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142 results on '"Uttenreuther‐Fischer, Martina"'

5. Afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one previous trastuzumab treatment (LUX-Breast 1): an open-label, randomised, phase 3 trial

Author

Harbeck, Nadia, Huang, Chiun-Sheng, Hurvitz, Sara, Yeh, Dah-Cherng, Shao, Zhimin, Im, Seock-Ah, Jung, Kyung Hae, Shen, Kunwei, Ro, Jungsil, Jassem, Jacek, Zhang, Qingyuan, Im, Young-Hyuck, Wojtukiewicz, Marek, Sun, Qiang, Chen, Shin-Cheh, Goeldner, Rainer-Georg, Uttenreuther-Fischer, Martina, Xu, Binghe, and Piccart-Gebhart, Martine

Published
2016
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12. Comprehensive analysis of the ErbB receptor family in pediatric nervous system tumors and rhabdomyosarcoma

Author

Varlet, Pascale, primary, Bouffet, Eric, additional, Casanova, Michela, additional, Giangaspero, Felice, additional, Antonelli, Manila, additional, Hargrave, Darren, additional, Ladenstein, Ruth, additional, Pearson, Andy, additional, Hawkins, Cynthia, additional, König, Fatima Barbara, additional, Rüschoff, Josef, additional, Schmauch, Christian, additional, Bühnemann, Claudia, additional, Garin‐Chesa, Pilar, additional, Schweifer, Norbert, additional, Uttenreuther‐Fischer, Martina, additional, Gibson, Neil, additional, Ittrich, Carina, additional, Krämer, Nicole, additional, Solca, Flavio, additional, Stolze, Britta, additional, and Geoerger, Birgit, additional

Published
2021
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15. A phase II trial to assess efficacy and safety of afatinib in extensively pretreated patients with HER2-negative metastatic breast cancer

Author

Schuler, Martin, Awada, Ahmad, Harter, Philipp, Canon, Jean Luc, Possinger, Kurt, Schmidt, Marcus, De Grève, Jacques, Neven, Patrick, Dirix, Luc, Jonat, Walter, Beckmann, Matthias W., Schütte, Jochen, Fasching, Peter A., Gottschalk, Nina, Besse-Hammer, Tatiana, Fleischer, Frank, Wind, Sven, Uttenreuther-Fischer, Martina, Piccart, Martine, and Harbeck, Nadia

Published
2012
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17. Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine

Author

Goh, Gerald, Schmid, Ramona, Guiver, Kelly, Arpornwirat, Wichit, Chitapanarux, Imjai, Ganju, Vinod, Im, Seock-Ah, Kim, Sung-Bae, Dechaphunkul, Arunee, Maneechavakajorn, Jedzada, Spector, Neil, Yau, Thomas, Afrit, Mehdi, Ahmed, Slim Ben, Johnston, Stephen R., Gibson, Neil, Uttenreuther-Fischer, Martina, Herrero, Javier, and Swanton, Charles

Subjects
Vinorelbine -- Patient outcomes, Afatinib -- Patient outcomes, Gene mutation -- Health aspects, Breast cancer -- Genetic aspects -- Development and progression -- Drug therapy, Biological sciences
Abstract

