key: cord-0874195-xx89jqxi
authors: Sarkar, R. R.; Wu, A. J.; Reyngold, M.; Cuaron, J. J.; Zinovoy, M.; Hajj, C.; Pappou, E.; Segal, N.; Yaeger, R.; Wei, I. H.; Widmar, M.; Weiser, M.; Paty, P.; Cercek, A.; Smith, J. J.; Saltz, L.; Garcia-Aguilar, J.; Crane, C. H.; Romesser, P. B.
title: Feasibility of Organ Preservation With Short Course Radiation Therapy as Part of Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer During the COVID-19 Pandemic
date: 2021-11-01
journal: International Journal of Radiation Oncology*Biology*Physics
DOI: 10.1016/j.ijrobp.2021.07.434
sha: 9923213704d81849e5ae8f91d516f7e88267ffe0
doc_id: 874195
cord_uid: xx89jqxi

Purpose/Objective(s) While long course chemoradiation therapy has been studied as part of a watch-and-wait (WW) strategy for patients with locally advanced rectal cancer, it is unclear whether short-course radiation therapy (SCRT) will be associated with similar rates of organ preservation. We hypothesized that a WW strategy to facilitate organ preservation with SCRT, as part of a total neoadjuvant therapy (TNT) approach during the COVID-19 pandemic, would be both safe and feasible. Materials/Methods From March to June of 2020, due to the COVID-19 pandemic, per institutional policy, all patients undergoing radiation therapy for locally advanced rectal cancer were treated with SCRT. After completion of SCRT-TNT, patients were clinically restaged by exam, endoscopy and MRI and the decision was made to manage the patient surgically or with a WW approach. The decision for WW or surgery was made by the surgeon in conjunction with patient consent. After IRB waiver was obtained, we reviewed consecutive patients treated during our SCRT mandate. The main outcome of interest was total mesorectal excision (TME)-free survival among patients eligible for WW after SCRT-TNT. Results Our cohort included 42 patients with a median age of 57 years (Interquartile Range [IQR] 48-67), 24 (57%) of whom were male. Median follow-up from end of SCRT-TNT was 7 months (IQR 6-8). The median tumor cranio-caudal size was 4.1 cm (IQR 3.3-5.2) with a median distance from the anal verge of 7 cm (IQR 5-9). The majority had cT3 (71%) or cN+ (74%) disease. Patients underwent a median of 14 weeks (IQR 13-15) of FOLFOX or CAPEOX chemotherapy, with 32 (76%) patients receiving chemotherapy prior to SCRT and 10 (24%) patients receiving chemotherapy after SCRT. The median time from completion of TNT to endoscopic restaging was 9 weeks (IQR 7-10). Nineteen (45%) patients were recommended to undergo surgical resection, of whom 17 went on to TME and 2 refused TME. Of the 15 patients with pathology available, 2 had a pCR (13%). Notably, one of these patients had a cCR at post-TNT endoscopy, but due to the presence of a stricture, WW was deemed unfeasible. Of the 23 patients managed by a WW strategy after SCRT-TNT completion, 19 had a clinical complete response (cCR), 3 had a near-CR, and 1 had an incomplete response. The 6-month TME-free survival was 85% for patients on WW. Four (17%) patients had a local regrowth at a median of 20 weeks (IQR 17-24), 3 of whom were salvaged with TME and 1 who declined surgery and opted for further surveillance. One of these patients had regrowth confirmed by biopsy, but had a pCR confirmed in the TME specimen. The 6-month TME- free survival of the entire cohort was 52%, and the combined pCR/6-month cCR was 52%. Conclusion Our data suggest WW after SCRT-TNT is feasible. Longer term follow-up is required to confirm the durability and oncologic safety of these results.

