Abstracts / Gynecologic Oncology 141 (2016) 2–208
doi:10.1016/j.ygyno.2016.04.182
151 - Featured Poster Session A pilot study of pNGVL4a-CRT/E7 (detox) in conjunction with imiquimod for patients with HPV 16 + cervical intraepithelial neoplasia 2/3 B.Q. Smitha, E.D. Thomasa, R.D. Alvareza, W.K. Huha, S. Baea, L. Lamb Jr.a, M.G. Connera, M. Paradisb, T.C. Wuc, C. Trimblec. a University of Alabama at Birmingham, Birmingham, AL, USA, bJohns Hopkins School of Medicine, Baltimore, MD, USA, cJohns Hopkins Medical Institutions, Baltimore, MD, USA Objectives: The purpose of this study was to evaluate the safety and efficacy of intralesional injection of the DNA plasmid vaccine, pNGVL4a-CRT-E7(detox), in combination with topical imiquimod in women with biopsy-confirmed HPV16-associated cervical intraepithelial neoplasia (CIN) 2/3. Methods: An expansion cohort was added to a phase I trial evaluating the safety, efficacy, and immunogenicity of pNGVL4aCRT/E7(detox) administered alone, intradermally (via gene gun), intramuscularly, or directly into the cervix (intralesional), in women with HPV16+ CIN2/3. In this expansion cohort, patients received intralesional injection of pNGVL4a-CRT/E7(detox) at a dose of 3 mg, with concurrent application of 5% imiquimod cream at the injection site, at study weeks 0, 4, and 8. At week 15, patients underwent standard of care loop electrosurgical excision procedure (LEEP). Patients were monitored for clinical and laboratory adverse effects and for clinical efficacy by comparison of pre- and post-treatment histopathologic findings. Results: Twenty-one women with CIN 2/3 recruited from dysplasia clinics in participating institutions were screened for human papillomavirs (HPV) 16. Eight (42%) of 19 women were confirmed to be HPV 16 + and, of these, 7 consented to participate in this trial. pNGVL4a-CRT-E7(detox), in combination with topical imiquimod was well tolerated and no grade 3 or 4 events were seen. Five patients completed vaccination and underwent LEEP, and 2 are still in the vaccination phase. Of the 5 patients who underwent LEEP, 1 had no evidence of CIN2/3 and 4 had persistent CIN 2/3. Conclusions: Preliminary analysis demonstrates that the combination of intralesional pNGVL4a-CRT/E7(detox) and topical imiqimod is well tolerated. Accrual is ongoing and planned immunogenicity studies in the peripheral blood and in the target tissues will be performed once accrual is completed.
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doi:10.1016/j.ygyno.2016.04.181
Conclusions: When matched based on tumor stage, grade, and adjuvant management, our study suggests that there is no difference between younger and older patients with early-stage EC. High tumor grade, stage, and the presence of lymphovascular invasion remained as independent predictors of survival endpoints in women with early-stage EC.
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Results: Over the 3 time periods, African American patients continued to be younger, less likely to be married, and less likely to have cancerdirected surgery and extensive lymphadenectomy compared with white patients. On the other hand, when stratified by the 3 time periods, no difference in stage distribution, rate of lymph node metastasis, and adjuvant radiation was found between the 2 racial groups. In multivariable analysis, adjusting for age, race, marital status, stage, cancer-directed surgery, extent of lymphadenectomy, adjuvant radiation, and geographic location, AA race was significantly associated with worse DSS and OS in the 3 time periods compared with white race. AA patients were more likely to die of uterine cancer than their white counterparts by 29% in 1988–1997 (95% CI 1.03–1.62, P = .027), 40% in 1998–2004 (95% CI 1.21–1.63, P b .0001), and 34% in 2005–2011 (95% CI 1.13–1.59, P = .0008). A slight improvement in the difference in OS over time was noted between AA and white patients. AA patients were more likely to die from any cause compared with their white counterparts by 46% in 1988–1997 (95% CI 1.23–1.73, P b .0001), 39% in 1998–2004 (95% CI 1.23–1.56, P b .0001) and 26% in 2005–2011 (95% CI 1.10– 1.45, P b .0001). Conclusions: Significant improvement in outcome was noted in both racial groups over time. However, AA patients continued to have worse outcomes than white patients over time.
