[Long-term efficacy and safety of adjuvant trastuzumab for HER2-positive early breast cancer].

Objective: To explore the long-term efficacy and safety of adjuvant trastuzumab for HER2-positive early breast cancer.

Methods: The clinicopathological data were collected 31 HER2-positive early breast cancer patients on the 1/2-year adjuvant therapy of trastuzumab at our hospital from October 2001 to October 2003. And the disease-free survival, recurrence-free survival, overall survival and safety were respectively analyzed. SPSS 13.0 software was used for statistical analysis.

Results: During a median follow-up period of 9.3 years, 6 cases had recurrence, there were 5 cases of second primary cancer and 4 patients died. In total, the 5 and 10-year recurrence-free survival rates were 83.3% and 80.0%, the 5 and 10-year disease-free survival rates 80.6% and 57.3% and the 5 and 10-year overall survival rates 96.8% and 87.1% respectively. The 10-year recurrence-free survival rate of 13 patients with ER and/or PR positive and 18 ER/PR negative patients were 100.0% and 64.7% (χ² = 5.44, P = 0.019) and 10-year overall survival rate 100% and 77.8% respectively (χ² = 3.163, P = 0.075). Trastuzmab was well-tolerated when used as adjuvant treatment. There was no occurrence of cardiac events.

Conclusion: Adjuvant trastuzmab has definite efficacies and excellent safety in the treatment of HER2-positive breast cancer patients. And there was no long-term cumulative cardiac toxicity.