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The Chinese Cervical Cancer Prevention Study (CHICAPS) - The development of a new model for population based cervical cancer screening
Abstracts / Gynecologic Oncology 130 (2013) e1–e169
assessment of ECA is accurate determination of depth of invasion (DOI), a parameter widely used for staging. More than 97% of patients undergoing lymph node dissection (LND) have negative lymph nodes (LNs). This study evaluated other pathologic parameters or patterns that predict risk of LN metastasis and overall patient survival and, therefore, can guide therapy. Methods: Collated data on EAC cases from 14 international institutions were reviewed, including patient age, tumor size, grade of differentiation, DOI, presence of lymphovascular invasion (LVI) or of LN metastases, recurrences, stage, and follow-up. The cases were also classified using the new proposed system, which is based on the pattern of tumor invasion: Pattern A: well- demarcated glands (regardless of DOI),; Pattern B: early stromal invasion arising from well-demarcated glands; and Pattern C: diffuse, destructive invasion. Results: A total of 410 cases with LND were identified (stage IA1 to IVB). Patient ages ranged from 20 to 83 years, tumor size was 0.5 to 65 mm, and DOI ranged from 0.5 to 40 mm but did not exceed 20 mm in pattern B cases. LVI was present in 41.5% of cases: pattern A = 0%, pattern B = 34%, and pattern C = 63.3%. Despite the nearly identical DOI in patients with patterns A and B (4.7 and 4.6 mm, respectively), 6.6% of pattern B patients were LN-positive and 2 had tumor recurrence, whereas no pattern A patients had positive LN or recurrence. Among pattern C patients, 27% had positive LNs and 21% had recurrence (Table). Conclusions: Analysis of additional cases following our initial study further validates our observation of the clinical utility of the patternbased classification. All pattern A cases had stage I disease and did not need LND. Few patients with pattern B had LN metastases or recurrences. Pattern C patients had the highest rate of LN metastasis and tumor recurrence and could benefit from LND. Our proposed pattern-based method is reproducible and correlates well with status of LVI and LN metastases and with patient outcome. The clinical utility of sentinel LN assessment should be evaluated as a potentially safe alternative for pattern B and possibly for pattern C patients without clinical or imaging suspicion of LN involvement.
Table. Patient Characteristics Based on Pattern of Tumor Invasion.
doi:10.1016/j.ygyno.2013.04.150
92 Accuracy of detection of high-grade cervical intra-epithelial neoplasia using electrical impedance spectroscopy with colposcopy J. Tidy1, J. Healey1, B. Brown2. 1Royal Hallamshire Hospital, Sheffield, United Kingdom, 2University of Sheffield, Sheffield, United Kingdom. Objective: To determine if electrical impedance spectroscopy [EIS] improves the diagnostic accuracy of colposcopy when used as an adjunct. Methods: Prospective, comparative, multicenter clinical study of women referred with abnormal cytology to 2 colposcopy clinics in England and 1 in Ireland. In phase I, EIS was assessed against colposcopic impression and histopathology of the biopsies taken. A probability index and cutoff value for the detection of high-grade
e39
cervical intraepithelial neoplasia (HG-CIN) (CIN2+) was derived to indicate sites for biopsy in phase II. EIS data collection and analyses were performed in real time and blinded to the clinician. The phase II data were analyzed using different cutoff values to assess performance of EIS as an adjunct. Results: 474 women were recruited, 214 were eligible for analysis in phase I, and 215 were eligible in phase II. Average age was 33.2 years (median age, 30.3 years; range, 20–64 years). 48.5% (208/429) had high-grade cytology. Using the cutoff from phase I, the accuracy of colposcopic impression to detect HG-CIN when using EIS as an adjunct at the time of examination improved positive predictive value (PPV) from 78.1% (95% CI 67.5-86.4%) to 91.5%. Specificity was also increased from 83.5% (95% CI 75.2-89.9%) to 95.4%, but sensitivity was significantly reduced from 73.6% (95% CI 63.082.5%) to 62.1%, and negative predictive value (NPV) was unchanged. The positive likelihood ratio for colposcopic impression alone was 4.46. This increased to 13.5 when EIS was used as an adjunct. The overall accuracy of colposcopy when used with EIS as an adjunct was assessed by varying the cutoff applied to a combined test