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10 results on '"Biti, G"'

1. Breast cancer 'tailored follow-up' in Italian oncology units: a web-based survey

Author

Natoli, C., Brocco, D., Sperduti, I., Nuzzo, A., Tinari, N., De Tursi, M., Grassadonia, A., Mazzilli, L., Iacobelli, S., Gamucci, T., Vici, P., Study, Group, Adamo, V., Airoldi, M., Amoroso, D., Angelini, F., Angiolini, C., Angiolucci, G., Ardizzoia, A., Baldini, E., Ballardini, P., Barni, S., Barone, C., Battelli, N., Bernardi, D., Bianchetti, S., Bianco, N., Biglia, Nicoletta, Bilancia, D., Biti, G., Boni, C., Bordonaro, R., Botta, M., Bretti, S., Brunello, A., Brunetti, C., Bruno, D., Bucci, E., Buzzoni, R., Cagossi, K., Cappelletti, C., Cappuzzo, F., Cardillo, F., Carroccio, R., Cascinu, S., Cavanna, L., Cianchetti, E., Clerico, M., Contu, A., Corsi, D., Cortesi, L., Cretella, E., Crispino, S., Di Lieto, M., Di Lullo, L., Durini, E., Fabi, A., Failla, G., Fattorusso, S., Ferraù, F., Ferro, A., Ficorella, C., Fogazzi, G., Foglietta, J., Francini, G., Fusco, O., Gennari, A., Ghiani, M., Gianni, L., Giordano, M., Giotta, F., Giuliani, R., Gori, S., Graiff, C., Guarneri, V., Guarneri, D., Guglielmi, F., Landriscina, M., Laudadio, L., Lombardo, M., Longo, F., Macellari, G., Madeddu, C., Magnanini, S., Maiorino, L., Mangiameli, A., Marini, G., Massidda, B., Mattioli, R., Michelotti, A., Molino, A., Montesarchio, V., Morale, A., Murgo, R., Naso, G., Natale, D., Orditura, M., Orrù, S., Pace, R., Palazzo, A., Palma, F., Pancotti, A., Pandoli, G., Papaldo, P., Parisi, A. M., Passalacqua, R., Pellegrino, A., Perrucci, B., Proietti, E., Recchia, F., Riccardi, F., Rispoli, A. I., Rocca, A., Romaniello, I., Rossetti, R., Rossi, D., Rosti, G., Ruggeri, E. M., Russo, A., Savarino, A., Savastano, C., Scognamiglio, G., Scognamiglio, M., Seminara, P., Serrachini, S., Sidoti, V., Silva, R. R., Surace, G., Tomao, S., Tonini, G., Trenta, P., Turazza, M., Valenza, R., Veltri, E., Zampa, G., Zaniboni, A., Zanirato, S., C, Natoli, D, Brocco, I, Sperduti, A, Nuzzo, N, Tinari, M, De Tursi, A, Grassadonia, L, Mazzilli, S, Iacobelli, T, Gamucci, P, Vici, Study Group, 'FOLLOW-UP', and Orditura, Michele

Subjects
Oncology, breast cancer, Follow-up, survey, Medical Oncology, law.invention, Randomized controlled trial, law, Aged, Breast Neoplasms, Female, Follow-Up Studies, Health Care Surveys, Humans, Italy, Middle Aged, Secondary Prevention, Guideline Adherence, Breast Tumors, Medicine and Health Sciences, Web based survey, Multidisciplinary, Pharmaceutics, Surgical Oncology, Cancer Therapy, Medicine, medicine.symptom, Disease staging, Research Article, medicine.medical_specialty, Adjuvant Cancer Chemotherapy, Science, MEDLINE, Asymptomatic, Breast cancer, Drug Therapy, Internal medicine, medicine, Cancer Detection and Diagnosis, Chemotherapy, Modalities, business.industry, Cancers and Neoplasms, medicine.disease, Blood chemistry, Women's Health, Clinical Medicine, business
Abstract

