18 vaccine

18 vaccine

S112 Abstracts / Gynecologic Oncology 125 (2012) S3–S167 (93%) of the doctors surveyed said they were willing to discuss FP with patients, sighting ...

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S112

Abstracts / Gynecologic Oncology 125 (2012) S3–S167

(93%) of the doctors surveyed said they were willing to discuss FP with patients, sighting personal knowledge as the limiting factor. Of 91 physicians responding regarding the live birth rate following embryo cryopreservation, only 20 (22%) answered correctly, and of 83 responding regarding the live birth rate following oocyte cryopreservation only 8 (10%) were correct. Additionally, only 25 (36%) of 70 physicians responded correctly to the cost of oocyte cryopreservation. Fifty-seven (52%) of 109 respondents were unaware of length of time needed to acquire oocytes for cryopreservation. Conclusions: Physicians treating HBOC patients are interested and willing to share information on FP procedures. Limiting factors include physician awareness and understanding of options: specifically, intervention outcomes, financial costs, and procedure time commitment. Greater education is needed regarding FP for physicians treating women with HBOC Syndrome. doi:10.1016/j.ygyno.2011.12.267

267 A phase II study of modified dose-dense paclitaxel and every 4 week carboplatin for the treatment of advanced stage primary epithelial ovarian, fallopian tube, or peritoneal carcinoma L. Abaid, J. Micha, M. Rettenmaier, J. Brown, A. Mendivil, K. Lopez, B. Goldstein. Gynecologic Oncology Associates, Newport Beach, CA. Objective: The purpose of this study was to assess the response rate and toxicity of modified dose-dense paclitaxel and every 4-week carboplatin for the treatment of advanced stage ovarian, fallopian tube, and primary peritoneal carcinoma. Methods: All eligible patients were treated with intravenous weekly paclitaxel (80 mg/m2) days 1, 8, and 15 and carboplatin (AUC 5 or 6) day 1 during a 28-day cycle for 6 cycles. Patients with clinically defined stable disease or better with a CA-125 ≤35 U/ml following the completion of primary induction therapy were then treated with a planned 12 cycles of paclitaxel (135 mg/m2; Q 21 days) consolidation. Clinical response was assessed according to the RECIST criteria and toxicity was evaluated using the National Cancer Institute criteria (version 3.0). Statistical analyses comprised descriptive evaluation, Kaplan–Meier survival estimates and Cox proportional-hazards regression. Results: Of 103 patients who were enrolled, 88 received at least 3 cycles and 76 patients received all six cycles of induction chemotherapy and were evaluable for toxicity and survival assessment. Of the 76 patients who received 6 cycles, overall response rate was 84% (56% complete response). Fifty-three patients received an aggregate 473 cycles of consolidation chemotherapy (median = 9; range 1–12). Grade 3–4 hematological toxicity included neutropenia (22.7%), thrombocytopenia (7.9%) and anemia (1.1%). Further, grade 3 neuropathy developed in one patient. Sixteen patients (21%) experienced a chemotherapy dose delay attributed to grade ≥2 neutropenia and 65 subjects (85%) received pegfilgrastim. Of the 76 patients who completed 6 cycles, the mean progression free survival and overall survival were respectively 26 months (95% confidence interval [CI]: 22–29) and 34 months (95% CI: 30–38). Conclusions: Traditional dose-dense regimens for advanced ovarian cancer administer weekly paclitaxel on a 21-day cycle and are associated with favorable efficacy but high rates of neutropenia, thrombocytopenia, and anemia. This study suggests that first line treatment comprising modified dose-dense paclitaxel and every 4week carboplatin induction chemotherapy with paclitaxel consolidation preserves the efficacy of traditional dose-dense therapy, while minimizing hematologic toxicity. doi:10.1016/j.ygyno.2011.12.268

