Stereotactic body radiation therapy use for high risk prostate cancer in the United States.
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SUBMITTER: Patel SA
PROVIDER: S-EPMC8116349 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Purpose Whole gland cryoablation is a guideline-approved definitive treatment for localized prostate cancer, and is being explored for partial gland ablation. However, there is limited data regarding management of cryoablation failures. Stereotactic body radiation therapy (SBRT) is a well-established method of primary treatment for prostate cancer. Here we review salvage SBRT after cryoablation failures. Methods and Materials A large database of patients treated with definitive SBRT was interrogated to identify those who underwent primary cryoablation. All patients were determined to have progressive disease based on a rising prostate specific antigen and/or postcryoablation biopsy. All patients were treated with SBRT over 5 treatment fractions using a robotic radiosurgical platform. Baseline cryoablation characteristics and pre- and posttreatment Expanded Prostate Cancer Index Composite questionnaires were analyzed. Acute and late toxicity was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Cancer outcomes after salvage SBRT were stratified by disease and treatment characteristics. Results A total of 51 patients were identified who underwent cryoablation followed by salvage SBRT. The majority (47%) were found to have intermediate-risk disease at the time of SBRT salvage and most commonly were treated with 3500 cGy in 5 fractions to the prostate and seminal vesicles. Only 1 grade 3+ toxicity was identified. Patient-reported quality of life metrics after SBRT salvage followed prior patterns observed in the de novo SBRT setting. With a median follow-up of 40 months, 76% of the cohort demonstrated disease control. Median time to prostate cancer recurrence was 57.5 months, and recurrence was predominantly seen in patients with underlying high-risk disease. Conclusions This is the largest cohort of patients treated with any radiation therapy salvage after cryoablation and the first institution to report SBRT as a modality of salvage. Salvage SBRT after cryoablation results in low rates of high-grade toxicity, acceptable changes in patient-reported quality of life, and durable rates of long-term oncologic control.
| S-EPMC9133399 | biostudies-literature
Project description:IntroductionLocal coverage determinations (LCDs) are local decisions that regulate healthcare coverage. We evaluated the impact of LCDs as well as patient, tumor, and market characteristics on the adoption of stereotactic body radiation therapy (SBRT) for prostate cancer.MethodsUsing Surveillance, Epidemiology, and End Results (SEER)-Medicare, we identified men treated with SBRT, intensity-modulated radiotherapy (IMRT), and robotic prostatectomy. We compared demographics, clinical characteristics, and market factors among these three treatments. Our primary exposure was LCD policy; using the Medicare Coverage Database, we categorized LCDs as favorable (SBRT covered), neutral (SBRT covered in the context of a clinical trial or registry), unfavorable (SBRT not covered), or absent (i.e., SBRT not governed by an LCD at the time of treatment). We fit a multivariable multinomial logistic regression model and generated predicted probabilities to examine the relation between LCDs and SBRT.ResultsDuring this early period of SBRT adoption, IMRT was the most common of the three treatments followed by robotic prostatectomy and then SBRT. SBRT use was high when governed by favorable and neutral LCDs and lowest when governed by unfavorable LCDs. Compared with favorable LCDs, areas where LCDs were absent were associated with higher SBRT use compared with IMRT (odds ratio [OR] 1.56; 95%CI, 1.07-2.25) and robotic prostatectomy (OR 1.84; 95%CI, 1.25-2.69).ConclusionsWhen present, LCDs appear to regulate early SBRT adoption, but, when absent, are associated with increased SBRT use. Although SBRT use was uncommon, it varied across a wide range of patient, tumor, and market characteristics.
