Watch and Wait in Rectal Cancer Patients with Clinical Complete Response to Neoadjuvant Therapy: The American Viewpoint

2019 ◽  
pp. 195-211
Author(s):  
Felipe Quezada-Díaz ◽  
Tarik Sammour ◽  
J. Joshua Smith ◽  
Y. Nancy You
2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 692-692
Author(s):  
Rosa Maria Jimenez-Rodriguez ◽  
Felipe Fernando Quezada-Diaz ◽  
Irbaz Hameed ◽  
Sujata Patil ◽  
Jesse Joshua Smith ◽  
...  

692 Background: Retrospective case series suggest that watch-and-wait (WW) is a safe alternative to total mesorectal excision (TME) in selected patients with a clinical complete response (cCR) after chemoradiotherapy (CRT). Because treatment strategies vary widely and total numbers of patients treated at different institutions have not been reported, the proportion of rectal cancer patients who can potentially benefit from WW is not known. Here, we report the results of a treatment strategy incorporating WW in a cohort of rectal cancer patients treated with total neoadjuvant therapy (TNT). Methods: Consecutive patients with stage II/III (MRI staging) rectal adenocarcinoma treated with TNT from 2012 to 2017 by a single surgeon were included. TNT consisted of mFOLFOX6 (8 cycles) or CapeOX (5 cycles) either before or after CRT (5600 cGy in 28 fractions with sensitizing fluorouracil or capecitabine). Tumor response was assessed with a digital rectal exam, endoscopy, and MRI according to predefined criteria. Patients with a cCR were offered WW, and patients with residual tumor were offered TME. WW and TME patients were compared based on intention to treat, using the chi-square or rank sum test. Relapse-free survival (RFS) was evaluated by Kaplan-Meier analysis. Results: A total of 109 patients were identified. One patient died during CRT. Of the 108 patients, 64 (59%) had an incomplete clinical response; 4 of the 64 patients declined surgery or had local excision, and 60 underwent TME. The remaining 44 patients (41%) had a cCR and underwent WW. On average, patients in the WW group were older and had smaller, more distal tumors. Median radiation dose, number of chemotherapy cycles, number ofadverse events, or length of follow-up (28 months) did not differ between the TME and WW groups. Five (11%) of the 44 WW patients had local tumor regrowth, at a median of 14 (4–25) months after TNT; 2 of the 5 also had distant metastasis. Six (10%) of the 60 TME patients had a pathological complete response. RFS did not differ between the TME and WW groups (log rank P= 0.09). Conclusions: Approximately 40% of patients with stage II/III rectal cancer treated with TNT achieve a clinical complete response and can benefit from a WW approach with the aim of preserving the rectum.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Qiao-xuan Wang ◽  
Rong Zhang ◽  
Wei-wei Xiao ◽  
Shu Zhang ◽  
Ming-biao Wei ◽  
...  

Abstract Background The watch-and-wait strategy offers a non-invasive therapeutic alternative for rectal cancer patients who have achieved a clinical complete response (cCR) after chemoradiotherapy. This study aimed to investigate the long-term clinical outcomes of this strategy in comparation to surgical resection. Methods Stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy and achieved a cCR were selected from the databases of three centers. cCR was evaluated by findings from digital rectal examination, colonoscopy, and radiographic images. Patients in whom the watch-and-wait strategy was adopted were matched with patients who underwent radical resection through 1:1 propensity score matching analyses. Survival was calculated and compared in the two groups using the Kaplan–Meier method with the log rank test. Results A total of 117 patients in whom the watch-and-wait strategy was adopted were matched with 354 patients who underwent radical resection. After matching, there were 94 patients in each group, and no significant differences in term of age, sex, T stage, N stage or tumor location were observed between the two groups. The median follow-up time was 38.2 months. Patients in whom the watch-and-wait strategy was adopted exhibited a higher rate of local recurrences (14.9% vs. 1.1%), but most (85.7%) were salvageable. Three-year non-regrowth local recurrence-free survival was comparable between the two groups (98% vs. 98%, P = 0.506), but the watch-and-wait group presented an obvious advantage in terms of sphincter preservation, especially in patients with a tumor located within 3 cm of the anal verge (89.7% vs. 41.2%, P < 0.001). Three-year distant metastasis-free survival (88% in the watch-and-wait group vs. 89% in the surgical group, P = 0.874), 3-year disease-specific survival (99% vs. 96%, P = 0.643) and overall survival (99% vs. 96%, P = 0.905) were also comparable between the two groups, although a higher rate (35.7%) of distant metastases was observed in patients who exhibited local regrowth in the watch-and-wait group. Conclusion The watch-and-wait strategy was safe, with similar survival outcomes but a superior sphincter preservation rate as compared to surgery in rectal cancer patients achieving a cCR after neoadjuvant chemoradiotherapy, and could be offered as a promising conservative alternative to invasive radical surgery.


Diagnostics ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 516
Author(s):  
Daan Linders ◽  
Marion Deken ◽  
Maxime van der Valk ◽  
Willemieke Tummers ◽  
Shadhvi Bhairosingh ◽  
...  

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.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 509-509 ◽  
Author(s):  
Jesse Joshua Smith ◽  
Oliver S Chow ◽  
Anne Eaton ◽  
Maria Widmar ◽  
Garrett Michael Nash ◽  
...  

509 Background: Nonoperative management (NOM) of rectal cancer following a clinical complete response (cCR) to neoadjuvant therapy is a non-standard approach. We review our experience with NOM to evaluate safety and efficacy. Methods: A retrospective review of prospectively collected data between 2006 and 2014 was conducted. We compared patients completing neoadjuvant therapy for stage I to III rectal cancers who: a) achieved cCR and were treated with NOM, or b) underwent standard total mesorectal excision (TME) and achieved a pathologic complete response (pCR). Kaplan-Meier estimates and the log-rank test were used. Results: Seventy-three patients underwent NOM after cCR. From 369 rectal resections performed, 72 (20%) achieved pCR and form the comparison group. Median follow-up across both groups was 3.3 years. Rectal preservation was achieved in 56 (77%) of the patients treated with NOM. Of the 19 NOM patients with local regrowth, 18 were salvaged successfully with standard TME (n=16) or local excision (n=2), with one patient pending a salvage operation (n=1). No significant differences were noted in the number of distant recurrences between the NOM and pCR groups. Four-year disease-specific survival and overall survival between the two groups were not significantly different. Conclusions: In this highly selected group of patients with cCR to neoadjuvant treatment, NOM with surgical salvage of local tumor regrowth achieved local control in all patients. The oncologic outcome for NOM patients at 4 years was comparable to patients with pCR after rectal resection. These data continue to suggest that NOM does not compromise oncologic outcome, and that preservation of the rectum is achieved in a majority of patients. [Table: see text]


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