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C. Hu
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O10 - Stereotactic Ablative Body Radiotherapy (ID 104)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Radiation Oncology + Radiotherapy
- Presentations: 1
- Moderators:H. Onishi, J.Y. Chang
- Coordinates: 10/28/2013, 16:15 - 17:45, Parkside 110 A+B, Level 1
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O10.02 - Radiation Therapy Oncology Group (RTOG) protocol 0915: A randomized phase II study comparing 2 Stereotactic Body Radiation Therapy (SBRT) schedules for medically inoperable patients (pts) with stage I peripheral Non-Small Cell Lung Cancer. (ID 68)
16:25 - 16:35 | Author(s): C. Hu
- Abstract
- Presentation
Background
To select the most favorable treatment regimen based on the rate of grade 3 or higher protocol-specified adverse events (psAEs) at 1 year.Methods
Pts 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 (pts) were randomized to receive either 34 Gy in one fraction (arm 1) or 48 Gy in 4 consecutive once-daily fractions (arm 2). Rigorous central accreditation and quality assurance assessments were used to assure pts were treated according to protocol guidelines. The study was designed to detect whether psAEs rate>17% at a 10% significance level (1-sided) and 90% power. Secondary endpoints included primary tumor control (PC) rate, 1-year overall survival (OS), progression-free survival (PFS). The regimen selection criteria were based on pre-specified rules of psAEs and PC for each arm. Formal comparisons were not performed.Results
The study opened in September 2009 and closed in March 2011 after accruing a total of 94 pts. Median follow up was 20.6 months. Of 86 evaluable pts, 41 were in arm 1 and 45 in arm 2. Baseline pt and tumor characteristics were balanced between both arms. 4 (9.8%) pts on arm 1 (95% CI: 2.7-23.1%; p=0.151) and 6 (13.3%) pts on arm 2 (95% CI: 5.1-26.8%; p=0.337) experienced psAEs. 39 (95.1%) pts on arm 1 and 45 (100%) pts on arm 2 received planned SBRT treatment. Contouring compliance indicated 100% and 95.6% of targets and 89.5% and 82.2% of normal tissue structures were outlined per protocol/minor deviations, for arms 1 and 2, respectively. OS at 1 year was 85.4% (95% CI: 70.3-93.1%) for arm 1 pts and 91.1% (95% CI: 78.0-96.6%) for arm 2. PFS at 1 year was 78.0% (95% CI: 62.1-87.9%) for arm 1 and 84.4% (95% CI: 70.1-92.3%) for arm 2. The PC rates at 1 year were 97.1% (95% CI: 85.1-99.9%) for arm 1 and 97.6% (95% CI: 87.1-99.9%) for arm 2.Conclusion
At one year, 34 Gy in one fraction met pre-specified criteria with respect to adverse events and primary control, and therefore is selected as the experimental arm for a planned phase III trial. Supported by RTOG U10 CA21661 and CCOP U10 CA37422 grants from 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.
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PL03 - Presidential Symposium Including Top Rated Abstracts (ID 85)
- Event: WCLC 2013
- Type: Plenary Session
- Track:
- Presentations: 1
- Moderators:M. Boyer, K. Fong
- Coordinates: 10/29/2013, 08:15 - 09:45, Plenary Hall, Ground Level
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PL03.05 - An intergroup randomized phase III comparison of standard-dose (60 Gy) versus high-dose (74 Gy) chemoradiotherapy (CRT) +/- cetuximab (cetux) for stage III non-small cell lung cancer (NSCLC): Results on cetux from RTOG 0617 (ID 1424)
08:59 - 09:11 | Author(s): C. Hu
- Abstract
Background
The two primary objectives of RTOG 0617 were to compare the overall survival(OS) differences of 1) standard-dose(SD)(60Gy) versus high-dose(HD)(74Gy) radiotherapy (RT) with concurrent chemotherapy(CT); and 2) the addition of cetux to standard CRT. Cetux is a monoclonal Ab targeting EGFR with activity when combined with CT in metastatic NSCLC and head and neck cancer (HNC), and with RT in locally advanced HNC.Methods
This Phase III Intergroup trial randomized pts in a 2 x 2 factorial design. Concurrent CRT included weekly paclitaxel(45 mg/m2) & carboplatin(AUC=2). Pts randomized to cetux received a 400 mg/m2 loading dose on Day 1 followed by weekly doses of 250 mg/m2. All pts were to receive 2 cycles of consolidation CT. This is the initial report of survival outcome based on cetux. The trial was designed for 450 evaluable patients with 80% power and a 1-sided alpha of 0.0125 to detect a 29% reduction in OS failure for each comparison (RT and cetux).Results
544 pts were accrued, and 419 and 465 are eligible for RT and cetux analyses. Median follow up is 18.7 months. Cetux delivery was acceptable in both the concurrent and consolidation phases. Therapy related ≥Grade 3 non-hematologic toxicity was higher in the cetux group; 70.5% vs 50.7% (p<.0001). Grade 4 and 5 events were 35.8% and 28.2%, respectively. Median survival was 23.1 vs 23.5 months, & 18-month OS rates were 60.8% vs 60.2% on the cetux vs non-cetux arms, respectively (p=0.484, HR=0.99), which crossed a protocol-specified futility boundary for early reporting. As previously reported, median survival times and 18-month OS rates for SD and HD arms were 28.7 vs 19.5 months, and 66.9% vs 53.9% respectively (p=0.0007, HR=1.56). There was no significant interaction between RT dose and the use of cetux. The OS rates for the 4 arms of this trial are shown in Table. An H-score analysis, a measure EFGR positivity, is forthcoming.Table: Overall Survival Rates with 95% CI (pts accrued while all 4 arms were open)
Time 60 Gy 74 Gy 60 Gy + Cetux 74 Gy + Cetux 12m 78.4% (68.9, 85.4) 62.6% (51.7, 71.6) 80.0% (70.8, 86.6) 74.7% (64.9, 82.2) 18m 67.9% (57.6, 76.2) 52.3% (41.5, 62.0) 67.1% (56.8, 75.5) 58.0% (47.6, 67.1) Conclusion
In pts receiving CRT for Stage III NSCLC, 74 Gy is not superior to and may be worse than 60 Gy in terms of OS. Cetux provides no survival benefit in the setting of CRT for Stage III NSCLC.