Background Inflammatory breast cancer (IBC) is a rare, aggressive form of breast cancer associated with HER2 amplification, with high risk of metastasis and an estimated median survival of 2.9 y. We performed an open-label, single-arm phase II clinical trial (ClinicalTrials.gov NCT01325428) to investigate the efficacy and safety of afatinib, an irreversible ErbB family inhibitor, alone and in combination with vinorelbine in patients with HER2-positive IBC. This trial included prospectively planned exome analysis before and after afatinib monotherapy. Methods and Findings HER2-positive IBC patients received afatinib 40 mg daily until progression, and thereafter afatinib 40 mg daily and intravenous vinorelbine 25 mg/m.sup.2 weekly. The primary endpoint was clinical benefit; secondary endpoints were objective response (OR), duration of OR, and progression-free survival (PFS). Of 26 patients treated with afatinib monotherapy, clinical benefit was achieved in 9 patients (35%), 0 of 7 trastuzumab-treated patients and 9 of 19 trastuzumab-naïve patients. Following disease progression, 10 patients received afatinib plus vinorelbine, and clinical benefit was achieved in 2 of 4 trastuzumab-treated and 0 of 6 trastuzumab-naïve patients. All patients had treatment-related adverse events (AEs). Whole-exome sequencing of tumour biopsies taken before treatment and following disease progression on afatinib monotherapy was performed to assess the mutational landscape of IBC and evolutionary trajectories during therapy. Compared to a cohort of The Cancer Genome Atlas (TCGA) patients with HER2-positive non-IBC, HER2-positive IBC patients had significantly higher mutational and neoantigenic burden, more frequent gain-of-function TP53 mutations and a recurrent 11q13.5 amplification overlapping PAK1. Planned exploratory analysis revealed that trastuzumab-naïve patients with tumours harbouring somatic activation of PI3K/Akt signalling had significantly shorter PFS compared to those without (p = 0.03). High genomic concordance between biopsies taken before and following afatinib resistance was observed with stable clonal structures in non-responding tumours, and evidence of branched evolution in 8 of 9 tumours analysed. Recruitment to the trial was terminated early following the LUX-Breast 1 trial, which showed that afatinib combined with vinorelbine had similar PFS and OR rates to trastuzumab plus vinorelbine but shorter overall survival (OS), and was less tolerable. The main limitations of this study are that the results should be interpreted with caution given the relatively small patient cohort and the potential for tumour sampling bias between pre- and post-treatment tumour biopsies. Conclusions Afatinib, with or without vinorelbine, showed activity in trastuzumab-naïve HER2-positive IBC patients in a planned subgroup analysis. HER2-positive IBC is characterized by frequent TP53 gain-of-function mutations and a high mutational burden. The high mutational load associated with HER2-positive IBC suggests a potential role for checkpoint inhibitor therapy in this disease. Trial Registration ClinicalTrials.gov NCT01325428, Author(s): Gerald Goh 1,2, Ramona Schmid 3, Kelly Guiver 4, Wichit Arpornwirat 5, Imjai Chitapanarux 6, Vinod Ganju 7, Seock-Ah Im 8, Sung-Bae Kim 9, Arunee Dechaphunkul 10, Jedzada Maneechavakajorn [...]

Published
2016
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21. Comprehensive analysis of the ErbB receptor family in pediatric nervous system tumors and rhabdomyosarcoma.

Author

Varlet, Pascale, Bouffet, Eric, Casanova, Michela, Giangaspero, Felice, Antonelli, Manila, Hargrave, Darren, Ladenstein, Ruth, Pearson, Andy, Hawkins, Cynthia, König, Fatima Barbara, Rüschoff, Josef, Schmauch, Christian, Bühnemann, Claudia, Garin‐Chesa, Pilar, Schweifer, Norbert, Uttenreuther‐Fischer, Martina, Gibson, Neil, Ittrich, Carina, Krämer, Nicole, and Solca, Flavio

Published
2022
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28. Implementation of mechanism of action biology-driven early drug development for children with cancer

Author

Pearson, Andrew D.J., primary, Herold, Ralf, additional, Rousseau, Raphaël, additional, Copland, Chris, additional, Bradley-Garelik, Brigid, additional, Binner, Debbie, additional, Capdeville, Renaud, additional, Caron, Hubert, additional, Carleer, Jacqueline, additional, Chesler, Louis, additional, Geoerger, Birgit, additional, Kearns, Pamela, additional, Marshall, Lynley V., additional, Pfister, Stefan M., additional, Schleiermacher, Gudrun, additional, Skolnik, Jeffrey, additional, Spadoni, Cesare, additional, Sterba, Jaroslav, additional, van den Berg, Hendrick, additional, Uttenreuther-Fischer, Martina, additional, Witt, Olaf, additional, Norga, Koen, additional, Vassal, Gilles, additional, Georger, B., additional, Iannone, R., additional, Jakacki, R., additional, and Russo, M., additional

Published
2016
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29. A phase I study of afatinib combined with carboplatin or carboplatin plus paclitaxel in patients (pts) with advanced solid tumors.

Author

Gao, Fangfei, primary, O'Brien, Mary, additional, Sarker, Debashis, additional, Bhosle, Jaishree, additional, Yap, Timothy Anthony, additional, Uttenreuther-Fischer, Martina Maria, additional, Pemberton, Karine, additional, Goeldner, Rainer-Georg, additional, Wiebe, Sabrina, additional, De Bono, Johann S., additional, and Spicer, James F., additional

Published
2016
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30. A phase II study of afatinib, an irreversible ErbB family blocker, added to letrozole in patients with estrogen receptor-positive hormone-refractory metastatic breast cancer progressing on letrozole

Author

Gunzer, Katharina, primary, Joly, Florence, additional, Ferrero, Jean-Marc, additional, Gligorov, Joseph, additional, de Mont-Serrat, Helene, additional, Uttenreuther-Fischer, Martina, additional, Pelling, Katy, additional, Wind, Sven, additional, Bousquet, Guilhem, additional, and Misset, Jean-Louis, additional

Published
2016
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32. Abstract P5-19-01: Randomized Phase III trial of afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one prior trastuzumab treatment: LUX-Breast 1

