First-Line Dose-Dense Chemo Fails to Prolong PFS in Ovarian Cancer
First-line treatment failed to improve progression-free survival among women of European descent with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
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First-line treatment with dose-dense chemotherapy failed to improve progression-free survival (PFS) among women of European descent with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), according to results from the phase 3 ICON8 trial presented at the European Society of Medical Oncology (ESMO) 2017 Congress in Spain
The previous JGOG3016 trial reported prolonged PFS and overall survival, but increased toxicity, among Japanese women who received dose-dense chemotherapy. The purpose of the ICON8 trial was to evaluate the efficacy and safety of a dose-dense regimen among women of European descent.
The trial randomly assigned 1566 women with International Federation of Gynecology and Obstetrics (FIGO) stage IcG3 to IV EOC to 1 of 3 arms: carboplatin area under the curve (AUC) 5/6 every 3 weeks plus 175 mg/m2 of paclitaxel every 3 weeks; carboplatin AUC 5/6 every 3 weeks plus 80 mg/m2 of paclitaxel once weekly; or carboplatin AUC 2 once weekly plus 80 mg/m2 of paclitaxel once weekly.
All patients were enrolled after immediate primary surgery or after receiving neoadjuvant therapy with planned delayed primary surgery. The median age at baseline was 62, 93% of patients had a performance status of 0 or 1, and 72% had serous histology. The protocol-defined treatment of 6 cycles was completed by 72%, 60%, and 63% of patients in arms 1, 2, and 3.
There was no significant difference in PFS with weekly paclitaxel plus carboplatin every 3 weeks or weekly carboplatin plus weekly paclitaxel compared with chemotherapy administered every 3 weeks. The median PFS was 17.9, 20.6, and 21.1 months in arms 1, 2, and 3, respectively.
Grade 3/4 adverse events (AEs) occurred among 42% of patients who received chemotherapy every 3 weeks compared with 63% and 53% of patients who received once weekly paclitaxel plus carboplatin every 3 weeks or once weekly paclitaxel plus once weekly carboplatin, respectively. The frequency of grade 3/4 febrile neutropenia and grade 2 or greater sensory neuropathy was similar among arms.
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According to the investigators, these data suggest that dose-dense carboplatin plus paclitaxel is a tolerable option for the first-line treatment of EOC, but does not improve PFS compared with the current standard of care.
Read more of Cancer Therapy Advisor's coverage of the European Society of Medical Oncology (ESMO) 2017 Congress by visiting the conference page.
- Clamp AR, McNeish I, Dean A, et al. ICON8: a GCIG phase III randomized trial evaluating weekly dose-dense chemotherapy integration in first-line epithelial ovarian/fallopian tube/primary peritoneal carcinoma (EOC) treatment: results of primary progression-free survival (PFS) analysis. Presented at: ESMO 2017 Congress; Madrid, Spain: September 8-12, 2017. Abstract 929O_PR.