- |||||||||| Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
[VIRTUAL] Patterns and predictors of oral anticancer agent utilization in diverse metastatic renal cell carcinoma patients. () - Jan 8, 2021 - Abstract #ASCOGU2021ASCO_GU_457; We used a novel, North Carolina, registry-linked multi-payer claims data resource to examine patterns of use of sorafenib, sunitinib, pazopanib, everolimus, axitinib, cabozantinib, and levantinib in a cohort of metastatic RCC patients diagnosed over 10 years (2006-2015, with claims through 2016)... These data underscore the importance of distinguishing clinically appropriate from potentially poor-quality care and warrant additional studies to understand in more depth the system, provider and patient level drivers of these patterns.
- |||||||||| FDA event, Review, Journal: Properties of FDA-approved small molecule protein kinase inhibitors: a 2020 update. (Pubmed Central) - Jan 6, 2021
More than half of the antagonists (29) have lipophilic efficiency values of less than five while the recommended optima range from 5-10. One of the troublesome problems with both targeted and cytotoxic drugs in the treatment of malignant diseases is the near universal development of resistance to every therapeutic modality.
- |||||||||| Avastin (bevacizumab) / Roche
Clinical, P4 data, Journal, Combination therapy: Final results from IMPROVE: a randomized, controlled, open-label, two-arm, cross-over phase IV study to determine patients' preference for everolimus in combination with exemestane or capecitabine in combination with bevacizumab in advanced HR-positive, HER2-negative breast cancer. (Pubmed Central) - Jan 6, 2021 P4 Cap+Bev showed superior first-line PFS, while QoL was similar in both arms. No new safety signals were reported.
- |||||||||| metformin / Generic mfg., everolimus / Generic mfg., sirolimus / Generic mfg.
Journal: Metformin: a novel promising option for fertility preservation during cyclophosphamide-based chemotherapy. (Pubmed Central) - Jan 5, 2021 In conclusion, concurrent metformin treatment during CP therapy could significantly preserve ovarian function and fertility and could be a promising novel fertility preserving agent during chemotherapy. The relatively acceptable cost and well-established long-term safety profiles of this old drug might prompt its further clinical application at a faster pace.
- |||||||||| Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Metastases: Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors (clinicaltrials.gov) - Jan 5, 2021 P1b/2, N=261, Active, not recruiting, Trial completion date: Jan 2023 --> Aug 2022 | Trial primary completion date: Jan 2023 --> Aug 2022 Recruiting --> Active, not recruiting | Trial completion date: Apr 2022 --> Nov 2021 | Trial primary completion date: Apr 2022 --> Nov 2021
- |||||||||| Avastin (bevacizumab) / Roche
Trial completion, Trial completion date, Trial primary completion date, Metastases: Everolimus and Bevacizumab in Advanced Non-Clear Cell Renal Cell Carcinoma (RCC) (clinicaltrials.gov) - Dec 30, 2020 P2, N=58, Completed, This retrospective analysis suggests that EVE-EXE is more effective than PALBO-FUL for second line ET of metastatic LBC, allowing us to speculate on the optimal therapeutic sequence. Active, not recruiting --> Completed | Trial completion date: Jul 2021 --> Dec 2020 | Trial primary completion date: Jul 2021 --> Dec 2020
- |||||||||| everolimus / Generic mfg.
[VIRTUAL] Dashboard development to identify and track clinical and operational outcomes associated with high-cost/high-utilization medications () - Dec 26, 2020 - Abstract #ASHP2020ASHP_1871; Medications tested included: sugammadex, vasopressin, pembrolizumab, albumin, everolimus, propofol, acetaminophen, fentanyl, oxycodone immediate-release, and morphine injection...Operations focused variables will include incremental changes in drug expenditure and utilization, compared to internal benchmarks and peer institutions within the network. The dashboard with comparative reporting will be utilized to identify areas where cost savings may occur through changes in utilization or in purchasing practices.
- |||||||||| everolimus / Generic mfg., lenvatinib / Generic mfg.
Clinical, Journal: Activity of lenvatinib plus everolimus combination in a heavily pretreated patient with papillary renal cell carcinoma: a case report. (Pubmed Central) - Dec 23, 2020 To our knowledge, we describe for the first time a case of a patient with heavily pretreated metastatic pRCC who benefited from the combination of lenvatinib plus everolimus for more than 2 years. According to immunohistologic and biological findings in our patient both on primary tumor and liver metastasis, we hypothesize that selected patients with metastatic pRCC, progressed to standard/available treatments (including angiogenic drugs, mTOR inhibitors, and immunotherapy) and dissociated response to everolimus, could benefit from adding lenvatinib to everolimus.
