Efficacy and safety assessments
tumor, Toxicity, Cancer
ADVERSE EVENT, TUMOR, ADVERSE EVENTS, DISEASE, CANCER
The primary objective of this study was to assess the antitumor activity of lurbinectedin in terms of ORR, primary endpoint, assessed by the investigators. Radiological tumor evaluation was performed every six weeks (two cycles) until Cycle 6, and every nine weeks (three cycles) thereafter. Objective response was to be confirmed at least four weeks later. Secondary efficacy endpoints included disease control rate (ORR or stable disease), duration of response (DoR), progression-free survival (PFS), and OS.Safety was evaluated in all patients who received at least one lurbinectedin infusion, complete or incomplete, by assessment of adverse events (AEs), clinical laboratory test results, physical examinations and vital signs. Laboratory tests were done weekly during Cycles 1 and 2, and on Day 1 of subsequent cycles. AEs were recorded and coded with the Medical Dictionary for Regulatory Activities (MedDRA), v.21.0. AEs and laboratory values were graded according to the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE), v. 4.0. All patients were followed until recovery from any lurbinectedin-related AE.