The levels were assayed by Network Pathology (Melbourne, Australia), using the Chromogranin A ELISA kit (DakoCytomation, Sydney, Australia). Statistical methods The sample size of 63 was Pacritinib designed to give >80% power to detect an 8-month difference in median survival comparing the 40% patients expected to have a positive octreoscan vs the remainder expected to have a negative octreoscan (estimated survivals 12 and 4 months, respectively, as per the treatment and control arms in the Kouroumalis study). Survival times were calculated from the day of registration. Survival curves were calculated using the method of Kaplan�CMeier. The log-rank test was use to compare the relationship between receptor expression by scintigraphy and survival duration. Proportions were compared using ��2 tests.
Quality-of-life results were described and analysed with simple descriptive and comparative methods. For each item in the Patient Benefit Form, we recorded the proportions of patients reporting that each aspect was much better, a little better, the same, a little worse, or much worse than before starting treatment, and used ��2 tests to compare the proportions of patients who reported feeling better vs those who reported feeling worse. For the Patient DATA Form and FACT-Hep, we used Wilcoxon’s rank-sum tests for paired data to compare baseline and 1-month scores for each domain. Responses from the Patient Benefit Form were compared with change scores from the Patient DATA Form using Spearman’s rank-correlation coefficient. RESULTS The study accrued 63 patients with otherwise untreatable HCC between April 2001 and January 2002.
Study sites are listed in Appendix A. The patients’ baseline characteristics are shown in Table 1. The median age was 67 years (range 28�C81 years) and most of them were male. Most had good performance status. Eleven had Child�CPugh class B cirrhosis and 52 had well-compensated disease (Child�CPugh class A). Viral hepatitis was the main cause of cirrhosis, with 28 patients (44%) having evidence of hepatitis B or C infection. A small number of patients had cirrhosis from other causes. Approximately half had received other treatment for HCC. Table 1 Patient characteristics Administration of treatment Four patients (6%) did not receive any octreotide because their disease progressed so rapidly they were unable to start treatment.
These patients were not eligible for analysis Dacomitinib of response or toxicity, but are included in the survival analysis. Three patients (5%) received one dose, 12 (19%) two doses, 10 (16%) three doses, 10 (16%) four doses, seven (11%) five doses, four (6%) six doses, five (8%) seven doses, and seven (18%) eight doses or more. The main reason for stopping treatment was disease progression in 19 patients (30%). A further five patients (8%) withdrew and nine (14%) died during treatment, all from progressive disease.