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241 Impact of co-medication on survival in patients with ovarian cancer – A analysis of 4 prospective trials of the AGO-OVAR and ENGOT/GCIG collaborators
  1. D Denschlag1,
  2. F Heitz2,
  3. J Pfisterer3,
  4. D Tutschkow4,
  5. W Meier5,
  6. P Harter2,
  7. P Wimberger6,
  8. MR Mirza7,
  9. I Ray-Coquard8,
  10. G Scambia9,
  11. JW Kim10,
  12. N Colombo11,
  13. A Oaknin12,
  14. J Sehouli13,
  15. K Lindemann14,
  16. A Floquet15,
  17. M Eichbaum16,
  18. S Spiegelberg1,
  19. H Woopen13 and
  20. A Du Bois2
  1. 1Hochtaunus-Klinken Bad Homburg, Gynecology, Bad Homburg, Germany
  2. 2Klinikum Essen Mitte , Gynecologic Oncology
  3. 3Gynecologic Oncology Center Kiel
  4. 4University of Marburg, Center for Clinical Trials, Germany
  5. 5University of Düsseldorf, Germany
  6. 6University of Dresden, Gynecology, Germany
  7. 7Copenhagen University Hospital, Department of Oncology, Copenhagen, Denmark
  8. 8Centre Leon Berard, Universite Claude Bernard Lyon Est, France
  9. 9Universita Cattolica del Sacro Cuore , Policlinico Gemelli, Rome, Italy
  10. 10Seoul National University, Obstetrics and Geynecology, Seoul, Korea, Dem. People’s Rep. Of
  11. 11European Institute of Oncology, Gynecologic Oncology, Milano, Italy
  12. 12Vall d’Hebron University Hospital, Barcelona, Spain
  13. 13Charite University Hospital Campus Virchow, Gynecologic Oncology, Germany
  14. 14Oslo University Hospital Division of Cancer Medicine, Gynecologic Oncology, Oslo, Norway
  15. 15Institut Bergonie, Bordeaux Cedex, France
  16. 16Helios Dr. Horst Schmidt Kliniken, Gynecology, Wiesbaden, Germany


Introduction/Background*There is poor evidence from mostly retrospective series whether co-medication with metformin, statin or beta-blocker have an impact on survival in patients with primary ovarian cancer. The aim of this study was to investigate the association of these medications with survival.

Methodology Individual data from 3 prospective phase III randomized controlled trials (AGO-OVAR 11/ICON 7, 12, 16) and one phase II trial (AGO-OVAR 15) were pooled and analyzed. Patients were either classified as “ever-user” if the specific co-medication was documented at least once during the trial. In. contrast, “never-users” served as controls.

Data were adjusted for potential confounders (age, FIGO stage, histology, residual tumor after surgery, ECOG performance status, BMI, Charlson Comorbidity Index and assigned treatment within the trial) in multivariate Cox regression analyses.

Result(s)*Overall, 2.857 patients were included in the analyses. “Ever-users” were: N=100 patients received metformin (3.5%), N=226 received statins (7.9%), and N=475 (16.6%) received beta-blockers (BB) (N=391 selective (sBB); N=84 non-selective (nsBB)) as co-medication.

There were no significant differences regarding the baseline characteristics (histology, FIGO stage, residual tumor after surgery, and chemotherapy-schedule) between “ever- and never-users” except that “ever-users” were significantly older and more obese, compared to controls.

Median progression-free (PFS) and overall survival (OS) for the entire cohort was 18.7 months and 60.1 months, respectively

Multivariate analyses for PFS and OS including age, BMI, Histology, FIGO stage, residual tumor after surgery, ECOG performance status and CCI revealed neither a significant impact of metformin on survival of “ever-users”, compared to “never-users” (PFS HR 0.94 95%-CI 0.69-1.29, p=0.7; OS HR 0.82 95%-CI 0.58-1.17, p=0.28), nor for statins (PFS HR 0.98 95%-CI 0.82-1.18, p=0.87; OS HR 0.91 95%-CI 0.74-1.12, p=0.37), respectively. In contrast, “ever-users” of sBB had a significantly elevated risk for recurrence and death in multivariate analysis (PFS HR 1.22 95%-CI 1.05-1.41, p=0.009; OS HR 1.25 95%-CI 1.06-1.47, p=0.009).

Conclusion*In this large pooled analysis neither a co-medication with metformin nor with statins had a significant impact on survival in patients with primary ovarian cancer. In contrast, co-medication with a beta-blocker was associated with worse survival. Further studies are warranted to confirm this observation.

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