index. Using a cutoff set to give the same sensitivity as colposcopy in phase II, EIS increased the PPV to detect HG-CIN from 53.5% (95% CI 45.0-61.8%) to 67%, and specificity increased from 38.5% (95% CI 29.4-48.3%) to 65.1%. NPV was not significantly increased. Alternatively, applying a cutoff to give the same specificity as colposcopy alone, EIS increased sensitivity from 88.5% (95% CI 79.9-94.4%) to 96.6% and NPV from 80.8% (95%CI 67.5-90.4%) to 93.3%. PPV was not significantly increased. Receiver operator characteristic to detect HG- CIN had an AUC of 0.887 (95% CI 0.840-0.934). Conclusions: EIS used as an adjunct to colposcopy improves colposcopic performance. The addition of EIS could lead to more appropriate patient management with lower intervention rates. doi:10.1016/j.ygyno.2013.04.151
93 The Chinese Cervical Cancer Prevention Study (CHICAPS) - The development of a new model for population based cervical cancer screening J. Belinson1, R. Wu2, G. Wang2, H. Du2, J. Zou3, J. Shen2, S. Belinson4, X. Qu5. 1Preventive Oncology International/The Cleveland Clinic Foundation, Cleveland Heights, OH, 2Peking University Shenzhen Hospital, Shenzhen, Guangdong, China, 3BGI Shenzhen, Shenzhen, Guangdong, China, 4Preven5 tive Oncology International, Cleveland Heights, OH, Preventive Oncology International, Shenzhen, Guangdong, China. Objective: To develop and implement a community-based preventive health care model using cervical cancer screening as the target medical intervention. Methods: In multiple communities in rural Guangdong Province, China, using the concepts founded in community-based participatory research (CBPR), 10,000 women between the ages of 30 and 59 will be screened. The goal is the development of a model that allows the communities to totally manage the screening and results reporting process and the available health care resources to focus on management of patients. A CBPR-based system should allow massive acquisition of samples to take full advantage of the technologies of self-collection, solid transport media, and centralized high throughput to allow highly sensitive, low cost per case processing with good quality control. Positive patients will be randomized between immediate cryotherapy after VIA triage vs. “standard of care” of colposcopy/biopsy/ loop electrosurgical excision procedure. Secondary screens of cytology and genotyping will also be reported. Results: Five thousand, seven hundred and sixty-two women have been screened in the developmental phases of the project. We now
e40
Abstracts / Gynecologic Oncology 130 (2013) e1–e169
believe that our model, which can be communicated through a 1hour workshop conducted with “poster showing” and “role playing,” is ready and will be tested in the completion of the study. Fifty-three percent of the census-based eligible population has participated in the villages already screened. Accurate evaluation of those truly available (within the census) is the target for the final test. We anticipate the remaining 4,338 women will be screened by their villages over a period of 7-10 days. Eighty-four percent of those who had positive results returned for evaluation and treatment. Satisfaction in the process is N95%. Interim results of the 6 month follow-up will be reported. Conclusions: We have a community-based model involving a selfcollection, a solid media transport system (for cervical cancer screening), and “public health affordable” assays, and most patients can be treated in their community. We understand the contribution of genotyping and cytology as secondary screens, and we have developed a manual to guide communities in developing their own framework for cervical cancer screening. We believe we have demonstrated that the community can successfully conduct the screenings themselves after attending the 1-hour workshop. doi:10.1016/j.ygyno.2013.04.152
