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Blood, Vol. 92 No. 5 (September 1), 1998:
pp. 1556-1564
A Randomized Controlled Trial of Filgrastim During Remission
Induction and Consolidation Chemotherapy for Adults With Acute
Lymphoblastic Leukemia: CALGB Study 9111
Richard A. Larson,
Richard K. Dodge,
Charles A. Linker,
Richard M. Stone,
Bayard L. Powell,
Edward J. Lee,
Philip Schulman,
Frederick R. Davey,
Stanley R. Frankel,
Clara D. Bloomfield,
Stephen L. George, and
Charles A. Schiffer
From the University of Chicago, IL; the Cancer and Leukemia Group B
Statistical Center, Durham, NC; the University of California in San
Francisco, CA; the Dana Farber Cancer Institute, Boston, MA; Wake
Forest University School of Medicine, Winston-Salem, NC; the University
of Maryland, Baltimore, MD; North Shore University Hospital, Manhasset,
NY; the State University of New York Health Science Center at Syracuse,
NY; the Roswell Park Cancer Institute, Buffalo, NY; the Ohio State
University, Columbus, OH; and the Cancer and Leukemia Group B (CALGB),
Chicago, IL.
Recombinant human granulocyte colony-stimulating factor (G-CSF;
filgrastim) shortens the time to neutrophil recovery after intensive
chemotherapy, but its role in the treatment of adults with acute
lymphoblastic leukemia (ALL) is uncertain. We randomly assigned 198 adults with untreated ALL (median age, 35 years; range, 16 to 83) to
receive either placebo or G-CSF (5 µg/kg/d) subcutaneously, beginning
4 days after starting intensive remission induction chemotherapy and
continuing until the neutrophil count was  1,000/µL for 2 days. The
study assignment was unblinded as individual patients achieved a
complete remission (CR). Patients initially assigned to G-CSF then
continued to receive G-CSF through 2 monthly courses of consolidation
therapy. Patients assigned to placebo received no further study drug.
The median time to recover neutrophils 1,000/µL during the
remission induction course was 16 days (interquartile range [IQR], 15 to 18 days) for the patients assigned to receive G-CSF and 22 days
(IQR, 19 to 29 days) for the patients assigned to placebo (P
< .001). Patients in the G-CSF group had significantly shorter
durations of neutropenia (<1,000/µL) and thrombocytopenia
(<50,000/µL) and fewer days in the hospital (median, 22 days
v 28 days; P = .02) compared with patients receiving
placebo. The patients assigned to receive G-CSF had a higher CR rate
and fewer deaths during remission induction than did those receiving
placebo (P = .04 by the chi-square test for trend). During
Courses IIA and IIB of consolidation treatment, patients in the G-CSF
group had significantly more rapid recovery of neutrophils
1,000/µL than did the control group by approximately 6 to 9 days.
However, the patients in the G-CSF group did not complete the planned
first 3 months of chemotherapy any more rapidly than did the patients
in the placebo group. Overall toxicity was not lessened by the use of
G-CSF. After a median follow-up of 4.7 years, there were no significant
differences in either the disease-free survival (P = .53) or
the overall survival (P = .25) for the patients assigned to
G-CSF (medians, 2.3 years and 2.4 years, respectively) compared with
those assigned to placebo (medians, 1.7 and 1.8 years, respectively).
Adults who received intensive chemotherapy for ALL benefited from G-CSF
treatment, but its use did not markedly affect the ultimate outcome.
© 1998 by The American Society of Hematology.
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