Allison Quick

The microbiome and gynecologic cancer: cellular mechanisms and clinical applications

ROCC/GOG-3043: a randomized controlled trial of robotic versus open surgery for early-stage cervical cancer

The Laparoscopic Approach to Cervical Cancer trial is the only randomized trial to date addressing the role of surgical approach in cervical cancer; however, this non-inferiority trial of minimally invasive surgery vs an open approach in patients undergoing radical hysterectomy for early-stage cervical cancer did not meet its primary end point of 4.5-year disease-free survival and was terminated early because of significantly worse disease-specific survival, overall survival, and locoregional recurrence in the minimally invasive surgery cohort. Our trial compares 3-year disease-free survival after robotic-assisted or abdominal radical or simple (in select cases) hysterectomy in early-stage cervical cancer. We hypothesize that disease-free survival is non-inferior after robotic-assisted vs abdominal radical or simple hysterectomy. This multi-center, randomized non-inferiority trial conducted through the Gynecologic Oncology Group has specified surgeon qualification criteria. It requires a pelvic magnetic resonance imaging scan in all patients before enrollment and will use 1:1 randomization to assign patients to robotic-assisted or abdominal hysterectomy. All surgeons must use specified tumor-containment techniques in both arms. It does not allow trans-cervical uterine manipulators. Patients with early-stage (2018 International Federation of Gynecology and Obstetrics stages IA2-IB2) cervical cancer. Histologic types are limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Pelvic magnetic resonance imaging must confirm a tumor that is 4 cm or less without definitive extra-cervical spread. A simple hysterectomy is allowed in select cases after trial study principal investigator review. The primary end point is the 3-year disease-free survival between robotic-assisted or abdominal hysterectomy. The trial will randomly allocate 840 patients, with planned interim analysis for futility (oncologic safety) after we have randomly allocated 370 and 640 patients. 2030. ClinicalTrials.gov identifier: NCT04831580.

Cervical Cancer Among Older Women: Analyses of Surveillance, Epidemiology and End Results Program Data

Objective: To describe age-specific cervical cancer incidence rates based on demographic and clinical characteristics. Methods: Women with cervical cancer in the SEER program were grouped into 3 age categories. Demographics, clinical characteristics, and incidence rates were obtained for each age group. Results: Older women (≥65 years) had higher incidence rates of cervical cancer than women <65 years with the highest rates in black women ≥75 years. Older black women had more adverse factors at diagnosis than similarly aged white and younger black women. There was a higher incidence rate of cervical cancer in women with lower socioeconomic status (SES), with the highest rates in older black women. However, the incidence rates were similar for older black women regardless of SES. Conclusion: Older black have the highest cervical cancer incidence rates, regardless of SES, suggesting an age and race disparity when compared to younger and white women.

Image guided brachytherapy quality assurance on NRG GY017 investigating immunotherapy in addition to chemoradiation for locally advanced cervical cancer

Brachytherapy is a critical component of curative treatment in locally advanced cervical cancer. NRG GY-017 is a randomized Phase I trial of the anti-PD-L1 antibody atezolizumab administered neoadjuvantly and concurrently with chemoradiation (Arm A) or only concurrently with chemoradiation (Arm B) in patients with node positive locally advanced cervical cancer. Image guided brachytherapy (IGBT) was mandated in the protocol with a quality assurance (QA) workflow. Herein, we report the BT quality data on NRG GY-017 trial and practice patterns from the participating centers in this trial as a guide for future protocol brachytherapy QA. The participating sites were to submit brachytherapy plans online after BT was completed. IROC QA center compiled the BT fractions for each patient using the trial specific dosimetry evaluation template. An expert physician reviewer scored the contours and plans as per protocol, variation acceptable or major deviation as prespecified in the protocol dose metrics. The BT dosimetry results were available for 32 patients. Seventeen patients (53%) had intracavitary applicator, and 15 patients (47%) had hybrid or interstitial applicators. Point A directed planning was performed for 4 patients (12.5%) and 28 patients had volume directed plans (87.5%). For imaging use, 2 patients had MRI based plans, and 30 had CT based planning (94%). For the dose constraints compliance per protocol, 7 patients had 9 events scored as major deviations (22%). BT trial specific QA has the potential to enhance BT quality for clinical trials. This report will help guide future gynecologic BT trial data collection and QA process.

Agreement between Surveillance, Epidemiology, and End Results– and Medicare Claims–Derived Uterine Cancer Treatment Data

Abstract Background: Despite the prevalent use of Surveillance, Epidemiology, and End Results (SEER)–Medicare data to study uterine cancer treatment patterns and survival, concordance between SEER and Medicare claims has not been a focus of prior research. We assessed the agreement between SEER and Medicare claims, predictors of disagreement between sources, and associations between treatment (identified in SEER vs. Medicare) and survival. Methods: Patients diagnosed with uterine cancer between 2000 and 2019 were identified using the SEER–Medicare linked database. We calculated kappa statistics to assess the agreement between the two data sources for receipt of hysterectomy with or without bilateral salpingo-oophorectomy (BSO), hysterectomy with BSO, lymphadenectomy, external beam radiotherapy (EBRT), vaginal brachytherapy (VBT), and chemotherapy. For each treatment type, we examined temporal trends in the kappa and used multivariable-adjusted logistic regression to examine predictors of disagreement. Treatment hazard ratios in Cox proportional hazards regression models using treatment information from SEER versus Medicare were compared. Results: For each treatment, we excluded patients with unknown SEER information, resulting in variable sample sizes. Agreement was lowest for hysterectomy with BSO (kappa = 0.71) and highest for lymphadenectomy and chemotherapy (kappas = 0.85). Temporal variation was evident, with lymphadenectomy, EBRT, and VBT agreement dropping in recent years. Black race, younger age at diagnosis, high-risk histology, and advanced stage were associated with higher odds of disagreement for certain treatments. Associations between treatment identified in SEER versus Medicare and survival outcomes were similar. Conclusions: Treatment agreement between SEER and Medicare was high. Impact: Our results support the use of both data sources for uterine cancer treatment–survival analyses.

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

This is a randomized controlled trial to compare survival for patients who undergoe robotic assisted laparoscopy versus open hysterectomy and lymph node assessment for the treatment of early stage cervical cancer.