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Comparison of quality of life after secondary cytoreductive surgery (SCS) ± HIPEC in recurrent ovarian cancer
Abstracts / Gynecologic Oncology 137 (2015) 92–179
Medicine, New York, NY, USA, bSUNY—Downstate, Brooklyn, NY, USA, c Icahn School of Medicine at Mount Sinai, New York, NY, USA Objectives: Ovarian cancer presents in late stages with nonspecific symptoms. Although no screening methods exist for the general population, trials evaluating the efficacy of screening high-risk individuals are currently in process. Screening has been suggested to increase anxiety and potentially lead to unnecessary psychological harm, but we hypothesized that an organized screening program decreases anxiety scores. Methods: The study was approved by the internal review board at the Icahn School of Medicine at Mount Sinai. Women undergoing screening through the National Ovarian Cancer Early Detection Program were offered and consented to participate in the study before their scheduled visit. Each participant completed a validated Spielberger State-Trait Anxiety Inventory (STAI) before and after evaluation by a board-certified gynecologic oncologist. During the evaluation, each participant received transvaginal ultrasonography and results were shared immediately before completion of the visit. The mean pre-evaluation and post-evaluation states, trait, and total scores were compared using the Wilcoxon rank-sum test, performed using Statistical Analysis System 9.4. Results: Between January 2014 and April 2014, 105 women completed the study. The average age was 46 ± 12 years. The ethnicities of the women were as follows: 67% Caucasian (non-Hispanic, non-Asian), 11% Hispanic, 11% African-American, 7% Asian, and 4% multiracial or other. The proportion of women considered at high risk for ovarian cancer was 59%. Ten women (9.5%) had medically treated underlying anxiety. Among all participants, there was a statistically significant decrease in the mean STAI score (pre-evaluation 73.4 ± 17.7, post-evaluation 64.6 ± 18.4; P b 0.0001), state score (pre-evaluation 36.7 ± 11.3, postevaluation 31.2 ± 10.2, P b 0.0001), and trait score (pre-evaluation 36.7 ± 9.0, post-evaluation 33.3 ± 9.6, P b 0.0001). When patients with underlying anxiety were excluded, the mean differences between preevaluation and post-evaluation STAI, state, and trait scores improved. Conclusions: In this study, ovarian cancer screening improved anxiety levels. This may be due to immediate disclosure of results and counseling by a gynecologic oncologist as part of an organized screening program.
doi:10.1016/j.ygyno.2015.01.311
309 - Poster Session Comparison of quality of life after secondary cytoreductive surgery (SCS) ± HIPEC in recurrent ovarian cancer M. Petrilloa, B. Costantinia, S. Ciancia, C. Ronsinia, F. Cosentinoa, E. Shallayevaa, G. Scambiaa, A. Fagottib. aCatholic University of the Sacred Heart, Milan, Italy, bCatholic University of the Sacred Heart, Rome, Italy Objectives: This is the first prospective, longitudinal evaluation of quality of life (QoL) in patients with platinum-sensitive recurrent ovarian cancer receiving SCS ± heated intraperitoneal chemotherapy (HIPEC). Methods: Between September 2012 and September 2013, 34 patients underwent complete SCS and were randomly assigned to cisplatin-based HIPEC or observation (NCT01539785), followed by 6 cycles of carboplatin–paclitaxel. The European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQOV28 were administered before surgery, 7 days, and 3 and 6 months after SCS ± HIPEC. ANOVA for repeated measures and betweensubject test were used to analyze QoL scales/items modifications over time and their association with independent variables. Tenpoint differences were considered clinically relevant.