94 First experience of enhanced recovery in a tertiary gynecologic oncology centre in the UK M. Doohan, J. Bailey. University Hospital Bristol, Bristol, United Kingdom. Objective: Enhanced recovery is a novel approach to elective surgery that ensures that patients are in the optimal condition for the surgical treatment, thus minimizing complications, offering more effective rehabilitation and a shorter length of stay. The main aim of this project was to prospectively assess the effectiveness of this approach in patients undergoing major surgery for gynecologic cancers. Methods: Patients were recruited between March and August 2012, from the outpatient clinic following an initial consultation with an option to refuse participation. Data were collected prospectively from the selected patients at the outset, soon after the surgery, and 28 days later using specially designed questionnaires. In addition, patients were asked to complete a daily diary documenting their care, pain control, number of walks, nutrition, and their overall experience, which they handed in at the time of discharge. Data were compared to previous studies on length of stay from within the department. Results: From March to August 2012, 75 patients were recruited, but data were available for 50 patients who underwent surgery. The mean age of the sample was 62 years (range, 32-82 years). 92% of the cases were operated for cancer or suspected cancer. 86% of the patients were graded as ASA grade 2 or 3. Of the sample, 48% had laparoscopic surgery, 44% had laparotomy, and 6% had vaginal hysterectomy. The average length of stay following laparotomy was 5 days (range, 2 - 15 days) and following laparoscopic procedure was 2 days (range, 1-6 days), making overall average length of stay of 3.5 days. In comparison, the length of stay in cases of endometrial cancer from the same hospital in 2007 following laparotomy was 4.7 days and following laparoscopic procedures was 4.6 days. The overall complication rate was 16%, reoperation rate was 6%, and readmission rate within 4 weeks was 4%. Of all the patients responding to the patient experience questionnaire, 100% were satisfied with care provided. Conclusions: This initial analysis of the data following the introduction of the enhanced recovery approach has confirmed a significant reduction in the length of stay after laparoscopic surgery (2 days vs. 4.6 days) while enhancing patient empowerment, involvement, and satisfaction and without any increase in the complication or
readmission rates. If further analysis supports these findings, this approach should be implemented for all cancer patients.
doi:10.1016/j.ygyno.2013.04.153
95 The impact of cancer policy: Specialist surgery for ovarian cancer in England 2000 to 2009 J. Butler1, C. Gildea2, A. Nordin3. 1Royal Marsden Hospital, London, United Kingdom, 2Trent Cancer Registry, Sheffield, United Kingdom, 3 East Kent Hospitals, Kent, United Kingdom. Objective: To investigate the proportion of women with ovarian cancer in England undergoing surgery in gynecologic cancer centers (GCCs) or by specialist gynecological oncologists (GOs) since the publication of the Improving Outcomes Guidance in Gynaecological Cancers (1999) and the National Health Service Cancer Plan (2000). Methods: We conducted a retrospective analysis of English cancer registry records, Hospital Episode Statistics (HES), and General Medical Council (GMC) subspecialty accreditation. All English NHS providers from 2000 to 2009 were reviewed, and study participants were patients with ovarian cancer (ICD10 C56, C57) undergoing major gynecologic surgery within 13 months of their diagnosis (-1 to +12). The primary outcome measures were annual proportion of patients undergoing surgery at GCCs and operated on by GMCaccredited GOs or high caseload surgeons in England and by each Strategic Health Authority (SHA) area. Results: From 2000 to 2009, 2,428 consultants were responsible for surgery on 30,753 ovarian cancer patients. There was a significant increase in the proportion of ovarian cancer patients undergoing surgery at GCCs (43% to 76%, P b 0.001), by GMC-accredited gynecological oncology surgeons (5% to 36%, P b 0.001), and by high ovarian cancer caseload (≥18 cases) surgeons (22% to 56%, P b 0.001) (Figure). Conclusions: Centralization and specialization of surgery for ovarian cancer patients has increased in England since the NHS cancer plan. In 2009, there remained room for improvement, with many patients still receiving nonspecialist surgery and large variations apparent by SHA. Although, more than half of the ovarian cancer patients were operated on by high-volume surgeons and in specialist cancer centers by 2009, the majority of patients were not operated on by GMC-accredited gynecologic oncologists. Systems of accreditation should be reviewed and trusts should ensure that HES data accurately record clinical activity and procedures.
doi:10.1016/j.ygyno.2013.04.154
96 The wait time creep: Changes in the surgical wait time for women with uterine cancer in Ontario, Canada during 2000-2009 L. Elit1, H. Seow2, E. O’Leary2, G. Pond2. 1Juravinski Cancer Centre, Hamilton, Ontario, Canada, 2McMaster University, Hamilton, Ontario, Canada.
