Li ZJ, Zhang K. Matched analysis of long-term oncological outcomes between watch-and-wait strategy and radical surgery after neoadjuvant therapy for rectal cancer. World J Gastrointest Surg 2026; 18(9): 121131 [DOI: 10.4240/wjgs.121131]
Corresponding Author of This Article
Ke Zhang, Associate Chief Physician, General Surgery Center, Jiujiang City Key Laboratory of Cell Therapy, Jiujiang No. 1 People’s Hospital, No. 48 Taling South Road, Xunyang District, Jiujiang 332000, Jiangxi Province, China. cole66866@126.com
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Li ZJ, Zhang K. Matched analysis of long-term oncological outcomes between watch-and-wait strategy and radical surgery after neoadjuvant therapy for rectal cancer. World J Gastrointest Surg 2026; 18(9): 121131 [DOI: 10.4240/wjgs.121131]
Zi-Jun Li, Department of Medical Oncology, Jiujiang City Key Laboratory of Cell Therapy, Jiujiang No. 1 People’s Hospital, Jiujiang 332000, Jiangxi Province, China
Ke Zhang, General Surgery Center, Jiujiang City Key Laboratory of Cell Therapy, Jiujiang No. 1 People’s Hospital, Jiujiang 332000, Jiangxi Province, China
Author contributions: Li ZJ responsible for research design, data collection, statistical analysis, and manuscript drafting; Zhang K provided guidance for this study and reviewed the final draft; and all authors have approved the final version of the manuscript.
AI contribution statement: The authors declare that no AI tools were used in the development or writing of this manuscript and take full responsibility for its integrity, accuracy, and originality.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Jiujiang No. 1 People’s Hospital, approval No. JJSDYRMYY-YXLL-121.
Informed consent statement: Signed informed consent was obtained from all participants and their legal guardians.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Data sharing statement: No additional data are available.
Corresponding author: Ke Zhang, Associate Chief Physician, General Surgery Center, Jiujiang City Key Laboratory of Cell Therapy, Jiujiang No. 1 People’s Hospital, No. 48 Taling South Road, Xunyang District, Jiujiang 332000, Jiangxi Province, China. cole66866@126.com
Received: April 22, 2026 Revised: May 23, 2026 Accepted: July 7, 2026 Published online: September 27, 2026 Processing time: 145 Days and 22.6 Hours
Abstract
BACKGROUND
For patients with clinical complete response (cCR) after neoadjuvant therapy for rectal cancer (RC), traditional radical surgery involves significant trauma, and the long-term oncological safety of the wait-and-see strategy for organ preservation needs further verification.
AIM
To assess and compare long-term oncological outcomes between the watch-and-wait approach and radical surgery in patients with locally advanced RC achieving cCR following neoadjuvant chemoradiotherapy.
METHODS
This retrospective cohort study included 100 RC patients treated at our hospital from October 2020 to October 2022 who achieved cCR after neoadjuvant therapy. Patients were allocated to the watch-and-wait group (n = 45) or the radical surgery group (n = 45) based on patient preference and multidisciplinary team recommendations. Three-year disease-free survival (DFS), overall survival (OS), recurrence patterns, and quality of life were evaluated and compared between groups.
RESULTS
Kaplan-Meier analysis showed 3-year DFS rates of 86.67% (39/45) in the watch-and-wait group and 91.11% (41/45) in the radical surgery group, with no statistically significant difference (Log-rank χ2 = 0.512, P = 0.474). Three-year OS rates were 95.56% (43/45) and 97.78% (44/45), respectively, with no significant difference (Log-rank χ2 = 0.347, P = 0.556). Overall recurrence rates were comparable between the two groups (P > 0.05). At 24 months post-enrollment, the watch-and-wait group showed significantly higher scores for role, emotional, and social functioning, and global health status (P < 0.05) and lower scores for fatigue, pain, insomnia, diarrhea, and urinary dysfunction (P < 0.05) compared with the radical surgery group. Cox regression identified baseline cN2 stage as an independent predictor of 3-year DFS (hazard ratio = 4.128, 95% confidence interval: 1.265-13.468, P = 0.019), whereas treatment strategy did not significantly influence DFS.
