5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial

The Lancet Oncology

Volumn 17, Issue 6, 2016, Pages 791-800

  Gianni, Luca ^a   Pienkowski, Tadeusz ^b   Im, Young Hyuck ^c   Tseng, Ling Ming ^d   Liu, Mei Ching ^e   Lluch, Ana ^f   Starosławska, Elżbieta ^g   de la Haba Rodriguez, Juan ^h   Im, Seock Ah ⁱ   Pedrini, Jose Luiz ^j   Poirier, Brigitte ^k   Morandi, Paolo ^l   Semiglazov, Vladimir ^m   Srimuninnimit, Vichien ⁿ   Bianchi, Giulia Valeria ^o   Magazzù, Domenico ^p   McNally, Virginia ^q   Douthwaite, Hannah ^q   Ross, Graham ^q,r   Valagussa, Pinuccia ^p  

^a Oncologia Medica   (Italy)

^b MEDICAL CENTER FOR POSTGRADUATE EDUCATION   (Poland)

^c Samsung Medical Center   (South Korea)

^d NATIONAL YANG MING UNIVERSITY   (Taiwan)

^e KOO FOUNDATION SUN YAT SEN CANCER CENTER   (Taiwan)

^f HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

^g St John's Cancer Centre   (Poland)

^h UNIVERSITY OF CÓRDOBA   (Spain)

ⁱ Seoul National University College of Medicine   (South Korea)

^j HOSPITAL ERNESTO DORNELLES   (Brazil)

^k LAVAL UNIVERSITY   (Canada)

^l OSPEDALE DELL'ANGELO   (Italy)

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

ⁿ MAHIDOL UNIVERSITY   (Thailand)

^o NATIONAL CANCER INSTITUTE   (Italy)

^p Fondazione Michelangelo   (Italy)

^q ROCHE PRODUCTS LTD   (United Kingdom)

^r ASTRAZENECA   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; ESTROGEN; FLUOROURACIL; PERTUZUMAB; PROGESTERONE; TRASTUZUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ACUTE PYELONEPHRITIS; ADJUVANT THERAPY; ADVANCED CANCER; ALOPECIA; APPENDICITIS; ARTICLE; ASTHENIA; BREAST CANCER; CANCER LOCALIZATION; CANCER STAGING; CANCER SURVIVAL; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; EARLY CANCER; FATIGUE; FEBRILE NEUTROPENIA; FEVER; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GRANULOCYTOPENIA; HEART LEFT VENTRICLE FAILURE; HUMAN; INTENTION TO TREAT ANALYSIS; LEUKOPENIA; LOADING DRUG DOSE; LONG TERM CARE; MAJOR CLINICAL STUDY; MENSTRUAL IRREGULARITY; METRORRHAGIA; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PATIENT SAFETY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RASH; SKIN INJURY; SURVIVAL RATE; URINARY TRACT INFECTION; VOMITING; WOUND INFECTION; ADJUVANT CHEMOTHERAPY; ADOLESCENT; ADULT; AGED; CLINICAL TRIAL; FEMALE; INFLAMMATORY BREAST NEOPLASMS; METABOLISM; MIDDLE AGED; NEOADJUVANT THERAPY; PATHOLOGY; PHASE 3 CLINICAL TRIAL; PROGNOSIS; TIME FACTOR; TUMOR RECURRENCE; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFLAMMATORY BREAST NEOPLASMS; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PROGNOSIS; RECEPTOR, ERBB-2; SURVIVAL RATE; TIME FACTORS; TRASTUZUMAB; YOUNG ADULT;

EID: 84966539925     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(16)00163-7     Document Type: Article

References (23)

