Fractionated cyclophosphamide and back to back high dose methotrexate and cytosine arabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (Snccl): A randomized trial of the pediatric oncology group
✍ Scribed by Brecher, Martin L.; Schwenn, Molly R.; Coppes, Max J.; Bowman, W. Paul; Link, Michael P.; Berard, Costan W.; Shuster, Jon J.; Murphy, Sharon B.
- Publisher
- John Wiley and Sons
- Year
- 1997
- Tongue
- English
- Weight
- 279 KB
- Volume
- 29
- Category
- Article
- ISSN
- 0098-1532
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✦ Synopsis
Background:
The pediatric oncology group (pog) conducted a two-arm, randomized study for the treatment of children and adolescents with stage iii small, non-cleaved cell lymphoma (snccl). regimen a, based on the group's previous best treatment for this group of patients, included cyclophosphamide (ctx) and high-dose methotrexate (mtx), as well as vincristine (vcr), prednisone (pred), and intrathecal (it) chemoprophylaxis. regimen b, based on a single institution pilot study (total b therapy), consisted of two rapidly alternating chemotherapy combinations (ctx, vcr, doxorubicin; mtx, and cytarabine (ara-c) plus coordinated it chemotherapy.
Procedure:
One hundred thirty-four consecutive patients were entered on this study. seventy patients were randomized to regimen a, and 64 patients to regimen b. one hundred and twenty-two patients are eligible for response.
Results:
Complete remission (cr) was achieved by 81% (52/64) of patients on regimen a, and 95% (55/58) of patients on regimen b (p=0.014 one-sided). the two-year event-free survival (efs) is 64% (se=6%) on regimen a, and 79% (se=6%) on regimen b (p=0.027 by one-sided logrank test). no patient has relapsed on either regimen after a year from diagnosis, although one patient had a second malignancy at day 371. severe, but manageable, hematologic toxicity was seen in the majority of patients on both regimens, but was more frequent on regimen b.
Conclusions:
We conclude that the cure rate in stage iii snccl is significantly improved with the use of a short, six-month chemotherapy regimen of fractionated ctx alternated with coordinated mtx and ara-c. results suggest that drug schedule, not simple drug selection, influences outcome.