assessment of ECA is accurate determination of depth of invasion (DOI), a parameter widely used for staging. More than 97% of patients undergoing lymph node dissection (LND) have negative lymph nodes (LNs). This study evaluated other pathologic parameters or patterns that predict risk of LN metastasis and overall patient survival and, therefore, can guide therapy. Methods: Collated data on EAC cases from 14 international institutions were reviewed, including patient age, tumor size, grade of differentiation, DOI, presence of lymphovascular invasion (LVI) or of LN metastases, recurrences, stage, and follow-up. The cases were also classified using the new proposed system, which is based on the pattern of tumor invasion: Pattern A: well- demarcated glands (regardless of DOI),; Pattern B: early stromal invasion arising from well-demarcated glands; and Pattern C: diffuse, destructive invasion. Results: A total of 410 cases with LND were identified (stage IA1 to IVB). Patient ages ranged from 20 to 83 years, tumor size was 0.5 to 65 mm, and DOI ranged from 0.5 to 40 mm but did not exceed 20 mm in pattern B cases. LVI was present in 41.5% of cases: pattern A = 0%, pattern B = 34%, and pattern C = 63.3%. Despite the nearly identical DOI in patients with patterns A and B (4.7 and 4.6 mm, respectively), 6.6% of pattern B patients were LN-positive and 2 had tumor recurrence, whereas no pattern A patients had positive LN or recurrence. Among pattern C patients, 27% had positive LNs and 21% had recurrence (Table). Conclusions: Analysis of additional cases following our initial study further validates our observation of the clinical utility of the patternbased classification. All pattern A cases had stage I disease and did not need LND. Few patients with pattern B had LN metastases or recurrences. Pattern C patients had the highest rate of LN metastasis and tumor recurrence and could benefit from LND. Our proposed pattern-based method is reproducible and correlates well with status of LVI and LN metastases and with patient outcome. The clinical utility of sentinel LN assessment should be evaluated as a potentially safe alternative for pattern B and possibly for pattern C patients without clinical or imaging suspicion of LN involvement.
Table. Patient Characteristics Based on Pattern of Tumor Invasion.
doi:10.1016/j.ygyno.2013.04.150
92 Accuracy of detection of high-grade cervical intra-epithelial neoplasia using electrical impedance spectroscopy with colposcopy J. Tidy1, J. Healey1, B. Brown2. 1Royal Hallamshire Hospital, Sheffield, United Kingdom, 2University of Sheffield, Sheffield, United Kingdom. Objective: To determine if electrical impedance spectroscopy [EIS] improves the diagnostic accuracy of colposcopy when used as an adjunct. Methods: Prospective, comparative, multicenter clinical study of women referred with abnormal cytology to 2 colposcopy clinics in England and 1 in Ireland. In phase I, EIS was assessed against colposcopic impression and histopathology of the biopsies taken. A probability index and cutoff value for the detection of high-grade
e39
cervical intraepithelial neoplasia (HG-CIN) (CIN2+) was derived to indicate sites for biopsy in phase II. EIS data collection and analyses were performed in real time and blinded to the clinician. The phase II data were analyzed using different cutoff values to assess performance of EIS as an adjunct. Results: 474 women were recruited, 214 were eligible for analysis in phase I, and 215 were eligible in phase II. Average age was 33.2 years (median age, 30.3 years; range, 20–64 years). 48.5% (208/429) had high-grade cytology. Using the cutoff from phase I, the accuracy of colposcopic impression to detect HG-CIN when using EIS as an adjunct at the time of examination improved positive predictive value (PPV) from 78.1% (95% CI 67.5-86.4%) to 91.5%. Specificity was also increased from 83.5% (95% CI 75.2-89.9%) to 95.4%, but sensitivity was significantly reduced from 73.6% (95% CI 63.082.5%) to 62.1%, and negative predictive value (NPV) was unchanged. The positive likelihood ratio for colposcopic impression alone was 4.46. This increased to 13.5 when EIS was used as an adjunct. The overall accuracy of colposcopy when used with EIS as an adjunct was assessed by varying the cutoff applied to a combined test index. Using a cutoff set to give the same sensitivity as colposcopy in phase II, EIS increased the PPV to detect HG-CIN from 53.5% (95% CI 45.0-61.8%) to 67%, and specificity increased from 38.5% (95% CI 29.4-48.3%) to 65.1%. NPV was not significantly increased. Alternatively, applying a cutoff to give the same specificity as colposcopy alone, EIS increased sensitivity from 88.5% (95% CI 79.9-94.4%) to 96.6% and NPV from 80.8% (95%CI 67.5-90.4%) to 93.3%. PPV was not significantly increased. Receiver operator characteristic to detect HG- CIN had an AUC of 0.887 (95% CI 0.840-0.934). Conclusions: EIS used as an adjunct to colposcopy improves colposcopic performance. The addition of EIS could lead to more appropriate patient management with lower intervention rates. doi:10.1016/j.ygyno.2013.04.151
