|
|
Interim report of the
JROSG99-1 multi-institutional randomized trial, comparing radiosurgery alone vs.
radiosurgery plus whole brain irradiation for 1-4 brain metastases
H. Aoyama, H. Shirato, K. Nakagawa, M. Tago
Hokkaido University School of Medicine, Sapporo, Japan; Tokyo
University School of Medicine, Tokyo, Japan
Background.
Stereotactic radiosurgery (SRS) is effective treatment for
brain metastases when the number is 4 or less, however the role of upfront whole
brain irradiation (WBI) combined with SRS has not been well known.
Methods.
Eligibility criteria include pathologically confirmed systemic
cancer, number of brain metastases 4 or less, and size of brain metastases 3 cm
or less.
Patients were randomly assigned to either SRS alone arm or SRS+WBI arm after the
stratification according to the primary tumor site (lung vs. others),
extracranial tumor status (active vs. inactive), and number of brain metastases
(1 vs. 2-4).
Primary endpoint is survival rate.
Secondary endpoint includes cause of death, free from new brain metastases rate,
KPS preservation (> 70%) rate, local tumor control, and late radiation
morbidity (RTOG score).
Results were analyzed according to the intention-to-treat basis.
Results.
The planned accrual number of each arm was 85 patients.
The reported accrual number for this interim analysis was 61 patients in SRS
alone arm and 59 patients in SRS+WBI arm.
The median follow-up duration was 6 months (range, 1-40).
The mean marginal radiation dose of radiosurgery was 21.8 Gy in SRS alone arm
and 16.6 Gy in SRS+WBI arm.
The schedule of WBI was 30 Gy in 10 fractions.
The actuarial 1-year survival rate was 26% in SRS alone arm and 39% in SRS+WBI
arm(log-rank, p=0.58).
Death was attributed to neurologic causes in 9 patients in SRS arm and 6
patients in WBI+SRS arm (χ-square, p=0.48).
Actuarial 1-year KPS-preservation (KPS > 70%) rate were 25% in SRS
alone arm and 37% in WBI+SRS arm (log-rank, p=0.54).
Actuarial 6-months free from new brain metastases rate was 49% in SRS alone arm
and 82% in SRS+WBI arm (log-rank, p=0.003).
Actuarial 1-year local tumor control rate was 70% in SRS alone arm and 88% in
SRS+WBI arm (log-rank, p=0.019).
Grade 3,4 late radiation morbidity was observed in 1 patient in each arm.
Conclusions.
Although survival benefit was not confirmed, the use of
upfront WBI combined with SRS is superior to SRS alone regarding the free from
new brain metastases rate and local tumor control rate.
Copyright 2004 American Society of Clinical Oncology All rights
reserved worldwide.
Source: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-00443,00.asp
|
