Study drugs, treatment assignment and plan.
toxicity, toxicities, tumor
ADVERSE EVENTS, ADVERSE EVENT, TUMOR, EMA
As of August 2022, 13 drugs are available in ProTarget and administered as monotherapy, unless otherwise indicated. Alectinib (Alecensa®), atezolizumab (Tecentriq®), erlotinib (Tarceva®), cobimetinib (Cotellic®) and vemurafenib (Zelboraf®) in combination, trastuzumab (Herceptin®) and pertuzumab (Perjeta®) in combination, trastuzumab emtansine (Kadcyla®), and vismodegib (Erivedge®) are supplied by Roche. Avelumab (Bavencio®) is supplied by Pfizer, as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945), and axitinib (Inlyta®) is supplied by Pfizer. Niraparib (Zejula®) is supplied by GSK. Pemigatinib (Pemazyre®) is supplied by Incyte.The study drugs are administered in cycles of 21–28 days. Patients are followed according to standard of care, unless otherwise specified in the drug-specific study manual. Initial drug dose and schedule, dose modifications, and management of treatment-related toxicities are performed according to the FDA and/or EMA approved label. All patients are followed for protocol-specified toxicity and efficacy outcomes including tumor response, progression-free survival and overall survival as well as duration of treatment. Treatment-related adverse events are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and followed up until 1 month after the last administration of study drug. For all orally formulated drugs pts. complete dosing diaries and drug accountability is performed after each cycle. All pts. are treated free-of-charge, costs for transportation and accommodation are covered by the Danish healthcare system.