Improving the local excision strategy for rectal cancer after chemoradiotherapy: Surgical and oncological results.

INTRODUCTION: Local excision (LE) for good responders after chemoradiotherapy (CRT) for rectal cancer is oncologically safe. Although the GRECCAR 2 trial did not demonstrate any advantages in morbidity, it provided useful information for optimising patient selection. This study assessed the impact of these results on our practice by focusing on the evolution of our selection criteria and management modalities for these patients over 10 years. METHODS: Data were collected using our retrospective database of 110 patients who underwent LE after CRT for low and middle rectal cancer between 2010 and 2022 before (Group 1) and after (Group 2) consideration of the GRECCAR 2 trial results. RESULTS: The pretherapeutic selection criteria remained stable after the GRECCAR 2 trial, although in Group 2, completion total mesorectal excision (TME) for ypT2 tumours with favourable tumour regression grade was abandoned, improving the organ preservation rate at 1 year from 63.3 % to 91.8 % (p < 0.01). The operative time and length of stay after LE were reduced by half in Group 2 (p < 0.01). The intention-to-treat rate for severe morbidity was also halved, but was not significant (8.2 % vs. 16.3 %, p = 0.24). Among patients with a 3-year follow-up data, disease-free survival was comparable between Group 1 (89.8 %) and Group 2 (85.4 %) (p = 0.51) with one locoregional recurrence in each group (2.0 % vs. 2.1 %, p = 1). CONCLUSION: LE is a safe and effective strategy when performed in a "high-volume" centre. Improved methods for assessing tumour response and the selection criteria for completion TME enhanced surgical outcomes without compromising oncological outcomes.

Total mesorectal excision after rectal-sparing approach in locally advanced rectal cancer patients after neoadjuvant treatment: a high volume center experience.

Background: In patient with a complete or near-complete clinical response after neoadjuvant treatment for locally advanced rectal cancer, the organ-sparing approach [watch & wait (W&W) or local excision (LE)] is a possible alternative to major rectal resection. Although, in case of local recurrence or regrowth, after these treatments, a total mesorectal excision (TME) can be operated. Method: In this retrospective study, we selected 120 patients with locally advanced rectal cancer (LARC) who had a complete or near-complete clinical response after neoadjuvant treatment, from June 2011 to June 2021. Among them, 41 patients were managed by W&W approach, whereas 79 patients were managed by LE. Twenty-three patients underwent salvage TME for an unfavorable histology after LE (11 patients) or a local recurrence/regrowth (seven patients in LE group - five patients in W&W group), with a median follow-up of 42 months. Results: Following salvage TME, no patients died within 30 days; serious adverse events occurred in four patients; 8 (34.8%) patients had a definitive stoma; 8 (34.8%) patients undergone to major surgery for unfavorable histology after LE - a complete response was confirmed. Conclusion: Notably active surveillance after rectal sparing allows prompt identifying signs of regrowth or relapse leading to a radical TME. Rectal sparing is a possible strategy for LARC patients although an active surveillance is necessary.

Organ sparing to cure stage IV rectal cancer: A case report and review of literature.

BACKGROUND: Rectal sparing is an option for some rectal cancers with complete or good response after chemoradiotherapy (CRT); however, it has never been evaluated in patients with metastases. We assessed long-term outcomes of a rectal-sparing approach in a liver-first strategy for patients with rectal cancer with resectable liver metastases. CASE SUMMARY: We examined patients who underwent an organ-sparing approach for rectal cancer with synchronous liver metastases using a liver-first strategy during 2010-2015 (n = 8). Patients received primary chemotherapy and pelvic CRT. Liver surgery was performed during the interval between CRT completion and rectal tumor re-evaluation. Clinical and oncological characteristics and long-term outcomes were assessed.All patients underwent liver metastatic resection with curative intent. The R0 rate was 100%. Six and two patients underwent local excision and a watch-and-wait (WW) approach, respectively. All patients had T3N1 tumors at diagnosis and had good clinical response after CRT. The median survival time was 60 (range, 14-127) mo. Three patients were disease free for 5, 8, and 10 years after the procedure. Five patients developed metastatic recurrence in the liver (n = 5) and/or lungs (n = 2). Only one patient developed local recurrence concurrent with metastatic recurrence 24 mo after the WW approach. Two patients died during follow-up. CONCLUSION: The results suggest good local control in patients undergoing organ-sparing strategies for rectal cancer with synchronous liver metastasis. Prospective trials are required to validate these data and identify good candidates for these strategies.

Rectal Sparing Approaches after Neoadjuvant Treatment for Rectal Cancer: A Systematic Review and Meta-Analysis Comparing Local Excision and Watch and Wait.

