A protective stoma is suitable after sphincter-saving resection for rectal cancer for anastomoses situated at or less than 5 cm from the anal verge, particularly for men and obese patients.

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Purpose A pathologic complete response (pCR; ypT0N0) of a rectal tumor after neoadjuvant radiochemotherapy (RCT) is associated with an excellent prognosis. Several retrospective studies have investigated the effect of increasing the delay after RCT. The aim of this study was to evaluate the effect of increasing the interval between the end of RCT and surgery on the pCR rate. Methods GRECCAR6 was a phase III, multicenter, randomized, open-label, parallel-group controlled trial. Patients with cT3/T4 or Tx N+ tumors of the mid or lower rectum who had received RCT (45 to 50 Gy with fluorouracil or capecitabine) were included. Patients were randomly included in the 7-week or the 11-week (11w) group. Primary end point was the pCR rate defined as a ypT0N0 specimen (NCT01648894). Results A total of 265 patients from 24 centers were enrolled between October 2012 and February 2015. The majority of the tumors were cT3 (82%). After RCT, surgery was not performed in nine patients (3.4%) because of the occurrence of distant metastasis (n = 5) or other reasons. Two patients underwent local resection of the tumor scar. A total of 47 (18.6%) specimens were classified as ypT0 (four had invaded lymph nodes [8.5%]). The primary end point (ypT0N0) was not different (7 weeks: 20 of 133, 15.0% v 11w: 23 of 132, 17.4%; P = .5983). Morbidity was significantly increased in the 11w group (44.5% v 32%; P = .0404) as a result of increased medical complications (32.8% v 19.2%; P = .0137). The 11w group had a worse quality of mesorectal resection (complete mesorectum [I] 78.7% v 90%; P = .0156). Conclusion Waiting 11 weeks after RCT did not increase the rate of pCR after surgical resection. A longer waiting period may be associated with higher morbidity and more difficult surgical resection.

The technique of intersphincteric resection permits us to achieve conservative surgery in patients with a tumor close to or in the anal canal without compromising local control and survival. Tumor distance from the anal verge is no longer a limit for sphincter-saving resection.

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4007 Background: PRODIGE 23 investigated the role of neoadjuvant mFOLFIRINOX before preoperative (preop) chemoradiation (CRT), with TME-surgery and adjuvant chemotherapy (CT) in resectable locally advanced rectal cancer. Methods: PRODIGE 23 is a phase III multicenter randomized clinical trial. Eligible pts had cT3 or cT4, M0 rectal adenocarcinomas <15 cm from the anal verge, age 18-75 years, and WHO PS ≤1. Randomization was stratified by center, T stage, N status, tumor location, and perirectal fat extramural extension. Primary endpoint was 3-yr disease-free survival (DFS). Main secondary endpoints were ypT0N0 rate, overall survival (OS) and metastasis-free survival (MFS). 460 pts were required to observe 136 events to show a gain in 3-year DFS from 75% to 85% (HR=0.56) with a 2-sided α=0.05 and 90% power. HR and 95% CI were estimated by a stratified Cox proportional hazard model. Arm A pts received preop CRT (50 Gy, 2 Gy/fraction [fr]; 25 fr + capecitabine), surgery, then adjuvant CT for 6 months (mos). Arm B pts received 6 cycles of mFOLFIRINOX (oxaliplatin 85 mg/m², leucovorin 400 mg/m², irinotecan 180 mg/m² D1, and 5-FU 2.4 g/m² over 46 h) every 14 days, followed by the same preop CRT, surgery and 3 mos of adjuvant CT. Adjuvant CT consisted of mFOLFOX6 or capecitabine, depending on the centre’s choice for all pts. Imaging work-up, operative and pathology reports were centrally reviewed. Results: (ITT) Between 6/2012 and 6/2017, 230 and 231 pts were randomly assigned in Arm A/B, respectively by 35 participating centers. Pts characteristics were well balanced. Neoadjuvant mFOLFIRINOX and CRT in both arms were well tolerated. Compliance to CRT and to adjuvant CT was not hampered by neoadjuvant CT. Surgical morbidity did not differ between the 2 arms. The ypT0N0 rate was 11.7 vs 27.5% in Arm A/B (p<0.001). Median follow-up was 46.5 mos. 136 DFS events was reported. 3-yr DFS was significantly increased in arm B (HR 0.69, 95% CI 0.49-0.97, p=0.034): 68.5% (CI: 61.9-74.2) vs 75.7% (CI: 69.4-80.8) in arm A/B. The subgroup analysis showed no evidence of heterogeneity of the effect size of treatment on DFS. 3-yr MFS was also significantly higher in arm B: 71.7 in arm A vs 78.8% (HR 0.64, CI 0.44-0.93, p<0.02) in arm B. 3-yr OS was 87.7 vs 90.8% (HR 0.65, CI 0.40-1.05, p=0.077) in arm A/B, with 54.2% of the pts with recurrence being alive. Conclusions: Neoadjuvant mFOLFIRINOX plus CRT is safe, and significantly increased ypCR rate, DFS and MFS. OS data are not mature. Clinical trial information: NCT01804790 .