Poster Area 3: Abstracts 268-310 Public Health/Epidemiology, Quality of Life, Supportive Care, Surgical Techniques/Robotics/Minimally Invasive Surgery Public Health/Epidemiology 268 The role of urethral hpv infection in relapse following treatment for high grade cervical lesions M. Congiu, M. Carosi, A. Francesconi, A. Vocaturo, D. Mazza. IFOIstituto Regina Elena, Rome, Italy. Objective: In order to test the rate of urethral hpv infection and the role that it plays in relapses of high grade cervical lesions, we conducted a prospective observational study at our institution. Methods: From January 2010 to March 2011, 101 patients with high grade cervical lesions were studied. Sexual and social habits were recorded together with any referred symptom. All patients were tested for urethral, cervical and anal hpv prior to surgery (pcr followed by inverse hybridization for genotyping). Before and at follow up (every 3 months) they were also tested with liquid phase Pap test and colposcopy. Relapse was defined as cytologic/histologic positive sample taken at any of the follow up appointments. Follow up was stopped in those pts who were found twice consecutively negative. Results: All 101 patients had cervical hpv infection, 97% had hpv urethral positivity, and 83% had anal hpv infection. Preoperatively, the median number of hpv type per patient was 2 (range 1–8). In more than 50% of cases, cervix and urethra had the same hpv type, this percentage dropped to 35% when comparing cervical and anal samples. Hpv16 was the most frequent type with cervical, urethral and anal samples positive in 47%, 47% and 38% of patients. 15 out of 101 patients had suspicious/ positive surgical resection margins, and 21 had also intraglandular involvement. The median follow up period was 12 months (range 5–18), we observed a median time to relapse of 5 months (range 1–11). Overall 9 patients relapsed and underwent a 2nd cone biopsy, 8 out of 9 had suspicious positive margins following their prior surgery. 8 had urethral hpv (hpv16 in 66%, HPV 31 in 33%), 1 patient had hpv16 positive cervix. Pathology revealed 6 CIN3, 2 CIN2 and 1 Lsil. Colposcopic examination was not satisfactory in all but 1 case. The median number of hpv type found on the urethral, cervical and anal specimens at time of relapse was 1 (range 1–3) with 100% of relapses presenting with a hpv positive urethral specimen, 66% and 12% respectively with a positive anal and cervical specimen. Conclusions: This is the first study assessing hpv urethral involvement in patients with cervical lesions. Urethra seems to have a role in acting as a reservoir for subsequent disease. Further studies are warranted for better defining the recurrence risk when urethral HPV positivity is found. doi:10.1016/j.ygyno.2011.12.269

269 IgA immune response in saliva induced by AS04-adjuvant HPV-16/18 vaccine Y. Kim1, D. Chung2, M. Lee2, G. Yim2, S. Kim2, S. Kim2, E. Nam2, J. Kim3. 1 Yonsei University College of Medicine, Seoul, Republic of Korea, 2Yonsei University, Seoul, Republic of Korea, 3Kwandong University, Seoul, Republic of Korea. Objective: This study was performed to evaluate IgA and IgG secretion in saliva induced by AS04-adjuvanted HPV-16/18 vaccine. Methods: This study was designed as double blind, randomized, placebo-controlled manner. Thirty six subjects with written informed consent were enrolled in this study. However, 8 subjects were

Abstracts / Gynecologic Oncology 125 (2012) S3–S167

excluded because of protocol violation. Twenty-two subjects received AS04-adjuvanted HPV-16/18 vaccine and the others were injected with aluminum hydroxide placebo. The vaccine or placebo was administered intramuscularly on a 0, 1, 6 month schedule. Subjects' saliva, serum and oral mucosal cells were collected before initiation of vaccination and 1 month after completion. To determine oral infection by HPV-16/18, nested PCR for HPV-16/18 E6 was performed with mucosal cells of subjects. The level of HPV-16/18 VLP specific IgA and IgG in saliva was determined by ELISA. HPV-16/18 IgG level was also evaluated using ELISA to identify HPV-16/18 seroconversion. Results: All subjects had no evidence of oral infection by HPV-16/18. All subjects in study group showed IgG seropositivity for HPV-16/18 after vaccination. There was no subject in control group who showed HPV 16/ 18 seroconversion due to placebo injection. In addition, all subjects in control group had no IgA immune response for HPV 16/18 in saliva. In the study group, IgA for HPV 16 and 18 were detected in 27.3% (6/22) and 45.4% (10/22), respectively. There was no difference in HPV-16/18 VLP IgA level which was examined with obtained saliva at pre-injection. However, HPV-16/18 VLP IgA level measured from saliva at post-injection was significantly higher in the study group than that in the control group. Conclusions: This study indicates that AS04 adjuvanted HPV-16/18 vaccination induces HPV-16/18 specific IgA secretion in saliva. It might contribute to examining the role of AS04-adjuvanted HPV-16/ 18 vaccine in preventing not only HPV infection of uterine cervix, but oropharyngeal HPV infection.

S113

trend toward an association between enrollment in smoking cessation and return to a negative Papanicolaou smear with a p-value of 0.07. Conclusions: There was a significant trend toward an association between enrollment in smoking cessation and quicker return to a negative cervical cytology. Although not statistically significant, largely due to a small sample size, this study has provided the preliminary data to support a larger study evaluating the role of a dedicated smoking cessation in ameliorating abnormal cervical cytology.

