Treatments and procedures
toxicity, toxicities, tumour, mg/mDose reductions, Cancer
ADVERSE EVENT, ADVERSE EVENT, TUMOUR, CANCER
Patients received intravenous PLD 30 mg/mDose reductions and interruptions were permitted according to criteria based on haematological and non-haematological toxicities reported in the study protocol. A maximum of two dose reductions was allowed, regardless of the type of toxicity. Treatment was permanently discontinued for any patient who required a third dose reduction.Patients underwent tumour assessments according to RECIST version 1.1 [During the trial, health-related quality of life (HRQoL) assessments were done twice: at screening (before randomisation) and within 4 weeks from the end of the sixth cycle or at the time of progression, whichever came first. HRQoL was assessed with two validated questionnaires: the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30) [Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 and coded using the MedDRA, v.11. Adverse events were collected from informed consent signature until 30 days after the last dose of the drug or until the start of a new antitumor therapy, whichever came first.