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PURPOSE: Total neoadjuvant therapy (TNT) is a newly established standard treatment for rectal adenocarcinoma. Current methods to communicate magnitudes of regression during TNT are subjective and imprecise. Magnetic resonance tumor regression grade (MR-TRG) is an existing, but rarely used, regression grading system. Prospective validation of MR-TRG correlation with pathologic response in patients undergoing TNT is lacking. Utility of adding diffusion-weighted imaging to MR-TRG is also unknown. METHODS: We conducted a multi-institutional prospective imaging substudy within NRG-GI002 (ClinicalTrials.gov identifier: NCT02921256) examining the ability of MR-based imaging to predict pathologic complete response (pCR) and correlate MR-TRG with the pathologic neoadjuvant response score (NAR). Serial MRIs were needed from 110 patients. Three radiologists independently, then collectively, reviewed each MRI for complete response (mriCR), which was tested for positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity with pCR. MR-TRG was examined for association with the pathologic NAR score. All team members were blinded to pathologic data. RESULTS: A total of 121 patients from 71 institutions met criteria: 28% were female (n = 34), 84% White (n = 101), and median age was 55 (24-78 years). Kappa scores for T- and N-stage after TNT were 0.38 and 0.88, reflecting fair agreement and near-perfect agreement, respectively. Calling an mriCR resulted in a kappa score of 0.82 after chemotherapy and 0.56 after TNT reflected near-perfect agreement and moderate agreement, respectively. MR-TRG scores were associated with pCR (P < .01) and NAR (P < .0001), PPV for pCR was 40% (95% CI, 26 to 53), and NPV was 84% (95% CI, 75 to 94). CONCLUSION: MRI alone is a poor tool to distinguish pCR in rectal adenocarcinoma undergoing TNT. However, the MR-TRG score presents a now validated method, correlated with pathologic NAR, which can objectively measure regression magnitude during TNT.

Simple Summary: Intraoperative radiation therapy (IORT) can be a useful treatment modality in patients with recurrent cervical or endometrial cancer. The existing literature on IORT use in recurrent gynecologic malignancies is limited by small sample sizes because few centers use IORT and few patients are ideal candidates. The aim of our study is to describe a modern cohort of patients who were considered for IORT and predict risk factors of morbidity and mortality. We found that appreciable survival gain can be achieved with the use of IORT, with factors such as ECOG performance status (ECOG PS), neoadjuvant chemotherapy/immunotherapy, pelvic sidewall involvement, whether exenteration was performed, and resection margin status influencing the risk of morbidity and/or mortality. Background/Objectives: Our objective was to describe the use of intraoperative radiation therapy (IORT) for the treatment of recurrent/persistent cervical or endometrial cancer and assess predictors of postoperative complications and 3-year mortality. Methods: In this multi-site retrospective study, data were abstracted for recurrent/persistent endometrial or cervical cancer patients who underwent IORT from June 2004 to May 2021. Complications were graded on the six-point Accordion scale. Variables associated with complications were analyzed with univariate logistic regression, while variables associated with death within 3 years were analyzed with Cox proportional hazards modeling. Survival was analyzed with the Kaplan–Meier method. Results: Eighty patients had planned IORT for recurrent/persistent endometrial (n = 35) or cervical cancer (n = 45). The mean age of the cohort was 56.8 years (SD = 13.7), and the median disease-free interval from primary disease to recurrence was 20.0 months (IQR 10.0–63.1). The overall survival at 3 years was 48.6% (95% CI: 38.3–61.6%) with a median survival of 2.8 years. Within 30 days postoperative, 16 patients (20.1%) had grade 3–5 complications and one death (1.3%) occurred. Factors associated with grade 3+ complication included ECOG PS 2–3 (OR 18.00, p = 0.04), neoadjuvant chemotherapy and/or immunotherapy (OR 6.98, p < 0.01), and pelvic sidewall involvement (OR 8.80, p = 0.04). Factors associated with death within 3 years of surgery included ECOG PS 2–3 (HR 8.97, p < 0.01), neoadjuvant chemotherapy and/or immunotherapy (HR 2.34, p = 0.03), whether exenteration was performed (HR 2.64, p = 0.01), and positive resection margin (HR 3.37, p < 0.01). Conclusions: In well-selected patients, IORT is a feasible and safe option for the treatment of recurrent/persistent gynecologic malignancy with an appreciable survival benefit. [ABSTRACT FROM AUTHOR]

