Abstract
Background: To establish the maximum tolerated dose (MTD) and toxicity profile of cyclophosphamide with cisplatin, etoposide, and bleomycin (C-PEB) in children with high-risk malignant germ cell tumors (HR-MGCT). Procedure: Eligibility criteria included untreated patients≤21 years of age with stage III/IV extragonadal, extra cranial MGCT. Patients received four cycles (repeated every 3 weeks) of cisplatin (20mg/m2/day×5 days), etoposide (100mg/m2/day×5 days), and bleomycin (15mg/m2 on Day 1) with escalating doses of cyclophosphamide on Day 1, assigned at the time of enrollment (1.2, 1.8, or 2.4g/m2). Patients with complete response had therapy discontinued. Patients with residual disease underwent second-look surgery, those with pathologic evidence of residual MGCT or whose markers had not normalized received two more cycles. All other patients had protocol therapy stopped. Results: Nineteen patients were enrolled between July 2004 and August 2007. Three patients were non-evaluable. Sixteen patients completed four cycles. Eleven had complete response, one had progressive disease and four had partial response. All four with partial response underwent second look surgery followed by two more cycles. Only one patient, on dose 1.8g/m2, experienced dose-limiting toxicity (DLT) during the first cycle of therapy (grade 3 hyperglycemia). The 4-year EFS and OS (± standard deviation) were 74±7% and 89±10%, respectively. Conclusion: The addition of cyclophosphamide to the standard PEB regimen (cisplatin, etoposide, and bleomycin) is feasible and well-tolerated at all dose levels used on this study. Pediatr Blood Cancer 2013;60:1602-1605.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1602-1605 |
| Number of pages | 4 |
| Journal | Pediatric Blood and Cancer |
| Volume | 60 |
| Issue number | 10 |
| DOIs | |
| State | Published - Oct 1 2013 |
| Externally published | Yes |
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Keywords
- Cyclophosphamide
- Germ cell tumors
- Maximum tolerated doses
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Hematology
- Oncology
Cite this
Pilot study of cisplatin, etoposide, bleomycin, and escalating dose cyclophosphamide therapy for children with high risk germ cell tumors : A report of the children's oncology group (COG). / Malogolowkin, Marcio; Krailo, Mark; Marina, Neyssa; Olson, Thomas; Frazier, A. Lindsay.
In: Pediatric Blood and Cancer, Vol. 60, No. 10, 01.10.2013, p. 1602-1605.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Pilot study of cisplatin, etoposide, bleomycin, and escalating dose cyclophosphamide therapy for children with high risk germ cell tumors
T2 - A report of the children's oncology group (COG)
AU - Malogolowkin, Marcio
AU - Krailo, Mark
AU - Marina, Neyssa
AU - Olson, Thomas
AU - Frazier, A. Lindsay
PY - 2013/10/1
Y1 - 2013/10/1
N2 - Background: To establish the maximum tolerated dose (MTD) and toxicity profile of cyclophosphamide with cisplatin, etoposide, and bleomycin (C-PEB) in children with high-risk malignant germ cell tumors (HR-MGCT). Procedure: Eligibility criteria included untreated patients≤21 years of age with stage III/IV extragonadal, extra cranial MGCT. Patients received four cycles (repeated every 3 weeks) of cisplatin (20mg/m2/day×5 days), etoposide (100mg/m2/day×5 days), and bleomycin (15mg/m2 on Day 1) with escalating doses of cyclophosphamide on Day 1, assigned at the time of enrollment (1.2, 1.8, or 2.4g/m2). Patients with complete response had therapy discontinued. Patients with residual disease underwent second-look surgery, those with pathologic evidence of residual MGCT or whose markers had not normalized received two more cycles. All other patients had protocol therapy stopped. Results: Nineteen patients were enrolled between July 2004 and August 2007. Three patients were non-evaluable. Sixteen patients completed four cycles. Eleven had complete response, one had progressive disease and four had partial response. All four with partial response underwent second look surgery followed by two more cycles. Only one patient, on dose 1.8g/m2, experienced dose-limiting toxicity (DLT) during the first cycle of therapy (grade 3 hyperglycemia). The 4-year EFS and OS (± standard deviation) were 74±7% and 89±10%, respectively. Conclusion: The addition of cyclophosphamide to the standard PEB regimen (cisplatin, etoposide, and bleomycin) is feasible and well-tolerated at all dose levels used on this study. Pediatr Blood Cancer 2013;60:1602-1605.
AB - Background: To establish the maximum tolerated dose (MTD) and toxicity profile of cyclophosphamide with cisplatin, etoposide, and bleomycin (C-PEB) in children with high-risk malignant germ cell tumors (HR-MGCT). Procedure: Eligibility criteria included untreated patients≤21 years of age with stage III/IV extragonadal, extra cranial MGCT. Patients received four cycles (repeated every 3 weeks) of cisplatin (20mg/m2/day×5 days), etoposide (100mg/m2/day×5 days), and bleomycin (15mg/m2 on Day 1) with escalating doses of cyclophosphamide on Day 1, assigned at the time of enrollment (1.2, 1.8, or 2.4g/m2). Patients with complete response had therapy discontinued. Patients with residual disease underwent second-look surgery, those with pathologic evidence of residual MGCT or whose markers had not normalized received two more cycles. All other patients had protocol therapy stopped. Results: Nineteen patients were enrolled between July 2004 and August 2007. Three patients were non-evaluable. Sixteen patients completed four cycles. Eleven had complete response, one had progressive disease and four had partial response. All four with partial response underwent second look surgery followed by two more cycles. Only one patient, on dose 1.8g/m2, experienced dose-limiting toxicity (DLT) during the first cycle of therapy (grade 3 hyperglycemia). The 4-year EFS and OS (± standard deviation) were 74±7% and 89±10%, respectively. Conclusion: The addition of cyclophosphamide to the standard PEB regimen (cisplatin, etoposide, and bleomycin) is feasible and well-tolerated at all dose levels used on this study. Pediatr Blood Cancer 2013;60:1602-1605.
KW - Cyclophosphamide
KW - Germ cell tumors
KW - Maximum tolerated doses
UR - http://www.scopus.com/inward/record.url?scp=84881502073&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84881502073&partnerID=8YFLogxK
U2 - 10.1002/pbc.24601
DO - 10.1002/pbc.24601
M3 - Article
VL - 60
SP - 1602
EP - 1605
JO - Pediatric Blood and Cancer
JF - Pediatric Blood and Cancer
SN - 1545-5009
IS - 10
ER -