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.
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 patientsdied on trial due to progression of disease whereas no patientsdied 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.
Authors: David S Hong; Jesal C Patel; Jennifer Wheler; Aung Naing; Ignacio Garrido-Laguna; Gerald Falchook; Siqing Fu; Apostolia M Tsimberidou; Scott Kopetz; Sijin Win; Razelle Kurzrock Journal: Clin Colorectal Cancer Date: 2012-04-25 Impact factor: 4.481
Authors: T Bachelot; I Ray-Coquard; G Catimel; C Ardiet; J P Guastalla; A Dumortier; F Chauvin; J P Droz; T Philip; M Clavel Journal: Ann Oncol Date: 2000-02 Impact factor: 32.976
Authors: A Italiano; C Massard; R Bahleda; A-L Vataire; E Deutsch; N Magné; J-P Pignon; G Vassal; J-P Armand; J-C Soria Journal: Ann Oncol Date: 2007-11-27 Impact factor: 32.976
Authors: Jennifer Wheler; Apostolia M Tsimberidou; David Hong; Aung Naing; Tiffiny Jackson; Suyu Liu; Lei Feng; Razelle Kurzrock Journal: Cancer Date: 2009-03-01 Impact factor: 6.860
Authors: Yang Zhou; Rowan Chlebowski; Michael J LaMonte; Jennifer W Bea; Lihong Qi; Robert Wallace; Sayeh Lavasani; Brian W Walsh; Garnet Anderson; Mara Vitolins; Gloria Sarto; Melinda L Irwin Journal: Gynecol Oncol Date: 2014-04 Impact factor: 5.304
Authors: Nienke van de Kruis; Phyllis van der Ploeg; Jody H C Wilting; M Caroline Vos; Anna M J Thijs; Joanne de Hullu; Petronella B Ottevanger; Christianne Lok; Jurgen M J Piek Journal: Gynecol Oncol Rep Date: 2022-06-28