| S-EPMC4968880 | biostudies-literature
Project description:Stereotactic body radiation therapy (SBRT) is a technically demanding prostate cancer treatment that may be less expensive than intensity-modulated radiation therapy (IMRT). Because SBRT may deliver a greater biologic dose of radiation than IMRT, toxicity could be increased. Studies comparing treatment cost to the Medicare program and toxicity are needed.We performed a retrospective study by using a national sample of Medicare beneficiaries age ? 66 years who received SBRT or IMRT as primary treatment for prostate cancer from 2008 to 2011. Each SBRT patient was matched to two IMRT patients with similar follow-up (6, 12, or 24 months). We calculated the cost of radiation therapy treatment to the Medicare program and toxicity as measured by Medicare claims; we used a random effects model to compare genitourinary (GU), GI, and other toxicity between matched patients.The study sample consisted of 1,335 SBRT patients matched to 2,670 IMRT patients. The mean treatment cost was $13,645 for SBRT versus $21,023 for IMRT. In the 6 months after treatment initiation, 15.6% of SBRT versus 12.6% of IMRT patients experienced GU toxicity (odds ratio [OR], 1.29; 95% CI, 1.05 to 1.53; P = .009). At 24 months after treatment initiation, 43.9% of SBRT versus 36.3% of IMRT patients had GU toxicity (OR, 1.38; 95% CI, 1.12 to 1.63; P = .001). The increase in GU toxicity was due to claims indicative of urethritis, urinary incontinence, and/or obstruction.Although SBRT was associated with lower treatment costs, there appears to be a greater rate of GU toxicity for patients undergoing SBRT compared with IMRT, and prospective correlation with randomized trials is needed.
| S-EPMC3986382 | biostudies-other
Project description:BackgroundTo evaluate acute and late genitourinary and gastrointestinal toxicities and patient reported urinary and sexual function following accelerated, hypofractionated external beam radiotherapy to the prostate, seminal vesicles and pelvic lymph nodes and high dose rate (HDR) brachytherapy or stereotactic body radiation therapy (SBRT) prostate boost.MethodsPatients at a single institution with NCCN intermediate- and high-risk localized prostate cancer with logistical barriers to completing five weeks of whole pelvic radiotherapy (WPRT) were retrospectively reviewed for toxicity following accelerated, hypofractionated WPRT (41.25 Gy in 15 fractions of 2.75 Gy). Patients also received prostate boost radiotherapy with either HDR brachytherapy (1 fraction of 15 Gy) or SBRT (19 Gy in 2 fractions of 9.5 Gy). The duration of androgen deprivation therapy was at the discretion of the treating radiation oncologist. Toxicity was evaluated by NCI CTCAE v 5.0.ResultsBetween 2015 and 2017, 22 patients with a median age of 71 years completed accelerated, hypofractionated WPRT. Median follow-up from the end of radiotherapy was 32 months (range 2-57). 5%, 73%, and 23% of patients had clinical T1, T2, and T3 disease, respectively. 86% of tumors were Gleason grade 7 and 14% were Gleason grade 9. 68% and 32% of patients had NCCN intermediate- and high-risk disease, respectively. 91% and 9% of patients received HDR brachytherapy and SBRT prostate boost following WPRT, respectively. Crude rates of grade 2 or higher GI and GU toxicities were 23% and 23%, respectively. 3 patients (14%) had late or persistent grade 2 toxicities of urinary frequency and 1 patient (5%) had late or persistent GI toxicity of diarrhea. No patient experienced grade 3 or higher toxicity at any time. No difference in patient-reported urinary or sexual function was noted at 12 months.ConclusionsAccelerated, hypofractionated whole pelvis radiotherapy was associated with acceptable GU and GI toxicities and should be further validated for those at risk for harboring occult nodal disease.
