Abstract
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.
Highlights
Metastatic brain tumors are the most common intracranial neoplasm in adults, and the exact incidence is unknown, it has been estimated that they can occur in up to 20% - 40% of cancer patients during the course of their disease; an incidence 10 times greater than primary brain tumors [1]-[3].Brain metastases are associated with poor prognosis
50 met the eligibility criteria and were enrolled, with 25 patients assigned to the irinotecan and whole brain radiation therapy (WBRT) arm and 25 patients assigned to the WBRT arm, with a median follow up time of 8.5 months
As patients with brain metastases have a short life expectancy, our treatment regimen appeared to be quite appropriate for them. This local brain control was not translated into prolongation of overall survival, possible explanation may be due to a high failure rate predominantly at extra-cranial sites that erased any survival advantage that might have been the result of a better local control of brain metastases
Summary
Metastatic brain tumors are the most common intracranial neoplasm in adults, and the exact incidence is unknown, it has been estimated that they can occur in up to 20% - 40% of cancer patients during the course of their disease; an incidence 10 times greater than primary brain tumors [1]-[3].Brain metastases are associated with poor prognosis. Phase III trials of the Radiation Therapy Oncology Group (RTOG) showed that treatment of brain metastasis with WBRT results in a median survival of 3 to 6 months and improve the neurologic function in most patients. 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. 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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