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J.D. Bradley
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MINI 33 - Radiotherapy and Complications (ID 164)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
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MINI33.01 - Prospective Phase II Trial of SBRT for Centrally-Located Lung Cancer (ID 162)
18:35 - 18:40 | Author(s): J.D. Bradley
- Abstract
- Presentation
Background:
We report safety and efficacy results for an institutional prospective phase II trial for medically-inoperable patients with centrally-located early-stage non-small cell lung cancers receiving dose escalated SBRT. The Phase II objectives were to determine the overall survival and patterns of local failure.
Methods:
Eligible patients with biopsy-proven NSCLC within 2cm of the proximal bronchial tree (RTOG definition) were enrolled on an IRB-approved institutional clinical trial between 2006-2015. All patients were medically inoperable. The Phase I portion consisted of 4 radiation dose levels using 5 fraction regimens. Dose levels were 9, 10, 11, and 12 Gy/fraction. Phase I was previously reported (ASTRO 2011). Based on an early analysis of efficacy, the Phase II radiation dose was 11 Gy x 5 fractions.
Results:
64 patients were enrolled to the trial; 23 to Phase I and 41 to Phase II. The median follow up for phase II patients alive is 6.2 months (range 1.3-46.3 months). 41 patients are eligible for toxicity analysis and 37 with at least 1 post-treatment visits are eligible for efficacy. Regarding treatment-related toxicity, 1 patient experienced acute Grade 3 hypoxia (2.4%; 95% CI 0.1-12.8%), 3 patients developed late Grade 3, 2 had late grade 4, and 1 had late grade 5 events. The grade 4 events were lung atelectasis resulting in hospitalization and dyspnea, respectively. The grade 5 event was fatal hemoptysis in a patient with tumor involving the pulmonary artery. The one-year local lobar recurrence rate using 11 Gy x 5 fractions is 4.6% (95% CI 0.7-13.6%). The one-year OS is 81.2% (60.0-91.8%).The predominant causes of death were distant metastasis (N=6), intercurrent illness without recurrence (N=6), and secondary lung cancer (N=2). One patient is alive with gastric cancer. Two patients developed nodal recurrence and two developed local failures.
Conclusion:
SBRT for central tumors using 11 Gy x 5 fractions was tolerable, but can contribute to severe toxicity as shown by others where tumor involves the pulmonary vasculature. The lobar tumor control was excellent using 11 Gy x 5 fractions. The results of RTOG 0813, which was methodologically based on this trial, may help to clarify the preferred dose for central lesions.
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MS 09 - Worldwide Perspective/Review of Limitations, Resources, Programs and Accomplishments of Supportive Care and Palliative Care Multidisciplinary Teams, by Continent (ID 27)
- Event: WCLC 2015
- Type: Mini Symposium
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:R.I. Lopez, A. Oton
- Coordinates: 9/07/2015, 14:15 - 15:45, 108+110+112
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MS09.03 - Radiation Oncologist's Perspective (ID 1883)
14:40 - 14:50 | Author(s): J.D. Bradley
- Abstract
- Presentation
Abstract not provided
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ORAL 19 - Radiation for Localized Lung Cancer (ID 126)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:D. De Ruysscher, M. Hiraoka
- Coordinates: 9/08/2015, 10:45 - 12:15, 102+104+106
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ORAL19.03 - NRG Oncology/RTOG 0813 Trial of Stereotactic Body Radiotherapy (SBRT) for Central Tumors - Adverse Events (ID 1458)
11:07 - 11:18 | Author(s): J.D. Bradley
- Abstract
- Presentation
Background:
The safety of SBRT for medically inoperable patients with centrally located early stage non-small cell lung cancer (NSCLC) was evaluated in this phase I/II multicenter RTOG study that completed accrual in Sept 2013. This is the first report of adverse events (AE) observed on the study.
Methods:
Eligible patients were medically inoperable with biopsy proven, PET staged T1-2N0M0 NSCLC, ≤ 5 cm in size, centrally located tumors (within or touching the zone of the proximal bronchial tree or adjacent to mediastinal or pericardial pleura). Patients were successively accrued onto dose-escalating 5 fraction SBRT schedules delivered over 1.5-2 weeks, starting with 10 Gy per fraction (fr), then 10.5Gy/fr, 11 Gy/fr, 11.5 Gy/fr and 12 Gy /fr. Toxicity was graded using CTCAE v4.0; any potential dose-limiting toxicity within the initial 365 days post SBRT could have led to dose reduction for subsequent patients accrued, using TITE-CRM (time-to-event continual reassessment method) statistical design.
