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Y. Garces
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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): Y. Garces
- 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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P2.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 213)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.03-025 - Predictors of Relapse and Evaluation of Post-Operative Radiotherapy in Patients with Resected Stage III (N2) Non-Small Cell Lung Cancer (ID 1291)
09:30 - 09:30 | Author(s): Y. Garces
- Abstract
Background:
For patients with stage III (N2) NSCLC treated with surgical resection, chemotherapy improves survival, whereas the role of PORT is controversial. The purpose of this study was to evaluate risk factors for recurrence and the role of PORT in a modern series of patients with surgically resected stage III (N2) NSCLC.
Methods:
A retrospective review was performed of patients with Stage III (N2) NSCLC who underwent curative intent surgical resection at our institution between February 1999 and January 2012. Patients who received neoadjuvant RT were excluded. Chi-Square or Fisher’s exact tests assessed associations between patient/disease characteristics and receipt of PORT. Local control was defined as lack of disease recurrence within the radiation field for PORT patients, or in the mediastinum or resection area for chemotherapy patients. Overall survival (OS), local control (LC), and metastasis-free survival (MFS) were estimated from the date of surgery using the Kaplan Meier method, with between-group comparisons (PORT vs. no PORT) made with the Log-rank test. Univariate Cox proportional hazards models were used to assess association of patient/disease characteristics and outcomes.
Results:
A total of 76 patients were included. Median age was 62.5 years. Histology was adenocarcinoma in 66%. Clinical N stage was N0 (51%), N1 (4%), or N2 (45%). Baseline positron emission tomography staging was performed in 91%. Pre-operative chemotherapy was administered to 21%. Surgery was pneumonectomy in 16%. Median (range) number of positive pN2 nodes was 1 (0-15). Seven patients with biopsy-proven cN2 had negative pN2 nodes after induction chemotherapy. Extranodal extension occurred in 9%. Surgical margins were positive in 4%. Chemotherapy (preoperative and/or postoperative) was administered to 83%. PORT was administered to 41 patients (54%) with a median (range) dose of 50 (41.4 – 60) Gy. Factors associated with increased likelihood of receiving PORT were increasing age (p=0.006) and no receipt of chemotherapy (p=0.0001). Median follow-up time for living patients was 4.5 (range 0.2 – 15.4) years. For all patients, OS at 5 years was 65%. OS at 5 years for patients receiving PORT vs. no PORT was 71% vs. 58% (p=0.19). For all patients, LC at 5 years was 84%. LC at 5 years for patients receiving PORT vs. no PORT was 89% vs. 77% (p=0.16). Factors associated with decreased LC were male gender (p=0.004), pT3/4 (vs. pT1/2, p=0.008). For all patients, MFS at 5 years was 61%. MFS at 5 years for patients receiving PORT vs. no PORT was 62% vs. 61% (p=0.89).
Conclusion:
In this modern series of patients with surgically resected stage III (N2) NSCLC, patients who received PORT (vs. no PORT) had numerically higher rates of OS and LC, although these differences were not statistically significant, potentially related to limited statistical power.
