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Eur J Cancer. 2017 Sep;82:237-246. doi: 10.1016/j.ejca.2017.05.010. Epub 2017 Jun 16.

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.

Collaborators (486)

Koroveshi D11, Bouzid K12, Casalnuovo M13, Cascallar D13, Korbenfeld EP13, Bastick P14, Beith J14, Colosimo M14, Friedlander M14, Ganju V14, Green M14, Patterson K14, Redfern A14, Richardson G14, Ceric T15, Gordana K15, Beato CA16, Ferrari M16, Hegg R16, Helena V16, Ismael GF16, Lessa AE16, Mano M16, Morelle A16, Nogueira JA16, Timcheva K17, Tomova A17, Tsakova M17, Zlatareva-Petrova A17, Asselah J18, Assi H18, Brezden-Masley C18, Chia S18, Freedman O18, Harb M18, Joy AA18, Kulkarni S18, Prady C18, Gaete AAA19, Matamala L19, Torres R19, Yanez E19, Franco S20, Urrego M20, Gugić D21, Vrbanec D21, Melichar B22, Prausová J22, Vyzula R22, Pilarte RG23, León MI24, Muñoz R24, Ramos G24, Azeem HA25, Aziz AA25, El Zawahry H25, Osegueda FR26, Alexandre J27, Artignan X27, Barletta H27, Beguier E27, Berdah JF27, Marty CB27, Bollet M27, Bourgeois H27, Bressac C27, Burki F27, Campone M27, Coeffic D27, Cojocarasu OZ27, Dagada C27, Dalenc F27, Del Piano F27, Desauw C27, Desmoulins I27, Dohollou N27, Egreteau J27, Ferrero JM27, Foa C27, Garidi R27, Gasnault L27, Gligorov J27, Guardiola E27, Hamizi S27, Jarcau R27, Jacquin JP27, Jaubert D27, Jolimoy G27, Mineur HL27, Largillier R27, Leduc B27, Martin P27, Melis A27, Monge J27, Moullet I27, Mousseau M27, Nguyen S27, Orfeuvre H27, Petit T27, Pivot X27, Priou F27, Bach IS27, Simon H27, Stefani L27, Uwer L27, Youssef A27, Aktas B28, von der Assen A28, Augustin D28, Balser C28, Bauer LE28, Bechtner C28, Beyer G28, Brucker C28, Bückner U28, Busch S28, Christensen B28, Deryal M28, Farrokh A28, Faust E28, Friedrichs K28, Graf H28, Griesshammer M28, Grischke EM28, Hänle C28, Heider A28, Henschen S28, Hesse T28, Jackisch C28, Kisro J28, Köhler A28, Kuemmel S28, Lampe D28, Lantzsch T28, Latos K28, Lex B28, Liedtke C28, Luedders D28, Maintz C28, Müller V28, Overkamp F28, Park-Simon TW28, Paul M28, Prechtl A28, Ringsdorf U28, Runnebaum I28, Ruth S28, Salat C28, Scheffen I28, Schilling J28, Schmatloch S28, Schmidt M28, Schneeweiss A28, Schrader I28, Seipelt G28, Simon E28, Stefek A28, Stickeler E28, Thill M28, Tio J28, Tuczek A28, Warm M28, Weigel M28, Wischnik A28, Wojcinski S28, Ziegler-Löhr K28, Aravantinos G29, Ardavanis A29, Fountzilas G29, Gogas H29, Kakolyris S29, Mavroudis D29, Papadimitriou C29, Papandreou C29, Papazisis K29, Castro H30, Hernandez-Monroy CE30, Ngan R31, Yeo W31, Bittner N32, Boer K32, Csejtei A32, Horvath Z32, Kocsis J32, Mangel LC32, Mezei K32, Nagy Z32, Szanto J32, Atmakusuma D33, Fadjari H33, Kurnianda D33, Prayogo N33, Tanggo EH33, Coate L34, Hennessy B34, Kelly C34, Martin M34, Nasim S34, O'Connor M34, Aieta M35, Allegrini G35, Amadori D35, Bidoli P35, Biti G35, Bordonaro R35, Bottini A35, Carterni G35, Cavanna L35, Cazzaniga M35, Cognetti F35, Contu A35, Cruciani G35, Donadio M35, Falcone A35, Farci D35, Forcignanò RC35, Frassoldati A35, Gaion F35, Gamucci T35, Giotta F35, de Laurentiis M35, Livi L35, Lorusso V35, Maiello E35, Marchetti P35, Mariani G35, Mion M35, Moscetti L35, Musolino A35, Pazzola A35, Pedrazzoli P35, Pigi A35, de Placido S35, Caremoli ER35, Santoro A35, Tienghi A35, Ahn JS36, Jung KH36, Lee KS36, Lee SH36, Seo