- Email: [email protected]
II TRIAL OF CONCURRENT CHEMO-RADIATION WITH DOSE-ESCALATED RADIOTHERAPY IN PATIENTS WITH STAGE II OR STAGE III NON-SMALL CELL LUNG CANCER
S24 for survival. Limited resection (p < 0.001), visceral pleural invasion (p = 0.002) and lymphatic vessel invasion (p < 0.001) were shown to be related to the poor disease free interval. Conclusions: Limited resection had poor prognosis in solid type clinical stage IA lung cancer. Prognostic factors as lymph node metastasis and lymphatic vessel invasion are associated with clinical outcomes despite of small sized solid type lung cancer. Lobectomy remains standard surgical procedure in solid type clinical stage IA lung cancer. Disclosure: All authors have declared no conflicts of interest. 53P ROBOTIC RADIOSURGERY FOR INOPERABLE PATIENTS WITH STAGE IA IB NON SMALL CELL LUNG CANCER G. Beltramo, A. Bergantin, A.S. Martinotti, C. Vite, F. Ria, M. Invernizzi, L.C. Bianchi Cyberknife, Centro Diagnostico Italiano, Milan, Italy Purpose: Although surgical resection remains the standard of care for patients with early stage non-small cell lung cancer (NSCLC), impressive local control rates have been reported using stereotactic ablative radiotherapy. The purpose of this paper is to analyze and evaluate outcome and follow up data on our patients who received Cyberknife Radiosurgery for early stage medically inoperable non small cell lung cancer (NSCLC). Materials and Methods: From February 2005 to December 2011, a total of 81 medically inoperable patients, 13 female 68 male, median age of 74 years (range 42 90 years) with pathologically proven NSCLC (squamous cell carcinoma, adenocarcinoma, largecell carcinoma, bronchoalveolar cell carcinoma, or NSCLC not otherwise specified), diagnosed as 38 stage IA and 43 stage Ib were referred to our Department for Cyberknife stereotactic radiotherapy treatment (SBRT). Selected tracking modality depended on tumor size, location and extent of respiratory movement were performed. 27 patients with lower lobe lesions were treated with fiducial (1 3) in the other 54 pts fiducialless x sight option was used for targeting purpose. Depending on tumor size and location different curative dose regimens were used. In all patients a high BED 10 (>100 Gy) was delivered to the tumor bed. The SBRT treatment dose of 48 60 Gy was prescribed to the 75 85% isodose line in three-four fractions. Median follow-up was 24 months (range, 2 74 months). Results: The Kaplan Meier local control rate at 1, 2 and 3 years was 93.7%, 88.8% and 80.0% respectively, overall survival (OS) at 1, 2 and 3 years was 88.9%, 72.4% and 57.4%, disease free Survival (DFS) at 1, 2 and 3 years was 80.2%, 61.3% and 43.4%. Reported acute side effects have generally been mild and have included esophagitis, fatigue, chest wall tenderness and cough. We detected a late radiation-induced local fibrosis using CT imaging in most patients, in 2 patients we observed grade 3 pneumonitis, in 1 pt rib fractures and in another one RTOG 4 radiation induced myelopathy at an interval of 30 months following CK/SRS treatment. Conclusions: Our preliminary results suggest that CyberKnife-based SRT is a useful treatment approach for patients with primary lung cancer, offering excellent in-field tumor control, low toxicity profile and is promising compared to standard radiation. Disclosure: All authors have declared no conflicts of interest.
EARLY STAGE NON-SMALL CELL LUNG CANCER 54P A PHASE I/II TRIAL OF CONCURRENT CHEMO-RADIATION WITH DOSE-ESCALATED RADIOTHERAPY IN PATIENTS WITH STAGE II OR STAGE III NON-SMALL CELL LUNG CANCER D.B. Landau1 , V. Laurence2 , M. Illsley3 , S. Hughes4 , E. Miles5 , Y. Ngai6 , L. Hughes6 , I. Khan6 , P. Mayles7 , J. Fenwick8 1 Oncology Management Offices, Guy’s & St. Thomas’ NHS Trust, London, United Kingdom, 2 Dorset Cancer Centre, Poole Hospital, Poole, United Kingdom, 3 St Luke’s Cancer Centre, Royal Surrey County Hospital, Surrey, United Kingdom, 4 Department of Oncology, Guy’s & St. Thomas’ NHS Trust, London, United Kingdom, 5 NCRI Radiotherapy Trials QA, Mount Vernon Hospital, Middlesex, United Kingdom, 6 University College London, Cancer Research UK & UCL Cancer Trials Centre, London, United Kingdom, 7 Physics, Clatterbridge Cancer Centre, Wirral, United Kingdom, 8 University of Oxford, Gray Institute of Radiation Oncology and Biology, Oxford, United Kingdom Background: We introduce a novel approach to radiotherapy (RT) dose escalation investigating individualised isotoxic dose escalation for RT delivered in 30 once daily fractions over 6 weeks. Dose calculations are driven by a toxicity model using historical clinical trial data which provided more insightful radiobiological modelling and prediction of lung toxicity. By ensuring these risks are controlled, each patient will receive doses to the max level achievable according to predefined toxicity and dose constraints. Methods: A target of 71 patients with pathological confirmed NSCLC stages II or III, WHO status 0 or 1 and life expectancy of >6 months were planned for RT. Radiobiological models were used to predict a patient’s specific RT dose (TDPneum ) associated with