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Background: Locally advanced rectal cancer (LARC) poses a significantly challenge in clinical management, requiring a multimodal treatment approach. Among innovative strategies, Total Neoadjuvant Therapy (TNT) has emerged, delivering all planned chemotherapy before surgery. Objective: Our aim was to evaluate the real-world application and efficacy of TNT and to compare it with the non-TNT standard strategy. Methods: This retrospective study compared locally advanced rectal adenocarcinoma patients treated with Total Neoadjuvant Therapy (TNT) in 2022 with those who underwent traditional chemoradiotherapy (CRT) in 2020–2021. The primary endpoints were the pathologic complete response rate and the sustained clinical complete response rate in patients under W&W. Results: Among 107 patients (54.2% male, mean age 62.48 years), non-TNT (67 patients) and TNT (40 patients) mean follow-ups were 26.7 and 8.2 months, respectively. No differences in gender(p = 0.163), staging (p = 0.707), or location (p = 0.727) were noted. TNT patients received more short-course radiotherapy (42.5% vs1.5%, p < 0.001). Clinical responses favored TNT (p = 0.030) with no significant differences in pathological responses, recurrence rates, or survival. TNT exhibited higher chemotherapy completion (p = 0.007) and lower adverse events (p < 0.001). Post-surgery events showed no significant differences (p = 0.470). Single center with retrospective design and carries limitations that may restrict the generalizability of the findings and the relatively short follow-up duration are our main limitations. Conclusion: Our data add to the body of literature favoring the TNT treatment strategy for locally advanced rectal cancer, aiming to achieve comparable complete response rates with less adverse events. [ABSTRACT FROM AUTHOR]

Abstract Background Locally advanced rectal cancer (LARC) poses a significantly challenge in clinical management, requiring a multimodal treatment approach. Among innovative strategies, Total Neoadjuvant Therapy (TNT) has emerged, delivering all planned chemotherapy before surgery. Objective Our aim was to evaluate the real-world application and efficacy of TNT and to compare it with the non-TNT standard strategy. Methods This retrospective study compared locally advanced rectal adenocarcinoma patients treated with Total Neoadjuvant Therapy (TNT) in 2022 with those who underwent traditional chemoradiotherapy (CRT) in 2020–2021. The primary endpoints were the pathologic complete response rate and the sustained clinical complete response rate in patients under W&W. Results Among 107 patients (54.2% male, mean age 62.48 years), non-TNT (67 patients) and TNT (40 patients) mean follow-ups were 26.7 and 8.2 months, respectively. No differences in gender(p = 0.163), staging (p = 0.707), or location (p = 0.727) were noted. TNT patients received more short-course radiotherapy (42.5% vs1.5%, p

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. [ABSTRACT FROM AUTHOR]

Aim: The standard treatment for low rectal cancer is preoperative chemoradiotherapy followed by surgery with low anterior resection with diverting ileostomy or abdominoperineal resection, both of which have significant long‐term effects on bowel and sexual function. Due to the high morbidity of surgery, there has been increasing interest in nonoperative management for low rectal cancer. The aim of this work is to conduct a pan‐Canadian Phase II trial assessing the safety of nonoperative management for low rectal cancer. Method: Patients with Stage II or III low rectal cancer completing chemoradiotherapy according to standard of care at participating centres will be assessed for complete clinical response 8–14 weeks following completion of chemoradiotherapy. Subjects achieving a clinical complete response will undergo active surveillance including endoscopy, imaging and bloodwork at regular intervals for 24 months. The primary outcome will be the rate of local regrowth 2 years after chemoradiotherapy. Nonoperative management will be considered safe (i.e. as effective as surgery to achieve local control) if the rate of local regrowth is ≤30% and surgical salvage is possible for all local regrowths. Secondary outcomes will include disease‐free and overall survival. Conclusion: The results will be highly clinically relevant, as it is expected that nonoperative management will be safe and lead to widespread adoption of nonoperative management in Canada. This change in practice has the potential to decrease the number of patients requiring surgery and the costs associated with surgery and long‐term surgical morbidity. [ABSTRACT FROM AUTHOR]

Aim: Health Technology Wales sought to evaluate the clinical and cost‐effectiveness of contact X‐ray brachytherapy (CXB) for early‐stage rectal cancer. Methods: Relevant studies were identified through systematic searches of MEDLINE, Embase, Cochrane Library and Scopus. A cost‐utility model was developed to estimate the cost‐effectiveness of CXB in National Health Service Wales, using results of the Organ Preservation in Early Rectal Adenocarcinoma (OPERA) trial. Patient perspectives were obtained through the Papillon Patient Support group and All‐Wales Cancer Network. Results: The OPERA randomized controlled trial showed that CXB improved complete response and organ preservation rates compared with external‐beam boost for people with T2–3b, N0–1, M0 rectal cancer who are fit for surgery. Managing more of this population non‐operatively after CXB was estimated to provide 0.2 quality‐adjusted life years at an additional cost of £887 per person. CXB was cost effective compared with external‐beam boost at a cost of £4463 per quality‐adjusted life year gained. This conclusion did not change in scenario analysis and CXB was cost effective in 91% of probabilistic sensitivity analyses. Patients valued receiving clear information on all available options to support their individual treatment choices. The detrimental impact of a stoma on quality of life led some patients to reject the idea that surgery was their only option. Conclusion: This evidence review and cost‐utility analysis indicates that CXB is likely to be clinically and cost effective, as part of a watch and wait strategy for adults fit for surgery. Wider access to CXB is supported by patient testimonies. [ABSTRACT FROM AUTHOR]

Purpose of the study. Evaluation of the diagnostic value of vacuum-assisted biopsy (VAB) based on pathomorphological studies in patients with breast cancer (BC) who have achieved a complete clinical response (cCR) after neoadjuvant polychemotherapy (NACT).Patients and methods. In the study, conducted from 2021 to 2023 at the P. A. Hertsen Moscow Oncology Research Institute – a branch of the National Medical Research Radiology Center of the Ministry of Health of Russia, 35 patients with BC cT1–3N0–3M0 of various molecular-biological types who were diagnosed with cCR after NACT were included. All patients underwent VAB (needle size 7–10 G) of the breast followed by histological examination, after which surgical treatment was performed. Subsequently, histological conclusions of VAB and surgical materials were compared with each other for the presence and degree of pathomorphological response.Results. According to the pathomorphological conclusion when conducting VAB, the following results were obtained: 1 – true positive, 29 – true negative, 3 – false negative, and 0 – false positive. No statistically significant results of the association between complete pathomorphological response and the molecular-biological type of breast cancer were obtained (p > 0.05), however, there is a tendency towards the greatest number of complete pathomorphological responses in Her2-neu-positive (luminal – 100 %, non-luminal – 90.9 %) and triple-negative (87.50 %) types of breast cancer. The overall sensitivity of the method was 25.0 % (CI 6.8–60.2 %); specificity – 100 % (CI 88.1–100 %); false-negative result (presence of tumor cells in the surgical material and a negative result of VAB) – 9.1 % (CI 3.4–20.2 %); false-positive result (absence of tumor cells in the surgical material and a positive result of VAB) – 0 % (CI 0–10.6 %). The overall diagnostic accuracy of the method was 90.9 % (CI 79.8–96.6 %).Conclusion. The results of the conducted research allow for the consideration of excluding surgical treatment when a complete pathomorphological response is obtained by VAB. However, further research is required with the inclusion of a larger number of patients.