- |||||||||| Lumakras (sotorasib) / Amgen
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, PD(L)-1 Biomarker, IO biomarker, Metastases: CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - Dec 21, 2020 P1b, N=520, Recruiting, According to immunohistologic and biological findings in our patient both on primary tumor and liver metastasis, we hypothesize that selected patients with metastatic pRCC, progressed to standard/available treatments (including angiogenic drugs, mTOR inhibitors, and immunotherapy) and dissociated response to everolimus, could benefit from adding lenvatinib to everolimus. Trial completion date: Aug 2026 --> Jul 2027 | Trial primary completion date: May 2026 --> Jul 2027
- |||||||||| Sutent (sunitinib) / Pfizer
Journal: Influence of pretreatment with everolimus or sunitinib on the subacute hematotoxicity of Lu-DOTATATE PRRT. (Pubmed Central) - Dec 20, 2020 Limitations of this study include the potential bias in lack of use of targeted agents in patients more susceptible to toxicity, and the limited number of patients and events. In a patient cohort with NET pretreated with everolimus and/or sunitinib, we could not demonstrate a significant effect of prior/pretreatment with everolimus and/or sunitinib on the subacute hematotoxicity of Lu-DOTATATE PRRT.
- |||||||||| letrozole / Generic mfg., everolimus / Generic mfg.
Trial completion, Trial completion date, Trial primary completion date, Metastases: PerELISA: Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients (clinicaltrials.gov) - Dec 19, 2020 P1, N=37, Completed, In a patient cohort with NET pretreated with everolimus and/or sunitinib, we could not demonstrate a significant effect of prior/pretreatment with everolimus and/or sunitinib on the subacute hematotoxicity of Lu-DOTATATE PRRT. Active, not recruiting --> Completed | Trial completion date: Jul 2021 --> Dec 2020 | Trial primary completion date: Jul 2021 --> Dec 2020
- |||||||||| everolimus / Generic mfg.
Clinical, Review, Journal: Tumor dormancy as an alternative step in the development of chemoresistance and metastasis - clinical implications. (Pubmed Central) - Dec 18, 2020 That is especially the case for breast cancer, against which the mTOR inhibitor everolimus displays potent antitumor activity in patients with metastatic disease by impeding autophagy and tumor dormancy onset. Here we will also discuss other targeted therapies directed towards tumor dormancy onset, e.g. specific inhibitors of SFK and MEK, or aimed at keeping tumor cells dormant, e.g. prosaposin derivatives, that may shortly enter clinical assessment in breast, and possibly other cancer types.
- |||||||||| everolimus / Generic mfg.
Preclinical, Journal: Effect of MDM2 inhibitors in preclinical models of advanced clear cell carcinomas originating from ovaries and kidneys. (Pubmed Central) - Dec 18, 2020 Meanwhile, combined therapy with MDM2 inhibitors and everolimus showed synergistic, and dose-reduction potential, for clear cell carcinoma treatment. Our findings suggest that Murine double-minute 2 inhibitors represent promising molecular targeted therapy for clear cell carcinomas, thereby warranting further studies to evaluate the efficacy and safety of dual Murine double-minute 2/mammalian target of rapamycin inhibitors in clear cell carcinoma patients.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Journal: Treating metastatic clear-cell renal cell carcinoma: beyond immunotherapy. (Pubmed Central) - Dec 16, 2020 The treating physician should choose an appropriate treatment according to the patient's age, comorbidities, and tolerability of previous checkpoint inhibitors, among other considerations. Cases of patients with renal cell carcinoma refractory to checkpoint inhibitor treatment are growing, warranting a review of the activity and safety of target therapies after immunotherapy.
- |||||||||| everolimus / Generic mfg., paclitaxel / Generic mfg.
Review, Journal, PD(L)-1 Biomarker, IO Biomarker: Recent advances in the management of anaplastic thyroid cancer. (Pubmed Central) - Dec 10, 2020 Surgery should be as complete as possible, securing the airway and ensuring access for nutritional support; the current standard of care of radiotherapy is the intensity-modulated radiation therapy; chemotherapy includes the use of doxorubicin or taxanes (paclitaxel or docetaxel) generally with platin (cisplatin or carboplatin)...These include multitarget tyrosine kinase inhibitors (Lenvatinib, Sorafenib, Sunitinib, Vandetanib, Axitinib, Pazopanib, Pyrazolo-pyrimidine compounds), single target tyrosine kinase inhibitors (Dabrafenib plus Trametinib and Vemurafenib against BRAF, Gefitinib against EGFR, PPARγ ligands (e.g. Efatutazone), Everolimus against mTOR, vascular disruptors (e.g. Fosbretabulin), and immunotherapy (e.g. Spartalizumab and Pembrolizumab, which are anti PD-1/PD-L1 molecules)...Other single target mutation agents with fair results are Everolimus when a mutation involving the PI3K/mTOR pathway is detected, Imatinib in case of PDGF-receptors overexpression, and Spartalizumab in case of PD-L1 positive tumors...Since in this tumor several genetic alterations are usually found, the aim is to inhibit or disrupt several pathways: these combination strategies use therapy targeting angiogenesis, survival, proliferation, and may act against both MAPK and PI3K pathways. Investigating new treatment options is eagerly awaited since, to date, even the molecules with the best radiological results have not been able to provide a durable disease control.
- |||||||||| everolimus / Generic mfg., sorafenib / Generic mfg.
Enrollment closed: Phase I-II Everolimus and Sorafenib in Recurrent High-Grade Gliomas (clinicaltrials.gov) - Dec 10, 2020 P1/2, N=85, Active, not recruiting, Investigating new treatment options is eagerly awaited since, to date, even the molecules with the best radiological results have not been able to provide a durable disease control. Recruiting --> Active, not recruiting
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