A prospective study of surgery plus biodegradable carmustine wafers for local control and neurocognitive function in 39 patients with one to three brain metastases: Preliminary results.
Authors: S. Brem, C. A. Meyers, M. Booth-Jones, S. Jain, M. G. Ewend
Journal: Journal of Clinical Oncology (2010)

2066^ Background: A prospective, multicenter, single-arm, feasibility study in pts with single or limited (≤ 3) brain metastases was designed to determine rates of local control and neurocognitive effects after surgical resection and BCNU wafer placement, while deferring whole brain radiation therapy (WBRT). Methods: 43 eligible adults had 1-3 brain metastases, with 1 tumor appropriate for surgical resection. 39 had surgery with wafer implants. The remaining smaller tumors were treated with radiosurgery. Endpoints were evaluation of local recurrence and neurocognitive function measured with a neurocognitive test battery (n= 33). Results: The median age was 62; 87% had a single brain lesion; 46% had a primary of non-small-cell lung cancer. At baseline, the RPA status was 44% in class 1 and 56% in class 2. After one year of follow- up (median follow-up = 4 mos), only one of 33 pts (3%) experienced a decline in neurocognitive function. By contrast, at the first assessment (2 mos postoperatively), there was significant neurocognitive improvement. The local recurrence rate was 18% (6 of 34 evaluable pts); distant recurrence was 29% (10 of 34 evaluable pts). 33 of 39 (85%) pts remain alive; 6 who died succumbed to non-neurologic, systemic illness. 5 pts had serious adverse events (9 events were identified as wafer-related); 8 of 9 events were resolved at the time of this report. Conclusions: Use of BCNU wafers after surgical resection of metastatic brain tumors provides local control similar or superior to WBRT but with significant preservation of neurocognitive function. BCNU wafers after surgery to control single brain metastases, and in combination with SRS for oligometastatic disease, appears to provide local control and can improve neurocognitive function, while avoiding radiation toxicity by deferring WBRT. Neurocognitive domains, standardized scores by time Domain Month Mean change from baseline 95% CI P value* Memory 2 0.1 −0.4, 0.6 0.7270 4 0.7 0.0, 1.5 0.0474 6 1.2 0.5, 2.0 0.0035 Executive function 2 0.5 0.2, 0.9 0.0069 4 1.1 0.7, 1.6 <0.0001 6 1.2 0.6, 1.7 0.0005 Fine motor coordination 2 0.5 0.2, 0.8 0.0022 4 0.7 0.2, 1.1 0.0039 6 0.7 0.1, 1.3 0.0257 * Versus baseline. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eisai Eisai Eisai In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519-521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2010 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest.