Low dose bleomycin every three weeks with cisplatin and etoposide results in excellent event free survival and survival in children and adolescents with gonadal malignant germ cell tumors (MGCT) A POG/CCG Study
Reviewer: Walter Sall, MD
Last Modified: June 2, 2003
Presenter: T.A. Olson Presenter's Affiliation: Children's Oncology Group Type of Session: Scientific
Bleomycin is a standard component of multi-drug chemotherapy for MGCT. It is the least effective single agent in this regimen.
Concern for the pulmonary toxicity of bleomycin led to the development of this trial which employs reduced dose bleomycin in the treatment of MGCT.
Materials and Methods
Between 1990 and 1996, 208 MGCT patients (77 testis and 141 ovarian) were enrolled.
Patients were staged by the intergroup post-surgical staging system.
Low risk patients, defined as stage II testis or stage I-II ovarian were treated with PEB chemotherapy x 4 cycles. Stage I testis patients were excluded from this trial as they received no chemotherapy.
High risk patients, defined as stage III or IV were randomized to standard PEB vs PEB with high dose cisplatin, all x four courses.
Bleomycin dose was 15units/m2 on day one of each chemo cycle.
No EFS or OS differences were seen between the cisplatin arms for the high risk patients.
Overall 6 year survival for stage II-IV testicular MGCT was 94.7%, for stage I-IV ovarian cancer 96%.
Subgroup analysis of older children showed 6 year OS for stage III/IV testicular age > 15 of 87.1%, stage I-IV ovarian age > 10 of 95.2%.
No pulmonary toxicity was reported, though pulmonary function data was not centrally reviewed.
Low dose bleomycin based therapy is curative in > 90% of MGCT patients. The cumulative bleomycin dose in this trial was limited to 1/3 of that used in adults with no decrement in efficacy seen.
Results are comparable to those of older studies using conventional, higher doses of bleomycin.
No advantage to high dose cisplatin regimens was see.
Though very difficult to test in the pediatric population, no pulmonary toxicity was reported.
This trial provides preliminary evidence that bleomycin dose may be safely limited in pediatric MGCT patients. No decrease in treatment effectiveness was seen with this dose reduction. Though it has been difficult to quantify, these data provide hope that the risk of long term pulmonary toxicty in this population can be decreased.
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