JH36, Sohn JH36, Cesas A37, Juozaityte E37, Cheah NLC38, Chong FLT38, Devi BCR38, Phua V38, Teoh D38, Ching LW38, Yusof M38, Corona J39, Dominguez A39, Mendoza RLG39, Hernandez CA39, Ramiro AJ39, Santos JM39, Espinosa PM39, Villarreal Garza CM39, Errihani H40, Bakker S41, van den Berkmortel F41, Blaisse RJB41, Huinink DTB41, van den Bosch J41, Braun JJ41, Dercksen MW41, Droogendijk H41, Erdkamp F41, Haringhuizen A41, de Jongh FE41, Kok TC41, Los M41, Madretsma S41, Terwogt JMM41, van der Padt A41, van Rossum-Schornagel QC41, Smilde TJ41, de Valk B41, van der Velden A41, van Warmerdam L41, van de Wouw AJ41, North R42, Kersten C43, Mjaaland I43, Wist E43, Aziz Z44, Masood N44, Rashid K44, Shah M44, Alcedo JC45, Aleman D46, Neciosup S46, Reategui R46, Valdiviezo N46, Vera L46, Fernando G47, Roque F47, Strebel HM47, Krzemieniecki K48, Litwiniuk M48, Mruk A48, Pienkowski T48, Sawrycki P48, Slomian G48, Tomczak P48, Afonso N49, Cardoso F49, Damasceno M49, Nave M49, Badulescu F50, Ciule L50, Curescu S50, Eniu A50, Filip D50, Grecea D50, Jinga DC50, Lungulescu D50, Oprean CM50, Stanculeanu DL50, Turdean M50, Dvornichenko V51, Emelyanov S51, Lichinitser M51, Manikhas A51, Sakaeva D51, Shirinkin V51, Stroyakovskiy D51, Abulkhair O52, Zekri J52, Filipovic S53, Kovcin V53, Nedovic J53, Pesic J53, Vasovic S53, Ng R54, Bystricky B55, Leskova J55, Mardiak J55, Mišurová E55, Wagnerova M55, Takač I56, Demetriou GS57, Dreosti L57, Govender P57, Jordaan JP57, Veersamy P57, Romero JLA58, Lopez NB58, Arias CC58, Chacon J58, Aramburo AF58, Morales LAF58, Garcia M58, Estevez LG58, Garcia-Palomo Perez A58, Garcia Saenz JA58, Garcia Sanchis L58, Cubells LG58, Cortijo LG58, Santiago SG58, De Aranguiz BHF58, Mañas JJI58, Gallego PJ58, Cussac AL58, Ferrandiz CL58, Garrido ML58, Alvarez PL58, Vega JML58, Del Prado PM58, Jañez NM58, Murillo SM58, Rosales AM58, Jaso LM58, Fernandez IP58, Martorell AP58, Carrion RP58, Simon SP58, Alcibar AP58, Lorenzo JP58, Garcia VQ58, Asensio TRYC58, Maicas MDT58, Villanueva Silva MJ58, Killander F59, Svensson JH59, Fehr M60, Hauser N60, Müller A60, Pagani O60, Passmann-Kegel H60, Popescu R60, Rabaglio M60, Rauch D60, Schlatter C60, Zaman K60, Chang TW61, Huang CS61, Wang HC61, Yu JC61, Bandidwattanawong C62, Maneechavakajorn J62, Seetalarom K62, Dejthevaporn TS62, Somwangprasert A62, Vongsaisuwon M62, Akbulut H63, Altundag K63, Arican A63, Bozcuk H63, Eralp Y63, Idris M63, Isikdogan A63, Senol CH63, Sevinc A63, Uygun K63, Yucel E63, Yucel I63, Yumuk F63, Shparyk Y64, Voitko N64, Jaloudi M65, Adams J66, Agrawal R66, Ahmed S66, Alhasso A66, Allerton R66, Anwar S66, Archer C66, Ashford R66, Barraclough L66, Bertelli G66, Bishop J66, Branson T66, Butt M66, Chakrabarti A66, Chakraborti P66, Churn M66, Crowley C66, Davis R66, Dhadda A66, Eldeeb H66, Fraser J66, Hall J66, Hickish T66, Hogg M66, Howe T66, Joffe J66, Kelleher M66, Kelly S66, Kendall A66, Kristeleit H66, Lumsden G66, Macmillan C66, MacPherson I66, Malik Z66, Mithal N66, Neal A66, Panwar U66, Proctor A66, Proctor SJ66, Raj S66, Rehman S66, Sandri I66, Scatchard K66, Sherwin E66, Sims E66, Singer J66, Smith S66, Tahir S66, Taylor W66, Tsalic M66, Verrill M66, Wardley A66, Waters S66, Wheatley D66, Wright K66, Yuille F66, Alonso I67, Artagaveytia N67, Rodriguez R67, Arbona E68, Garcia Y68, Lion L68, Marcano D68, Van Thuan T69.

