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Preliminary Results of Multi-Institutional Phase I Dose Escalation Trial Using Single Fraction Stereotactic Partial Breast Irradiation for Early Stage Breast Cancer: Dose Escalated Single Fraction Stereotactic PBI

Rahimi, Asal; Simmons, Ambrosia; Kim, D Nathan; Leitch, Marilyn; Haas, Jonathan; Gu, Xuejun; Ahn, Chul; Gao, Ang; Spangler, Ann; Morgan, Howard E; Goudreau, Sally; Seiler, Stephen; Farr, Deborah; Wooldridge, Rachel; Haley, Barbara; Bahrami, Shohreh; Neufeld, Sarah; Mendez, Christopher; Alluri, Prasanna; Rao, Roshni; Timmerman, Robert D
PURPOSE/OBJECTIVES/OBJECTIVE:We report on our early experience of our prospective multi-center phase I dose escalation study of single fraction stereotactic partial breast irradiation (S-PBI) for early stage breast cancer after partial mastectomy using a robotic stereotactic radiation system. MATERIALS/METHODS/METHODS:Thirty women with in situ or invasive breast cancer stage 0, I, or II with tumor size < 3 cm, treated with lumpectomy were enrolled to this phase 1 single fraction S-PBI dose escalation trial. Women received either 22.5 Gy, 26.5Gy, or 30 Gy in a single fraction using a robotic stereotactic radiation system.  The primary outcome was to reach tumoricidal dose of 30Gy in single fraction to the lumpectomy cavity without exceeding the maximum tolerated dose (MTD). Secondary outcomes were to determine dose-limiting toxicity (DLT) and cosmesis.  Tertiary goals were ipsilateral breast recurrence rate, distant disease-free interval, recurrence-free survival, and overall survival. RESULTS:From 6/2016 to 1/2021, 11, 8, and 10 patients were treated to doses of 22.5Gy, 26.5Gy, or 30Gy in a single fraction, respectively, with median follow-up being 47.9, 25.1, and 16.2 months. No patients experienced acute (<90 days) grade 3 or higher treatment-related toxicity and MTD was not reached. There were two delayed grade 3 toxicities. Four patients (13.8%) developed fat necrosis across all three cohorts, which compares favorably with results from other PBI trials. No dose cohort had a statistically significant cosmetic detriment from baseline to 12 months or 24 months follow-up by patient- or physician-reported global cosmetic scores. There were no reports of disease recurrence. CONCLUSION/CONCLUSIONS:This phase 1 trial demonstrates that S-PBI can be used to safely escalate dose to 30Gy in single fraction with low toxicity and without detriment in cosmesis relative to baseline.
PMID: 34710523
ISSN: 1879-355x
CID: 5042692

Stereotactic body radiation therapy for the treatment of localized prostate cancer in men with underlying inflammatory bowel disease

Lischalk, Jonathan W; Blacksburg, Seth; Mendez, Christopher; Repka, Michael; Sanchez, Astrid; Carpenter, Todd; Witten, Matthew; Garbus, Jules E; Evans, Andrew; Collins, Sean P; Katz, Aaron; Haas, Jonathan
BACKGROUND:Historically, IBD has been thought to increase the underlying risk of radiation related toxicity in the treatment of prostate cancer. In the modern era, contemporary radiation planning and delivery may mitigate radiation-related toxicity in this theoretically high-risk cohort. This is the first manuscript to report clinical outcomes for men diagnosed with prostate cancer and underlying IBD curatively treated with stereotactic body radiation therapy (SBRT). METHODS:A large institutional database of patients (n = 4245) treated with SBRT for adenocarcinoma of the prostate was interrogated to identify patients who were diagnosed with underlying IBD prior to treatment. All patients were treated with SBRT over five treatment fractions using a robotic radiosurgical platform and fiducial tracking. Baseline IBD characteristics including IBD subtype, pre-SBRT IBD medications, and EPIC bowel questionnaires were reviewed for the IBD cohort. Acute and late toxicity was evaluated using the CTCAE version 5.0. RESULTS:A total of 31 patients were identified who had underlying IBD prior to SBRT for the curative treatment of prostate cancer. The majority (n = 18) were diagnosed with ulcerative colitis and were being treated with local steroid suppositories for IBD. No biochemical relapses were observed in the IBD cohort with early follow up. High-grade acute and late toxicities were rare (n = 1, grade 3 proctitis) with a median time to any GI toxicity of 22 months. Hemorrhoidal flare was the most common low-grade toxicity observed (n = 3). CONCLUSION/CONCLUSIONS:To date, this is one of the largest groups of patients with IBD treated safely and effectively with radiation for prostate cancer and the only review of patients treated with SBRT. Caution is warranted when delivering therapeutic radiation to patients with IBD, however modern radiation techniques appear to have mitigated the risk of GI side effects.
PMCID:8267228
PMID: 34243797
ISSN: 1748-717x
CID: 4965222

