- A combination of the North Central Cancer Treatment Group (NCCTG) N9831 trial and the National Adjuvant Breast and Bowel Project (NSABP) B-31 clinical trials:
- Showed a:
- 40% improvement in disease-free survival
- 37% improvement in overall survival:
- With the addition of a year of trastuzumab to doxorubicin, cyclophosphamide, and paclitaxel chemotherapy.
- Improvements in disease-free survival and overall survival were observed in all patients:
- Independent of hormone receptor status and extent of nodal involvement.
- Improvements in disease-free survival and overall survival were observed in all patients:
- With the addition of a year of trastuzumab to doxorubicin, cyclophosphamide, and paclitaxel chemotherapy.
- Showed a:
- The duration of trastuzumab therapy has been debated:
- The Herceptin Adjuvant (HERA) trial:
- Evaluated 1 year of therapy versus 2 years of therapy:
- It did not show a significant difference in disease-free survival and overall survival between the two groups.
- Evaluated 1 year of therapy versus 2 years of therapy:
- The Protocol of Herceptin Adjuvant with Reduced Exposure (PHARE) trial:
- A Randomized Comparison of 6 Months vs 12 Months in All Women Receiving Adjuvant Herceptin (PHARE) trial:
- Evaluated 6 months of trastuzumab compared to 12 months:
- At 3.5-year follow-up:
- The shorter trastuzumab course did not have a worse survival outcome compared to the 12-month course.
- At 3.5-year follow-up:
- Evaluated 6 months of trastuzumab compared to 12 months:
- A Randomized Comparison of 6 Months vs 12 Months in All Women Receiving Adjuvant Herceptin (PHARE) trial:
- A Cochrane meta-analysis of eight trials:
- Including more than 11,900 patients with early and locally advanced HER2-positive breast cancer:
- Found improvements in disease-free survival (HR 0.66) and overall survival (HR 0.60) with chemotherapy plus trastuzumab versus chemotherapy alone or trastuzumab alone regimens.
- Including more than 11,900 patients with early and locally advanced HER2-positive breast cancer:
- Two small trials administering trastuzumab for less than six months:
- Did not differ from trials with longer treatment duration and had less trastuzumab-associated toxicities:
- However, given these studies’ small cohort size and short follow-up:
- 12 months of trastuzumab treatment remains standard therapy.
- However, given these studies’ small cohort size and short follow-up:
- Did not differ from trials with longer treatment duration and had less trastuzumab-associated toxicities:
- The Herceptin Adjuvant (HERA) trial:
- References:
- Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32(33):3744-3752.
- Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, et al. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013;382(9897):1021-1028.
- Pivot X, Romieu G, Debled M, et al. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 2013;14(8):741-748.
- Moja L, Tagliabue L, Balduzzi S, et al. Trastuzumab containing regimens for early breast cancer. Cochrane Database Syst Rev. 2012;4:CD006243.
Rodrigo Arrangoiz MS, MD, FACS, FSSO 