CONCLUSION
In patients with locally advanced RC achieving cCR after neoadjuvant chemoradiotherapy, the watch-and-wait strategy provides comparable 3-year DFS, OS, and recurrence rates to radical surgery while conferring superior medium- and long-term quality of life. These findings support watch-and-wait as a safe and feasible organ-preserving approach.
Core Tip: This study compared long-term oncological outcomes between the watch-and-wait strategy and radical surgery in 100 rectal cancer patients with clinical complete response after neoadjuvant therapy. Results showed comparable 3-year disease-free survival, overall survival, and recurrence rates, while watch-and-wait conferred better quality of life, supporting watch-and-wait as a safe organ-preserving option.
Citation: Li ZJ, Zhang K. Matched analysis of long-term oncological outcomes between watch-and-wait strategy and radical surgery after neoadjuvant therapy for rectal cancer. World J Gastrointest Surg 2026; 18(9): 121131
Rectal cancer (RC) is a prevalent malignant tumor of the gastrointestinal tract worldwide. Radical surgery has traditionally been the standard treatment for middle and low locally advanced RC, effectively reducing local recurrence rates; however, it is associated with complications such as surgical trauma, permanent enterostomy, and genitourinary dysfunction, which adversely affect patients’ quality of life (QoL)[1,2]. To enhance local control and increase the possibility of sphincter preservation, neoadjuvant chemoradiotherapy has become the standard treatment approach for locally advanced RC[3,4]. Studies have reported that following neoadjuvant therapy, approximately 15%-25% of RC patients achieve clinical complete response (cCR), with some attaining pathological complete response (pCR)[5,6]. Evidence suggests that residual occult tumour cells may persist even in cases of complete clinical remission. The omission of radical surgical resection in such cases may increase the risk of local recurrence and potentially compromise patient prognosis[7]. Recent data further indicate that, although the watch-and-wait strategy preserves anorectal function and avoids surgical morbidity, concerns remain regarding its long-term oncological safety. A 2024 network meta-analysis by Du et al[8] reported that watch-and-wait management may be associated with an increased risk of local recurrence beyond 3 years, while a definitive adverse impact on overall survival (OS) has not yet been established.
The watch-and-wait strategy proposes that, for patients who achieve a cCR following neoadjuvant therapy, radical surgery may be deferred under strict surveillance, with salvage surgery reserved for cases of tumour recurrence. This approach aims to preserve rectal function and improve QoL, providing an alternative paradigm for the personalised management of locally advanced RC[9,10]. However, concerns have been raised regarding the potential persistence of residual tumour cells, which may increase the risk of distant metastasis, and the long-term oncological safety of this strategy remains to be fully established[11,12]. To further investigate these issues, the present study enrolled 100 patients with RC who achieved cCR following neoadjuvant therapy at our hospital between October 2020 and October 2022. Long-term oncological outcomes were compared between patients managed with the watch-and-wait strategy and those who underwent curative radical surgery, with the aim of providing evidence to support clinical decision-making.
MATERIALS AND METHODS
Study subjects
The Hospital Medical Ethics Committee approved this study. A total of 90 patients with RC who received neoadjuvant therapy and were assessed as achieving cCR at our hospital between October 2020 and October 2022 were enrolled. Propensity score matching was applied to balance baseline characteristics between the two groups. The inclusion criteria were as follows: (1) Age between 18 and 80 years; (2) Pathologically confirmed rectal adenocarcinoma via colonoscopic biopsy; (3) Clinical stage cT2-4aN0-2M0 before treatment; (4) Completion of standard long-course neoadjuvant chemoradiotherapy, consisting of a total radiotherapy dose of 45.0-50.4 Gy delivered in 25-28 fractions, combined with fluoropyrimidine- or capecitabine-based chemotherapy; (5) cCR assessed 8-12 weeks after completion of neoadjuvant therapy by the hospital’s colorectal cancer multidisciplinary team (MDT); and (6) Availability of complete clinical records and provision of informed consent.
