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.

Reviewer: William Levin, MD
The Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado:: 10 de diciembre de 2001

Presenter: David Eilender
Presenter's Affiliation: Wayne State University
Type of Session: Poster

Background
  • 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
  • Elgibility:
  • 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:
    1. Plts < 20x10(9)(ten-to-the-9th) or an ANC < 0.5x10(9) for >10 days.
    2. Plts not >100x10(9) or ANC not >1.5x10(9) by day 43.
    3. 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)
    1. Maximum dose level RT, with DLT in < 3 of 8 patients.
    2. Treat at least 8 patients at the MTD.
Results
  • 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.
  • Deaths:
  • 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.

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