| S-EPMC8772149 | biostudies-literature
Project description:PurposeTo establish the safety and efficacy of gantry-mounted linear accelerator-based stereotactic body radiation therapy (SBRT) for low- and intermediate-risk prostate cancer.MethodsWe pooled 921 patients enrolled on 7 single-institution prospective phase II trials of gantry-based SBRT from 2006 to 2017. The cumulative incidences of biochemical recurrence (defined by the Phoenix definition) and physician-scored genitourinary (GU) and gastrointestinal (GI) toxicities (defined per the original trials using Common Terminology Criteria for Adverse Events) were estimated using a competing risk framework. Multivariable logistic regression was used to evaluate the relationship between late toxicity and prespecified covariates: biologically effective dose, every other day versus weekly fractionation, intrafractional motion monitoring, and acute toxicity.ResultsMedian follow-up was 3.1 years (range, 0.5-10.8 years). In addition, 505 (54.8%) patients had low-risk disease, 236 (25.6%) had favorable intermediate-risk disease, and 180 (19.5%) had unfavorable intermediate-risk disease. Intrafractional motion monitoring was performed in 78.0% of patients. The 3-year cumulative incidence of biochemical recurrence was 0.8% (95% confidence interval [CI], 0-1.7%), 2.2% (95% CI, 0-4.3%), and 5.1% (95% CI, 1.0-9.2%) for low-, favorable intermediate-, and unfavorable intermediate-risk disease. Acute grade ≥2 GU and GI toxicity occurred in 14.5% and 4.6% of patients, respectively. Three-year cumulative incidence estimates of late grade 2 GU and GI toxicity were 4.1% (95% CI, 2.6-5.5%) and 1.3% (95% CI, 0.5-2.1%), respectively, with late grade ≥3 GU and GI toxicity estimates of 0.7% (95% CI, 0.1-1.3%) and 0.4% (95% CI, 0-0.8%), respectively. The only identified significant predictors of late grade ≥2 toxicity were acute grade ≥2 toxicity (P < .001) and weekly fractionation (P < .01), although only 12.4% of patients were treated weekly.ConclusionsGantry-based SBRT for prostate cancer is associated with a favorable safety and efficacy profile, despite variable intrafractional motion management techniques. These findings suggest that multiple treatment platforms can be used to safely deliver prostate SBRT.
| S-EPMC7276661 | biostudies-literature
Project description:BACKGROUND:Ultrahypofractionation using stereotactic body radiotherapy (SBRT) is an increasingly utilized technique for men with prostate cancer (PC). The comparative efficacy of SBRT plus androgen deprivation therapy (ADT) compared to fractionated radiotherapy (EBRT) plus ADT in higher-risk prostate cancer is unknown. METHODS:Men >?40?years old with localized PC treated with external beam radiation and concomitant ADT for curative intent between 2004 and 2016 were analyzed from the National Cancer Database. Patients who lacked ADT or risk stratification data were excluded. 558 men treated with SBRT versus 40,797 men treated with conventional or moderately hypofractionated EBRT were included. Patients were stratified by unfavorable intermediate (UIR) and high (HR) risk using NCCN criteria. Kaplan Meier and Cox proportional hazards were used to compare overall survival (OS) between RT modality, adjusting for age, race, and comorbidity index. RESULTS:With a median follow up of 74?months, there was no difference in estimated 6-year OS between men treated with SBRT versus EBRT regardless of risk group. On multivariable analysis, there was no difference in risk of death for men treated with SBRT compared to EBRT (UIR: adjusted HR 1.09, 95% CI 0.68-1.74, p?=?.72; HR: adjusted HR 0.93, 95% CI 0.76-1.14, p?=?.51). On sensitivity analyses, when confining the cohort to men treated with NCCN-preferred dose fractionations, with no comorbidities, or?<?65?years old, there remained no survival difference between treatment groups for both UIR and HR. CONCLUSION:Within study limitations, we found no difference in survival between SBRT+ADT and standard of care EBRT+ADT for UIR or HR PC. These results support recent NCCN guideline updates, which include SBRT as a non-preferred option for higher risk men. Prospective validation would further strengthen the evidence basis behind these recommendations.