Simple Summary: The efficacy of carbon-ion radiotherapy (CIRT) alone vs. multimodality therapy, including surgery, chemoradiotherapy, and intraoperative radiotherapy for previously irradiated locally recurrent rectal cancer, has not been evaluated. A total of 85 patients receiving 70.4 Gy (RBE) in 16 fractions of CIRT were compared with 86 patients receiving 30 Gy in 15 fractions of chemoradiation, resection, and intraoperative electron radiotherapy. CIRT demonstrated improved two- and five-year overall survival (83.1% and 46.8% vs. 62.5% and 25.7% for CMT), with statistically equivalent local recurrence and disease progression, with reduced treatment toxicity and decreased patient cost. A prospective comparison is warranted. No standard treatment paradigm exists for previously irradiated locally recurrent rectal cancer (PILRRC). Carbon-ion radiotherapy (CIRT) may improve oncologic outcomes and reduce toxicity compared with combined modality therapy (CMT). Eighty-five patients treated at Institution A with CIRT alone (70.4 Gy/16 fx) and eighty-six at Institution B with CMT (30 Gy/15 fx chemoradiation, resection, intraoperative electron radiotherapy (IOERT)) between 2006 and 2019 were retrospectively compared. Overall survival (OS), pelvic re-recurrence (PR), distant metastasis (DM), or any disease progression (DP) were analyzed with the Kaplan–Meier model, with outcomes compared using the Cox proportional hazards model. Acute and late toxicities were compared, as was the 2-year cost. The median time to follow-up or death was 6.5 years. Median OS in the CIRT and CMT cohorts were 4.5 and 2.6 years, respectively (p ≤ 0.01). No difference was seen in the cumulative incidence of PR (p = 0.17), DM (p = 0.39), or DP (p = 0.19). Lower acute grade ≥ 2 skin and GI/GU toxicity and lower late grade ≥ 2 GU toxicities were associated with CIRT. Higher 2-year cumulative costs were associated with CMT. Oncologic outcomes were similar for patients treated with CIRT or CMT, although patient morbidity and cost were lower with CIRT, and CIRT was associated with longer OS. Prospective comparative studies are needed. [ABSTRACT FROM AUTHOR]

Background: Anal squamous cell carcinoma (ASCC) is a rare cancer with increased occurrence of multiple cancers before and after the ASCC diagnosis. However, there is limited data on this aspect. This multi-institutional analysis aimed to define the occurrence of malignancies before and after ASCC, time trends, impact on survival, and identify prognostic factors., Material and Methods: Initial primary malignancy (IPM) was defined as a malignancy occurring before the ASCC. Second primary malignancy (SPM) was defined as a distinct primary cancer that developed after ASCC diagnosis. Retrospective multi-institutional chart review was done. Progression free survival (PFS), overall survival (OS) and prognostic factors were evaluated., Results: 647 patients with ASCC treated with curative intent were analyzed. Median age was 61.23 years with 72% as females. 150 patients (23.3%) had multiple malignancies with IPM in 16% and SPM in 8%. Patients without prior cancer had better 5-year PFS (81.2% vs 67.2%, p = .011) and OS (81% vs 69%, p = .008) compared to those with prior cancer. SPMs had a significant adverse impact on PFS (HR 4.22) and OS (HR 3.56). Females had better 5-year PFS (82% vs 70%, p = .016) as compared to males. The median time interval for developing ASCC (as SPM) after IPM was 9.32 years., Conclusions: ASCC patients have increased risk of multiple malignancies. Patients with prior cancer have inferior outcomes. SPM is a poor prognostic factor in patients without any prior cancer. SPM can develop years after treatment of primary ASCC., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)