The diagnosis of cCR was established when all of the following criteria were simultaneously met: (1) Digital rectal examination revealed no palpable mass, or only soft, flat scar tissue; (2) White-light endoscopy showed no ulcers, nodules, or elevated lesions. The mucosa could show pallor, telangiectasia, or mild cicatrization. Biopsy of any suspicious area demonstrated absence of tumor cells, with only fibrosis or mucin pools present; (3) Pelvic high-resolution magnetic resonance imaging (MRI) showed mrTRG 1 (uniformly dark wall with no residual lesion) or mrTRG 2 (predominantly dark wall with minimal fibrous strands) according to the mrTRG scoring system, with no suspicious lymphadenopathy (short-axis diameter < 5 mm and regular morphology); and (4) Serum carcinoembryonic antigen (CEA) levels were within the normal range.
Exclusion criteria included: (1) The presence of distant metastasis; (2) A history of other malignancies; (3) Severe cardiac, pulmonary, hepatic, or renal insufficiency; (4) Intolerance to surgery; and (5) Inability to complete the scheduled follow-up due to personal reasons.
Following a comprehensive discussion by the MDT, all patients were fully informed of the risks and benefits of both management strategies and chose their treatment plan based on personal preference. Patients were then assigned to either the watch-and-wait group (n = 50) or the radical surgery group (n = 50). There were no statistically significant differences in baseline characteristics between the two groups at the start (P > 0.05), as shown in Table 1.
Table 1 Baseline characteristics of patients in the watch-and-wait and radical surgery groups, n (%)/mean ± SD.
Watch-and-wait strategy: Patients achieving complete remission (cCR) who did not require inpatient management were enrolled in a structured outpatient surveillance programme. Patients and their families received standardized health education, including detailed instruction regarding alarm symptoms such as new-onset rectal bleeding, tenesmus, anal pain, and persistently elevated serum CEA levels, with advice to seek immediate medical evaluation if any of these features developed. Patients were followed for 3 years, with comprehensive assessments every 3 months, including medical history review, physical examination, serum CEA measurement, enhanced computed tomography of the chest, abdomen, and pelvis, and liver MRI. Proctoscopy was performed every 6 months, with targeted biopsies of the original tumor bed and any mucosal areas showing suspicious changes. If imaging or endoscopy suggested recurrence, the colorectal cancer MDT reassessed the patient, and upon pathological confirmation of adenocarcinoma, salvage therapy was initiated, with radical surgery performed within 4-6 weeks of reassessment.
Radical surgery strategy: Patients in the radical surgery group underwent surgery 10-14 weeks after completion of neoadjuvant therapy. Surgical methods were selected according to pre-treatment tumor characteristics and patient preference. For middle and high RCs (≥ 5 cm from the anal verge), laparoscopic or robot-assisted low anterior resection was preferred. For low RCs (< 5 cm from the anal verge) with preserved anal sphincter function, ultra-low anterior resection combined with preventive ileostomy was performed when a distal resection margin of ≥ 1 cm could be ensured. Tumors involving the anal sphincter complex, or cases in which postoperative anal function was expected to be poor after sphincter-preserving surgery, were treated with abdominoperineal resection. All surgeries adhered to the principles of total mesorectal excision surgery. Intraoperatively, the operating surgeon determined the need for a prophylactic ileostomy based on factors including anastomotic tension, vascular perfusion, and the patient’s overall clinical status. Resected specimens were processed according to standardized protocols, including gross examination, fixation, tissue sampling, and histopathological evaluation by a pathologist. A comprehensive pathological report was generated to inform adjuvant treatment planning. Postoperative follow-up was aligned with that of the watch-and-wait group, consisting of imaging studies and serum tumour marker assessment, without the requirement for routine colonoscopic biopsies.
