Efficacy of trastuzumab in routine clinical practice and after progression for metastatic breast cancer patients: the observational Hermine study

Abstract

Background: The Hermine study observed the use of trastuzumab for metastatic breast cancer (MBC) in routine practice, including patients who received trastuzumab treatment beyond progression (TBP).

Patients and methods: The study observed 623 patients for > or = 2 years. Treatment was given according to oncologists' normal clinical practices. Endpoints included duration of treatment, efficacy, and cardiac safety. The TBP subanalysis compared overall survival (OS) in 177 patients who received first-line trastuzumab and either continued trastuzumab for > or = 30 days following progression or stopped at or before progression.

Results: The median treatment duration was 13.3 months. In the first-, second-, and third-line or beyond treatment groups, the median time to progression (TTP) were 10.3 months, 9.0 months, and 6.3 months, and the median OS times were 30.3 months, 27.1 months, and 23.2 months, respectively. Heart failure was observed in 2.6% of patients, although no cardiac-associated deaths occurred. In the TBP subanalysis, the median OS duration from treatment initiation and time of disease progression were longer in patients who continued receiving trastuzumab TBP (>27.8 months and 21.3 months, respectively) than in those who stopped (16.8 months and 4.6 months, respectively). However, the groups were not completely comparable, because patients who continued trastuzumab TBP had better prognoses at treatment initiation. The median TTP was longer in patients who continued trastuzumab TBP (10.2 months) than in those who stopped (7.1 months).

Conclusion: The Hermine findings confirm that the pivotal trials of first-line trastuzumab treatment in MBC patients are applicable in clinical practice. The subanalysis suggests that trastuzumab TBP offers a survival benefit to MBC patients treated with first-line trastuzumab.

Figure 1.

Consolidated Standards of Reporting Trials diagram of patients in the Hermine study.

Figure 2.

Kaplan–Meier curve of time to progression (A) and overall survival (B) in the overall study population. Date of death was not recorded in five patients.

Figure 3.

Kaplan–Meier plot comparing OS data from patients who continued trastuzumab beyond progression with that of patients who stopped trastuzumab treatment at or prior to progression from initiation of trastuzumab (A) and date of progression (B). Abbreviations: CI, confidence interval; OS, overall survival.

Figure 4.

Independent prognostic survival factors for first-line trastuzumab in metastatic breast cancer. Abbreviations: CI, confidence interval; ER, estrogen receptor; PgR, progesterone receptor.