Dataset Information

Asian Society of Gynecologic Oncology International Workshop 2014.

ABSTRACT: The Asian Society of Gynecologic Oncology International Workshop 2014 on gynecologic oncology was held in Asan Medical Center, Seoul, Korea on the 23rd to 24th August 2014. A total of 179 participants from 17 countries participated in the workshop, and the up-to-date findings on the management of gynecologic cancers were presented and discussed. This meeting focused on the new trends in the management of cervical cancer, fertility-sparing management of gynecologic cancers, surgical management of gynecologic cancers, and recent advances in translational research on gynecologic cancers.

SUBMITTER: Park JY

PROVIDER: S-EPMC4302288 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Asian Society of Gynecologic Oncology International Workshop 2014.

Park Jeong Yeol JY Ngan Hextan Yuen Sheung HY Park Won W Cao Zeyi Z Wu Xiaohua X Ju Woong W Chung Hyun Hoon HH Chang Suk Joon SJ Park Sang Yoon SY Ryu Sang Young SY Kim Jae Hoon JH Cho Chi Heum CH Lee Keun Ho KH Lee Jeong Won JW Kumarasamy Suresh S Kim Jae Weon JW Wilailak Sarikapan S Kim Byoung Gie BG Kim Dae Yeon DY Konishi Ikuo I Lee Jae Kwan JK Wang Kung Liahng KL Nam Joo Hyun JH

Journal of gynecologic oncology 20150101 1

The Asian Society of Gynecologic Oncology International Workshop 2014 on gynecologic oncology was held in Asan Medical Center, Seoul, Korea on the 23rd to 24th August 2014. A total of 179 participants from 17 countries participated in the workshop, and the up-to-date findings on the management of gynecologic cancers were presented and discussed. This meeting focused on the new trends in the management of cervical cancer, fertility-sparing management of gynecologic cancers, surgical management of ...[more]

PMID: 25609163

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Project description:To explore the value of multiple clinical endpoints in the unique setting of ovarian cancer.A clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts.Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvantages of the numerous endpoints available are herein discussed within the unique context of ovarian cancer where both crossover and post-progression therapies potentially uncouple surrogacy between progression-free survival (PFS) and OS, the two most widely supported and utilized endpoints. The roles of patient reported outcomes (PRO) and health related quality of life (HRQoL) are discussed, but even these widely supported parameters are affected by the unique characteristics of ovarian cancer where a significant percentage of patients may be asymptomatic. Original data regarding the endpoint preferences of ovarian cancer advocates is presented.Endpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment cohort while reflecting true patient benefit. Both OS and PFS have led to regulatory approvals and are clinically important. OS remains the most objective and accepted endpoint because it is least vulnerable to bias; however, the feasibility of OS in ovarian cancer is compromised by the requirement for large trial size, prolonged time-line for final analysis, and potential for unintended loss of treatment effect from active post-progression therapies. A large magnitude of effect in PFS improvement should establish benefit, and further communication with regulatory authorities to clarify acceptable endpoints should be undertaken.

Dataset Information

Asian Society of Gynecologic Oncology International Workshop 2014.

Publications

Asian Society of Gynecologic Oncology International Workshop 2014.

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