TABLE 1.
Trial | Histology | Therapy tested | Cumulative prescribed doxorubicin dose, mg/m2 | DRZ statusa | Cumulative prescribed etoposide dose, mg/m2 | No. eligible enrolled overall | No. US residentsb | No. Treated at PHIS sitec |
---|---|---|---|---|---|---|---|---|
| ||||||||
DFCI 95–01 high risk arm | Pre-B/T-cell ALL | DFCI 87–01 treatment backbone, addition of high-dose methotrexate, E. Coli vs Erwinia Asparaginase; cranial RT 18 Gy | 300 | 1:1 random-ization | 0 | 58d | 58 | 58 |
P9404 | T-cell ALL | DFCI 87–01 treatment backbone, ±high-dose methotrexate; cranial RT 18 Gy | 360 | 1:1 random-ization | 0 | 537 | 489 | 163 |
P9425 | Intermediate/advanced risk Hodgkin lymphoma | Response-adapted, 3–5 cycles DBVE +PC; involved region RT 21 Gy | 180–300 | 1:1 random-ization | 1125–1875 | 216 | 183 | 51 |
P9426 | Low risk Hodgkin lymphoma | Response-adapted, 2–4 cycles DBVE; involved field RT 25.5 Gy | 100–200 | 1:1 random-ization | 1000–2000 | 255 | 230 | 79 |
P9754 | Localized osteosarcoma | MAP or MAP/ifosfamide, with either doxorubicin or ifosfamide/etoposide intensification if standard response | 450–600 | All received DRZ | 0 –1500 | 242e | 217 | 90 |
CCSS | Osteosarcomaf | N/A | 40–1170g | No DRZ | N/A | 495 | 495 | N/A |
ALL, acute lymphoblastic leukemia/lymphoma; CCSS, Childhood Cancer Survivor Study; DBVE, doxorubicin, bleomycin, vincristine, etoposide; DFCI, Dana-Farber Cancer Institute; DRZ, dexrazoxane; Gy, Gray; MAP, methotrexate, doxorubicin, cisplatin; N/A, not applicable; PC, prednisone, cyclophosphamide; PHIS, Pediatric Health Information System; RT, radiotherapy
In all trials, DRZ was given as an intravenous bolus before each doxorubicin dose in a DRZ:doxorubicin dose ratio of 10:1
Only these individuals were linked with the National Death Index (through December 2017), Organ Procurement and Transplantation Network (through March 2019), and Medicaid claims (through December 2010)
Data available through December 2018
Due to regulatory reasons, only patients directly enrolled at DFCI (and not at consortium sites) were available for this analysis; the overall trial enrolled 219 patients on the high-risk arm
If limited to 5-year survivors, n=144
Initial disease stage information not collected, but cohort is limited to ≥5-year survivors by design
CCSS doses are received doses, with median 379 mg/m2 (interquartile range 288–455)