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Vincristine, ACNU, Carboplatin and Interferon Beta with
Radiation (VAC-FERON-R) for Newly Diagnosed Glioblastoma Multiforme
Tomokazu Aoki, Tetsuya Ueba, Jun Takahashi, Natstuo Ooya,
Masahiro Hiraoka, Masatsune Ishikwa, and Nobuo Hashimoto
Kyoto Neuro-Oncology Group, Kitno Hospital, Osaka, Japan;
Faculty of Medicine, Kyoto University, Kyoto, Japan
Purpose. Novel combination therapies are needed for patients
with newly diagnosed glioblastoma multiforme.
From reports on meta-analysis, we selected 4 drugs (vincristine, ACNU, carboplatin, and interferon
beta [IFN-β]).
This phase II study was performed to determine the safety,
tolerability, and efficiency of this therapy.
Patients and Methods. Forty-one
patients were enrolled onto this open-label, phase II study.
ACNU (60 mg/m2),
carboplatin (110 mg/m2),
vincristine (0.6 mg/m2),
and interferon (300 million/body) were administered in day 1, concomitant with fractionated
radiotherapy (63 Gy total dose: 1.8 Gy × 5 days for 7 cycles), and vincristine ( 0.6 mg/m2)
and interferon (300 million/body) were administered in days 7 and
15; IFN-β (300 million/body) was administered 3 times for a week during
the radiation course.
Two months after the radiation, ACNU (60 mg/m2),
carboplatin (110 mg/m2),
vincristine (0.6 mg/m2),
and interferon β (300 million/body) were administered in day 1, and vincristine (0.6 mg/m2)
and interferon β (300 million/body) were administered in days 7 and 15, every 58 days.
The
primary end points were safety and tolerability, and the secondary end
point was overall survival.
Results. VAC-feron-R was safe and well tolerated.
Nonhematologic toxicities were rare and mild to moderate in severity.
During
the concomitant treatment phase, grade 3 neurocytopenia, thrombocytopenia, or both were observed in 23% of patients.
Grade 4 hematological
toxicities were not observed.
During adjuvant chemotherapy after radiation,
3% cycles were associated with grade 3 neutropenia or thrombocytopenia.
None of the cycles were associated with grade 4 toxicities.
Time to
progression was 8 months.
Median survival was 16 months.
Conclusion. VAC-feron-R
is safe and well tolerated.
This regimen of concomitant
chemoradiationtherapy followed by adjuvant chemotherapy may prolong the survival of patients
with glioblastoma multiforme.
Further investigation is warranted.
Copyright © 2003 by the Society for Neuro-Oncology
Source: http://ninetta.ingentaselect.com/vl=8274130/cl=50/nw=1/rpsv/cw/dup/15228517/previews/031005 |
