PMID- 28625777 OWN - NLM STAT- MEDLINE DCOM- 20170907 LR - 20180121 IS - 1879-0852 (Electronic) IS - 0959-8049 (Linking) VI - 82 DP - 2017 Sep TI - Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients. PG - 237-246 LID - S0959-8049(17)30961-9 [pii] LID - 10.1016/j.ejca.2017.05.010 [doi] AB - AIM: To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin((R)) SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). METHODS: Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to /= 3 AEs and 326 (12.7%) experienced serious AEs. Grade >/= 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy. CONCLUSION: SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC. CI - Copyright (c) 2017 Elsevier Ltd. All rights reserved. FAU - Gligorov, J AU - Gligorov J AD - APHP-Tenon, IUC-UPMC, Sorbonne University, Paris, France. Electronic address: joseph.gligorov@aphp.fr. FAU - Ataseven, B AU - Ataseven B AD - Kliniken Essen-Mitte, Department of Gynecology and Gynecologic Oncology, Essen, Germany. FAU - Verrill, M AU - Verrill M AD - Northern Centre for Cancer Care, Medical Oncology Department, Newcastle, UK. FAU - De Laurentiis, M AU - De Laurentiis M AD - Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Division of Breast Oncology, Naples, Italy. FAU - Jung, K H AU - Jung KH AD - Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. FAU - Azim, H A AU - Azim HA AD - Cairo University, Clinical Oncology Department, Cairo, Egypt. FAU - Al-Sakaff, N AU - Al-Sakaff N AD - F. Hoffmann-La Roche Ltd, Global Pharma Development, Basel, Switzerland. FAU - Lauer, S AU - Lauer S AD - F. Hoffmann-La Roche Ltd, Biostatistics, Basel, Switzerland. FAU - Shing, M AU - Shing M AD - Genentech, Inc., Global Pharma Development, South San Francisco, CA, USA. FAU - Pivot, X AU - Pivot X AD - University Hospital Jean Minjoz, INSERM 1098, Besancon, France. CN - SafeHer Study Group LA - eng SI - ClinicalTrials.gov/NCT01566721 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20170616 PL - England TA - Eur J Cancer JT - European journal of cancer (Oxford, England : 1990) JID - 9005373 RN - 0 (Antineoplastic Agents) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P188ANX8CK (Trastuzumab) SB - IM CIN - Eur J Cancer. 2017 Sep;82:228-229. PMID: 28592381 MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/*administration & dosage/adverse effects MH - Breast Neoplasms/*drug therapy/metabolism MH - Chemotherapy, Adjuvant MH - Female MH - Humans MH - Injections, Subcutaneous/adverse effects MH - Middle Aged MH - Receptor, ErbB-2/metabolism MH - Survival Analysis MH - Trastuzumab/*administration & dosage/adverse effects MH - Young Adult OTO - NOTNLM OT - Adjuvant OT - Breast cancer OT - HER2/neu OT - Herceptin OT - Subcutaneous OT - Trastuzumab FIR - Koroveshi, Dhurata IR - Koroveshi D IRAD- Albania. FIR - Bouzid, Kamel IR - Bouzid K IRAD- Algeria. FIR - Casalnuovo, Monica IR - Casalnuovo M IRAD- Argentina. FIR - Cascallar, Diana IR - Cascallar D IRAD- Argentina. FIR - Korbenfeld, Ernesto Pablo IR - Korbenfeld EP IRAD- Argentina. FIR - Bastick, Patricia IR - Bastick P IRAD- Australia. FIR - Beith, Jane IR - Beith J IRAD- Australia. FIR - Colosimo, Maree IR - Colosimo M IRAD- Australia. 