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150 - Featured Poster Session Survival endpoints for young women with early-stage uterine endometrioid carcinoma: A matched analysis D. Isrowa, C. Burmeistera, A.R. Munkarahb, M.A. Elshaikhb. aHenry Ford Hospital, Detroit, MI, USA, bHenry Ford Health System, Detroit, MI, USA
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Objectives: Younger age is viewed as a favorable prognostic factor in women with early-stage endometrial carcinoma (EC) but the available data are controversial. Survival endpoints were compared between 2 groups of patients with early-stage EC solely of endometrioid histology: women 45 years or younger and similarly matched older women. Methods: We identified 1,254 patients with 2009 FIGO stage I-II EC who underwent hysterectomy at our institution between January 1990 and December 2014. We created 2 matched groups based on FIGO stage, tumor grade, lymph node dissection status and the type of adjuvant management (observation, pelvic external beam, or vaginal brachytherapy). Recurrence-free (RFS), disease-specific (DSS), and overall survival (OS) were calculated for the 2 groups. Results: A total of 516 patients (86 younger patients and 430 older patients, matched 1:5) were included in this study. Median followup was 42.8 months for the entire study cohort (35.2 months for younger and 49.0 for older patients). The 2 groups were well balanced except for the obvious greater age in the older group (P b .0001) and a higher percentage of myometrial invasion in older patients (P = .003). There were no significant differences between younger and older groups with regard to 5-year RFS (94% younger vs 91% older, P = .69). Similarly, there was no significant difference with regard to DSS (96% younger vs 97% older, P = .90). There was no significant difference between younger and older patients in terms of 5-year OS (89% for both groups, P = .99), but 10-year OS was 83% for younger women compared with 68% for older patients, (P = .1). On multivariate analysis for DSS for the entire study cohort, high tumor grade and the presence of lower uterine segment involvement were the only 2 predictors of shorter DSS (P = .01). On multivariate analysis for RFS, higher stage and the presence of lymphovascular space invasion were the only 2 predictors of shorter RFS (P b .0001 and P = .01, respectively). Older age and higher stage were the only 2 predictors of shorter OS (P b .0001 and P = .01, respectively).
doi:10.1016/j.ygyno.2016.04.183
152 - Featured Poster Session Impact of invitation and reminder letters on cervical cancer screening participation in Ontario S. Tavasolia, A. Konea, A. Leea, R. Kupetsb. aCancer Care Ontario, Toronto, ON, Canada, bSunnybrook Cancer Center, University of Toronto, Toronto, ON, Canada Objectives: To explore the impact of mailing invitation and reminder letters on cervical cancer screening to patients who had not received a Pap smear test in the previous 3 years.
Abstracts / Gynecologic Oncology 141 (2016) 2–208
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screening patterns. Health and economic outcomes were compared among the 3 screening strategies to assess cost-effectiveness. Future costs and life-years were discounted at 3%. Results: Cotesting demonstrates a 5.8% reduction in incidence and mortality per 100,000 compared with the Pap smear, on average, between 2015 and 2050. Over a lifetime, PAP3/HPV5 and cotesting resulted in 2.3% and 7.5% fewer cases than PAP3, respectively, and 2.9% and 7.9% fewer deaths compared with Pap3, respectively. Cotesting was projected to require the most annual colposcopies, 201,800, versus 148,900 and 102,600 for Pap3 and Pap3/HPV5 scenarios, respectively. When aggregating lifetime costs of vaccination, cervical screening and treatment, PAP3/HPV5 was the least costly, $20.48 billion compared with PAP3 ($22.28 billion) and cotest ($27.98 billion). For direct screening costs, the cotest was the costliest ($23.22 billion), compared with PAP3/HPV5 ($16.04 billion) and PAP3 ($17.58 billion). PAP3/HPV5 and cotesting produced projected gains in quality-adjusted life-years. PAP3/HPV5 had the dominant incremental cost-effectiveness ratio (ICER) over cotesting compared with PAP3 (Fig. 1). Conclusions: According to CRMM-HPV, in a partially vaccinated population, cotesting had the highest screening costs and resulted in the lowest cervical cancer incidence and mortality. The cost savings resulting from PAP3/HPV5, together with the projected gains in quality-adjusted life-years, results in a dominant ICER over cotesting compared with PAP3.
