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J. Chang



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    O10 - Stereotactic Ablative Body Radiotherapy (ID 104)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 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): J. Chang

      • Abstract
      • Presentation
      • Slides

      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.

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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-010 - Physical Targeting of Locally Advanced Non-Small Cell Lung Cancer (NSCLC): Proton Therapy (ID 1020)

      09:30 - 09:30  |  Author(s): J. Chang

      • Abstract

      Background
      Radiation therapy is a critical element in the potentially curative treatment of locally advanced NSCLC. Important developments have permitted more precise and effective physical targeting with radiations, an important complement to molecular targeting with drugs. Proton beam therapy (PBT) represents the most advanced physical targeting available thus far. A review of our experiences with proton therapy for NSCLC may serve as a benchmark for technically advanced radiation therapy.

      Methods
      Patients were enrolled on a protocol to investigate normal tissue effects of proton therapy between 2006 and December, 2010. Patients were excluded if they did not received concurrent chemotherapy, were treated on a phase II study of high dose PBT (JY Chang, PI) or were part of a randomized trial of PBT vs. intensity modulated radiation therapy (IMRT) (Z Liao, PI). They were evaluated before treatment with positron emission tomography (PET) and contrast enhanced computed tomography (CT), studies that were also used for planning treatment. Consultation with thoracic surgeons assured they were not candidates for resection. The mediastinal lymph nodes stations were evaluated with mediastinoscopy and/or fiberoptic bronchoscopy with ultrasound. Treatment planning consistently included motion management with 4D CT simulation and creation of an internal target volume (ITV). Patients were assessed for failure patterns and survival as well as normal tissue effects. Kaplan Meier estimates and Cox regression analysis were used to calculate survival outcomes.

      Results
      Of the 178 patients enrolled, the median age at diagnosis was 69 yrs (range 37.8 yrs to 94.9 yrs). KPS ranged from 60 to 100, median 80. 43% of patients had squamous carcinoma, and 57% had non-squamous histology. Stage distribution was 15% stage II, 65% III, 5% IV, 15% postoperative recurrence. The median tumor volume was 59 cc (range 4-753 cc) and the median total tumor dose was 74 Gy(RBE). Median follow-up time for living patients was 34.6 mos. Median survival was 32.7 mos. Three year survival rate was 46.5% (49.8% for squamous, 42.1% for non-squamous. Local failure at 3 years was 36.4% for squamous and 48.9% for non-squamous tumors. Distant metastasis-free survival at 3 years was 44.5% for squamous and 55.8% for non-squamous cell histology. Multivariate analysis found age, squamous histology and tumor size adversely affected survival.

      Conclusion
      Prognostic factors with PBT and concurrent chemotherapy are similar to those seen in series of patients treated with x-irradiation. Favorable median and 3 year survival rates with this relatively large data set suggest superior outcomes with PBT and quite possibly a new platform for physical targeting upon which to build chemical and molecular targeting strategies.