Duration of second or greater complete clinical remission in ovarian cancer: Exploring potential endpoints for clinical trials Journal Article

   

Authors:	Harrison, M. L.; Gore, M. E.; Spriggs, D.; Kaye, S.; Iasonos, A.; Hensley, M.; Aghajanian, C.; Venkatraman, E.; Sabbatini, P.
Article Title:	Duration of second or greater complete clinical remission in ovarian cancer: Exploring potential endpoints for clinical trials
Abstract:	Objective.: To explore benchmarks for future consolidation strategies, we evaluated a strictly defined (normal CA-125 and normal CT) second-complete-remission (CR) ovarian cancer population for 1) the median progression-free survival (PFS), 2) the frequency with which second remission exceeds first, and 3) the proportion of patients in remission at given time points. Methods.: Retrospective sampling was carried out at Memorial Sloan-Kettering (10/1993-12/2000) and the Royal Marsden Hospital (1/1995-4/2003) for the following: histological confirmation and elevated CA-125 at diagnosis; primary surgery; first-and second-line platinum-based chemotherapy with CR; and no maintenance therapy. Results.: In 35 patients 1) the duration of first PFS was 17.8 months (95% CI, 13.2-24.5 months) and second PFS was 10.8 months (95% CI, 9.6-12.2 months); 2) the number of patients with second response longer than first was 3/35 (9%); 3) the proportion of patients remaining in second complete remission was 100% (3 months), 100% (6 months), 83% (9 months), 34% (12 months), 23% (15 months) and 8.6% (18 months), respectively. Conclusion.: 1) The median PFS from second complete remission is short. 2) A second response is rarely longer than the first even in this second CR population. 3) The number of patients with a second response longer than the first, or the proportion of patients remaining in complete remission at given time points could be evaluated as an outcome measure in future studies. © 2007 Elsevier Inc. All rights reserved.
Keywords:	adult; cancer survival; clinical article; aged; disease-free survival; middle aged; retrospective studies; cancer combination chemotherapy; cancer growth; paclitaxel; cancer patient; neoadjuvant therapy; ovarian cancer; ovarian neoplasms; carboplatin; ovary cancer; neoplasm recurrence, local; antineoplastic combined chemotherapy protocols; maintenance therapy; retrospective study; cancer regression; remission induction; platinum; disease duration; taxane derivative; ca-125 antigen; endpoint determination; clinical trials; consolidation trials; remission duration
Journal Title:	Gynecologic Oncology
Volume:	106
Issue:	3
ISSN:	0090-8258
Publisher:	Elsevier Inc.
Date Published:	2007-09-01
Start Page:	469
End Page:	475
Language:	English
DOI:	10.1016/j.ygyno.2007.05.008
PUBMED:	17614127
PROVIDER:	scopus
PMCID:	PMC2694792
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-34548120869&partnerID=40&md5=ac170bc17d67d61fba66323d096aac0a
Notes:	--- - "Cited By (since 1996): 13" - "Export Date: 17 November 2011" - "CODEN: GYNOA" - "Source: Scopus"

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