For Immediate Release
PHILADELPHIA, PA– The American Cancer Society estimates that approximately 22,500 women will be diagnosed with ovarian cancer this year and 14,000 will die from disease. More than 80% of women who have ovarian cancer will experience recurrent disease in their lifetime with ten-year disease-free survival rates falling below 15% for women who do experience ovarian cancer recurrence. The NRG Oncology clinical trial GOG 0213 was designed to test if a second surgical cytoreduction, a procedure aimed to completely remove all visible tumors, could improve survival outcomes for women who have platinum-sensitive recurrent ovarian cancer. While complete gross resection was reached in the majority of trial participants, researchers were unable to prove that the addition of secondary surgical cytoreduction was able to extend survival outcomes for women when compared to chemotherapy alone. These results were recently published in the New England Journal of Medicine.
Although secondary surgical cytoreduction in ovarian cancer is widely practiced, the procedure had yet to be tested in a phase III setting for a trial. NRG-GOG 0213 compared the standard of care treatment of chemotherapy alone to secondary surgical cytoreduction combined with chemotherapy in 485 women with recurrent ovarian cancer. The 485 women were randomly assigned to receive one of the two treatment plans and researchers measured overall survival as the primary endpoint.
Complete gross resection was achieved in 67% of the women who received the secondary surgical cytoreduction. Platinum based chemotherapy with bevacizumab followed by bevacizumab was administered to 84% of the women on this trial. The hazard ratio (HR) for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI]: 0.97-1.72, P=0.08), with a median overall survival of 50.6 months vs. 64.7 months. The HR for progression (surgery vs. no surgery) was 0.82 (95%CI: 0.66-1.01; median 18.9 months vs. 16.2 months). Patient-reported quality of life outcomes were also reduced following surgery, however, did not differ to following recovery when compared to the patients treated with chemotherapy alone.
“Although the results from this study are somewhat unexpected, they are robust demonstrating similar associations across a number of subgroup analyses, including patients with oligometastatic disease: a metastasis that causes cancer cells stemming from the original tumor to travel and form new tumors in other parts of the body, a long platinum-free interval, and complete gross resection as a surgical outcome. Future work will investigate the impact of surgical intervention among patients with tumors exhibiting mutations in genes such as in BRCA1/2 or demonstrating homologous recombination deficiency. Since systemic therapy appears to play a dominant role in this setting, understanding the optimal use of our clinical tools will be important to improving the quality and quantity of our patient’s lives,” states Robert L. Coleman, MD, of the University of Texas MD Anderson Cancer Center and lead author of NRG-GOG 0213.
This study was supported by National Cancer Institute (NCI) grants to the Gynecologic Oncology Group (GOG) Administrative Office (CA 27469), the Gynecologic Oncology Group Statistical Office (CA 37517), NRG-Oncology (1U10 CA180822) and NRG-Operations (U10CA180868). In addition, this work was supported
, in part by the National Institutes of Health/NCI under award number P30CA016672 and used the clinical research shared resource. Roche/Genentech supported the NCI-CRADA enabling this trial. The lead author of this manuscript was support in part by the Ann Rife Cox Chair in Gynecology, the Judy Reis/Abert Pisani, MD Ovarian Cancer Research Fund.
Coleman RL, Spirtos NM, Enserro D, Herzog TJ, Sabbatini P, Armstrong DK, Kim JW, Park SY, Kim BG, Nam JH, Fujiwara K, Walker JL, Casey AC, Secord AA, Rubin S, Chan JK, Di Silvestro P, Davidson SA, Cohn DE, Tewari KS, Basen-Engquist K, Huang HQ, Brady MF, Mannel RS. Second Surgical Cytoreduction for Recurrent Ovarian Cancer. N Engl J Med. Nov. 14. 2019. doi: 10.1056/NEJMoa1902626. [Epub ahead of print]
About NRG Oncology
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), and Gynecologic Oncology Group (GOG) programs. The research network seeks to carry out clinical trials with emphases on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI’s National Clinical Trials Network. www.nrgoncology.org