Induction chemotherapy followed by concomitant chemoradiotherapy (CT/XRT) versus CT/XRT alone for regionally advanced unresectable non-small cell lung cancer (NSCLC): Initial analysis of a randomized phase III trial.
Induction chemotherapy followed by concomitant chemoradiotherapy (CT/XRT) versus CT/XRT alone for regionally advanced unresectable non-small cell lung cancer (NSCLC): Initial analysis of a randomized phase III trial.
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DOI：
10.1200/jco.2004.22.14_suppl.7005
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发表时间：
2004-07
期刊：
影响因子：
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通讯作者：
E. Vokes;J. E. Herndon;Michael J. Kelley;D. Watson;M. Cicchetti;Michael R. Green
中科院分区：
文献类型：
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作者：
E. Vokes;J. E. Herndon;Michael J. Kelley;D. Watson;M. Cicchetti;Michael R. Green
7005 背景：不可切除的 III 期 NSCLC 的标准治疗包括同步放化疗。在 CALGB 39801 中，我们评估了在 CT/XRT 之前添加诱导化疗是否会提高生存率。方法 10/1998 至 5/2002 期间，366 名 III 期患者 (pts) 被随机分配接受立即 CT/XRT [卡铂 AUC 为 2，紫杉醇 50 mg/m2，在 66 Gy 胸部 XRT 期间每周给予一次；第 1 组（182 名患者）] 或两个周期的卡铂 AUC 6 和紫杉醇 200 mg/m2，每 21 天 x 2 个周期，随后进行相同的 CT/XRT；第 2 臂（184 分）。累积目标是 360 名患者。假设在 0.025 显着性水平上进行单尾对数秩检验，需要 290 例死亡病例有 80% 的功效才能检测到中位生存期增加 40%。结果 34% 的患者为女性，66% 为男性，63% 年龄在 60 岁或以上。诱导化疗期间的3级或4级毒性主要包括中性粒细胞减少症（17%/21%）。 CT/XRT 期间，3/4 级中性粒细胞减少症分别为 11%/4%（第 1 组）和 21%/6%（第 2 组），3 级贫血为 5% 与 11%，3/4 级疲劳为 16%/1% 与 16%/4%，食管炎为 30%/1% 与 28%/7%，呼吸困难为 9%/3% 与15%/4%。总体而言，第 1 组有 24% 的患者经历了 4 种毒性，而第 2 组有 41% 的患者出现过 4 种毒性 (p=0.001)。 290 例目标死亡中有 254 例死亡，第 1 组的中位生存期为 11.4 个月，而第 2 组的中位生存期为 14 个月 (p=0.154)。一年生存率估计分别为 48% (41%-57%) 和 54% (47%-62%)。结论 与文献中最近的其他经验相比，每个治疗组实现的中位生存期较低。其原因尚不确定。在立即同步 CT/XRT 的基础上添加诱导化疗可使中位生存期延长 2.6 个月。然而，这些发现不足以拒绝两个研究组之间没有治疗差异的零假设。需要进一步跟进该数据集。我们的结果不支持使用诱导化疗后 CT/XRT 作为不可切除的 III 期 NSCLC 患者的循证护理标准。 [表：见正文]。
7005 Background: Standard therapy for unresectable stage III NSCLC includes concomitant chemoradiotherapy. In CALGB 39801, we evaluated whether the addition of induction chemotherapy prior to CT/XRT would result in improved survival. METHODS Between 10/1998 and 5/2002, 366 stage III patients (pts) were randomized to either immediate CT/XRT [carboplatin AUC of 2 and paclitaxel 50 mg/m2 each given weekly during 66 Gy chest XRT to; arm 1 (182 pts)] or two cycles of carboplatin AUC 6 and paclitaxel 200 mg/m2 given q 21 days x 2 cycles followed by identical CT/XRT; arm 2 (184 pts). The accrual goal was 360 patients. 290 deaths were required to have 80% power to detect a 40% increase in median survival assuming a one-tailed log-rank test conducted at the 0.025 level of significance. RESULTS 34% of pts were female, 66% male and 63% were age 60 or older. Grade 3 or 4 toxicities during induction chemotherapy consisted mainly of neutropenia (17%/21%). During CT/XRT, grade 3/4 neutropenia was noted in 11%/4% (arm 1) versus 21%/6% (arm 2), grade 3 anemia was 5% vs 11%, grade 3/4 fatigue 16%/1% vs 16%/4%, esophagitis 30%/1% vs 28%/7%, and dyspnea 9%/3% vs 15%/4%. Overall, 4 toxicities were experienced by 24% of patients on arm 1 versus 41% on arm 2 (p=0.001). With 254 of 290 targeted deaths, median survival on arm 1 is 11.4 months versus 14 months on arm 2 (p=0.154). One year survival estimates are 48% (41%-57%) and 54% (47%-62%) respectively. CONCLUSION The median survival achieved in each of the treatment groups is low compared to other recent experiences in the literature. The reason(s) for this are uncertain. The addition of induction chemotherapy to immediate concurrent CT/XRT is associated with a 2.6 month increase in median survival. However these findings are not sufficient to reject the null hypothesis of no treatment difference between the two study arms. Further follow up of this data set is required. Our results do not support the use of induction chemotherapy followed by CT/XRT as evidence based standard of care for patients with unresectable stage III NSCLC. [Table: see text].