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Oncology Times

September 2012, Volume 34 Number 18 , p 8 - 10


  • Robert H. Carlson


A subcutaneous formulation of trastuzumab appears to be equivalent to the standard intravenous formulation in terms of producing pathologic complete response (pCR) as well as in safety and pharmacokinetics in the treatment of women with HER2-positive breast cancer, according to the results of a Phase III, multicenter, neoadjuvant trial published in Lancet Oncology(2012;13:869-878).The shortened duration of subcutaneous administration has the potential to save time for patients, physicians, and nursing staff, the first author and co-principal investigator, Gustavo Ismael, MD, a medical oncologist and Medical Coordinator of Clinical Research at Hospital Amaral Carvalho, Miraglia in Jau, Brazil, noted in a telephone interview. "The injection takes no more than five minutes, instead of 30 to 60 minutes for an infusion."The subcutaneous formulation of trastuzumab is possible with the development of recombinant human hyaluronidase PH-20 (rHuPH-20), an enzyme that temporarily degrades interstitial hyaluronic acid in the subcutaneous space, allowing injection of larger volumes-in this case, 5 ml of the drug injected into the thigh with a hand-held syringe.The study's neoadjuvant setting made it possible to determine pCR, but Ismael said the potential convenience of a subcutaneous formulation could be in the adjuvant setting, when patients would typically return to the clinic every three weeks for IV treatment.The researchers also point to other potential benefits including improved patient convenience, better compliance, reduced pharmacy preparation times, and optimization of medical resources.The randomized, open-label "HannaH" study (enHANced treatment with NeoAdjuvant Herceptin) enrolled women with newly diagnosed HER2-positive, operable, locally advanced, or inflammatory invasive adenocarcinoma of the breast, clinical stage I to IIIC, with primary tumors 1 cm or larger by ultrasound or 2 cm or larger by palpation. The patients' mean age was 50.Patients were randomly assigned

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