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https://www.readbyqxmd.com/read/28438884/safety-evaluation-of-trastuzumab-emtansine-in-japanese-patients-with-her2-positive-advanced-breast-cancer
#1
Junichiro Watanabe, Yoshinori Ito, Toshiaki Saeki, Norikazu Masuda, Toshimi Takano, Shintaro Takao, Kazuhiko Nakagami, Koichiro Tsugawa, Shintaro Nakagawa, Kazumitsu Kanatani, Takahiro Nakayama
BACKGROUND/AIM: Tolerability and safety of trastuzumab emtansine (T-DM1) was investigated in Japanese patients with HER2-positive advanced breast cancer who were previously treated with chemotherapy and trastuzumab. PATIENTS AND METHODS: Patients with inoperable or recurrent breast cancer who were previously treated with chemotherapy and trastuzumab in adjuvant and/or metastatic disease were included. T-DM1 3.6 mg/kg was administered intravenously every 21 days...
May 2017: In Vivo
https://www.readbyqxmd.com/read/28415567/efficacy-and-safety-of-t-dm1-in-the-common-practice-of-her2-advanced-breast-cancer-setting-a-multicenter-study
#2
Alessandra Fabi, Michelino De Laurentiis, Michele Caruso, Enrichetta Valle, Luca Moscetti, Daniele Santini, Katia Cannita, Luisa Carbognin, Mariangela Ciccarese, Rosalba Rossello, Grazia Arpino, Vita Leonardi, Filippo Montemurro, Nicla La Verde, Daniele Generali, Alberto Zambelli, Giuseppa Scandurra, Michelangelo Russillo, Ida Paris, Anna Maria D'Ottavio, Gianfranco Filippelli, Marianna Giampaglia, Simonetta Stani, Agnese Fabbri, Daniele Alesini, Daniela Cianniello, Diana Giannarelli, Francesco Cognetti
Ado-trastuzumab emtansine (T-DM1) is an antibody-drug conjugate approved for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive, metastatic breast cancer (mBC). The aim of this 'field-practice' study was to investigate the efficacy and safety of T-DM1, focusing on treatment line, previous lapatinib treatment and patterns of metastasis. Three hundred and three patients with HER2-positive mBC who received T-DM1 were identified by reviewing the medical records of 24 Italian Institutions...
March 18, 2017: Oncotarget
https://www.readbyqxmd.com/read/28402624/near-infrared-photochemoimmunotherapy-by-photoactivatable-bifunctional-antibody-drug-conjugates-targeting-her2-positive-cancer
#3
Kimihiro Ito, Makoto Mitsunaga, Takashi Nishimura, Masayuki Saruta, Takeo Iwamoto, Hisataka Kobayashi, Hisao Tajiri
Near-infrared photoimmunotherapy (NIR-PIT) is a new class of molecular targeted cancer therapy based on antibody-photoabsorber conjugates and NIR light irradiation. Recent studies have shown effective tumor control, including that of human epidermal growth factor receptor 2 (HER2)-positive cancer, by selective molecular targeting with NIR-PIT. However, the depth of NIR light penetration limits its use. Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate consisting of the monoclonal antibody trastuzumab linked to the cytotoxic agent maytansinoid DM1...
April 12, 2017: Bioconjugate Chemistry
https://www.readbyqxmd.com/read/28388844/effects-of-drug-antibody-ratio-dar-on-pharmacokinetics-biodistribution-efficacy-and-tolerability-of-antibody-maytansinoid-conjugates
#4
Xiuxia Sun, Jose F Ponte, Nicholas Yoder, Rassol Laleau, Jennifer Coccia, Leanne Lanieri, Qifeng Qiu, Rui Wu, Erica Hong, Megan Bogalhas, Lintao Wang, Ling Dong, Yulius Setiady, Erin Maloney, Olga Ab, Xiaoyan Zhang, Jan Pinkas, Thomas Keating, Ravi V J Chari, Hans Erickson, John M Lambert
Antibody-drug conjugates (ADCs) are being actively pursued as a treatment option for cancer following the regulatory approval of brentuximab vedotin (Adcetris®) and ado-trastuzumab emtansine (Kadcyla®). ADCs consist of a cytotoxic agent conjugated to a targeting antibody through a linker. The two approved ADCs (and most ADCs now in the clinic that use a microtubule disrupting agent as the payload) are heterogeneous conjugates with an average drug to antibody ratio (DAR) of 3-4 (potentially ranging from 0-8 for individual species)...