Abstract Background Neoadjuvant chemoradiation(nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait-WW). Consolidation chemotherapy(cCT) regimens using fluoropyrimidine-based with or without oxalipatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCT compared to fluoropirimidine alone regimens in terms of primary tumor response remains unclear. Since oxalipatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine + oxaliplatin) for patients with distal rectal cancer. Methods In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54 Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine + oxaliplatin. Magnetic resonance(MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1 cm above the anorectal ring determined by sagittal views on MR will be eligible for the study. Tumor response will be assessed after 12 weeks from radiotherapy(RT) completion. Patients with clinical complete response (clinical, endoscopic and radiological) may be enrolled in an organ-preservation program(WW). The primary endpoint of this trial is decision to organ-preservation surveillance (WW) at 18 weeks from RT completion. Secondary endpoints are 3-year surgery-free survival, TME-free survival, distant metastases-free survival, local regrowth-free survival and colostomy-free survival. Discussion Long-course nCRT with cCT is associated with improved complete response rates and may be a very attractive alternative to increase the chances for organ-preservation strategies. Fluoropyrimidine-based cCT with or without oxaliplatin has never been investigated in the setting of a randomized trial to compare clinical response rates and the possibility of organ-preservation. The outcomes of this study may significantly impact clinical practice of patients with distal rectal cancer interested in organ-preservation. Trial registration www.clinicaltrials.gov NCT05000697; registered on August 11th, 2021.

Background: Neoadjuvant chemoradiation(nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait-WW). Consolidation chemotherapy(cCT) regimens using fluoropyrimidine-based with or without oxalipatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCT compared to fluoropirimidine alone regimens in terms of primary tumor response remains unclear. Since oxalipatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine + oxaliplatin) for patients with distal rectal cancer. Methods: In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54 Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine + oxaliplatin. Magnetic resonance(MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1 cm above the anorectal ring determined by sagittal views on MR will be eligible for the study. Tumor response will be assessed after 12 weeks from radiotherapy(RT) completion. Patients with clinical complete response (clinical, endoscopic and radiological) may be enrolled in an organ-preservation program(WW). The primary endpoint of this trial is decision to organ-preservation surveillance (WW) at 18 weeks from RT completion. Secondary endpoints are 3-year surgery-free survival, TME-free survival, distant metastases-free survival, local regrowth-free survival and colostomy-free survival. Discussion: Long-course nCRT with cCT is associated with improved complete response rates and may be a very attractive alternative to increase the chances for organ-preservation strategies. Fluoropyrimidine-based cCT with or without oxaliplatin has never been investigated in the setting of a randomized trial to compare clinical response rates and the possibility of organ-preservation. The outcomes of this study may significantly impact clinical practice of patients with distal rectal cancer interested in organ-preservation. Trial registration: www.clinicaltrials.gov NCT05000697; registered on August 11th, 2021. [ABSTRACT FROM AUTHOR]

Objective: To define a predictive Artificial Intelligence (AI) algorithm based on the integration of a set of biopsy-based microRNAs expression data and radiomic features to understand their potential impact in predicting clinical response (CR) to neoadjuvant radio-chemotherapy (nRCT). Summary background data: The identification of patients who would truly benefit from nRCT for Locally Advanced Rectal Cancer (LARC) could be crucial for an improvement in a tailored therapy. Methods: Forty patients with LARC were retrospectively analyzed. An MRI of the pelvis before and after nRCT was performed. In the diagnostic biopsy, the expression levels of 7 miRNAs were measured and correlated with the tumor response rate (TRG), assessed on the surgical sample. The accuracy of complete CR (cCR) prediction was compared for i) clinical predictors; ii) radiomic features; iii) miRNAs levels; and iv) combination of radiomics and miRNAs. Results: Clinical predictors showed the lowest accuracy. The best performing model was based on the integration of radiomic features with miR-145 expression level (AUC-ROC = 0.90). AI algorithm, based on radiomics features and the overexpression of miR-145, showed an association with the TRG class and demonstrated a significant impact on the outcome. Conclusion: The pre-treatment identification of responders/NON-responders to nRCT could address patients to a personalized strategy, such as total neoadjuvant therapy (TNT) for responders and upfront surgery for non-responders. The combination of radiomic features and miRNAs expression data from images and biopsy obtained through standard of care has the potential to accelerate the discovery of a noninvasive multimodal approach to predict the cCR after nRCT for LARC. [ABSTRACT FROM AUTHOR]

Objective: to compare short-term and long-term treatment outcomes between patients with lower and middle rectal cancer with complete clinical and pathomorphological response after comprehensive treatment.Materials and methods. we performed retrospective analysis of treatment outcomes in patients with lower and middle rectal cancer. The experimental group included 27 patients with complete clinical response, whereas the control group comprised 31 patients with complete pathomorphological response (ypT0n0m0) who had undergone total mesorectal excision following neoadjuvant therapy. The main evaluated parameters included postoperative complications, proportion of R0 resections, proportion of sphincter-preserving surgeries, 2-year overall survival, and progression-free survival.Results. At a median follow-up time of 41 months (range: 25–114 months), 2 patients from the experimental group had progressive disease registered 18 and 19 months after treatment initiation; both patients underwent abdominoperineal extirpation of the rectum. The remaining 25 patients had sphincter sparing surgeries. At a median follow-up time of 48 months (range: 24–101 months), one patient was found to have liver metastasis 5 months following treatment initiation. He underwent simultaneous surgery that included low anterior resection of the rectum and liver resection and had no postoperative complications. In the group of surgical treatment, all patients underwent radical surgeries (R0), including those with permanent stoma formation (n = 11; 35.5 %) or preventive stoma formation (n = 20; 64.5 %) with subsequent bowel repair. The 2-year overall survival rate was 100 % in both groups. The 2-year progression-free survival rate was 92.6 % in the experimental group and 96.8 % in the control group (p = 0.473).Conclusion. The watch and wait strategy with active dynamic follow-up is a safe alternative to surgery in patients with complete clinical response after neoadjuvant therapy, since it ensures the results equivalent to those in patients with complete pathomorphological response.

