Pneumonitis: Occurred in 0.8% of patients exposed to LYNPARZA monotherapy, and some cases were fatal. Discontinue LYNPARZA if MDS/AML is confirmed. If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery. Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment.
All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.ĭo not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). The median duration of therapy in patients who developed MDS/AML was 2 years (range: 10 years). Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. There are no contraindications for LYNPARZA. The data will be presented at forthcoming medical meetings and shared with health authorities. The safety and tolerability of these combinations are broadly consistent with that observed in prior clinical trials and the known profiles of the individual medicines. It will be important to understand the key secondary endpoints as well as data for relevant subgroups.”
#The visitor returns walkthrough mutation trial
These data from the DUO-O trial provide encouraging evidence for this LYNPARZA and IMFINZI combination in patients without tumor BRCA mutations and reinforce our continued commitment to finding new treatment approaches for these patients. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "While there has been significant progress for patients with advanced ovarian cancer, an unmet need still remains. I’m grateful for the academic cooperative study groups and patients around the world that made this trial possible and look forward to sharing the results with the clinical community."
Philipp Harter, Director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany and principal investigator for the trial, said: "DUO-O showcases the power of academia and industry collaboration in advancing new treatment combinations for patients with ovarian cancer. Unfortunately, 50-70% of patients with advanced disease die within five years. 1 Over two thirds of patients are diagnosed with advanced disease which can progress quickly, often within two years, diminishing their quality of life despite treatment. Ovarian cancer is one of the most common gynecologic cancers.
#The visitor returns walkthrough mutation plus
In an additional arm, IMFINZI, chemotherapy plus bevacizumab showed a numerical improvement in PFS versus the control arm but did not reach statistical significance at this interim analysis.Īt the time of this planned interim analysis, the overall survival (OS) and other secondary endpoints are immature and will be formally assessed at a subsequent analysis. Patients were treated with IMFINZI in combination with chemotherapy and bevacizumab followed by IMFINZI, LYNPARZA and bevacizumab as maintenance therapy. One such project is this one - high-level results from a planned interim analysis of the DUO-O Phase III trial showed treatment with a combination of LYNPARZA® (olaparib), IMFINZI® (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumor BRCA mutations. Longer and somehow added applied directive support on their own. Obviously, some projects couldn't wait any (almost 4 years old at the time of this writing). Getting applied directives through introspection. There has long been a need in the community for a specification to describe the possibility of Moreover, a directive is not limited to field resolvers like middleware is.įor more information about field middlewares see Field Middleware. A directive, at the same time, would only affect specific schema elementsĪnd only those elements. You can think of a Field Middleware as something global that controls how all fields of all types If you do not explicitly set this property (either to true or false) then by default yourĭirective definition along with all applications of this directive to the schema elements willīe present in the introspection response if and only if directive definition has all its locations Query HeroQuery ( $id : ID, $withFriends : Boolean ! )
0 kommentar(er)