93 The Chinese Cervical Cancer Prevention Study (CHICAPS) - The development of a new model for population based cervical cancer screening J. Belinson1, R. Wu2, G. Wang2, H. Du2, J. Zou3, J. Shen2, S. Belinson4, X. Qu5. 1Preventive Oncology International/The Cleveland Clinic Foundation, Cleveland Heights, OH, 2Peking University Shenzhen Hospital, Shenzhen, Guangdong, China, 3BGI Shenzhen, Shenzhen, Guangdong, China, 4Preven5 tive Oncology International, Cleveland Heights, OH, Preventive Oncology International, Shenzhen, Guangdong, China. Objective: To develop and implement a community-based preventive health care model using cervical cancer screening as the target medical intervention. Methods: In multiple communities in rural Guangdong Province, China, using the concepts founded in community-based participatory research (CBPR), 10,000 women between the ages of 30 and 59 will be screened. The goal is the development of a model that allows the communities to totally manage the screening and results reporting process and the available health care resources to focus on management of patients. A CBPR-based system should allow massive acquisition of samples to take full advantage of the technologies of self-collection, solid transport media, and centralized high throughput to allow highly sensitive, low cost per case processing with good quality control. Positive patients will be randomized between immediate cryotherapy after VIA triage vs. “standard of care” of colposcopy/biopsy/ loop electrosurgical excision procedure. Secondary screens of cytology and genotyping will also be reported. Results: Five thousand, seven hundred and sixty-two women have been screened in the developmental phases of the project. We now
e40
Abstracts / Gynecologic Oncology 130 (2013) e1–e169
believe that our model, which can be communicated through a 1hour workshop conducted with “poster showing” and “role playing,” is ready and will be tested in the completion of the study. Fifty-three percent of the census-based eligible population has participated in the villages already screened. Accurate evaluation of those truly available (within the census) is the target for the final test. We anticipate the remaining 4,338 women will be screened by their villages over a period of 7-10 days. Eighty-four percent of those who had positive results returned for evaluation and treatment. Satisfaction in the process is N95%. Interim results of the 6 month follow-up will be reported. Conclusions: We have a community-based model involving a selfcollection, a solid media transport system (for cervical cancer screening), and “public health affordable” assays, and most patients can be treated in their community. We understand the contribution of genotyping and cytology as secondary screens, and we have developed a manual to guide communities in developing their own framework for cervical cancer screening. We believe we have demonstrated that the community can successfully conduct the screenings themselves after attending the 1-hour workshop. doi:10.1016/j.ygyno.2013.04.152
94 First experience of enhanced recovery in a tertiary gynecologic oncology centre in the UK M. Doohan, J. Bailey. University Hospital Bristol, Bristol, United Kingdom. Objective: Enhanced recovery is a novel approach to elective surgery that ensures that patients are in the optimal condition for the surgical treatment, thus minimizing complications, offering more effective rehabilitation and a shorter length of stay. The main aim of this project was to prospectively assess the effectiveness of this approach in patients undergoing major surgery for gynecologic cancers. Methods: Patients were recruited between March and August 2012, from the outpatient clinic following an initial consultation with an option to refuse participation. Data were collected prospectively from the selected patients at the outset, soon after the surgery, and 28 days later using specially designed questionnaires. In addition, patients were asked to complete a daily diary documenting their care, pain control, number of walks, nutrition, and their overall experience, which they handed in at the time of discharge. Data were compared to previous studies on length of stay from within the department. Results: From March to August 2012, 75 patients were recruited, but data were available for 50 patients who underwent surgery. The mean age of the sample was 62 years (range, 32-82 years). 