Background. Currently available chemoradiotherapy regimens for distal rectal cancer often ensure complete regression of the tumor and lymph node lesions. Therefore, patients with a complete clinical response can be managed with a “watch and wait” (ww) strategy.Objective: to evaluate 2-year overall and progression-free survival in patients with local and locally advanced rectal cancer with a complete clinical response who were managed with the ww strategy.Materials and methods. we performed retrospective analysis of treatment outcomes in patients with newly diagnosed, histologically verified, stage II–III, mrT1–2n1–2m0, T3–4n0–2m0 (within 0–10 cm of the anal verge), and mrT2n0m0 (within 0–5 cm of the anal verge) rectal cancer who had demonstrated complete clinical response to chemoradiotherapy. mandard tumor regression grade (TRg1–2) (assessed using magnetic resonance imaging of the pelvis) and palpatory/visual signs of residual tumor (assessed by digital examination and colonoscopy) were the main parameters evaluated. Overall and disease-free survival was analyzed using the Kaplan–meier method.Results. Twenty-seven patients with a complete clinical response were assigned to the ww group. mRI scans of the pelvis demonstrated that 5 patients (18.5 %) had TRg1, whereas 22 patients (81.5 %) had TRg2. T-downstaging after therapy was observed in 21 participants (77.7 %). n-downstaging was registered in all 14 patients (100 %) with regional lymph nodes affected. median follow-up time was 41 months (range: 25–114 months). Two individuals (7.4 %) developed progressive disease. Both of them had lengthy tumors as demonstrated by digital examination, colonoscopy, and magnetic resonance imaging; they immediately underwent radical surgery. The two-year overall and disease-free survival rates were 100 % and 92.6 %, respectively. Conclusion. The ww strategy with active dynamic follow-up is safe for the management of patients with local and locally advanced middle and lower rectal cancer, provided that inclusion/exclusion criteria are adhered to and patients are carefully followed-up in specialized centers.

Background: Neoadjuvant long course chemoradiotherapy (NLCRT) for rectal cancer can result in complete pathological response (pCR). In 2017, we started offering patients who had a complete clinical response (cCR), a choice between total mesorectal excision (TME) and an intensive surveillance or 'watch and wait' (W&W) program. We report the early outcomes of this prospective study. Methods: All patients undergoing NLCRT from 2017 to 2019 were included. All patients were restaged at 8 weeks, and those who had a cCR were offered TME or W&W. Results: Of 59 patients who underwent NLCRT, 55 had restaging. Eleven of these patients had a cCR (20%). Three chose to have TME and all had a pCR. Eight were enrolled in W&W. Two patients were diagnosed with local regrowth and underwent TME at 7 and 17 months after NLCRT. A further nine patients, who were surgically unfit or refused TME, and had an excellent response to NLCRT, but one that did not reach criteria for a cCR, were also managed with W&W. Of these, two patients developed regrowth with distant metastases. From 2017 to 2019, of the 17 patients who were managed with a W&W approach, 13 patients have remained regrowth free after a median of 28 (13–58) months of W&W. Conclusion: Preliminary findings suggest management with W&W, following cCR, may be a safe alternative to TME. There have so far been no instances of distant failure, and those with cCR that had regrowth, were identified early and successfully managed with salvage TME. [ABSTRACT FROM AUTHOR]

Objective: To investigate the clinical and immunological characteristics of anti-synthetase syndrome (ASS) patients overlap with rheumatoid arthritis (RA)., Methods: A retrospective analysis was conducted on ASS patients with arthritis who were treated at Peking University People' s Hospital. Data collected included demographic information, clinical manifestations, laboratory features, lymphocyte subsets in peripheral blood, and treatments. The patients with ASS were divided into two groups based on the presence or absence of RA for comparative analysis., Results: A total of 104 ASS patients with arthritis were included, among whom 23.1% (24/104) were diagnosed with RA. The ASS with RA group had a significantly higher incidence of rapidly progressive interstitial lung disease (RP-ILD) (41.7% vs . 17.6%, P =0.032), number of tender joints [10 (7, 14) vs . 4 (0, 8), P < 0.001], number of swollen joints [4 (2, 8) vs . 2 (0, 4), P =0.012], and rate of bone erosion (47.8% vs . 2.5%, P < 0.001) compared with the non-RA group. Levels of platelets [(289.57±68.74)×10 3 /μL vs . (247.94±77.04)×10 3 /μL, P =0.022], erythrocyte sedimentation rate (ESR) [43 (19, 59) mm/h vs . 18 (10, 44) mm/h, P =0.019], and C-reactive protein (CRP) [19.20 (4.80, 55.36) mg/L vs . 5.68 (1.10, 14.96) mg/L, P =0.006] were found significantly higher in the ASS with RA group than those in non-RA group. Analysis of immune cells in peripheral blood mononuclear cell (PBMC) showed that significantly decreased proportions of CLA + Treg cells [(11.12±4.10)% vs . (17.22±8.49)%, P =0.003], B cells [8.56% (4.80%, 11.90%) vs . 14.55% (8.75%, 20.29%), P =0.025], and natural killer (NK) cells [7.56% (4.65%, 13.20%) vs . 13.25% (7.46%, 19.25%), P =0.045] in the overlap group compared with non-RA group. Proportion of Naïve Th cells [(52.66±17.66)% vs . (40.76±14.96)%, P =0.033)] was significantly increased in overlap group compared with non-RA group. Overlap group had lower rate of complete clinical response than non-RA group (16.7% vs . 43.8%, P =0.031)., Conclusion: Among ASS patients with arthritis, those with RA have more severe lung and joint involvement and a lower treatment response rate, highlighting the need for early recognition and aggressive intervention.

