Becerra AZ, Aquina CT, Tejani MA, Hensley BJ, González MG, Noyes K, Monson JR, Fleming FJ (2016) Watch and Wait?–Elevated pretreatment CEA is associated with decreased pathological complete response in rectal cancer. J Gastrointest Surg Off J Soc Surg Aliment Tract 20(1):43–52. https://doi.org/10.1007/s11605-015-2987-9
Lee JH, Hyun JH, Kim DY, Yoo BC, Park JW, Kim SY, Chang HJ, Kim BC, Kim TH, Oh JH, Sohn DK (2015) The role of fibrinogen as a predictor in preoperative chemoradiation for rectal cancer. Ann Surg Oncol 22(1):209–215. https://doi.org/10.1245/s10434-014-3962-5
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
Bibi S, Edilbe MW, Rao C (2023) The cost-effectiveness of watch and wait for rectal cancer. Clin Oncol (R Coll Radiol) 35(2):132–137. https://doi.org/10.1016/j.clon.2022.10.002
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
Rodriguez-Pascual J, Nuñez-Alfonsel J, Ielpo B, Lopez M, Quijano Y, de Vicente E, Cubillo A, Saborido CM (2022) Watch-and-wait policy versus robotic surgery for locally advanced rectal cancer: a cost-effectiveness study (RECCOSTE). Surg Oncol 41:101710. https://doi.org/10.1016/j.suronc.2022.101710
Smith JJ, Paty PB, Garcia-Aguilar J (2020) Watch and wait in rectal cancer or more wait and see? JAMA Surg 155(7):657–658. https://doi.org/10.1001/jamasurg.2020.0226
Acknowledgements
We are grateful to Dr. Mihoko Nakagawa, Dr. Hiroaki Kobayashi, Dr. Kensuke Kakisako, Dr. Yojiro Takano, Dr .Junichi Seki, Dr. Kenta Nakahara, and Dr. Shoji Shimada for their collaborations in the early stages of this work.
We also would like to thank the Medical English Service (https://www.med-english.com) for English language editing.
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All authors contributed to the conception and design of the study. Material preparation and data collection and analyses were performed by NS and SM. The first draft of the manuscript was written by NS and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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Sawada, N., Mukai, S., Takehara, Y. et al. The “Watch and Wait” Method After Chemoradiotherapy for Rectal Cancer Requiring Abdominoperineal Resection. Indian J Surg Oncol 14, 765–772 (2023). https://doi.org/10.1007/s13193-023-01831-8
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DOI: https://doi.org/10.1007/s13193-023-01831-8