J Gynecol Oncol.  2020 Mar;31(2):e15. 10.3802/jgo.2020.31.e15.

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

Affiliations
  • 1Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea.
  • 2Department of Obstetrics and Gynecology, Dankook University Hospital, Cheonan, Korea.
  • 3Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 4Center for Gynecologic Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
  • 5Department of Obstetrics and Gynecology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • 6Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 7Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Korea.
  • 8Gynecologic Cancer Center, Department of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon, Korea.
  • 9Department of Obstetrics and Gynecology, Chung-Ang University College of Medicine, Seoul, Korea.
  • 10Department of Obstetrics and Gynecology, Research Institute of Medical Science, Konkuk University School of Medicine, Seoul, Korea. nastassja@hanmail.net

Abstract


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

Keyword

Ovarian Cancer; Recurrence; Platinum; Prognosis; Chemotherapy
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