Author

Harbeck, Nadia, primary, Huang, Chiun-Sheng, additional, Hurvitz, Sara, additional, Yeh, Dah-Cherng, additional, Shao, Zhimin, additional, Im, Seock-Ah, additional, Jung, Kyung Hae, additional, Shen, Kunwei, additional, Ro, Jungsil, additional, Jassem, Jacek, additional, Zhang, Qingyuan, additional, Im, Young-Hyuck, additional, Wojtukiewicz, Marek, additional, Sun, Qiang, additional, Chen, Shin-Cheh, additional, Goeldner, Rainer-Georg, additional, Lahogue, Annick, additional, Uttenreuther-Fischer, Martina, additional, Xu, Binghe, additional, and Piccart-Gebhart, Martine, additional

Published
2015
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34. Phase I study of pulsatile 3-day administration of afatinib (BIBW 2992) in combination with docetaxel in advanced solid tumors.

Author

Awada, Ahmad, Dumez, Herlinde, Hendlisz, Alain, Wolter, P, Besse-Hammer, Tatiana, Uttenreuther-Fischer, Martina, Stopfer, P, Fleischer, Frank, Piccart-Gebhart, Martine, Schöffski, Patrick, Awada, Ahmad, Dumez, Herlinde, Hendlisz, Alain, Wolter, P, Besse-Hammer, Tatiana, Uttenreuther-Fischer, Martina, Stopfer, P, Fleischer, Frank, Piccart-Gebhart, Martine, and Schöffski, Patrick

Abstract

Background A phase I study to assess the maximum tolerated dose (MTD) of a short course of afatinib in combination with docetaxel for the treatment of solid tumors. Methods Patients with advanced solid malignancies received docetaxel 75 mg/m(2) intravenously on day 1 and oral afatinib once daily on days 2-4, in 3-week treatment cycles. The afatinib dose was escalated in successive cohorts of 3-6 patients until dose-limiting toxicity (DLT). The MTD cohort was expanded to 13 patients. Pharmacokinetic parameters were assessed. Results Forty patients were treated. Afatinib doses were escalated to 160 mg/day in combination with 75 mg/m(2) docetaxel. Three patients had drug-related DLTs during cycle 1. The MTD was defined as 90 mg/day afatinib (days 2-4) with docetaxel 75 mg/m(2). The most frequent drug-related adverse events (all grades) were alopecia, diarrhea, stomatitis (all 50 %) and rash (40 %, all grade ≤2). Three patients had confirmed responses, two patients had unconfirmed responses and nine patients had durable stable disease >6 cycles. No pharmacokinetic interaction was observed. Conclusion Afatinib 90 mg administered for 3 days after docetaxel 75 mg/m(2) is the MTD for this treatment schedule and the recommended phase II/phase III dose. This combination showed anti-tumor activity in phase I, with a manageable adverse-event profile., Journal Article, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2013

35. A phase II trial to assess efficacy and safety of afatinib in extensively pretreated patients with HER2-negative metastatic breast cancer.

Author

Schuler, M, Awada, Ahmad, Harter, Philipp, Canon, Jean-Luc, Possinger, Kurt, Schmidt, M, De Greve, Jacques, Neven, Patrick, Dirix, Luc Y, Jonat, Walter, Beckmann, Matthias W, Schütte, Jochen, Fasching, Peter A, Gottschalk, Nina, Besse-Hammer, Tatiana, Fleischer, Frank, Wind, Sven, Uttenreuther-Fischer, Martina, Piccart-Gebhart, Martine, Harbeck, Nadia, Schuler, M, Awada, Ahmad, Harter, Philipp, Canon, Jean-Luc, Possinger, Kurt, Schmidt, M, De Greve, Jacques, Neven, Patrick, Dirix, Luc Y, Jonat, Walter, Beckmann, Matthias W, Schütte, Jochen, Fasching, Peter A, Gottschalk, Nina, Besse-Hammer, Tatiana, Fleischer, Frank, Wind, Sven, Uttenreuther-Fischer, Martina, Piccart-Gebhart, Martine, and Harbeck, Nadia

