Clinical Investigation
Local Recurrence After Complete Clinical Response and Watch and Wait in Rectal Cancer After Neoadjuvant Chemoradiation: Impact of Salvage Therapy on Local Disease Control

https://doi.org/10.1016/j.ijrobp.2013.12.012Get rights and content

Purpose

To review the risk of local recurrence and impact of salvage therapy after Watch and Wait for rectal cancer with complete clinical response (cCR) after chemoradiation therapy (CRT).

Methods and Materials

Patients with cT2-4N0-2M0 distal rectal cancer treated with CRT (50.4-54 Gy + 5-fluorouracil-based chemotherapy) and cCR at 8 weeks were included. Patients with cCR were enrolled in a strict follow-up program with no immediate surgery (Watch and Wait). Local recurrence-free survival was compared while taking into account Watch and Wait strategy alone and Watch and Wait plus salvage.

Results

90 of 183 patients experienced cCR at initial assessment after CRT (49%). When early tumor regrowths (up to and including the initial 12 months of follow-up) and late recurrences were considered together, 28 patients (31%) experienced local recurrence (median follow-up time, 60 months). Of those, 26 patients underwent salvage therapy, and 2 patients were not amenable to salvage. In 4 patients, local re-recurrence developed after Watch and Wait plus salvage. The overall salvage rate for local recurrence was 93%. Local recurrence-free survival at 5 years was 69% (all local recurrences) and 94% (after salvage procedures). Thirteen patients (14%) experienced systemic recurrence. The 5-year cancer-specific overall survival and disease-free survival for all patients (including all recurrences) were 91% and 68%, respectively.

Conclusions

Local recurrence may develop in 31% of patients with initial cCR when early regrowths (≤12 months) and late recurrences are grouped together. More than half of these recurrences develop within 12 months of follow-up. Salvage therapy is possible in ≥90% of recurrences, leading to 94% local disease control, with 78% organ preservation.

Introduction

Up to 42% of patients with distal rectal cancer may experience a complete pathologic response after neoadjuvant chemoradiation (CRT) and total mesorectal excision (TME) (1). These patients seem to have improved oncologic outcomes (2). However, these results after TME are at the cost of significant postoperative morbidity, including long-term urinary, sexual, and fecal continence dysfunction and the frequent need for temporary or definitive stomas. In this setting, alternative treatment strategies have been suggested to avoid major postoperative complications and still maintain optimal oncologic results (3). These strategies include full-thickness local excision (FTLE) or no immediate surgery (also known as the Watch and Wait strategy).

Full-thickness local excision may provide the advantage of allowing pathologic assessment of the primary tumor 4, 5. However, even though the risk of sexual, urinary, and fecal incontinence is minimal, postoperative morbidity, including wound dehiscence, is significantly higher after CRT 6, 7. Another alternative treatment strategy with no immediate resection and observation has been suggested for patients with complete clinical response (cCR) (8). This alternative has the advantages of an organ-sparing strategy, with even lower morbidity or functional consequences (9). However, it requires identification of patients with cCR who are likely to have a complete pathologic response (10). Still, these patients with cCR have the potential risk for harboring microscopic residual disease within both the rectal wall and the mesorectal nodes and therefore remain at risk for the development of local recurrence (11).

In this setting, a proportion of patients undergoing observation and no immediate surgery after a cCR (or Watch and Wait strategy) may experience local recurrence and ultimately require a salvage procedure. Ideally, the use of any organ-sparing treatment strategy without radical surgery would allow salvage resection for the majority of local recurrences with no oncologic compromise. The aim of the study was to review local recurrence, salvage rates, and oncologic outcomes among patients with cCR treated without immediate surgery and the impact of salvage on local disease control. In previous studies, cCR was considered for patients with at least 12 months of follow-up who showed no evidence of tumor regrowth. In the present study, all recurrences (including early regrowths within the initial 12 months of follow-up) were considered to enable understanding of the role and impact of salvage resection on local disease control after no immediate surgery after an initial cCR.

Section snippets

Methods and Materials

Between 1991 and 2011, consecutive patients from a single institution (Angelita & Joaquim Gama Institute) were assessed before neoadjuvant CRT by a single surgeon and underwent full physical examination, digital rectal examination, and rigid proctoscopy. Carcinoembryonic antigen (CEA) levels were obtained for all patients (8). Radiologic staging included chest and abdominopelvic computed tomographic (CT) scans, pelvic magnetic resonance imaging (MRI), and/or endorectal ultrasonography (ERUS)

Results

Between 1991 and 2011, 183 patients with distal rectal cancer underwent neoadjuvant CRT at the Angelita & Joaquim Gama Institute. After assessment of response at least 8 weeks after completion of CRT, 90 patients were considered to have initial cCR (49%) and were referred to no immediate surgery (Watch and Wait). The baseline features of patients with initial cCR are available in Table 1. The median follow-up time was 60 months (range, 12-233 months). Loss to follow-up was considered for any

Discussion

The treatment of patients with cCR after neoadjuvant CRT remains controversial. The use of alternative treatment strategies without radical surgery is desirable to avoid the significant postoperative morbidity, need for intestinal stomas, and functional disorders (mainly anorectal, sexual, and urinary) associated with surgery. Surveillance without any immediate surgery (Watch and Wait) avoids postoperative complications and minimizes the risk of adverse functional outcomes in patients with

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