Observation indicators
This study compared the 3-year disease-free survival (DFS) rate, OS rate, recurrence patterns, and QoL between the watch-and-wait and radical surgery groups. DFS was defined as the time from enrolment or surgery to the first occurrence of local regrowth, recurrence, distant metastasis, or death from any cause and was analysed using Kaplan-Meier survival analysis. OS was defined as the time from enrolment or surgery to death from any cause and was evaluated using the same method. Recurrence patterns were categorized as local regrowth, regional recurrence, or distant metastasis. QoL was assessed at 24 months post-enrolment using the Chinese versions of the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 and the colorectal cancer-specific module [European Organisation for Research and Treatment of Cancer QoL Questionnaire-Colorectal Cancer Module (29 items)][13]. The QLQ-Core 30 comprises five functional scales (physical, role, cognitive, emotional, and social functioning), three symptom scales (fatigue, pain, and nausea/vomiting), and a global health status scale. The QLQ-Colorectal Cancer Module (29 items) addresses colorectal cancer-specific symptoms, including urinary dysfunction, diarrhea, and bowel function problems. All raw scores were linearly transformed to standardized scores ranging from 0 to 100. Higher scores on functional and global health status scales indicated better functional capacity or QoL, whereas higher scores on symptom scales reflected greater symptom severity.
Statistical analysis
All statistical analyses were performed using SPSS version 26.0. Continuous variables conforming to a normal distribution were expressed as mean ± SD and compared between groups using the independent samples t-test. Non-normally distributed data were presented as median (interquartile range) and compared using the Mann-Whitney U test. Categorical variables were expressed as counts (percentages) and analyzed using the χ2 test. Kaplan-Meier survival curves were constructed to evaluate 3-year DFS and OS between groups, with differences assessed by the Log-rank test. Multivariate analysis using the Cox proportional hazards regression model was performed to identify independent predictors of 3-year DFS. Statistical significance was set at P < 0.05.
RESULTS
Comparison of 3-year disease-free and OS between groups
Kaplan-Meier survival analysis indicated that the 3-year DFS rate was 86.67% (39/45) in the watch-and-wait group and 91.11% (41/45) in the radical surgery group, with no statistically significant difference between the two groups (Log-rank χ2 = 0.512, P = 0.474). Similarly, the 3-year OS rate was 95.56% (43/45) in the watch-and-wait group and 97.78% (44/45) in the radical surgery group, also showing no significant difference between the groups (Log-rank χ2 = 0.347, P = 0.556) (Figure 1).
Figure 1 Kaplan-Meier survival analyses of 3-year survival outcomes between the watch-and-wait group and radical surgery group.
A: 3-year disease-free survival curves; B: 3-year overall survival curves.
Comparison of recurrence between groups
No significant difference in overall recurrence rate was observed between the watch-and-wait and radical surgery groups (P > 0.05). Among patients in the watch-and-wait group who experienced local regrowth (n = 5), all underwent subsequent radical surgery. Postoperative pathological assessment revealed ypT1N0 in 2 cases, ypT2N0 in two instances, and ypT2N1a in 1 case, with all achieving R0 resection. All patients remained disease-free at the last follow-up (Table 2).
Table 2 Comparison of recurrence patterns between the watch-and-wait and radical surgery groups, n (%).
