In this study, two drug combinations were compared for treating advanced germ-cell tumours in men. The two combinations differed in the third drug: vinblastine or etoposide. The combination with etoposide caused fewer nerve and muscle side effects, such as tingling, stomach cramps and muscle pain. In patients with more extensive disease, this combination also worked better, and survival was higher in the etoposide group.
Metastatic germ cell tumour (seminoma or non-seminoma)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Bleomycin | 30 units (30 mg) | IV or IM | Days 1, 8 and 15 |
| Etoposide | 100 mg/m² | IV | Days 1 to 5 |
| Cisplatin | 20 mg/m² | IV | Days 1 to 5 |
Schedule as in Williams and colleagues.
Dose source:.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
The standard regimen of the time: cisplatin, vinblastine and bleomycin (PVB). Dose, schedule and number of cycles are not stated in the available sources (abstract of the paper).
Etoposide instead of vinblastine, with the same cisplatin and bleomycin (BEP). Dose, schedule and number of cycles are not stated in the available sources (abstract of the paper).
Source of the regimen details: Abstract of the paper (PubMed 2437455); the full text was not available in PMC, Europe PMC or open access, and the trial has no ClinicalTrials.gov registration, so the doses, schedule and number of cycles are not stated in the available sources
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Men with disseminated germ-cell tumours. Of the 261 patients enrolled, 244 were evaluable for response and 157 of them had high tumour volume. Other eligibility criteria are not given in the abstract, and the full text was not available.
Comparison of efficacy (patients becoming disease-free with or without subsequent surgery), survival and toxicity (especially neuromuscular toxicity) between the two regimens. Primary and secondary objectives are not specified separately in the abstract.
The two regimens were similar in myelosuppression and pulmonary toxicity. The etoposide-containing regimen caused markedly less paraesthesia (P = 0.02), abdominal cramps (P = 0.0008) and myalgia (P = 0.00002). Rates of grade 3 or higher adverse events are not reported in the abstract, and the full text was not available.
Based on the abstract, the cisplatin, etoposide and bleomycin regimen was superior to the vinblastine-containing regimen because of less neuromuscular toxicity and, in advanced disease, better efficacy. The status of this regimen in current guidelines should be checked in up-to-date sources.
This card is based only on the abstract. Doses, exact eligibility criteria and rates of grade 3 or higher adverse events are not given in the abstract. The response analysis was performed in 244 of 261 patients. The superiority in patients with high tumour volume comes from a subgroup. The study dates from 1987 and should be interpreted alongside newer evidence and guidelines.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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