Consecutive Daily vs. Every Other Day SBRT Scheduling for Stage I NSCLC

A national cancer database analysis on stereotactic body radiation therapy of head and neck cancers

8538 Background: Patients undergoing surgery for early-stage non-small cell lung cancer (NSCLC) may be at high-risk for post-operative mortality. Access to stereotactic body radiation therapy (SBRT) offers a less invasive alternative for this population that may facilitate more appropriate patient selection for surgery. Methods: An analysis of all patients with early-stage NSCLC reported to the National Cancer Database between 2004-2015 was performed. Post-operative mortality rates were derived using vital status data. Utilization of SBRT was defined by each facility’s SBRT Experience in years and SBRT-to-Surgery volume ratios, defined by quartiles. Multivariable logistic regression with backward elimination was used to test for independence of associations between exposures of interest and post-operative mortality. Interaction testing was performed to assess the statistical relationship of covariates found to have independent associations. Results: The study cohort consisted of 202,542 patients who underwent surgical resection of clinical stage T1-T2 NSCLC (AJCC 7th edition). The 90-day post-operative mortality rate declined significantly during the study period from 4.6% to 2.6% (p < 0.001). During this period, the proportion of facilities that utilized SBRT increased from 3.3% to 77.5% (p < 0.001) and the proportion of patients treated with SBRT increased significantly from 0.7% to 15.4% (p < 0.001). Lower 90-day post-operative mortality rates were observed at facilities with greater than six years of SBRT experience (OR 0.84, CI 0.76-0.94, p = 0.003) and SBRT-to-Surgery volume ratios above 17% (OR 0.85, CI 0.79-0.92, p < 0.001). Additional covariates associated with 90-day mortality included higher surgical volume, geographic region, year of diagnosis, age, sex, race, insurance status, facility type, Charlson-Deyo score, clinical T stage, histology, anatomic location, surgery type, and prior malignancy. Interaction testing between these covariates was negative, demonstrating that higher SBRT Experience and SBRT-to-Surgery volume ratios were independently associated with lower 90-day surgical mortality. Conclusions: Patients who underwent surgery for early-stage NSCLC at facilities with higher SBRT Experience and SBRT-to-Surgery volume ratios had lower rates of post-operative mortality. These findings suggest that the availability of SBRT may be a surrogate for a more comprehensive and safer approach to matching patients to surgery or SBRT. The observation of higher post-operative mortality rates at facilities without an SBRT program deserves further study.

: Pulmonary resection remains the accepted standard of care for early stage non-small cell lung cancer (NSCLC) in patients with adequate cardiopulmonary reserve. Radiation therapy, and in particular stereotactic body radiation therapy (SBRT), has traditionally been recommended as curative therapy for medically unfit patients who harbor early stage lung cancer. As a consequence of the rising success of SBRT in patients with medically inoperable early stage NSCLC (evidenced by Radiation Therapy Oncology Group trials 0236 and 0915), there has been keen interest in exploring this modality in operable patients. SBRT to lung is often very well tolerated, thus making it very attractive to patients. The risk of series complications in carefully selected patients is low. Equipoise among surgeons and the medical community for the use of SBRT as curative therapy for patients eligible for surgery has been limited, thus contributing to the poor accrual and early closure of 3 randomized trials attempting to directly compare SBRT to surgery in operable patients. These trials included the STARS trial (Study of Anastrozole and Radiotherapy Sequencing), the ROSEL trial [Either Surgery or Stereotactic Radiotherapy for Early-Stage (IA) Lung Cancer] and the American College of Surgeons Oncology Group (ACOSOG) Z4099 trial. No preliminary data is available from the ACOSOG trial. The STARS and ROSEL trial randomized operable patients with tumors <4 cm (cT1–T2a) and required invasive mediastinal staging in patients harboring radiographically suspicious lymph nodes. Sublobar resection was not permitted in these trials. Since patient accrual was limited (n=58 total patients) the two trials were combined in a controversial publication that showed improved overall survival and decreased toxicity with SBRT compared to surgery. This has spawned additional randomized trials including the STABLE-MATES trial comparing sublobar resection and SBRT in patients with stage I NSCLC (NCT02468024) with an estimated enrollment of 258 patients, a Veterans Affairs Lung Cancer or Stereotactic Radiotherapy (VALOR) trial (NCT02984761) with estimated enrollment of 670 patients, and lastly, a phase II United Kingdom sponsored SABRTooth study (NCT02629458) that is enrolling up to 54 patients. The lack of randomized data has stimulated multiple publications that retrospectively examine these modalities in single center case series and more recently in larger data sets derived from the National Cancer Database (NCDB), the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database and the United States Veterans Affairs Health Care System. These retrospective analyses are clearly limited by patient selection bias and different levels of staging accuracy. Propensity matched retrospective series showed that overall survival was no different at 1 year but favored surgery at 3 years. Cancer-specific survival (clearly a better outcome measure particularly in elderly patients receiving SBRT) was no different compared to surgery, nor was local failure, or the risk of developing distant metastases. Collectively, the studies that used large data with statistical matching demonstrated a survival advantage of surgery (namely lobectomy) over SBRT for stage I NSCLC but raised awareness of the increased post procedure morbidity and mortality for surgery compared to SBRT. Interestingly, sublobar resection versus SBRT in these large data sets had mixed results with some showing survival improvement with surgery and some showing no survival difference. Surgery appears superior at later time points. In a phase II ablate and resect human clinical trial (MISSILE-NSCLC, NCT02136355) for early stage (T1–T2) NSCLC, 35 patients underwent neoadjuvant SBRT using 54–60 Gy in 3–8 fractions followed by surgery at an interval of 10 weeks. The authors reported a 60% pathologic complete response rate, invoking many questions about local control of SBRT. Assessment of local control after SBRT remains the single most challenging real-world clinical problem. The lung injury post ablation is heterogenous and requires very careful observation with imaging modalities that lack sensitivity and specificity for recurrence. At present, the American Society of Radiation Oncology does not recommend SBRT for operable patients with early stage NSCLC outside of a clinical trial.