PurposeBreast cancer follow-up procedures after primary treatment are still a controversial issue. Aim of this study was to investigate, through a web-based survey, surveillance methodologies selected by Italian oncologists in everyday clinical practice.MethodsReferents of Italian medical oncology units were invited to participate to the study via e-mail through the SurveyMonkey website. Participants were asked how, in their institution, exams of disease staging and follow-up are planned in asymptomatic women and if surveillance continues beyond the 5th year.ResultsBetween February and May 2013, 125 out of 233 (53.6%) invited referents of Italian medical oncology units agreed to participate in the survey. Ninety-seven (77.6%) referents state that modalities of breast cancer follow-up are planned according to the risk of disease progression at diagnosis and only 12 (9.6%) oncology units apply the minimal follow-up procedures according to international guidelines. Minimal follow-up is never applied in high risk asymptomatic women. Ninety-eight (78.4%) oncology units continue follow-up in all patients beyond 5 years.ConclusionsOur survey shows that 90.4% of participating Italian oncology units declare they do not apply the minimal breast cancer follow-up procedures after primary treatment in asymptomatic women, as suggested by national and international guidelines. Interestingly, about 80.0% of interviewed referents performs the so called "tailored follow-up", high intensity for high risk, low intensity for low risk patients. There is an urgent need of randomized clinical trials able to determine the effectiveness of risk-based follow-up modalities, their ideal frequency and persistence in time.

Published
2014

2. Radioterapia neoadiuvante associata ad oxaliplatino e 5-fluorouracile in pazienti affetti da tumore rettale localmente avanzato: l'esperienza di un singolo centro

Author

Greto, D, Paiar, Fabiola, Saieva, C., Galardi, A., Mangoni, M., Livi, L., Agresti, B., Franceschini, D., Bonomo, P., Scotti, V., Detti, B., Tonelli, F., Valeri, A., Messerini, L., and Biti, G.

Subjects
Adult, Male, Organoplatinum Compounds, 5-Fluorouracil, Antineoplastic Agents, Nuclear Medicine and Imaging, 80 and over, Humans, Dose Fractionation, Locally advanced rectal cancer, Aged, Proportional Hazards Models, Retrospective Studies, Chemoradiotherapy, Oxaliplatin, Aged, 80 and over, Combined Modality Therapy, Female, Fluorouracil, Follow-Up Studies, Middle Aged, Neoadjuvant Therapy, Neoplasm Recurrence, Local, Radiotherapy Dosage, Rectal Neoplasms, Survival Rate, Treatment Outcome, Radiology, Nuclear Medicine and Imaging, Medicine (all), Neoplasm Recurrence, Local, Radiology
Published
2013

3. Uno studio di riferimento su 883 pazienti affetti da neoplasia della rinofaringe trattati in due Centri italiani dal 1977 al 2000. Parte I: evoluzione delle scelte tecniche e sopravvivenza

Author

Tonoli, S., Magrini, S. M., Costa, L, Paiar, Fabiola, Simontacchi, G., Scotti, V., Pasinetti, N., Barca, R., Barbieri, D., De Stefani, A., Cellai, E., Buglione, M., and Biti, G.

Subjects
Adult, Diagnostic Imaging, Male, Radiotherapy, Survival, Nasopharyngeal cancer, Patterns of care, Treatment techniques, Benchmarking, Female, Humans, Italy, Middle Aged, Nasopharyngeal Neoplasms, Neoplasm Staging, Prognosis, Radiotherapy Dosage, Retrospective Studies, Survival Rate, Treatment Outcome, Radiology, Nuclear Medicine and Imaging, Medicine (all), Nuclear Medicine and Imaging, Radiology
Published
2012

4. Di riferimento su 883 pazienti affetti da neoplasia della rinofaringe trattati in due Centri italiani dal 1977 al 2000. Parte II: evoluzione delle scelte tecniche e tossicità

Author

Magrini, S. M., Tonoli, S., Costa, L, Pasinetti, N., Paiar, Fabiola, Livi, L., Simontacchi, G., Meattini, I., Pegurri, L., Borghetti, P., Frata, P., Ponticelli, P., Buglione, M., and Biti, G.

