Comparative Study: Local Consolidation Therapy versus Observation for Oligometastatic Non Small Cell Lung Cancer Patients: Phase II Randomized Trial

We conducted phase II randomized study to determine whether oligometastatic NSCLC without
disease progression after first line chemotherapy, have pro-longed progression free survival when
treated with local consolidation therapy of residual disease followed by surveillance compared with no
local consolidation therapy (observation). Forty eight eligible patients were randomized to either
immediate or no local consolidation radiotherapy. 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. 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.