Insurance status and time to radiation care after pathologic diagnosis for cervical cancer patients

Delays in starting potentially curative treatment for locally-advanced cervical cancer (LACC) decrease survival. Reasons for these delays are poorly understood. We conducted a retrospective chart review examining disparities in time from diagnosis of LACC to first clinic visit and to initiation of treatment based on insurance status within a single health system. We analyzed time to treatment using multivariate regression, adjusted for race, age, and insurance status. 25% of patients had Medicaid and 53% had private insurance. Having Medicaid was associated with delayed time from diagnosis to seeing a radiation oncologist (Mean 76.9 v. 31.3 days, p = 0.03). However, time from first radiation oncology visit to starting radiation was not delayed (Mean 22.6 v. 22.2 days, p = 0.67). Patients with locally-advanced cervical cancer and Medicaid had over double the time from pathologic diagnosis of cervical cancer to seeing radiation oncology; insurance disparities were not observed in treatment start after seeing radiation oncology. Improved referral and navigation processes for patients with Medicaid are needed to improve timely receipt of radiation and potentially improve survival

Role of adjuvant chemotherapy in the management of stage IC ovarian granulosa cell tumors

Objective: The aim of the present study was to investigate the patterns of use and prognostic significance of adjuvant chemotherapy (CT) for patients with stage IC ovarian granulosa cell tumors (GCTs). Methods: We identified patients with stage IC GCTs diagnosed between 2004 and 2015 in the National Cancer Data Base (NCDB). Logistic regression was performed to identify variables independently associated with chemotherapy administration. Overall survival (OS) was evaluated for patients diagnosed between 2004 and 2014 following generation of Kaplan-Meier curves and compared with the log-rank test. A Cox model was constructed to control for known confounders. Results: A total of 492 patients with stage IC GCTs were identified, of which 166 (33.7%) received CT. Tumor size > = 10 cm (OR: 1.85, 95% CI: 1.21, 2.82) was independently associated with the administration of CT. There was no difference in OS between patients who did (n = 145) and did not (n = 282) receive CT, p = 0.52; 5-yr OS rates were 93.7% and 91.6% respectively. After controlling for patient age (<50 vs ≥50 years), tumor size and performance of lymphadenectomy (LND), the administration of CT was not associated with a survival benefit (HR: 1.07, 95% CI: 0.52, 2.21). Conclusions: Approximately one in three patients with stage IC GCTs received CT in the NCDB, however CT was not associated with a survival benefit. Keywords: Ovary, Tumor, Chemotherapy sex cord-stromal, Granulosa cel

Isolated distant lymph node metastases in ovarian cancer. Should a new substage be created?

Abstact: Objective: To evaluate the prognostic significance of isolated distant lymph node metastases in comparison to other metastatic sites and stage IIIC disease. Methods: The National Cancer Data Base was accessed and patients diagnosed between 2004 and 2014 with stage IV or IIIC epithelial ovarian cancer who met criteria for pathological staging were identified. Overall survival (OS) was calculated with Kaplan-Meier curves and compared with the log-rank test. A Cox model was constructed to control for confounders. Results: A total of 33,561 patients met the inclusion criteria; 582 (1.7%) had stage IV only due to distant lymph node metastases (stage IV-LN), 8130 (24.2%) had stage IV with other sites of distant metastases (stage IV-other) and 24,849 (75.4%) had stage IIIC disease. The median OS for patients with stage IV-LN was 42.41 months (95% CI: 37.59, 47.23) compared to 30.23 months (95% CI: 29.30, 31.16) for those with stage IV-other (p < .001) and 45.57 (95% CI: 44.86, 46.28) for those with stage IIIC disease (p = .54). On multivariate analysis, patients with stage IV-other had a worse survival (HR: 1.41, 95% CI: 1.27, 1.57) compared to those with stage IV-LN. There was no statistically significant difference in survival between patients with stage IV-LN and stage IIIC disease (HR: 1.00, CI: 0.90, 1.11, p = .99). Conclusions: Isolated distant LN metastases is associated with better survival compared to stage IV disease due to other metastatic sites and comparable to patients with stage IIIC disease. Keywords: Ovary, Cancer, Stage IV, Lymph nodes, Metastasi

