FILGRASTIM SCHEDULE VARIATION: IMPACT ON HEMATOPOIETIC TOXICITY POST CHEMOTHERAPY. PRELIMINARY RESULTS
*Buonadonna A, *Berretta M, *Libra M, *Bearz A, *Stefanovski P, +Soto-Parra
H, Lionetto R, Dani C, Dalla Palma M, Tagliaventi M, +Santoro A,
and *Frustaci S. From the *Aviano, Milan (+Humanitas), and other
Medical Oncology Divisions of the Italian Group on Rare Tumors.
Background: Despite the active research and the widespread use of hematopoetic growth factors in clinical practice, their optimal schedule in intermediate dose chemotherapy has to be further studied in order to reduce an inappropriate bone marrow stimulation and reduce the cost of clinical care. The intermittent administration in comparison with the usual daily use could be of interest in this scenario.
Patients and methods: A phase II trial to evaluate the activity of Epirubicin 60 mg/m2, day 1 and 2 and Ifosfamide 3g/m2 day 1-3 in association with Mesna was activated in soft tissue sarcoma patients (pts). Filgrastim, at the dose of 300 µg subcutaneously, was randomly assigned according to the following schedules: ARM A from day +9 to +16 (8 doses); ARM B from day +9 to +16 every other day (4 doses).
Preliminary results: From 7/96 41 patients were entered in the trial and up to now, 33 pts have been analyzed. Overall, 15 were randomized in arm A, 18 in arm B. Sex, age, PS and characteristics of disease are homogeneous in both arms. Analysis of cycle 1 revealed the subsequent parameters:
| Nadir of neutrophil |
ARM
A
|
ARM
B
|
|
86
(0-1100)
|
100
(0-7000)
|
|
| Neutropenia grade 4 |
91.7%
|
73.3%
|
| Febrile neutropenia |
40%
|
35%
|
| Duration of neutropenia grade 4 (days) |
1
(1-3)
|
3
(1-5)
|
| Nadir of platelets |
79
(26-228)
|
103
(21-331)
|
| Thrombocytopenia grade 4 |
0%
|
6.3%
|
| Nadir of hemoglobin |
10.7
(7.2-12.6)
|
10.4
(7.2-12.5)
|
| Antibiotic therapy (p.o.) |
80%
|
82.4%
|
| Hospitalization for toxicity |
20%
|
11%
|
The study is still ongoing, and up to now, we have not observed any important difference between the two treatment arms as concerns either laboratory or subjective parameters. The correct scheduling of the hematopoietic growth factors may have important implications for improving hematologic recovery post-chemotherapy as well as developing the most cost-effective strategy for the implementation of colony stimulating factors in clinical practice.
|
|