Park Cheol-Kyu, Oh Hyung-Joo, Yoo Seung Soo, Lee Shin Yup, Lee Sang Hoon, Kim Eun Young, Lee Sung Yong, Choi Juwhan, Lee Min Ki, Kim Mi-Hyun, Jang Tae Won, Chung Chaeuk, Oh In-Jae, Kim Young-Chul
Department of Internal Medicine, Chonnam National University Medical School and Hwasun Hospital, Jeonnam, Republic of Korea.
Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.
Transl Lung Cancer Res. 2022 Aug;11(8):1606-1618. doi: 10.21037/tlcr-22-183.
We aimed to evaluate the efficacy of postoperative adjuvant pemetrexed plus cisplatin (Pem-Cis) in pathologic stage IB-IIIA lung adenocarcinoma (LUAD) patients.
A prospective, phase II study was performed in seven institutions in South Korea. Patients with completely resected stage IB-IIIA LUAD received pemetrexed (500 mg/m) plus cisplatin (75 mg/m). Adjuvant treatments were administered every 3 weeks for 4 cycles. The primary endpoint was to prove the Pem-Cis's superiority in terms of 2-year disease-free survival rate (DFSR) compared with historical control without adjuvant chemotherapy (50%).
Between August 2015 and February 2018, 105 patients were enrolled in this study. Approximately 31.4% (n=33), 43.8% (n=46), and 24.8% (n=26) of patients had pathologic stage IB, II, and IIIA, respectively. Most of the patients underwent lobectomy (n=98, 93.3%). Moreover, 41.1% and 12.1% of the patients had epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase rearrangement. Four cycles of Pem-Cis were administered in 99 patients (94.3%). At a median follow-up of 57.7 months, the 2-year DFSR was 78.1%. Multivariable analysis showed that pathologic stage IIIA and EGFR mutation were significant risk factors for DFS. Grade 3 adverse events occurred in 10 patients (9.5%), and leukopenia (n=3, 2.9%) was the most common adverse event.
Adjuvant Pem-Cis is superior to historical control without adjuvant treatment in terms of 2-year DFSR; the proportion of patients with stage IB and driver mutations were higher than that of patients in previous trials. Pem-Cis showed favorable tolerability as adjuvant chemotherapy (clinicaltrial.gov; Identifier: NCT02498860).
我们旨在评估术后辅助培美曲塞联合顺铂（Pem-Cis）对病理分期为IB-IIIA期肺腺癌（LUAD）患者的疗效。
在韩国的7家机构进行了一项前瞻性II期研究。完全切除的IB-IIIA期LUAD患者接受培美曲塞（500mg/m²）联合顺铂（75mg/m²）治疗。辅助治疗每3周进行1次，共4个周期。主要终点是证明与未接受辅助化疗的历史对照（50%）相比，Pem-Cis在2年无病生存率（DFSR）方面的优越性。
2015年8月至2018年2月，105例患者纳入本研究。分别约有31.4%（n = 33）、43.8%（n = 46）和24.8%（n = 26）的患者病理分期为IB、II和IIIA期。大多数患者接受了肺叶切除术（n = 98，93.3%）。此外，41.1%和12.1%的患者有表皮生长因子受体（EGFR）突变和间变性淋巴瘤激酶重排。99例患者（94.3%）接受了4个周期的Pem-Cis治疗。中位随访57.7个月时，2年DFSR为78.1%。多变量分析显示，病理分期IIIA期和EGFR突变是DFS的显著危险因素。10例患者（9.5%）发生3级不良事件，白细胞减少（n = 3，2.9%）是最常见的不良事件。
在2年DFSR方面，辅助Pem-Cis优于未接受辅助治疗的历史对照；IB期和驱动基因突变患者的比例高于以往试验中的患者。Pem-Cis作为辅助化疗显示出良好的耐受性（clinicaltrial.gov；标识符：NCT02498860）。
