European journal of cancer : official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
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Comparative Study
In vivo antitumour efficacy of MGI-114 (6-hydroxymethylacylfulvene, HMAF) in various human tumour xenograft models including several lung and gastric tumours.
MGI-114 (6-hydroxymethylacylfulvene, HMAF) is a semi-synthetic analogue of the cytotoxic sesquiterpenoid illudins. In the present study, the in vivo antitumour efficacy of MGI-114 was examined in a panel of human tumour xenograft models consisting mainly of human lung and gastric tumours, and compared with that of other antitumour drugs such as irinotecan, paclitaxel, cisplatin, doxorubicin, vindesine, etoposide and 5-fluorouracil (5-FU). When different administration schedules were compared, daily administration of MGI-114 was found to be more effective than intermittent administrations. ⋯ Moreover, in four human lung and three gastric tumour xenograft models, MGI-114 showed a strong antitumour activity with complete tumour regression being observed in some of the models. The antitumour efficacy of MGI-114 was generally higher than or equivalent to that of other antitumour drugs such as irinotecan and paclitaxel. These results support the potential utility of MGI-114 in the treatment of a variety of human solid tumours.
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Multicenter Study Clinical Trial
A phase II trial of oral eniluracil/5-fluorouracil in patients with inoperable hepatocellular carcinoma.
Only a minority of patients with hepatocellular carcinoma (HCC) may benefit from curative treatments, whereas there is no standard therapy for the remaining patients. The objective of this multicentre, open label phase II study was to estimate the objective tumour response rate of a 28-day regimen of oral eniluracil/5-fluorouracil (5-FU) in patients with chemotherapy-naïve, or anthracycline-refractory, inoperable HCC. 45 patients received courses of twice daily oral 5-FU (1.0 mg/m(2)) and eniluracil (10 mg/m(2)) for the first 28 days of each 5-week course. Patients were assessed at regular intervals to determine the tumour response and to evaluate toxicity. ⋯ The combination of eniluracil/5-FU was well tolerated and had an acceptable safety profile. Only 7 patients (16%) reported at least one adverse event (AE) of grade 3 or 4 intensity considered reasonably attributable to the study medication. In conclusion, oral eniluracil/5-FU had minimal, if any, activity in patients with inoperable HCC, but the safety profile was acceptable.