Subjects
Adult, Diagnostic Imaging, Male, Complications, Nasopharyngeal cancer, Patterns of care, Treatment techniques, Radiotherapy, Benchmarking, Female, Humans, Incidence, Italy, Middle Aged, Nasopharyngeal Neoplasms, Neoplasm Staging, Prognosis, Radiation Injuries, Radiation Oncology, Radiotherapy Dosage, Retrospective Studies, Survival Rate, Treatment Outcome, Radiology, Nuclear Medicine and Imaging, Medicine (all), Nuclear Medicine and Imaging, Radiology
Published
2012

5. Radio-chemioterapia concomitante con regimi a base di antracicline nel trattamento adiuvante del carcinoma mammario: Esperienza di un singolo centro

Author

Livi, L., Meattini, I, Scotti, V., Saieva, C., Simontacchi, G., Marrazzo, L., Franzese, C., Cassani, S., Paiar, Fabiola, Di Cataldo, V., Nori, J., Jose Sanchez, L., Bianchi, S., Cataliotti, L., and Biti, G.

Subjects
Adult, Breast Neoplasms, Risk Assessment, Disease-Free Survival, Risk Factors, Nuclear Medicine and Imaging, Antineoplastic Combined Chemotherapy Protocols, Humans, Chemotherapy, Anthracyclines, Cyclophosphamide, Early Detection of Cancer, Adjuvant, Epirubicin, Retrospective Studies, Concomitant chemoradiotherapy, Radiotherapy, Medicine (all), Early breast cancer, Adjuvant radiotherapy, Cardiac toxicity, Doxorubicin, Feasibility Studies, Female, Fluorouracil, Follow-Up Studies, Methotrexate, Middle Aged, Treatment Outcome, Chemotherapy, Adjuvant, Radiotherapy, Adjuvant, Radiology, Nuclear Medicine and Imaging, Radiology
Published
2011

6. [Therapeutic implications of the peculiar clinical characteristics of Hodgkin's disease in clinical stages I-II with isolated neck presentation]

Author

Stefano Maria Magrini, Cellai E, Mg, Papi, Pertici M, Lastrucci L, Ponticelli P, Sulprizio S, and Biti G

Subjects
Adult, Aged, 80 and over, Male, Adolescent, Middle Aged, Hodgkin Disease, Actuarial Analysis, Child, Preschool, Lymphatic Metastasis, Humans, Female, Child, Neck, Aged, Neoplasm Staging, Retrospective Studies
Abstract

Among 703 patients with supradiaphragmatic clinical stages I-II Hodgkin's disease consecutively treated 1960 through 1989 at the Florence Radiotherapy Department, we identified 98 cases presenting with cervical and supraclavicular nodes involvement only. The latter cases were retrospectively reviewed to assess: a) if they presented any peculiar clinicopathologic features and b) the possible prognostic and therapeutic implications (if any) of these features. The high incidence of lymphocytic predominance histology (33%) and Waldeyer's ring (WR) involvement (24%) and the very low risk of occult infradiaphragmatic involvement (observed in only 2 of 44 patients submitted to staging laparotomy with splenectomy, 4.5%) are among the distinctive features of the patients with supradiaphragmatic clinical stages I-II Hodgkin's disease. All the 98 patients were treated at presentation with irradiation alone. Actuarial cause-specific survival 20 years after the end of treatment was 87%; the corresponding value for relapse-free survival was 78%. The most frequent complications were irradiation pneumonia, most often asymptomatic, and xerostomia. Our data seem to suggest that, for the majority of these patients: a) staging laparotomy could be avoided and b) "mini mantle" irradiation is an adequate treatment. Moreover, WR irradiation could be avoided in the patients without clinical WR involvement.

