Conditional recurrence-free survival of clinical complete responders managed by watch and wait after neoadjuvant chemoradiotherapy for rectal cancer in the International Watch &amp; Wait Database: a retrospective, international, multicentre registry study

Fernández, Laura Melina; Julião, Guilherme P. São; Figueiredo, Nuno; Beets, Geerard L.; Valk, Maxime J M van der; Bahadoer, Renu R.; Hilling, Denise E.; Kranenbarg, Elma Meershoek-Klein; Roodvoets, Annet G.H.; Renehan, Andrew G.; Velde, Cornelis J.H. van de; Habr‐Gama, Angelita; Perez, Rodrigo Oliva; Abdelrazeq, Ayman S.; Asoğlu, Oktar; Barroca, Rita; Beveridge, Joy; Bhowmick, Anup Kumar; Blower, Anthony; Braun, Mike; Bujko, Krzysztof; Carter, P.; Carvalho, Carlos; Coco, Claudio; Cunningham, Chris; D’Hoore, André; Dimofte, Gabriel; Ding, Pei-Rong; Duff, SE; Dwyer, Shon; Epstein, Jonathan I.; Evans, Daniel; Fulford, Paul E; Gaertner, Wolfgang B.; Gérard, Jean-Pierre; Gollins, Simon; Harris, Ryan A.; Harrison, Janet; Heat, J.; Hill, Jennifer; Hobbiss, J; Huertas, Eduardo; Huq, Zahirul; Iseas, Soledad; Jakobsen, Anders; Jones, Derek A.; Jones, Leslie S.; Khan, Uzair Ali; Kushwaha, RS; Lees, Nicholas P.; Linn, TY; Loganathan, S; Campos, F. López; Madoff, Robert D.; Мамедли, З. З.; Martling, Anna; Matzel, Klaus E.; Melenhorst, Jarno; Mitchell, Paul; Murad-Regadas, Sthela M.; O’Dwyer, Sarah T; Pairola, Alejandro; Paraoan, Marius; Parés, Oriol; Peeters, Koen; Pettit, S H; Pranesh, Nagarajan; Rajaganeshan, R; Ravi, Srinivasan; Rawat, Shyamji; Richards, David M.; Riyad, Kallingal; Rossi, Gustavo; Rutten, H.J.T.; Saeed, Mirza Faraz; Salaman, J. R.; Loria, Fernando Sánchez; Sande, Marit E. van der; Santiago, Inês; Selvasekar, Chelliah; Siddiqui, K.; Smart, C. J.; Solkar, Mamoon; Myint, Arthur Sun; Taylor, Bruce; Telford, Karen; Scott, Nigel; Vaccaro, Carlos; Vailati, Bruna Borba; Verberne, C.; Vieira, Pedro; Vimalchandran, Dale; Ward, Sarah; Wilson, Malcolm S; Winter, D. C.; Witjes, Carlijn; Wolthuis, Albert; Zhang, Jing; Zhang, Zhen

doi:10.1016/s1470-2045(20)30557-x

Cited by 130 publications

(61 citation statements)

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“…In our experience, the mean time to the local regrowth during follow-up was 20.8 months (range 10-31 months), with a higher rate of local recurrences within three years compared to surgical groups (15.3% vs. 2.9% and 9.5%). This seems to be lower than results from other authors who reported a larger data series of w&w strategy [12,[29][30][31], and higher than a multicentric registry study [32] with a very large follow-up.…”

Section: Discussioncontrasting

confidence: 72%

Watch and Wait Approach for Rectal Cancer Following Neoadjuvant Treatment: The Experience of a High Volume Cancer Center

et al. 2021

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Multimodal treatments for rectal cancer, along with significant research on predictors to response to therapy, have led to more conservative surgical strategies. We describe our experience of the rectal sparing approach in rectal cancer patients with clinical complete response (cCR) after neoadjuvant treatment. We also specifically highlight our clinical and imaging criteria to select patients for the watch and wait strategy (w&w). Data came from 39 out of 670 patients treated for locally advanced rectal cancer between January 2016 until February 2020. The selection criteria were a clinical complete response after neoadjuvant chemotherapy managed with a watch and wait (w&w) strategy. A strict follow-up period was adopted in these selected patients and follow-ups were performed every three months during the first two years and every six months after that. The median follow-up time was 28 months. Six patients had a local recurrence (15.3%); all were salvageable by total mesorectal excision (TME). Five patients had a distant metastasis (12.8%). There was no local unsalvageable disease after w&w strategy. The rectal sparing approach in patients with clinical complete response after neoadjuvant treatment is the best possible treatment and is appropriate to analyze from this perspective. The watch and wait approach after neoadjuvant treatment for rectal cancer can be successfully explored after inflexible and strict patient selection.

