title: Combination chemotherapy in malignant non-seminomatous germ-cell tumors: results of a cooperative study of the German Society of Pediatric Oncology (MAKEI 83).
abstract: In January 1983, the German Society of Pediatric Oncology started a cooperative trial (MAKEI 83) for non-testicular germ-cell tumors. The pilot phase closed in December 1985. The treatment regimen was stratified according to histology, tumor site and tumor stage. In malignant non-seminomatous germ-cell tumors (mNSGCTs), chemotherapy consisted of four courses of 3 mg/m2 vinblastine, on days 1 and 2 and 15 mg/m2 bleomycin on days 1-3, given by continuous infusion, and 20 mg/m2 cisplatin on days 4-8 with mannitol diuresis. Courses were repeated every 3 weeks. In mNSGCT patients with ovarian FIGO stages III-IV or extragonadal primaries, second-look surgery was carried out, followed by four additional courses of chemotherapy with 100 mg/m2 VP-16 on days 1-3, 1.5 g/m2 ifosfamide on days 1-5 with mesna uroprotection and 20 mg/m2 cisplatin on days 1-5 with mannitol diuresis. In patients with sacrococcygeal germ-cell tumors, en bloc resection of the tumor, including the coccygeal bone, was mandatory. During the registration period, 57 patients with mNSGCTs were entered: 37 protocol patients and 20 follow-up patients. The event-free survival for protocol patients at 57 months was 78% +/- 6% and that for follow-up patients was 40% +/- 10% (Kaplan-Meier): the crude survival for both groups was 83% +/- 6% and 54% +/- 12%, respectively. After a review by a panel of pathologists, the histological diagnoses in 7% of all registered cases of germ-cell tumors were changed. The results of the present studies show that the histological subclassification of mNSGCTs, tumor site and tumor stage no longer had prognostic value.
authors.affiliation: University Children's Hospital Düsseldorf, Federal Republic of Germany.
authors.forename: U
authors.initials: U
authors.lastname: Gobel
authors.forename: G
authors.initials: G
authors.lastname: Calaminus
authors.forename: R J
authors.initials: RJ
authors.lastname: Häas
authors.forename: H
authors.initials: H
authors.lastname: Jurgens
authors.forename: D
authors.initials: D
authors.lastname: Niethammer
authors.forename: J
authors.initials: J
authors.lastname: Ritter
authors.forename: H J
authors.initials: HJ
authors.lastname: Spaar
authors.forename: D
authors.initials: D
authors.lastname: Harms
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D005260:Female; D005500:Follow-Up Studies; D005860:Germany, West; D006801:Humans; D007223:Infant; D008297:Male; D008495:Medical Oncology; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy* / Q000401:mortality; D010372:Pediatrics; D012955:Societies, Medical