Author information

1
APHP-Tenon, IUC-UPMC, Sorbonne University, Paris, France. Electronic address: joseph.gligorov@aphp.fr.
2
Kliniken Essen-Mitte, Department of Gynecology and Gynecologic Oncology, Essen, Germany.
3
Northern Centre for Cancer Care, Medical Oncology Department, Newcastle, UK.
4
Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Division of Breast Oncology, Naples, Italy.
5
Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
6
Cairo University, Clinical Oncology Department, Cairo, Egypt.
7
F. Hoffmann-La Roche Ltd, Global Pharma Development, Basel, Switzerland.
8
F. Hoffmann-La Roche Ltd, Biostatistics, Basel, Switzerland.
9
Genentech, Inc., Global Pharma Development, South San Francisco, CA, USA.
10
University Hospital Jean Minjoz, INSERM 1098, Besançon, France.
11
Albania.
12
Algeria.
13
Argentina.
14
Australia.
15
Bosnia and Herzegovina.
16
Brazil.
17
Bulgaria.
18
Canada.
19
Chile.
20
Colombia.
21
Croatia.
22
Czech Republic.
23
Dominican Republic.
24
Ecuador.
25
Egypt.
26
El Salvador.
27
France.
28
Germany.
29
Greece.
30
Guatemala.
31
Hong Kong.
32
Hungary.
33
Indonesia.
34
Ireland.
35
Italy.
36
South Korea.
37
Lithuania.
38
Malaysia.
39
Mexico.
40
Morocco.
41
The Netherlands.
42
New Zealand.
43
Norway.
44
Pakistan.
45
Panama.
46
Peru.
47
Philippines.
48
Poland.
49
Portugal.
50
Romania.
51
Russian Federation.
52
Saudi Arabia.
53
Serbia.
54
Singapore.
55
Slovakia.
56
Slovenia.
57
South Africa.
58
Spain.
59
Sweden.
60
Switzerland.
61
Taiwan.
62
Thailand.
63
Turkey.
64
Ukraine.
65
United Arab Emirates.
66
United Kingdom.
67
Uruguay.
68
Venezuela.
69
Viet Nam.

Abstract

AIM:

To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin® 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 ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive.

RESULTS:

In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 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.

KEYWORDS:

Adjuvant; Breast cancer; HER2/neu; Herceptin; Subcutaneous; Trastuzumab

Comment in

PMID:
28625777
DOI:
10.1016/j.ejca.2017.05.010
[Indexed for MEDLINE]

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