The efficacy of laparoscopic surgery in a team specialized in rectal excision for cancer (open and laparoscopic surgery) is suggested with similar long-term local control and cancer-free survival than open surgery. Moreover, conversion had no negative impact on survival.

ObjectiveTo evaluate the complications and oncologic and functional results of preoperative radiochemotherapy and sphincter-saving resection for T3 cancers of the lower third of the rectum. Summary Background DataCarcinomas of the lower third of the rectum (i.e., located at or below 6 cm from the anal verge) are usually treated by abdominoperineal resection, especially for T3 lesions. Few data are available evaluating concomitant chemotherapy with preoperative radiotherapy for increasing sphincter-saving resection in low rectal cancer. MethodsBetween 1995 and 1999, 43 patients underwent preoperative radiochemotherapy with conservative surgery for a low rectal tumor located a mean of 4.5 cm from the anal verge (range 2-6); 70% of the lesions were less than 2 cm from the anal sphincter. There were 40 T3 and 3 T4 tumors. Patients received preoperative radiotherapy with a mean dose of 50 Gy (range 40 -54) and concomitant chemotherapy with 5-FU in continuous infusion (n ϭ 36) or bolus (n ϭ 7). Sphinctersaving resection was performed 6 weeks after treatment, in 25 patients by using intersphincteric resection. Coloanal anastomoses were associated with a colonic pouch in 86% of the patients, and all patients had a protecting stoma. ResultsThere were no deaths related to preoperative radiochemotherapy and surgery. Acute toxicity was mainly due to diarrhea, with 54% of grade 1 to 2. Four anastomotic fistulas and two pelvic hematomas occurred; all patients but one had closure of the stoma. Distal and radial surgical margins were respectively 23 Ϯ 8 mm (range 10 -40) and 8 Ϯ 4 mm (range 1-20) and were negative in 98% of the patients. Downstaging (pT0 -2N0) was observed in 42% of the patients (18/43) and was associated with a greater radial margin (10 vs. 6 mm; P ϭ .02). After a median follow-up of 30 months, the rate of local recurrence was 2% (1/43), and four patients had distal metastases. Overall and disease-free survival rates were both 85% at 3 years. Functional results were good (Kirwan continence I, II) in 79% of the available patients (n ϭ 37). They were slightly altered by intersphincteric resection (57 vs. 75% of perfect continence; NS) but were significantly improved by a colonic pouch (74 vs. 16%; P ϭ .01). ConclusionsThese results suggest that preoperative radiochemotherapy allowed sphincter-saving resection to be performed with good local control and good functional results in patients with T3 low rectal cancers that would have required abdominoperineal resection in most instances.Carcinomas of the rectum infiltrating the muscular layer and the perirectal adipose tissue and located in the lower third of the rectum (i.e., T3 tumors within 6 cm of the anal verge [or anal margin]) are traditionally treated by abdominoperineal resection (APR). Indeed, local excision and sphincter-saving resection (SSR) are proposed only in patients with well-differentiated T1-T2 disease. For T3 disease, APR is justified by the difficulties of achieving radial and distal negative margins because of the narrow shape of the distal pe...