Hiroyuki Fujiwara1, Kimio Ushijima2, Shoji Nagao3,4, Yuji Takei5, Muneaki Shimada6,7, Masashi Takano8, Kiyoshi Yoshino9,10, Yoshiaki Kawano11, Yasuyuki Hirashima12, Satoru Nagase13, Shin Nishio2, Tadaaki Nishikawa3, Kimihiko Ito14, Tadahiro Shoji15, Eizo Kimura16, Tadao Takano7, Toru Sugiyama15, Junzo Kigawa6,17, Keiichi Fujiwara3, Mitsuaki Suzuki5,18. 1. Department of Obstetrics and Gynecology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, 329-0498, Tochigi, Japan. fujiwara@jichi.ac.jp. 2. Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan. 3. Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan. 4. Department of Gynecologic Oncology, Hyogo Cancer Center, Akashi, Japan. 5. Department of Obstetrics and Gynecology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, 329-0498, Tochigi, Japan. 6. Department of Obstetrics and Gynecology, Tottori University School of Medicine, Tottori, Japan. 7. Department of Obstetrics and Gynecology, Tohoku University School of Medicine, Miyagi, Japan. 8. Department of Obstetrics and Gynecology, National Defense Medical College Hospital, Saitama, Japan. 9. Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Osaka, Japan. 10. Department of Obstetrics and Gynecology, University of Occupational and Environmental Health, Kitakyushu, Japan. 11. Department of Obstetrics and Gynecology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 12. Department of Gynecology, Shizuoka Cancer Center Hospital, Shizuoka, Japan. 13. Department of Obstetrics and Gynecology, Yamagata University School of Medicine, Yamagata, Japan. 14. Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Hyogo, Japan. 15. Department of Obstetrics and Gynecology, Iwate Medical University, Iwate, Japan. 16. Department of Obstetrics and Gynecology, Kosei Hospital, Tokyo, Japan. 17. Department of Obstetrics and Gynecology, Matsue City Hospital, Matsue, Japan. 18. Department of Obstetrics and Gynecology, Shin Yurigaoka General Hospital, Kawasaki, Japan.
Abstract
PURPOSE: To compare the efficacy, safety, and tolerability profiles of pegylated liposomal doxorubicin and carboplatin (PLDC) with those of gemcitabine and carboplatin (GC) for the treatment of patients with platinum-sensitive recurrent ovarian cancer. METHODS:Ovarian cancer patients with recurrence > 6 months after first-line platinum and taxane-based therapies were randomly assigned to PLDC [pegylated liposomal doxorubicin 30 mg/m2 plus carboplatin area under the curve (AUC) 5 mg/mL/min on day 1] every 4 weeks or GC (gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin AUC 4 mg/mL/min on day 1) every 3 weeks for at least 6 cycles. The primary endpoint was progression-free survival, and overall response rate, overall survival, toxicity, and dose administration were secondary endpoints. RESULTS:One-hundred patients (49 PLDC; 51 GC) were randomly assigned. Over a median follow-up of 24 months, the median progression-free survival was 12.0 months (95% CI 9.2-15.0) for PLDC and 9.8 months (8.9-12.3) for GC [HR 0.69 (0.455-1.047)] with a difference of 2.2 months. The response rate was 57.1% (41.0-72.3) for PLDC and 56.4% (39.6-72.2) for GC. No obvious differences in toxicity (G3/4) were noted between arms. The median relative dose intensity of planned dose per week was 88.9% for pegylated liposomal doxorubicin and 53.1% for gemcitabine (p < 0.0001). CONCLUSIONS:PLDC and GC are both good treatment candidates for platinum-sensitive recurrent ovarian cancer patients; however, the dose intensity was lower for GC than for PLDC. PLDC had a more favorable risk-benefit profile than that of GC for patients.
RCT Entities:
PURPOSE: To compare the efficacy, safety, and tolerability profiles of pegylated liposomal doxorubicin and carboplatin (PLDC) with those of gemcitabine and carboplatin (GC) for the treatment of patients with platinum-sensitive recurrent ovarian cancer. METHODS:Ovarian cancerpatients with recurrence > 6 months after first-line platinum and taxane-based therapies were randomly assigned to PLDC [pegylated liposomal doxorubicin 30 mg/m2 plus carboplatin area under the curve (AUC) 5 mg/mL/min on day 1] every 4 weeks or GC (gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin AUC 4 mg/mL/min on day 1) every 3 weeks for at least 6 cycles. The primary endpoint was progression-free survival, and overall response rate, overall survival, toxicity, and dose administration were secondary endpoints. RESULTS: One-hundred patients (49 PLDC; 51 GC) were randomly assigned. Over a median follow-up of 24 months, the median progression-free survival was 12.0 months (95% CI 9.2-15.0) for PLDC and 9.8 months (8.9-12.3) for GC [HR 0.69 (0.455-1.047)] with a difference of 2.2 months. The response rate was 57.1% (41.0-72.3) for PLDC and 56.4% (39.6-72.2) for GC. No obvious differences in toxicity (G3/4) were noted between arms. The median relative dose intensity of planned dose per week was 88.9% for pegylated liposomal doxorubicin and 53.1% for gemcitabine (p < 0.0001). CONCLUSIONS:PLDC and GC are both good treatment candidates for platinum-sensitive recurrent ovarian cancerpatients; however, the dose intensity was lower for GC than for PLDC. PLDC had a more favorable risk-benefit profile than that of GC for patients.
Authors: Shuyang Yao; Filip Janku; Kimberly Koenig; Apostolia Maria Tsimberidou; Sarina Anne Piha-Paul; Nai Shi; John Stewart; Amanda Johnston; John Bomalaski; Funda Meric-Bernstam; Siqing Fu Journal: Cancer Med Date: 2021-11-28 Impact factor: 4.452