A phase II study of irinotecan and pegylated liposomal doxorubicin in platinum-resistant recurrent ovarian cancer (Tohoku Gynecologic Cancer Unit 104 study)

Tadahiro Shoji, Eriko Takatori, Hideo Omi, Masahiro Kagabu, Tatsuya Honda, Masayuki Futagami, Yoshihito Yokoyama, Michiko Kaiho, Hideki Tokunaga, Takeo Otsuki, Tadao Takano, Nobuo Yaegashi, Takanobu Kojimahara, Tsuyoshi Ohta, Satoru Nagase, Shu Soeda, Takafumi Watanebe, Hiroshi Nishiyama, Toru Sugiyama

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

Abstract

Purpose: We report a phase II clinical study of the combination of irinotecan (CPT-11) and pegylated liposomal doxorubicin (PLD) in platinum- and taxane-resistant recurrent ovarian cancer, based on the recommended doses determined in a phase I trial. Methods: PLD was administered intravenously at a dose of 30 mg/m2 on day 3. CPT-11 was administered intravenously at a dose of 80 mg/m2 on days 1 and 15, according to the recommendations of the phase I study. A single course of chemotherapy lasted 28 days, and patients underwent at least 2 courses until disease progression. The primary endpoint was antitumor efficacy, and the secondary endpoints were adverse events, progression-free survival (PFS), and overall survival (OS). Results: The response rate was 32.3% and the disease control rate was 64.5%. Grade 3 and 4 neutropenia, anemia, and a decrease in platelet count were observed in 17 (54.9%), 3 (9.7%), and 1 patient (3.2%), respectively. In terms of grade 3 or higher non-hematologic toxicities, grade 3 nausea occurred in 1 patient (3.2%), vomiting in 3 patients (9.7%), and grade 3 diarrhea and fatigue in 1 patient (3.2%). The median PFS and OS rates were 2 months and not reached, respectively. Of the 11 patients with a treatment-free interval (TFI) of ≥3 months, the response rate was 63.3%, and the median PFS was 7 months. Conclusions: The treatment outcomes for the 31 patients enrolled in this study were unsatisfactory. However, sub-analysis suggested that patients with a TFI of ≥3 months had a good response rate and PFS. This suggests that CPT-11/PLD combination therapy may be a chemotherapy option for platinum-resistant recurrent ovarian cancer.

Original languageEnglish
Pages (from-to)355-361
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume80
Issue number2
DOIs
Publication statusPublished - 2017 Aug 1

Keywords

  • CPT-11
  • Chemotherapy
  • PLD
  • Recurrent ovarian cancer

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Fingerprint Dive into the research topics of 'A phase II study of irinotecan and pegylated liposomal doxorubicin in platinum-resistant recurrent ovarian cancer (Tohoku Gynecologic Cancer Unit 104 study)'. Together they form a unique fingerprint.

Cite this