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Feasibility of Trials in Ovarian Cancer by Line of Therapy and Platinum Sensitivity

Shaboodien, Roekshana MBChB; Diamantis, Nikolaos MBChB; Blagden, Sarah MBChB, FRCP, PhD; Gabra, Hani MBChB, FRCP, PhD; Agarwal, Roshan MBChB, FRCP, PhD

International Journal of Gynecological Cancer: March 2013 - Volume 23 - Issue 3 - p 481–487
doi: 10.1097/IGC.0b013e31828702f6
Ovarian Cancer

Background: To rapidly evaluate the significant numbers of novel therapies entering clinical development requires maximization of clinical trial capacity. To enable this, we evaluated the profile of patients with epithelial ovarian cancer (EOC) in clinical practice, compared with those targeted in clinical trials.

Methods: Patients with EOC treated between March–September 2009 (cohort A, n = 115 patients) and January–July 2012 (cohort B, n = 109 patients), in the North West London Cancer Network with a catchment of 1.2 million, were identified. Patient characteristics were compared with phase II/III EOC studies identified using clinicaltrials.gov (85 trials; 54,603 patients).

Results: In cohort A, comparing the proportion of patients in clinical practice with those in trials, 40% versus 55% (P = 0.0006) were chemotherapy-naive, 20% versus 9% (P < 0.0001) had platinum-resistant disease (platinum-free interval, <6 months), 16.2% versus 39% (P < 0.0001) were receiving second line, and 43.8% versus 5% (P < 0.0001) third-line chemotherapy or greater, respectively. Ninety-eight percent of treated patients had a performance status of 2 or less. These results were validated in cohort B, UK National Cancer Research Network and US Gynecologic Oncology Group trial databases.

Conclusions: These results provide the data to enable EOC trial portfolios to be balanced to clinical practice and suggest an increase in emphasis on trials for patients with platinum-resistant disease and third-line chemotherapy or greater, to address an area of clinical need and maximize recruitment.

Ovarian Cancer Action Research Centre, Division of Oncology, Hammersmith Hospital Campus, Imperial College London, London, United Kingdom.

Address correspondence and reprint requests to Roshan Agarwal, PhD, MBChB, FRCP, Division of Oncology, Hammersmith Hospital Campus, Imperial College London, Du Cane Rd, London, W12 0NN, United Kingdom. E-mail: roshan.agarwal@imperial.ac.uk.

Author Contributions: R.A., study design; R.S. and N.D., data collection; R.A., R.S., and N.D., data analysis; R.A., S.B., and H.G. were involved in the clinical care of the patients.

All authors contributed to the writing of the article.

R.A. is funded by a Cancer Research UK Clinician Scientist Fellowship. Funding was provided by the Imperial Experimental Cancer Medicine Centre and Biomedical Research Centre grants.

The authors declare no conflicts of interest.

Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s Web site (www.ijgc.net).

Received October 23, 2012

Accepted December 30, 2012

Copyright © 2013 by IGCS and ESGO