T-PLD is an effective alternative for the treatment of recurrent platinum-sensitive OC, especially in the partially platinum-sensitive population with a platinum-free interval (PFI) of 6-12 months. The aim of this work was to assess the clinical impact of the combination when used in routine practice.
This was a prospective, multicenter study carried out in 25 French centers. Eligible patients (pts) were women ≥18 years old with histologically proven relapsed disease following at least one platinum-based chemotherapy and candidates to receive T (1.1 mg/m2) plus PLD (30 mg/m2). Analysis were performed according to the PFI subgroups (PFI 6-12 and PFI>12 [fully platinum-sensitive]) using Stata and R software.
From 07/2014 to 06/2016, 91 pts with platinum-sensitive OC were included (median age 65 years-old, range: 42-86). Most pts had PFI 6-12 (n = 58; 63.7%) vs. n = 33 with PFI>12. Pts were treated with a median of 6 cycles (range: 1-12) of T-PLD. 47 (51.6%) pts received T-PLD as ≥ 3rd line of chemotherapy (range: 2-8). The toxicity profile in the PFI subgroups was not different from that of the overall population. The number of pts with grade 3/4 hematological toxicities in the PFI 6-12 and PFI>12 cohorts was: neutropenia 29.6%/17.6%, febrile neutropenia 4.4%/3.3%, thrombocytopenia 7.7%/12.1%, anemia 5.5%/2.2%. Grade 3 hand and foot syndrome (1 pt) and mucositis (1 pt) were observed in the PFI 6-12 group. Increases in transaminases (grade 3/4) were experienced by 11 pts (10/1) in the PFI 6-12 group and by 5 pts (4/1) in the PFI>12 group. 3 patients in the PFI 6-12 group and 3 in the PFI>12 group discontinued treatment because of toxicities, 6 and 2 due to premature death. Partial and complete responses were achieved in 43 pts (PFI 6-12: n = 26; PFI>12: n = 17, p = 0.82). Median PFS after T-PLD was 5.9 months (95%CI 4.9-6.7) in the PFI 6-12 group and 5.8 months (95%CI 3.7-8.5, logrank p = 0.37) in the PFI>12 group. OS data were not mature at the time of this analysis.
The safety profile of T-PLD when used in real-life management of non-selected OC pts is similar to that observed in clinical trials. T-PLD remains a valuable option to pts with both partially and fully platinum-sensitive disease.
Clinical trial identification
NCT02163720 May 28, 2014
Legal entity responsible for the study
L. Gladieff: PharmaMar fees in 2015 and 2016. All other authors have declared no conflicts of interest.