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. 2023 Jan 10:15:17588359221146133.
doi: 10.1177/17588359221146133. eCollection 2023.

Adjuvant trastuzumab and vinorelbine for early-stage HER2+ breast cancer

Shannon McLaughlin  1 , Erika Nakajima  1 , Yael Bar  1 , Jennifer A Hutchinson  1 , Jennifer Shin  1   2 , Beverly Moy  1   2 , Steven J Isakoff  1   2 , Aditya Bardia  1   2 , Irene Kuter  1   2 , Laura M Spring  3
Affiliations

Adjuvant trastuzumab and vinorelbine for early-stage HER2+ breast cancer

Shannon McLaughlin et al. Ther Adv Med Oncol. .

Abstract

Background: The single-arm phase II APT trial established trastuzumab and paclitaxel (TH) as the standard adjuvant regimen for small human epidermal growth factor receptor 2 (HER2+) tumors. However, paclitaxel causes alopecia and has high rates of neuropathy and hypersensitivity reactions. In patients with metastatic HER2+ breast cancer (BC), the combination of trastuzumab and vinorelbine (TV) is effective and well tolerated. There is a need for alternative non-anthracycline/taxane-based regimens for patients with HER2+ early-stage BC, especially for those with contraindications or who wish to avoid side effects of taxane-based regimens. Here we describe our institutional experience with adjuvant TV for patients with early-stage HER2+ BC.

Methods: Clinicopathological characteristics, treatment details, and outcomes of patients with localized HER2+ BC treated with adjuvant TV from 2007 to 2021 at a large academic medical institution were collected. Study endpoints included invasive disease-free survival (IDFS), overall survival (OS), and safety/tolerability. IDFS and OS were measured from start date of TV treatment to date of event/last follow-up and date of death/last follow-up, respectively.

Results: A total of 30 patients were treated with TV. All patients received trastuzumab at standard dosing and vinorelbine at a starting dose of 25 mg/m2 either on days 1/8 or on days 1/8/21 (weekly) of a 21-day cycle with four planned cycles. Median age at diagnosis was 59 years (range: 36-81). 90.3% of patients had anatomic pathologic stage IA BC and 9.7% stage IIA BC. Of the 30 patients, 24 of them opted to pursue TV due to concerns related to alopecia, neuropathy, and other toxicities, and 6 switched from treatment with TH to TV due to toxicities. Eight patients experienced neutropenia with no cases of febrile neutropenia. No patients experienced alopecia or long-term neuropathy. With a median follow-up of 68 months (5.7 years), the 5-year IDFS rate was 90.9%, with one local and one distant recurrence. The 5-year OS was 100%.

Conclusions: Trastuzumab in combination with vinorelbine in the adjuvant, early-stage setting for low-risk HER2+ BC demonstrated clinical efficacy and appeared to be well tolerated. TV warrants further evaluation as an alternative regimen to TH for patients with early-stage HER2+ BC.

Keywords: HER2+ breast cancer; HER2-targeted therapy; adjuvant therapy; breast cancer; chemotherapy.

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Conflict of interest statement

Shannon MacLaughlin: No COI Erika Nakajima: No COI Yael Bar: No COI Jennifer Hutchinson: Advisory board participant for Novartis Jennifer Shin: No COI Beverly Moy: No COI Steven J. Isakoff: SJI declares the following relationships: institutional research funding from Genentech, PharmaMar, Abbvie, OncoPep, Merck, and AstraZeneca/MedImmune Aditya Bardia: AB declares the following relationships: Consultant/advisory board: Genentech/Roche, Immunomedics, Novartis, Pfizer, Merck, Radius Health, Spectrum Pharma, Taiho Pharm, Diiachi, Sanofi, Puma Biotechnology; Research Grant (self): Biothernostics; Research Grant (Institution): Genentech/Roche, Immunomedics, Novartis, Pfizer, Merck, Radius Health, Sanofi, Mersana AB is supported by Department of Defense Breast Cancer grant and National Comprehensive Cancer Network grant. Irene Kuter: No COI Laura M. Spring: LMS has served as a compensated consultant or received honoraria from Novartis, Puma Biotechnology, G1 Therapeutics, Daiichi Sankyo, AstraZeneca; institutional research support from Merck, Gilead, Lilly, and Phillips Dr. Spring is supported by the National Cancer Institute (grant number K12CA087723) and a National Comprehensive Cancer Network grant.

Figures

Figure 1.
Figure 1.
Breakdown of patient tolerability of TV treatment. TV, trastuzumab and vinorelbine.
Figure 2.
Figure 2.
(a, b) IDFS and OS for combined cohorts (N = 30). 95% CI and no. at risk are included. CI, confidence interval; IDFS, invasive disease-free survival; OS, overall survival.
See this image and copyright information in PMC

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