Published
1995

7. [Late sequelae involving the breast after radiotherapy for lung metastasis of Wilms' tumor. Experience of the Florence Radiotherapy and analysis of the literature]

Author

Stefano Maria Magrini, Mg, Papi, Bagnoli R, Distante V, Bianchi S, and Biti G

Subjects
Lung Neoplasms, Neoplasms, Radiation-Induced, Radiotherapy, Child, Preschool, Humans, Breast Neoplasms, Female, Neoplasms, Second Primary, Wilms Tumor, Kidney Neoplasms
Abstract

A growing number of children treated for malignant tumors has been cured thanks to progress in the field of pediatric oncology, and therefore long-term treatment sequelae have been more frequently observed. Fourteen of 65 pediatric patients with Wilms' tumor treated in Florence 1957 through 1978, developed lung metastases and six survived at least five years after treatment. Four of these long-term survivors are girls. This paper reports on the long-term sequelae observed in the breast of these four patients: three of them presented breast hypoplasia and one breast cancer. We discuss our personal experience and the relative literature, describing the relationship between given dose and the incidence of breast hypoplasia. Some hypotheses on the etiology of secondary cancer are also discussed.

Published
1995

8. Extended-field radiotherapy is superior to MOPP chemotherapy for the treatment of pathologic stage I-IIA Hodgkin's disease: eight-year update of an Italian prospective randomized study

Author

Biti, G. P., Cimino, G., Cartoni, C., Magrini, S. M., Anselmo, A. P., Enrici, R. M., Bellesi, G. P., Bosi, A., Papa, G., and Diana Giannarelli

Subjects
Male, Radiotherapy, Hodgkin Disease, Survival Analysis, methods, drug therapy/pathology/radiotherapy, Actuarial Analysis, Recurrence, Vincristine, therapeutic use, Procarbazine, Antineoplastic Combined Chemotherapy Protocols, Multivariate Analysis, Actuarial Analysis, Antineoplastic Combined Chemotherapy Protocols, therapeutic use, Female, Hodgkin Disease, drug therapy/pathology/radiotherapy, Humans, Male, Mechlorethamine, administration /&/ dosage, Multivariate Analysis, Neoplasm Staging, Prednisone, administration /&/ dosage, Procarbazine, administration /&/ dosage, Prospective Studies, Radiotherapy, methods, Recurrence, Survival Analysis, Vincristine, administration /&/ dosage, Humans, Prednisone, Female, Mechlorethamine, Prospective Studies, Neoplasm Staging
Published
1992

9. Postmastectomy radiotherapy in breast cancer adjuvant treatment

Author

Lorenzo Livi, Meattini, I., Di Cataldo, V., Cardillo, C. Luca, Scotti, V., Sanchez, L., Nori, J., Agresti, B., Iermano, C., Basquetti, E. Monteleone, Bianchi, S., Cataliotti, L., and Biti, G.

Subjects
Humans, Breast Neoplasms, Female, Radiotherapy, Adjuvant, Mastectomy
Abstract

Radiotherapy (RT) plays an important role in the management of locally advanced breast cancer (BC). Postmastectomy RT has been shown to significantly reduce the risk of loco-regional failure and to improve disease free survival in high-risk women with BC. Many trials have shown a significant benefit in local control, disease-free and overall survival with the addition of RT for patients with stage II and III breast cancer. New perspectives are evaluating multiple biological variables that nowadays should be considered in clinical oncology for the prescription of postmastectomy radiation therapy. Tailored randomized trials are now ongoing to clarify the "grey zone" represented by the intermediate-risk group of patients (1-3 lymph nodes involved). We reviewed the major studies offered by literature with emphasis on the principal debated issues.

