Overall survival (OS) is the most meaningful endpoint in clinical trials. However, owing to their limitations, surrogate endpoints are commonly used and validation studies are required to assess their reliability. Analysis of phase III randomized controlled trials (RCTs) of advanced gastroesophageal cancer (AGC) with > 100 patients, correlation coefficients (r), and determination coefficients (R²) between OS and surrogates were evaluated through meta-analyses.
View Article and Find Full Text PDFObjective: To review the evidence of uncommon but fatal adverse event of hyperammonemic encephalopathy by tyrosine kinase inhibitors (TKI) and the possible mechanisms underlying this condition and to describe the case of a patient that developed drug-induced hyperammonemic encephalopathy related to TKI.
Data Sources: Literature search of different databases was performed for studies published from 1 January 1992 to 7 May 2023. The search terms utilized were hyperammonemic encephalopathy, TKI, apatinib, pazopanib, sunitinib, imatinib, sorafenib, regorafenib, trametinib, urea cycle regulation, sorafenib, carbamoyl-phosphate synthetase 1, ornithine transcarbamylase, argininosuccinate synthetase, argininosuccinate lyase, arginase 1, Mitogen activated protein kinases (MAPK) pathway and mTOR pathway, were used individually search or combined.
Neoadjuvant chemotherapy (NAC) is an optimal option in early breast cancer, but in ER-positive/HER2-negative (luminal) is still controversial, although a survival benefit has recently been observed when a histological response by Symmans' method type 0 or I is achieved. The 21-gene Oncotype DX Breast Recurrence Score® assay (Oncotype DX®) is a validated test to assess the survival benefit of adjuvant chemotherapy in these patients but its role in the neoadjuvant setting is less established. We analyzed the results of the Oncotype DX® test in a cohort of 122 consecutive patients selected to receive NAC based on classical clinicopathological parameters and the correlation between the Oncotype DX® results and the pathological response assessed by Symmans' method.
View Article and Find Full Text PDFBackground: The treatment of luminal metastatic breast cancer is based on endocrine therapy and chemotherapy treatment is limited to the progression of this treatment.
Materials & Methods: We analyzed the efficacy of treatment with bevacizumab plus paclitaxel in 43 patients with hormone receptor-positive and HER2-negative metastatic breast cancer.
Discussion: Paclitaxel plus bevacizumab combination is a useful treatment in metastatic luminal breast cancer with an impressive overall survival of 31 months, similar to combination to endocrine therapy and targeted therapy in first line.