Lv Wei-Ze, Lin Zhong, Wang Si-Yang, Lv Bao-Jun, Wang Zhi-Hui, Xiao Mei, Xu Xiao-Lu, Peng Pei-Jian
Department of Medical Oncology, The Fifth Affiliated Hospital of Sun-Yat-Sen University, Zhuhai, Guangdong Province, People's Republic of China.
Department of Radiation Oncology, The Fifth Affiliated Hospital of Sun-Yat-Sen University, Zhuhai, Guangdong Province, People's Republic of China.
Transl Oncol. 2019 Apr;12(4):656-660. doi: 10.1016/j.tranon.2019.01.008. Epub 2019 Feb 27.
The platinum-based, two-drug, 3-week regimen is currently the main first-line chemotherapy program for the treatment of advanced squamous cell lung cancer. The aim of this phase II clinical study was to evaluate the efficacy and adverse events of the bi-weekly program of liposomal paclitaxel combined with nedaplatin as a first-line treatment for advanced squamous cell lung cancer. A total of 52 cases of advanced squamous cell lung cancer were included in this phase II clinical trial. Patients received intravenous infusion of liposomal paclitaxel (100 mg/m) and nedaplatin (50 mg/m) on days 1 and 15 of a 4-week cycle. Each patient received two to six cycles of chemotherapy, consistent with the regimen of combined liposomal paclitaxel and nedaplatin. The total effective rate of this chemotherapy program was 37.5%. The median progression-free survival time was 8.5 months (95% confidence interval: 7.8-9.2). The median survival time was 16 months (95% confidence interval: 14.1-17.9). The main adverse event was myelosuppression. Grade 3 leukopenia was noted in seven patients (13.5%), and no grade 4 leukopenia was observed. Grade 3 anemia was noted in four patients (7.7%), and no grade 4 anemia was observed. In addition, no grade 2 or higher thrombocytopenia and no grade 3 or 4 non-bone marrow toxicity was detected. The bi-weekly program of liposomal paclitaxel combined with nedaplatin is effective for the treatment of advanced squamous cell lung cancer, with high safety and few adverse events. However, additional studies are warranted to confirm these results. The trial was registered under the number ChiCTR-OIN-17011423.
基于铂类的两药三周方案是目前治疗晚期肺鳞癌的主要一线化疗方案。本II期临床研究的目的是评估脂质体紫杉醇联合奈达铂两周方案作为晚期肺鳞癌一线治疗的疗效和不良事件。本II期临床试验共纳入52例晚期肺鳞癌患者。患者在4周周期的第1天和第15天接受脂质体紫杉醇（100mg/m²）和奈达铂（50mg/m²）静脉输注。每位患者接受两至六个周期的化疗，符合脂质体紫杉醇联合奈达铂方案。该化疗方案的总有效率为37.5%。中位无进展生存期为8.5个月（95%置信区间：7.8 - 9.2）。中位生存期为16个月（95%置信区间：14.1 - 17.9）。主要不良事件为骨髓抑制。7例患者（13.5%）出现3级白细胞减少，未观察到4级白细胞减少。4例患者（7.7%）出现3级贫血，未观察到4级贫血。此外，未检测到2级或更高等级的血小板减少，也未检测到3级或4级非骨髓毒性。脂质体紫杉醇联合奈达铂两周方案治疗晚期肺鳞癌有效，安全性高，不良事件少。然而，需要进一步研究来证实这些结果。该试验的注册号为ChiCTR - OIN - 17011423。