diathermy, photocoagulation, PDT, transpupillary thermotherapy, and Radiation. SRS is preferred in the treatment of CH because of its characteristic stiff dose-fall-off and accuracy. Current retrospective study evaluated tumor volume reductions and improvements to visual acuity following multisession Radiosurgery in the treatment of symptomatic circumscribed choroidal hemangioma. Materials/Methods: Study comprised of Thirteen patients with symptomatic circumscribed CHs diagnosed between August 2012 to December 2019 (8 Male & 5 female). 3 pts. had Sturge-Weber syndrome. All patients underwent frameless SRS following retrobulbar block, Thermoplastic immobilization & Imaging (CT & MRI) . A total of 15-18gy / 3 frcs was planned using a 5mm collimator, prescribed to 90% isodose and treatment delivered on a frameless robotic radiosurgery system with skull tracking or C arm Linac equipped with hexapod robotics. Best corrected visual acuity, funduscopic findings, basal tumor diameter and tumor thickness were recorded at baseline and at follow-up visits every 6 -month intervals. Results: The mean age of patients was 33 years (range: 12-61 years) and the mean duration of clinical or radiological follow-up was 33 months (range: 16-80 months). The mean volume, Basal diameter, tumor height & tumor thickness at baseline were 533.5 mm 3 (range: 124-1150 mm 3 ); 8 mm (range: 5-12mm, § 2.3); 2.8mm (range, 2.0 -4.5mm); tumor thickness was 5.1 (range: 3.0-11.0, § 2.7) mm respectively. 6 tumors were subfoveolar, 4 were juxtafoveolar, and 3 were extrafoveolar. Exudative retinal detachment resolved within a median of 5.5 months (response rate, 100%; 95% CI, 48%-100%). Median best-corrected visual acuity was 20/50 (range, 20/22-20/90) at diagnosis and 20/25 (range, 20/20-20/60) 18 months after treatment. The visual acuity of the affected eye had improved at the latest follow-up examination (P = .018) in all patients. Tumor height had decreased a median of 32% (range, 10-40%) by 6 months and 41% (range, 17%-59%) by 20 months. No recurrence of exudative RD occurred. Thinning of the CHs was observed in most patients; however, symptomatic radiation toxicity had not developed in any of the patients. Conclusion: Multisession radiosurgery could be an acceptable alternative treatment for symptomatic circumscribed CH with resolution of exudative RD being achieved within 5-6mo. Purpose/Objective(s): To evaluate the safety and efficacy of Low-Dose Radiation (LD-RT) to treat COVID-19 pneumonia. Materials/Methods: We conducted a prospective phase I-II trial enrolling patients ≥ 50 years-old, COVID-19 positive, with lung involvement at imaging study and oxygen requirement. Patients received 100 cGy to total lungs in a single fraction. Dose planning goals were PTV95 > 80% with Dmax < 115%. Primary outcome was radiological response assessed as severity and extension scores at days 0, +3 and +7. Secondary outcomes were toxicity (CTCAE v5.0), days of hospitalization, changes in inflammatory blood parameters (ferritin, lymphocytes, C-reactive protein, d-dimer and LDH) and SatO2/ FiO2 index (SAFI) at +3 and +7 (normal SAFI > 315, mild respiratory failure < 300, and severe < 200). Descriptive analyses were summarized as means with standard deviation (SD) and medians with interquartile ranges (IQR). A Wilcoxon sign rank test for paired data was used to assess the CT scores and Chi Square was used to assess for comparison of categorical variables. Results: Forty-one patients were included. Three patients died < 72h after LD-RT and were excluded from the analysis. Median age was 71 (IQR 60-84). Eighteen patients (47%) received previously any anti-COVID treatment (tocilizumab, lopinavir/ritonavir, remdesivir) and thirty-two patients (84%) received steroids (GC) during LD-RT. Extension score improved significantly (P = 0.02) on day +7; severity score was stable or slightly decreased (P = 0.1). Median SAFI on day 0 was 147 (IQR 118-264), 230 (IQR 120-343) on day +3 and 293 (IQR 121-353) on day +7 (P < 0.01). SAFI improvement was associated with overall survival (P = 0.01). Significant decrease was found in C-reactive protein on day +7 (P = 0.02) and in lymphocytes counts on day +3 and +7 (P = 0.02). Median time to receive RT from the date of admission was 19 days (ranging 2-87). Median number of days in hospital after RT was 11 (4-78) and overall was 37 days (range 11-155). With a median follow-up of 67 days after LD-RT, 24 (63%) patients were discharged, twelve (32%) died and two (5%) are still inpatients. Conclusion: Our preliminary results show that LD-RT was feasible and well-tolerated treatment, with potential clinical improvement. Randomized trials are needed to establish whether LD-RT improves severe pneumonia. Purpose/Objective(s): While long course chemoradiation therapy has been studied as part of a watch-and-wait (WW) strategy for patients with locally advanced rectal cancer, it is unclear whether short-course radiation therapy (SCRT) will be associated with similar rates of organ preservation. We hypothesized that a WW strategy to facilitate organ preservation with SCRT, as part of a total neoadjuvant therapy (TNT) approach during the COVID-19 pandemic, would be both safe and feasible. Materials/Methods: From March to June of 2020, due to the COVID-19 pandemic, per institutional policy, all patients undergoing radiation therapy for locally advanced rectal cancer were treated with SCRT. After completion of SCRT-TNT, patients were clinically restaged by exam, endoscopy and MRI and the decision was made to manage the patient surgically or with a WW approach. The decision for WW or surgery was made by the surgeon in conjunction with patient consent. After IRB waiver was obtained, we reviewed consecutive patients treated during our SCRT mandate. The main outcome of interest was total mesorectal excision (TME)-free survival among patients eligible for WW after SCRT-TNT. Results: Our cohort included 42 patients with a median age of 57 years (Interquartile Range [IQR] 48-67), 24 (57%) of whom were male. Median follow-up from end of SCRT-TNT was 7 months (IQR 6-8). The median tumor cranio-caudal size was 4.1 cm (IQR 3.3-5.2) with a median distance from the anal verge of 7 cm (IQR 5-9). The majority had cT3 (71%) or cN + (74%) disease. Patients underwent a median of 14 weeks (IQR 13-15) of FOLFOX or CAPEOX chemotherapy, with 32 (76%) patients receiving chemotherapy prior to SCRT and 10 (24%) patients receiving chemotherapy after SCRT. The median time from completion of TNT to endoscopic restaging was 9 weeks (IQR 7-10). Nineteen (45%) patients were recommended to undergo surgical resection, of whom 17 went on to TME and 2 refused TME. Of the 15 patients with pathology available, 2 had a pCR (13%). Notably, one of these patients had a cCR at post-TNT endoscopy, but due to the presence of a stricture, WW was deemed unfeasible. Of the 23 patients managed by a WW strategy after SCRT-TNT completion, 19 had a clinical complete response (cCR), 3 had a near-CR, and 1 had an incomplete response. The 6-month TME-free survival was 85% for patients on WW. Four (17%) patients had a local regrowth at a median of 20 weeks (IQR 17-24), 3 of whom were salvaged with TME and 1 who declined surgery and opted for further surveillance. One of these patients had regrowth confirmed by biopsy, but had a pCR confirmed in the TME specimen. The 6-month TME-free survival of the entire cohort was 52%, and the combined pCR/6-month cCR was 52%. Conclusion: Our data suggest WW after SCRT-TNT is feasible. Longer term follow-up is required to confirm the durability and oncologic safety of these results.

