Phase II study of Vigil® DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer.

OBJECTIVES: The majority of women with Stage III/IV ovarian cancer who achieve clinical complete response with frontline standard of care will relapse within 2years. Vigil immunotherapy, a GMCSF/bi-shRNA furin DNA engineered autologous tumor cell (EATC) product, demonstrated safety and induction of circulating activated T-cells against autologous tumor in Phase I trial Senzer et al. (2012, 2013) . Our objectives for this study include evaluation of safety, immune response and recurrence free survival (RFS). METHODS: This is a Phase II crossover trial of Vigil (1.0×107 cells/intradermal injection/month for 4 to 12 doses) in Stage III/IV ovarian cancer patients achieving cCR (normal imaging, CA-125≤35units/ml, physical exam, and no symptoms suggestive of the presence of active disease) following primary surgical debulking and carboplatin/paclitaxel adjuvant or neoadjuvant chemotherapy. Patients received Vigil or standard of care during the maintenance period. RESULTS: Forty-two patients were entered into trial, 31 received Vigil and 11 received standard of care. No≥Grade 3 toxicity related to product was observed. A marked induction of circulating activated T-cell population was observed against individual, pre-processed autologous tumor in the Vigil arm as compared to pre-Vigil baseline using IFNγ ELISPOT response (30/31 negative ELISPOT pre Vigil to 31/31 positive ELISPOT post Vigil, median 134 spots). Moreover, in correlation with ELISPOT response, RFS from time of procurement was improved (mean 826days/median 604days in the Vigil arm from mean 481days/median 377days in the control arm, p=0.033). CONCLUSION: In conjunction with the demonstrated safety, the high rate of induction of T-cell activation and correlation with improvement in RFS justify further Phase II/III assessment of Vigil.

Allometric scaling of strength scores in NCAA division I-A football athletes.

This study examined population-specific allometric exponents to control for the effect of body mass (BM) on bench press, clean, and squat strength measures among Division I-A collegiate football athletes. One repetition maximum data were obtained from a university pre-season football strength assessment (bench press, n = 207; clean, n = 88; and squat n = 86) and categorized into 3 groups by positions (line, linebacker, and skill). Regression diagnostics and correlations of scaled strength data to BM were used to assess the efficacy of the allometric scaling model and contrasted with that of ratio scaling and theoretically based allometric exponents of 0.67 and 0.33. The log-linear regression models yielded the following exponents (b): b = 0.559, 0.287, and 0.496 for bench press, clean, and squat, respectively. Correlations between bench press, clean, and squat to BM were r = -0.024, -0.047, and -0.018, respectively, suggesting that the derived allometric exponents were effective in partialling out the effect of BM on these lifts and removing between-group differences. Conversely, unscaled, ratio-scaled, and allometrically scaled (b = 0.67 or 0.33) data resulted in significant differences between groups. It is suggested that the exponents derived in the present study be used for allometrically scaling strength measures in National Collegiate Athletic Association Division I-A football athletes. Use of the normative percentile rank scores provide coaches and trainers with a valid means of judging the effectiveness of their training programs by allowing comparisons between individuals without the confounding influence of BM.

Recurrent phyllodes tumor of the vulva: a case report with review of diagnostic criteria and differential diagnosis.

Phyllodes tumor of the vulva is extremely rare with only 6 cases reported in the literature. We report a case of recurrent phyllodes tumor of the vulva in a 39-year-old woman. The tumor showed biphasic morphology with a typical leaf-like pattern and a cellular stroma with rare mitosis. Expression of estrogen receptors, progesterone receptors mammoglobin, and BRST-2 was shown in the epithelial component. Review of literature with emphasis on diagnostic features and differential diagnosis are discussed.

Secondary cytoreductive surgery for recurrent platinum-sensitive ovarian cancer.

OBJECTIVE: To determine the risks and benefits of secondary cytoreductive surgery for recurrent platinum-sensitive ovarian cancer. METHODS: Data were obtained retrospectively for all women with recurrent platinum-sensitive epithelial ovarian cancer who underwent a second debulking operation between 1998 and 2008 at the University of Texas Southwestern Medical Center. Survival analysis and comparisons were performed using the Kaplan-Meier method, log-rank test, and Cox multivariate proportional hazards model. RESULTS: Optimal secondary cytoreductive surgery (<5mm of residual disease) was achieved in 32 of 40 patients (80%). Nine women (23%) developed major complications. Two variables, residual disease of less than 5mm vs 5mm or greater (median 63 months vs 11 months; P=0.003); and less than 5 vs 5 or more sites of disease relapse (median 63 months vs 22 months; P=0.009), were independently associated with survival and retained prognostic significance on multivariate analysis. CONCLUSIONS: Optimal secondary cytoreductive surgery was associated with a survival advantage and acceptable risks.