10. 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

Author

Jose Chacon, Katja Ziegler-Löhr, Kamran Rashid, Stanley Madretsma, Hortense Laharie Mineur, Soo Hyeon Lee, Bohuslav Melichar, Jasna Pesic, Julia Hall, Jörg Schilling, Paola Morales Espinosa, Wendy Taylor, Francesco Cognetti, Doris Augustin, Ines Sandri, Laura Murillo Jaso, Alejandro Juarez Ramiro, Nora Artagaveytia, Rocio Reategui, Nataliia Voitko, Teresa Gamucci, Lisa H Barraclough, Jérôme Alexandre, Mohammed Butt, Frank Priou, A.J. van de Wouw, Cristina Marinela Oprean, Isabel Alonso, Suzana Vasovic, Fernando Roque, Marc Thill, Viktoria Dvornichenko, K. Bouzid, Idris Yucel, Andrea Stefek, Jose Manuel Lopez Vega, Daniil Stroyakovskiy, R. Chiara Forcignanò, Mohammed Harb, Andrzej Mruk, Jana Prausová, Lydia Dreosti, Prabir Chakraborti, Armando Santoro, Lee Wei Ching, Anna Tuczek, Jane Beith, Larisa Ciule, Hakan Bozcuk, Antonino Musolino, Hartmut Kristeleit, Clare Crowley, T.C. Kok, Dhurata Koroveshi, Natasha Mithal, Laura Garcia Sanchis, Stephan Henschen, Carmen Cañabate Arias, A. Contu, Antoaneta Tomova, Alper Sevinc, Helga Droogendijk, Gustavo Fernando Ismael, Konstantinos Papazisis, Laurent Gasnault, Sandra Bakker, Judit Kocsis, Bernd Christensen, Stephen Kelly, Rosana Jarcau, Christian Jackisch, George Fountzilas, Cyril Foa, Annebeth W. Haringhuizen, Silvia Neciosup, Juan Matos Santos, Finlander Rosales Osegueda, Robinson Rodriguez, Marcus Schmidt, Bart de Valk, Kathryn Wright, A.S. Dhadda, Elizabeth Sherwin, Sabino De Placido, Luigi Cavanna, Joelle Egreteau, Shazza Rehman, Giacomo Allegrini, Doerte Luedders, Poovandren Govender, Hugues Barletta, Iztok Takač, Yuraima Garcia, Michael Green, Geneviève Jolimoy, Marcela Urrego, Chanyoot Bandidwattanawong, Vito Lorusso, Annette van der Velden, Rene Muñoz, Djumhana Atmakusuma, Christos Papandreou, Craig Macmillan, Hassan Errihani, Iris Schrader, Isabelle Desmoulins, Jean-Marc Ferrero, Mohamed Idris, B. Ataseven, Andre Farrokh, Isabelle Moullet, Iain R. Macpherson, N. Al-Sakaff, Stephen Chia, Blanca Hernando Fernandez De Aranguiz, Lorena Lion, Alexandros Ardavanis, Ani Zlatareva-Petrova, Ernesto Pablo Korbenfeld, Hugo Castro, Mirta Garcia, Heike Passmann-Kegel, Lionel Uwer, Gary Richardson, Marion Paul, Georgia Demetriou, Andreas Köhler, V. Kovcin, Eliot Sims, Gerasimos Aravantinos, Adriana Dominguez, Daniel Rauch, Greta Beyer, Laurence J. C. van Warmerdam, Roberto Bordonaro, Raymond Ng, David Coeffic, Rostislav Vyzula, Bernard Leduc, Jozef Mardiak, Andrea Pigi, Ingo Runnebaum, Jose Angel Garcia Saenz, Areewan Somwangprasert, Cristina Llorca Ferrandiz, Coskun Hasan Senol, Martin Griesshammer, Friedrich Overkamp, Suzanne Nguyen, Maria Turdean, Udaiveer Panwar, Zsuzsanna Nagy, Francesco Giotta, Andreas Schneeweiss, Teresa Ramon y Cajal Asensio, Jae Hong Seo, Joohyuk Sohn, Jean-Philippe Jacquin, Daniela Grecea, Jasmina Nedovic, Arrate Plazaola Alcibar, Tadeusz Pienkowski, Jetske M. Meerum Terwogt, Elmar Stickeler, Hazem