Zhen Yuan1, Ying Zhang2, Dongyan Cao3, Keng Shen4, Qingshui Li5, Guonan Zhang6, Xiaohua Wu7, Manhua Cui8, Ying Yue9, Wenjun Cheng10, Li Wang11, Pengpeng Qu12, Guangshi Tao13, Jianqing Hou14, Lixin Sun15, Yuanguang Meng16, Guiling Li17, Changzhong Li18, Huirong Shi19, Yaqing Chen20. 1. Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, Zip code: 100730, China. 2. Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, Zip code: 100730, China. zhangyingpumch@163.com. 3. Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, Zip code: 100730, China. caodongyanpumch@sina.com. 4. Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, Zip code: 100730, China. shenkengpumch@163.com. 5. Department of Gynecologic Oncology, Shandong Cancer Hospital & Institute, Shandong, China. 6. Department of Gynecologic Oncology, Sichuan Cancer Hospital & Institute, Sichuan, China. 7. Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. 8. Department of Obstetrics and Gynecology, The Second Hospital of Jilin University, Jilin, China. 9. Department of Obstetrics and Gynecology, The First Bethune Hospital of Jilin University, Jilin, China. 10. Department of Obstetrics and Gynecology, Jiangsu Province Hospital, Jiangsu, China. 11. Department of Gynecologic Oncology, He Nan Cancer Hospital, Henan, China. 12. Department of Obstetrics and Gynecology, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China. 13. Department of Obstetrics and Gynecology, The Second Xiangya Hospital of Central South University, Hunan, China. 14. Department of Obstetrics and Gynecology, Yantai Yuhuangding Hospital, Shandong, China. 15. Department of Gynecologic Oncology, Shanxi Cancer Hospital, Shanxi, China. 16. Department of Obstetrics and Gynecology, Chinese PLA General Hospital, Beijing, China. 17. Department of Obstetrics and Gynecology, Wuhan Union Hospital of China, Hubei, China. 18. Department of Obstetrics and Gynecology, Shandong Provincial Hospital, Shandong, China. 19. Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, Henan, China. 20. Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Zhejiang, China.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of PLD in treating of in patients who experience epithelial ovarian, fallopian tubal, and peritoneal cancer progression within 12 months after the first-line platinum-based therapy. METHODS: This was an open-label, single-arm and multicenter clinical trial. The ORR was the interim primary objective, and the DCR, AEs and QOL were the secondary objectives. The impact of factors on efficacy outcomes, the change trend of CA125 and the artificial platinum-free interval were exploratory endpoints. RESULTS: Totally, 115 patients were enrolled in this study and included in the ITT population. Moreover, 101 patients were included in the safety population. The median follow-up time was 4 months (IQR 2-6). In the ITT population, the confirmed ORR was 37.4% (95% CI, 28.4-46.4%), and the DCR was 65.2% (95% CI, 56.4-74.1%). The previous response status to platinum-based chemotherapy and baseline CA125 levels were significantly correlated with the ORR. The ORR was significantly higher in patients with a CA125 decrease after the first cycle than in the patients with a CA125 increase. The most common grade 3 or higher AE was hand-foot syndrome (3 [3.0%] of 101 patients). No statistically significant differences existed between the baseline and the postbaseline questionnaires. CONCLUSIONS: For patients who experience platinum-resistant and platinum-refractory relapse, the use of PLD may be acceptable because of the associated satisfactory efficacy, low frequency of AEs and high patient QOL. Moreover, a low CA125 level at baseline and a reduction in CA125 after the first cycle are predictive factors for satisfactory efficacy.
OBJECTIVE: To evaluate the efficacy and safety of PLD in treating of in patients who experience epithelial ovarian, fallopian tubal, and peritoneal cancer progression within 12 months after the first-line platinum-based therapy. METHODS: This was an open-label, single-arm and multicenter clinical trial. The ORR was the interim primary objective, and the DCR, AEs and QOL were the secondary objectives. The impact of factors on efficacy outcomes, the change trend of CA125 and the artificial platinum-free interval were exploratory endpoints. RESULTS: Totally, 115 patients were enrolled in this study and included in the ITT population. Moreover, 101 patients were included in the safety population. The median follow-up time was 4 months (IQR 2-6). In the ITT population, the confirmed ORR was 37.4% (95% CI, 28.4-46.4%), and the DCR was 65.2% (95% CI, 56.4-74.1%). The previous response status to platinum-based chemotherapy and baseline CA125 levels were significantly correlated with the ORR. The ORR was significantly higher in patients with a CA125 decrease after the first cycle than in the patients with a CA125 increase. The most common grade 3 or higher AE was hand-foot syndrome (3 [3.0%] of 101 patients). No statistically significant differences existed between the baseline and the postbaseline questionnaires. CONCLUSIONS: For patients who experience platinum-resistant and platinum-refractory relapse, the use of PLD may be acceptable because of the associated satisfactory efficacy, low frequency of AEs and high patient QOL. Moreover, a low CA125 level at baseline and a reduction in CA125 after the first cycle are predictive factors for satisfactory efficacy.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
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