BACKGROUND AND AIMS: The aim of the study was to compare the clinical outcome of additional percutaneous ethanol instillation (PEI) against no further treatment in patients with hepatocellular carcinoma receiving hormonal treatment with long-acting octreotide. METHODS: In a randomized controlled trial conducted in a tertiary care center, a total of 61 patients with inoperable hepatocellular carcinoma were treated with long-acting octreotide 30 mg i.m. once a month and randomly assigned to receive either PEI (31 patients) or no further treatment (30 patients). RESULTS:Median survival time did not significantly differ between the long-acting octreotide plus PEI group (14 months; 95% CI: 9-28 months) and the long-acting octreotide alone group (22 months; 95% CI: 10-30 months) (logrank test P = 0.9). Similarly, an analysis stratifying for tumor diameter (< 5 cm or 5-8 cm) showed no significant survival differences between PEI or non-PEI treatment (logrank test P = 0.68). Progression-free survival according to RECIST was similar in the two groups (median: 3 months [3-6 months 95% CI] vs. 6 months [3-7 months 95% CI], logrank test P = 0.63). Time of local tumor control did not significantly differ between the two groups (6 months vs. 6 months). The course of alpha-fetoprotein levels and the reported quality of life were similar in the two groups. CONCLUSIONS: The addition of PEI to treatment with long-acting octreotide in patients with hepatocellular carcinoma did not result in better overall survival, longer progression-free survival or longer time of local tumor control.
RCT Entities:
BACKGROUND AND AIMS: The aim of the study was to compare the clinical outcome of additional percutaneous ethanol instillation (PEI) against no further treatment in patients with hepatocellular carcinoma receiving hormonal treatment with long-actingoctreotide. METHODS: In a randomized controlled trial conducted in a tertiary care center, a total of 61 patients with inoperable hepatocellular carcinoma were treated with long-actingoctreotide 30 mg i.m. once a month and randomly assigned to receive either PEI (31 patients) or no further treatment (30 patients). RESULTS: Median survival time did not significantly differ between the long-actingoctreotide plus PEI group (14 months; 95% CI: 9-28 months) and the long-actingoctreotide alone group (22 months; 95% CI: 10-30 months) (logrank test P = 0.9). Similarly, an analysis stratifying for tumor diameter (< 5 cm or 5-8 cm) showed no significant survival differences between PEI or non-PEI treatment (logrank test P = 0.68). Progression-free survival according to RECIST was similar in the two groups (median: 3 months [3-6 months 95% CI] vs. 6 months [3-7 months 95% CI], logrank test P = 0.63). Time of local tumor control did not significantly differ between the two groups (6 months vs. 6 months). The course of alpha-fetoprotein levels and the reported quality of life were similar in the two groups. CONCLUSIONS: The addition of PEI to treatment with long-actingoctreotide in patients with hepatocellular carcinoma did not result in better overall survival, longer progression-free survival or longer time of local tumor control.
Authors: S Arii; Y Yamaoka; S Futagawa; K Inoue; K Kobayashi; M Kojiro; M Makuuchi; Y Nakamura; K Okita; R Yamada Journal: Hepatology Date: 2000-12 Impact factor: 17.425
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: T Livraghi; A Giorgio; G Marin; A Salmi; I de Sio; L Bolondi; M Pompili; F Brunello; S Lazzaroni; G Torzilli Journal: Radiology Date: 1995-10 Impact factor: 11.105
Authors: Kerstin Wohlleber; Patrick Heger; Pascal Probst; Christoph Engel; Markus K Diener; André L Mihaljevic Journal: Qual Life Res Date: 2021-07-20 Impact factor: 4.147