Department of Radiation Oncology, VU Medical Center, Amsterdam, The Netherlands.
Department of Medical Oncology, Institut Catala d'Oncologia, Barcelona, Spain.
Ann Oncol. 2011 Mar;22(3):553-558. doi: 10.1093/annonc/mdq388. Epub 2010 Aug 9.
In stage III non-small-cell lung cancer (NSCLC), the role of systemic chemotherapy preceding or following concurrent chemo-radiotherapy (CT-RT) is unclear. We carried out a randomized phase II study to study the toxicity involved-field CT-RT with either induction or consolidation cisplatin-docetaxel (Taxotere).
Patients were randomly assigned to receive two cycles of docetaxel (D) 75 mg/m(2) on day 1 and cisplatin (C) 40 mg/m(2) on days 1 and 2, either preceding (IND arm) or following (CON arm) concurrent CT-RT, where 66 Gy was delivered using involved-fields concurrent with weekly D 20 mg/m(2) and C 20 mg/m(2). Patients at higher risk for lung toxicity (V(20) > 35%) crossed over to IND arm. Seventy patients were needed to exclude grade (G)3-4 esophagitis in >25%.
Of the 70 eligible patients, 26 were treated in IND and 34 CON; five with V(20) >35% switched from CON to IND. The differences in G3-4 esophagitis observed (32/2% IND versus 21/3% CON) were not significantly different from the hypothesized 25% rate. Rates of G≥2 pneumonitis were similar, but IND arm had less G3-4 neutropenia. One-year survival was 63.2% [95% confidence interval (CI) 48.4% to 78.0%] and 65.5% (95% CI 48.2% to 82.8%) for the IND and CON arms, respectively.
Both study arms merit further testing in patients with limited volume stage III NSCLC.
在 III 期非小细胞肺癌（NSCLC）中，全身化疗在同期放化疗（CT-RT）之前或之后的作用尚不清楚。我们进行了一项随机 II 期研究，以研究含诱导或巩固顺铂-多西紫杉醇（Taxotere）的适形放疗。
患者随机分为两组，分别接受两个周期的多西紫杉醇（D）75 mg/m²，第 1 天和第 2 天顺铂（C）40 mg/m²，分别在前（IND 臂）或后（CON 臂）同期 CT-RT，其中 66 Gy 采用适形放疗，与每周 20 mg/m² D 和 20 mg/m² C 同时进行。肺毒性风险较高（V（20）>35%）的患者交叉到 IND 臂。需要 70 例患者排除 >25%的 3-4 级食管炎。
在 70 例合格患者中，26 例接受 IND 治疗，34 例接受 CON 治疗；5 例 V（20）>35%的患者从 CON 转为 IND。观察到的 3-4 级食管炎发生率（IND 组为 32/2%，CON 组为 21/3%）与假设的 25%发生率无显著差异。≥2 级肺炎发生率相似，但 IND 组中性粒细胞减少症发生率较低。IND 臂和 CON 臂的 1 年生存率分别为 63.2%（95%CI 48.4%至 78.0%）和 65.5%（95%CI 48.2%至 82.8%）。
在局限性 III 期 NSCLC 患者中，两个研究臂都值得进一步研究。
