Local Consolidation Therapy versus Observation for Oligometastatic Non Small Cell Lung Cancer Patients: Phase II Randomized Trial — Oak Academic Publishing
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Local Consolidation Therapy versus Observation for Oligometastatic Non Small Cell Lung Cancer Patients: Phase II Randomized Trial
Clinical Oncology and Nuclear Medicine Department, Mansoura University, Mansoura, Egypt
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Clinical Oncology and Nuclear Medicine Department, Mansoura University, Mansoura, Egypt
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Public Health & Community Medicine Department, Benha University, Benha, Egypt
1 Clinical Oncology and Nuclear Medicine Department, Mansoura University, Mansoura, Egypt
2 Clinical Oncology and Nuclear Medicine Department, Mansoura University, Mansoura, Egypt
3 Public Health & Community Medicine Department, Benha University, Benha, Egypt
Background and Objective: Based on retrospective trials, most progression sites after first line systemic therapy for metastatic non small cell lung cancer (NSCLC) were the primary disease sites rather than new sites. Therefore we conducted phase II randomized study to determine whether oligometastatic NSCLC without disease progression after first line chemotherapy, have prolonged progression free survival when treated with local consolidation therapy of residual disease followed by surveillance compared with no local consolidation therapy (observation). Patients and Methods: Forty eight eligible patients were randomized to either immediate or no local consolidation radiotherapy. 26 patients of immediate local consolidation radiotherapy received 3 D-conformal radiation therapy to primary tumor site and metastatic sites of disease. 22 patients were followed up by observation. Results: Patients in local consolidation arm had significantly better progression free survival (PFS) compared with patients in observation group. Median PFS was 9.5 months (95% CI 7.8 - 11.08) in local consolidation arm and 4.5 months (95%CI 3.9 - 5.7) in observation arm. Patients in local consolidation arm had longer median time to appearance of new metastatic sites (10 months CI 9.3 - 12.6) than those patients in observation arm (4.5 months CI 4.2 - 6.9). Median overall survival (OS) of patients in local consolidation arm was 12 months (95% CI 12.1 - 18.01) and in observation arm 10 months (95% CI 8.7 - 13.8). One year OS rate was 42.3% in local consolidation arm and 31.8% in observation arm ; 2 year OS rate was 23.1% in local consolidation arm and only 4.5% in observation arm. Conclusion: Local consolidation radiotherapy is simple, safe, efficient, and not expensive treatment for oligometastatic non small cell lung cancer after upfront chemotherapy. Local consolidation radiotherapy achieved significantly prolonged progression free survival and delayed appearance of new metastatic sites. Phase III studies are recommended to test benefit of local consolidation radiotherapy to gain prolonged progression free survival and overall survival. Also, define optimal patients’ subgroups that are more likely to benefit of local consolidation radiotherapy.
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