Updated survival outcomes of NEJ005/TCOG0902: a randomised phase II study of concurrent versus sequential alternating gefitinib and chemotherapy in previously untreated non-small cell lung cancer with sensitive EGFR mutations.
Updated survival outcomes of NEJ005/TCOG0902: a randomised phase II study of concurrent versus sequential alternating gefitinib and chemotherapy in previously untreated non-small cell lung cancer with sensitive EGFR mutations.
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DOI：
10.1136/esmoopen-2017-000313
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发表时间：
2018
期刊：
影响因子：
7.3
通讯作者：
Nukiwa T
中科院分区：
文献类型：
--
作者：
Oizumi S;Sugawara S;Minato K;Harada T;Inoue A;Fujita Y;Maemondo M;Watanabe S;Ito K;Gemma A;Demura Y;Fukumoto S;Isobe H;Kinoshita I;Morita S;Kobayashi K;Hagiwara K;Aiba K;Nukiwa T
东北日本研究组（NEJ）005/东京肿瘤协作组（TCOG）0902研究报告称，表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（吉非替尼）+含铂二联化疗（卡铂/培美曲塞）一线同步和序贯交替联合治疗为EGFR突变型非小细胞肺癌患者提供了有前景的疗效和可预测的毒性。然而，由于缺乏死亡事件，主要报告中的总生存期（OS）数据不足。在最终数据截止点（2017年3月）重新评价整个人群（n=80）的无进展生存期（PFS）和OS。中位随访时间为35.6个月，88.8%的患者出现疾病进展，77.5%的患者死亡。并行治疗方案的中位PFS为17.5个月，序贯交替治疗方案为15.3个月（P=0.13）。中位OS分别为41.9和30.7个月（P=0.036）。两组的更新应答率相似（分别为90.2%和82.1%; P=0.34）。Del 19肿瘤患者的OS（中位数：分别为45.3和33.3个月）相对优于L 858 R患者（分别为31.4和28.9个月）。自主要报告以来，未发生重度不良事件，包括间质性肺病。这项更新的分析证实，与吉非替尼单药治疗相比，一线联合治疗可改善PFS，特别是在EGFR突变背景下，联合治疗方案可提供42个月的OS获益。我们正在进行的NEJ 009研究将阐明这种联合策略是否可以纳入常规临床实践。UMIN C 000002789，后结果。
The North-East Japan Study Group (NEJ) 005/Tokyo Cooperative Oncology Group (TCOG) 0902 study has reported that first-line concurrent and sequential alternating combination therapies of an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (gefitinib) plus platinum-based doublet chemotherapy (carboplatin/pemetrexed) offer promising efficacy with predictable toxicities for patients with EGFR-mutant non-small cell lung cancer. However, overall survival (OS) data were insufficient in the primary report because of the lack of death events. Progression-free survival (PFS) and OS were re-evaluated at the final data cut-off point (March 2017) for the entire population (n=80). At the median follow-up time of 35.6 months, 88.8% of patients had progressive disease and 77.5% of patients had died. Median PFS was 17.5 months for the concurrent regimen and 15.3 months for the sequential alternating regimen (P=0.13). Median OS was 41.9 and 30.7 months, respectively (P=0.036). Updated response rates were similar in both groups (90.2% and 82.1%, respectively; P=0.34). Patients with Del19 tumours displayed relatively better OS (median: 45.3 vs 33.3 months, respectively) than those with L858R (31.4 vs 28.9 months, respectively). No severe adverse events, including interstitial lung disease, occurred in the period since the primary report. This updated analysis confirms that PFS is improved with first-line combination therapy compared with gefitinib monotherapy and that the concurrent regimen, in particular, offers an OS benefit of 42 months in the EGFR-mutated setting. Our ongoing NEJ009 study will clarify whether this combination strategy can be incorporated into routine clinical practice. UMIN C000002789, Post-results.
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