February 07, 2016
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Racial, treatment-related factors may influence bevacizumab efficacy in advanced cervical cancer

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Use of Moore criteria may identify patients with advanced cervical cancer who may not benefit from treatment with bevacizumab, according to results of a study conducted by the Gynecologic Oncology Group.

Further, patients with moderate- or high-risk disease appeared to derive the greatest benefit from treatment with bevacizumab (Avastin, Genentech/Roche).

Krishnansu Tewari

Krishnansu S. Tewari, MD

“We were somewhat surprised with how strong the benefits were for the intermediate- and high-risk groups in that the benefits extended beyond OS [and included] PFS and objective response rate,” Krishnansu S. Tewari, MD, professor and director of research in the division of gynecologic oncology at University of California, Irvine, told HemOnc Today. “Now that the scoring system has been prospectively validated, it can be used with confidence.”

A randomized phase 3 trial conducted by the Gynecologic Oncology Group (GOG) showed that adding bevacizumab to chemotherapy significantly increased OS in women with advanced cervical cancer.

Tewari and colleagues aimed to prospectively analyze the influence of Moore criteria on predicting survival benefit, which served as a major objective of the initial trial.

Developed in 2010 by David H. Moore, MD, former chair of the GOG Cervix Cancer Committee, the Moore criteria consists of five clinical factors believed to be prognostic of poor outcomes among patients with advanced cervical cancer. These factors include black race, performance status of 1, pelvic disease, prior treatment with cisplatin and a PFS interval less than 1 year.

The researchers categorized women as low risk (zero or one risk factors), moderate risk (two or three risk factors) and high risk (four or five risk factors).

The analysis included data from 452 women (low risk, n = 84; moderate risk, n = 303; high risk, n = 65).

Patients in the low-risk category achieved a median OS of 21.8 months, compared with 14.7 months in the moderate-risk category and 8.2 months among the high-risk category (P < .0001).

Patients were assigned treatment with topotecan (Hycamtin, GlaxoSmithKline; n = 223) or bevacizumab (n = 227). In both cohorts, patients with low-risk disease achieved significantly longer OS than patients with high-risk disease (topotecan, 20.1 months vs. 8.2 months; bevacizumab, 22.9 months vs. 12.1 months).

When Tewari and colleagues compared patients assigned chemotherapy alone vs. those assigned chemotherapy and bevacizumab, Tewari and colleagues found that bevacizumab conferred significantly increased median OS (moderate-risk patients, 17.9 months vs. 12.1 months; high-risk patients, 12.1 months vs. 6.3 months) and PFS (moderate-risk patients, HR = 0.69; 95% CI, 0.54-0.89; high-risk patients, HR = 0.5; 95% CI, 0.27-0.92).

Median OS and PFS rates did not reach statistical significance among low-risk patients.

Tewari identified the lack of applicability of the Moore criteria to nonblack populations as a study limitation.

“However, we believe that African Americans are a surrogate for lack of access to health care because there are studies that show the clinical outcomes of African American patients with cervical cancer are similar to non–African Americans when the health care access playing field is level,” Tewari said in a press release.

Further, the researchers noted that bevacizumab has not demonstrated a curative effect among patients with advanced cervical cancer.

“As we learn more about determining the molecular phenotype of different tumors, we will be able to develop scoring systems that build upon this one in future research by adding validated predictive molecular biomarkers to the Moore clinical scoring criteria to develop an even more precise instrument,” Tewari said in an interview. “For clinical practice, these findings … provide the oncologist with an easy to use clinical instrument to counsel patients regarding the benefit or lack of benefit of adding anti-angiogenesis therapy in the management of recurrent and metastatic cervix cancer.” – by Cameron Kelsall

For more information:

Krishnansu S. Tewari, MD, can be reached at ktewari@uci.edu.

Disclosure: Tewari reports an advisory board position with Genentech/Roche. Other researchers report grants and honoraria from and consultant roles with Genentech/Roche.