Kerner Gerald S M A, van Dullemen Leon F A, Wiegman Erwin M, Widder Joachim, Blokzijl Edwin, Driever Ellen M, van Putten John W G, Liesker Jeroen J W, Renkema Tineke E J, Pieterman Remge M, Mertens Marc J F, Hiltermann Thijo J N, Groen Harry J M
University of Groningen and Department of Pulmonary Diseases, University Medical Center Groningen, Hanzeplein 1, P,O, Box 30,001, Groningen 9700 RB, The Netherlands.
Radiat Oncol. 2014 Aug 29;9:190. doi: 10.1186/1748-717X-9-190.
Stage III unresectable non-small cell lung cancer (NSCLC) is preferably treated with concurrent schedules of chemoradiotherapy, but none is clearly superior Gemcitabine is a radiosensitizing cytotoxic drug that has been studied in phase 1 and 2 studies in this setting. The aim of this study was to describe outcome and toxicity of low-dose weekly gemcitabine combined with concurrent 3-dimensional conformal radiotherapy (3D-CRT).
PATIENTS & METHODS: Treatment consisted of two cycles of a cisplatin and gemcitabine followed by weekly gemcitabine 300 mg/m2 during 5 weeks of 3D-CRT, 60 Gy in 5 weeks (hypofractionated-accelerated). Overall survival (OS), progression-free survival (PFS), and treatment related toxicity according to Common Toxicity Criteria of Adverse Events (CTCAE) version 3.0 were assessed.
Between February 2002 and August 2008, 318 patients were treated. Median age was 64 years (range 36-86); 72% were male, WHO PS 0/1/2 was 44/53/3%. Median PFS was 15.5 months (95% confidence interval [CI], 12.9-18.1) and median OS was 24.6 months (95% CI., 21.0-28.1). Main toxicity (CTCAE grade ≥3) was dysphagia (12.6%), esophagitis (9.6%), followed by radiation pneumonitis (3.0%). There were five treatment related deaths (1.6%), two due to esophagitis and three due to radiation pneumonitis.
Concurrent low-dose gemcitabine and 3D-CRT provides a comparable survival and toxicity profile to other available treatment schemes for unresectable stage III.
Ⅲ期不可切除的非小细胞肺癌(NSCLC)最好采用同步放化疗方案进行治疗,但尚无一种方案明显更具优势。吉西他滨是一种放射增敏性细胞毒性药物,已在该情况下进行了1期和2期研究。本研究的目的是描述低剂量每周一次吉西他滨联合同步三维适形放疗(3D-CRT)的疗效和毒性。
治疗包括两个周期的顺铂和吉西他滨,随后在3D-CRT的5周内每周给予吉西他滨300mg/m²,5周内给予60Gy(超分割加速放疗)。根据不良事件通用毒性标准(CTCAE)第3.0版评估总生存期(OS)、无进展生存期(PFS)和治疗相关毒性。
2002年2月至2008年8月期间,共治疗了318例患者。中位年龄为64岁(范围36-86岁);72%为男性,世界卫生组织(WHO)体能状态0/1/2级的患者分别为44/53/3%。中位PFS为15.5个月(95%置信区间[CI],12.9-18.1),中位OS为24.6个月(95%CI,21.0-28.1)。主要毒性(CTCAE≥3级)为吞咽困难(12.6%)、食管炎(9.6%),其次是放射性肺炎(3.0%)。有5例治疗相关死亡(1.6%),2例死于食管炎,3例死于放射性肺炎。
同步低剂量吉西他滨和3D-CRT与其他不可切除Ⅲ期的可用治疗方案相比,生存期和毒性相当。