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Section: Discussioncontrasting

confidence: 72%

Watch and Wait Approach for Rectal Cancer Following Neoadjuvant Treatment: The Experience of a High Volume Cancer Center

et al. 2021

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“…Distant metastases were identified in 8% of cases. In a retrospective analysis of the same international registry [ 228 ], using a conditional survival model, the probability of remaining free from local recurrence for an additional 2 years, after a sustained clinical response, was estimated around 88.1%, 97.3%, and 98.6% at 1, 3, and 5 years respectively with analog results about the risk of distance metastatic disease highlighting the need of active surveillance especially in the first 3 years of follow-up.…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2021

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Background and aims Although rectal cancer is predominantly a disease of older patients, current guidelines do not incorporate optimal treatment recommendations for the elderly and address only partially the associated specific challenges encountered in this population. This results in a wide variation and disparity in delivering a standard of care to this subset of patients. As the burden of rectal cancer in the elderly population continues to increase, it is crucial to assess whether current recommendations on treatment strategies for the general population can be adopted for the older adults, with the same beneficial oncological and functional outcomes. This multidisciplinary experts’ consensus aims to refine current rectal cancer-specific guidelines for the elderly population in order to help to maximize rectal cancer therapeutic strategies while minimizing adverse impacts on functional outcomes and quality of life for these patients. Methods The discussion among the steering group of clinical experts and methodologists from the societies’ expert panel involved clinicians practicing in general surgery, colorectal surgery, surgical oncology, geriatric oncology, geriatrics, gastroenterologists, radiologists, oncologists, radiation oncologists, and endoscopists. Research topics and questions were formulated, revised, and unanimously approved by all experts in two subsequent modified Delphi rounds in December 2020–January 2021. The steering committee was divided into nine teams following the main research field of members. Each conducted their literature search and drafted statements and recommendations on their research question. Literature search has been updated up to 2020 and statements and recommendations have been developed according to the GRADE methodology. A modified Delphi methodology was implemented to reach agreement among the experts on all statements and recommendations. Conclusions The 2021 SICG-SIFIPAC-SICE-WSES consensus for the multidisciplinary management of elderly patients with rectal cancer aims to provide updated evidence-based statements and recommendations on each of the following topics: epidemiology, pre-intervention strategies, diagnosis and staging, neoadjuvant chemoradiation, surgery, watch and wait strategy, adjuvant chemotherapy, synchronous liver metastases, and emergency presentation of rectal cancer.

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“…The lack of a pCR difference might be due to the small number of TRG 0 cases (27.0%). LARC patients with pCR may choose a “watch & wait” policy [ 30 ]. However, the main objective of this article was to select LARC patients who could benefit from nCRT, so it may be more meaningful to study patients who obtain good responses.…”

Section: Discussionmentioning

confidence: 99%

The value of the tumour-stroma ratio for predicting neoadjuvant chemoradiotherapy response in locally advanced rectal cancer: a case control study

et al. 2021

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Background The tumour-stroma ratio (TSR) is recognized as a practical prognostic factor in colorectal cancer. However, TSR assessment generally utilizes surgical specimens. This study aims to investigate whether the TSR evaluated from preoperative biopsy specimens by a semi-automatic quantification method can predict the response after neoadjuvant chemoradiotherapy (nCRT) of patients with locally advanced rectal cancer (LARC). Methods A total of 248 consecutive patients diagnosed with LARC and treated with nCRT followed by resection were included. Haematoxylin and eosin (HE)-stained sections of biopsy specimens were collected, and the TSR was evaluated by a semi-automatic quantification method and was divided into three categories, using the cut-offs determined in the whole cohort to balance the proportion of patients in each category. The response to nCRT was evaluated on the primary tumour resection specimen by an expert pathologist using the four-tier tumour regression grade (TRG) system. Results The TSR can discriminate patients that are major-responders (TRG 0–1) from patients that are non-responders (TRG 2–3). Patients were divided into stroma-low (33.5%), stroma-intermediate (33.9%), and stroma-high (32.7%) groups using 56.3 and 72.8% as the cutoffs. In the stroma-low group, 58 (69.9%) patients were major-responders, and only 39 (48.1%) patients were considered major-responders in the stroma-high group (P = 0.018). Multivariate analysis showed that the TSR was the only pre-treatment predictor of response to nCRT (adjusted odds ratio 0.40, 95% confidence interval 0.21–0.76, P = 0.002). Conclusion An elevated TSR in preoperative biopsy specimens is an independent predictor of nCRT response in LARC. This semi-automatic quantified TSR could be easily translated into routine pathologic assessment due to its reproducibility and reliability.

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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

Cited by 130 publications

References 18 publications

Watch and Wait Approach for Rectal Cancer Following Neoadjuvant Treatment: The Experience of a High Volume Cancer Center

Watch and Wait Approach for Rectal Cancer Following Neoadjuvant Treatment: The Experience of a High Volume Cancer Center

The value of the tumour-stroma ratio for predicting neoadjuvant chemoradiotherapy response in locally advanced rectal cancer: a case control study

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