The evaluation of follow‐up strategies of watch‐and‐wait patients with a complete response after neoadjuvant therapy in rectal cancer

521 Background: In 2014 the IWWD was established by EURECCA and the Champalimaud Foundation. The main goal of this database is to collect all available data to expand knowledge on the benefits, risks and oncological safety of organ preserving strategies in rectal cancer. In April 2015 the database was opened for data registration. Methods: An international multicentre observational study. Data was collected by participating centres and stored in a highly secured NEN7510 certified and encrypted research data server. Each centre always retains full ownership of their data. Results: In August 2016 the database included 775 patients from 11 countries and 35 participating institutes. 90% of all patients were included because of a clinical complete response (n = 679). All other reasons for a watch-and-wait regimen were excluded for the present analyses. As shown in table 1, imaging modalities used to assess response after induction therapy were variable. Induction treatment consisted of chemo-radiotherapy in 90% of cases. Median follow-up time is 2.6 years (range 0-24 years). Local regrowth occurred in 25% (n = 167) of all patients, of which 84% in the first 2 years of follow-up. A local regrowth was located endoluminal in 96% (n = 161) and in the loco-regional lymph nodes in 4% (n = 7). Distant metastasis occurred in 7% (n = 49). The overall 3 year-survival of all patients was 91% and for patients with a local regrowth this was 87%. Conclusions: This is the largest series of patients with rectal cancer in which surgery was omitted after induction therapy. These data illustrate differences in induction therapy as well as imaging strategies and provide some crude outcome data. Further data collection on the Watch-and-Wait strategy for rectal cancer is needed to increase knowledge on oncological safety of omitting surgery. This may contribute to international consensus on staging, treatment and surveillance guidelines in rectal cancer care. [Table: see text]

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Watch-and-Wait Compared to Operation for Patients with Complete Response to Neoadjuvant Therapy for Rectal Cancer

Journal of the American College of Surgeons ◽

10.1016/j.jamcollsurg.2020.08.775 ◽

2020 ◽

Vol 231 (6) ◽

pp. 681-692 ◽

Cited By ~ 2

Author(s):

Bryce W. Beard ◽

Robert L. Rettig ◽

Joan J. Ryoo ◽

Rex A. Parker ◽

Elisabeth C. McLemore ◽

...

Keyword(s):

Rectal Cancer ◽

Neoadjuvant Therapy ◽

Complete Response ◽

Watch And Wait

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Analysis of long-term oncological results of clinical versus pathological responses after neoadjuvant treatment in locally advanced rectal cancer

World Journal of Surgical Oncology ◽

10.1186/s12957-020-02094-1 ◽

2020 ◽

Vol 18 (1) ◽

Author(s):

Mariana F. Coraglio ◽

Martin A. Eleta ◽

Mirta R. Kujaruk ◽

Javier H. Oviedo ◽

Enrique L. Roca ◽

...

Keyword(s):

Rectal Cancer ◽

Anal Verge ◽

Neoadjuvant Treatment ◽

Complete Response ◽

Distant Recurrence ◽

Watch And Wait ◽

Oncological Results ◽

Group 2 ◽

Group 1

Abstract Background Nonoperative management after neoadjuvant treatment in low rectal cancer enables organ preservation and avoids surgical morbidity. Our aim is to compare oncological outcomes in patients with clinical complete response in watch and wait strategy with those who received neoadjuvant therapy followed by surgery with a pathological complete response. Methods Patients with non-metastatic rectal cancer after neoadjuvant treatment with clinical complete response in watch and wait approach (group 1, n = 26) and complete pathological responders (ypT0N0) after chemoradiotherapy and surgery (group 2, n = 22), between January 2011 and October 2018, were included retrospectively, and all of them evaluated and followed in a multidisciplinary team. A comparative analysis of local and distant recurrence rates and disease-free and overall survival between both groups was carried out. Statistical analysis was performed using log-rank test, Cox proportional hazards regression model, and Kaplan-Meier curves. Results No differences were found between patient’s demographic characteristics in both groups. Group 1: distance from the anal verge mean 5 cm (r = 1–12), 10 (38%) stage III, and 7 (27%) circumferential resection margin involved. The median follow-up of 47 months (r = 6, a 108). Group 2: distance from the anal verge mean 7 cm (r = 2–12), 16 (72%) stage III, and 13 (59%) circumferential resection margin involved. The median follow-up 49.5 months (r = 3, a 112). Local recurrence: 2 patients in group 1 (8.3%) and 1 in group 2 (4.8%) (p = 0.6235). Distant recurrence: 1 patient in group 1 (3.8%) and 3 in group 2 (19.2%) (p = 0.2237). Disease-free survival: 87.9% in group 1, 80% in group 2 (p = 0.7546). Overall survival: 86% in group 1 and 85% in group 2 (p = 0.5367). Conclusion Oncological results in operated patients with pathological complete response were similar to those in patients under a watch and wait strategy mediating a systematic and personalized evaluation. Surgery can safely be deferred in clinical complete responders.

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

Diagnostics ◽

10.3390/diagnostics11081507 ◽

2021 ◽

Vol 11 (8) ◽

pp. 1507

Author(s):

Daniela Rega ◽

Vincenza Granata ◽

Carmela Romano ◽

Valentina D’Angelo ◽

Ugo Pace ◽

...

