Activity and tolerability of courses of intra-arterial chemotherapy followed by chemoembolization in unresectable hepatocellular carcinoma.

AIMS AND BACKGROUND: We previously reported encouraging response rates and survival with combined intra-arterial (i.a.) chemotherapy and chemoembolization in unresectable hepatocellular carcinoma. We therefore evaluated a new program combining three courses of i.a. chemotherapy with chemoembolization administered every 28 days. PATIENTS AND METHODS: The treatment regimen consisted of L-leucovorin (100 mg/m2 i.v.), fluorouracil (800 mg/m2 i.a.), and carboplatin (250 mg/m2 i.a.). Chemoembolization with mitoxantrone (10 mg/m2) plus ethiodized oil and gelatin sponge was performed immediately after. The same treatment was given every 28 days for 3 times. RESULTS: Twenty-eight patients entered the study and were assessable for response and side effects. There were 24 males and 4 females (median age, 68 yrs; range, 42-75). TNM stage was II-III in 20 and IVA in 8; 17 were Child's A and 11 Child's B. Baseline alpha-fetoprotein was elevated in 15, and there was cirrhosis in 23. Twelve patients had a partial response (43%; 95% confidence interval, 24-63%), 13 had stabilization, and 3 progressive disease. Median survival was 16.6 months (range, 2-24). Sixteen patients had grade I-II pain and 14 grade I-II fever. CONCLUSIONS: Our results indicate that the regimen is safe and well tolerated. Despite 43% objective remissions, our results do not seem better than those obtained with less intensive regimens.

Formestane: an effective first-line endocrine treatment for advanced breast cancer.

Formestane, a new selective aromatase inhibitor devoid of severe side-effects, has been shown to be active in patients with advanced breast cancer. To investigate the clinical activity and endocrinological effects of formestane as a first-line treatment, 52 patients were administered two different doses: 24 received 250 mg formestane and 28 received 500 mg formestane i.m. fortnightly. All of the patients had a performance status of 2 or less (ECOG scale), 34 (65%) had a disease-free interval of at least 2 years and 21 (40%) were both oestrogen-receptor- and progesterone-receptor-positive; 20 patients received hormone and 13, received chemotherapeutical adjuvant treatment. Objective responses were obtained in 8 patients in the 250-mg group (33%; 95% CI: 14%-52%) and in 13 patients in the 500-mg group (46%; 95% CI: 28%-64%). The median response duration in the two groups was respectively 11 and 12 months. E2 serum levels of oestradiol had significantly (P < 0.001) decreased to more than 40% below the baseline value in both groups after 15 days of treatment, and remained unchanged thereafter. Local and systemic tolerability was satisfactory. We conclude that formestane is an effective and well-tolerated agent in previously untreated patients, and that these results should be confirmed by further studies.