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J.A. Gomez Suescun
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OA12 - SBRT and Other Issues in Early Stage NSCLC (ID 383)
- Event: WCLC 2016
- Type: Oral Session
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:D. De Ruysscher, M.R. Mueller
- Coordinates: 12/06/2016, 11:00 - 12:30, Strauss 2
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OA12.01 - Phase II Randomized Study of 2 SBRT Regimens for Medically Inoperable Patients with Node Negative Peripheral NSCLC (ID 4342)
11:00 - 11:10 | Author(s): J.A. Gomez Suescun
- Abstract
- Presentation
Background:
This phase II, multi-institutional (Roswell Park Cancer Institute, Cleveland Clinic, and Upstate Medical Center) randomized study was conducted to compare incidence of RTOG grade 3 or higher adverse events (AEs) associated with 2 different, established SBRT regimens for NSCLC
Methods:
Patients with documented baseline medical conditions precluding lobectomy and biopsy-proven peripheral (greater than 2 cm from the central bronchial tree) T1/T2, N0 (clinically node negative by PET), M0 tumors were eligible. Patients were randomized to receive either 30 Gy in one fraction (arm 1) or 60 Gy in 3 fractions (arm 2) over at least 8 days. Heterogeneity corrections were not used. Randomization was stratified by treatment center and Karnofsky performance status (100, 90, 80 and below.) The study was designed to detect whether psAEs rate > 17% at a 5% significance level (1-sided) and 81% power. Secondary endpoints included: local control, greater than 1 year toxicity, overall survival (OS) and progression-free survival (PFS).
Results:
The study opened in September 2008, was suspended between April 2010 to June 2010 as well as October 2010 to April 2011 while RTOG 0915 was open, and closed on April 15, 2015 after accruing a total of 98 patients. All patients received planned SBRT treatment. Median follow-up was 27 months. In follow-up, 10 patients were lost to follow-up; 1 was in arm 1 and 9 in arm 2. Baseline patient and tumor characteristics were balanced between both arms. On arm 1, 13 (27%) patients and 16 (33%) patients on arm 2 experienced RTOG grade 3 AEs, there were no grade 4 AEs. Thoracic grade 3 AEs were experienced by 8 (16%) patients on arm 1 and 6 (12%) patients on arm 2. There were no differences in OS or PFS survival, logrank p= 0.44 and 0.99 respectively. OS at 2 years was 71% (95% CI, 55-82%) for arm 1 and 61% (95% CI, 44-78%) for arm 2. PFS at 1 year was 63% (95% CI, 46-75%) for arm 1 and 51% (95% CI, 34-65%) for arm 2.
Conclusion:
This randomized phase II study demonstrated that 30 Gy in one fraction was equivalent to 60 Gy in three fractions in terms of toxicity, progression free survival and overall survival. Acknowledgment: Supported by Roswell Park Alliance Foundation grant
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P1.05 - Poster Session with Presenters Present (ID 457)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.05-033 - Comparison of Single- and Five-Fraction Schedules of Stereotactic Body Radiation Therapy for Central Lung Tumors (ID 4394)
14:30 - 14:30 | Author(s): J.A. Gomez Suescun
- Abstract
Background:
Stereotactic Body Radiation Therapy (SBRT) is a treatment option for patients with early-stage non-small cell lung cancer (NSCLC) who are medically inoperable or decline surgery. The safety of 20 Gray (Gy) x 3 fractions of SBRT within 2 cm of the proximal bronchial tree is unclear. Here we compare the clinical outcome of patients with centrally located lung tumors who underwent either single fraction (SF)- or five-fraction (FF-) SBRT at a single institution over 5 years.
Methods:
Between January 2009 and October 2014, 11 out of 42 patients received 26-30 Gy in 1 fraction, while the remaining 31 patients received 52.5-60 Gy (median 55 Gy) in 5 fractions. Data were retrospectively collected using an institutional review board-approved database. Kaplan-Meier method, competing risks method, and Cox regression model were used. Toxicities were graded using Common Terminology Criteria for Adverse Events version 4.0. R version 3.3.1 was used for statistical analysis.
Results:
After a median follow-up of 12 months for SF-SBRT and 17 months for FF-SBRT groups (p=0.64), 1-year overall survival rates for SF- and FF-SBRT groups were 82% and 87%, respectively. There was no statistically significant difference in overall survival (p=0.061), progression-free survival (p=0.47), local failure (p=0.43), nodal failure (p=0.42), and distant failure (p=0.45) at 18 months. No primary tumor failure was seen in both groups at 18 months. Distant failure rates at 18 months were 9.1% for SF-SBRT group and 54.5% for FF-SBRT group. Among the patients with distant failure (n=4 in SF-SBRT and n=6 in FF-SBRT), median time to distant failure was 29.5 months and 8.9 months for SF- and FF-SBRT groups, respectively (p=0.0095). 3 out of 11 patients in SF-SBRT group and 2 out of 32 patients in FF-SBRT group experienced grade 3-4 toxicities. No grade 4-5 toxicities were observed in the FF-SBRT group. SF-SBRT group showed higher cumulative incidence of grade 3+ toxicity at 18 months (p=0.018). However, univariate analysis showed SF-SBRT alone was not a significant factor that increased risk for grade 3+ toxicities (HR=5.50, p=0.063). 4 out of 5 toxicities occurred at least 12 months after SBRT.
Conclusion:
SF- and FF-SBRT showed no significant difference in overall survival and local control. No grade 4-5 toxicities were observed in our FF-SBRT group. The onset of distant failure was significantly delayed in the SF-SBRT compared to the FF-SBRT group. The majority of toxicities occurred late. Having SF-SBRT itself was not significantly associated with severe toxicity.
