Slide 1 ___________________________________ RTOG Lung Cancer ___________________________________ 2011 Trial Update ___________________________________ RTOG Lung Cancer Committee Chair: Jeffrey Bradley, M.D. Kling Associate Professor ___________________________________ Department of Radiation Oncology Washington University School of Medicine ___________________________________ ___________________________________ ___________________________________ Slide 2 ___________________________________ RTOG Lung Committee • Small Cell Lung Cancer ___________________________________ ▫ Limited Stage (Intergroup Trial) ▫ Extensive Stage (RTOG 0937) • Early Stage NSCLC ▫ In-operable (0813 and 0915) ▫ Operable (RTOG 1021/ACOSOG Z4099) ___________________________________ • Locally advanced NSCLC ▫ Stage IIIA/B (Intergroup Trial -0617) ▫ Stage IIIA with minimal N2 disease (0839) ▫ Stage IIIA – Individualized RT Rx with PET-adapted boost (1106) ___________________________________ ___________________________________ ___________________________________ ___________________________________ Slide 3 ___________________________________ Monthly RTOG Lung Accrual ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________
Slide 4 ___________________________________ Phase III Comparison of Thoracic Radiotherapy Regimens in Limited-stage ___________________________________ Small Cell Lung Cancer CALGB 30610 ___________________________________ RTOG 0538 Principal Investigator: Jeff Bogart, MD ___________________________________ RTOG PI: Ritsuko Komaki, MD ___________________________________ ___________________________________ ___________________________________ Slide 5 ___________________________________ RTOG 0538 / CALGB 30610 R 45 Gy 1.5 Gy BID ___________________________________ A CDDP CDDP CDDP CDDP VP-16 VP-16 VP-16 VP-16 N D 61.2 Gy, 1.8 Gy QD FB Con bst O ___________________________________ PCI M CDDP CDDP CDDP CDDP VP-16 VP-16 VP-16 VP-16 I Z 70 Gy Gy, 2.0 Gy QD ___________________________________ E CDDP CDDP CDDP CDDP VP-16 VP-16 VP-16 VP-16 ___________________________________ ___________________________________ ___________________________________ Slide 6 ___________________________________ RTOG 0538/CALGB 30610 ___________________________________ • Status ▫ Accrual thru 8/11: 185/670 patients 1/3 by RTOG ___________________________________ ▫ Interim analysis after initial 30 and 50 patients on each arm showed no difference in toxicity ▫ Accrual continuing to 70 patients per arm for ___________________________________ next interim toxicity analysis ___________________________________ ___________________________________ ___________________________________
Slide 7 ___________________________________ Prophylactic cranial irradiation in extensive disease small cell lung cancer (EORTC 08993-22993) ___________________________________ Slotman et al. NEJM 2007 Study Design PCI ___________________________________ 20-30 Gy in No response Chemotherapy 5-12 fractions (4-6 cycles) Any response Random No PCI < 5 weeks ___________________________________ 4-6 weeks Stratification: Performance score and Institute ___________________________________ ___________________________________ ___________________________________ Slide 8 ___________________________________ Prophylactic cranial irradiation in extensive disease small cell lung cancer Overall survival 100 ___________________________________ 90 1 year: VS. 27.1% 13.3% 80 HR: 0.68 (0.52-0.88) p=0.003 70 60 ___________________________________ 50 40 30 PCI 20 Control ___________________________________ 10 0 (months) 0 4 8 12 16 20 24 28 32 36 Slotman et al. NEJM 2007 ___________________________________ ___________________________________ ___________________________________ Slide 9 ___________________________________ Phase II Study of PCI and consolidative Extra-Cranial Radiation for ED-SCLC (RTOG 0937) ___________________________________ IF RT Study Design Chest and Other Sites ___________________________________ PCI Chemotherapy Random Any response 25 Gy in 10 fx (4-6 cycles) Observation Stratify: ___________________________________ PR vs CR 1 vs 2-3 mets PI: Elizabeth Gore, MD ___________________________________ ___________________________________ ___________________________________
Slide 10 ___________________________________ RTOG 0937 Specifics • Primary Objective: To compare 1-year median survival ___________________________________ • Eligibility: ▫ ES-SCLC, excluding brain metastases AND ▫ Only 1-3 metastatic sites prior to platinum-based chemotherapy AND ___________________________________ ▫ Radiographic PR or CR • Sample size = 154 • Radiation therapy dosing ▫ PCI given in 2.5 Gy fractions to 25 Gy ▫ Metastases dosing is 3 Gy fractions to 45 Gy ___________________________________ ▫ Acceptable alternative is 4 Gy fractions to 40 Gy ___________________________________ ___________________________________ ___________________________________ Slide 11 ___________________________________ RTOG Lung Committee • Small Cell Lung Cancer ___________________________________ ▫ Limited Stage (Intergroup Trial) ▫ Extensive Stage (RTOG 0937) • Early Stage NSCLC ▫ In-operable ___________________________________ ▫ Operable (RTOG 1021 / ACOSOG Z4099) • Locally advanced NSCLC ▫ Stage IIIA/B (Intergroup Trial -0617) ▫ Stage IIIA with minimal N2 disease (0839) ___________________________________ ▫ Stage IIIA with PET-adapted boost ___________________________________ ___________________________________ ___________________________________ Slide 12 ___________________________________ Early y Stage NSCLC Stereotactic ___________________________________ Body Pulmonary Vein Bronchus Radiation Lung ___________________________________ Therapy Esophagus Chestwall (SBRT) Cord Skin ___________________________________ Physical Targeting ___________________________________ ___________________________________ ___________________________________
Slide 13 ___________________________________ ___________________________________ • RTOG 0236 trial for medically inoperable ▫ Very high tumor control (similar to surgery)(94%) ▫ 56% 3-year survival ___________________________________ • SBRT has become a standard of care for medically inoperable patients ▫ Up to 10,000 patients per year in US • RTOG 0236 has become a model for expansion of ___________________________________ oligofractionated ablative radiotherapy ___________________________________ ___________________________________ ___________________________________ Slide 14 ___________________________________ RTOG 0236: Local Control 100 100 / / / / / / / / / / // / / / / / / / / / / / / / /// / / / ___________________________________ 36 month local control = 98% (CI: 84-100%) Local Control (%) 75 75 50 50 1 failure within PTV, 1 within same lobe ___________________________________ 25 25 Fail: 1 Total: 55 0 0 ___________________________________ 0 0 6 6 12 12 18 18 24 24 30 30 36 36 Months after Start of SBRT Patients at Risk 55 54 47 46 39 34 23 Timmerman et al. : JAMA 2010 ___________________________________ ___________________________________ ___________________________________ Slide 15 ___________________________________ RTOG: 0236 Disseminated Recurrence • 6 patients (11%) disseminated within 1 year of Rx 100 100 ___________________________________ Disseminated Recurrence (%) Fail: 11 75 75 Total: 55 50 50 ___________________________________ 36 month disseminated recurrence = 22% (CI: 12-38%) 25 25 / / / / / / / / / / / / / / / / / / / / / / / / ___________________________________ 0 0 0 0 6 6 12 12 18 18 24 24 30 30 36 36 Months after Start of SBRT Patients at Risk 55 51 44 43 38 33 21 Timmerman et al .JAMA 2010 ___________________________________ ___________________________________ ___________________________________
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