Prostate Fiducial Marker Placement in Patients on Anticoagulation: Feasibility Prior to Prostate SBRT

Iocolano, Michelle; Blacksburg, Seth; Carpenter, Todd; Repka, Michael; Carbone, Susan; Demircioglu, Gizem; Miccio, Maryann; Katz, Aaron; Haas, Jonathan
Background and Purpose: Fiducial marker placement is required in patients undergoing robotic-based Stereotactic Body Radiotherapy (SBRT) or image-guided radiation therapy (IGRT) for prostate cancer. Many patients take antiplatelet or anticoagulant medication due to other medical comorbidities. They are often required to temporarily discontinue these medications prior to invasive medical procedures as they are prone to bleed. Some patients are unable to discontinue therapy due to an elevated risk of thromboembolic events. The purpose of this study is to report this institution's experience placing fiducial markers in prostate cancer patients who are on chronic antiplatelet or anticoagulant medication. Materials and Methods: From August 2015-March 2019 57 patients on chronic antiplatelet or anticoagulation therapy who were not cleared to stop these medications underwent transrectal ultrasound guided (TRUS) fiducial marker placement for SBRT/IGRT. All patients were monitored by a registered nurse during the procedure for prolonged bleeding that required staff to hold pressure to the area with a 4 × 4 gauze until it resolved. All patients were also called the following day to assess for ongoing bleeding events. Treatment planning CT scan confirmed the ideal geometry of the marker placement. Results: All 57 patients on antiplatelet or anticoagulant medication who underwent fiducial marker placement were discharged home the same day of the procedure. Four patients experienced persistent bleeding that required a nurse to hold prolonged pressure to the area. No patient experienced significant bleeding the following day or any untoward cardiovascular event. Conclusions: This series suggests the use of antiplatelet or anticoagulant medication is not an absolute contraindication to fiducial marker placement in patients undergoing SBRT or IGRT for prostate cancer. These patients should be closely monitored after the procedure for bleeding complications. Practitioners may consider the patient's medical comorbidities, risk factors for thromboembolism, and overall functional status as there is no standardized protocol for discontinuing anticoagulant or antiplatelet therapy for fiducial marker placement.
PMCID:7056879
PMID: 32175274
ISSN: 2234-943x
CID: 4371092

Prostatic Artery Embolization Obviates the Need for Androgen Deprivation Therapy prior to Stereotactic Body Radiation Therapy in Prostate Cancer [Letter]

Szaflarski, Diane; Tembelis, Miltiadis; Katz, Aaron; Haas, Jonathan; Hoffmann, Jason C
PMID: 31378438
ISSN: 1535-7732
CID: 4046252

GRADE 2+BLADDER TOXICITY IN PATIENTS RECEIVING SBRT FOR PROSTATE CANCER: INCIDENCE AND DOSIMETRIC CHARACTERIZATION IN A LARGE PATIENT COHORT [Meeting Abstract]

Blacksburg, Seth; Sheu, Ren-Dih; Demircioglu, Gizem; Mirza, Awais; Carpenter, Todd; Morgenstern, Jason; Witten, Matthew; Mendez, Christopher; Katz, Aaron; Endres, Paul; Oshinsky, Gary; Lumerman, Jeffrey; Shepard, Barry; D\Esposito, Robert; Edelman, Robert; Gershbaum, Meyer David; Nejat, Robert; Haas, Jonathan
ISI:000473345203544
ISSN: 0022-5347
CID: 4610332

