Blood was also sampled for octreotide pharmacokinetics and assessment of chromogranin A levels before the 4th and 7th doses. All patients had an octreotide scintigraphy scan before commencing treatment. Tumour biopsy for receptor analysis was optional, depending on the availability of suitable tissue. Where available, selleck products archival material was assessed for receptor expression by IHC at a central laboratory. Subjects were seen monthly for clinical review, blood tests, and administration of the study drug. Response was assessed using the RECIST (response evaluation criteria in solid tumours) criteria (Therasse et al, 2000). Radiological assessment was undertaken 3-monthly and any partial or complete responses were confirmed 1 month later.
Health-related quality of life (HRQL) was self-rated by patients each month before their clinical review using two instruments: the FACT-Hep (Heffernan et al, 2002) and the ��Patient Disease And Treatment Assessment’ form (Pt DATA Form). After the first month of treatment, patients also rated how aspects of their HRQL had changed, using a series of transition scales referred to here as the subjective Patient Benefit Form. We decided a priori to focus on changes in HRQL at 1 month because the number of evaluable patients was expected to fall quickly from then on. The FACT-Hep (Heffernan et al, 2002) is a validated 45-item self-rated questionnaire, incorporating the FACT-G questionnaire (27 items) (Cella et al, 1993), which covers multiple general aspects of HRQL, and an 18-item module specific for hepatobiliary cancer.
Scores are calculated for four domains from the FACT-G: physical, social�Cfamily, emotional, and functional well-being. In addition, a total score including the hepatobiliary-specific items is calculated (Cella, 1997). The Patient DATA Form is a simple, pragmatic, patient-rated instrument designed to measure aspects of HRQL that are relevant to people with advanced cancer. Its development is reported elsewhere (Nowak et al, manuscript in preparation). It assesses 24 aspects of HRQL using simply worded items listed on a single page: 16 physical and emotional symptoms of cancer rated on a numeric scale from 0 (no trouble at all) to 10 (worst I can imagine) and eight aspects of well-being rated from 0 (worst possible) to 10 (best possible) (Appendix A).
The Patient DATA Form is designed to be rapidly and easily interpreted: there is no scoring or aggregation procedure. Items are arranged in two blocks: symptoms and dysfunctions (0 on left, 10 on Entinostat right) where high scores reflect worse quality of life or more severe symptoms; and aspects of well-being (10 on left, 0 on right) where high scores reflect better well-being and quality of life. Troublesome aspects stand out by being circled on the right side of the page.