Abstract

Afatinib (BIBW 2992) is an ErbB-family blocker that irreversibly inhibits signaling from all relevant ErbB-family dimers. Afatinib has demonstrated preclinical activity in human epidermal growth factor receptor HER2 (ErbB2)-positive and triple-negative xenograft models of breast cancer, and clinical activity in phase I studies. This was a multicenter phase II study enrolling patients with HER2-negative metastatic breast cancer progressing following no more than three lines of chemotherapy. No prior epidermal growth factor receptor-targeted therapy was allowed. Patients received 50-mg afatinib once daily until disease progression. Tumor assessment was performed at every other 28-day treatment course. The primary endpoint was clinical benefit (CB) for ≥4 treatment courses in triple-negative (Cohort A) metastatic breast cancer (TNBC) and objective responses measured by Response Evaluation Criteria in Solid Tumors in patients with HER2-negative, estrogen receptor-positive, and/or progesterone receptor-positive breast cancer (Cohort B). Fifty patients received treatment, including 29 patients in Cohort A and 21 patients in Cohort B. No objective responses were observed in either cohort. Median progression-free survival was 7.4 and 7.7 weeks in Cohorts A and B, respectively. Three patients with TNBC had stable disease for ≥4 treatment courses, one of them for 12 courses (median 26.3 weeks; range 18.9-47.9 weeks). The most frequently observed afatinib-associated adverse events (AEs) were gastrointestinal and skin-related side effects, which were manageable by symptomatic treatment and dose reductions. Afatinib pharmacokinetics were comparable to those observed in previously reported phase I trials. In conclusion, afatinib had limited activity in HER2-negative breast cancer. AEs were generally manageable and mainly affected the skin and the gastrointestinal tract., Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2012

40. A neoadjuvant, randomized, open-label phase II trial of afatinib (A) versus trastuzumab (T) versus lapatinib (L) in patients (pts) with locally advanced HER2-positive breast cancer (BC).

Author

Rimawi, Mothaffar F., primary, Aleixo, Sabina B., additional, Alarcon Rozas, Ashley, additional, Matos Neto, Joao Nunes, additional, Caleffi, Maira, additional, Vinholes, Jeferson J.F., additional, Figueira, Alicardo Cesar, additional, Souza, Sulene Cunha, additional, Reiriz, Andre B., additional, Arantes, Heloisa, additional, Uttenreuther-Fischer, Martina Maria, additional, and Osborne, C. Kent, additional

Published
2012
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41. Phase I Trial of the Irreversible EGFR and HER2 Kinase Inhibitor BIBW 2992 in Patients With Advanced Solid Tumors

Author

Yap, Timothy A., primary, Vidal, Laura, additional, Adam, Jan, additional, Stephens, Peter, additional, Spicer, James, additional, Shaw, Heather, additional, Ang, Jooern, additional, Temple, Graham, additional, Bell, Susan, additional, Shahidi, Mehdi, additional, Uttenreuther-Fischer, Martina, additional, Stopfer, Peter, additional, Futreal, Andrew, additional, Calvert, Hilary, additional, de Bono, Johann S., additional, and Plummer, Ruth, additional

Published
2010
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48. Diarrhea associated with afatinib: an oral ErbB family blocker.

Author

Chih-Hsin Yang, James, Reguart, Noemi, Barinoff, Jana, Köhler, Jens, Uttenreuther-Fischer, Martina, Stammberger, Uz, O'Brien, Dennis, Wolf, Jürgen, and Cohen, Ezra E. W.

Abstract

Gastrointestinal (GI) adverse events (AEs) are frequently observed in patients receiving EGF receptor (EGFR; also known as HER1 or ErbB1) tyrosine kinase inhibitor therapy. GI AEs are among the most common and most impactful on a patient's quality of life. Severe diarrhea can result in fluid and electrolyte losses, leading to dehydration, electrolyte imbalances and renal insufficiency. Afatinib is an irreversible, oral, ErbB family blocker, inhibiting EGFR (ErbB1), HER2 (ErbB2) and ErbB4 receptor kinases. It also inhibits transphosphorylation of ErbB3. Similar to reversible tyrosine kinase inhibitors of EGFR, GI AEs -- in particular, diarrhea -- have frequently been observed in afatinib-treated patients. This article summarizes current data on afatinibassociated diarrhea and provides strategies for its management. Patient education, early identification, timely management and ongoing assessment will help to prevent aggravation, afatinib dose reductions or therapy discontinuation, encouraging patient compliance and allowing patients to obtain the maximum therapeutic benefit from this agent. [ABSTRACT FROM AUTHOR]

Published
2013
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49. Session 1: Cancer.

Author

Hagiwara, Hideaki, Aotsuka, Yasuki, Yamamoto, Yasushi, Miyahara, Junichi, Mitoh, Yuko, Vollmers, H.P., Hensel, F., Krenn, V., Hermann, R., Brandlein, S., Schmausser, B., Timmerman, W., Illert, B., Willhelm, M., Thiede, A., Muller-Hermelink, H.K., Uttenreuther-Fischer, Martina M., Krueger, Joerg, and Gaedicke, Gerhard

Subjects
CANCER, MONOCLONAL antibodies, IMMUNOTHERAPY, MELANOMA treatment
Abstract

Focuses on different research papers related to cancer disease. Recognition of antigens by human monoclonal antibody; Application of immunotherapy for stomach carcinoma patients; Development of tumor vaccine; Utilization of novel immunotoxins in treating human melanoma.

Published
2001
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