Patient-reported quality of life progression in men with prostate cancer following primary cryotherapy, cyberknife, or active holistic surveillance

Werneburg, Glenn T; Kongnyuy, Michael; Halpern, Daniel M; Salcedo, Jose M; Kosinski, Kaitlin E; Haas, Jonathan A; Schiff, Jeffrey T; Corcoran, Anthony T; Katz, Aaron E
BACKGROUND:Technological advancements have led to the success of minimally invasive treatment modalities for prostate cancer such as CyberKnife and Cryotherapy. Here, we investigate patient-reported urinary function, bowel habits, and sexual function in patients following CyberKnife (CK) or Cryotherapy treatment, and compare them with active holistic surveillance (AHS) patients. METHODS:An IRB-approved institutional database was retrospectively reviewed for patients who underwent CK, Cryotherapy, or AHS. Quality of life (QoL) survey responses were collected every three months and the mean function scores were analyzed in yearly intervals over the 4 years post-treatment. RESULTS:279 patients (767 survey sets) were included in the study. There was no difference among groups in urinary function scores. The CyberKnife group had significantly lower bowel habit scores in the early years following treatment (year 2 mean difference: -5.4, P < 0.01) but returned to AHS level scores by year 4. Cryotherapy patients exhibited initially lower, but not statistically significant, bowel function scores, which then improved and approached those of AHS. Both CyberKnife (year 1 mean difference: -26.7, P < 0.001) and Cryotherapy groups (-35.4, P < 0.001) had early lower sexual function scores relative to AHS, but then gradually improved and were not significantly different from AHS by the third year post-treatment. A history of hormonal therapy was associated with a lower sexual function scores relative to those patients who did not receive hormones in both CyberKnife (-18.45, P < 0.01) and Cryotherapy patients (-14.6, P < 0.05). CONCLUSIONS:After initial lower bowel habits and sexual function scores, CyberKnife or Cryotherapy-treated patients had no significant difference in QoL relative to AHS patients. These results highlight the benefit of CyberKnife and Cryotherapy in the management of organ-confined prostate cancer.
PMID: 29217830
ISSN: 1476-5608
CID: 3499132

PRIMARY TREATMENT MODALITY FOR PROSTATE CANCER IS ASSOCIATED WITH RISK OF BIOCHEMICAL RECURRENCE FOLLOWING SALVAGE CRYOTHERAPY [Meeting Abstract]

Werneburg, Glenn T.; Salcedo, Jose M.; LeSueur, Amanda L.; Haas, Jonathan A.; Schiff, Jeffrey T.; Corcoran, Anthony T.; Katz, Aaron E.
ISI:000429166601705
ISSN: 0022-5347
CID: 3494352

PROSTATE FIDUCIAL MARKER PLACEMENT IN PATIENTS WHILE ON ANTICOAGULATION: FEASIBILITY PRIOR TO PROSTATE SBRT [Meeting Abstract]

Haas, Jonathan; Katz, Aaron; Harris, Joshua; Carpenter, Todd; Carbone, Susan; Kole, Thomas; Pristupa, Steven; Witten, Matthew; Blacksburg, Seth
ISI:000398276600099
ISSN: 0022-5347
CID: 3502622

Interventional uroradiology in the management of prostate cancer [Editorial]

Hellinger, Jeffrey C.; Blacksberg, Seth; Haas, Jonathan; Melnick, John
ISI:000370614800008
ISSN: 0160-9963
CID: 3502612

YOUNG AGE PREDICTS FOR TRANSIENT ELEVATION IN PSA AFTER DEFINITIVE STEREOTACTIC BODY RADIATION THERAPY FOR PROSTATE CANCER [Meeting Abstract]

Blacksburg, Seth; Witten, Matthew; Katz, Aaron; Haas, Jonathan
ISI:000362826500557
ISSN: 0022-5347
CID: 3511432