Mitoxantrone in metastatic apudomas: a phase II study of the EORTC Gastro-Intestinal Cancer Cooperative Group.
We performed a phase II study with mitoxantrone in patients with carcinoid tumours, islet cell tumours and medullary carcinomas of the thyroid. Thirty-five eligible patients received mitoxantrone 12 mg m-2 i.v. every 3 weeks. Among 18 previously untreated patients, three responded (17%, 95% CI = 4-41%); no responses were achieved in 17 previously treated patients. Of the 21 patients who had carcinoid tumours, 11 were previously untreated and two achieved a response (18%, 95% CI = 2-52%). Overall response rate was 9% (95% CI = 2-23%). At a median follow-up of 43 months, median overall survival was 16 months. The median survival of 21 patients with a normal alkaline phosphatase was 29 months and 9 months for 14 patients with elevated serum levels (P = 0.005). A similar observation was noticed for gamma-glutamyltransferase (P = 0.007). We concluded that mitoxantrone is not active in APUD tumours. Elevated alkaline phosphatase and gamma-glutamyltransferase are associated with a poor prognosis.
Neijt
J P
JP
Department of Internal Medicine, Utrecht University Hospital, The Netherlands.
Lacave
A J
AJ
Splinter
T A
TA
Taal
B G
BG
Veenhof
C H
CH
Sahmoud
T
T
Lips
C J
CJ
D007516:Adenoma, Islet Cell / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D001079:Apudoma / Q000188:drug therapy* / Q000401:mortality; D002276:Carcinoid Tumor / Q000188:drug therapy; D018276:Carcinoma, Medullary / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000009:adverse effects / Q000627:therapeutic use*; D009362:Neoplasm Metastasis; D010190:Pancreatic Neoplasms / Q000188:drug therapy; D015996:Survival Rate; D013964:Thyroid Neoplasms / Q000188:drug therapy
D008942:Mitoxantrone; D000469:Alkaline Phosphatase