| S-EPMC7493337 | biostudies-literature
Project description:BackgroundTo better understand how radiation oncologists perceive intensity-modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT) for prostate cancer and how these perceptions may influence treatment decisions.MethodsWe conducted semi-structured interviews of radiation oncologists between January-May, 2016. We used a purposeful sampling technique to select participants across a wide range of experience, regions, and practice types. Two trained qualitative researchers used an inductive, iterative approach to code transcripts and identify themes. We then used content analysis and thematic analysis of the coded transcripts to understand radiation oncologists' attitudes and beliefs about IMRT and SBRT.ResultsThematic saturation was achieved after 20 interviews. Participants were affiliated with academic (n = 13; 65%), private (n = 5; 25%), and mixed (n = 2; 10%) practices and had a wide range of clinical experience (median 19 years; range 4-49 years). Analysis of interview transcripts revealed four general themes: 1) most radiation oncologists offered surgery, brachytherapy, IMRT, and active surveillance for low-risk patients; 2) there was no consensus on the comparative effectiveness of IMRT and SBRT; 3) key barriers to adopting SBRT included issues related to insurance, reimbursement, and practice inertia; and 4) despite these barriers, most participants envisioned SBRT use increasing over the next 5-10 years.ConclusionsIn the absence of strong opinions about effectiveness, nonclinical factors influence the choice of radiation treatment. Despite a lack of consensus, most participants agreed SBRT may become a standard of care in the future.
| S-EPMC7449079 | biostudies-literature
Project description:PurposeUltrahypofractionationed radiation therapy for prostate cancer is increasingly studied and adopted. The American Association of Physicists in Medicine Working Group on Biological Effects of Hypofractionated Radiotherapy therefore aimed to review studies examining toxicity and quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer and model its effect.Methods and materialsWe performed a systematic PubMed search of prostate SBRT studies published between 2001 and 2018. Those that analyzed factors associated with late urinary, bowel, or sexual toxicity and/or quality of life were included and reviewed. Normal tissue complication probability modelling was performed on studies that contained detailed dose/volume and outcome data.ResultsWe found 13 studies that examined urinary effects, 6 that examined bowel effects, and 4 that examined sexual effects. Most studies included patients with low-intermediate risk prostate cancer treated to 35-40 Gy. Most patients were treated with 5 fractions, with several centers using 4 fractions. Endpoints were heterogeneous and included both physician-scored toxicity and patient-reported quality of life. Most toxicities were mild-moderate (eg, grade 1-2) with a very low overall incidence of severe toxicity (eg, grade 3 or higher, usually <3%). Side effects were associated with both dosimetric and non-dosimetric factors.ConclusionsProstate SBRT appears to be overall well tolerated, with determinants of toxicity that include dosimetric factors and patient factors. Suggested dose constraints include bladder V(Rx Dose)Gy <5-10 cc, urethra Dmax <38-42 Gy, and rectum Dmax <35-38 Gy, though current data do not offer firm guidance on tolerance doses. Several areas for future research are suggested.
| S-EPMC8053668 | biostudies-literature
Project description:This study examines the efficacy and toxicity of two stereotactic body radiation therapy (SBRT) dose regimens for treatment of early prostate cancer. Forty-one patients treated with 35?Gy were matched with 41 patients treated with 36.25?Gy. Both patient groups received SBRT in five fractions over five consecutive days using the CyberKnife. Each group had 37 low-risk patients and 4 intermediate-risk patients. No statistically significant differences were present for age, prostate volume, PSA, Gleason score, stage, or risk between the groups. The dose was prescribed to the 83-87% isodose line to cover the prostate and a 5-mm margin all around, except 3?mm posteriorly. The overall median follow-up is 51?months (range, 45-58?months) with a median 54 and 48?months follow-up for the 35 and 36.25-Gy dose groups, respectively. One biochemical failure occurred in each group yielding a 97.5% freedom from biochemical failure. The PSA response has been favorable for all patients with a mean PSA of 0.1?ng/ml at 4-years. Overall toxicity has been mild with 5% late grade 2 rectal toxicity in both dose groups. Late grade 1 urinary toxicity was equivalent between groups; grade 2 urinary toxicity was 5% (2/41 patients) and 10% (4/41 patients) in the 35-Gy and 36.25-Gy dose groups (p?=?0.6969), respectively. Overall, the highly favorable PSA response, limited biochemical failures, limited toxicity, and limited impact on quality of life in these low- to low-intermediate-risk patients are supportive of excellent long-term results for CyberKnife delivered SBRT.
| S-EPMC3356012 | biostudies-other
Project description: Not available
| S-EPMC10493250 | biostudies-literature