HER2+ Breast Cancer

FDA approves subcutaneous trastuzumab for HER2+ breast cancer

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Takeaway

  • The FDA has approved a subcutaneous formulation of trastuzumab that strikingly reduces administration time in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
  • Subcutaneous trastuzumab consists of trastuzumab plus hyaluronidase, an enzyme used to hasten absorption. Administration takes 2-5 minutes, according to an FDA news release, instead of 30-90 minutes with intravenous (IV) trastuzumab, according to a Genentech news release.

Why this matters

  • Subcutaneous trastuzumab is a new, more efficient treatment option.
  • Prescribing information is here.

Key points

  • Subcutaneous trastuzumab carries the same indications as the IV formulation for adjuvant treatment of HER2+ breast cancer and metastatic breast cancer, but is not indicated for metastatic gastric cancer.
  • The recommended dose is 600 mg trastuzumab and 10,000 units hyaluronidase once every 3 weeks.
  • Approval of subcutaneous trastuzumab was based on 2 trials, HannaH and SafeHER.
    • HannaH (N=596) showed noninferior pharmacokinetics and pathologic complete response with subcutaneous vs IV trastuzumab.
    • SafeHER (N=1864) was a nonrandomized trial assessing safety of a 600-mg fixed dose of subcutaneous trastuzumab. The most frequent adverse events (in ≥10% of patients) included fatigue, arthralgia, diarrhea, and injection site reaction, according to the FDA news release.

Neoadjuvant Trastuzumab or Lapatinib With Standard Chemotherapy for HER2+ Breast Cancer.

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ABSTRACT

BACKGROUND

The addition of trastuzumab (T) and lapatinib (L) to neoadjuvant chemotherapy increases the pathological complete response (pCR) rate in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We investigated the efficacy of T or L with neoadjuvant chemotherapy and specific efficacy biomarkers.

METHODS

Patients with stages I–III (including inflammatory) HER2-positive breast cancer were randomised to receive epirubicin (E) plus cyclophosphamide (C) × 4 cycles followed by docetaxel (D) plus either T (EC-DT) or L (EC-DL). End points included pCR (primary), clinical response, toxicity, and pCR-predictive biomarkers.

RESULTS

We randomised 102 patients to EC-DT (50) and EC-DL (52). Median age was 48, 56% were premenopausal and 58% had oestrogen receptor (ER)-positive tumours. Pathological complete response in breast was 52.1% (95% CI:38.0–66.2%) for EC-DT and 25.5% (95% CI:13.5–37.5%) for EC-DL (P=0.0065). Pathological complete response in breast and axilla was 47.9% for EC-DT and 23.5% for EC-DL (P=0.011). Grade 3–4 toxicity did not differ across treatments, except for diarrhoea (2% in EC-DT vs 13.5% in EC-DL, P=0.030). Multivariate analyses showed that treatment (P=0.036) and ER (P=0.014) were the only predictors of pCR in both groups.

CONCLUSION

EC-DT exhibited higher efficacy and lower toxicity than EC-DL. Of the different biomarkers studied, only the absence of ER expression was associated with increased pCR.