Carolyn M. Matthews M.D.

Oh, J., M. Barve, C. M. Matthews, E. C. Koon, T. P. Heffernan, B. Fine, E. Grosen, M. K. Bergman, E. L. Fleming, L. R. DeMars, L. West, D. L. Spitz, H. Goodman, K. C. Hancock, G. Wallraven, P. Kumar, E. Bognar, L. Manning, B. O. Pappen, N. Adams, N. Senzer and J. Nemunaitis (2016). “Phase ii study of vigil(r) DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer.” Gynecol Oncol 143(3): 504-510.

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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/=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 IFNgamma 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.

Cass, I., L. R. Duska, S. V. Blank, G. Cheng, N. C. duPont, P. J. Frederick, E. K. Hill, C. M. Matthews, T. L. Pua, K. S. Rath, R. Ruskin, P. H. Thaker, A. Berchuck, B. S. Gostout, D. M. Kushner and J. M. Fowler (2016). “Stress and burnout among gynecologic oncologists: A society of gynecologic oncology evidence-based review and recommendations.” Gynecol Oncol 143(2): 421-427.

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Burnout and compassion fatigue are endemic among healthcare providers. It has been estimated that half of all medical students, residents and attending physicians experience burnout, and that physicians suffer more burnout than do other American workers [7], [8] and [9]. Conflicting data suggest that primary care physicians on the ‘front line’ experience the lowest job satisfaction and the highest burnout, while the oncology, trauma and surgical literature show that physicians dealing with the most acutely ill patients have a high prevalence of burnout. In a meta-analysis of burnout among healthcare professionals that care for patients with cancer, the prevalence of emotional exhaustion was 36%, depersonalization 34% and low sense of personal accomplishment 25%, with severe involvement in up to 51% of surveyed subjects [10]. Forty percent of surgical oncologists, 35% of medical oncologists and 64% of obstetrician gynecologists were estimated to have symptoms of burnout in specialty specific surveys [11], [12] and [13]. While it is to be expected that caring for extremely ill and dying patients is emotionally draining, it is alarming that doing so causes potential harm to the physician as well.

Cass, I., L. R. Duska, S. V. Blank, G. Cheng, N. C. duPont, P. J. Frederick, E. K. Hill, C. M. Matthews, T. L. Pua, K. S. Rath, R. Ruskin, P. H. Thaker, A. Berchuck, B. S. Gostout, D. M. Kushner and J. M. Fowler (2016). “Stress and burnout among gynecologic oncologists: A society of gynecologic oncology evidence-based review and recommendations.” Gynecol Oncol: 2016 Aug [Epub ahead of print].

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Burnout has been studied among medical oncologists and surgeons; however, there is less data specific to gynecologic oncolxogists [14] and [15]. Job satisfaction and work related stress among gynecologic oncologists have been assessed [2], but until recently, burnout was not assessed. Two large, seminal studies, a 2014 survey of 369 members of the Society of Gynecologic Oncologists (SGO) and a 2008 survey of 7900 members of the American College of Surgeons (ACS), established the high prevalence of physician burnout in gynecologic oncologists and surgeons respectively, affecting 32%–40% of responders [16] and [17]. Both works are cited throughout this paper and were driving forces motivating the Society of Gynecologic Oncology (SGO) to assemble a Wellness Task Force to address this issue. This paper represents an effort by the Task Force to acknowledge the high rate of burnout in gynecologic oncology as a specialty by bringing the subject forward for discussion, and exploring potential solutions.