Objective: Chemoradiation followed by esophagectomy is a standard treatment option for patients with locally advanced esophageal cancer (LAEC). Esophagectomy is a high-risk procedure, and recent evidence suggests select patients may benefit from omitting or delaying surgery. This study aims to compare surgery versus active surveillance for LAEC patients with complete clinical response (cCR) after neoadjuvant chemoradiotherapy (nCRT)., Methods: Decision analysis with Markov modeling was used. The base case was a 60-year-old man with T3N0M0 esophageal cancer with cCR after nCRT. The decision was modeled for a 5-year time horizon. Primary outcomes were life-years and quality-adjusted life-years (QALY). Probabilities and utilities were derived through the literature. Deterministic sensitivity analyses were performed using ranges from the literature with consideration for clinical plausibility., Results: Surgery was favored for survival with an expected life-years of 2.89 versus 2.64. After incorporating quality of life, active surveillance was favored, with an expected QALY of 1.70 versus 1.56. The model was sensitive to probability of recurrence on active surveillance (threshold value 0.598), probability of recurrence being resectable (0.318), and disutility of previous esophagectomy (-0.091). The model was not sensitive to perioperative morbidity and mortality., Conclusions: Our study finds that surgery increases life expectancy but decreases QALY. Although the incremental change in QALY for either modality is insufficient to make broad clinical recommendations, our study demonstrates that either approach is acceptable. As probabilities of key factors are further defined in the literature, treatment decisions for patients with LAEC and a cCR after nCRT should consider histology, patient values, and quality of life., Competing Interests: Conflict of Interest Statement Dr Kidane discloses receiving speaker and advisory board honoraria from AstraZeneca, Merk, Bristol-Meyers-Squibb, and Medtronic. Dr Kidane is the associate statistical editor for the American Association for Thoracic Surgery. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2024 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background This study aimed to evaluate tumor-infiltrating lymphocytes (TILs) as predictors of response to neoadjuvant chemotherapy (NACT) in patients with locally advanced breast cancer (LABC). Methods Overall, 35 patients with LABC were included in the study. Information on demographic profile, medical history, and signs and symptoms was collected for each patient, and a complete clinical evaluation was conducted, which involved physical examination, imaging studies (mammogram/ultrasound imaging), biopsy of each patient, and a metastatic workup. Patient consent was obtained for core-needle biopsy under local anesthesia, followed by a pathologic assessment of the type of breast cancer, before NACT and after mastectomy. Patients treated with NACT were followed up for response using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and were scheduled for modified radical mastectomy (MRM) on completion of NACT. MRM specimens were sent for immunohistopathologic analysis for CD3 and CD5, and for grading. Subsequently, correlations between TILs and grading with NACT response and type of cancer were analyzed. Results Of the 35 patients, 24 were positive for CD3. A correlation was identified between NACT in LABC patients and CD3 TILs, as 68.6% of patients were CD3-positive, with 54.3% showing stromal CD3 variants and 14.3% showing intramural CD3 variants. This result indicates that CD3 TILs can be an indicator of response to NACT in LABC patients. In the sample, 48.6% of patients showed CD5 positivity, with stromal predominance. Overall, 17 patients (48.6%) had a RECIST complete response to NACT, 16 (45.7%) had a partial response, and 1 (2.9%) had progressive disease. Therefore, the study showed a significant response to NACT in LABC patients (p-value < 0.0001), and reductions in tumor size could be evaluated using RECIST criteria. Conclusions NACT had a significant effect on tumors, as shown by RECIST assessments in patients with LABC. TILs can be used as promising prognostic markers to evaluate and predict patients' responses to NACT. Evaluating TILs is expensive but may be useful for the diagnosis and prediction of immunologic responses in breast cancer and other types of carcinomas following chemotherapy., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Vardhaman Mahavir Medical College and Safdarjung Hospital issued approval IEC/VMMC/SJH/THESIS/2020-11/CC-131. After a detailed scrutinization, discussion and assessment of the research project/thesis, the members of IPRC arrived at a unanimous resolution approving this research project/thesis for all ethical purposes. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Kumar et al.)

Abstract Background Some clinical researchers have reported that patients with cCR (clinical complete response) status after neoadjuvant chemoradiotherapy (nCRT) could adopt the watch-and-wait (W&W) strategy. Compared with total mesorectal excision (TME) surgery, the W&W strategy could achieve a similar overall survival. Could the W&W strategy replace TME surgery as the main treatment option for the cCR patients? By using the meta-analysis method, we evaluated the safety and efficacy of the W&W strategy and TME surgery for rectal cancer exhibiting cCR after nCRT. Methods We evaluated two treatment strategies for rectal cancer with cCR after nCRT up to July 2021 by searching the Cochrane Library, PubMed, Wanfang, and China National Knowledge Infrastructure (CNKI) databases. Clinical data for primary outcomes (local recurrence, cancer-related death and distant metastasis), and secondary outcomes (disease-free survival (DFS) and overall survival (OS)) were collected to evaluate the efficacy and safety in the two groups. Results We included nine studies with 818 patients in the meta-analysis, and there were five moderate-quality studies and four high-quality studies. A total of 339 patients were in the W&W group and 479 patients were in the TME group. The local recurrence rate in the W&W group was greater than that in the TME group in the fixed-effects model (OR 8.54, 95% CI 3.52 to 20.71, P < 0.001). The results of other outcomes were similar in the two groups. Conclusion The local recurrence rate of the W&W group was greater than that in the TME group, but other results were similar in the two groups. With the help of physical examination and salvage therapy, the W&W strategy could achieve similar treatment effects with the TME approach. Trial registration Protocol registration number: CRD42021244032 .

Purpose: Cisplatin-based neoadjuvant chemotherapy (NAC) is the standard of care in non-metastatic muscle-invasive bladder cancer (MIBC). There are limited data regarding the alternative choices for cisplatin-ineligible patients. This study has investigated the oncological outcomes of gemcitabine plus cisplatin (Gem/Cis) and gemcitabine plus carboplatin (Gem/Carbo) in this setting.Materials and Methods: One hundred forty consecutive patients with MIBC (cT2-T4a) receiving neoadjuvant Gem/Cis or Gem/Carbo before chemoradiation (CRT) or radical cystectomy (RC) were retrospectively evaluated between April 2009 and April 2019. Patients with ECOG performance status 2, creatinine clearance < 60 mL/min, hydronephrosis, ejection fraction < 50%, or single kidney received Gem/Carbo. The complete clinical response (cCR) and overall survival (OS) of NAC regimens were compared. Prognostic significance was assessed with Cox proportional hazards model.Results: In total, 79 patients (56.4%) received Gem/Cis. The cCR was not significantly different between Gem/Cis and Gem/Carbo regimens (38.7% vs. 36.2%, P = .771). After NAC, 79 patients (56.4%) received CRT, and other cases underwent RC. After a median follow-up of 43 months, patients in the Gem/Cis group had significantly better OS than Gem/Carbo (median OS: 41.0 vs. 26.0 months, P = .008). Multivariable Cox proportional hazards models identified cT4a stage (95% confidence interval [95% CI]: 1.001-4.85, hazard ratio [HR] = 2.08, P = .03) and cCR (95% CI: 0.26-0.99, HR = 0.51, P = .04) as the only independent prognostic factors of OS, and ruled out the type of NAC regimen.Conclusion: The choice of NAC (between Gem/Cis and Gem/Carbo) is not the predictor of survival and both regimens had similar cCR. [ABSTRACT FROM AUTHOR]

There has been a staggering increase in the incidence of rectal cancer, drawing our attention to early detection and optimization of its medical and surgical treatment. With this review we highlight all the major trials that revolutionized rectal cancer management and improved oncologic outcomes. We present the origins of the trimodal therapy and the studies that supported the sequence of treatment. We describe the evolution in surgical management with total mesorectal excision as the standard of care, and we review the most impactful short- vs. long-course long-course radiation therapy trials. Today, the current standard of care for non-metastatic locally advanced rectal cancer includes preoperative chemoradiation with either induction or consolidation chemotherapy, total mesorectal excision and adjuvant therapy. We discuss the advent of the "watch and wait" strategy for patients who have a complete clinical response after total neoadjuvant treatment, as well as possible future directions in the treatment of locoregional disease. [ABSTRACT FROM AUTHOR]