I. Assi, Vadim Shirinkin, Grzegorz Slomian, Etela Mišurová, Roberto Hegg, K. Friedrichs, Corinne Dagada, Jean-François Berdah, Fulden Yumuk, Alexandru Eniu, Amit Chakrabarti, Mathias Fehr, Christoph Salat, Dan Lungulescu, Heinrik Martin Strebel, Antonio Llombart Cussac, Rémy Largillier, Stefan Curescu, Albert von der Assen, Emmanuel Guardiola, Andras Csejtei, Tamas Hickish, Krzysztof Krzemieniecki, Yaroslav Shparyk, Ramon Perez Carrion, Michela Donadio, Purificacion Martinez del Prado, Sandra Franco, J.J. Braun, Michael Friedlander, Suhail Anwar, Thierry Petit, Sarah Smith, Rafael Gutierrez Pilarte, Laia Garrigos Cubells, Frans L. G. Erdkamp, Jedzada Maneechavakajorn, Mastura Yusof, Jocelyn Adams, Diana Cascallar, Luis Antonio Fernandez Morales, Max S. Mano, Simon Waters, Carlos Beato, Philippe Martin, Martin Hogg, Isabelle Sillet Bach, Monica Casalnuovo, Klara Mezei, Alexey Manikhas, Margarida Damasceno, Sergey Emelyanov, Gabriella Mariani, Kecman Gordana, Gianfilippo Bertelli, Ignacio Pelaez Fernandez, Damir Vrbanec, Maria Wagnerova, Johannes Petrus Jordaan, Marina Cazzaniga, Mustafa Deryal, Ruth Davis, Abdurrahman Isikdogan, Sanjay Raj, José Juan Illarramendi Mañas, Vinod Ganju, Maria Dolores Torregrosa Maicas, Glenda Ramos, Nugroho Prayogo, H. Orfeuvre, Filipovic S, Joke Tio, Andrew Redfern, M. Shing, Eduardo Yanez, Khalil Zaman, Jin-Seok Ahn, Dino Amadori, Bahriye Aktas, Miriam O'Connor, Uta Ringsdorf, Christophe Desauw, J. Gligorov, Jorge Corona, Michele De Laurentiis, Arthur Wischnik, Paolo Pedrazzoli, Katalin Boér, Caroline Archer, Anne Kendall, Ori Freedman, Maya Tsakova, Dana Lucia Stanculeanu, Kevin Patterson, Cathy Kelly, Nellie Lay Chin Cheah, X. Artignan, Anil A. Joy, Steffi Busch, Monica Nave, Bryan Hennessy, Lorenzo Livi, X. Pivot, R.J.B. Blaisse, Adolfo Murias Rosales, Juan Carlos Alcedo, Dalila Marcano, Emmanuel Beguier, Andreas Müller, László Csaba Mangel, Christina Schlatter, Fernando Gaion, Tjoung-Won Park-Simon, Sebastian Wojcinski, Ute Bückner, Florinel Badulescu, Cynthia Mayte Villarreal Garza, Rozenn Allerton, Mikhail Lichinitser, Damir Gugić, Manuela Rabaglio, Jens Kisro, Iris Scheffen, Vincent Phua, Marc A. Bollet, Giampaolo Biti, M. Verrill, Adrien Melis, Andrew M Wardley, Ali Arican, Hamdy A. Azim, Lelia-Eveline Bauer, Tsai-Wang Chang, Nik Hauser, René Lazaro González Mendoza, Dominique Jaubert, Samreen Ahmed, Mazhar Shah, János Szántó, Kunibert Latos, Xavier Pivot, Helen Gogas, Elona Juozaityte, Luca Moscetti, Helene Simon, Giacomo Carterni, Dan-Corneliu Jinga, Olivia Pagani, Elena Rota Caremoli, Esther Arbona, Cornelia Liedtke, Stylianos Kakolyris, Abdulla Alhasso, Omalkhair Abulkhair, Jose Ponce Lorenzo, Julian Singer, Tony Branson, Claudia Hänle, Ingvild Mjaaland, Chiun-Sheng Huang, Heri Fadjari, Jonathan Joffe, Laetitia Stefani, Dieter Lampe, Franck Burki, S. Lauer, Sabine Schmatloch, Gracieux Fernando, Dina Sakaeva, Christina Balser, Michael Martin, Nora Bittner, Andrea Heider, Antonio Frassoldati, Serafin