A phase II randomized controlled study of pegylated liposomal doxorubicin and carboplatin vs. gemcitabine and carboplatin for platinum-sensitive recurrent ovarian cancer (GOTIC003/intergroup study)

Hiroyuki Fujiwara, Kimio Ushijima, Shoji Nagao, Yuji Takei, Muneaki Shimada, Masashi Takano, Kiyoshi Yoshino, Yoshiaki Kawano, Yasuyuki Hirashima, Satoru Nagase, Shin Nishio, Tadaaki Nishikawa, Kimihiko Ito, Tadahiro Shoji, Eizo Kimura, Tadao Takano, Toru Sugiyama, Junzo Kigawa, Keiichi Fujiwara, Mitsuaki Suzuki

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1284-1291
Number of pages8
JournalInternational Journal of Clinical Oncology
Volume24
Issue number10
DOIs
Publication statusPublished - 2019 Oct 1

Keywords

  • Gemcitabine
  • Pegylated liposomal doxorubicin
  • Platinum-sensitive recurrent ovarian cancer
  • Randomized clinical trial

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

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