Local Excision (LE) or Watch and Wait (WW) for patients with complete clinical response or near-complete clinical response after neoadjuvant chemoradiotherapy (nCRT) were proposed to avoid morbidity and impairment of quality of life after rectal resection. The aim of this study is to perform a systematic review of the literature, and to compare rectal-sparing approaches, in terms of rectum-preservation rate, local control, and distant recurrences. A systematic review and meta-analysis were performed of studies published until July 2022 (PROSPERO, registration CRD42022341480), and the quality of evidence was assessed using a GRADE approach. Seven retrospective studies and one prospective trial were included. In six studies, patients were treated with standard long-course nCRT, and in two with Total Neoadjuvant Therapy (TNT). Overall, there were 213 and 188 patients in WW and LE group, respectively, and no difference was found between WW and LE when considering rectum-preservation rate (OR 0.80 95%CI 0.31-2.01, p = 0.63), local disease (OR 1.60 95%CI 0.75-3.42, p = 0.22), locoregional failure (OR 0.85 95%CI 0.20-3.66, p = 0.83) and distant recurrence (OR 0.76 95%CI 0.37-1.55, p = 0.45). Studies directly comparing WW and LE are still lacking, even though no differences between WW and LE in terms of rectum-preservation, local control, and distant recurrences have been found.

A comparison of dosimetric parameters in high-dose-rate intracavitary brachytherapy using tandem and ring applicators: is the combination of a rectal retractor and radio-opaque vaginal packing better than rectal retractor alone for rectum sparing in cervical cancer?

Purpose: To describe a novel packing technique of combining radio-opaque vaginal packing (VP) with rectal retractor (RR) blade to displace rectum and to compare the standard International Commission on Radiation Units & Measurements-38 (ICRU-38) rectal, bladder point doses and volume parameters with the conventional technique of using RR alone with tandem and ring (T&R) applicators in high-dose-rate (HDR) intracavitary brachytherapy (ICB) for cervical cancer. Materials and methods: A retrospective analysis of the treatment plans of a cohort of 24 consecutively treated patients with locally advanced cervical cancer was performed. All patients received external beam radiotherapy with a dose of 45-50.4 Gy, in fractions of 1.8-2 Gy, to the whole pelvis with concurrent weekly chemotherapy, followed by HDR-ICB. The treatment plans for each brachytherapy session using T&R applicators that these patients received were included for analysis. A total of 17 treatment plans in which the combination of RR and radio-opaque VP was used for rectum separation were included in the combination (RR+VP) group, and 21 treatment plans in which a RR alone was used were included in the conventional (RR) group. Results: The mean dose to the ICRU rectal point was 39.7% of the point A dose (range, 28.8%-50.4%; median 38.6%) in the RR+VP group and 52.7% (range, 46.9%-63.6%; median 51.7%) in the RR group. This 13% reduction in the mean dose to the ICRU rectal point was statistically significant (p = 0.001). The mean dose to the ICRU bladder point was 55.4% of the point A dose (range, 26.3%-73.6%; median 57.4%) in the RR+VP group and 45.3% (range, 23.7%-72.7%; median 46.9%) in the RR group. This 10.1% increase in the mean dose to the ICRU bladder point was also significant (p = 0.024). The other point dose and volume parameters were similar between groups. Conclusion: Compared to the conventional use of a RR blade alone for rectum separation, combining a RR blade with radio-opaque VP significantly reduced the ICRU rectal point dose.

Clinical characteristics and prognosis of patients with ulcerative colitis that shows rectal sparing at initial diagnosis.

BACKGROUND: Ulcerative colitis (UC) is characterised by mucosal inflammation from the rectum to its proximal area in a symmetric and continuous fashion. However, although uncommon, we encounter cases of UC with rectal sparing in the initial stage. AIM: To evaluate the clinical characteristics and clinical course for rectal sparing UC compared with typical UC. METHODS: We looked at records from 2004 to 2015, and selected patients who were newly diagnosed with UC, and who could be followed up for at least 5 years in our hospital. We then retrospectively analysed the medical records and endoscopic findings of those patients. To compare the clinical course and prognosis, we matched each patient with rectal sparing UC 1:3 with controls by age, sex, and disease extent. RESULTS: Of 619 UC patients, 24 (3.9%) showed rectal sparing at diagnosis. During the follow-up period (median 8 years), in two (8.3%) of the 24 patients, rectal sparing remained through follow-up inspections; but for the other 22 (91.7%) patients, obvious rectal inflammation was found at follow-up endoscopy. Of the 24 patients, 8 (33.3%) were initially misdiagnosed with infectious colitis. No diagnosis was changed to Crohn's disease. The uses of corticosteroid or biologic agents, hospitalisation rate, and colectomy rates were not different between the rectal sparing UC group and typical UC group. CONCLUSION: Some patients with UC can reveal atypical patterns of disease distribution, such as rectal sparing in its initial stage; but despite this, the clinical course and prognosis may not differ from those of typical UC patients.