Surgical Outcomes for Early-Stage Non-Small Cell Lung Cancer at Facilities With Stereotactic Body Radiation Therapy Programs

An opportunity to save? SBRT is less costly than IMRT for intermediate-risk prostate cancer.

The impact of histology in the outcomes of patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) and adjuvant chemotherapy

Pelvic nodal irradiation is often used for high-risk prostate adenocarcinoma. A commonly used alternative to low dose rate (LDR) brachytherapy, a 3-fraction SBRT boost with fiducial tracking may allow for better coverage of extracapsular extension and macroscopic seminal vesicle invasion. This study evaluates the practical impact of prior pelvic nodal irradiation on fiducial tracking during a subsequent 3-fraction robotic stereotactic body radiation therapy (SBRT) boost for high-risk prostate cancer and compares these outcomes to a cohort of patients undergoing definitive 5-fraction SBRT. In this institutional analysis, we prospectively collected fiducial tracking data for patients receiving a 3-fraction boost to the prostate and seminal vesicles after conventional nodal radiation. We also identified patients treated with 5-fraction SBRT with a low risk of nodal involvement. Monte Carlo estimates of the Fisher's Exact Test assessed fiducial tracking loss. Continuous variables within the 5- and 3-fraction cohorts were compared using the Mann-Whitney Test. Changes in fiducial tracking and their association with pre-treatment factors were analyzed through the Kruskal-Wallis test and Monte Carlo for tracking patterns, and Spearman Correlation Coefficient and Mann-Whitney Test for deviations in tracking over 5 fractions. A total of 405 patients were treated from April 2021 to September 2023 with: (1) 5-fraction SBRT (n = 309, 76%), and (2) 3-fraction boost after nodal irradiation (n = 96, 24%). There was no significant fiducial tracking loss over the three-fraction boost treatment regimen that proceeded nodal treatment (p = 0.63). However, there was a significant (p < 0.001) loss of fiducial tracking fidelity as demonstrated by progressive loss of one tracked fiducial over 5-fractions. There was significantly more volatility observed in the 5-fraction versus 3-fraction boost treatment (median volatility 2.4 vs. 0.0, p < 0.001). There were no significant associations between fiducial tracking, independently for 3- or 5-fractions, using either analysis method or volatility for ADT, time from fiducial placement to SBRT, CTV, and QOD vs. daily SBRT. Pelvic nodal treatment does not affect the quantity/quality of fiducial tracking in 3-fraction treatments. However, 5-fraction treatments showed a progressive loss and increased volatility in fiducial tracking over time. No pre-treatment factors significantly influenced fiducial tracking changes in either cohort, though ADT use trended towards increased volatility in the 5-fraction group. With a minimum of 4 fiducials placed for treatment, the loss/volatility of a single fiducial had no clinical impact on the tracking system.

