- |||||||||| tamoxifen / Generic mfg., everolimus / Generic mfg.
Clinical, P2 data, Journal: Final results of the randomized phase 2 LEO trial and bone protective effects of everolimus for premenopausal hormone receptor-positive, HER2-negative metastatic breast cancer. (Pubmed Central) - Apr 28, 2021 The phase 2 LEO study showed that everolimus (EVE) plus letrozole (LET) with ovarian suppression increased progression-free survival (PFS) in tamoxifen-exposed premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer with visceral metastases...Patients who were exposed to or progressed on tamoxifen as adjuvant/palliative treatments were randomly assigned (2:1) to the EVE (leuprorelin+LET+EVE, n=92) or LET (leuprorelin+LET, n=45) arm...EVE+LET with ovarian suppression prolonged PFS in patients with baseline visceral or bone metastases and offered bone-protective effects in the overall study population. However, these clinical benefits did not translate into an OS benefit.
- |||||||||| sirolimus / Generic mfg.
Review, Journal: Convergent and Divergent Mechanisms of Epileptogenesis in mTORopathies. (Pubmed Central) - Apr 27, 2021 We report the outcomes on cortical pyramidal neuronal placement, morphology, and electrophysiological phenotypes, and discuss some of the converging and diverging mechanisms responsible for these alterations and their contribution to epileptogenesis. We also discuss potential therapeutic strategies for epilepsy, beyond mTORC1 inhibition with rapamycin or everolimus, that could offer personalized medicine based on the gene variant.
- |||||||||| camizestrant (AZD9833) / AstraZeneca
Trial completion date, Trial primary completion date, Metastases: SERENA-1: Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer. (clinicaltrials.gov) - Apr 26, 2021 P1, N=276, Recruiting, Not yet recruiting --> Recruiting | Trial completion date: Nov 2022 --> Jun 2022 | Trial primary completion date: Nov 2022 --> Jun 2022 Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: May 2022 --> Oct 2022
- |||||||||| volasertib (BI 6727) / Oncoheroes
Preclinical, Journal: High in vitro and in vivo synergistic activity between mTORC1 and PLK1 inhibition in adenocarcinoma NSCLC. (Pubmed Central) - Apr 24, 2021 Pharmacodynamics study demonstrated that this synergy was due to (1) tumor vascularization decrease, increase of the HIF1 protein expression and decrease of the intracellular pH, and (2) decrease of the Carbonic Anhydrase 9 (CAIX) protein that could not correct intracellular acidosis. In conclusion, all these preclinical data strongly suggest that the inhibition of mTORC1 and PLK1 proteins may be a promising therapeutic approach for NSCLC patients.
- |||||||||| Rituxan (rituximab) / Roche
Trial termination: Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia (clinicaltrials.gov) - Apr 23, 2021 P1/2, N=46, Terminated, In conclusion, all these preclinical data strongly suggest that the inhibition of mTORC1 and PLK1 proteins may be a promising therapeutic approach for NSCLC patients. Active, not recruiting --> Terminated; Per protocol, Phase II is to be terminated early if a less than 5% of the Phase II participants observe a Very Good Partial Response or Better in the first 23 participants enrolled to Phase II.
- |||||||||| xentuzumab (BI-836845) / Boehringer Ingelheim
Enrollment open, Combination therapy, Metastases: The XENERA (clinicaltrials.gov) - Apr 23, 2021 P2, N=100, Recruiting, Active, not recruiting --> Terminated; Per protocol, Phase II is to be terminated early if a less than 5% of the Phase II participants observe a Very Good Partial Response or Better in the first 23 participants enrolled to Phase II. Active, not recruiting --> Recruiting
- |||||||||| temozolomide / Generic mfg.
Clinical, Review, Journal, Adverse events: Comparative safety review of the current therapies for gastroenteropancreatic neuroendocrine tumors. (Pubmed Central) - Apr 23, 2021 The use of the aforementioned therapeutic options is associated with several and not uncommonly severe treatment-related adverse events. However, the benefits offered inclusive of improved prognosis, amelioration of symptoms and better quality of life amidst others, by far outweighs any adverse event.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Journal: Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. (Pubmed Central) - Apr 23, 2021 P3 Lenvatinib plus pembrolizumab was associated with significantly longer progression-free survival and overall survival than sunitinib. (Funded by Eisai and Merck Sharp and Dohme; CLEAR ClinicalTrials.gov number, NCT02811861.).
