Cisplatin-Based Chemotherapy in Pediatric Extracranial Malignant Germ Cell Tumors
In a study reported in the Journal of Clinical Oncology, Shaikh et al, of the Children’s Oncology Group, found that event-free survival rates were not maintained with the use of reduced and compressed cisplatin-based regimens in children and adolescents with intermediate-risk extracranial malignant germ cell tumors.
Study Details
In a phase III single-arm trial, 210 patients with intermediate-risk disease (stages II–IV testicular, II–III ovarian, I–II extragonadal, or I gonadal tumors with subsequent recurrence) had cisplatin, etoposide, and bleomycin treatment reduced from the standard of 4 to 3 cycles and compressed from 5 to 3 days/cycle. A parametric comparator model specified that the observed 4-year event-free survival rate should not be significantly < 92%; a one-sided P value ≤ .10 defined statistical significance. A post hoc analysis compared results with a comparable group of patients treated with four cycles in two prior studies.
Event-Free Survival
Among 210 eligible patients enrolled from 2003 to 2011, 4-year event-free survival was 89%, significantly lower than the threshold value of the comparator model (P = .08). Among 181 newly diagnosed patients, 4-year event-free survival was 87%, compared with 92% among 92 comparable children in the post hoc analysis (P = .15). Four-year event-free survival in the patients receiving reduced and compressed treatments was 100% for stage I, 92% for stage II, 85% for stage III, and 54% for stage IV disease (overall P < .001).
The investigators concluded: The [event-free survival] rate for children with [intermediate-risk malignant germ cell tumors] observed after three cycles of [cisplatin, etoposide, and bleomycin] was less than that of a prespecified parametric model, particularly for patients with higher-stage tumors. These data do not support a reduction in the number of cycles of [cisplatin, etoposide, and bleomycin] from four to three. However, further investigation of a reduction in the number of cycles for patients with lower-stage tumors is warranted.”
The study was supported by grants from the Children’s Oncology Group Chair and Group Statistician.
Furqan Shaikh, MD, of The Hospital for Sick Children, Toronto, is the corresponding author of the Journal of Clinical Oncology article.
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