Among the 90 patients included in the final analysis, follow-up completion rates were 93.3% in the watch-and-wait group and 95.6% in the radical surgery group. Three patients in the watch-and-wait group and two patients in the radical surgery group were excluded from the final QoL analysis due to incomplete questionnaire data or irregular follow-up attendance. Compared with the radical surgery group, the watch-and-wait group showed significantly higher scores in role functioning, emotional functioning, social functioning, and global health status (P < 0.05). Symptom scores for fatigue, pain, insomnia, diarrhoea, and urinary dysfunction were significantly lower in the watch-and-wait group than in the radical surgery group (P < 0.05) (Table 3).
Table 3 Comparison of quality of life scores between the watch-and-wait and radical surgery groups, mean ± SD.
A Cox proportional hazards regression model incorporating age, sex, baseline cT/N stage, treatment strategy (watch-and-wait vs radical surgery), and achievement of pCR was performed. Baseline cN2 stage emerged as an independent risk factor for 3-year DFS (hazard ratio = 4.128, 95% confidence interval: 1.265-13.468, P = 0.019), whereas treatment strategy did not significantly influence prognosis (Table 4).
Table 4 Multivariate Cox regression analysis of factors associated with 3-year disease-free survival.
Variable
β value
SE
Wald χ2
P value
HR (95%CI)
Age (≥ 60 vs < 60)
0.452
0.531
0.724
0.395
1.571 (0.555-4.450)
Gender (male vs female)
-0.287
0.518
0.307
0.580
0.751 (0.272-2.073)
Baseline cT stage (T3-4 vs T2)
0.891
0.712
1.566
0.211
2.438 (0.604-9.838)
Baseline cN stage (N2 vs N0-1)
1.418
0.604
5.512
0.019
4.128 (1.265-13.468)
Treatment strategy (radical surgery vs watch-and-wait)
In routine clinical practice, radical surgery with total mesorectal excision remains the standard treatment for RC. Although effective for local disease control, this approach is frequently associated with permanent stoma formation, genitourinary dysfunction, and substantial deterioration in QoL[14,15]. Neoadjuvant chemoradiotherapy not only improves local tumour control but also enables a subset of patients to achieve cCR, hence creating the potential to avoid radical surgical intervention and preserve organ function[16,17]. In 2004, Habr-Gama and colleagues from Brazil first introduced the watch-and-wait strategy. In this approach, patients with a high probability of pCR are identified through comprehensive clinical, endoscopic, and radiological assessment and may defer immediate surgery in favour of intensive surveillance. Salvage surgery is undertaken promptly in cases of tumour regrowth detected during follow-up, thus offering a non-operative, organ-preserving management option[18-20]. In the present study, the watch-and-wait strategy was applied to patients with locally advanced RC who achieved cCR following neoadjuvant chemoradiotherapy. Long-term oncological outcomes were compared with those of patients who underwent radical surgery during the same period.
The 3-year DFS rates were 86.67% in the watch-and-wait group and 91.11% in the radical surgery group, while the corresponding OS rates were 95.56% and 97.78%, respectively. Kaplan-Meier analysis displayed no statistically significant differences between the two groups (P > 0.05). These results indicate that, in carefully selected patients achieving cCR, deferral or omission of surgery does not significantly compromise oncological outcomes in terms of recurrence or survival. These findings are consistent with the systematic review by Wang et al[21], which reported no significant difference in survival outcomes between watch-and-wait management and surgical resection in RC patients achieving cCR after neoadjuvant therapy, with both approaches demonstrating high 3-year OS rates. In the present study, the overall recurrence rates were 13.33% in the watch-and-wait group and 8.89% in the radical surgery group. Although slightly higher in the watch-and-wait cohort, the difference was not statistically significant (P > 0.05). All five patients with local regrowth in the watch-and-wait group underwent successful salvage surgery with R0 resection and remained disease-free thereafter. These findings suggest that effective disease control can still be achieved through intensive surveillance and timely intervention, even in cases of local regrowth. A strict follow-up protocol was implemented in the watch-and-wait group, including imaging and tumour marker evaluation every 3 months, colonoscopy with biopsy every 6 months, and patient education regarding alarm symptoms to facilitate early detection of tumour regrowth. This structured surveillance framework is essential for the safe and effective application of the watch-and-wait strategy.
