6533b862fe1ef96bd12c6c1f

RESEARCH PRODUCT

Definitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and CA 125 agreed by the Gynecological Cancer Intergroup (GCIG)

Gordon J. S. RustinAndrés CervantesMichael A. QuinnJan B. VermorkenMahesh K. B. ParmarKathryn M. GrevenTate ThigpenMichael FriedlanderEric Pujade-lauraineAnders JakobsenGunnar KristensenAndreas Du BoisSatoru SagaeElizabeth EisenhauerIgnace Vergote

subject

Oncologymedicine.medical_specialtyMEDLINEAntineoplastic AgentsDisease-Free SurvivalInternal medicinemedicineRecurrent diseaseHumansIn patientOvarian NeoplasmsClinical Trials as Topicbusiness.industryObstetrics and Gynecologymedicine.diseaseGynecological cancerResponse to treatmentSurgeryClinical trialOncologyResponse Evaluation Criteria in Solid TumorsCA-125 AntigenDisease ProgressionFemaleHuman medicineNeoplasm Recurrence LocalOvarian cancerbusiness

description

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.

10.1097/igc.0b013e3182070f17https://portal.findresearcher.sdu.dk/da/publications/8740d1b7-0e75-4a3e-9e4f-cc1fc589fe0b