Editorial: Negative trials in ovarian cancer: is there such a thing as too much optimism? (popular article by # views) Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Thursday, September 01, 2016

Editorial: Negative trials in ovarian cancer: is there such a thing as too much optimism? (popular article by # views)



Editorials: open access

(viewed 650 times)
 
Abstract
Recently, two clinical trials of novel agents in metastatic ovarian cancer were published: a phase 3 study of nintedanib and a phase 2 study of volasertib. There seemed to be discordance between the results and conclusions in the publication of both these trials. Despite not very optimistic results, the studies concluded optimistically in favor of the new agents under study. Using these examples, we point out the discrepancies and the risks of concluding optimistically based on statistical significance when the actual benefit is minimal. We also appeal against conducting large phase 3 trials that require significant resources without good phase 2 evidence for doing so.
Published: 17/08/2016

 Conclusion
As a profession, we must learn to call a spade a spade. Ineffective drugs must be acknowledged as such by the oncology community. Additionally, conducting large phase III trials entails a huge sum of financial, logistic and human resources which is not worth spending on questions that are foolish, ill-supported or over-powered at the outset. Care must be made to clarify if results are statistically or clinically significant, and above all caution should always be observed during the interpretation of clinical trial data. The true lessons of negative trials in ovarian cancer apply broadly to all fields of oncology.
 References
1. Siegel RL, Miller KD and Jemal A (2015) Cancer statistics, 2015 CA Cancer J Clin 65(1) 5–29
2. Stuart GC et al (2011) 2010 Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer: report from the Fourth Ovarian Cancer Consensus Conference Int J Gynecol Cancer 21(4) 750–5
3. Oza AM et al (2015) Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial Lancet Oncology 16(8) 928–36

4. Burger RA et al (2011) Incorporation of bevacizumab in the primary treatment of ovarian cancer New Engl J Med 365(26) 2473–83
5. Aghajanian C et al (2012) OCEANS:A randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer J Clin Oncol 30(17) 2039–45
6. Pujade-Lauraine E et al (2014) Bevacizumab combined with chemotherapy for platinum- resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial J Clin Oncol 32(13) 1302–8
7. du Bois A et al (2014) Incorporation of pazopanib in maintenance therapy of ovarian cancer J Clin Oncol 32(30) 3374–82
8. Monk BJ et al (2014) Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial Lancet Oncol 15(8) 799–808
9. Ledermann JA et al (2016) Cediranib in patients with relapsed platinum-sensitive ovarian cancer (ICON6): a randomised, double-blind, placebo-controlled phase 3 trial Lancet 387(10023) 1066–74
10. Gyawali B, Shimokata T and Ando Y (2015) Discordance between the results and conclusions of ICON7 Lancet Oncol 16(13) e478
11. Sun X et al (2014) How to use a subgroup analysis: users’ guide to the medical literature JAMA 311(4) 405–11
12. du Bois A et al (2016) Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial Lancet Oncol 17(1) 78–89
13. Pujade-Lauraine E et al (2016) Volasertib versus chemotherapy in platinum-resistant or -refractory ovarian cancer: a randomized phase II Groupe des Investigateurs Nationaux pour l’Etude des Cancers de l’Ovaire Study J Clin Oncol 34(7) 706–13
14. Sacher AG, Le LW and Leighl NB (2014) Shifting patterns in the interpretation of phase III clinical trial outcomes in advanced non-small-cell lung cancer: the bar is dropping J Clin Oncol 32(14) 1407–11
15. Ledermann JA et al (2011) Randomized phase II placebo-controlled trial of maintenance therapy using the oral triple angiokinase inhibitor BIBF 1120 after chemotherapy for relapsed ovarian cancer J Clin Oncol 29(28) 3798–804

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