Assessments and endpoints
death, neutropenia, SD, tumour, treatment-emergent adverse events, Cancer
ADVERSE EVENT, DISEASE PROGRESSION, NEUTROPENIA, DISEASE, ADVERSE EVENT, TUMOUR, CANCER
Patients were assessed at baseline (within 7 days of the first FTD/TPI dose), and on the first day of each 28-day cycle of FTD/TPI treatment. Additional unscheduled assessments could be made according to the investigators’ assessment (e.g., for tumour and adverse event evaluation).The primary endpoint was safety, assessed by the incidence of treatment-emergent adverse events (TEAEs), graded according to the National Institute of Health Common Terminology Criteria for Adverse Events version 4.03, from baseline through to the end-of-treatment visit, and by time to first ECOG PS deterioration [Secondary endpoints included PFS, response rate (objective response rate [ORR] and disease control rate [DCR]), and QoL. PFS was defined as the time from the first intake of FTD/TPI until the date of investigator-assessed disease progression or death from any cause. ORR was defined as the proportion of patients achieving a complete response (CR) or partial response (PR), and DCR was defined as the proportion of patients achieving a CR, PR, or stable disease (SD). The assessment of response rates was by RECIST V1.1. The withdrawal criteria mentioned above were not compatible with an assessment of OS.QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) health questionnaire (completed by the patients) [The number of 15 or 20 mg tablets of FTD/TPI dispensed per cycle, and the number of tablets returned and/or estimated to have been taken, was recorded. This information was used to estimate the administered dose and dose intensity.In this analysis of PRECONNECT, data are presented for all patients that received ≥1 dose of FTD/TPI and in three subgroups according to duration of FTD/TPI treatment (i.e., 0–3, 4–7, or ≥ 8 cycles). Exploratory analyses were undertaken to examine potential prognostic factors for PFS, risk factors for neutropenia, and the association between neutropenia and PFS.