e15603 Background: Neoadjuvant chemoradiotherapy (nCRT) not only could bring tumor downsizing and downstaging but also could achieve clinical complete response (cCR) or pathological complete response (pCR). Although immunotherapy benefits MSI-H/dMMR rectal cancer patients, little response is observed in MSS/pMMR patients. Several clinical trials including VOLTAGE trial demonstrated that a combination of PD-1 inhibitor and nCRT could result in a promising pathological response even in MSS/pMMR patients. But the elucidation regarding organ preservation after treatment is lacking. Watch and Wait (W&W) is an effective strategy in rectal cancer patients showing cCR after nCRT to preserve organs. This study was designed to explore the efficacy, safety, and organ preservation rate of a combination of nCRT and PD-1 inhibitor(sintilimab) in MSS/pMMR patients with ultra-low rectal cancers. Methods: This was a single-arm, phase II trial. Patients with ultra-low rectal cancer that was confirmed as MSS/pMMR T1-3aN0-1M0 and received 50 Gy (25×2 Gy) chemoradiotherapy and 2 cycles of sintilimab, followed by 6 cycles of capecitabine or CAPOX regimen plus 2 cycles of sintilimab as consolidation therapy. Patients with cCR were managed using the W&W strategy, patients with ncCR were given local excision. The primary outcome was cCR rate and secondary outcomes were anal preservation rate, organ preservation rate, tumor regression grade (TRG), and safety profile. Results: From 2021 January to 2021 December, a total of 23 patients were enrolled. The median age was 55 y (range; 38 to 75). Male patients were 61%. cT2 was 56.5% (13/23), cT3 was 43.5% (10/23), cN0 was 69.6% (16/23), and cN1 was 30.4% (7/23). All patients completed 50Gy chemoradiotherapy. Nineteen patients received 4 cycles of sintilimab treatment, 3 patients received 3 cycles of sintilimab, and 1 patient received 1 cycle of sintilimab. cCR was 43.5% (10/23), ncCR was 26.1% (6/23), and cPR was 30.4% (7/23). The anal preservation rate was not assessed in 1 patient due to cerebral ischemic stroke. The anal preservation rate was 95.5% (21/22), rectal preservation rate was 59.1% (13/22). Ten patients underwent surgery. Among them, two patients achieved pCR, and the major pathologic response rate (TRG0-1) was 60.0% (6/10). The overall CR(cCR+pCR) rate was 52.2% (12/23). Grade 3/4 treatment-related adverse events occurred in 17.4% (4/23) of patients. No unexpected adverse events or deaths were observed. Conclusions: Given the favorable tolerability and encouraging cCR rate, nCRT plus sintilimab could be a feasible and safe option for patients with pMMR/MSS, ultra-low rectal cancer who have a strong desire to preserve the anus. Based on these results, a prospective, randomized, controlled, multicenter, phase III study is currently in progress (NCT05215379). Clinical trial information: ChiCTR2100042785.

Background: To assess postoperative anal function and quality of life of ultra-low rectal cancer patients treated by laparoscopic modified Parks surgery. Methods: From February 2017 to March 2019, 114 patients with ultra-low rectal cancer above T2 were treated respectively with ultra-low anterior resection (Dixon), modified coloanal anastomosis (modified Parks), and Miles according to the preoperative stage and anastomotic position. The postoperative anal function and Fecal Incontinence Quality of Life Scale (FIQL) of each patient were collected and synthetically analyzed. Results: Compared with the Dixon group, the postoperative anal function and FIQL in the Parks group were poor at the early stage. However, from 6 to 12 months after surgery, the scores of anal function and FIQL in the Parks group were similar to those in the Dixon group (P > 0.05). Compared with the Miles group, the FIQL of the two groups were similar in the early postoperative stage. However, with the passage of time, from 3 to 9 months after surgery, the four domains of FIQL in the Parks group were higher than those in the Miles group successively (P < 0.05). Conclusions: Laparoscopic modified Parks is a safe, effective, and economical anus-preserving surgery. Although its early anal function and FIQL were poor, it could gradually recover to the similar level as Dixon. Moreover, it can save the anus and obtain a better postoperative quality of life for some patients who previously could only undergo Miles.

Background To investigate the learning curve of conformal sphincter preservation operation (CSPO) in the treatment of ultralow rectal cancer and to further explore the influencing factors of operation time. Methods From August 2011 to April 2020, 108 consecutive patients with ultralow rectal cancer underwent CSPO by the same surgeon in the Department of Colorectal Surgery of Changhai Hospital. The moving average and cumulative sum control chart (CUSUM) curve were used to analyze the learning curve. The preoperative clinical baseline data, postoperative pathological data, postoperative complications, and survival data were compared before and after the completion of learning curve. The influencing factors of CSPO operation time were analyzed by univariate and multivariate analysis. Results According to the results of moving average and CUSUM method, CSPO learning curve was divided into learning period (1–45 cases) and learning completion period (46–108 cases). There was no significant difference in preoperative clinical baseline data, postoperative pathological data, postoperative complications, and survival data between the two stages. Compared with the learning period, the operation time (P < 0.05), blood loss (P < 0.05), postoperative flatus and defecation time (P < 0.05), liquid diet time (P < 0.05), and postoperative hospital stay (P < 0.05) in the learning completion period were significantly reduced, and the difference was statistically significant. Univariate and multivariate analysis showed that distance of tumor from anal verge (≥ 4cm vs. < 4cm, P = 0.039) and T stage (T3 vs. T1-2, P = 0.022) was independent risk factors for prolonging the operation time of CSPO. Conclusions For surgeons with laparoscopic surgery experience, about 45 cases of CSPO are needed to cross the learning curve. At the initial stage of CSPO, beginners are recommended to select patients with ultralow rectal cancer whose distance of tumor from anal verge is less than 4 cm and tumor stage is less than T3 for practice, which can enable beginners to reduce the operation time, accumulate experience, build self-confidence, and shorten the learning curve on the premise of safety.

Background: This study was performed to investigate the gaps among patient-reported data, physician-reported data, and laboratory test data in human immunodeficiency virus (HIV)-infected patients and to detect potential risk factors for the awareness gap. Methods: We included patients from 38 hospitals in China. Patient-reported data, physician-reported data, and laboratory test data on four typical noninfectious comorbidities (NICMs) (osteoporosis, kidney disease, neuropsychiatric comorbidities, and atherosclerotic cardiovascular disease (ASCVD)) were collected. We compared differences in and consistency of these types of data and investigated the associations between baseline characteristics and the awareness gap between patients and physicians. Results: This study included 1390 patients. The difference between the diagnosis rate and laboratory test positivity rate for all NICMs was significant. Patient-reported data on the three NICMs other than kidney disease were significantly different from the diagnosis rates. The agreement between patients and physicians for all NICMs was poor. The region, infection stage, hospital level, sex, and age influenced the awareness gap between patients and physicians. Conclusions: Our findings suggest that NICMs in HIV-infected patients in China are underestimated; gaps among patient awareness of disease exist, the clinical diagnosis rate, and the actual prevalence; patient characteristics influence the awareness gap between patients and physicians.