A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN).

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST. METHODS: The primary end point was "average pain" after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90. RESULTS: Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the "real" ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the "real" group (P = .14). All "real" patients wanted to continue treatment if available. DISCUSSION: We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.

Personalized Medicine in the Oncology Clinic: Implementation and Outcomes of the Johns Hopkins Molecular Tumor Board.

PURPOSE: Tumor genomic profiling for personalized oncology therapy is being widely applied in clinical practice even as it is being evaluated more formally in clinical trials. Given the complexities of genomic data and its application to clinical use, molecular tumor boards with diverse expertise can provide guidance to oncologists and patients seeking to implement personalized genetically targeted therapy in practice. METHODS: A multidisciplinary molecular tumor board reviewed tumor molecular profiling reports from consecutive referrals at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins over a 3-year period. The tumor board weighed evidence for actionability of genomic alterations identified by molecular profiling and provided recommendations including US Food and Drug Administration-approved drug therapy, clinical trials of matched targeted therapy, off-label use of such therapy, and additional tumor or germline genetic testing. RESULTS: One hundred fifty-five patients were reviewed. Actionable genomic alterations were identified in 132 patients (85%). Off-label therapies were recommended in 37 patients (24%). Eleven patients were treated off-label, and 13 patients were enrolled onto clinical trials of matched targeted therapies. Median progression-free survival of patients treated with matched therapies was 5 months (95% CI, 2.9 months to not reached), and the progression-free survival probability at 6 months was 43%(95% CI, 26% to 71%). Lack of locally available clinical trials was the major limitation on clinical actionability of tumor profiling reports. CONCLUSION: The molecular tumor board recommended off-label targeted therapies for a quarter of all patients reviewed. Outcomes were heterogeneous, although 43% of patients receiving genomically matched therapy derived clinical benefit lasting at least 6 months. Until more data become available from precision oncology trials, molecular tumor boards can help guide appropriate use of tumor molecular testing to direct therapy.

Population-based incidence of macular holes.

PURPOSE: To determine the incidence of full-thickness macular holes in Olmsted County, Minnesota. DESIGN: Population-based retrospective chart review (cross-sectional study). PARTICIPANTS: Ninety-four eyes of 85 patients who were residents of Olmsted County, Minnesota. METHODS: A population-based retrospective chart review was performed for all diagnoses of macular hole between 1992 and 2002 among residents of Olmsted County, Minnesota. Yearly incidence rates for each given age and sex group were determined by dividing the number of cases within that group by the estimated total Olmsted County resident population of the group for that given year. MAIN OUTCOME MEASURES: Documented clinical diagnosis of a macular hole. RESULTS: Idiopathic macular holes occur at an age- and sex-adjusted incidence in 7.8 persons and 8.69 eyes per 100,000 population per year in Olmsted County, Minnesota. The female-to-male ratio was determined to be 3.3 to 1, and bilateral idiopathic macular holes occurred in 11.7% of patients and accounted for 20.9% of the affected eyes. CONCLUSIONS: This study uniquely determined the incidence of macular holes in a predominantly Caucasian population.