a 10% risk of grade 3+ pneumonitis (constrained to a prescribed dose of 63 73 Gy). An estimate of the max oesophageal dose associated with the TDPneum was determined for allocation to a dose escalation arm (Arm 2, n = 48 max, 6+6 design and continual reassessment model) in 30 fractions over 6 weeks. Patients unable to enter ARM 2 were either taken off trial or treated at RT doses (Arm 1, n = 23) lower than those of Arm 2, taking into account spinal cord, cardiac and brachial plexus constraints. Dose limiting toxicity (DLT) was defined as Grade 3+ oesophagitis. Other endpoints include Grade 2 5 pneumonitis and oesophagitis. The MTD is determined if grade3+ oesophagitis is >42% (>5/12). Results: From 2009 2012, 62 patients were recruited of which 33 (53%) patients were in Arm 1 and 29 patients (47%) were in Arm 2 (dose escalation arm) in 9 centres in the UK. The median age was 65 years (range 42 84); 52% vs. 48% female; 33% and 67% WHO 0 and 1 respectively. In arm 1, 12 (36%) and 21 (67%) patients received 63 Gy and 65 Gy respectively; in arm 2, 13 (45%), 11 (38%) and 5 (17%) patients received 65, 68 and 71 Gy. One patient in Arm 1 had Grade 3+ pneumonitis (63 Gy); 2 patients had Grade 3+ oesophagitis. In Arm 2, there were no DLTs on 65 Gy, 2 DLT (oesophagitis) on 68 Gy and no DLTs currently reported on 71 Gy. There were 2 Grade 3+ pneumonitis events on Arm 2, 1 each at 65 Gy and 68 Gy. Current recommended dose (RD) dose is 71 Gy. Final estimates of toxicities, and the final RD dose, including response rate and PFS will be presented in 2013. Conclusions: Current RD dose is 71 Gy. Final results will be available in 2013. Disclosure: All authors have declared no conflicts of interest.
EARLY STAGE NON-SMALL CELL LUNG CANCER 54P A PHASE I/II TRIAL OF CONCURRENT CHEMO-RADIATION WITH DOSE-ESCALATED RADIOTHERAPY IN PATIENTS WITH STAGE II OR STAGE III NON-SMALL CELL LUNG CANCER D.B. Landau1 , V. Laurence2 , M. Illsley3 , S. Hughes4 , E. Miles5 , Y. Ngai6 , L. Hughes6 , I. Khan6 , P. Mayles7 , J. Fenwick8 1 Oncology Management Offices, Guy’s & St. Thomas’ NHS Trust, London, United Kingdom, 2 Dorset Cancer Centre, Poole Hospital, Poole, United Kingdom, 3 St Luke’s Cancer Centre, Royal Surrey County Hospital, Surrey, United Kingdom, 4 Department of Oncology, Guy’s & St. Thomas’ NHS Trust, London, United Kingdom, 5 NCRI Radiotherapy Trials QA, Mount Vernon Hospital, Middlesex, United Kingdom, 6 University College London, Cancer Research UK & UCL Cancer Trials Centre, London, United Kingdom, 7 Physics, Clatterbridge Cancer Centre, Wirral, United Kingdom, 8 University of Oxford, Gray Institute of Radiation Oncology and Biology, Oxford, United Kingdom Background: We introduce a novel approach to radiotherapy (RT) dose escalation investigating individualised isotoxic dose escalation for RT delivered in 30 once daily fractions over 6 weeks. Dose calculations are driven by a toxicity model using historical clinical trial data which provided more insightful radiobiological modelling and prediction of lung toxicity. By ensuring these risks are controlled, each patient will receive doses to the max level achievable according to predefined toxicity and dose constraints. Methods: A target of 71 patients with pathological confirmed NSCLC stages II or III, WHO status 0 or 1 and life expectancy of >6 months were planned for RT. Radiobiological models were used to predict a patient’s specific RT dose (TDPneum ) associated with a 10% risk of grade 3+ pneumonitis (constrained to a prescribed dose of 63 73 Gy). An estimate of the max oesophageal dose associated with the TDPneum was determined for allocation to a dose escalation arm (Arm 2, n = 48 max, 6+6 design and continual reassessment model) in 30 fractions over 6 weeks. Patients unable to enter ARM 2 were either taken off trial or treated at RT doses (Arm 1, n = 23) lower than those of Arm 2, taking into account spinal cord, cardiac and brachial plexus constraints. Dose limiting toxicity (DLT) was defined as Grade 3+ oesophagitis. Other endpoints include Grade 2 5 pneumonitis and oesophagitis. The MTD is determined if grade3+ oesophagitis is >42% (>5/12). Results: From 2009 2012, 62 patients were recruited of which 33 (53%) patients were in Arm 1 and 29 patients (47%) were in Arm 2 (dose escalation arm) in 9 centres in the UK. The median age was 65 years (range 42 84); 52% vs. 48% female; 33% and 67% WHO 0 and 1 respectively. In arm 1, 12 (36%) and 21 (67%) patients received 63 Gy and 65 Gy respectively; in arm 2, 13 (45%), 11 (38%) and 5 (17%) patients received 65, 68 and 71 Gy. One patient in Arm 1 had Grade 3+ pneumonitis (63 Gy); 2 patients had Grade 3+ oesophagitis. In Arm 2, there were no DLTs on 65 Gy, 2 DLT (oesophagitis) on 68 Gy and no DLTs currently reported on 71 Gy. There were 2 Grade 3+ pneumonitis events on Arm 2, 1 each at 65 Gy and 68 Gy. Current recommended dose (RD) dose is 71 Gy. Final estimates of toxicities, and the final RD dose, including response rate and PFS will be presented in 2013. Conclusions: Current RD dose is 71 Gy. Final results will be available in 2013. Disclosure: All authors have declared no conflicts of interest.