Results:
120 patients (100 evaluable) from 43 centers were accrued between 2/2009 and 9/2013. 12 were excluded as they did not receive protocol treatment (6 of these on the 12Gy/fr cohort) and another 8 did not meet eligibility criteria. Cohort sizes were 8 (10Gy/fr), 8 (10.5Gy/fr), 18 (11Gy/fr), 43 (11.5Gy/fr), and 43 pts (12Gy/fr). Median age was 72 (range 52- 89) years, 57% were female, 45% had squamous cell carcinoma, 39% had adenocarcinoma, 65% had T1 tumors. Median follow up was 26.6 months. Most adverse events were grade (G) 1 or 2. 5/8 pts in lowest SBRT dose cohort (10 Gy/fr) experienced G2 toxicity, none had G>3. Of 7 pts in 10.5 Gy/fr, 1 had G2 and 1 had G5 toxicity. Of 14 pts in 11 Gy/fr cohort, 4 had G2 and 1 had G3. Of 38 pts in 11.5Gy/fr cohort, 11 had G2, 4 had G3 and 2 had G5. Of 33 pts in 12Gy/fr, 4 had G2, 5 had G3, 1 G4 and 1Gr 5 as the worst overall toxicity definitely, probably or possibly related to SBRT. All Gr 5 toxicities were due to hemoptysis, occuring at a mean of 13 mo post SBRT (range 5.5-14mo). G2+ GI toxicity only occurred in the 11.5Gy/fr (1/38) and 12.0Gy/fr (2/33) cohorts. G2+ pulmonary toxicity occurred in 4/8 10.0Gy/fr, 0/8 10.5Gy/fr, 5/14 11.0Gy/fr, 15/38 11.5Gy/fr, and 10/33 12.0Gy/fr pts.
Conclusion:
This phase I/II trial of SBRT provides data to inform patients of the potential toxicities with a 5 fraction SBRT schedule for centrally located NSCLC. Although SBRT was well tolerated, 4/100 pts (4%) had fatal hemoptysis potentially attributable to SBRT. Determination of the optimal SBRT dose needs to await analysis of tumor locations, DVH data and efficacy data. This project was supported by grants U10CA21661, U10CA180868, U10CA180822 and U10CA37422 from the National Cancer Institute (NCI).
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ORAL 20 - Chemoradiotherapy (ID 124)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:G. Blumenschein, J.Y. Chang
- Coordinates: 9/08/2015, 10:45 - 12:15, 201+203
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ORAL20.06 - Outcomes of Intensity Modulated and 3D-Conformal Radiotherapy for Stage III Non-Small Cell Lung Cancer in NRG Oncology/RTOG 0617 (ID 938)
11:28 - 11:39 | Author(s): J.D. Bradley
- Abstract
Background:
Intensity modulated radiation therapy (IMRT) has the potential to improve target coverage and spare toxicity in locally-advanced non-small cell lung cancer (NSCLC). However, the effect of IMRT on outcomes for NSCLC has not previously been assessed in a large prospective cooperative group clinical trial.
Methods:
A secondary analysis was performed in patients with stage III NSCLC in NRG/RTOG 0617, a randomized phase III comparison of standard-dose (60 Gy) versus high-dose (74 Gy) chemoradiotherapy +/- cetuximab. Radiotherapy (RT) technique was stratified by IMRT and 3D-conformal radiotherapy (3D-CRT). Baseline prognostic and RT dosimetric parameters were compared between IMRT and 3D-CRT after adjusting for RT dose levels and cetuximab use. The prognostic value of RT technique with respect to toxicity and efficacy was assessed through multivariate logistic regression (MVA) and Cox proportional hazards model after controlling for RT dose level, cetuximab use and other factors.
Results:
Of the 482 eligible patients treated with RT, 53% and 47% were treated with 3D-CRT and IMRT, respectively. The IMRT group had more stage IIIB (38.6 vs. 30.3%, P = 0.056), larger PTVs (mean 486 vs. 427 mL, P = 0.005), and larger PTV:lung ratio (mean 0.15 vs. 0.13, P = 0.013). In spite of larger PTV volumes, IMRT was associated with lower lung V20 (P = 0.08), and lower heart doses (V5, V20, V40) than 3D-CRT. In turn, IMRT was associated with a lower rate (3.5 versus 7.9%) of Grade 3+ pneumonitis (P = 0.0653). On MVA, the lung V20 significantly predicted grade 3+ pneumonitis, while the lung V5 and mean lung doses did not. Larger heart V40 was associated with worse OS (HR=1.013, P < 0.001), and the heart V40 was significantly lower in patients treated with IMRT. Patients treated with IMRT were also more likely (37 versus 29%) to receive full doses of consolidative chemotherapy (P = 0.05).
Conclusion:
Although IMRT was used to treat larger and less favorable tumors in RTOG 0617, it was associated with reduced risk of Grade 3+ pneumonitis and higher likelihood of receiving full doses of consolidative chemotherapy. The heart V40, shown to be highly prognostic for survival, can be substantially reduced with IMRT compared to 3D-CRT.