April 7, 2017: Bioconjugate Chemistry
https://www.readbyqxmd.com/read/28374319/application-of-a-pk-pd-modeling-and-simulation-based-strategy-for-clinical-translation-of-antibody-drug-conjugates-a-case-study-with-trastuzumab-emtansine-t-dm1
#5
Aman P Singh, Dhaval K Shah
Successful clinical translation of antibody-drug conjugates (ADCs) can be challenging due to complex pharmacokinetics and differences between preclinical and clinical tumors. To facilitate this translation, we have developed a general pharmacokinetic-pharmacodynamic (PK-PD) modeling and simulation (M&S)-based strategy for ADCs. Here we present the validation of this strategy using T-DM1 as a case study. A previously developed preclinical tumor disposition model for T-DM1 (Singh and Shah, AAPSJ. 2015; 18(4):861-875) was used to develop a PK-PD model that can characterize in vivo efficacy of T-DM1 in preclinical tumor models...
April 3, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28361465/antibody-drug-conjugates-adcs-for-personalized-treatment-of-solid-tumors-a-review
#6
REVIEW
John M Lambert, Charles Q Morris
Attaching a cytotoxic "payload" to an antibody to form an antibody-drug conjugate (ADC) provides a mechanism for selective delivery of the cytotoxic agent to cancer cells via the specific binding of the antibody to cancer-selective cell surface molecules. The first ADC to receive marketing authorization was gemtuzumab ozogamicin, which comprises an anti-CD33 antibody conjugated to a highly potent DNA-targeting antibiotic, calicheamicin, approved in 2000 for treating acute myeloid leukemia. It was withdrawn from the US market in 2010 following an unsuccessful confirmatory trial...
March 30, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28343975/trastuzumab-emtansine-versus-taxane-use-for-previously-treated-her2-positive-locally-advanced-or-metastatic-gastric-or-gastro-oesophageal-junction-adenocarcinoma-gatsby-an-international-randomised-open-label-adaptive-phase-2-3-study
#7
Peter C Thuss-Patience, Manish A Shah, Atsushi Ohtsu, Eric Van Cutsem, Jaffer A Ajani, Hugo Castro, Wasat Mansoor, Hyun Cheol Chung, Gyorgy Bodoky, Kohei Shitara, Gail D Lewis Phillips, Tina van der Horst, Marie-Laurence Harle-Yge, Betsy L Althaus, Yoon-Koo Kang
BACKGROUND: Although trastuzumab plus chemotherapy is the standard of care for first-line treatment of HER2-positive advanced gastric cancer, there is no established therapy in the second-line setting. In GATSBY, we examined the efficacy and tolerability of trastuzumab emtansine in patients previously treated for HER2-positive advanced gastric cancer (unresectable, locally advanced, or metastatic gastric cancer, including adenocarcinoma of the gastro-oesophageal junction). METHODS: This is the final analysis from GATSBY, a randomised, open-label, adaptive, phase 2/3 study, done at 107 centres (28 countries worldwide)...
March 23, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28325631/new-concepts-of-personalized-therapy-in-salivary-gland-carcinomas
#8
REVIEW
Gunter Keller, Diana Steinmann, Alexander Quaas, Viktor Grünwald, Stefan Janssen, Kais Hussein
Salivary gland carcinomas are rare tumours and therapy strategies are less standardized than in lung, gastric or breast cancer. Therapy is based on surgery, but not all carcinomas are completely resectable, e.g. because carcinomas often show infiltration of nerves. For further therapy decision pathology is recommended, but evaluation of potential targets for personalized therapy is not part of the routine panel. Many salivary gland carcinomas can be resistant to radio- and/or chemotherapy, which limits therapeutic options...
March 18, 2017: Oral Oncology
https://www.readbyqxmd.com/read/28303026/strategies-and-challenges-for-the-next-generation-of-antibody-drug-conjugates
#9
REVIEW
Alain Beck, Liliane Goetsch, Charles Dumontet, Nathalie Corvaïa
Antibody-drug conjugates (ADCs) are one of the fastest growing classes of oncology therapeutics. After half a century of research, the approvals of brentuximab vedotin (in 2011) and trastuzumab emtansine (in 2013) have paved the way for ongoing clinical trials that are evaluating more than 60 further ADC candidates. The limited success of first-generation ADCs (developed in the early 2000s) informed strategies to bring second-generation ADCs to the market, which have higher levels of cytotoxic drug conjugation, lower levels of naked antibodies and more-stable linkers between the drug and the antibody...
