Future oncology
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Meta Analysis
Neoadjuvant breast cancer treatment as a sensitive setting for trastuzumab biosimilar development and extrapolation.
Identify sensitive end points and populations for similarity studies of trastuzumab and biosimilar monoclonal antibodies. ⋯ Treatment of patients with neoadjuvant breast cancer represents a sensitive setting for establishing biosimilarity of efficacy and immunogenicity. tpCR is a sensitive end point in this setting to establish biosimilarity between a biosimilar candidate and its reference product.
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Review Meta Analysis
Risk of hematological toxicities in patients with solid tumors treated with ramucirumab: a meta-analysis.
We performed a meta-analysis of the risk of hematological adverse events associated with ramucirumab. ⋯ Our meta-analysis has demonstrated an increased risk of febrile neutropenia, all-grade and high-grade neutropenia and thrombocytopenia with ramucirumab-based treatment compared with control.
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ABSTRACT Rearrangement of ALK gene has been identified as exerting a potent transforming effect as driver oncogene in patients with non-small-cell lung cancer (NSCLC). Crizotinib is a small-molecule oral inhibitor of ALK, c-Met/HGF receptor and ROS1 receptor kinases. ⋯ Resistance mechanisms such as secondary gatekeeper mutations in ALK gene and activation of other oncogenes have been identified to confer acquired resistance to crizotinib. This article reviews the pharmacological properties of crizotinib, preclinical and clinical results that led to its approval in ALK-positive NSCLC and current directions of clinical research in overcoming crizotinib resistance.
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Review Meta Analysis
Risk of cutaneous toxicities in patients with solid tumors treated with immune checkpoint inhibitors: a meta-analysis.
We performed a meta-analysis of the risk of cutaneous toxicities associated with immune checkpoint inhibitors. ⋯ Our meta-analysis demonstrates that immune checkpoint inhibitors are associated with an increased risk of all grade skin rash, vitiligo and pruritus. Clinicians should perform regular clinical cutaneous monitoring.
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Randomized Controlled Trial Multicenter Study
The SOFT trial: a Phase III study of the dihydropyrimidine dehydrogenase inhibitory fluoropyrimidine S-1 and oxaliplatin (SOX) plus bevacizumab as first-line chemotherapy for metastatic colorectal cancer.
A combination of oxaliplatin, leucovorin and 5-fluorouracil (FOLFOX) plus bevacizumab has been widely used for the first-line chemotherapy of metastatic colorectal cancer (mCRC). S-1 is an oral fluoropyrimidine preparation that combines tegafur, a prodrug of 5-fluorouracil, with two modulators. ⋯ The SOFT trial (JapicCTI-090699) was a randomized Phase III trial designed to evaluate the noninferiority of SOX plus bevacizumab to mFOLFOX6 plus bevacizumab in patients with mCRC. This review summarizes the drug concept of S-1 and the results of clinical trials of S-1 and SOX in CRC and presents an overview of the SOFT trial.