Comparative study on efficacy and safety of generic and original pemetrexed in patients with non-small cell lung cancer
10.3760/cma.j.cn114015-20210209-00170
- VernacularTitle:仿制与原研培美曲塞治疗非小细胞肺癌疗效与安全性的比较研究
- Author:
Jun YANG
1
;
Yafei SHI
1
;
Shuya QI
1
;
Wei CHEN
1
;
Guohui LI
1
Author Information
1. 国家癌症中心·国家肿瘤临床医学研究中心·中国医学科学院北京协和医学院肿瘤医院药剂科，北京 100021
- Publication Type:Journal Article
- Keywords:
Drugs, generic;
Pemetrexed;
Carcinoma, non-small-cell lung
- From:
Adverse Drug Reactions Journal
2021;23(9):468-473
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the efficacy and safety between the generic pemetrexed produced by Sichuan Huiyu Pharmaceutical Co., LTD and the original pemetrexed produced by Eli Lilly Nederland B.V. in the treatment for patients with non-small cell lung cancer (NSCLC).Methods:The subjects were patients who received generic and original pemetrexed from March 2019 to December 2019 in Cancer Hospital of Chinese Academy of Medical Sciences. Demographic characteristics (age, gender, past history, etc.), treatment-related information (NSCLC stage, treatment regimen, underlying diseases, etc.), occurrence of adverse events, and efficacy evaluation in patients were collected. Patients were divided into the generic group and the original group, and the general situation, clinical use of pemetrexed, and adverse events in patients in the 2 groups were compared. After propensity score matching for 7 variables such as gender, age, body weight, body surface area, Eastern Cooperative Oncology Group (ECOG) score, tumor stage, and standardized chemotherapy dose, the efficacy and safety in patients between the 2 groups after 2 cycles of treatment with generic and original pemetrexed were compared.Results:A total of 182 patients were enrolled in the study, including 85 patients in the generic group and 97 patients in the original group. The differences in age, gender, ECOG score, body weight and body surface area, and underlying chronic diseases between the 2 groups were not statistically significant (all P>0.05). The patients with advanced stage Ⅲ and Ⅳ cancer in the generic group were significantly more than those in the original group [92%(78/85) vs. 79% (77/97), P=0.032]. The proportion of palliative chemotherapy and maintenance chemotherapy in the generic group was higher than that in the original group ( P<0.001). The difference in median dosage between the generic group and the original group was statistically significant [900 (800, 1 000) mg/m 2vs. 800 (800, 900) mg/m 2, P=0.019]. The difference in chemotherapy cycles between the 2 groups was statistically significant [5 (4, 10) vs. 4 (2, 4), P<0.001]. The overall incidence of adverse events and the incidences of bone marrow toxicity and liver toxicity in the generic group were higher than those in the original group ( P=0.018, P=0.037, P=0.018). After propensity score matching, there were 38 patients in both groups, and the differences in the objective response rate, disease control rate and the incidence of adverse events between the 2 groups were not statistically significant [26% (10/38) vs. 32%(12/38), P=0.723; 89% (34/38) vs. 96% (36/38), P=0.674; 47% (18/38) vs. 24%(9/38), P=0.055]. Conclusion:After propensity score matching, the difference in the efficacy and safety between the generic and the original pemetrexed was not significant.
