1P - A phase III randomized study of paclitaxel and trastuzumab versus paclitaxel alone for early stage, ER and PR receptor negative and HER2-positive br...

Date 07 May 2015
Event IMPAKT 2015
Session Welcome reception and Poster Walk
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Early Stage
Presenter Mukesh Singhal
Citation Annals of Oncology (2015) 26 (suppl_3): 1-3. 10.1093/annonc/mdv113
Authors M.K. Singhal1, A. Kapoor1, S. Narayan1, S. Maharia1, R.K. Nirban1, S.K. Beniwal2, H.S. Kumar1
  • 1Radiation Oncology, Acharya Tulsi Cancer Treatment & Research Institut, 334001 - Bikaner/IN
  • 2Medical Oncology, Acharya Tulsi Cancer Treatment & Research Institut, 334001 - Bikaner/IN

Abstract

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Background: Among women with small, node-negative breast cancers, those with HER2-positive tumors have a higher risk of cancer recurrence. This suggests that consideration of HER2-targeted therapy such as trastuzumab may be important, even for women with small tumors. However, most of these patients have been ineligible for the pivotal trials of adjuvant trastuzumab.

Methods: We randomized 134 patients with tumors measuring up to 3 cm in the greatest dimension (with ER and PR receptor negative and Her-2 positive) 1:1 to receive adjuvant paclitaxel and trastuzumab versus paclitaxel alone. Patients received weekly treatment with paclitaxel and trastuzumab for 12 weeks, followed by 9 months of three weekly trastuzumab as a single agent. The analysis was based on intention to treat; the primary end point was disease-free survival (DFS).

Results: The median follow-up period was 5 years. The 3-year rate of survival free from invasive disease was 96.8% (95% confidence interval [CI], 95.2% to 98.4%) in the trastuzumab arm (n = 67) versus 86.4% (95% CI, 84.1% to 88.7%) in the paclitaxel only arm (n = 67, log rank p = 0.003). Incidence of symptomatic congestive heart failure with trastuzumab was 2.9%; 95% CI, 1.4% to 4.4%), however, restoration of the normal left ventricular ejection fraction was achieved after discontinuation of trastuzumab. The incidence of significant asymptomatic declines in ejection fraction in the trastuzumab arm was 8.9%; 95% CI, 7.2% to 10.6%), versus 1.4% (95% CI, 0.7% to 2.1%).

Conclusions: Among women with early stage, ER and PR receptor negative and Her2-positive breast cancer, addition of trastuzumab was associated with a significant improvement in disease-free survival at the cost of manageable cardiac toxicities.

Disclosure: All authors have declared no conflicts of interest.