Watch and Wait Approach for Rectal Cancer Following Neoadjuvant Treatment: The Experience of a High Volume Cancer Center.

Multimodal treatments for rectal cancer, along with significant research on predictors to response to therapy, have led to more conservative surgical strategies. We describe our experience of the rectal sparing approach in rectal cancer patients with clinical complete response (cCR) after neoadjuvant treatment. We also specifically highlight our clinical and imaging criteria to select patients for the watch and wait strategy (w&w). Data came from 39 out of 670 patients treated for locally advanced rectal cancer between January 2016 until February 2020. The selection criteria were a clinical complete response after neoadjuvant chemotherapy managed with a watch and wait (w&w) strategy. A strict follow-up period was adopted in these selected patients and follow-ups were performed every three months during the first two years and every six months after that. The median follow-up time was 28 months. Six patients had a local recurrence (15.3%); all were salvageable by total mesorectal excision (TME). Five patients had a distant metastasis (12.8%). There was no local unsalvageable disease after w&w strategy. The rectal sparing approach in patients with clinical complete response after neoadjuvant treatment is the best possible treatment and is appropriate to analyze from this perspective. The watch and wait approach after neoadjuvant treatment for rectal cancer can be successfully explored after inflexible and strict patient selection.

Maximizing rectal dose sparing with hydrogel: A retrospective planning study.

External beam radiation therapy for prostate cancer can result in urinary, sexual, and rectal side effects, often impairing quality of life. A polyethylene glycol-based product, SpaceOAR© hydrogel (SOH), implanted into the connective tissue between the prostate gland and rectum can significantly reduce the dose received by the rectum and hence risk of rectal toxicity. The optimal way to manage the hydrogel and rectal structures for plan optimization is therefore of interest. In 13 patients, computerized tomography (CT) scans were taken pre- and post-SpaceOAR© implant. A prescription of 60 Gy in 20 fractions was planned on both scans. Six treatment plans were produced per anonymized dataset using either a structure of rectum plus the hydrogel, termed composite rectum wall (CRW), or rectal wall (RW) as an inverse optimization structure and intensity modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) as a treatment technique. Dose-volume histogram metrics were compared between plans to determine which optimization structure and treatment technique offered the maximum rectal dose sparing. RW structures offered a statistically significant decrease in rectal dose over CRW structures, whereas the treatment technique (IMRT vs VMAT) did not significantly affect the rectal dose. There was improvement seen in bladder and penile bulb dose when VMAT was used as a treatment technique. Overall, treatment plans using the RW optimization structure offered the lowest rectal dose while VMAT treatment technique offered the lowest bladder and penile bulb dose.

Rectal-sparing type of ulcerative colitis predicts lack of response to pharmacotherapies.

BACKGROUND: Ulcerative colitis (UC) is known as an immune disorder of the colon that generally involves the rectum, but an atypical distribution of inflamed mucosa has previously been noted in certain subtypes of UC, such as the rectal-sparing type (RST). As noted in a previous report, patients with the RST may be at elevated risk for disease refractoriness, but the clinical significance of RST remains unknown. METHODS: UC patients who underwent surgery between January 2010 and April 2015 were included. Patients were classified as having the RST or a non-RST based on colectomy specimens or a pre-operative endoscopy. Possible risk factors for urgent/emergent surgery were analyzed. We specifically determined whether the RST is a significant predictor for urgent/emergent surgery. RESULTS: In total, 46/482 patients were classified as having the RST. Disease severity was significantly worse in patients with the RST than in other patients (p = 0.02). Urgent/emergent surgery was required for 24/46 patients with the RST, compared with 107/436 non-RST patients (p < 0.01). The overall incidence of urgent/emergent surgery was 131/482. Disease duration < 70.2 months [odds ratio (OR) 2.45], severe disease (OR 87.1), total administered steroid dose < 5000 mg (OR 3.02), daily pre-operative steroid dose ≥ 9 mg (OR 2.59), and the RST (OR 5.59) were identified as independent risk factors for urgent/emergent surgery. CONCLUSION: The RST was an independent risk factor for urgent/emergent surgery in our analysis of surgically treated patients with UC.

Image-Guided High-Dose Rate Brachytherapy in Cervix Carcinoma Using Balloon Catheter and Belt Immobilization System.

