Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: Updated results from the phase III HannaH study

Annals of Oncology

Volumn 26, Issue 2, 2015, Pages 320-325

  Jackisch, Christian ^a   Kim, S B ^b   Semiglazov, V ^c   Melichar, B ^d   Pivot, X ^e   Hillenbach, C ^f   Stroyakovskiy, D ^g   Lum, B L ^h   Elliott, R ^h   Weber, H A ^f   Ismael, G ⁱ  

^a Klinikum Offenbach GmbH   (Germany)

^b University of Ulsan College of Medicine   (South Korea)

^c N N PETROV RESEARCH INSTITUTE OF ONCOLOGY   (Russian Federation)

^d PALACKÝ UNIVERSITY   (Czech Republic)

^e UNIVERSITY HOSPITAL JEAN MINJOZ   (France)

^f F HOFFMANN LA ROCHE LTD   (Switzerland)

^g Moscow City Oncological Hospital No   (Russian Federation)

^h GENENTECH INC   (United States)

ⁱ Hospital Amaral Carvalho   (Brazil)

Author keywords

Breast cancer; Chemotherapy; HER2 neu; Neoadjuvant; Subcutaneous; Trastuzumab

Indexed keywords

TRASTUZUMAB; ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR 2;

ALOPECIA; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BODY WEIGHT; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER SURVIVAL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EVENT FREE SURVIVAL; FATIGUE; FOLLOW UP; HER2 POSITIVE EARLY BREAST CANCER; HUMAN; IMMUNOGENICITY; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MONOTHERAPY; NAUSEA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; ADULT; BIOSYNTHESIS; BREAST NEOPLASMS; CLINICAL TRIAL; FEMALE; GENETICS; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; SUBCUTANEOUS DRUG ADMINISTRATION;

ADULT; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; MIDDLE AGED; RECEPTOR, ERBB-2; TRASTUZUMAB;

EID: 84925342829     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdu524     Document Type: Article

References (15)

1. Cardoso F, Harbeck N, Fallowfield L et al. Locally recurrent or metastatic breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2012; 23(Suppl 7): vii11-vii19.
2. Goldhirsch A, Winer EP, Coates AS et al. Personalizing the treatment of women with early breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer. Ann Oncol 2013; 24: 2206-2223.
3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. V1, 2014.
4. Wynne CJ, Ellis-Pegler RB, Waaka DS et al. Comparative pharmacokinetics of subcutaneous trastuzumab administered via handheld syringe or proprietary singleuse injection device in healthy males. Cancer Chemother Pharmacol 2013; 72: 1079-1087.
5. Ismael G, Hegg R, Muehlbauer S et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre randomised trial. Lancet Oncol 2012; 13: 869-878.
6. Jackisch C, Dank M, Frasci G et al. Additional safety results of HannaH: A Phase III randomised, open-label, international study of the subcutaneous formulation of trastuzumab (H) in HER2-positive early breast cancer patients. In 37th European Society for Medical Oncology Conference (Abstract 271P), Vienna, Austria, 28 September-2 October 2012.
7. Hegg R, Pienkowski T, Chen ST et al. Immunogenicity of trastuzumab intravenous and subcutaneous formulations in the Phase III HannaH study. In 37th European Society for Medical Oncology Conference (Abstract 273P), Vienna, Austria, 28 September-2 October 2012.
8. Fallowfield L, Jenkins V, Kilkerr J et al. Reasons for patients' preferences for subcutaneous or intravenous trastuzumab in the PrefHer study. In European Cancer Congress (Abstract 719), Amsterdam, the Netherlands, 27 September-1 October 2013.
9. Pivot X, Gligorov J, Mu¨ller V et al. Patient preference for subcutaneous trastuzumab via handheld syringe versus intravenous infusion in HER2-positive early breast cancer: Cohort 2 of the PrefHer study. In 36th San Antonio Breast Cancer Symposium (Abstract P4-12-11), San Antonio, TX, USA, December 10-14, 2013.
10. Pivot X, Gligorov J, Muller V et al. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol 2013; 14: 962-970.
11. Melichar B, Stroyakovskiy D, Ahn JS et al. Pathological complete response to trastuzumab subcutaneous fixed-dose formulation in the HannaH study: Subgroup analysis of patient demographics and tumour characteristics and influence of body weight and serum trough concentration of trastuzumab. In 37th European Society for Medical Oncology Conference (Abstract 254PD), Vienna, Austria, 28 September-2 October 2012.
12. Herceptin™Summary of Product Characteristics. March 2010.
13. Gligorov J, Azim HA, Ataseven B et al. SafeHer: A study of assisted-and selfadministered subcutaneous trastuzumab (H-SC) as adjuvant therapy in patients with early HER2-positive breast cancer (EBC). In 37th European Society for Medical Oncology Conference (Abstract 315TiP), Vienna, Austria, 28 September-2 October 2012.
14. Haller MR. Converting intravenous dosing to subcutaneous dosing with recombinant human hyaluronidase. Pharm Tech 2007; 10: 861-864.
15. De Cock E, Knoop A, Jakobsen EH et al. Manual injection of subcutaneous trastuzumab vs intravenous infusion for HER2-positive early breast cancer: a timeand-motion study. In European Cancer Congress (Abstract 128), Amsterdam, the Netherlands, 27 September-1 October 2013.