Definitions for Response and Progression in Ovarian Cancer Clinical Trials Incorporating RECIST 1.1 and CA 125 Agreed by the Gynecological Cancer Intergroup (GCIG)

International Journal of Gynecological Cancer - Tập 21 Số 2 - Trang 419-423 - 2011
Gordon Rustin1, Ignace Vergote2, Elizabeth A. Eisenhauer3, Éric Pujade-Lauraine4, Michael Quinn5, Tate Thigpen6, Andreas du Bois7, Gunnar B. Kristensen3,2, Anders Jakobsen3,2, Satoru Sagae8, Kathryn M. Greven9, Mahesh Parmar10, Michael Friedlander11, Andrés Cervantes12, Jan B. Vermorken13
1MD, MSc, FRCP, Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, Middlesex HA62RN, UK. E-mail: grustin{at}nhs.net.
2University Hospital Leuven, Leuven, Belgium
3NCIC Clinical Trials Group, Kingston, Ontario, Canada
4Hopital Hotel Dieu, Paris, France
5Royal Women’s Hospital, Melbourne, Australia
6University of Mississippi School of Medicine, Jackson, MS
7Dr. Horst-Schmidt-Klinik, Wiesbaden, Germany
8Sapporo Railway Hospital, Sapporo, Japan
9Wake Forest University Medical Center, Winston Salem, NC
10MRC Clinical Trials Unit, London, UK
11Prince of Wales Cancer Centre, Randwick, NSW, Australia
12Hospital Clínico, University of Valencia, Valencia, Spain
13Antwerp University Hospital, Edegem, Belgium

Tóm tắt

The Gynecological Cancer Intergroup (GCIG) has previously reached consensus regarding the criteria that should be used in clinical trial protocols to define progression-free survival after first-line therapy as well as the criteria to define response to treatment in recurrent disease using the serum marker CA 125 and has specified the situations where these criteria should be used. However, the publications did not include detailed definitions, nor were they written to accommodate the new version of Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) now available. Thus, we recommend that the definitions described later in detail are incorporated into clinical trial protocols to maintain consistency. The criteria for defining progression are now acceptable in clinical trials of recurrent disease as they have since been validated (Pujade-Lauraine, personal communication, 2010). The GCIG requests that data from all clinical trials using these definitions are made available to GCIG trial centers so that continual validation and improvement can be accomplished. These definitions were developed from analyzing patients receiving cytotoxic chemotherapy and have not yet been validated in patients receiving molecular targeting agents.

Từ khóa


Tài liệu tham khảo

Vergote, 2000, J Natl Cancer Inst, 92, 1534, 10.1093/jnci/92.18.1534

Rustin, 2004, J Natl Cancer Inst, 96, 487, 10.1093/jnci/djh081

Eisenhauer, 2009, Eur J Cancer, 45, 228, 10.1016/j.ejca.2008.10.026

Rustin, 2005, J Natl Cancer Inst, 97, 152, 10.1093/jnci/dji028

Rustin, 2010, Lancet, 376, 1155, 10.1016/S0140-6736(10)61268-8

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Thông tin xuất bản

International Journal of Gynecological Cancer

Tập 21 Số 2

419-423

Thông tin tác giả