Concurrent Fludarabine and Total Body Irradiation (F-TBI) for Patients with Advanced Relapsed, Refractory, or Resistant Indolent Non-Hodgkin's Lymphoma (NHL): A Phase I Trial.
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: December 10, 2001
Presenter: David Eilender
Presenter's Affiliation: Wayne State University
Type of Session: Poster
- Both chemotherapy (CHT) and radiation therapy (RT) are used in the treatment of non-Hodgkin's lymphoma (NHL).
- It is well known that when certain chemotherapeutic agents are given with RT there is a synergistic effect.
- The current study investigates the combination of Fludarabine and total body irradiation (TBI) in the treatment of patients with advanced relapsed, refractory, or resistant indolent NHL.
- The goal of this Phase I study was to determine the toxicity and maximum tolerated dose (MTD) of F and TBI (F-TBI).
- The other aim of the study was to observe the response of F-TBI in patients with relapsed, refractory NHL.Materials and Methods
- Advanced relapsed, refractory, or resistant indolent NHL.
- Previously treated, but not post-bone marrow or peripheral stem cell transplant.
- Good renal function,absolute neutrophil count and platelet count.
- Good perfomance status
- Criteria for dose-limiting toxicity (DLT) (any of the following 4:
- Plts < 20x10(9)(ten-to-the-9th) or an ANC < 0.5x10(9) for >10 days.
- Plts not >100x10(9) or ANC not >1.5x10(9) by day 43.
- If bone marrow >30%, then plts not >50x10(9) or ANC >0.8x10(9) for the first 2 cycles, by day 43.
- Maximum tolerated Dose (MTD)
- Maximum dose level RT, with DLT in < 3 of 8 patients.
- Treat at least 8 patients at the MTD.
- 20 pts were enrolled from 1998-2001
- 6 pts were enrolled at the first dose level (F was 25mg/m2/d IV and TBI was 0.1Gy/d given on d1-3 q4-6 wks)
- 5 pts were enrolled at the second dose level (TBI dose was 0.15 Gy/d), 3 of them did not receive >3 cycles due to prolonged thrombocytopenia.
- Since the intent of the study was to give 4-6 cycles of F q4-6 weeks 9 more patients were enrolled at the first TBI dose, the MTD.
- DLT was prolonged thrombocytopenia.
- Only 1 patient died within 30 days of treatment.
- 5 pts died of progressive disease.
- 2 deaths were not evaluable.
- 3 patients died of infection (not neutropenic).
- 10 pts are still alive to date.Author's Conclusions
- Toxicity of F-TBI was low compared to other salvage therapies, such as bone marrow transplant.
- Aggressive treatment of infections was required.Clinical/Scientific Implications
- This phase I study offers some evidence of efficacy and safety in the treatment of advanced relapsed, refractory, or resistant indolent NHL with F-TBI.
- Further studies with increased numbers of patients and longer follow-up are necessaryOncolink's ASH Coverage made possible by an unrestricted Educational Grant from Amgen.