Research Grant; CivaTech Oncology, Inc. Honoraria; 1199SEIU. Consultant; AstraZeneca, MORE Health. Advisory Board

Pure-Tech Ventures, Revitope Oncology, prIME

Smith: Honoraria; Guardant Health. L. Saltz: Advisory; Value in Cancer Care Consortium

High Sierra Area Health Education Center. Stock; Pfizer. Advisory; HPV Alliance, HPV and Anal Cancer Foundation

Long-Term Characterization of MRI-Morphologic Alterations After Active Motion-Compensated Liver SBRT

Heggemann 2 ; 1 Department of Radiation Oncology

Purpose/Objective(s): Several academic institutions have investigated stereotactic MR guided adaptive radiation therapy (SMART) to safely dose escalate for locally advanced and borderline resectable pancreatic cancer with initial favorable toxicity and survival outcomes. In 2018 our institution began to evaluate SMART on trial in borderline and locally advanced patients. We previously presented toxicity outcomes for standard fractionated chemoradiation (chemoRT) and SMART groups with acute grade 3+ GI toxicity in 28% vs 11% (P = 0.18) and late toxicity 43% vs 36% (P = 0.77). The purpose of this abstract was to compare overall survival (OS) between chemoRT and SMART. Materials/Methods: In this IRB approved analysis, we retrospectively reviewed 115 consecutive patients from 2017-2020 with locally advanced or borderline resectable pancreatic cancer who were treated with neoadjuvant radiation therapy. Initially all patients received chemoRT to a dose of 50.4 Gy in 28 fractions. In September 2018 we began to investigate SMART (50Gy in 5 fractions) for these patients. OS was evaluated by Kaplan-Meier and log-rank test. Univariate and multivariate analysis was also performed on multiple treatment variables. Results: Of the patients included, 30 received chemoRT and 85 received SMART. Median follow up for the chemoRT group was 32.8 months and for SMART was 14.9 months from last day of RT. Groups did not have significant differences in age, gender, tumor location, or initial CA 19-9. Pancreatectomy was performed in 13.3% vs 18.8% of patients in chemoRT and SMART groups. Per NCCN.1.2021 staging in the chemoRT group 33.3% were borderline (BL), 50% were locally advanced (LA), and 16.7% medically unresectable (MU) as compared to 24.7% BL, 49.4% LA, and 25.9% MU in the SMART group. Mean months of neoadjuvant chemo was slightly higher in the SMART group at 3.6 vs 2.3 months. Patients in the chemoRT arm were 36.7% African American vs 15.3% in the SMART

Purpose/Objective(s): To characterize the post-SBRT MRI-morphologic alterations in long-term survivors with MRI-based follow-up (FU) in patients treated by actively motion managed gantry-based and robotic liver SBRT. Materials/Methods: Patients treated with gantry-based (with breath-holdgating and ultrasound tracking) or robotic-based SBRT (with real-time fiducial tracking) who had long-term follow-up (FU, ≥ 90 days) were evaluated. Post-SBRT MRI-evidenced morphologic alterations (MMAs) were contoured manually on each T1-weighted contrast-enhanced. Volumetric data and liver volume were documented at each FU. Change's dynamics and significance was assessed for each time point. MMAs did not resolve completely and reduced in volume with longer FU. Since the 3-month control baseline, a significant volume reduction to a median of 43.3% after 6 months (P < 0.001), 31% after 9 months (P = 0.022) and 13% after 12 − 24 months (P = 0.041), was observed. Liver volumes reduced to a mean 95.1% from the baseline at 3 months (P = 0.001) and remained afterwards unmodified. Conclusion: Post-radiogenic MRI-morphologic alterations in peritumoral healthy liver tissue either completely resolve or significantly reduce in volume along the first 2 years after treatment. Clinical correlation should be further investigated.