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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
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
European Journal of Cancer, Volume 82, Year 2017
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Description
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. © 2017 Elsevier Ltd
Authors & Co-Authors
Gligorov, Joseph
France, Paris
Hôpital Tenon
Ataseven, Beyhan
Germany, Essen
Kliniken Essen-mitte
Verrill, Mark W.
United Kingdom, Newcastle
Northern Centre for Cancer Care
De Laurentiis, Michelino
Italy, Naples
Istituto Nazionale Tumori Irccs - Fondazione g Pascale, Napoli
Jung, Kyung-hae
South Korea, Seoul
Asan Medical Center
Azim, Hamdy Abdel
Egypt, Cairo
Faculty of Medicine
Al-Sakaff, Nedal
Switzerland, Basel
F. Hoffmann-la Roche ag
Lauer, Sabine
Switzerland, Basel
F. Hoffmann-la Roche ag
Shing, Mona
United States, San Francisco
Genentech, Inc
Pivot, Xavier B.
France, Besancon
Interactions Hôte-greffon, Tumeur et Ingénierie Cellulaire et Génique
Koroveshi, Dhurata
Unknown Affiliation
Bouzid, Kamel
Unknown Affiliation
Casalnuovo, Monica
Unknown Affiliation
Cascallar, Diana Vera
Unknown Affiliation
Korbenfeld, Ernesto Pablo
Unknown Affiliation
Bastick, Patricia A.
Unknown Affiliation
Beith, Jane Mc Neil
Unknown Affiliation
Colosimo, Maree Louise
Unknown Affiliation
Friedlander, M. L.
Unknown Affiliation
Ganju, Vinod
Unknown Affiliation
Patterson, Kevin
Unknown Affiliation
Redfern, Andrew D.
Unknown Affiliation
Richardson, Gary Edward
Unknown Affiliation
Cerić, Timur
Unknown Affiliation
Gordana, Kecman
Unknown Affiliation
Beato, Carlos Augusto De Mendonça
Unknown Affiliation
Ferrari, Marcela Simonis M.
Unknown Affiliation
Hegg, Robberto
Unknown Affiliation
Helena, Vanessa Petry
Unknown Affiliation
Ismael, Gustavo Fernando V.
Unknown Affiliation
Lessa, Álvaro Edson Ramos
Unknown Affiliation
Mano, Max Senna
Unknown Affiliation
Morelle, Alessandra Menezes
Unknown Affiliation
Nogueira, Jose Alberto
Unknown Affiliation
Timcheva, Konstanta Velinova
Unknown Affiliation
Tomova, Antoaneta
Unknown Affiliation
Tsakova, Maya
Unknown Affiliation
Zlatareva-Petrova, Ani
Unknown Affiliation
Asselah, Jamil
Unknown Affiliation
Assi, Hazem I.
Unknown Affiliation
Brezden-Masley, Christine B.
Unknown Affiliation
Chia, Stephen K.L.
Unknown Affiliation
Freedman, Orit C.
Unknown Affiliation
Harb, Mohammed
Unknown Affiliation
Joy, Anil Abraham
Unknown Affiliation
Kulkarni, Swati V.
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Prady, Catherine
Unknown Affiliation
Gaete, Alejandro Andres Acevedo
Unknown Affiliation
Torres, Roberto
Unknown Affiliation
Yañez Ruiz, Eduardo Patricio
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Franco, Sandra Ximena
Unknown Affiliation
Urrego, Marcela
Unknown Affiliation
Gugić, Damir
Unknown Affiliation
Vrbanec, Damir
Unknown Affiliation
Melichar, Bohuslav
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Prausová, Jana
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Vyzula, Rostislav
Unknown Affiliation
Pilarte, Rafael Gutierrez
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León, María Isabel
Unknown Affiliation
Muñoz, Rene
Unknown Affiliation
Ramos, Glenda
Unknown Affiliation
Azeem, Hamdy Abdel
Unknown Affiliation
Aziz, Amr Abdel
Unknown Affiliation
El-Zawahry, Heba Mohammed
Unknown Affiliation
Osegueda, Finlander Rosales
Unknown Affiliation
Alexandre, Jérôme H.
Unknown Affiliation
Artignan, Xavier
Unknown Affiliation
Barletta, Hugues
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Béguier, Emmanuel
Unknown Affiliation
Berdah, Jean François
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Marty, Chantal Bernard
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Bollet, Marc Andrew
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Bourgeois, Hugues
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Bressac, Claude
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Bürki, Franck
Unknown Affiliation
Campone, Mario M.
