Trastuzumab emtansine with or without pertuzumab versus trastuzumab with taxane for human epidermal growth factor receptor 2–positive advanced breast cancer: Final results from MARIANNE

帕妥珠单抗 曲妥珠单抗 医学 紫杉烷 曲妥珠单抗 内科学 肿瘤科 多西紫杉醇 乳腺癌 转移性乳腺癌 耐受性 危险系数 癌症 卡培他滨 紫杉醇 人表皮生长因子受体2 化疗 表皮生长因子受体 不利影响 养生 置信区间
作者
Edith A. Perez,Carlos H. Barrios,W. Eiermann,Masakazu Toi,Young Hyuck Im,Pierfranco Conte,Miguel Martín,Tadeusz Pieńkowski,Xavier Pivot,Howard A. Burris,Jennifer Petersen,Sanne de Haas,Silke Hoersch,Monika Patre,Paul Ellis
出处
期刊:Cancer [Wiley]
卷期号:125 (22): 3974-3984 被引量:61
标识
DOI:10.1002/cncr.32392
摘要

In the phase 3 MARIANNE trial, trastuzumab emtansine (T-DM1) with or without pertuzumab showed noninferior progression-free survival and better tolerability than trastuzumab plus a taxane (HT) for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer. This article reports the final descriptive overall survival (OS) analysis, updated safety data, and additional patient-reported outcomes and biomarker analyses.OS was assessed in 1095 patients with HER2-positive breast cancer and no prior therapy for advanced disease who had been randomized to HT, T-DM1 plus a placebo (hereafter T-DM1), or T-DM1 plus pertuzumab (T-DM1+pertuzumab). A post hoc exploratory landmark analysis of OS, baseline patient and disease characteristics, and tumor biomarkers in patients with and without an objective tumor response (OR) according to the Response Evaluation Criteria in Solid Tumors within 6.5 months of randomization was conducted.The median OS was similar across groups (50.9, 53.7, and 51.8 months for the HT, T-DM1, and T-DM1+pertuzumab groups, respectively). Among patients with an OR, the median OS was longer with T-DM1 (64.4 months) and T-DM1+pertuzumab (not reached) versus HT (56.3 months). No baseline characteristics or biomarkers were strongly associated with OR. The incidence of grade 3 or higher adverse events was greater with HT (55.8%) than T-DM1 (47.1%) or T-DM1+pertuzumab (48.6%). The median time to clinically meaningful deterioration (a 3-point or greater change) in neurotoxicity symptoms was shorter with HT (2.1 months) and T-DM1+pertuzumab (4.2 months) than T-DM1 (6.2 months). Fewer patients reported alopecia and diarrhea and were bothered by treatment side effects in the T-DM1 arm.These results support T-DM1 as a first-line treatment for patients with HER2-positive metastatic breast cancer who are deemed unsuitable for taxane-based therapy.
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