Carboplatin AUC8 in combination with etoposide and bleomycin in the treatment of intermediate and poor-risk metastatic germ cell tumours: a phase II study.
OBJECTIVE
Carboplatin has demonstrated significantly poorer response rates in non-seminomatous germ cell tumours. A phase II study of higher than standard doses of carboplatin was conducted because of suspicion that the poorer response might have been due to suboptimal dosing.


METHODS
A group of 19 patients with advanced germ cell tumours (International Germ Cell Cancer Collaborative Group intermediate and poor prognosis) were treated with carboplatin at an AUC of 8 mg/ml.min (using Calvert's formula) on day 1, etoposide 120 mg/m2 days 1-3 and bleomycin 60,000 U over 2 days (EBCa). Treatment was repeated every 3 weeks and a maximum of four courses was given.


RESULTS
Of the 19 patients, 7 (37%) achieved complete remission, of whom 6 (32%) remained long-term progression-free. Post-chemotherapy surgery and further chemotherapy salvaged an additional 26%, leading to an overall disease-free survival rate of 58%. No relationship between outcome and degree of myelosuppression could be established.


CONCLUSIONS
Dose-escalated carboplatin in combination, although feasible, did not improve the results and led to poorer results than those expected with cisplatin-based therapy. There is no evidence that the patients relapsing following this were easier to salvage. Further investigation of this regimen cannot be recommended.
Shamash
J
J
Department of Medical Oncology, St Bartholomew's Hospital, West Smithfield, London EC1A 7BE, UK.
McLaren
B
B
LeVay
J H
JH
Ong
J
J
Murray
P
P
Asterling
S
S
Oliver
R T
RT
D000293:Adolescent; D000328:Adult; D000617:Aminoglycosides; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D019540:Area Under Curve; D001761:Bleomycin / Q000008:administration & dosage; D016190:Carboplatin / Q000008:administration & dosage / Q000493:pharmacokinetics; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D018237:Germinoma / Q000188:drug therapy*; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D009362:Neoplasm Metastasis / Q000473:pathology; D012189:Retrospective Studies
D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D001761:Bleomycin; D005047:Etoposide; D016190:Carboplatin