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Results: Eighteen (52.9%) women received SCS + HIPEC and 16 (47.1%) received SCS alone. No differences were observed in clinical, surgical, and histological variables or QoL baseline values between the two groups. After surgery, among the evaluable functioning scales, global health worsened in both groups, reaching a clinically relevant difference in favor of HIPEC patients. Focusing on symptom scales, fatigue, financial difficulties, and attitude to disease/treatment showed an overall worsening, with a significant difference in favor of SCS alone regarding fatigue and in favor of SCS + HIPEC regarding attitude to disease/treatment and financial difficulties. At 3-month evaluation, a statistically significant difference was observed for fatigue, appetite loss, body image, attitude to disease/treatment, and chemotherapy side effects in favor of the HIPEC group. None of these differences were maintained at 6-month evaluation. Overall, physical, role, emotional, social, and global health functioning scales as well as pain and abdominal/gastrointestinal symptoms significantly improved from baseline to 6-month evaluation. In multivariate analysis, only lower educational level and unemployment status were associated with poorer recovery of QoL levels over time. Conclusions: SCS ensures an overall improvement of several functioning and symptom scales. HIPEC administration does not worsen QoL compared to SCS alone while providing a benefit in term of women's perception of their own cancer care. doi:10.1016/j.ygyno.2015.01.312
310 - Poster Session Program evaluation of a female sexual medicine and women's health program J. Carter, B. Seidel, C. Stabile, R.E. Baser, A. Eaton, S. Benfante, A.R. Gunn, S. Goldfarb, D.J. Goldfrank. Memorial Sloan Kettering Cancer Center, New York, NY, USA Objectives: To evaluate the effectiveness of simple sexual/vaginal health treatment strategies in women seeking treatment at a female sexual medicine program and to evaluate compliance and clinical outcomes. Methods: Demographics, medical information, and clinical assessment findings from 161 new visits with at least one follow-up were analyzed. The assessment form consisted of a clinician evaluation form with the Vaginal Assessment Scale; patient-reported outcomes of the Sexual Activity Questionnaire, Sexual Self-Schema Scale, and Female Sexual Function Index; and exploratory items. Results at last visit were compared for compliance with treatment recommendations for the outcomes vaginal pH; moisture; pain with examination; vaginal assessment of dryness, soreness, and irritation; and future confidence. Results: The mean number of follow-up visits was 3.2 (range, 2–10). The majority of women had a history of breast (88 [55%]), gynecologic (50 [31%]), or anal/colorectal (14 [9%]) cancer. Mean age was 54.6 years (range, 23–79 years) and 73% (117) were married or in an intimate relationship. Treatment recommendations included use of vaginal moisturizers, lubricants with sexual activity, pelvic floor exercises, and dilator therapy. At last visit, 94% (120/128) of women complied with the clinical recommendation to moisturize at least 2 to 5+ times per week. Vaginal pH scores N6.5 declined from 29% (42/146) at visit 1 to 22% (34/154) at last visit. Twenty percent of women who moisturized 4+ times a week had pH N 6.5 at last visit compared to 33% of women who moisturized 2 to 3 times per week. Approximately two thirds of women (92/142) performed pelvic floor exercises a few times per week to daily at last visit. At visit 1, 42% (64/152) of the women reported current sexual activity with a partner, and sexual activity rates increased over time: 51% at visit 2 (77/150) and 58% (48/83) at visit 3. Confidence about future
Medicine, New York, NY, USA, bSUNY—Downstate, Brooklyn, NY, USA, c Icahn School of Medicine at Mount Sinai, New York, NY, USA Objectives: Ovarian cancer presents in late stages with nonspecific symptoms. Although no screening methods exist for the general population, trials evaluating the efficacy of screening high-risk individuals are currently in process. Screening has been suggested to increase anxiety and potentially lead to unnecessary psychological harm, but we hypothesized that an organized screening program decreases anxiety scores. Methods: The study was approved by the internal review board at the Icahn School of Medicine at Mount Sinai. Women undergoing screening through the National Ovarian Cancer Early Detection Program were offered and consented to participate in the study before their scheduled visit. Each participant completed a validated Spielberger State-Trait Anxiety Inventory (STAI) before and after evaluation by a board-certified gynecologic oncologist. During the evaluation, each participant received transvaginal ultrasonography and results were shared immediately before completion of the visit. The mean pre-evaluation and post-evaluation states, trait, and total scores were compared using the Wilcoxon rank-sum test, performed using Statistical Analysis System 9.4. Results: Between January 2014 and April 2014, 105 women completed the study. The average age was 46 ± 12 years. The ethnicities of the women were as follows: 67% Caucasian (non-Hispanic, non-Asian), 11% Hispanic, 11% African-American, 7% Asian, and 4% multiracial or other. The proportion of women considered at high risk for ovarian cancer was 59%. Ten women (9.5%) had medically treated underlying anxiety. Among all participants, there was a statistically significant decrease in the mean STAI score (pre-evaluation 73.4 ± 17.7, post-evaluation 64.6 ± 18.4; P b 0.0001), state score (pre-evaluation 36.7 ± 11.3, postevaluation 31.2 ± 10.2, P b 0.0001), and trait score (pre-evaluation 36.7 ± 9.0, post-evaluation 33.3 ± 9.6, P b 0.0001). When patients with underlying anxiety were excluded, the mean differences between preevaluation and post-evaluation STAI, state, and trait scores improved. Conclusions: In this study, ovarian cancer screening improved anxiety levels. This may be due to immediate disclosure of results and counseling by a gynecologic oncologist as part of an organized screening program.
