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Antibody-Based Therapies
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
The FDA approved trastuzumab emtansine in 2013 for HER2+ve metastatic breast cancer in patients who have been treated previously with trastuzumab and a taxane (i.e., paclitaxel or docetaxel), and who have already been treated for metastatic breast cancer or have developed tumor recurrence within six months of adjuvant therapy. At the request of the FDA, in the US this agent was approved with the generic name of “ado-trastuzumab emtansine”, rather than the original USAN (United States Adopted Name) name of “trastuzumab emtansine” issued in 2009 to help prevent dispensing errors. During preclinical development and clinical trials, it also became known as trastuzumab-DM1 or T-DM1 (DM1 = mertansine) or trastuzumab-MCC-DM1 (MCC-DM1 = emtansine).
Breast Cancer
Published in Pat Price, Karol Sikora, Treatment of Cancer, 2020
Amy Case, Gwenllian Edwards, Catherine Pembroke
Targeted agents currently available for the treatment of HER2-positive breast cancers include the monoclonal antibodies trastuzumab and pertuzumab; a small-molecule tyrosine kinase inhibitor, lapatinib; and an antibody–cytotoxic drug conjugate of trastuzumab and a microtubule inhibitor DM1 named ado-trastuzumab-emtansine (Kadcyla).
Breast cancer
Published in Peter Hoskin, Peter Ostler, Clinical Oncology, 2020
Trastuzumab emtansine is an antibody drug conjugate (trastuzumab linked to the cytotoxic agent emtansine) and has also shown efficacy when patients have progressed on trastuzumab alone. This is an exciting concept as the trastuzumab targets cancer cells leading to targeted delivery of the cytotoxic agent.
Cost-efficiency analysis of conversion to biosimilar filgrastim for supportive cancer care and resultant expanded access analysis to supportive care and early-stage HER2+ breast cancer treatment in Saudi Arabia: simulation study
Published in Journal of Medical Economics, 2023
Consuela Cheriece Yousef, Mansoor Ahmed Khan, Hind Almodaimegh, Majed Alshamrani, Meteb Al-Foheidi, Hana AlAbdalkarim, Ahmed AlJedai, Anjum Naeem, Ivo Abraham
Table 5 shows the associated expanded access to therapeutic care and supportive care with filgrastim resulting from a 100% conversion from reference filgrastim to biosimilar filgrastim over six cycles. In the base case analysis, an additional 61 patients with HER2+ breast cancer could receive adjuvant treatment with ado-trastuzumab emtansine under the 5-day reference filgrastim to Nivestim scenario, while 8,244 patients could receive access to supportive care. Under the 14-day reference filgrastim to Nivestim scenario, the number of patients with expanded access to ado-trastuzumab emtansine increased to 170 while 23,082 patients would have access to supportive care. In the scenario analyses, the number of patients with expanded access to ado-trastuzumab emtansine ranged from 52 (4.3 days) to 79 (6.5 days). For expanded access to supportive care, it was 7,089 (4.3 days) to 10,717 (6.5 day). With a shift from reference filgrastim to Zarzio with a 5-day scenario, an additional 68 patients had expanded access to ado-trastuzumab emtansine with an increase to 191 additional patients under a 14-day scenario in the base-case analysis. For expanded access to supportive care, there would be 9,244 patients (5 days) up to 25,882 patients (14 days). In the scenario analysis, the number of patients with expanded access to ado-trastuzumab emtansine ranged from 59 (4.3 days) to 89 (6.5 days) and for supportive care from 7,949 (4.3 days) and 12,017 (6.5 days).
A systematic review of clinical trials of treatment regimens in HER2-amplified metastatic colorectal cancer
Published in Expert Review of Anticancer Therapy, 2023
Daniel Sur, Cristina Lungulescu, Elena Adriana Dumitrescu, Vlad Afrăsânie, Ștefan Spînu, Cristian Virgil Lungulescu, Hans- Joachim Schmoll
The most common treatment-related adverse events (AEs) of chemotherapy (capecitabine) in combination with lapatinib were fatigue (83%), hand-foot syndrome (69%), and diarrhea (59%). Lapatinib in combination with trastuzumab often caused diarrhea (78%), rash (48%), and fatigue (48%). In the FOCUS4-D trial skin rash occurred in 20% of the AZD8931 group versus none in the placebo group, and diarrhea occurred in 7% of the AZD8931 group versus 6% in the placebo group. The combination of trastuzumab and pertuzumab frequently caused fatigue (32%), diarrhea (34%), nausea (30%) in My-Pathway study, while the TRIUMPH trial found that infusion-related events, diarrhea, stomatitis, and malaise were the most common side effects. Trastuzumab-deruxtecan (T-DXd), an antibody–drug conjugate, was associated with a high incidence of nausea (60%), fatigue (33%), and diarrhea (28%), while ado-trastuzumab-emtansine (T-DM1) combined with pertuzumab-induced fatigue (18%), hyperbilirubinemia (9%), and thrombocytopenia (8%). Summaries of each of the seven papers included in this study are presented in Table 2.
Immunotherapy for Bladder Cancer: Latest Advances and Ongoing Clinical Trials
Published in Immunological Investigations, 2022
Daniela F. Ward Grados, Hamed Ahmadi, Thomas S Griffith, Christopher A. Warlick
Several targets are being explored for the development or repurpose of ADCs for the treatment of BC. Human epidermal growth factor 2 (HER2) is a commonly expressed antigen throughout several solid malignancies. Trastuzumab, a mAb specific for HER2, is widely used to treat HER2+ breast cancer. A recently published metanalysis by Gan et al. stated a significant correlation between HER2 expression and different stages of BC (from CIS to metastatic BC), suggesting HER2 could be an ideal target for BC treatment (Gan et al. 2021). Trastuzumab-emtansine is an ADC already approved as a treatment for patients with HER2+ breast cancer who have failed therapy with trastuzumab and taxanes (Gan et al. 2021). NCT02675829 is an ongoing trial evaluating the use of trastuzumab-emtansine in several different HER2+ solid tumors, including bladder cancer.