Abstract P2-15-11: A phase II trial of genexol-PM and doxorubicin in patients with advanced Her-2 negative breast cancer

Abstract

Abstract Background: Genexol PM is a lyophilized polymeric micellar formulation of paclitaxel that delivers a higher paclitaxel dose with lower vehicle-related toxicities than conventional paclitaxel formulations. This study was designed to evaluate the efficacy and safety of genexol- PM and doxorubicin combination in advanced Her-2 negative Breast cancer as first line treatment. Methods: Patients with advanced Her-2 negative Breast cancer received Genexol-PM at 260mg/m2 on day 1 and doxorubicin 50mg/m2 on day 1 of 3-week interval cycle. Six to nine cycles of combination chemotherapy were planned unless there was disease progression. The primary endpoint was objective response rate. Results: Thirty patients received this combination chemotherapy with a median 6cycles per patient (range 1-9). The objective response rate was 67% with disease control rate 87%, Median duration of response was 5.5months (95%CI 3.0-8.1months). Median progression free survival was 7.4 months (95%CI 5.3-9.6months) and overall survival 38.7months (95%CI 21.4-55.9months). The common toxicities were alopecia(93%), peripheral neuropathy(60%), nausea(57%), neutropenia(47%). The most common G3/4 toxicities were neutropenia(43%) and neutropenic fever(27%). There was no treatment related mortality. Conclusion: Genexol-PM, CrEL-free paclitaxel, in combination with doxorubicin demonstrated favorable antitumor activity in advanced Her-2 negative breast cancer. The most common G3/4 toxicities was neutropenia but it was manageable. Citation Format: Eun Kyung Cho, Hyo Yeon Yun, Yun Yeong Kim, Yong Soon Jeon, Heungkyu Park. A phase II trial of genexol-PM and doxorubicin in patients with advanced Her-2 negative breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-15-11.