Phase Ⅰ/Ⅱ study of gemcitabine and oxaliplatin chemotherapy in combination with concurrent 3-D confo

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Background and objective Recent studies have showed that combination of chemotherapy and radiotherapy might result in better outcome for locally advanced non-small cell lung cancer (NSCLC). The aim of this study is to determine the maximal tolerance dose (MTD) and efficacy of full-dose gemcitabine and oxaliplatin when given concurrently with 3-dimentional radiation therapy (3D-RT) for locally advanced NSCLC. Methods Oxaliplatin was administered at a fixed dose of 130mg/m~2, and gemcitabine was administered at a starting dose of 800mg/m~2 with an incremental dose gradient of 200mg/m~2 for 3 dose levels. MTD was defined as the immediate dose level lower than the dose at which dose-limiting toxicity (DLT) occurred in more than one-third of the patients. The chemotherapy was administered at 3-week cycle. The RT was given as 3-D conformal manner at a single daily dose of 2Gy for 5 days per week. Results Twenty-two patients were evaluable and distributed to three different dose levels: 6 at level 1, 8 at level 2 and 8 at level 3. Pulmonary toxicity, esophageal and hematologic toxicity were the main DLT. Grade Ⅲ acute pulmonary toxicity occurred in one patient each at level 2 and level 3, both with V20>20%, and grade Ⅲ esophagitis in two patients at level 3. The MTD of gemcitabine in this study was 1000mg/m~2. The overall response rate was 75.0% (9/12). The 1- and 2-year survival rate was 70.0% and 30.5% respectively. The median time to progression was 8.7 months (range 5--11.8 months). Conclusion With reduced radiation volume, gemcitabine of 1000mg/m~2 in combination with oxaliplatin of 130mg/m~2 was effective and could be safely administered for NSCLC. The aim and this study is to determine the maximal tolerance dose (MTD) and efficacy of full combination of chemotherapy and radiotherapy might result in better outcome for locally advanced non-small cell lung cancer (NSCLC). -dose gemcitabine and oxaliplatin when given concurrently with 3-dimentional radiation therapy (3D-RT) for locally advanced NSCLC. Methods Oxaliplatin was administered at a fixed dose of 130mg/m~2, and gemcitabine was administered at a starting dose of 800mg/m~2 with an incremental dose of 200mg/m~2 for 3 dose levels. MTD was defined as the immediate dose level lower than the dose at which dose-limiting toxicity (DLT) occurred in more than than The one-third of the patients. The chemotherapy was administered at 3-week cycle. The RT was given as 3-D conformal manner at a single daily dose of 2Gy for 5 days per week. Results Twenty-two patients were evaluable and Distributed to three different dose l Evels: 6 at level 1, 8 at level 2 and 8 at level 3. Pulmonary toxicity, esophageal and hematologic toxicity were the main DLT. Grade III acute pulmonary toxicity occurred in one patient each at level 2 and level 3, both with V20> 20%, and grade III esophagitis in two patients at level 3. The MTD of gemcitabine in this study was 1000mg/m~2. The overall response rate was 75.0% (9/12). The 1- and 2-year The survival rate was 70.0% and 30.5% respectively. The median time to progression was 8.7 months (range 5-1.8 months). Conclusion With reduced radiation volume, gemcitabine of 1000mg/m~2 in combination with oxaliplatin of 130mg /m~2 was effective and could be safely administered for NSCLC.
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