1. 1 Baselga, J, Gelmon, KA, Verma, S, et al. Phase II trial of pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapy. J Clin Oncol 28 (2010), 1138–1144.
2. 2 Gianni, L, Pienkowski, T, Im, YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol 13 (2012), 25–32.
3. 3 Schneeweiss, A, Chia, S, Hickish, T, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol 24 (2013), 2278–2284.
4. 4 Baselga, J, Cortés, J, Kim, SB, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 366 (2012), 109–119.
5. 5 Swain, SM, Baselga, J, Kim, SB, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med 372 (2015), 724–734.
6. 6 Untch, M, Fasching, PA, Konecny, GE, et al. Pathologic complete response after neoadjuvant chemotherapy plus trastuzumab predicts favorable survival in human epidermal growth factor receptor 2-overexpressing breast cancer: results from the TECHNO trial of the AGO and GBG study groups. J Clin Oncol 29 (2011), 3351–3357.
7. 7 Cortazar, P, Zhang, L, Untch, M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet 384 (2014), 164–172.
8. 8 de Azambuja, E, Holmes, AP, Piccart-Gebhart, M, et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response. Lancet Oncol 15 (2014), 1137–1146.
9. 9 Gianni, L, Eiermann, W, Semiglazov, V, et al. Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet Oncol 15 (2014), 640–647.
10. 10 von Minckwitz, G, Rezai, M, Fasching, PA, et al. Survival after adding capecitabine and trastuzumab to neoadjuvant anthracycline-taxane-based chemotherapy for primary breast cancer (GBG 40–GeparQuattro). Ann Oncol 25 (2014), 81–89.
11. 11 Gonzalez-Angulo, AM, Parinyanitikul, N, Lei, X, et al. Effect of adjuvant trastuzumab among patients treated with anti-HER2-based neoadjuvant therapy. Br J Cancer 112 (2015), 630–635.
12. 12 Loibl, S, von Minckwitz, G, Blohmer, JU, et al. pCR as a surrogate in HER2-positive patients treated with trastuzumab. Cancer Res 71 (2011), S5–S6 (abstr).
13. 13 US Food and Drug Administration (FDA). Guidance for Industry. Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval. Draft Guidance. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm305501.pdf (accessed Jan 28, 2016).
14. 14 European Medicines Agency (EMA) & Committee for Medicinal Products for Human Use (CHMP). Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man. EMA/CHMP/703715/2012 Revised July 1, 2015. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/10/WC500195215.pdf (accessed Jan 28, 2016).
15. 15 Cancer Therapy Evaluation Program (CTEP). Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. DCTD, NCI, NIH, DHHS. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf (accessed Jan 28, 2016).
16. 16 The Criteria Committee for the New York Heart Association. Dolgin, M, (eds.) Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels, 9th edn., 1994, Little, Brown and Company, Boston, MA, USA, 253–255.
17. 17 Bianchi, G, Albanell, J, Eiermann, W, et al. Pilot trial of trastuzumab starting with or after the doxorubicin component of a doxorubicin plus paclitaxel regimen for women with HER2-positive advanced breast cancer. Clin Cancer Res 9:16 Pt 1 (2003), 5944–5951.
18. 18 Jackisch, C, Hegg, R, Stroyakovskiy, D, et al. Total pathologic complete response (tpCR) and event-free survival (EFS) with subcutaneous (SC) or intravenous (IV) trastuzumab in HER2-positive early breast cancer (EBC): The HannaH Phase III study. J Clin Oncol, 13(suppl), 2015, 585 (abstr).
19. 19 Baselga, J, Bradbury, I, Eidtmann, H, et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet 379 (2012), 633–640.
20. 20 Piccart-Gebhart, MJ, Holmes, AP, Baselga, J, et al. First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T->L), or their combination (T+L) in the adjuvant treatment of HER2-positive early breast cancer (EBC). J Clin Oncol, 32, 2014, LBA4 (abstr).
21. 21 DeMichele, A, Yee, D, Berry, DA, et al. The neoadjuvant model is still the future for drug development in breast cancer. Clin Cancer Res 21 (2015), 2911–2915.
22. 22 Wolmark, N, Wang, J, Mamounas, E, Bryant, J, Fisher, B, Preoperative chemotherapy in patients with operable breast cancer: nine-year results from National Surgical Adjuvant Breast and Bowel Project B-18. J Natl Cancer Inst Monogr 30 (2001), 96–102.
23. 23 Prowell, TM, Pazdur, R, Pathological complete response and accelerated drug approval in early breast cancer. N Engl J Med 366 (2012), 2438–2441.