Background: Organ sparing by the transanal endoscopic microsurgery (TEM) procedure is a treatment for patients with locally advanced rectal cancer after chemoradiotherapy (CRT) and complete clinical response (cCR).Aims: To assess the surgical and long-term oncological outcomes of TEM for the treatment in T2-3 rectal cancer after CRT and cCR.Methods: This study was a retrospective review of a prospective database of patients with rectal cancer who underwent TEM after CRT and cCR from April 2011 to March 2020.Results: 52 patients underwent TEM during a period of 9 years. This group of patients included 27 females and 25 males. The median age was 62 (32-86) years, lesion size was 2.5 (1-4) cm, and lesion distance from the anal verge 7.3 (4-10) cm. Median operative time was 79.5 (25-120) min and hospital stay was 1 day (14 h-4 days). Morbidity rate was 13.5% and reoperation rate due to major complications was 3.8%. Final histological findings confirmed 34 (65.4%) patients with ypT0, 7 (13.5%), 6 (11.5%), and 5 (9.6%) patients with carcinoma ypT1, ypT2, and ypT3, respectively. After a median follow-up period of 86 (5-107) months, 1 (2.4%) patient had local recurrences and 3 (7.3%) distant metastases. The 5-year disease-free survival was 91.7% and 5-year overall survival 89.5%.Conclusion: Our experience has shown significant rates of ypT0 and ypT1 associated with excellent long-term results. Performing TEM to treat T2-3N0 rectal cancer after CRT and cCR appears to be an oncologically safe and effective procedure. [ABSTRACT FROM AUTHOR]

The best treatment strategy for oesophageal cancer patients achieving a complete clinical response after neoadjuvant chemoradiation is a burning topic. The available diagnostic tools, such as 18F-FDG PET/CT performed routinely, cannot accurately evaluate the presence or absence of the residual tumour. The emerging field of radiomics may encounter the critical challenge of personalised treatment. Radiomics is based on medical image analysis, executed by extracting information from many image features; it has been shown to provide valuable information for predicting treatment responses in oesophageal cancer. This systematic review with a meta-analysis aims to provide current evidence of 18F-FDG PET-based radiomics in predicting response treatments following neoadjuvant chemoradiotherapy in oesophageal cancer. A comprehensive literature review identified 1160 studies, of which five were finally included in the study. Our findings provided that pooled Area Under the Curve (AUC) of the five selected studies was relatively high at 0.821 (95% CI: 0.737–0.904) and not influenced by the sample size of the studies. Radiomics models exhibited a good performance in predicting pathological complete responses (pCRs). This review further strengthens the great potential of 18F-FDG PET-based radiomics to predict pCRs in oesophageal cancer patients who underwent neoadjuvant chemoradiotherapy. Additionally, our review imparts additional support to prospective studies on 18F-FDG PET radiomics for a tailored treatment strategy of oesophageal cancer patients. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/ , identifier CRD42021274636. [ABSTRACT FROM AUTHOR]

For (locally advanced) rectal cancer, a multimodal therapy concept comprising neoadjuvant radiotherapy/chemoradiotherapy, radical surgical resection with partial/complete mesorectal excision and subsequent adjuvant chemotherapy represents the current international standard of care. Further developments in neoadjuvant therapy concepts, such as the principle of total neoadjuvant therapy, lead to an increasing number of patients who show a complete clinical response in restaging after neoadjuvant therapy without clinically detectable residual tumor. In view of the risk associated with radical surgical resection in terms of perioperative morbidity and a potentially non-continence-preserving procedure, the question of the oncological justifiability of an organ-preserving procedure in the case of a complete clinical response under neoadjuvant therapy is increasingly being raised. The therapeutic principle of watch and wait, defined by refraining from immediate radical surgical resection and inclusion in a close-meshed, structured follow-up program, currently appears to be oncologically justifiable based on the current study situation; however, for the initial evaluation of the extent of the clinical response and for the structuring of the close-meshed follow-up program, further optimization and standardization based on broadly designed studies appear necessary in order to be able to provide this concept to a clearly defined patient collective as an oncologically equivalent therapy principle also outside specialized centers. [ABSTRACT FROM AUTHOR]

The best treatment strategy for oesophageal cancer patients achieving a complete clinical response after neoadjuvant chemoradiation is a burning topic. The available diagnostic tools, such as 18F-FDG PET/CT performed routinely, cannot accurately evaluate the presence or absence of the residual tumour. The emerging field of radiomics may encounter the critical challenge of personalised treatment. Radiomics is based on medical image analysis, executed by extracting information from many image features; it has been shown to provide valuable information for predicting treatment responses in oesophageal cancer. This systematic review with a meta-analysis aims to provide current evidence of 18F-FDG PET-based radiomics in predicting response treatments following neoadjuvant chemoradiotherapy in oesophageal cancer. A comprehensive literature review identified 1160 studies, of which five were finally included in the study. Our findings provided that pooled Area Under the Curve (AUC) of the five selected studies was relatively high at 0.821 (95% CI: 0.737–0.904) and not influenced by the sample size of the studies. Radiomics models exhibited a good performance in predicting pathological complete responses (pCRs). This review further strengthens the great potential of 18F-FDG PET-based radiomics to predict pCRs in oesophageal cancer patients who underwent neoadjuvant chemoradiotherapy. Additionally, our review imparts additional support to prospective studies on 18F-FDG PET radiomics for a tailored treatment strategy of oesophageal cancer patients. Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42021274636.

Background Watchful waiting and non-operative management of patients with complete clinical response to neoadjuvant treatment in locally advanced rectal cancers is an emerging practice now, especially in patients whose surgery would require permanent stoma. Methodology This is a retrospective study of patients presenting to the National Cancer Institute, Cairo University, Egypt from January 2005 to December 2019 with pathologically proven locally advanced rectal cancer who had a complete clinical response after neoadjuvant treatment. Patients who underwent surgery after achieving complete clinical response and patients who were kept under watchful waiting were compared in terms of overall survival (OS), disease-free survival (DFS), metastasis-free survival (MFS), and local recurrence-free survival (LRFS). Results Of the 51 patients identified, 31 (61%) went to surgery, and 20 (39%) were kept under watchful waiting. There was no difference in five-year OS between both groups (65% for both, p = 0.57). Five-year DFS for the watchful waiting group was 68% versus 62% for the surgery group (p = 0.75). Five-year LRFS was 100% in the watchful waiting group versus 83% in the surgery group (p = 0.15). Conclusions Watchful waiting after a complete clinical response to neoadjuvant treatment in locally advanced rectal cancer is feasible without compromising disease-related outcomes, especially in patients with distal rectal cancers requiring permanent stoma after surgery. However, further prospective validation is needed., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Institutional Review Board of National Cancer Institute, Cairo University, Egypt issued approval NA. IRB approval was obtained before data collection from the ethical committee, National Cancer Institute, Cairo University. A waiver for patient consent was obtained given the retrospective nature of the study. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Ashour et al.)

