Pilot Study Of Egfr-Tkis In Combination With Radiation For Patients With Locally Advanced And Metastatic Non-Small Cell Lung Cancer

Purpose/Objective(s)To establish the safety and toxicity profile of daily epidermal growth factor receptor tyrosine kinase inhibitors (gefitinib or erlotinib) with radiation alone in patients with locally advanced and metastatic non–small cell lung (NSCLC).Materials/MethodsPatients with locally advanced and metastatic NSCLC were treated with concomitant modern radiotherapy (three-dimensional conformal radiotherapy, stereotactic body radiotherapy) alone with of daily EGFR-TKI (gefitinib 250 mg) or (erlotinib 150 mg). Once a safety profile was determined, patients were then treated with daily EGFR-TKIs up to occurrence of tumor progression or intolerable toxicity.ResultsTwenty patients were enrolled and assessable for toxicity and 19 patients were available for progression-free survival (PFS) and time to progression (TTP). The median age was 56 years (range, 30–84); the ratio of male and female was 1:1; the median score of Eastern Cooperative Oncology performance status was 1 (range, 0–2). Histological types included 11 adenocarcinomas, 6 squamous cell carcinoma, and 3 mixed type; 13 patients were Stage IV and 7 patients for Stage IIIB. With the median follow-up of 6.4 months(range, 2.1–22.2 months), the median PFS and TTP were 5.0 months and 4.6 months, respectively. The median survival time was 11.8 months and 1-year overall survival was about 50%. The most common toxic side effects (≥20%) included acne -like skin rashes (70%) with the median occurrence of Day 7, fatigue (55%), anorexia (50%) and nausea (40%), pruritus (35%), mucositis (30%) and diarrhea (25%). One patient experienced Grade 4 neutropenia and thrombocytopenia, who received chemotherapy of gemcitabine plus cisplatin four weeks before. Acute radiation morbidity mainly included Grade1/2 esophagitis (15%, 3/20) and Grade 1/2 pneumonitis (15%, 3/20). Three patients suffered from Grade 1/2 pulmonary fibrosis (15%, 3/20) in late radiation morbidity. There was no Grade3/4 acute and late radiation toxicity. There was no treatment-related death.ConclusionsEGFR-TKIs with concomitant RT was well-tolerated and could serve as a therapeutic option for patients with locally advanced and metastatic NSCLC. Purpose/Objective(s)To establish the safety and toxicity profile of daily epidermal growth factor receptor tyrosine kinase inhibitors (gefitinib or erlotinib) with radiation alone in patients with locally advanced and metastatic non–small cell lung (NSCLC). To establish the safety and toxicity profile of daily epidermal growth factor receptor tyrosine kinase inhibitors (gefitinib or erlotinib) with radiation alone in patients with locally advanced and metastatic non–small cell lung (NSCLC). Materials/MethodsPatients with locally advanced and metastatic NSCLC were treated with concomitant modern radiotherapy (three-dimensional conformal radiotherapy, stereotactic body radiotherapy) alone with of daily EGFR-TKI (gefitinib 250 mg) or (erlotinib 150 mg). Once a safety profile was determined, patients were then treated with daily EGFR-TKIs up to occurrence of tumor progression or intolerable toxicity. Patients with locally advanced and metastatic NSCLC were treated with concomitant modern radiotherapy (three-dimensional conformal radiotherapy, stereotactic body radiotherapy) alone with of daily EGFR-TKI (gefitinib 250 mg) or (erlotinib 150 mg). Once a safety profile was determined, patients were then treated with daily EGFR-TKIs up to occurrence of tumor progression or intolerable toxicity. ResultsTwenty patients were enrolled and assessable for toxicity and 19 patients were available for progression-free survival (PFS) and time to progression (TTP). The median age was 56 years (range, 30–84); the ratio of male and female was 1:1; the median score of Eastern Cooperative Oncology performance status was 1 (range, 0–2). Histological types included 11 adenocarcinomas, 6 squamous cell carcinoma, and 3 mixed type; 13 patients were Stage IV and 7 patients for Stage IIIB. With the median follow-up of 6.4 months(range, 2.1–22.2 months), the median PFS and TTP were 5.0 months and 4.6 months, respectively. The median survival time was 11.8 months and 1-year overall survival was about 50%. The most common toxic side effects (≥20%) included acne -like skin rashes (70%) with the median occurrence of Day 7, fatigue (55%), anorexia (50%) and nausea (40%), pruritus (35%), mucositis (30%) and diarrhea (25%). One patient experienced Grade 4 neutropenia and thrombocytopenia, who received chemotherapy of gemcitabine plus cisplatin four weeks before. Acute radiation morbidity mainly included Grade1/2 esophagitis (15%, 3/20) and Grade 1/2 pneumonitis (15%, 3/20). Three patients suffered from Grade 1/2 pulmonary fibrosis (15%, 3/20) in late radiation morbidity. There was no Grade3/4 acute and late radiation toxicity. There was no treatment-related death. Twenty patients were enrolled and assessable for toxicity and 19 patients were available for progression-free survival (PFS) and time to progression (TTP). The median age was 56 years (range, 30–84); the ratio of male and female was 1:1; the median score of Eastern Cooperative Oncology performance status was 1 (range, 0–2). Histological types included 11 adenocarcinomas, 6 squamous cell carcinoma, and 3 mixed type; 13 patients were Stage IV and 7 patients for Stage IIIB. With the median follow-up of 6.4 months(range, 2.1–22.2 months), the median PFS and TTP were 5.0 months and 4.6 months, respectively. The median survival time was 11.8 months and 1-year overall survival was about 50%. The most common toxic side effects (≥20%) included acne -like skin rashes (70%) with the median occurrence of Day 7, fatigue (55%), anorexia (50%) and nausea (40%), pruritus (35%), mucositis (30%) and diarrhea (25%). One patient experienced Grade 4 neutropenia and thrombocytopenia, who received chemotherapy of gemcitabine plus cisplatin four weeks before. Acute radiation morbidity mainly included Grade1/2 esophagitis (15%, 3/20) and Grade 1/2 pneumonitis (15%, 3/20). Three patients suffered from Grade 1/2 pulmonary fibrosis (15%, 3/20) in late radiation morbidity. There was no Grade3/4 acute and late radiation toxicity. There was no treatment-related death. ConclusionsEGFR-TKIs with concomitant RT was well-tolerated and could serve as a therapeutic option for patients with locally advanced and metastatic NSCLC. EGFR-TKIs with concomitant RT was well-tolerated and could serve as a therapeutic option for patients with locally advanced and metastatic NSCLC.