A Single Institutional Phase II Randomized Trial of Whole Brain Radiation Therapy with or without Irinotecan for the Treatment of Brain Metastases from Solid Tumours
2015
Background: The relatively suboptimal results
of whole brain radiation therapy (WBRT) alone in
eradication of brain metastases and an attempt to improve outcomes with WBRT
have led to studies combining radiotherapy with chemotherapy drugs that could
act as radiosensitizers with a rationale of improving local tumor control.
Materials and Methods: This randomized phase II study evaluated the use of
Irinotecan concomitant with 37.5 Gray (Gy) of WBRT in 2.5 Gy daily fractions ×
5 days each week for 3 weeks versus Whole WBRT alone in patients with brain
metastasis (BM) from solid tumors. Fifty patients were randomized to receive
either WBRT alone
or concomitant with three irinotecan IV infusions 80 mg/m2, 2 hrs
before RT on days 1, 8, and 15. Results: The objective response rate (ORR) was
significantly improved in patients receiving Irinotecan with radiotherapy
versus radiotherapy alone (48% vs. 28%; p = 0.048). The median time to
progression of brain metastasis was significantly longer in the irinotecan and
WBRT arm as compared to the WBRT arm (8 vs. 5 months; p < 0.001). There was
no significant difference in survival between treatment arms (p = 0.361).
Irinotecan with radiotherapy was generally well tolerated and did not interfere
with the delivery of WBRT. Conclusions: Irinotecan concomitant with WBRT was
well tolerated and significantly improved local control of BM compared with
WBRT alone. These findings require confirmation in a phase III trial with
addition of quality of life assessment.
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