Background: Rectal malignancy ranks among the most prevalent malignancies in humans. Neoadjuvant chemoradiotherapy (nCRT) is advocated as the standard treatment for locally advanced rectal cancer. In patients who achieve complete clinical response (cCR), successive surgical intervention may result in favorable immediate and long-lasting results; however, it may be associated with decreased quality of life. This study aims to evaluate the incidence of local recurrence in rectal adenocarcinoma between patients who underwent a watch-and-wait approach and those who underwent abdominoperineal resection following the achievement of a cCR after nCRT., Methods: This is an analytic cohort study that included 68 patients and was conducted in Baghdad Teaching Hospital/Medical City, Baghdad. The data were collected from the 1st of April 2021 to the 1st of October 2023. All patients with stage II and III rectal adenocarcinoma who achieved cCR after receiving nCRT were included in the study., Results: There was no statistically significant difference between the two study groups regarding non-regrowth disease-free survival (p-value = 0.708). Cox-regression multivariate analysis revealed that baseline T stage and serum carcinoembryonic antigen (CEA) were significantly associated with locoregional failure., Conclusion: The present study reveals that implementing the watch-and-wait strategy had the benefit of avoiding major surgery, stoma, and their complications without coming at the cost of reduced locoregional recurrence., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Iraqi Board for Medical Specializations issued approval 1053. Verbal and written consent has been obtained from all participants before data collection. An official letter of approval has been obtained from the Scientific Committee of the Scientific Council of General Surgery – Iraqi Board for Medical Specializations. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Mahmood et al.)

Background: Owing to multimodal treatment and complex surgery, locally advanced rectal cancer (LARC) exerts a large healthcare burden. Watch and wait (W&W) may be cost saving by removing the need for surgery and inpatient care. This systematic review seeks to identify the economic impact of W&W, compared with standard care, in patients achieving a complete clinical response (cCR) following neoadjuvant therapy for LARC., Methods: The PubMed, OVID Medline, OVID Embase, and Cochrane CENTRAL databases were systematically searched from inception to 26 April 2024. All economic evaluations (EEs) that compared W&W with standard care were included. Reporting and methodological quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), BMJ and Philips checklists. Narrative synthesis was performed. Primary and secondary outcomes were (incremental) cost-effectiveness ratios and the net financial cost., Results: Of 1548 studies identified, 27 were assessed for full-text eligibility and 12 studies from eight countries (2016-2024) were included. Seven cost-effectiveness analyses (complete EEs) and five cost analyses (partial EEs) utilized model-based (n = 7) or trial-based (n = 5) analytics with significant variations in methodological design and reporting quality. W&W showed consistent cost effectiveness (n = 7) and cost saving (n = 12) compared with surgery from third-party payer and patient perspectives. Critical parameters identified by uncertainty analysis were rates of local and distant recurrence in W&W, salvage surgery, perioperative mortality and utilities assigned to W&W and surgery., Conclusion: Despite heterogenous methodological design and reporting quality, W&W is likely to be cost effective and cost saving compared with standard care following cCR in LARC. Clinical Trials Registration PROSPERO CRD42024513874., (© 2024. The Author(s).)

Background: Some clinical researchers have reported that patients with cCR (clinical complete response) status after neoadjuvant chemoradiotherapy (nCRT) could adopt the watch-and-wait (W&W) strategy. Compared with total mesorectal excision (TME) surgery, the W&W strategy could achieve a similar overall survival. Could the W&W strategy replace TME surgery as the main treatment option for the cCR patients? By using the meta-analysis method, we evaluated the safety and efficacy of the W&W strategy and TME surgery for rectal cancer exhibiting cCR after nCRT. Methods: We evaluated two treatment strategies for rectal cancer with cCR after nCRT up to July 2021 by searching the Cochrane Library, PubMed, Wanfang, and China National Knowledge Infrastructure (CNKI) databases. Clinical data for primary outcomes (local recurrence, cancer-related death and distant metastasis), and secondary outcomes (disease-free survival (DFS) and overall survival (OS)) were collected to evaluate the efficacy and safety in the two groups. Results: We included nine studies with 818 patients in the meta-analysis, and there were five moderate-quality studies and four high-quality studies. A total of 339 patients were in the W&W group and 479 patients were in the TME group. The local recurrence rate in the W&W group was greater than that in the TME group in the fixed-effects model (OR 8.54, 95% CI 3.52 to 20.71, P < 0.001). The results of other outcomes were similar in the two groups. Conclusion: The local recurrence rate of the W&W group was greater than that in the TME group, but other results were similar in the two groups. With the help of physical examination and salvage therapy, the W&W strategy could achieve similar treatment effects with the TME approach. Trial registration: Protocol registration number: CRD42021244032. [ABSTRACT FROM AUTHOR]

This article demonstrates the experience of successful treatment of a patient with locally advanced rectal cancer, who received a combined treatment with a non-standard course of chemoradiotherapy in hypofractionation mode according to a prolonged program. After the end of a course of chemoradiation received the complete clinical response of the tumor.

Objective A North American registry of JDM patients was examined for frequency of and factors associated with corticosteroid discontinuation, complete clinical response and remission. Methods We evaluated probability of achieving final corticosteroid discontinuation, complete clinical response and remission in 307 JDM patients by Weibull time-to-event modelling; conditional probability of complete clinical response and remission using Bayesian network modelling; and significant predictors with multivariable Markov chain Monte-Carlo Weibull extension models. Results The probability of corticosteroid discontinuation was 56%, complete clinical response 38% and remission 30% by 60 months after initial treatment in 105 patients. The probability of remission was conditional on corticosteroid discontinuation and complete clinical response. Photosensitivity, contractures and a longer time to complete clinical response were predictive of the time to final corticosteroid discontinuation. Anti-MJ (NXP2) autoantibodies and a Northwest residential geoclimatic zone were predictive of shorter time to complete clinical response, while dysphonia, contractures, an increase in medications within 24 months and a longer time to corticosteroid discontinuation were associated with longer time to complete clinical response. Anti-p155/140 (TIF1) autoantibodies, an increase in medications within 12–24 months, or longer times to corticosteroid discontinuation and complete clinical response were associated with longer time to remission. Conclusion JDM patients achieve favourable outcomes, including corticosteroid discontinuation, complete clinical response and remission, although timelines for these may be several years based on time-dependent analyses. These outcomes are inter-related and strong predictors of each other. Selected clinical features and myositis autoantibodies are additionally associated with these outcomes. [ABSTRACT FROM AUTHOR]

Objective: Analyze conditional recurrence-free survival (cRFS) for rectal cancer patients with complete clinical response (cCR) after neoadjuvant chemoradiation (nCRT) managed nonoperatively after each year without recurrence. Summary Background Data: Select patients with cCR after nCRT have been managed nonoperatively. Risk factors for local recurrence, the need for prolonged follow-up, and the risk of recurrence over time are not well defined. Methods: Retrospective review of patients with rectal cancer cT2-4N0-2M0 treated with nCRT. Mean follow-up was 64 months. Patients who achieved cCR were managed nonoperatively. cRFS was used to investigate the evolution of recurrence-odds, as patients remain recurrence-free after completion of nCRT. Three-year cRFS was estimated at ''x'' years after completion of nCRT based on the formula cRFS3RFS(xþ3)/RFS(x). Results: One hundred ninety-seven patients with cCR after nCRT were included. Overall survival and recurrence-free survival (RFS) at 5 years were 81.9% (95% CI 74.0%-87.6%) and 60.4% (95% CI 52.5%-67.4%) respectively. Using cRFS estimates, the probability of remaining disease-free for an additional 3 years if the patient survived without disease at 1, 3, and 5 years, was 77.4% (95% CI 68.8%-83.8%), 91.0% (95% CI 81.9%-95.7%), and 94.3% (95% CI 82.9%-98.2%), respectively. In contrast, actuarial RFS rates for similar intervals were 79.1% (95% CI 72.5%-84.2%), 64.2% (95% CI 56.5%-70.8%), and 60.4% (95% CI 52.5%-67.4%). After 2 years diseasefree, 3 year cRFS became similar for T2 and T3 cancers. In contrast, patients undergoing extended nCRT became less likely to develop recurrences only after initial 2 years of successful organ-preservation. Conclusions: Conditional survival suggests that patients have significantly lower risks (-10%) of developing recurrences after 2 years of achieving cCR following nCRT. [ABSTRACT FROM AUTHOR]