PURPOSE: The efficacy of image-guided high-dose rate brachytherapy for cervical cancer is limited by the ineffective rectal sparing devices available commercially and the potential applicator movement. We developed a novel device using a balloon catheter and a belt immobilization system, serving for rectal dose reduction and applicator immobilization purposes, respectively. METHODS: The balloon catheter is constructed by gluing a short inflatable tube to a long regular open-end catheter. Contrast agent (10) cm3 is injected into the inflatable end, which is affixed to the tandem and ring applicator, to displace the posterior vaginal wall. The belt immobilization system consists of a specially designed bracket that can hold and fix itself to the applicator, a diaper-like Velcro fastener package used for connecting the patient's pelvis to the bracket, and a buckle that holds the fasteners to stabilize the whole system. The treatment data for 21 patients with cervical cancer using both balloon catheter and belt immobilization system were retrospectively analyzed. Computed tomography and magnetic resonance images, acquired about 30 minutes apart, were registered to evaluate the effectiveness of the immobilization system. RESULTS: In comparison with a virtual rectal blade, the balloon decreased the rectal point dose by 34% ± 4.2% (from 276 ± 57 to 182 ± 38 cGy), corresponding to an extra sparing distance of 7.9 ± 1.1 mm. The maximum sparing distance variation per patient is 1.4 ± 0.6 mm, indicating the high interfractional reproducibility for rectum sparing. With the immobilization system, the mean translational and rotational displacements of the applicator set are <3 mm and <1.5°, respectively, in all directions. CONCLUSIONS: The rectal balloon provides significant dose reduction to the rectum and it may potentially minimize patient discomfort. The immobilization system permits almost no movement of the applicator during treatment. This work has the potential to be promoted as a standardized solution for high-dose rate treatment of cervical cancer.

Reduced dose to urethra and rectum with the use of variable needle spacing in prostate brachytherapy: a potential role for robotic technology.

PURPOSE: Several robotic delivery systems for prostate brachytherapy are under development or in pre-clinical testing. One of the features of robotic brachytherapy is the ability to vary spacing of needles at non-fixed intervals. This feature may play an important role in prostate brachytherapy, which is traditionally template-based with fixed needle spacing of 0.5 cm. We sought to quantify potential reductions in the dose to urethra and rectum by utilizing variable needle spacing, as compared to fixed needle spacing. MATERIAL AND METHODS: Transrectal ultrasound images from 10 patients were used by 3 experienced planners to create 120 treatment plans. Each planner created 4 plan variations per patient with respect to needle positions: (125)I fixed spacing, (125)I variable spacing, (103)Pd fixed spacing, and (103)Pd variable spacing. The primary planning objective was to achieve a prostate V100 of 100% while minimizing dose to urethra and rectum. RESULTS: All plans met the objective of achieving prostate V100 of 100%. Combined results for all plans show statistically significant improvements in all assessed dosimetric variables for urethra (Umax, Umean, D30, D5) and rectum (Rmax, Rmean, RV100) when using variable spacing. The dose reductions for mean and maximum urethra dose using variable spacing had p values of 0.011 and 0.024 with (103)Pd, and 0.007 and 0.029 with (125)I plans. Similarly dose reductions for mean and maximum rectal dose using variable spacing had p values of 0.007 and 0.052 with (103)Pd, and 0.012 and 0.037 with (125)I plans. CONCLUSIONS: The variable needle spacing achievable by the use of robotics in prostate brachytherapy allows for reductions in both urethral and rectal planned doses while maintaining prostate dose coverage. Such dosimetric advantages have the potential in translating to significant clinical benefits with the use of robotic brachytherapy.

Comparison of two different rectal spacers in prostate cancer external beam radiotherapy in terms of rectal sparing and volume consistency.

BACKGROUND AND PURPOSE: In external beam radiation (EBRT) of the prostate, the rectum is the dose-limiting organ at risk, and sparing of the anterior rectal wall is a prerequisite for safe delivery of doses beyond 70 Gy. Spatial sparing of the rectum can be achieved by introducing a spacer material into the retroprostatic space, thus separating the anterior rectal wall from the PTV. MATERIALS AND METHODS: Two spacer technologies, Spacer OAR, a polyethylene glycol gel and ProSpace, a saline inflated balloon, were compared in terms of spacer volume, stability, and dose reduction to the anterior rectum wall in 78 patients. RESULTS: Both spacer systems significantly reduced the rectum surface encompassed by the 95% isodose (gel: -35%, p<0.01; balloon -63.4%, p<0.001) compared to a control group. The balloon spacer was superior in reducing rectum dose (-27.7%, p=0.034), but exhibited an average volume loss of >50% during the full course of treatment of 37-40 fractions, while the volume of gel spacers remained fairly constant. CONCLUSIONS: In choosing between the two spacer technologies, the advantageous dose reduction of the balloon needs to be weighed up against the better volume consistency of the gel spacer with respect to the duration of hypofractionated vs normofractionated regimens.