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FIR - Nedovic, Jasmina IR - Nedovic J IRAD- Serbia. FIR - Pesic, Jasna IR - Pesic J IRAD- Serbia. FIR - Vasovic, Suzana IR - Vasovic S IRAD- Serbia. FIR - Ng, Raymond IR - Ng R IRAD- Singapore. FIR - Bystricky, Branislav IR - Bystricky B IRAD- Slovakia. FIR - Leskova, Jaroslava IR - Leskova J IRAD- Slovakia. FIR - Mardiak, Jozef IR - Mardiak J IRAD- Slovakia. FIR - Misurova, Etela IR - Misurova E IRAD- Slovakia. FIR - Wagnerova, Maria IR - Wagnerova M IRAD- Slovakia. FIR - Takac, Iztok IR - Takac I IRAD- Slovenia. FIR - Demetriou, Georgia Savva IR - Demetriou GS IRAD- South Africa. FIR - Dreosti, Lydia IR - Dreosti L IRAD- South Africa. FIR - Govender, Poovandren IR - Govender P IRAD- South Africa. FIR - Jordaan, Johannes Petrus IR - Jordaan JP IRAD- South Africa. FIR - Veersamy, Petrosian IR - Veersamy P IRAD- South Africa. FIR - Romero, Jose Luis Alonso IR - Romero JLA IRAD- Spain. FIR - Lopez, Norberto Batista IR - Lopez NB IRAD- Spain. FIR - Arias, Carmen Canabate IR - Arias CC IRAD- Spain. FIR - Chacon, Jose IR - Chacon J IRAD- Spain. FIR - Aramburo, Antonio Fernandez IR - Aramburo AF IRAD- Spain. FIR - Morales, Luis Antonio Fernandez IR - Morales LAF IRAD- Spain. FIR - Garcia, Mirta IR - Garcia M IRAD- Spain. FIR - Estevez, Laura Garcia IR - Estevez LG IRAD- Spain. FIR - Garcia-Palomo Perez, Andres IR - Garcia-Palomo Perez A IRAD- Spain. FIR - Garcia Saenz, Jose Angel IR - Garcia Saenz JA IRAD- Spain. FIR - Garcia Sanchis, Laura IR - Garcia Sanchis L IRAD- Spain. FIR - Cubells, Laia Garrigos IR - Cubells LG IRAD- Spain. FIR - Cortijo, Lucia Gonzalez IR - Cortijo LG IRAD- Spain. FIR - Santiago, Santiago Gonzalez IR - Santiago SG IRAD- Spain. FIR - De Aranguiz, Blanca Hernando Fernandez IR - De Aranguiz BHF IRAD- Spain. FIR - Manas, Jose Juan Illarramendi IR - Manas JJI IRAD- Spain. FIR - Gallego, Pedro Jimenez IR - Gallego PJ IRAD- Spain. FIR - Cussac, Antonio Llombart IR - Cussac AL IRAD- Spain. FIR - Ferrandiz, Cristina Llorca IR - Ferrandiz CL IRAD- Spain. FIR - Garrido, Maria Lomas IR - Garrido ML IRAD- Spain. FIR - Alvarez, Pilar Lopez IR - Alvarez PL IRAD- Spain. FIR - Vega, Jose Manuel Lopez IR - Vega JML IRAD- Spain. FIR - Del Prado, Purificacion Martinez IR - Del Prado PM IRAD- Spain. FIR - Janez, Noelia Martinez IR - Janez NM IRAD- Spain. FIR - Murillo, Serafin Morales IR - Murillo SM IRAD- Spain. FIR - Rosales, Adolfo Murias IR - Rosales AM IRAD- Spain. FIR - Jaso, Laura Murillo IR - Jaso LM IRAD- Spain. FIR - Fernandez, Ignacio Pelaez IR - Fernandez IP IRAD- Spain. FIR - Martorell, Antonia Perello IR - Martorell AP IRAD- Spain. FIR - Carrion, Ramon Perez IR - Carrion RP IRAD- Spain. FIR - Simon, Sonia Pernas IR - Simon SP IRAD- Spain. FIR - Alcibar, Arrate Plazaola IR - Alcibar AP IRAD- Spain. FIR - Lorenzo, Jose Ponce IR - Lorenzo JP IRAD- Spain. FIR - Garcia, Vanesa Quiroga IR - Garcia VQ IRAD- Spain. FIR - Asensio, Teresa Ramon Y Cajal IR - Asensio TRYC IRAD- Spain. FIR - Maicas, Maria Dolores Torregrosa IR - Maicas MDT IRAD- Spain. FIR - Villanueva Silva, Maria Jose IR - Villanueva Silva MJ IRAD- Spain. FIR - Killander, Fredrika IR - Killander F IRAD- Sweden. FIR - Svensson, Jan Henry IR - Svensson JH IRAD- Sweden. FIR - Fehr, Mathias IR - Fehr M IRAD- Switzerland. FIR - Hauser, Nik IR - Hauser N IRAD- Switzerland. FIR - Muller, Andreas IR - Muller A IRAD- Switzerland. FIR - Pagani, Olivia IR - Pagani O IRAD- Switzerland. FIR - Passmann-Kegel, Heike IR - Passmann-Kegel H IRAD- Switzerland. FIR - Popescu, Razvan IR - Popescu R IRAD- Switzerland. FIR - Rabaglio, Manuela IR - Rabaglio M IRAD- Switzerland. FIR - Rauch, Daniel IR - Rauch D IRAD- Switzerland. FIR - Schlatter, Christina IR - Schlatter C IRAD- Switzerland. FIR - Zaman, Khalil IR - Zaman K IRAD- Switzerland. FIR - Chang, Tsai-Wang IR - Chang TW IRAD- Taiwan. FIR - Huang, Chiun-Sheng IR - Huang CS IRAD- Taiwan. FIR - Wang, Hwei-Chung IR - Wang HC IRAD- Taiwan. FIR - Yu, Jyh-Cherng IR - Yu JC IRAD- Taiwan. FIR - Bandidwattanawong, Chanyoot IR - Bandidwattanawong C IRAD- Thailand. FIR - Maneechavakajorn, Jedzada IR - Maneechavakajorn J IRAD- Thailand. FIR - Seetalarom, Kasan IR - Seetalarom K IRAD- Thailand. FIR - Dejthevaporn, Thitiya Sirisinha IR - Dejthevaporn TS IRAD- Thailand. FIR - Somwangprasert, Areewan IR - Somwangprasert A IRAD- Thailand. FIR - Vongsaisuwon, Mawin IR - Vongsaisuwon M IRAD- Thailand. FIR - Akbulut, Hakan IR - Akbulut H IRAD- Turkey. FIR - Altundag, Kadri IR - Altundag K IRAD- Turkey. FIR - Arican, Ali IR - Arican A IRAD- Turkey. FIR - Bozcuk, Hakan IR - Bozcuk H IRAD- Turkey. FIR - Eralp, Yesim IR - Eralp Y IRAD- Turkey. FIR - Idris, Mohamed IR - Idris M IRAD- Turkey. FIR - Isikdogan, Abdurrahman IR - Isikdogan A IRAD- Turkey. FIR - Senol, Coskun Hasan IR - Senol CH IRAD- Turkey. FIR - Sevinc, Alper IR - Sevinc A IRAD- Turkey. FIR - Uygun, Kazim IR - Uygun K IRAD- Turkey. FIR - Yucel, Eftal IR - Yucel E IRAD- Turkey. FIR - Yucel, Idris IR - Yucel I IRAD- Turkey. FIR - Yumuk, Fulden IR - Yumuk F IRAD- Turkey. FIR - Shparyk, Yaroslav IR - Shparyk Y IRAD- Ukraine. FIR - Voitko, Nataliia IR - Voitko N IRAD- Ukraine. FIR - Jaloudi, Mohammed IR - Jaloudi M IRAD- United Arab Emirates. FIR - Adams, Jocelyn IR - Adams J IRAD- United Kingdom. FIR - Agrawal, Rajiv IR - Agrawal R IRAD- United Kingdom. FIR - Ahmed, Samreen IR - Ahmed S IRAD- United Kingdom. FIR - Alhasso, Abdulla IR - Alhasso A IRAD- United Kingdom. FIR - Allerton, Rozenn IR - Allerton R IRAD- United Kingdom. FIR - Anwar, Suhail IR - Anwar S IRAD- United Kingdom. FIR - Archer, Caroline IR - Archer C IRAD- United Kingdom. FIR - Ashford, Richard IR - Ashford R IRAD- United Kingdom. FIR - Barraclough, Lisa IR - Barraclough L IRAD- United Kingdom. FIR - Bertelli, Gianfilippo IR - Bertelli G IRAD- United Kingdom. FIR - Bishop, Jill IR - Bishop J IRAD- United Kingdom. FIR - Branson, Tony IR - Branson T IRAD- United Kingdom. FIR - Butt, Mohammed IR - Butt M IRAD- United Kingdom. FIR - Chakrabarti, Amit IR - Chakrabarti A IRAD- United Kingdom. FIR - Chakraborti, Prabir IR - Chakraborti P IRAD- United Kingdom. FIR - Churn, Mark IR - Churn M IRAD- United Kingdom. FIR - Crowley, Clare IR - Crowley C IRAD- United Kingdom. FIR - Davis, Ruth IR - Davis R IRAD- United Kingdom. FIR - Dhadda, Amandeep IR - Dhadda A IRAD- United Kingdom. FIR - Eldeeb, Hany IR - Eldeeb H IRAD- United Kingdom. FIR - Fraser, Judith IR - Fraser J IRAD- United Kingdom. FIR - Hall, Julia IR - Hall J IRAD- United Kingdom. FIR - Hickish, Tamas IR - Hickish T IRAD- United Kingdom. FIR - Hogg, Martin IR - Hogg M IRAD- United Kingdom. FIR - Howe, Theresa IR - Howe T IRAD- United Kingdom. FIR - Joffe, Jonathan IR - Joffe J IRAD- United Kingdom. FIR - Kelleher, Muireann IR - Kelleher M IRAD- United Kingdom. FIR - Kelly, Stephen IR - Kelly S IRAD- United Kingdom. FIR - Kendall, Anne IR - Kendall A IRAD- United Kingdom. FIR - Kristeleit, Hartmut IR - Kristeleit H IRAD- United Kingdom. FIR - Lumsden, Graeme IR - Lumsden G IRAD- United Kingdom. FIR - Macmillan, Craig IR - Macmillan C IRAD- United Kingdom. FIR - MacPherson, Iain IR - MacPherson I IRAD- United Kingdom. FIR - Malik, Zafar IR - Malik Z IRAD- United Kingdom. FIR - Mithal, Natasha IR - Mithal N IRAD- United Kingdom. FIR - Neal, Anthony IR - Neal A IRAD- United Kingdom. FIR - Panwar, Udaiveer IR - Panwar U IRAD- United Kingdom. FIR - Proctor, Andrew IR - Proctor A IRAD- United Kingdom. FIR - Proctor, Steven John IR - Proctor SJ IRAD- United Kingdom. FIR - Raj, Sanjay IR - Raj S IRAD- United Kingdom. FIR - Rehman, Shazza IR - Rehman S IRAD- United Kingdom. FIR - Sandri, Ines IR - Sandri I IRAD- United Kingdom. FIR - Scatchard, Kate IR - Scatchard K IRAD- United Kingdom. FIR - Sherwin, Elizabeth IR - Sherwin E IRAD- United Kingdom. FIR - Sims, Eliot IR - Sims E IRAD- United Kingdom. FIR - Singer, Julian IR - Singer J IRAD- United Kingdom. FIR - Smith, Sarah IR - Smith S IRAD- United Kingdom. FIR - Tahir, Saad IR - Tahir S IRAD- United Kingdom. FIR - Taylor, Wendy IR - Taylor W IRAD- United Kingdom. FIR - Tsalic, Medy IR - Tsalic M IRAD- United Kingdom. FIR - Verrill, Mark IR - Verrill M IRAD- United Kingdom. FIR - Wardley, Andrew IR - Wardley A IRAD- United Kingdom. FIR - Waters, Simon IR - Waters S IRAD- United Kingdom. FIR - Wheatley, Duncan IR - Wheatley D IRAD- United Kingdom. FIR - Wright, Kathryn IR - Wright K IRAD- United Kingdom. FIR - Yuille, Frances IR - Yuille F IRAD- United Kingdom. FIR - Alonso, Isabel IR - Alonso I IRAD- Uruguay. FIR - Artagaveytia, Nora IR - Artagaveytia N IRAD- Uruguay. FIR - Rodriguez, Robinson IR - Rodriguez R IRAD- Uruguay. FIR - Arbona, Esther IR - Arbona E IRAD- Venezuela. FIR - Garcia, Yuraima IR - Garcia Y IRAD- Venezuela. FIR - Lion, Lorena IR - Lion L IRAD- Venezuela. FIR - Marcano, Dalila IR - Marcano D IRAD- Venezuela. FIR - Van Thuan, Tran IR - Van Thuan T IRAD- Viet Nam. EDAT- 2017/06/20 06:00 MHDA- 2017/09/08 06:00 CRDT- 2017/06/20 06:00 PHST- 2016/11/16 00:00 [received] PHST- 2017/02/14 00:00 [revised] PHST- 2017/05/04 00:00 [accepted] PHST- 2017/06/20 06:00 [pubmed] PHST- 2017/09/08 06:00 [medline] PHST- 2017/06/20 06:00 [entrez] AID - S0959-8049(17)30961-9 [pii] AID - 10.1016/j.ejca.2017.05.010 [doi] PST - ppublish SO - Eur J Cancer. 2017 Sep;82:237-246. doi: 10.1016/j.ejca.2017.05.010. Epub 2017 Jun 16.