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Methods: A cross-sectional study was used to describe factors associated with screening and screening patterns for eligible women. A cohort design was used to compare the impact of invitation and reminder letters on Pap smear uptake comparing women who received the intervention (n=99,278) with a historical nonintervention group (n=130,068). Factors that might influence screening participation were included as covariates in a multivariable logistic regression model. Results: A total of 1,150,783 women were mailed an invitation letter. Overall, 26.7% of women who had a Pap smear test 3 to 5 years earlier and 9.8% of women with no Pap smear test in the previous 5 years were screened within 9 months after the intervention. On cohort analysis, 14.1% of women in the intervention group and 8.5% of women in the nonintervention group had a Pap smear test within 9 months. Being mailed an invitation letter (OR 1.8, 95% CI 1.7–1.8) was associated with a greater likelihood of screening. Controlling for covariates, the letter intervention was associated with 9-month screening for both women with a Pap smear test 3 to 5 years earlier (OR 1.7, CI 1.6–1.8) and those with no Pap smear test in the previous 5 years (OR 1.8, CI 1.7–1.9). The effect of all covariates on screening participation was significant. The most significant covariates included being rostered to a Primary Enrollment Model physician practice (OR 1.6, 95% CI 1.6– 1.7) and age. Increasing age was negatively associated with likelihood of screening participation. Women aged 65 to 69 years had the smallest odds of screening (OR 0.5, 95% CI 0.5–0.6) compared with women aged 30 to 34 years. Conclusions: The invitation and reminder letter strategy increased cervical cancer screening participation. Additional strategies are needed that could encourage women who are reluctant to be screened to participate and to remove barriers to screening for eligible women. A significant unscreened rate among older women and among individuals who had no Pap smear test in the previous 5 years underscores the need for further targeted strategies.
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doi:10.1016/j.ygyno.2016.04.184
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153 - Featured Poster Session Comparing the health and economic impacts of cervical cancer screening strategies using the Cancer Risk Management Model (CRMM) C. Popadiuka, A.J. Coldmanb, S. Memonb, N. Fitzgeraldb, S. Gribbleb, G. Lockwoodb, M.G. Wolfsonc, A.B. Millerd. aMemorial University of Newfoundland, St. Joshn's, NF, Canada, bCanadian Partnership Against Cancer, Toronto, ON, Canada, cUniversity of Ottawa, Ottawa, ON, Canada, d University of Toronto, Faculty of Medicine, Toronto, ON, Canada
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Objectives: The Cancer Risk Management Model–Human Papillomavirus (CRMM-HPV) is a Canadian population multitype HPV transmission and cervical cancer microsimulation model that projects the effects of HPV vaccination and cervical cancer control strategies. Methods: A comparison was undertaken of 3 screening strategies in an HPV (6/11/16/18) vaccinated population: (1) triennial Pap smear in 25 to 69 year olds (PAP3); (2) triennial Pap smear in 25 to 29 year olds with HPV DNA testing every 5 years from ages 30 to 69 years (PAP3/HPV5), and (3) triennial Pap smear in 25 to 29 year olds and Pap/HPV cotesting every 5 years from ages 30 to 69 years (cotest). The following assumptions were made: (1) 70% HPV vaccination rate among girls aged 12 years with the vaccination program starting in 2007, and (2) screening participation rate of 70% for eligible women with screening beginning in 2015. The model simulated historical
Fig. 1. Incremental Cost-effectiveness Ratio.
doi:10.1016/j.ygyno.2016.04.185
154 - Featured Poster Session Contribution of cervical cytologic testing to the diagnosis of endometrial and ovarian cancer A.H. Freemana, B. Fettermanb, N. Poitrasb, T. Loreyb, W.K. Kinneyc, P.E. Castled. aKaiser Permanente San Francisco Medical Center, San Francisco, CA, USA, bThe Permanente Medical Group, Berkeley, CA, USA, cThe Permanente Medical Group, Sacramento, CA, USA, dAlbert Einstein College of Medicine, New York, NY, USA Objectives: To determine the contribution of cervical cytologic testing to the diagnosis of endometrial and ovarian cancers. Methods: Women who underwent cervical cytology screening within Kaiser Permanente Northern California over a 5-year study period were identified. An abnormal cervical cytology was defined as the following: atypical glandular cells (AGC), other (normal postmenopausal endometrial cells), or malignant. We confirmed all endometrial and ovarian cancer cases via our local cancer registry during the determined study period. Laboratory databases, including