Abstract
PurposeWe 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.MethodsPLD 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).ResultsThe 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.ConclusionsThe 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.
Highlights
In the treatment of patients with platinum-resistant recurrent ovarian cancer, it is essential to select drugs that do not demonstrate cross-resistance to the initial therapy
Sugiyama et al reported that CPT-11/cisplatin combination therapy was effective as a second-line chemotherapy for recurrent ovarian cancer after treatment with a platinum agent [5], which means that CPT-11 may be effective for platinumand taxane-resistant tumors
The doses of CPT-11 and pegylated liposomal doxorubicin (PLD) in the course were reduced according to the severity of any adverse reactions that occurred in the previous course
Summary
In the treatment of patients with platinum-resistant recurrent ovarian cancer, it is essential to select drugs that do not demonstrate cross-resistance to the initial therapy. In a phase III noninferiority study comparing PLD with topotecan, PLD achieved an overall response rate of 19.7%, a median progression-free survival (PFS) of 16.1 weeks, and a mean survival time (MST) of 60.0 weeks; in particular, in patients with platinum-resistant tumors, the response rate was 12.3%, the median PFS was 9.1 weeks, and the MST was 35.6 weeks [4]. These results suggested that PLD could be a promising therapeutic agent for recurrent ovarian cancer. Sugiyama et al reported that CPT-11/cisplatin combination therapy was effective as a second-line chemotherapy for recurrent ovarian cancer after treatment with a platinum agent [5], which means that CPT-11 may be effective for platinumand taxane-resistant tumors
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