doi:10.1016/j.ygyno.2015.01.311
309 - Poster Session Comparison of quality of life after secondary cytoreductive surgery (SCS) ± HIPEC in recurrent ovarian cancer M. Petrilloa, B. Costantinia, S. Ciancia, C. Ronsinia, F. Cosentinoa, E. Shallayevaa, G. Scambiaa, A. Fagottib. aCatholic University of the Sacred Heart, Milan, Italy, bCatholic University of the Sacred Heart, Rome, Italy Objectives: This is the first prospective, longitudinal evaluation of quality of life (QoL) in patients with platinum-sensitive recurrent ovarian cancer receiving SCS ± heated intraperitoneal chemotherapy (HIPEC). Methods: Between September 2012 and September 2013, 34 patients underwent complete SCS and were randomly assigned to cisplatin-based HIPEC or observation (NCT01539785), followed by 6 cycles of carboplatin–paclitaxel. The European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQOV28 were administered before surgery, 7 days, and 3 and 6 months after SCS ± HIPEC. ANOVA for repeated measures and betweensubject test were used to analyze QoL scales/items modifications over time and their association with independent variables. Tenpoint differences were considered clinically relevant.
125
Results: Eighteen (52.9%) women received SCS + HIPEC and 16 (47.1%) received SCS alone. No differences were observed in clinical, surgical, and histological variables or QoL baseline values between the two groups. After surgery, among the evaluable functioning scales, global health worsened in both groups, reaching a clinically relevant difference in favor of HIPEC patients. Focusing on symptom scales, fatigue, financial difficulties, and attitude to disease/treatment showed an overall worsening, with a significant difference in favor of SCS alone regarding fatigue and in favor of SCS + HIPEC regarding attitude to disease/treatment and financial difficulties. At 3-month evaluation, a statistically significant difference was observed for fatigue, appetite loss, body image, attitude to disease/treatment, and chemotherapy side effects in favor of the HIPEC group. None of these differences were maintained at 6-month evaluation. Overall, physical, role, emotional, social, and global health functioning scales as well as pain and abdominal/gastrointestinal symptoms significantly improved from baseline to 6-month evaluation. In multivariate analysis, only lower educational level and unemployment status were associated with poorer recovery of QoL levels over time. Conclusions: SCS ensures an overall improvement of several functioning and symptom scales. HIPEC administration does not worsen QoL compared to SCS alone while providing a benefit in term of women's perception of their own cancer care. doi:10.1016/j.ygyno.2015.01.312
310 - Poster Session Program evaluation of a female sexual medicine and women's health program J. Carter, B. Seidel, C. Stabile, R.E. Baser, A. Eaton, S. Benfante, A.R. Gunn, S. Goldfarb, D.J. Goldfrank. Memorial Sloan Kettering Cancer Center, New York, NY, USA Objectives: To evaluate the effectiveness of simple sexual/vaginal health treatment strategies in women seeking treatment at a female sexual medicine program and to evaluate compliance and clinical outcomes. Methods: Demographics, medical information, and clinical assessment findings from 161 new visits with at least one follow-up were analyzed. The assessment form consisted of a clinician evaluation form with the Vaginal Assessment Scale; patient-reported outcomes of the Sexual Activity Questionnaire, Sexual Self-Schema Scale, and Female Sexual Function Index; and exploratory items. Results at last visit were compared for compliance with treatment recommendations for the outcomes vaginal pH; moisture; pain with examination; vaginal assessment of dryness, soreness, and irritation; and future confidence. Results: The mean number of follow-up visits was 3.2 (range, 2–10). The majority of women had a history of breast (88 [55%]), gynecologic (50 [31%]), or anal/colorectal (14 [9%]) cancer. Mean age was 54.6 years (range, 23–79 years) and 73% (117) were married or in an intimate relationship. Treatment recommendations included use of vaginal moisturizers, lubricants with sexual activity, pelvic floor exercises, and dilator therapy. At last visit, 94% (120/128) of women complied with the clinical recommendation to moisturize at least 2 to 5+ times per week. Vaginal pH scores N6.5 declined from 29% (42/146) at visit 1 to 22% (34/154) at last visit. Twenty percent of women who moisturized 4+ times a week had pH N 6.5 at last visit compared to 33% of women who moisturized 2 to 3 times per week. Approximately two thirds of women (92/142) performed pelvic floor exercises a few times per week to daily at last visit. At visit 1, 42% (64/152) of the women reported current sexual activity with a partner, and sexual activity rates increased over time: 51% at visit 2 (77/150) and 58% (48/83) at visit 3. Confidence about future