Ofranergene Obadenovec (Ofra-Vec, VB-111) With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer: Randomized Controlled Phase III Trial (OVAL Study/GOG 3018)

PURPOSE: To evaluate the addition of ofranergene obadenovec (ofra-vec, VB-111), a novel gene-based anticancer targeted therapy, to once a week paclitaxel in patients with recurrent platinum-resistant ovarian cancer (PROC). METHODS: This placebo-controlled, double-blind, phase III trial (ClinicalTrials.gov identifier: NCT03398655) randomly assigned patients with PROC 1:1 to receive intravenous ofra-vec every 8 weeks with once a week IV paclitaxel or placebo with paclitaxel until disease progression. The dual primary end points were overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review. RESULTS: Between December 2017 and March 2022, 409 patients were randomly assigned. The median PFS was 5.29 months in the ofra-vec arm and 5.36 months in the control arm, hazard ratio (HR) 1.03 (CI, 0.83 to 1.29; P = .7823). The median OS with ofra-vec was 13.37 months versus 13.14 months, HR 0.97 (CI, 0.75 to 1.27; P = .8440). Objective response rates (ORRs) per RECIST 1.1 were similar in both arms: 28.9% with ofra-vec versus 29.6% with control. In both treatment arms, response to CA-125 was a substantial prognostic factor for both PFS and OS. In the ofra-vec arm, the HR in CA-125 responders compared with that in nonresponders for PFS was 0.2428 (CI, 0.1642 to 0.3588), and for OS, the HR was 0.3343 (CI, 0.2134 to 0.5238). Safety profile was characterized by common transient flu-like symptoms such as fever and chills. CONCLUSION: The addition of ofra-vec to paclitaxel did not improve PFS or OS. The PFS and ORR in the control arm exceeded the results that were anticipated on the basis of the AURELIA chemotherapy control arm. CA-125 response was a substantial prognostic biomarker for PFS and OS in patients with PROC treated with paclitaxel

Ofranergene Obadenovec (Ofra-Vec, VB-111) With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer: Randomized Controlled Phase III Trial (OVAL Study/GOG 3018)

To evaluate the addition of ofranergene obadenovec (ofra-vec, VB-111), a novel gene-based anticancer targeted therapy, to once a week paclitaxel in patients with recurrent platinum-resistant ovarian cancer (PROC). This placebo-controlled, double-blind, phase III trial (ClinicalTrials.gov identifier: NCT03398655) randomly assigned patients with PROC 1:1 to receive intravenous ofra-vec every 8 weeks with once a week IV paclitaxel or placebo with paclitaxel until disease progression. The dual primary end points were overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review. Between December 2017 and March 2022, 409 patients were randomly assigned. The median PFS was 5.29 months in the ofra-vec arm and 5.36 months in the control arm, hazard ratio (HR) 1.03 (CI, 0.83 to 1.29; = .7823). The median OS with ofra-vec was 13.37 months versus 13.14 months, HR 0.97 (CI, 0.75 to 1.27; = .8440). Objective response rates (ORRs) per RECIST 1.1 were similar in both arms: 28.9% with ofra-vec versus 29.6% with control. In both treatment arms, response to CA-125 was a substantial prognostic factor for both PFS and OS. In the ofra-vec arm, the HR in CA-125 responders compared with that in nonresponders for PFS was 0.2428 (CI, 0.1642 to 0.3588), and for OS, the HR was 0.3343 (CI, 0.2134 to 0.5238). Safety profile was characterized by common transient flu-like symptoms such as fever and chills. The addition of ofra-vec to paclitaxel did not improve PFS or OS. The PFS and ORR in the control arm exceeded the results that were anticipated on the basis of the AURELIA chemotherapy control arm. CA-125 response was a substantial prognostic biomarker for PFS and OS in patients with PROC treated with paclitaxel