Keyword(s):

Rectal Cancer ◽

Locally Advanced ◽

Neoadjuvant Treatment ◽

High Volume ◽

Complete Response ◽

Response To Therapy ◽

Cancer Center ◽

Watch And Wait ◽

Clinical Complete Response

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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Watch-and-wait Management for Rectal Cancer After Clinical Complete Response to Neoadjuvant Therapy

Advances in Surgery ◽

10.1016/j.yasu.2021.05.007 ◽

2021 ◽

Author(s):

Jonathan B. Yuval ◽

Julio Garcia-Aguilar

Keyword(s):

Rectal Cancer ◽

Neoadjuvant Therapy ◽

Complete Response ◽

Watch And Wait ◽

Clinical Complete Response

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Re-staging and follow-up of rectal cancer patients with MR imaging when “Watch-and-Wait” is an option: a practical guide

Insights into Imaging ◽

10.1186/s13244-021-01055-w ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

Inês Santiago ◽

Bernardete Rodrigues ◽

Maria Barata ◽

Nuno Figueiredo ◽

Laura Fernandez ◽

...

Keyword(s):

Rectal Cancer ◽

Mr Imaging ◽

Cancer Patients ◽

Rectal Wall ◽

Primary Tumour ◽

Locally Advanced ◽

Complete Response ◽

Watch And Wait ◽

Practical Guide

AbstractIn the past nearly 20 years, organ-sparing when no apparent viable tumour is present after neoadjuvant therapy has taken an increasingly relevant role in the therapeutic management of locally-advanced rectal cancer patients. The decision to include a patient or not in a “Watch-and-Wait” program relies mainly on endoscopic assessment by skilled surgeons, and MR imaging by experienced radiologists. Strict surveillance using the same modalities is required, given the chance of a local regrowth is of approximately 25–30%, almost always surgically salvageable if caught early. Local regrowths occur at the endoluminal aspect of the primary tumour bed in almost 90% of patients, but the rest are deep within it or outside the rectal wall, in which case detection relies solely on MR Imaging. In this educational review, we provide a practical guide for radiologists who are, or intend to be, involved in the re-staging and follow-up of rectal cancer patients in institutions with an established “Watch-and-Wait” program. First, we discuss patient preparation and MR imaging acquisition technique. Second, we focus on the re-staging MR imaging examination and review the imaging findings that allow us to assess response. Third, we focus on follow-up assessments of patients who defer surgery and confer about the early signs that may indicate a sustained/non-sustained complete response, a rectal/extra-rectal regrowth, and the particular prognosis of the “near-complete” responders. Finally, we discuss our proposed report template.

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Faculty Opinions recommendation of 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.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.733211858.793553317 ◽

2018 ◽

Author(s):

Kellie Mathis

Keyword(s):

Systematic Review ◽

Rectal Cancer ◽

Neoadjuvant Chemoradiotherapy ◽

Complete Response ◽

Pooled Analysis ◽

Survival Outcomes ◽

Watch And Wait ◽

Clinical Complete Response

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CEA, EpCAM, αvβ6 and uPAR Expression in Rectal Cancer Patients with a Pathological Complete Response after Neoadjuvant Therapy

Diagnostics ◽

10.3390/diagnostics11030516 ◽

2021 ◽

Vol 11 (3) ◽

pp. 516

Author(s):

Daan Linders ◽

Marion Deken ◽

Maxime van der Valk ◽

Willemieke Tummers ◽

Shadhvi Bhairosingh ◽

...

Keyword(s):

Rectal Cancer ◽

Neoadjuvant Therapy ◽

Cancer Patients ◽

Pathological Complete Response ◽

Neoadjuvant Treatment ◽

Complete Response ◽

Response Evaluation ◽

Tumor Bed ◽

Upar Expression ◽

Diagnostic Biopsy

Rectal cancer patients with a complete response after neoadjuvant therapy can be monitored with a watch-and-wait strategy. However, regrowth rates indicate that identification of patients with a pathological complete response (pCR) remains challenging. Targeted near-infrared fluorescence endoscopy is a potential tool to improve response evaluation. Promising tumor targets include carcinoembryonic antigen (CEA), epithelial cell adhesion molecule (EpCAM), integrin αvβ6, and urokinase-type plasminogen activator receptor (uPAR). To investigate the applicability of these targets, we analyzed protein expression by immunohistochemistry and quantified these by a total immunostaining score (TIS) in tissue of rectal cancer patients with a pCR. CEA, EpCAM, αvβ6, and uPAR expression in the diagnostic biopsy was high (TIS > 6) in, respectively, 100%, 100%, 33%, and 46% of cases. CEA and EpCAM expressions were significantly higher in the diagnostic biopsy compared with the corresponding tumor bed (p < 0.01). CEA, EpCAM, αvβ6, and uPAR expressions were low (TIS < 6) in the tumor bed in, respectively, 93%, 95%, 85%, and 62.5% of cases. Immunohistochemical evaluation shows that CEA and EpCAM could be suitable targets for response evaluation after neoadjuvant treatment, since expression of these targets in the primary tumor bed is low compared with the diagnostic biopsy and adjacent pre-existent rectal mucosa in more than 90% of patients with a pCR.

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