Grossi Francesco, Jaśkiewicz Piotr, Ferreira Marion, Czyżewicz Grzegorz, Kowalski Dariusz, Ciuffreda Libero, Garcia-Gomez Ramon, Caruso Salvatore, Bosch-Barrera Joaquim, Gautier Stéphanie, Ta Thanh Minh Christine, Henriet Sébastien, de Castro Gilberto
UOC Oncologia Medica, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, Italy.
Lung Cancer and Chest Tumours Department, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Ther Adv Med Oncol. 2021 Jul 16;13:17588359211022905. doi: 10.1177/17588359211022905. eCollection 2021.
The study investigated the efficacy and safety of oral vinorelbine-cisplatin (OV-CDDP) and gemcitabine-cisplatin (GEM-CDDP) in patients with squamous non-small cell lung cancer (sq-NSCLC).
This was an open-label, prospective, multicenter, international phase II study that enrolled untreated patients with advanced sq-NSCLC. Patients were randomized to receive 3-week cycles of either 60-80 mg/m OV days 1 and 8 in combination with 80 mg/m CDDP day 1 (arm A) or 1250 mg/m GEM days 1 and 8 in combination with 75 mg/m CDDP day 1 (arm B). After four cycles, patients without disease progression continued maintenance dose of OV or GEM until progression or unacceptable toxicity. The primary objective was disease control rate (DCR). Secondary objectives included progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS), safety, and quality of life (QoL).
A total of 114 patients with sq-NSCLC were randomized, and 113 were treated (57 in arm A and 56 in arm B). DCR was high in both arms: 73.7% (95%CI: 62.4-100.0) in arm A and 75.0% (95%CI: 63.7-100.0) in arm B. Median PFS and TTF were similar in arm A and B 4.2 and 2.8 months, and 4.3 and 3.1 months, respectively. Even though the difference was not significant, the OS was 10.2 for arm A and 8.4 months for arm B. The safety profiles were consistent with the current knowledge of adverse events. QoL results revealed an improvement in patients under OV treatment.
The OV-CDDP combination showed comparable efficacy to GEM-CDDP with acceptable safety profile and enhanced patients' QoL.
The study was registered under EudraCT number 2012-003531-40.
本研究调查了口服长春瑞滨-顺铂（OV-CDDP）和吉西他滨-顺铂（GEM-CDDP）治疗鳞状非小细胞肺癌（sq-NSCLC）患者的疗效和安全性。
这是一项开放标签、前瞻性、多中心、国际II期研究，纳入未经治疗的晚期sq-NSCLC患者。患者被随机分为两组，接受为期3周的周期治疗，A组在第1天和第8天给予60-80mg/m²的OV，联合第1天给予80mg/m²的顺铂；B组在第1天和第8天给予1250mg/m²的吉西他滨，联合第1天给予75mg/m²的顺铂。四个周期后，疾病无进展的患者继续接受OV或吉西他滨的维持剂量，直至疾病进展或出现不可接受的毒性。主要目标是疾病控制率（DCR）。次要目标包括无进展生存期（PFS）、治疗失败时间（TTF）、总生存期（OS）、安全性和生活质量（QoL）。
共有114例sq-NSCLC患者被随机分组，113例接受治疗（A组57例，B组56例）。两组的DCR均较高：A组为73.7%（95%CI：62.4-100.0），B组为75.0%（95%CI：63.7-100.0）。A组和B组的中位PFS和TTF相似，分别为4.2和2.8个月，以及4.3和3.1个月。尽管差异不显著，但A组的OS为10.2个月，B组为8.4个月。安全性与目前已知的不良事件一致。QoL结果显示接受OV治疗的患者有所改善。
OV-CDDP联合方案显示出与GEM-CDDP相当的疗效，安全性可接受，并提高了患者的QoL。
本研究在欧洲临床试验数据库（EudraCT）注册号为2012-003531-40。
