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. 2020 Oct 1;126(19):4289-4293.
doi: 10.1002/cncr.33073. Epub 2020 Jul 22.

Survival and clinical outcomes of patients with ovarian cancer who were treated on phase 1 clinical trials

Bradley R Corr  1 , Marisa Moroney  1 , Jeanelle Sheeder  1 , S Gail Eckhardt  2 , Brandon Sawyer  1 , Kian Behbakht  1 , Jennifer R Diamond  2
Affiliations

Survival and clinical outcomes of patients with ovarian cancer who were treated on phase 1 clinical trials

Bradley R Corr et al. Cancer. .

Abstract

Background: Patients with ovarian cancer who are enrolled on phase 1 trials typically have platinum-resistant and heavily pretreated disease, with a poor prognosis. In the current study, the authors assessed prognostic factors and survival in women with recurrent ovarian cancer who were treated on phase 1 clinical trials.

Methods: The authors performed a retrospective analysis of patients treated from 2008 through 2018 at the University of Colorado Cancer Center. Patient characteristics and treatment and toxicity-related survival data were assessed. Descriptive statistics and Cox proportional hazards models were used to identify risk factors associated with survival time.

Results: A total of 132 patients were treated on phase 1 clinical trials. Patients had a median age of 59 years (range, 33-88 years) with a median of 5.5 previous chemotherapy lines (range, 1-13 lines). Of the 132 patients, 53 (40%) were treated on multiple phase 1 trials with a median of 1 (range, 0-5) prior phase 1 trial. The overall response rate was 14.7%. The median overall survival was 11.3 months (95% CI, 9.1-13.4 months). Two patients died on trial due to progression of disease whereas no patients died of treatment-related toxicity. Independent risk factors found to be predictive of shorter survival were an elevated cancer antigen 125 (CA 125) level (hazard ratio [HR], 2.8; 95% CI, 1.6-5.2) and albumin <3.5 g/dL (HR, 2.5; 95% CI, 1.65-3.79). A body mass index >25 kg/m2 was predictive of longer survival (HR, 0.65; 95% CI, 0.44-0.96).

Conclusions: In the current single-institution series, patients with heavily pretreated ovarian cancer who were treated on phase 1 clinical trials experienced a median overall survival of 11.3 months. When available, phase 1 clinical trials represent a reasonable treatment option for patients with heavily pretreated ovarian cancer with a preserved performance status.

Keywords: clinical trial; ovarian cancer; phase 1; phase I; recurrent ovarian cancer.

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Figures

Figure 1:
Figure 1:
Kaplan-Meier curves for progression free survival (PFS) and overall survival (OS).
See this image and copyright information in PMC

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