- |||||||||| Ibrance (palbociclib) / Pfizer
Preclinical, Journal, PARP Biomarker: A first-in-class CDK4 inhibitor demonstrates in vitro, ex-vivo and in vivo efficacy against ovarian cancer. (Pubmed Central) - Apr 20, 2021 The 5-factor CBS may identify patients with metastatic RCC who would benefit from lenvatinib-plus-everolimus versus everolimus; additional validation is required. Given its high specificity in targeting CDK4 and excellent anti-tumor efficacy with low toxicity, CDDD2-94 has potential to be developed as a standalone agent or in combination with targeted therapeutics for the treatment of ovarian cancer.
- |||||||||| Simulect (basiliximab) / Novartis, Cytovene (ganciclovir) / Roche
[VIRTUAL] SUSTAINED BK VIRURIA: A FORGOTTEN ALLY FOR EARLY DIAGNOSIS OF BK VIRUS NEPHROPATHY IN KIDNEY TRANSPLANTATION () - Apr 17, 2021 - Abstract #ISNWCN2021ISN-WCN_1287; Immunosuppression (IS) consisted of Basiliximab, Tacrolimus (TAC), Mycophenolate Mofetil (MMF) and Prednisolone (PDN)...19,3 months after KT he had CMV infection treated with Ganciclovir and suspension of MMF...IS was changed to everolimus (EVR) and low dose TAC...Our study highlights the importance of BK viruria screening, and that BKVN should be considered in KT patients with allograft disfunction and persistent viruria, even without viremia. The early recognition of BK viruria could guide early therapeutic decisions with impact on the outcome of BKVN.
- |||||||||| Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] ECULIZUMAB IN ATYPICAL HEMOLYTIC UREMIC SYNDROME RELATED TO LUNG TRANSPLANT () - Apr 17, 2021 - Abstract #ISNWCN2021ISN-WCN_708; Induction and maintenance immunosuppressive therapy was based tacrolimus, mycophenolate and prednisone in all cases...Conversion from mycophenolate to everolimus had been carried out in 3 of the 4 patients...Conclusions aHUS is a critical complication in lung transplantation closely related to the immunosuppressive scheme, that can lead to end-stage kidney disease. Treatment with eculizumab appears promising.
- |||||||||| tamoxifen / Generic mfg., fulvestrant / Generic mfg.
Clinical, Review, Journal, BRCA Biomarker: Clinical Challenges in the Management of Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: A Literature Review. (Pubmed Central) - Apr 15, 2021 However, the optimal sequencing of treatments is unknown, especially following disease progression on a CDK4/6 inhibitor. This review aims to provide practical guidance for the management of HR+, HER2- MBC based on available data and the utility of genomic biomarkers, including germline breast cancer genes 1 and 2 (BRCA1/2) mutations, and somatic estrogen receptor alpha gene (ESR1), HER2, and PIK3CA mutations.
- |||||||||| Votrient (pazopanib) / Novartis, sunitinib / Generic mfg., Zelboraf (vemurafenib) / Roche
Trial completion, Metastases: ICK: Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies. (clinicaltrials.gov) - Apr 15, 2021 P=N/A, N=43, Completed, This review aims to provide practical guidance for the management of HR+, HER2- MBC based on available data and the utility of genomic biomarkers, including germline breast cancer genes 1 and 2 (BRCA1/2) mutations, and somatic estrogen receptor alpha gene (ESR1), HER2, and PIK3CA mutations. Active, not recruiting --> Completed
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Phase classification, Trial completion date, Trial primary completion date, Metastases: Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors (clinicaltrials.gov) - Apr 14, 2021 P2, N=100, Recruiting, Active, not recruiting --> Completed Phase classification: P=N/A --> P2 | Trial completion date: Jan 2023 --> Jan 2025 | Trial primary completion date: Jan 2022 --> Jan 2023
- |||||||||| Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] LI- FRAUMENI SYNDROME RELATED MALIGNANCIES IN A SINGLE TERTIARY CENTER () - Apr 14, 2021 - Abstract #ASPHO2021ASPHO_555; While our ability to consider and diagnose cancer predisposition syndromes has improved in the era of genomic sequencing, LFS is still probably underdiagnosed in children. Since making a diagnosis early in life and subsequent surveillance has clear benefits, we would recommend a low threshold to investigate a child with cancer for LFS regardless of family history.
- |||||||||| Sutent (sunitinib) / Pfizer, Nexavar (sorafenib) / Bayer, Amgen
Review, Journal: Systemic therapy for chromophobe renal cell carcinoma: A systematic review. (Pubmed Central) - Apr 13, 2021 The optimum therapy for metastatic chRCC is still missing, as results from ongoing trials are awaited. More studies, of high quality and adequate sample size, that will be based on the specific biology of chRCC, have to be carried out in order to identify the best treatment.
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