1. Among HER2-positive breast cancer patients treated with adjuvant paclitaxel and trastuzumab (Herceptin), 3 year survival without invasive disease was 98.7%
Evidence Rating Level: 2 (Good)
Study Rundown: Randomized trials have shown that trastuzumab, an antibody against the human epidermal growth factor receptor type 2 (HER2), can improve outcomes for patients with breast cancers that over-express HER2. However, most of the patients in these trials have stage II or III breast cancers, which means that the results of these trials may not be applicable to women with stage I cancers, which are smaller and less extensive.
For patients with stage I HER2-positive breast cancer, the issue is one of balancing risks and benefits. In general, stage I breast cancers have relatively good outcomes. At the same time, the treatment regimens given in the trials for stage II and III disease are associated with serious complications. As such, using the same regimen in patients with stage I disease may not be appropriate, as the risks often outweigh the benefits.
This study reports the outcomes for stage I HER2-positive patients treated with a regimen consisting of paclitaxel and trastuzumab. It does not include a control group, which limits interpretation of its results. However, it does demonstrate that the study regimen has a low risk of severe cardiac side effects in patients.
Relevant Reading: Outcomes by Tumor Subtype and Treatment Pattern in Women With Small, Node-Negative Breast Cancer: A Multi-Institutional Study; Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer
In-Depth [prospective cohort]: 406 women with HER2-positive breast cancers not greater than 3cm were enrolled. The study regimen consists of 12 weeks of paclitaxel and up to a year of trastuzumab as adjuvant chemotherapy (in addition to surgery/ radiation). There were 2 non breast-cancer-related deaths and 10 breast cancer recurrences over a median follow-up of 4 years.
Neuropathy is a side effect of paclitaxel and 13 patients had at least one episode of severe neuropathy. Only 2 patients had symptomatic congestive heart failure, but they recovered after stopping trastuzumab. 13 patients had asymptomatic decreases in cardiac function.
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