A B S T R A C T PurposeThis prospective, randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine (TPZ) to standard cisplatin (CIS) chemoradiotherapy in locally advanced cervix cancer. Patients and MethodsPatients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy. Primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS) and tolerability. ResultsPFS was evaluable in 387 of 402 patients randomly assigned over 36 months, with enrollment ending in September 2009. Because of the lack of TPZ supply, the study did not reach its original target accrual goal. At median follow-up of 28.3 months, PFS and OS were similar in both arms. Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0% and 64.4%, respectively (log-rank P ϭ .7869). Three-year OS for the TPZ/CIS/RT and CIS/RT arms were 70.5% and 70.6%, respectively (log-rank P ϭ .8333). A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm, with resulting tolerance in both treatment arms. ConclusionTPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS, although definitive commentary was limited by an inadequate number of events (progression or death). TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose.

Objective To investigate disparities in the frequency of ovarian cancer-related surgical procedures and access to high-volume surgical providers among women undergoing initial surgery for ovarian cancer according to race. Methods The California Office of Statewide Health Planning and Development database was accessed for women undergoing a surgical procedure that included oophorectomy for a malignant ovarian neoplasm between 1/1/06 and 12/31/10. Multivariate logistic regression analyses were used to evaluate differences in the odds of selected surgical procedures and access to high-volume centers (hospitals≥20 cases/year) according to racial classification. Results A total of 7,933 patients were identified: White=5,095 (64.2%), Black=290 (3.7%), Hispanic/Latino=1,400 (17.7%), Asian/Pacific Islander=836 (10.5%) and other=312 (3.9%). White patients served as reference for all comparisons. All minority groups were significantly younger (Black mean age 57.7 years, Hispanic 53.2 years, Asian 54.5 years vs. 61.1 years, p <0.01). Hispanic patients had lower odds of obtaining care at a high-volume center (adjusted OR (adj. OR)=0.72, 95% CI=0.64-0.82, p<0.01) and a lower likelihood of lymphadenectomy (adj. OR=0.80, 95%CI=0.70–0.91, p<0.01), bowel resection (adj. OR=0.80, 95% CI=0.71–0.91, p<0.01), and peritoneal biopsy/omentectomy (adj. OR=0.69, 95% CI=0.58–0.82, p<0.01). Black racial classification was associated with a lower likelihood of lymphadenectomy (adj. OR=0.76, 95%CI=0.59–0.97, p=0.03). Conclusions Among women undergoing initial surgery for ovarian cancer, Hispanic patients are significantly less likely to be operated on at a high-volume center, and both Black and Hispanic patients are significantly less likely to undergo important ovarian cancer-specific surgical procedures compared to White patients.

• NACT and PDS are comparable in cost for women with stage IIIC EOC.• PDS is 12% more expensive for women with stage IV EOC.• Increasing Charlson score was associated with an increase in 7-month cost of care in both stages. Objective. To analyze the cost of treating women with advanced stage epithelial ovarian cancer (EOC) undergoing primary debulking surgery (PDS) or neo-adjuvant chemotherapy (NACT). a b s t r a c t a r t i c l e i n f oMethods. The Surveillance, Epidemiology, and End Results (SEER) -Medicare database (1992 to 2009) was used to evaluate the 7-month cost of care following PDS and NACT for advanced EOC. Multivariate analyses were used to evaluate differences between women treated by PDS and NACT on cost and survival.Results. Of the 4506 women eligible for analysis, 82.4% underwent PDS and 17.6% received NACT. Eighty-five percent with stage IIIC and 78.5% with stage IV EOC underwent PDS (p b 0.0001). No significant difference in the median cost of care between PDS and NACT existed in women with stage IIIC EOC ($59,801 vs. $59,905). There was a 12% increase in adjusted cost of care for stage IV patients ($63,131 vs. $55,302) who received PDS (p b 0.0001). Increasing Charlson score was associated with an increase in 7-month cost of care in both stages. NACT was associated with a decreased 5-year overall survival in women with stage IIIC EOC (HR = 1.27, 95% CI: 1.10-1.47) and stage IV EOC (HR = 1.19, 95% CI: 1.03-1.37) compared to PDS.Conclusion. NACT and PDS are comparable in cost for women with stage IIIC EOC, and PDS is minimally more expensive for women with stage IV EOC. PDS was associated with an increase 5-year overall survival. Future investigations should include cost-effectiveness analyses where additional measures such as quality adjusted life years and propensity scored survival are included.