Maintenance Chemotherapy in Ovarian Cancer: A Trial-Sequential Analysis

Andrea Messori, Valeria Fadda, Dario Maratea, Sabrina Trippoli

HTA Unit, ESTAV Toscana Centro, Regional Health Service, Firenze, Italy.

DOI: 10.4236/jct.2013.47145                

Abstract

In patients with epithelian ovarian cancer who have achieved remission after initial surgery and induction chemotherapy, the role of maintenance chemotherapy is controversial. We carried out a trial-sequential analysis that included 4 randomised controlled trials. The end-point was progression at 3 years while the boundary for non-inferiority was set at ±20% in risk ratio. The results of our trial-sequential analysis indicated the futility of maintenance chemotherapy, i.e. proof of no effectiveness. Consequently, no further trials of this type should be performed to assess the effectiveness of this intervention in this clinical condition.

Keywords

Chemotherapy; Ovarian Cancer; Trial-Sequential Analysis; Futility

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	L. Mei, H. Chen, D. M. Wei, F. Fang, G. J. Liu, H. Y. Xie, et al., “Maintenance Chemotherapy for Ovarian Cancer,” Cochrane Database Systematic Reviews, Vol. 6, 2013, Article ID: CD007414. doi:10.1002/ 14651858.CD007414.pub3
[2]	J. Wetterslev, K. Thorlund, J. Brok and C. Gluud, “Trial Sequential Analysis May Establish When Firm Evidence Is Reached in Cumulative Meta-Analysis,” Journal of Clinical Epidemiology, Vol. 61, No. 1, 2008, pp. 64-75. doi:10.1016/j.jclinepi.2007.03.013
[3]	J. Brok, K. Thorlund, C. Gluud and J. Wetterslev, “Trial Sequential Analysis Reveals Insufficient Information Size and Potentially False Positive Results in Many MetaAnalyses,” Journal of Clinical Epidemiology, Vol. 61, No. 8, 2008, pp. 763-769. doi:10.1016/j.jclinepi.2007.10.007
[4]	A. Messori, V. Fadda, D. Maratea and S. Trippoli, “ω-3 Fatty Acid Supplements Form Secondary Prevention of Cardiovascular Disease: From No Proof of Effectiveness to Proof of No Effectiveness,” JAMA Internal Medicine, 2013, Epub.
[5]	D. Maratea, V. Fadda, S. Trippoli and A. Messori, “OffPump versus On-Pump Coronary Artery Bypass Grafting: Quantifying Information Size by Trial Sequential Analysis,” European Journal of Internal Medicine, 2013, Epub.
[6]	S. Pecorelli, G. Favalli, A. Gadducci, D. Katsaros, P. B. Panici, A. Carpi, et al., “Phase III Trial of Observation versus Six Courses of Paclitaxel in Patients with Advanced Epithelial Ovarian Cancer in Complete Response after Six Courses of Paclitaxel/Platinum-Based Chemotherapy: Final Results of the After-6 Protocol 1,” Journal of Clinical Oncology, Vol. 27, No. 28, 2009, pp. 4642-4648. doi:10.1200/JCO.2009.21.9691