Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): An open-label randomised study

The Lancet Oncology

Volumn 14, Issue 10, 2013, Pages 962-970

  Pivot, Xavier ^a   Gligorov, Joseph ^b,c   Müller, Volkmar ^d   Barrett Lee, Peter ^e   Verma, Sunil ^f   Knoop, Ann ^g   Curigliano, Giuseppe ^h   Semiglazov, Vladimir ⁱ   López Vivanco, Guillermo ^j   Jenkins, Valerie ^k   Scotto, Nana ^l   Osborne, Stuart ^l   Fallowfield, Lesley ^k  

^a UNIVERSITY HOSPITAL JEAN MINJOZ   (France)

^b HÔPITAL TENON   (France)

^c INSTITUT UNIVERSITAIRE DE FRANCE   (France)

^d UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^e VELINDRE CANCER CENTRE   (United Kingdom)

^f DEPARTMENT OF RADIATION ONCOLOGY   (Canada)

^g Mental Health Center Glostrup   (Denmark)

^h EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

ⁱ N N PETROV RESEARCH INSTITUTE OF ONCOLOGY   (Russian Federation)

^j HOSPITAL DE CRUCES   (Spain)

^k UNIVERSITY OF SUSSEX   (United Kingdom)

^l F HOFFMANN LA ROCHE LTD   (Switzerland)

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Author keywords

[No Author keywords available]

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB;

ADULT; ARTHRALGIA; ARTICLE; ASTHENIA; BRADYCARDIA; BREAST ADENOCARCINOMA; BREAST CANCER; CANCER HORMONE THERAPY; CANCER RADIOTHERAPY; CANCER STAGING; COHORT ANALYSIS; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPIDERMAL GROWTH FACTOR RECEPTOR 2 POSITIVE EARLY BREAST CANCER; EVENT FREE SURVIVAL; FATIGUE; FEMALE; HEART EJECTION FRACTION; HEART LEFT VENTRICLE EJECTION FRACTION; HEART LEFT VENTRICLE FAILURE; HEART PALPITATION; HEART VALVE REGURGITATION; HUMAN; INFLUENZA; INJECTION SITE CONTUSION; INJECTION SITE IRRITATION; INJECTION SITE PAIN; INJECTION SITE REACTION; INTENTION TO TREAT ANALYSIS; KARNOFSKY PERFORMANCE STATUS; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; OPEN STUDY; OUTCOME ASSESSMENT; PATIENT ATTITUDE; PATIENT PREFERENCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SATISFACTION; SIDE EFFECT; SYRINGE; TUMOR INVASION;

ADMINISTRATION, INTRAVENOUS; ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CROSS-OVER STUDIES; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; INTENTION TO TREAT ANALYSIS; MIDDLE AGED; RECEPTOR, ERBB-2;

EID: 84883049426     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(13)70383-8     Document Type: Article

References (25)

1. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005, 353:1659-1672. Herceptin Adjuvant (HERA) Trial Study Team.
2. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005, 353:1673-1684.
3. Smith I, Procter M, Gelber RD, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet 2007, 369:29-36. for the HERA Study Team.
4. Gianni L, Dafni U, Gelber RD, et al. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol 2011, 12:236-244. Herceptin Adjuvant (HERA) Trial Study Team.
5. Perez EA, Romond EH, Suman VJ, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: Joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol 2011, 29:3366-3373.
6. Perez EA, Suman VJ, Davidson NE, et al. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J Clin Oncol 2011, 29:4491-4497.
7. 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, published online July 18. http://dx.doi.org/10.1016/S0140-6736(13)61094-6.
8. Romond E, Suman VJ, Jeong J-H, et al. Trastuzumab plus adjuvant chemotherapy for HER2-positive breast cancer: Final planned joint analysis of overall survival (OS) from NSABP B-31 and NCCTG N9831. Cancer Res 2012, 72(suppl). abstr S5-5.
9. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001, 344:783-792.
10. Marty M, Cognetti F, Maraninchi D, et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol 2005, 23:4265-4274.
11. Wynne C, Waaka DS, Ellis-Pegler RB, et al. Comparative pharmacokinetics of trastuzumab subcutaneous formulation administered using a proprietary single-use injection device, or manually using a syringe. European Society for Medical Oncology Conference 2012; Vienna, Austria; Sept 28-Oct 2, 2012. Abstract 470.
12. 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.
13. Herceptin. Summary of product characteristics European Medicines Agency, (accessed Jan 4, 2013). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf.
14. De Cock E, Tao S, Urspruch A, Knoop A. Potential time savings with trastuzumab subcutaneous (SC) injection vs. trastuzumab intravenous (IV) infusion: results from interviews conducted as part of a time-and-motion study (T&M) across 17 sites. ISPOR 15th Annual European Congress; Berlin, Germany; Nov 3-7, 2012. Abstract RU2.
15. De Cock E, Tao S, Urspruch A, Pivot X, Knoop A. Time savings with trastuzumab subcutaneous (SC) injection vs trastuzumab intravenous (IV) infusion: first results from a time-and-motion study (T&M). 35th San Antonio Breast Cancer Symposium 2012; San Antonio, TX, USA; Dec 4-8, 2012. Abstract P5-15-07.
16. De Cock E, Semiglazov V, Lopez-Vivanco G, et al. Time savings with trastuzumab subcutaneous vs intravenous administration: a time and motion study. 13th St Gallen International Breast Cancer Conference 2013; St Gallen, Switzerland; March 13-16, 2013. Abstract 328.
17. National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (accessed Feb 1, 2013). http://evs.nci.nih.gov/ftp1/CTCAE/Archive/CTCAE_4.0_2009-05-29_QuickReference_8.5x11.pdf.
18. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels 1994, The Criteria Committee for the New York Heart Association, Little, Brown and Company, New York. 9th edn.
19. Clinical safety data management: definitions and standards for expedited reporting E2A Harmonised Tripartite Guideline ICH, (accessed Jan 4, 2013). http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002749.pdf.
20. Wynne C, Harvey V, Schwabe C, Waaka D, McIntyre C, Bittner B Comparison of subcutaneous and intravenous administration of trastuzumab: a phase I/Ib trial in healthy male volunteers and patients with HER2-positive breast cancer. J Clin Pharmacol 2013, 53:192-201.
21. Pivot X, Semiglazov V, Chen S-C, et al. Subcutaneous injection of trastuzumab-analysis of administration time and injection site reactions. European Society for Medical Oncology Conference 2012; Vienna, Austria; Sept 28-Oct 2, 2012. Abstract 272.
22. Wang DD, Zhang S, Zhao H, Men AY, Parivar K Fixed dosing versus body size-based dosing of monoclonal antibodies in adult clinical trials. J Clin Pharmacol 2009, 49:1012-1024.
23. Basch E, Iasonos A, McDonough T, et al. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol 2006, 7:903-909.
24. Basch E, Jia X, Heller G, et al. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst 2009, 101:1624-1632.
25. Gligorov J, Azim HA, Ataseven B, et al. SafeHer: a study of assisted- and self-administered subcutaneous trastuzumab (H-subcutaneous) as adjuvant therapy in patients with early HER2-positive breast cancer. European Society for Medical Oncology Conference 2012; Vienna, Austria; Sept 28-Oct 2, 2012. Abstract 315TiP.