Mean duration of smoking (yrs) Mean duration of enrollment (months) % HR-HPV % HIV positive % other STDs Mean age (yrs) % ethnicity African-American White Hispanic % Initial degree of dysplasia ASCUS LGSIL HGSIL Mean BMI (kg/m2) % Gardasil vaccine Mean duration to negative cytology (months)

Enrolled

Not enrolled

P value

16.6 11.7 33.3 50 16.6 44

11.4 – 57.1 14.3 0 38

0.14 0.28 0.06 0.24 0.18

50 16.6 33.3

21.4 21.4 57.1

0.15 1 0.29

50 33.3 11.1 31 5.5 18.5

42.9 42.9 14.3 31 0 46.9

0.73 0.72 1 0.81 1 0.07

doi:10.1016/j.ygyno.2011.12.271 doi:10.1016/j.ygyno.2011.12.270

270 Enrollment in a tobacco smoking cessation program and the regression of abnormal cervical cytology D. English1, F. Andrade1, M. Pasternak1, A. Aftab2, J. Garcia1. 1University of Miami/Jackson Memorial Hospital, Miami, FL, 2University of Miami, Miami, FL. Objective: A consistent association between cigarette smoking and cervical dysplasia has been noted in previous studies as far back as the 1960s. We sought to assess the relationship between smoking cessation, as achieved through a dedicated smoking cessation program at our County Hospital and the spontaneous regression of cervical precursor lesions. Other significant variables such as presence of high risk HPV and sexual practices were also considered in the analysis. Methods: This is a pilot study. Records were reviewed of women who were smokers and attended our colposcopy clinic between January 2006 and December 2010. The health information is kept in a prospectively collected medical record system. All smokers were referred to our established smoking cessation program. The patients who accepted and enrolled in this program were then compared with those who continued their smoking habits. The smoking cessation database was also queried using patient identifiers in order to identify the smoking cessation intervention received and patient compliance. High-risk human papillomavirus (hr-HPV) testing on cervical samples was detected by standard polymerase chain reaction based techniques. The triage of abnormal pap smears at presentation and follow-up was based on the guidelines by the American Society for Colposcopy and Cervical Pathology (ASCCP). All analyses were carried out using standard statistical packages. Results: We identified thirty-two women smokers being followed in our colposcopy clinic during the period of the study. 18 patients enrolled in the smoking cessation program and 14 patients declined smoking cessation. There were no statistical differences with regard to ethnicity, age, BMI and presence of sexually transmitted infections between the two groups. The mean duration until the return to negative cervical cytology in those enrolled in the smoking cessation was 18.5 months compared to 46.9 months in those who declined. There was a significant

271 Stage distribution of gynecologic cancers at a tertiary care county hospital K. Doll1, R. Puliaev2, J. Chor1, A. Roston2, U. Patel2, A. Patel1. 1 Northwestern University, Chicago, IL, 2John H. Stroger Hospital of Cook County, Chicago, IL. Objective: The epidemiology of gynecologic cancers has been well reported, with associations between race and ethnicity and poorer outcomes published. There are limited studies linking socioeconomic and insurance status to advanced stage disease. The purpose of this study is to compare the stage of presentation of common gynecologic cancers at an urban county hospital with national norms, and to describe the demographic and socioeconomic characteristics of this population. Methods: All new patients presenting to our gynecologic oncology clinic from Jan 1 2008 to December 31 2009 were reviewed using an IRB approved protocol. Patients receiving primary treatment at our institution during these dates were included for analysis. Exclusion criteria were treatment at an outside hospital, age b18 years, final benign pathology, and diagnosis of recurrent disease. Stage distributions were compared used chi-square tests for linear trend. Results: Of 613 women seen as new patients by the gynecologic oncology service, 222 met inclusion criteria for analysis. Minorities predominated with 43% (96/222) African-American, 25.2% (56/222) White, 16.2% (36/222) Latina, 7.7% Asian (17/222) and 7.7% (17/222) uncategorized. Over half of patients (57.7%, 128/222) were uninsured and an additional 38.7% (86/222) were covered by Medicaid or Medicare. There were 101 (45.1%) cervical cancers, 94 (42%) uterine cancers, and 29 (12.9%) ovarian cancers, including 2 synchronous primaries. As demonstrated in the table below, in comparison to the National Cancer Database (NCDB), women with uterine cancer were significantly more likely to present with later stage disease (p b 0.05), cervical cancer was more likely to be detected earlier (p b 0.05) and ovarian cancer stage distribution compared similarly. Conclusions: Compared to national trends, women with uterine cancer presenting to a tertiary care county hospital have significantly more advanced disease, though those with cervical cancer do not.