Abstract
Trastuzumab is the backbone of HER2-positive early breast cancer (eBC) and metastatic breast cancer (mBC) treatment, but limited data exist as to re-treatment in relapsed patients. In this prospective, single arm, multicenter trial, we assessed efficacy and safety of trastuzumab and taxane combination in Chinese patients with HER2-positive mBC relapsed after prior (neo)adjuvant trastuzumab. Patients with previous (neo)adjuvant trastuzumab treatment for≥9 weeks and a relapse-free interval ≥6 months were assigned to trastuzumab treatment with paclitaxel or docetaxel. The primary endpoint was progression free survival (PFS). Secondary endpoints included overall response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), time to progression (TTP), overall survival (OS) and safety profile. Thirty-two patients were enrolled and treated for a median duration of 33.5 weeks. The median PFS was 9.9 months (95% CI, 6.28 - 13.63 months). The ORR was 81.3% (95% CI, 63.6% - 92.8%) and CBR (CR+PR+SD≥6months) was 81.3% (95% CI, 63.6% - 92.8%). The median DOR was 9.8 months (95% CI, 5.82 - 11.60 months) and median TTP was 9.9 months (95% CI, 6.28-13.63 months). OS median follow-up time was 20.1 months and 25% OS time was 25.5 months. The safety profile was acceptable with common adverse events including leukopenia (59.4%), neutropenia (56.3%), hypoaesthesia (34.4%) and granulocytopenia (31.3%). In conclusion, re-treatment with trastuzumab plus a taxane as first-line therapy is an effective regimen for patients with HER2-positive mBC relapsed after (neo)adjuvant trastuzumab. The safety profile was good and the adverse reactions were tolerable and manageable.
Highlights
Breast cancer is the most common cancer in women among all racial and ethnic groups by a wide margin [1]
Re-treatment after Herceptin Adjuvant Trial reported with a median progression free survival (PFS) of 8.0 months and overall survival of 25.0 months in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBC) patients relapsed after adjuvant trastuzumab[19]
Twenty four patients (75.0%) had received the chemotherapy with anthracyclines in which 23 patients had received it as adjuvant chemotherapy and 5 patients had received it as neoadjuvant chemotherapy
Summary
Breast cancer is the most common cancer in women among all racial and ethnic groups by a wide margin [1]. Around 20-30% of breast cancer cases are characterized with an overexpression of the human epidermal growth factor receptor 2 (HER2), and HER2-positive breast cancer is associated with increased aggressiveness in disease progression and worse clinical outcomes including lower disease-free survival and overall survival (OS) [3, 4]. In (neo)adjuvant setting as reported in the NOAH trial, treatment with trastuzumab plus chemotherapy showed a 3-year event-free survival of 71% versus 56% compared with chemotherapy alone in patients with HER2-positive breast cancer [7]. The eligible patients in most of the trials studying the above anti-cancer agents were trastuzumabnaïve, their clinical outcomes in patients who develop recurrent disease from (neo)adjuvant trastuzumab setting are still largely unknown. Re-treatment after Herceptin Adjuvant Trial reported with a median progression free survival (PFS) of 8.0 months and overall survival of 25.0 months in HER2-positive mBC patients relapsed after adjuvant trastuzumab[19]
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