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Lenograstim Effective After Consolidation Chemotherapy for Elderly Patients With Acute Myeloid Leukaemia: Presented at EHA

By Chris Berrie

AMSTERDAM, THE NETHERLANDS -- June 21, 2006 -- Prophylactic administration of lenograstim after consolidation chemotherapy is safe and provides better clinical benefits for elderly patients with acute myeloid leukaemia (AML), according to a multicentre, prospective, randomised phase study.

Shigeki Ohtake, MD, PhD, coinvestigator and professor, division of haematology, internal medicine, Graduate School of Medical Science, Kanazawa University, Kanazawa, Japan, presented this study here on June 16^th at the 11^th Congress of the European Hematology Association (EHA).

Although some clinical guidelines recommend the use of granulocyte colony stimulating factor administration after consolidation chemotherapy for elderly patients with AML, an effective schedule remains under investigation.

Therefore, Dr. Ohtake and his colleagues in the Japanese Adult Leukemia Study Group (JALSG) conducted this study to compare 2 different administration schedules of lenograstim after consolidation therapy -- prophylactic and therapeutic.

The eligibility criteria stated an age > 65 years, newly diagnosed de novo AML (except M3, by the French-American-British [FAB] criteria), complete remission after induction therapy with daunorubicin (DNR), and enocitabine (BH-AC), no antecedent history of myelodysplastic syndrome, and adequate liver, kidney, and renal function.

Following consolidation chemotherapy with BH-AC 200 mg/m² (3 hour IV, days 1-5) and mitoxantrone (MIT) 7 mg/m² (greater than or equal to 70 years, 5 mg/m²; 30 minute IV, days 1-3), 110 patients were randomised to receive lenograstim 5 microg/kg for 30 minutes IV, either after an absolute neutrophil count (ANC) of < 1,000/micoL was reached (prophylactic; arm A) or after the same plus fever above 37.5 degrees Celsius (therapeutic; arm B).

Patient baseline characteristics following randomisation were essentially the same across arm A (n = 54) and arm B (n = 56), as (respectively): median age, 71.0 versus 71.0 years; male, 44.4% versus 50.0%; performance status: 0, 56% versus 63%; 1, 39% versus 34%; 2, 6% versus 4%; FAB: M0, 6% versus 4%; M1, 24% versus 20%; M2, 41% versus 41%; M4, 13% versus 18%; M5, 11% versus 16%; M6, 4% versus 0%; M7, 2% versus 2%.

Median interval between diagnosis and first day of consolidation was similar in the 2 arms (49.5 vs 51.5 days), although the median duration of induction was significantly shorter in arm B (40 days, vs 34 days for arm A).

Of note, while all patients in arm A, prophylactic, received lenograstim, 51.8% in arm B received lenograstim, as the remaining arm B patients did not experience fever above 37 degrees Celsius.

For incidence of fever (greater than or equal to 38 degrees Celsius), and including all patients from both arms, there was no significant difference in incidence rates between the 2 arms: arm A, 42.6%; arm B, 51.8% (P =.3343). Similarly, duration of fever was not significantly different between the arms (A vs B): 1.2 versus 1.4 days (P =.34). This did not change when the patients were compared as < 70 and greater than or equal to 70 years.

For febrile neutropenia (fever > 37.5 degrees Celsius with neutrophil count < 500/microL), there was a trend towards higher incidence with therapeutic use of lenograstim: arm A, 29.6%; arm B, 44.6% (P =.1035). Similarly, the same trend was seen for duration of febrile neutropenia: 1.2 versus 1.6 days (P =.08). When the patients were divided according to age, within each group, this trend became significant in patients < 70 years: 0.8 versus 2.0 days (P =.032). Of note, this younger group of patients had also received more intensive chemotherapy.

The researchers also looked at the incidence of infection during the first consolidation therapy (within 60 days); here, duration of infectious complications was slightly shorter in arm A (P =.06).

Finally, the median duration of recovery from neutropenia was significantly shorter for prophylactic use: ANC > 500/microL: arm A, 5.0 days; arm B, 9.0 days (P <.0001); ANC > 1,000/microL: arm A, 8.5 days; arm B, 14.5 days (P <.0001).

There were no adverse events that were attributable to lenograstim, and no significant differences seen between the arms in terms of adverse events.

Dr. Ohtake said that this study's findings demonstrated that the prophylactic administration of lenograstim obtained better clinical results, and especially in the patients who received more intense chemotherapy.

"This means that we should use lenograstim just after chemotherapy, and so we must not wait until patients become febrile, and thus we can avoid possible later complications," he added.

Furthermore, lenograstim is also safe for administration after consolidation for elderly patients with AML, he said.


[Presentation title: A Multicentre Prospective Randomised Study of Lenograstim in Consolidation Chemotherapy for Elderly Patients With Acute Myeloid Leukaemia (JALSG GML200-S Study). Abstract 0129]

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