Morales Murillo, Hakan Akbulut, Saad Tahir, Tilmann Lantzsch, Christine Brezden-Masley, Vanessa Helena, Tran Van Thuan, F.E. de Jongh, Roger K.C. Ngan, Elke Faust, Hugues Bourgeois, Flora Li Tze Chong, Nehal Masood, Keun Seok Lee, J. Bishop, Mathias Warm, Dimitris Mavroudis, Petrosian Veersamy, Judith Fraser, Andres Garcia-Palomo Perez, Heiko Graf, Vanesa Quiroga Garcia, Jyh-Cherng Yu, Maria Jose Villanueva Silva, Elke Simon, Diana Aleman, Kazim Uygun, Cosima Brucker, Michael Weigel, Volkmar Müller, Djohan Kurnianda, Duncan Wheatley, Amr Abdel Aziz, Benno Lex, Laura G. Estévez, Darren Teoh, María Isabel León, Noemia Afonso, Frances Yuille, Amelia Tienghi, Gernot Seipelt, Jose Alberto Nogueira, Dumitru Filip, Zafar Malik, Fatima Cardoso, Giorgio Cruciani, Winnie Yeo, Luis Vera, Santiago Gonzalez Santiago, Richard North, M.W. Dercksen, Zsolt Horváth, Noelia Martinez Jañez, Marta Mion, Marcela Ferrari, Natalia Valdiviezo, Oana Zveltlana Cojocarasu, Alessandra Morelle, Medy Tsalic, Sonia Pernas Simon, Christoph Maintz, Daniele Farci, Alvaro Edson Lessa, Jeremy Monge, Joseph Gligorov, Anthony Neal, Norberto Batista Lopez, Piotr Tomczak, Yesim Eralp, Kasan Seetalarom, Thitiya (Sirisinha) Dejthevaporn, Jamal Zekri, Steven John Proctor, Saira Nasim, Muireann Kelleher, Eftal Yucel, Quirine Clementine van Rossum-Schornagel, Linda Coate, Paolo Marchetti, Theresa Howe, Carlos Alberto Hernandez, Roberto Torres, Konstanta Timcheva, Evaristo Maiello, Anita Prechtl, Jamil Asselah, Branislav Bystricky, Kate Scatchard, Zeba Aziz, Jaroslava Leskova, Sherko Kuemmel, Paolo Bidoli, Richard Ashford, Piotr Sawrycki, Claude Bressac, Alberto Bottini, Pilar Lopez Alvarez, Nadine Dohollou, Alejandro Andres Acevedo Gaete, M. De Laurentiis, T.J. Smilde, Andrew Proctor, Catherine Prady, Michele Aieta, Jan Henry Svensson, Reda Garidi, Erik Wist, Antonia Perello Martorell, Mohammed Jaloudi, Graeme Lumsden, Eva-Maria Grischke, Ali Youssef, Annemieke van der Padt, Kadri Altundag, Christina Bechtner, Mireille Mousseau, Heba El Zawahry, Maartje Los, Alvydas Česas, Alfredo Falcone, Salima Hamizi, Franchette W P J van den Berkmortel, Cesar Estuardo Hernandez-Monroy, K.H. Jung, Swati Kulkarni, R.K. Agrawal, Hwei Chung Wang, Hany Eldeeb, Fredrika Killander, Jose Luis Alonso Romero, Antonio Pazzola, Daan ten Bokkel Huinink, Mario Campone, Beena C.R. Devi, Florence Dalenc, Pedro Jimenez Gallego, Mawin Vongsaisuwon, Timur Ceric, Chantal Bernard Marty, R. A. Popescu, J. van den Bosch, Luis Matamala, Sylvia Ruth, Maria Litwiniuk, Maria Lomas Garrido, Mark Churn, Christian Kersten, Francesco Del Piano, Eddie Herman Tanggo, Antonio Fernandez Aramburo, Kyung Hae Jung, Christos Papadimitriou, Hamdy Abdel Azeem, Patricia Bastick, Tobias Hesse, Maree Colosimo, Lucia Gonzalez Cortijo, Mark Verrill, Gligorov, J, Ataseven, B, Verrill, M, De Laurentiis, M, Jung, K. H, Azim, H. A, Al-sakaff, N, Lauer, S, Shing, M, Pivot, X., de