March 17, 2017: Nature Reviews. Drug Discovery
https://www.readbyqxmd.com/read/28259011/clinical-use-of-biomarkers-in-breast-cancer-updated-guidelines-from-the-european-group-on-tumor-markers-egtm
#10
REVIEW
M J Duffy, N Harbeck, M Nap, R Molina, A Nicolini, E Senkus, F Cardoso
Biomarkers play an essential role in the management of patients with invasive breast cancer. For selecting patients likely to respond to endocrine therapy, both oestrogen receptors (ERs) and progesterone receptors (PRs) should be measured on all newly diagnosed invasive breast cancers. On the other hand, for selecting likely response to all forms of anti-HER2 therapy (trastuzumab, pertuzumab, lapatinib or ado-trastuzumab emtansine), determination of HER2 expression or gene copy number is mandatory. Where feasible, measurement of ER, PR and HER2 should be performed on recurrent lesions and the primary invasive tumour...
April 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28236776/evolving-landscape-of-human-epidermal-growth-factor-receptor-2-positive-breast-cancer-treatment-and-the-future-of-biosimilars
#11
REVIEW
Christian Jackisch, Philip Lammers, Ira Jacobs
Human epidermal growth factor receptor 2-positive (HER2+) breast cancer comprises approximately 15%-20% of all breast cancers and is associated with a poor prognosis. The introduction of anti-HER2 therapy has significantly improved clinical outcomes for patients with HER2+ breast cancer, and multiple HER2-directed agents (ie, trastuzumab, pertuzumab, lapatinib, and ado-trastuzumab emtansine [T-DM1]) are approved for clinical use in various settings. The treatment landscape for patients with HER2+ breast cancer is continuing to evolve...
April 2017: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/28229982/circulating-free-dna-mutation-associated-with-response-of-targeted-therapy-in-human-epidermal-growth-factor-receptor-2-positive-metastatic-breast-cancer
#12
Qing Ye, Fan Qi, Li Bian, Shao-Hua Zhang, Tao Wang, Ze-Fei Jiang
BACKGROUND: The addition of anti-human epidermal growth factor receptor 2 (HER2)-targeted drugs, such as trastuzumab, lapatinib, and trastuzumab emtansine (T-DM1), to chemotherapy significantly improved prognosis of HER2-positive breast cancer patients. However, it was confused that metastatic patients vary in the response of targeted drug. Therefore, methods of accurately predicting drug response were really needed. To overcome the spatial and temporal limitations of biopsies, we aimed to develop a more sensitive and less invasive method of detecting mutations associated with anti-HER2 therapeutic response through circulating-free DNA (cfDNA)...
March 5, 2017: Chinese Medical Journal
https://www.readbyqxmd.com/read/28228709/targeted-therapies-in-her2-overexpressing-metastatic-breast-cancer
#13
REVIEW
Soumaya Labidi, Nesrine Mejri, Aymen Lagha, Nouha Daoud, Houda El Benna, Mehdi Afrit, Hamouda Boussen
Human epidermal growth factor receptor-2 (HER2) is amplified in 25-30% of breast cancers and is associated with aggressive disease and poorer survival. Multiple anti-HER2 targeted therapies have dramatically changed management and outcome of this subgroup, both in adjuvant and metastatic settings. Despite the improvement of survival thanks to trastuzumab, unclear mechanisms of resistance occur, which has led to the development of new anti-HER2 therapies such as lapatinib, pertuzumab, and trastuzumab emtansine (T-DM1)...
December 2016: Breast Care
https://www.readbyqxmd.com/read/28133215/-long-term-survival-of-a-patient-with-stage-iv-breast-cancer-and-an-intrathoracic-space-occupying-metastatic-lesion
#14
Toshimori Koh, Tomohito Sakai, Shunji Kato, Shoji Hirajima, Minoru Nishio, Koji Soga, Atsushi Oguro, Noboru Nakagawa
A 50-year old woman noticed left axillary lymph node swelling and presented at our hospital. CNB showed adenocarcinoma( pap-tub, ER+, PgR+, HER2 3+). CT revealed a right lung metastatic nodule and swollen lymph nodes above the left collarbone and left axilla. However, no breast tumor was found at that time. We diagnosed occult breast cancer, TxN3bM1 (lung), Stage IV . FEC(100), paclitaxel, letrozole, anastrozole, exemestane plus trastuzumab, tegafur/uracil plus trastuzumab, and lapatinib plus capecitabine were sequentially administered...
November 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28131055/lc-ms-ms-method-for-the-simultaneous-determination-of-lys-mcc-dm1-mcc-dm1-and-dm1-as-potential-intracellular-catabolites-of-the-antibody-drug-conjugate-trastuzumab-emtansine-t-dm1
#15
Yazhong Liu, Fang Zhou, Hua Sang, Hui Ye, Qianying Chen, Lan Yao, Ping Ni, Guangji Wang, Jingwei Zhang
Lysine-MCC-DM1, MCC-DM1 and DM1 are potential catabolites of trastuzumab emtansine (T-DM1). A convenient liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated to detect these catabolites simultaneously in in vitro investigations for the first time. Protein precipitation was utilized to prepare the samples. Chromatographic separation was achieved on a Phenomenex Kinetex C18 column (100×2.1mm, 2.6μm) with mobile-phase gradient elution. The calibration curves of each analyte ranging from 1 to 100nM showed good linearity (r(2)>0...