Introduction: Ribociclib is an orally bioavailable cyclin-dependent kinase 4/6 inhibitor. In combination with aromatase inhibitor letrozole, it has approval for treatment of hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer. First-line therapy with ribociclib + letrozole significantly improves progression-free survival compared to placebo + letrozole in patients with HR+/HER2− advanced breast cancer. In patients with de novo advanced or metastatic breast cancer, ribociclib was able to provide substantial clinical benefit according to data from the MONALEESA-2 study. Case Presentation: Here, we report the complete clinical response in a postmenopausal patient with de novo, locally advanced, pulmonary metastatic breast cancer treated with ribociclib + letrozole. Our patient presented an ulcerated breast-consuming tumor with multiple pulmonary metastases. HR+/HER2– breast cancer was confirmed by tumor biopsy. Ki67 expression was 90%. After three months of initial treatment, the tumor-associated ulcerations disappeared, and no measurable pulmonary disease was detectable on CT scan. Treatment was well tolerated, and after dosage reduction due to neutropenia, no further side effects have been documented. At present, complete clinical response remains after 15 months of ongoing treatment. Conclusion: This case report documents an exceptional tumor response of a fast growing, locally advanced, pulmonary metastatic HR+/HER2– de novo breast cancer treated by ribociclib/letrozole combination therapy. Treatment success was long lasting with few side effects. The patient was very satisfied with the treatment and had no specific restrictions in her daily life. [ABSTRACT FROM AUTHOR]

Objective: to evaluate the results of “watch and wait” approach for rectal cancer patients with complete clinical response after neoadjuvant chemoradiotherapy (CRT) followed by consolidation chemotherapy.Materials and methods. Between 2013 and 2016, 130 patients who were diagnosed with stage T2N0–1M0–T3(CRM+)–4N0–2M0 middle and low rectal cancer were treated by CRT (single dose 2 Gy to a total dose 50–54 Gy with concominant capecitabine 850 mg/m2 /day of radiotherapy) with consolidation chemotherapy (CapOx) (capecitabine 2000 mg/m2 14 days and oxaliplatin 130 mg/m2 intravenous once in 3 weeks).Results. 21 patient showed complete clinical response. During the time of observation (median 14.6 month) all patients alive without signs of recurrence and progression.Conclusion. Preliminary results showed that organ saving treatment for rectal cancer patients with a complete clinical response is oncologically safe when followed by strict selection criteria and active follow-up, including endoscopy and magnetic resonance imagin. Future investigation is needed to justify this statement. Probability of complete response is higher for early stages of rectal cancer.

Introduction: Locally advanced rectal cancers are most often treated with neoadjuvant chemoradiation followed by surgical resection. However, there are differing opinions surrounding management of rectal cancer, including a lack of consensus on the optimal time interval between chemoradiation and surgery, and the management of patients with complete clinical response following neoadjuvant therapy. This study seeks to summarize management trends for rectal cancer among a sample of Canadian surgeons. Methods: A 14-question survey was distributed to surgeons across Canada managing rectal cancer. Surgeons were identified from the membership lists of the Canadian Association of General Surgeons and the Canadian Society of Colon and Rectal Surgeons. Web-based questionnaires were distributed by email. Results: A total of 115 surgeons were emailed the survey with a response rate of 38.4%. Approximately 50% of surgeon responders had been in practice for more than 10 years, with the majority practicing in academic centers. Half were considered high-volume rectal cancer surgeons with more than 20 cases per year. All surgeons used magnetic resonance imaging for staging of rectal cancer, but only 50% presented all rectal cancer cases at multidisciplinary cancer conferences. The majority of surgeons applied minimally invasive techniques for surgical resection, including the utilization of transanal endoscopic microsurgery (TEMs) and transanal minimally invasive surgery (TAMIS); however, only a small fraction performed high-volume transanal total mesorectal excision (taTME). Regarding the management of complete clinical response (cCR) following neoadjuvant chemoradiation, less than 5% chose the watch and wait management strategy for all patients and 40% did not use it at all. The majority of surgeons reported waiting between eight and 10 weeks between chemoradiation and surgery, and 40% made that decision regardless of patient or tumor factors. Conclusion: The majority of surveyed surgeons use MRI for pelvic staging and discuss rectal cancer cases at multidisciplinary cancer conference. Many are using minimally invasive techniques; however, the use of taTME is not yet widespread. Surgeons currently favor longer intervals from neoadjuvant chemoradiation to surgery, and the management strategy for patients with complete clinical response remains controversial. Great variability exists in rectal cancer management, thus presenting an opportunity for improvements by adopting standardization and centralization of rectal cancer management. [ABSTRACT FROM AUTHOR]

Background/Aims: The management of locally advanced rectal cancer has changed substantially over the last few decades with neoadjuvant chemoradiotherapy. The aim of the present study is to compare the results between neoadjuvant post-treatment rectoscopy and the anatomopathological findings of the surgical specimen. Patients and Methods: We conducted a prospective study of 67 patients with locally advanced adenocarcinoma of the rectum (stages II and III). Two groups were established: One with complete clinical response (cCR) and one without (non-cCR), based on the findings at rectoscopy. Assessment of tumor regression grade in the surgical specimen was determined using Mandard's tumor regression scale. Results: Seventeen patients showed a cCR. Thirty-five biopsies were negative and 32 were positive for mailgnancy. All the cCR patients had a negative biopsy (P < 0.0001). All 32 positive biopsies revealed the presence of adenocarcinoma, and of the 35 negative biopsies, 18 had no malignancy and 17 were diagnosed with adenocarcinoma (P < 0.0001). Sixteen of the 17 cCR patients showed a complete pathological response and one patient showed the presence of adenocarcinoma. Of the 50 non-cCR patients 48 revealed the presence of adenocarcinoma and two had absence of malignancy. According to the Mandard classification, 16 of the 17 cCR patients were grade I and 1 grade II; 2 non-cCR patients were grade I, 7 grade II, 13 grade III, 19 grade IV, and 9 grade V. Conclusions: Endoscopic and histological findings could be determinants in the assessment of response to neoadjuvant treatment.

