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. e15 - 13
• Main Authors: Park, Soo Jin, Kim, Jihye, Kim, Hee Seung, Lee, Jeong-Won, Chang, Ha Kyun, Lee, Keun Ho, Kim, Dae-Yeon, Kim, Sunghoon, Chang, Suk-Joon, Han, Seung Su, Park, Sang-Yoon, Shim, Seung-Hyuk
• Format: Journal Article
• Language: English
• Published: Korea (South) Asian Society of Gynecologic Oncology; Korean Society of Gynecologic Oncology 01.03.2020; 대한부인종양학회
• Subjects: Adult; Aged; Carboplatin - administration & dosage; Carboplatin - adverse effects; Carboplatin - therapeutic use; Cohort Studies; Doxorubicin - administration & dosage; Doxorubicin - adverse effects; Doxorubicin - analogs & derivatives; Doxorubicin - therapeutic use; Fallopian Tube Neoplasms - drug therapy; Female; Humans; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Staging; Original; Ovarian Neoplasms - drug therapy; Paclitaxel - therapeutic use; Peritoneal Neoplasms - surgery; Polyethylene Glycols - administration & dosage; Polyethylene Glycols - adverse effects; Polyethylene Glycols - therapeutic use; Progression-Free Survival; Republic of Korea; Retrospective Studies; 산부인과학; Republic of Korea; Ovarian Cancer; Recurrence; Chemotherapy; Prognosis; Platinum
• ISSN: 2005-0380; 2005-0399; 2005-0399
• DOI: 10.3802/jgo.2020.31.e15

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. 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). 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. 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. ClinicalTrials.gov Identifier: NCT03562533.