Real world effectiveness and safety of pegylated liposomal doxorubicin in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer: a Korean multicenter retrospective cohort study

• Published in: Journal of gynecologic oncology Vol. 31; no. 2; pp. 1 - 13
• Main Authors: Soo Jin Park, Jihye Kim, Hee Seung Kim, Jeong-won Lee, Ha Kyun Chang, Keun Ho Lee, Dae-yeon Kim, Sunghoon Kim, Suk-joon Chang, Seung Su Han, Sang-yoon Park, Seung-hyuk Shim
• Format: Journal Article
• Language: Korean
• Published: 대한부인종양학회 01.03.2020
• Subjects: Chemotherapy; Ovarian Cancer; Platinum; Prognosis; Recurrence
• ISSN: 2005-0380

Objective: To evaluate the effectiveness and safety of the combination of pegylated liposomal doxorubicin with carboplatin (CD) compared with those of carboplatin and paclitaxel (CP) for platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer in a real-world setting in Korea. Methods: We enrolled relevant patients from 9 institutions. All patients received CD or CP as the second- or third-line chemotherapy in routine clinical practice during 2013-2018. The primary endpoints were progression-free survival (PFS) and toxicity. The secondary endpoint included the objective response rate (ORR). Results: Overall, 432 patients (224 and 208 in the CD and CP groups, respectively) were included. With a median follow-up of 18.9 months, the median PFS was not different between the groups (12.7 vs. 13.6 months; hazard ratio, 1.161; 95% confidence interval, 0.923-1.460; p=0.202). The ORR was 74.6% and 80.1% in the CD and CP group, respectively (p=0.556). Age and surgery at relapse were independent prognostic factors. More patients in the CD group significantly experienced a grade 3 to 4 hematologic toxicity and hand-foot syndrome (13.8% vs. 6.3%), whereas grade 2 or more alopecia (6.2% vs. 36.1%), peripheral neuropathy (4.4% vs. 11.4%), and allergic/hypersensitivity reaction (0.4% vs. 8.5%) developed more often in the CP group. Conclusions: The safety and effectiveness of chemotherapy with CD in a real-world setting were consistent with the results from a randomized controlled study. The different toxicity profiles between the 2 chemotherapy (CD and CP) regimens should be considered in the clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT03562533