Preoperative staging by digital examination, endorectal ultrasound and magnetic resonance imaging (MRI) allows an assessment of the risk of local recurrence after surgery alone. The successful management of rectal cancer requires a multidisciplinary approach, with treatment decisions based on precise patient evaluations. Chemoradiotherapy (CRT) is associated with reduction of tumor size and downstaging.The aim of this study is to assess how often complete clinical response is achieved after eoadjuvant CRT and its concordance with pathologic complete response.Results. Patients with biopsy-proven, locally advanced rectal cancer (T3, T4) were treated by CRT followed by radical surgery. Tumors were re-assessed after 8 weeks from CRT completion using MRI and endoscopic examination. The results of examination were comparedwith the final histopathologic status.Conclusions. Neoadjuvant CRT leads to significant tumor regression and in some patients there is complete disappearance of neoplasm. MRI combining with colonoscopic findings is a useful tool to evaluate these features.

Background The present study aims to evaluate the response of locally advanced breast carcinoma (LABC) to neoadjuvant chemotherapy (NACT) using image-guided clip placement based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Methods Thirty-four patients with LABC were included in the study. Consent for three-dimensional titanium clip placement (400/300/200 mm Liga clips) under local anesthesia with USG guidance was obtained. Serial sonographic/X-ray evaluations of tumor bed size were conducted before every cycle of NACT. All data were recorded in millimeters of concentric tumor regression/non-regression. Tumor regression in a concentric or Swiss cheese pattern and non-responders were evaluated. Assessment of the response to NACT was performed using RECIST criteria, dividing it into four categories. Tumor response was confirmed with computerized tomography (CT) conducted before and after the completion of NACT. Patients underwent surgical management, mostly modified radical mastectomy (MRM), as they had locally advanced breast carcinoma. Following MRM, the clips in the specimen guided the original site of the tumor for histopathological evaluation and response to chemotherapy. Results Tumor response was classified into four types: complete response (CR), partial response (PR), progressive disease (PD), and stable disease. RECIST 1.1 criteria were elaborated and defined. Data for all patients were entered into an Excel sheet (Microsoft Corporation, Redmond, Washington) to prepare a master chart, and the following observations were made and analyzed using SPSS software. The duration of chemotherapy for the study population ranged from 32 to 206 days, with a mean (±SD) of 111.82 (± 52.64) days and a median (IQR) of 81 (63, 158) days. The mean period between clip insertion and completion of NACT was 111.82 days. The baseline sum diameters and post-NACT diameters of the tumors were 70.50 (±13.60) mm before NACT and 17.75 (±17.20) mm after NACT. Hence, the mean size of the lump was statistically significantly lower after NACT, with a mean difference of 52.75 (p<0.05). The mean rate of reduction in tumor diameter was found to be 74.32% (±23.44%) based on RECIST 1.1 criteria. Pathological response was observed in all patients except for 8.8% of the patients. Clinical complete response was seen in 35.29% of patients, and partial response was observed in 52.92% of the patients based on RECIST 1.1 criteria. The study thus demonstrates the effectiveness of NACT in LABC, with a mean reduction in tumor diameter of 74.32%, assessed with the help of RECIST 1.1 criteria. Conclusion NACT for patients with LABC has shown a significant reduction in tumor size. NACT should be the initial mode of management for patients with LABC. RECIST 1.1 criteria are effective and can be used to assess tumor response to NACT. This has aided in the stratification of the response of NACT for further management through systemic therapy (adjuvant chemotherapy) after the surgical excision of the tumor., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Pandurangappa et al.)

Aim: Observation with close follow‐up ("watch and wait") is a recognized treatment option in patients who achieve a complete clinical response to long course chemoradiotherapy. This review of a prospective database aims to evaluate the clinical outcomes among patients with a complete clinical response managed with observation. Methods: A prospective study of 32 patients who achieved a complete clinical response was undertaken. The primary outcomes measured were overall and recurrence‐free survival, and rate of organ preservation in patients who deferred immediate surgery. Results: Seven patients developed local regrowth over a median follow‐up period of 38 months (range, 9–91 months). Median time to detection was 12 months. All seven underwent salvage surgery with complete surgical clearance. One patient developed combined local and systemic recurrence following a low anterior resection. Organ preservation was possible in 25 (78%) patients who sustained a complete clinical response with no evidence of local regrowth or disease recurrence. Among the patients who sustained a complete response, two developed isolated systemic disease. Overall and recurrence‐free survival was 95.7% and 87.0%, respectively. Conclusion: The majority of patients with rectal cancer who achieved a complete clinical response after chemoradiotherapy and managed with a "watch and wait" approach preserved their rectum and did not develop cancer relapse. Salvage surgery was achieved in all patients who developed local regrowth. The study supports a period of observation in rectal cancer patients who achieve a complete clinical response. [ABSTRACT FROM AUTHOR]

Aims Following chemoradiotherapy in patients with rectal cancer, the addition of contact X-ray brachytherapy (CXB) in partial responders might increase the proportion of patients with a clinical complete response (cCR) and who are thus suitable for watch and wait management. However, the long-term cost-effectiveness of this approach has not been evaluated. Materials and methods Decision analytical modelling and a Markov simulation were used to compare long-term costs, quality-adjusted life years (QALYs) and cost-effectiveness from a third-party payer (National Health Service) perspective for treatment strategies after chemoradiotherapy; watch and wait with CXB when a cCR was not initially achieved after external beam radiotherapy (EBRT) (WW CXB ), watch and wait with EBRT alone (WW EBRT ) and radical surgery for all patients. The effect of uncertainty in model parameters and patient demographics was investigated. Results WW CXB had a higher QALY payoff than both radical surgery and WW EBRT and was less costly in most scenarios and demographic cohorts. In all plausible scenarios, WW CXB was the most cost-effective, at a threshold of £20 000/QALY. This finding was insensitive to uncertainty associated with model parameters. Conclusions WW CXB is likely to be cost-effective compared with both WW EBRT alone and radical surgery. These findings support the use of CXB boost as an adjunct to a watch and wait strategy. [ABSTRACT FROM AUTHOR]

Preoperative chemoradiation is the standard of care for patients with locally advanced rectal cancer to reduce the risk of local recurrence. Chemoradiation can achieve a pathological complete response (pCR) in 10-20% of patients when surgery is performed at 4-12 weeks following completion, and a clinical complete response (cCR) in 15-30% if surgery is withheld. The probability of pCR and cCR is partly dependent on initial clinical T- and N-stage. Observational/retrospective studies suggest a selective watch-and-wait policy with rigorous surveillance, avoiding radical surgery, is a safe option to offer patients who achieve a cCR or near cCR. With a watch-and-wait approach, approximately one third will relapse within 12 months, but regrowth is almost invariably endoluminal, and can often be salvaged without compromising overall survival. The aim of this overview is to examine the current status of the watch-and-wait policy for patients with cCR following chemoradiation in rectal cancer. [ABSTRACT FROM AUTHOR]