Background: We evaluated the efficacy, toxicity, and dose responses of re-irradiation with stereotactic body radiotherapy (SBRT) in patients with recurrent non- small cell lung cancer (NSCLC) after previous irradiation. Patients and Methods: 28 patients were included. Previous median radiation doses were 54 and 66 Gy. The median interval time between previous radiotherapy and SBRT was 14 months. The median follow-up time after SBRT was 9 months (range 3-93 months). To evaluate the effectiveness of SBRT, local control, overall survival, and treatment-related toxicity were reported. Results: SBRT doses and fractionation ranged from 60 to 30 Gy and from 3 to 8, respectively, according to previous doses, location of the recurrence, and interval time. 65% of tumor recurrences overlapped with previous treatment, while 35% of tumors recurred outside of the previous treatment. 4 patients had local progression after SBRT at their first follow-up. The Kaplan-Meier estimates of the 1- and 2-year actuarial overall survival were 71 and 42%, respectively. The mean survival following SBRT was 32.8 months, and the median survival was 21 months. No grade 3 or higher toxicities were observed. Conclusion: Robotic SBRT is a tolerable treatment option with manageable toxicity which can be used with radical or palliative intent in carefully selected patients with locally recurrent tumors after previous irradiation.

Three- Versus Five-Fraction Regimens of Stereotactic Body Radiotherapy for Peripheral Early-Stage Non–Small-Cell Lung Cancer: A Two-Institution Propensity Score–Matched Analysis

Stereotactic Body Radiotherapy (SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Patients With Painful Spinal Metastases: A Phase 3, Randomized Controlled Trial

Patterns of Care and Outcomes in Non-Operative, Early-Stage Non-Small Cell Lung Cancer when Stereotactic Body Radiation Therapy is not Feasible

BackgroundWe aimed to assess the uptake of minimally invasive surgery (MIS) and stereotactic body radiation therapy (SBRT) among early stage (stage IA–IIB) non-small cell lung cancer (NSCLC) cases in the...

Individualized altered fractionation as a more effective radiotherapy for non-small cell lung cancer.

e17054 Background: Conventionally fractionated radiotherapy (CFRT) or moderately hypofractionated radiotherapy (MFRT) ± short-course androgen deprivation therapy (ADT) is commonly employed for unfavorable intermediate-risk (UIR) prostate cancer. Stereotactic body radiation therapy (SBRT) has not been widely adopted, but may have radiobiologic advantages over more conventionally fractionated treatments. We hypothesized that radiotherapy dose-escalation with SBRT (35-40Gy in ≤5 fractions) is associated with improved overall survival (OS) relative to biologically equivalent doses of CFRT (72-86.4Gy in 1.8-2.0Gy/fraction) or MFRT (≥60Gy in 2.4-3.2Gy/fraction) ± ADT. Methods: The National Cancer Database (NCDB) was used to identify 28,028 men with UIR prostate cancer who received CFRT with (n = 12,872) or without ADT (n = 12,984), MFRT with (n = 251) or without ADT (n = 281), and SBRT with (n = 212) or without ADT (n = 1,428). SBRT+ADT patients were excluded due to low patient numbers. Inverse probability of treatment weighting was used to balance measured confounders. Unweighted- and weighted- multivariable analysis (MVA) using Cox regression was used to compare OS hazard ratios. Results: Relative to CFRT without ADT, CFRT+ADT (Hazard Ratio (HR): 0.92, [95% Confidence Interval: 0.87-0.97], P = .002) and SBRT without ADT (HR: 0.74 [0.61-0.89], P = .002) were both associated with improved OS on MVA. Relative to CFRT+ADT, SBRT without ADT correlated with improved OS on MVA (HR: 0.81 [0.67-0.99], P = .04). Weight-adjusted MVA demonstrated that SBRT (HR: 0.80 [0.65-0.98], P = .036) and ADT (HR: 0.91 [0.86-0.97], P = .002) correlated with improved OS. SBRT was not associated with improved OS relative to MFRT. Conclusions: Using inverse propensity treatment weighting, we adjusted for age, comorbidity score, and tumor factors, and observed a significant overall survival benefit in favor of administering dose-escalated SBRT over CFRT+ADT. To our knowledge, this is the first study to show that SBRT is associated with improved OS relative to CFRT for men with UIR prostate cancer. Together, this suggests that SBRT offers a cheaper and shorter course of therapy that mitigates COVID-19 exposure, which also is associated with improved OS relative to CFRT for UIR prostate cancer and may obviate the need for ADT in this population. While we await results from several ongoing clinical trials, we believe this study lends support to the use of SBRT in men with UIR prostate cancer.

Time-Driven Activity-Based Costing Demonstrates the Fiscal Superiority of Stereotactic Body Radiotherapy Compared to Protracted Radiotherapy Schemes or Other Therapies.