92% of the cases were operated for cancer or suspected cancer. 86% of the patients were graded as ASA grade 2 or 3. Of the sample, 48% had laparoscopic surgery, 44% had laparotomy, and 6% had vaginal hysterectomy. The average length of stay following laparotomy was 5 days (range, 2 - 15 days) and following laparoscopic procedure was 2 days (range, 1-6 days), making overall average length of stay of 3.5 days. In comparison, the length of stay in cases of endometrial cancer from the same hospital in 2007 following laparotomy was 4.7 days and following laparoscopic procedures was 4.6 days. The overall complication rate was 16%, reoperation rate was 6%, and readmission rate within 4 weeks was 4%. Of all the patients responding to the patient experience questionnaire, 100% were satisfied with care provided. Conclusions: This initial analysis of the data following the introduction of the enhanced recovery approach has confirmed a significant reduction in the length of stay after laparoscopic surgery (2 days vs. 4.6 days) while enhancing patient empowerment, involvement, and satisfaction and without any increase in the complication or
readmission rates. If further analysis supports these findings, this approach should be implemented for all cancer patients.
doi:10.1016/j.ygyno.2013.04.153
95 The impact of cancer policy: Specialist surgery for ovarian cancer in England 2000 to 2009 J. Butler1, C. Gildea2, A. Nordin3. 1Royal Marsden Hospital, London, United Kingdom, 2Trent Cancer Registry, Sheffield, United Kingdom, 3 East Kent Hospitals, Kent, United Kingdom. Objective: To investigate the proportion of women with ovarian cancer in England undergoing surgery in gynecologic cancer centers (GCCs) or by specialist gynecological oncologists (GOs) since the publication of the Improving Outcomes Guidance in Gynaecological Cancers (1999) and the National Health Service Cancer Plan (2000). Methods: We conducted a retrospective analysis of English cancer registry records, Hospital Episode Statistics (HES), and General Medical Council (GMC) subspecialty accreditation. All English NHS providers from 2000 to 2009 were reviewed, and study participants were patients with ovarian cancer (ICD10 C56, C57) undergoing major gynecologic surgery within 13 months of their diagnosis (-1 to +12). The primary outcome measures were annual proportion of patients undergoing surgery at GCCs and operated on by GMCaccredited GOs or high caseload surgeons in England and by each Strategic Health Authority (SHA) area. Results: From 2000 to 2009, 2,428 consultants were responsible for surgery on 30,753 ovarian cancer patients. There was a significant increase in the proportion of ovarian cancer patients undergoing surgery at GCCs (43% to 76%, P b 0.001), by GMC-accredited gynecological oncology surgeons (5% to 36%, P b 0.001), and by high ovarian cancer caseload (≥18 cases) surgeons (22% to 56%, P b 0.001) (Figure). Conclusions: Centralization and specialization of surgery for ovarian cancer patients has increased in England since the NHS cancer plan. In 2009, there remained room for improvement, with many patients still receiving nonspecialist surgery and large variations apparent by SHA. Although, more than half of the ovarian cancer patients were operated on by high-volume surgeons and in specialist cancer centers by 2009, the majority of patients were not operated on by GMC-accredited gynecologic oncologists. Systems of accreditation should be reviewed and trusts should ensure that HES data accurately record clinical activity and procedures.
doi:10.1016/j.ygyno.2013.04.154
96 The wait time creep: Changes in the surgical wait time for women with uterine cancer in Ontario, Canada during 2000-2009 L. Elit1, H. Seow2, E. O’Leary2, G. Pond2. 1Juravinski Cancer Centre, Hamilton, Ontario, Canada, 2McMaster University, Hamilton, Ontario, Canada.