Virtual Library
Start Your Search
M. Suntharalingam
Author of
-
+
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
-
+
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): M. Suntharalingam
- 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).
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
-
+
P2.01-082 - Pathological Response with Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker Use in Advanced Non-Small Cell Lung Cancer (ID 2156)
09:30 - 09:30 | Author(s): M. Suntharalingam
- Abstract
Background:
Angiotensin converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB) are among the most common medications in the treatment of hypertension and diabetes. These drugs are under evaluation as a means to mitigate radiation pneumonitis/fibrosis likely mediated by anti-inflammatory and endothelial effects. Their collateral impact on oncological outcomes is unknown. We retrospectively evaluate the effect of ACEi and ARB usage on pathological response during preoperative platinum-based concurrent chemoradiotherapy (CCRT) with high-dose radiotherapy (≥59.4 Gy) in a cohort of patients with stage III non-small cell lung cancer (NSCLC).
Methods:
Between June 2000 and December 2009, 79 patients with stage III NSCLC (AJCC 7[th] ed.) were treated with preoperative CCRT at our institution. Data on ACEi/ARB usage during CCRT and pathological response was available for 72 patients. The primary end-point was pathological complete response (pCR), in both the primary site and involved lymph nodes. X[2] analysis was to assess distribution of categorical variables, Kaplan-Meier survival analysis with log rank test for univariate and Cox regression multivariate (age, gender, race, stage, RT dose and chemotherapy regimen) analysis of overall survival (OS) and freedom-from recurrence (FFR) was performed.
Results:
The median age at diagnosis was 56 years (range, 38-78) with 56% males, 74% Caucasians and 96% smokers. Stage distribution was IIIA (72%), IIIB (28%), T1/2 (54%), T3/4 (46%), N0/1 (14%) and N2/3 (86%). The median radiation dose was 66.6 Gy (range 59.4-69.6 Gy) with the most common CCRT regimen being carboplatin-paclitaxel (54%). At a median follow up of 3.8 years for all patients and 6.8 years for surviving patients, the median OS and FFR of the entire cohort were 4.9 years (95% Confidence Interval (CI): 3.5-6.5) and 3.1 years (95% CI: 1.3-4.9), respectively with overall pCR rate of 44%. During CCRT, 11 patients (15%) were taking ACEi/ARB and 61 patients (85%) were not taking ACEi/ARB. No statistical differences were seen in the distribution of baseline variables between the two cohorts. None of the patients developed acute radiation pneumonitis in the time interval between radiotherapy completion and surgery (median 55 days; range, 33-105 days). The pCR rate without and with ACEi/ARB was 46% vs 36% (p=0.56). The median FFR without and with concurrent ACEi/ARB use was 3.1 years vs. not reached, p = 0.35, while the corresponding median OS values were 4.8 years and 5.5 years, p = 0.59, respectively. On multivariate analysis, an improved OS was associated with younger age (HR: 0.39, 95%CI: 0.2-0.8, p<0.01), an improved FFR was associated with lower stage (HR: 0.3, 95%CI: 0.15-0.76, p<0.01) and Caucasian race (HR=0.37, 95% CI: 0.15-0.88, p=0.02), with no impact of ACEi/ARB use on either outcome.
Conclusion:
The use of ACEi/ARB did not have any apparent influence the rates of pCR in this small cohort of advanced stage NSCLC patients treated with trimodality therapy following preoperative platinum-based CCRT with high-dose radiotherapy. As the role of these drugs in mitigating radiation pneumonitis continues to be evaluated, simultaneous assessment of lack of a negative impact on disease outcomes needs to be validated in larger, prospective analyses.