January 12, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28119394/use-and-outcomes-of-targeted-therapies-in-early-and-metastatic-her2-positive-breast-cancer-in-australia-protocol-detailing-observations-in-a-whole-of-population-cohort
#16
Benjamin Daniels, Sarah J Lord, Belinda E Kiely, Nehmat Houssami, Philip Haywood, Christine Y Lu, Robyn L Ward, Sallie-Anne Pearson
BACKGROUND: The management of human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) has changed dramatically with the introduction and widespread use of HER2-targeted therapies. However, there is relatively limited real-world information on patterns of use, effectiveness and safety in whole of population cohorts. The research programme detailed in this protocol will generate evidence on the prescribing patterns, safety monitoring and outcomes of patients with BC treated with HER2-targeted therapies in Australia...
January 24, 2017: BMJ Open
https://www.readbyqxmd.com/read/28110417/splenic-enlargement-and-bone-marrow-hyperplasia-in-patients-receiving-trastuzumab-emtansine-for-metastatic-breast-cancer
#17
Michael Kosmin, Andreas Makris, Noorulhuda Jawad, David Woolf, David Miles, Anwar R Padhani
BACKGROUND: An association between trastuzumab-emtansine (T-DM1) and splenic enlargement is reported in preclinical data, and has been noted anecdotally in patients receiving T-DM1 at our institution. Use of whole-body MRI examinations (WB-MRI) allows for detailed bone marrow assessment and semi-automated splenic volume calculations. OBJECTIVE: To retrospectively evaluate changes in splenic volume versus evidence of bone marrow hyperplasia and/or changes in portal venous pressure in patients receiving T-DM1 for metastatic breast cancer...
January 21, 2017: Targeted Oncology
https://www.readbyqxmd.com/read/28108597/bispecific-antibodies-and-antibody-drug-conjugates-adcs-bridging-her2-and-prolactin-receptor-improve-efficacy-of-her2-adcs
#18
Julian Andreev, Nithya Thambi, Andres E Perez Bay, Frank J Delfino, Joel H Martin, Marcus P Kelly, Jessica R Kirshner, Ashique Rafique, Arthur Kunz, Thomas Nittoli, Douglas MacDonald, Christopher Daly, William Olson, Gavin Thurston
The properties of cell surface proteins targeted by Antibody-drug conjugates (ADCs) have not been fully exploited; of particular importance are the rate of internalization and the route of intracellular trafficking. In this study we compared the trafficking of HER2, which is the target of the clinically approved ADC ado-trastuzumab emtansine (T-DM1), with that of prolactin receptor (PRLR), another potential target in breast cancer. In contrast to HER2, we found that PRLR is rapidly and constitutively internalized, and traffics efficiently to lysosomes, where it is degraded...
January 20, 2017: Molecular Cancer Therapeutics
https://www.readbyqxmd.com/read/28091366/trastuzumab-emtansine-and-cost-based-decision-making
#19
EDITORIAL
The Lancet
No abstract text is available yet for this article.
January 7, 2017: Lancet
https://www.readbyqxmd.com/read/28062707/optimization-of-a-pegylated-glucuronide-monomethylauristatin-e-linker-for-antibody-drug-conjugates
#20
Patrick J Burke, Joseph Z Hamilton, Scott C Jeffrey, Joshua H Hunter, Svetlana O Doronina, Nicole M Okeley, Jamie B Miyamoto, Martha E Anderson, Ivan J Stone, Michelle L Ulrich, Jessica K Simmons, Erica E McKinney, Peter D Senter, Robert P Lyon
The emergence of antibody-drug conjugates (ADC), such as brentuximab vedotin and ado-trastuzumab emtansine, has led to increased efforts to identify new payloads and develop improved drug-linker technologies. Most antibody payloads impart significant hydrophobicity to the ADC, resulting in accelerated plasma clearance and suboptimal in vivo activity, particularly for conjugates with high drug-to-antibody ratios (DAR). We recently reported on the incorporation of a discrete PEG24 polymer as a side chain in a β-glucuronidase-cleavable monomethylauristatin E (MMAE) linker to provide homogeneous DAR 8 conjugates with decreased plasma clearance and increased antitumor activity in xenograft models relative to a non-PEGylated control...
January 2017: Molecular Cancer Therapeutics
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