PMID- 27042098 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20160404 LR - 20200930 IS - 1178-6930 (Print) IS - 1178-6930 (Electronic) IS - 1178-6930 (Linking) VI - 9 DP - 2016 TI - Feasibility, tolerability, and efficacy of the concurrent addition of erlotinib to thoracic radiotherapy in locally advanced unresectable non-small-cell lung cancer: a Phase II trial. PG - 1057-66 LID - 10.2147/OTT.S89755 [doi] AB - PURPOSE: Although many studies have confirmed the synergic effects of combining chemotherapy (CT) and radiotherapy (RT), clinical data evaluating safety and efficacy of erlotinib in combination with RT in locally advanced non-small-cell lung cancer (NSCLC) are limited. The aim of this study was to determine the feasibility, tolerability, and efficacy of the concurrent addition of erlotinib to the standard three-dimensional conformal thoracic RT in patients with unresectable or locally advanced NSCLC who are not candidates for receiving standard CT. PATIENTS AND METHODS: Feasibility and tolerability, assessed by evaluating adverse events (AEs), and effectiveness, by calculating progression-free survival (PFS), overall survival (OS), cancer-specific survival (CSS), and objective response rate (ORR), were analyzed in 30 patients receiving RT alone and 60 receiving RT and erlotinib. RESULTS: Erlotinib with RT showed an extended CSS and a higher rate of complete responses compared with RT alone. No differences between groups were found regarding OS, PFS, and ORR. AEs were significantly higher in the combined treatment, which mainly included cutaneous toxicity, dyspnea, fatigue, hyporexia, diarrhea, and infection. Erlotinib did not increase the toxicity produced by RT. CONCLUSION: The combination of erlotinib with RT produced, in our study, a scarce clinical benefit in the treatment of unresectable or locally advanced NSCLC, limited to complete responses and longer CSS rate compared with RT alone. Increased toxicity events were associated with combined therapy, which mainly included cutaneous toxicity. In our opinion, further studies in molecularly unselected lung cancer patients treated with EGFR TKIs and RT are not indicated. The use of biomarkers for the identification of patients that are most likely to benefit from this treatment is an essential next step in the research of this condition. FAU - Martinez, Enrique AU - Martinez E AD - Radiation Oncology Services, Hospital of Navarra, Pamplona, Spain. FAU - Martinez, Maite AU - Martinez M AD - Radiation Oncology Services, Hospital of Navarra, Pamplona, Spain. FAU - Rico, Mikel AU - Rico M AD - Radiation Oncology Services, Hospital of Navarra, Pamplona, Spain. FAU - Hernandez, Berta AU - Hernandez B AD - Radiation Oncology Services, Hospital of Navarra, Pamplona, Spain. FAU - Casas, Francesc AU - Casas F AD - Medical Oncology Department, Clinical Hospital of Barcelona, Barcelona, Spain. FAU - Vinolas, Nuria AU - Vinolas N AD - Medical Oncology Department, Clinical Hospital of Barcelona, Barcelona, Spain. FAU - Perez-Casas, Ana AU - Perez-Casas A AD - Department of Radiation Oncology, Jimenez Diaz Foundation, Madrid, Spain. FAU - Domine, Manuel AU - Domine M AD - Department of Radiation Oncology, Jimenez Diaz Foundation, Madrid, Spain. FAU - Minguez, Julian AU - Minguez J AD - Department of Radiation Oncology, University Hospital of Donostia, San Sebastian, Spain. LA - eng PT - Journal Article DEP - 20160301 PL - New Zealand TA - Onco Targets Ther JT - OncoTargets and therapy JID - 101514322 PMC - PMC4780183 OTO - NOTNLM OT - concurrent OT - erlotinib OT - non-small-cell lung cancer OT - radiotherapy EDAT- 2016/04/05 06:00 MHDA- 2016/04/05 06:01 PMCR- 2016/03/01 CRDT- 2016/04/05 06:00 PHST- 2016/04/05 06:00 [entrez] PHST- 2016/04/05 06:00 [pubmed] PHST- 2016/04/05 06:01 [medline] PHST- 2016/03/01 00:00 [pmc-release] AID - ott-9-1057 [pii] AID - 10.2147/OTT.S89755 [doi] PST - epublish SO - Onco Targets Ther. 2016 Mar 1;9:1057-66. doi: 10.2147/OTT.S89755. eCollection 2016.