Unknown Affiliation
Coeffic, David
Unknown Affiliation
Cojocarasu, Oana Zveltlana
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Dagada, Corinne
Unknown Affiliation
Dalenc, Florence
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del Piano, Francesco
Unknown Affiliation
Desauw, Christophe
Unknown Affiliation
Desmoulins, Isabelle
Unknown Affiliation
Dohollou, Nadine
Unknown Affiliation
Egreteau, Joëlle P.
Unknown Affiliation
Ferréro, Jean Marc
Unknown Affiliation
Foa, Cyril
Unknown Affiliation
Garidi, Réda
Unknown Affiliation
Gasnault, Laurent
Unknown Affiliation
Guardiola, Emmanuel
Unknown Affiliation
Hamizi, Salima
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Jarcau, Rosana
Unknown Affiliation
Jacquin, Jean Philippe
Unknown Affiliation
Jaubert, Dominique
Unknown Affiliation
Jolimoy, Geneviève
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Mineur, Hortense Laharie
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Largillier, Rémy
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Leduc, Bernard E.
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Petit, Thierry
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Simon, Hélène
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Aktaş, Bahriye
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Farrokh, André
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Friedrichs, Kay
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Jackisch, Christian
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Kisro, Jens
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Runnebaum, Ingo Bernhard
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Schmidt, Marcus
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Schneeweiß, Andreas
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Seipelt, Gernot
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Stickeler, Elmar
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Tio, Joke
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Wojcinski, Sebastian
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Aravantinos, Gerasimos
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Ardavanis, Alexandros S.
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Fountzilas, George
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Gogas, H. J.
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Mavroudis, Dimitris A.
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Yeo, Winnie M.
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Boér, Katalin
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Mángel, László Csaba
Unknown Affiliation
Szanto, Janos
Unknown Affiliation
Coate, Linda E.
Unknown Affiliation
Hennessy, Bryan T.J.
Unknown Affiliation
Kelly, Catherine Margaret A.
Unknown Affiliation
Amadori, Dino
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Bidoli, Paolo
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Cavanna, Luigi
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Cruciani, Giorgio
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Frassoldati, Antonio
Unknown Affiliation
Livi, Lorenzo Francesco
Unknown Affiliation
Moscetti, Luca
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Musolino, Antonino
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Santoro, Armando
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Tienghi, Amelia
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Lee, Soohyeon
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Sohn, Joohyuk
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Česas, Alvydas
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Juozaitytė, Elona
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Yusof, Mastura Md
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Dominguez, Adriana
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Errihani, Hassan H.
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Erdkamp, Frans L.G.
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de Valk, Bart
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Mjaaland, Ingvil
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Aziz, Zeba
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Masood, Nehal
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Neciosup, Silvia P.
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Krzemieniecki, Krzysztof
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Litwiniuk, Maria M.
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Piénkowski, Tadeusz J.
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Cardoso, Fatima
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Eniu, Alexandru E.
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Lichinitser, Mikhail R.
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Manikhas, Alexey G.
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Sakaeva, Dina Damirovna
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Abulkhair, Omalkhair A.
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Zekri, Jamal Eddin
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Kovciń, Vladimir Nikola
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Vasović, Suzana
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Ng, Raymond Chee Hui
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Wágnerová, Mária
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Demetriou, Georgia Savva
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Dreosti, Lydia M.
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Govender, Poovandren S.
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Jordaan, Johannes Petrus J.
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Chacón, José Ignacio
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García, Mirta
Unknown Affiliation
García-Estévez, Laura
Unknown Affiliation
García-Saénz, José Ángel
Unknown Affiliation
Pagani, O.
Unknown Affiliation
Rabaglio, Manuela
Unknown Affiliation
Rauch, Daniel P.
Unknown Affiliation
Zaman, Khalil
Unknown Affiliation
Chang, Tsai-Wang
Unknown Affiliation
Huang, Chiun Sheng
Unknown Affiliation
Maneechavakajorn, Jedzada
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Akbulut, Hakan
Unknown Affiliation
Altundag, Kadri
Unknown Affiliation
Idris, M. A.
Unknown Affiliation
Sevinç, Alper
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Yumuk, Perran Fulden
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Jaloudi, Mohammed A.
Unknown Affiliation
Ahmed, Samreen I.
Unknown Affiliation
Eldeeb, Hany
Unknown Affiliation
Lumsden, Graeme R.
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Macpherson, Iain R.J.
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Rehman, Shazza
Unknown Affiliation
Wardley, Andrew M.
Unknown Affiliation
Rodríguez, Robinson
Unknown Affiliation
Statistics
Citations: 40
Authors: 189
Affiliations: 9
Identifiers
Doi:
10.1016/j.ejca.2017.05.010
ISSN:
09598049
Research Areas
Cancer
Noncommunicable Diseases
Study Design
Cross Sectional Study
Cohort Study