Laurentiis, M, Jung, K, Azim, H, Al-Sakaff, N, Pivot, X, Koroveshi, D, Bouzid, K, Casalnuovo, M, Cascallar, D, Korbenfeld, E, Bastick, P, Beith, J, Colosimo, M, Friedlander, M, Ganju, V, Green, M, Patterson, K, Redfern, A, Richardson, G, Ceric, T, Gordana, K, Beato, C, Ferrari, M, Hegg, R, Helena, V, Ismael, G, Lessa, A, Mano, M, Morelle, A, Nogueira, J, Timcheva, K, Tomova, A, Tsakova, M, Zlatareva-Petrova, A, Asselah, J, Assi, H, Brezden-Masley, C, Chia, S, Freedman, O, Harb, M, Joy, A, Kulkarni, S, Prady, C, Gaete, A, Matamala, L, Torres, R, Yanez, E, Franco, S, Urrego, M, Gugic, D, Vrbanec, D, Melichar, B, Prausova, J, Vyzula, R, Pilarte, R, Leon, M, Munoz, R, Ramos, G, Azeem, H, Aziz, A, El Zawahry, H, Osegueda, F, Alexandre, J, Artignan, X, Barletta, H, Beguier, E, Berdah, J, Marty, C, Bollet, M, Bourgeois, H, Bressac, C, Burki, F, Campone, M, Coeffic, D, Cojocarasu, O, Dagada, C, Dalenc, F, Del Piano, F, Desauw, C, Desmoulins, I, Dohollou, N, Egreteau, J, Ferrero, J, Foa, C, Garidi, R, Gasnault, L, Guardiola, E, Hamizi, S, Jarcau, R, Jacquin, J, Jaubert, D, Jolimoy, G, Mineur, H, Largillier, R, Leduc, B, Martin, P, Melis, A, Monge, J, Moullet, I, Mousseau, M, Nguyen, S, Orfeuvre, H, Petit, T, Priou, F, Bach, I, Simon, H, Stefani, L, Uwer, L, Youssef, A, Aktas, B, von der Assen, A, Augustin, D, Balser, C, Bauer, L, Bechtner, C, Beyer, G, Brucker, C, Buckner, U, Busch, S, Christensen, B, Deryal, M, Farrokh, A, Faust, E, Friedrichs, K, Graf, H, Griesshammer, M, Grischke, E, Hanle, C, Heider, A, Henschen, S, Hesse, T, Jackisch, C, Kisro, J, Kohler, A, Kuemmel, S, Lampe, D, Lantzsch, T, Latos, K, Lex, B, Liedtke, C, Luedders, D, Maintz, C, Muller, V, Overkamp, F, Park-Simon, T, Paul, M, Prechtl, A, Ringsdorf, U, Runnebaum, I, Ruth, S, Salat, C, Scheffen, I, Schilling, J, Schmatloch, S, Schmidt, M, Schneeweiss, A, Schrader, I, Seipelt, G, Simon, E, Stefek, A, Stickeler, E, Thill, M, Tio, J, Tuczek, A, Warm, M, 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Subjects
0301 basic medicine, Oncology, Cancer Research, Receptor, ErbB-2, medicine.medical_treatment, Medizin, Antineoplastic Agent, 0302 clinical medicine, Breast cancer, Trastuzumab, Adjuvant, Aged, 80 and over, education.field_of_study, Middle Aged, HER2/neu, Tolerability, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Herceptin, Subcutaneous, subcutaneous, Female, Survival Analysi, Breast Neoplasm, medicine.drug, Human, Adult, medicine.medical_specialty, Injections, Subcutaneous, Population, Socio-culturale, Antineoplastic Agents, Breast Neoplasms, Injections, Subcutaneou, 03 medical and health sciences, Young Adult, Internal medicine, medicine, Adjuvant therapy, Humans, Subcutaneou, education, Adverse effect, Aged, Chemotherapy, Adjuvant, breast cancer, HER2/neu, herceptin, trastuzumab, business.industry, medicine.disease, Survival Analysis, Surgery, Discontinuation, 030104 developmental biology, business
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.

Published
2017

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