Weekly dose-dense chemotherapy does not improve survival in epithelial ovarian cancer
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Final analysis results from the ICON8 trial confirmed that weekly dose-dense chemotherapy does not significantly improve progression-free survival or overall survival in patients with epithelial ovarian cancer.
However, this treatment offers a safe alternative to chemotherapy administered every 3 weeks and can be delivered successfully in first-line setting to these patients, according to a presentation at ESMO Virtual Congress 2020.
“For most of the last 3 decades, platinum-paclitaxel doublet chemotherapy administered on a once every 3-week schedule for six to eight cycles has been a cornerstone in the first-line multimodality management of epithelial ovarian cancer,” Andrew Clamp, PhD, of the Christie NHS Foundation Trust, Manchester, U.K., said. “There is a strong rationale for the evaluation of weekly dose-dense paclitaxel scheduling in the first-line treatment.”
Clamp reported the mature OS and PFS results of the phase 3 ICON8 trial, which investigated the safety and efficacy of weekly dose-dense chemotherapy (every week) in patients with epithelial ovarian cancer compared with standard 3-weekly chemotherapy.
Researchers randomly assigned patients to receive standard chemotherapy (carboplatin AUC5/6 every 3 weeks plus paclitaxel 175mg/m2 every 3 weeks; arm 1), weekly paclitaxel (carboplatin AUC5/6 every 3 weeks plus weekly paclitaxel 80mg/m2; arm 2) or weekly carboplatin-paclitaxel (carboplatin AUC2 weekly plus paclitaxel 80mg/m2 weekly; arm 3). Prior to starting the study, patients received immediate primary surgery or neo-adjuvant chemotherapy with planned delayed primary surgery during chemotherapy.
Arm 1 comprised 522 patients, arm 2 comprised 523 patients and arm 3 comprised 521 patients. There were 923 deaths, (319 in arm 1; 300 in arm 2 and 304 in arm 3).
“Weekly dose-dense chemotherapy regimens are safe and well-tolerated in a European patient group, both as adjuvant treatment and as primary neoadjuvant therapy with a plan for interval cytoreductive surgery,” Clamp said.
However, the investigators found no significant improvement in OS. The results showed a median OS of 47.4 months in arm 1, 54.1 months in arm 2 and 53.4 months in arm 3. Further, there was no significant difference in PFS with either weekly treatment (restricted mean PFS time: 25, 25.5 and 25.9 months in arms 1, 2 and 3), according to the results.
Clamp and colleagues also observed no heterogeneity in treatment effect in subgroup analysis that compared surgical approach (immediate primary vs. planned delayed primary surgery).
“We need to conclude 3-weekly carboplatin-paclitaxel remains the standard-of-care chemotherapy component for the majority of women undergoing of first-line ovarian cancer treatment,” Clamp said. “However, further hypothesis-generating analyses are underway in our DPS patient cohort to determine if there’s a subgroup of patients who may benefit from a dose-dense approach.”
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Clamp A, et al. Abstract 805O. Presented at: European Society for Medical Oncology Virtual Congress 2020; Sept. 19-21, 2020.
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