局限期小細(xì)胞肺癌加速超分割放療同步EP方案化療的劑量遞增Ⅰ期研究
發(fā)布時(shí)間:2018-06-16 20:44
本文選題:局限期小細(xì)胞肺癌 + 同步放化療; 參考:《中國(guó)肺癌雜志》2017年01期
【摘要】:背景與目的加速超分割放療(每日兩次方案)聯(lián)合EP方案同步化療是美國(guó)國(guó)立綜合癌癥網(wǎng)絡(luò)(National Comprehensive Cancer Network,NCCN)指南推薦的局限期小細(xì)胞肺癌的標(biāo)準(zhǔn)治療方式,但國(guó)人對(duì)EP方案標(biāo)準(zhǔn)化療劑量耐受性尚不明確。本研究旨在探討局限期小細(xì)胞肺癌同步放化療EP方案的最大耐受劑量。方法研究納入病理證實(shí)的局限期小細(xì)胞肺癌患者,進(jìn)行加速超分割放療同步EP方案(依托泊苷+順鉑)化療,放療處方劑量為45Gy/30 f,1.5 Gy/f,每日兩次,同一日兩次放療間隔時(shí)間≥6 h,5天/周,共3周完成;煼桨覆捎靡劳胁窜章(lián)合順鉑,每21天為1周期,具體依托泊苷100 mg/m~2,d1-d3,順鉑采用劑量遞增的方式(第1組為70 mg/m~2 d1,第2組為75 mg/m~2 d1)。主要觀察指標(biāo)為治療期間的血液學(xué)毒性。次要觀察指標(biāo)為非血液學(xué)毒性和1年總生存期(overall survival,OS)、無進(jìn)展生存期(progression free survival,PFS)。根據(jù)不良事件常用術(shù)語(yǔ)評(píng)定標(biāo)準(zhǔn)(Common Terminology Criteria for Adverse Events,NCI-CTCAE)4.0,最大耐受劑量設(shè)定為6例患者中不超過1例患者出現(xiàn)劑量限制毒性(4級(jí)血液學(xué)毒性)的劑量,同時(shí)下一劑量組6例患者至少2例出現(xiàn)劑量限制性毒性。結(jié)果研究共納入20例局限期小細(xì)胞肺癌患者,平均年齡49.50(30-68)歲。第1組入組6例患者,1例患者出現(xiàn)4度中性粒細(xì)胞減少;后第2組入組14例患者,1例患者出現(xiàn)4度中性粒細(xì)胞減少。其中,第1組有4例患者出現(xiàn)≥3度血液學(xué)毒性,1例患者出現(xiàn)3度以上放射性食管炎;第2組有10例患者出現(xiàn)≥3度血液學(xué)毒性,無患者出現(xiàn)3度以上放射性食管炎。中位隨訪9.0個(gè)月(3.2個(gè)月-36.2個(gè)月),1年OS、PFS分別為91%、62%。結(jié)論局限期小細(xì)胞肺癌患者采用加速超分割放療聯(lián)合EP方案化療將順鉑劑量遞增至75 mg/m~2是安全的,其有效性還需要進(jìn)一步擴(kuò)大樣本量和隨訪更長(zhǎng)的時(shí)間來證實(shí)。
[Abstract]:Background & objective accelerated hyperfractionation radiotherapy (twice a day) combined with concurrent chemotherapy with EP regimen is the standard therapy for localized small cell lung cancer recommended by the National Comprehensive Cancer Network (NCCNN) guidelines. However, the tolerance of Chinese to standard dose of EP regimen is not clear. The aim of this study was to investigate the maximum tolerated dose of EP regimen in simultaneous radiotherapy and chemotherapy for local small cell lung cancer. Methods patients with localized small cell lung cancer (SCLC) who were confirmed by pathology were treated with accelerated hyperfractionation radiotherapy combined with EP regimen (etoposide cisplatin). The prescribed dose of radiotherapy was 45 Gy / 30 fU 1.5 Gy / f, twice a day. The interval between two times of radiotherapy on the same day was more than 6 h / week for 3 weeks. The chemotherapy regimen was etoposide combined with cisplatin for one cycle every 21 days. Etoposide 100 mg / m ~ (2) ~ (-1) d ~ (-1) and cisplatin were used as dose-increasing method (group 1 was 70 mg/m~2 / d ~ (-1), group 2 was 75 mg/m~2 / d ~ (-1). The main outcome measure was hematological toxicity during treatment. The secondary indexes were non-hematological toxicity, total survival time of one year and progression free survival. According to the standard of Common Terminology criteria for Adverse events (NCI-CTCAE4), the maximum tolerated dose was set as the dose of no more than one patient out of 6 patients with hematological toxicity of grade 4. At the same time, at least 2 patients in the next dose group had dose-limited toxicity. Results A total of 20 patients with small cell lung cancer (SCLC) with an average age of 49.50- 68 years were enrolled in the study. In the first group, 6 patients with neutropenia and 1 patient with 4 degree neutropenia were found in the first group, and 14 patients in the latter group and 1 patient with neutropenia in the latter group. In the first group, there were 4 patients with hematological toxicity 鈮,
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