At 24 months of follow-up, the watch-and-wait group demonstrated significantly higher scores in role functioning, emotional functioning, social functioning, and global health status compared with the radical surgery group (P < 0.05). In addition, symptom scores for fatigue, pain, insomnia, diarrhoea, and urinary dysfunction were significantly lower in the watch-and-wait group (P < 0.05). Radical surgery is commonly associated with a range of complications, including permanent or temporary stoma formation, urinary dysfunction, and sexual impairment, all of which may substantially affect physiological function and psychosocial adaptation[22-24]. In contrast, the watch-and-wait strategy avoids surgical trauma and preserves anorectal sphincter function as well as pelvic autonomic nerve integrity, thus reducing the incidence of these dysfunctions and improving medium- to long-term QoL[25-27]. Ferri et al[28] similarly reported that the watch-and-wait strategy is associated with superior outcomes in terms of QoL, psychological well-being, and social participation compared with surgical management, which is consistent with the findings of the present study. Furthermore, the lower incidence of diarrhoea and urinary symptoms observed in the watch-and-wait group further supports its role in preserving bowel and urinary function.
Multivariate Cox regression analysis identified baseline cN2 stage as an independent risk factor for 3-year DFS (P < 0.05). In contrast, treatment strategy (watch-and-wait vs radical surgery) was not independently associated with prognosis (P > 0.05). These findings indicate that long-term outcomes are primarily driven by underlying tumour biology rather than the choice or timing of surgical intervention. This observation is consistent with a multicentre study by Cerdán-Santacruz et al[29], which reported that even in patients achieving pCR, a high initial nodal disease burden remains associated with an increased risk of long-term recurrence. These results underscore that clinical decision-making should not rely solely on surgical strategy but should instead prioritise accurate pre-treatment staging and comprehensive risk stratification.
This study has several limitations that warrant consideration. First, it was a retrospective, single-centre study with a relatively small sample size, which may introduce selection bias and limit the generalisability of the findings. Although propensity score matching was applied to balance baseline characteristics between groups, the possibility of residual confounding cannot be excluded. Second, baseline QoL data before treatment allocation were not available due to the retrospective design. Therefore, the observed superior QoL outcomes in the watch-and-wait group should be interpreted with caution, as patients selecting organ-preserving management may have had better baseline functional status, psychological well-being, or a stronger preference for QoL preservation. Third, the criteria for cCR assessment were based on institutional standards used during the study period (2020-2022) and did not fully incorporate more recent international consensus recommendations, including the International Watch & Wait Database criteria and routine diffusion-weighted MRI. As a result, residual occult disease cannot be completely excluded. Fourth, although pelvic MRI was routinely performed, retrospective reassessment of lateral pelvic lymph nodes using contemporary standardized criteria was not feasible. Given the relatively high prevalence of lateral lymph node metastasis in Asian populations with RC, occult nodal involvement may have been underestimated in some patients. Fifth, the watch-and-wait strategy required an intensive surveillance protocol with frequent imaging and endoscopic evaluation, which may not be readily implementable in routine clinical practice and may limit external applicability. Finally, the median follow-up duration was relatively limited for robust evaluation of long-term oncological safety. Larger, prospective, multicentre studies with standardized imaging protocols, longitudinal QoL assessment, and extended follow-up are needed to further define the optimal indications and long-term outcomes of the watch-and-wait strategy.
CONCLUSION
These findings suggest that, in carefully selected patients achieving cCR after neoadjuvant chemoradiotherapy, the watch-and-wait strategy may provide comparable short- to mid-term oncological outcomes while potentially improving QoL. However, appropriate patient selection, strict surveillance protocols, and further prospective multicentre studies are required to confirm long-term oncological safety and validate these results across broader clinical settings.
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