Papers by Catherine Devine
Cancers, Mar 19, 2021
Bladder cancer is a complex disease, the sixth most common cancer, and one of the most expensive ... more Bladder cancer is a complex disease, the sixth most common cancer, and one of the most expensive cancers to treat. In the last few decades, there has been a significant decrease in the bladder cancer-related mortality rate, potentially related to decreased smoking prevalence, improvements in diagnosing bladder cancer, and advances in treatment. Those advances in diagnostic tools and therapies and greater understanding of the disease are helping to evolve how bladder cancer is managed. The purpose of this article is to provide a review of bladder cancer pathology, diagnosis, staging, radiologic imaging, and management, and highlight recent developments and research.
Pet Clinics, Apr 1, 2018
This paper will provide an overview of PET in cervical cancer, primarily with regard to the use o... more This paper will provide an overview of PET in cervical cancer, primarily with regard to the use of FDG PET/CT. A brief discussion of upcoming technologies, such as PET/MRI, will be presented.
Journal of gastrointestinal oncology, Aug 1, 2016
Background: Despite the wide spread use of trastuzumab in human epidermal growth factor receptor ... more Background: Despite the wide spread use of trastuzumab in human epidermal growth factor receptor 2 (HER2) overexpressing metastatic gastric cancer patients, its optimal duration of administration beyond first-line disease progression is unknown. In HER2 overexpressing metastatic breast cancer, trastuzumab continuation beyond first-line disease progression has shown improvement in time to progression (TTP) without an increased risk of treatment related toxicity. Methods: HER2-overexpressing metastatic gastric cancer patients were identified from our database between January 2010 and December 2014. We retrospectively reviewed the medical records of 43 patients who received trastuzumab in combination with chemotherapy as first-line and continued trastuzumab beyond disease progression. Results: Forty-three cases were identified, 27 males (62.8%), median age of the patients was 58 years. Thirty-five (81.4%) presented with stage 4 as their initial presentation. Eighty one percent had 3+ HER2 overexpression by immunohistochemistry (IHC) and 18% had 2+ HER2 overexpression confirmed by fluorescence in situ hybridization (FISH). Thirteen (52%) were moderately differentiated, 16 (37.1%) were poorly differentiated. The most common sites of metastasis were liver 35 (81.4%) and lung 14 (32.5%). The most commonly used first-line regimen was oxaliplatin, 5-fluorouracil (5-FU), and trastuzumab in 22 (51.1%) patients. Twenty-five (58.1%) patients received irinotecan, 5-FU and trastuzumab in the second-line. Progression-free survival (PFS) was 5 months (95% CI: 4.01-5.99 months). Five patients are still alive and excluded from calculating the median overall survival (OS) which was 11 months (range, 5-53 months) for the remaining 20 subjects of this second-line group. Trastuzumab was not discontinued due to side effects in any of the study population. In conclusion, this retrospective analysis suggests that continuation of trastuzumab beyond disease progression in patients with HER2-overexpressing metastatic gastric cancer is feasible and safe. Randomized studies are warranted.
Journal of Clinical Oncology, Feb 1, 2014
441^ Background: Previous studies have shown minimal impact of tyrosine kinase inhibitors on prim... more 441^ Background: Previous studies have shown minimal impact of tyrosine kinase inhibitors on primary renal tumors. In this phase II trial, we investigate the safety and role of the axitinib in downsizing tumors in patients with non-metastatic clear cell renal cell carcinoma (RCC) prior to surgical resection. Methods: Patients with clinical stage T2-T3b N0 M0 biopsy-proven RCC were eligible for this study. Patients received axitinib daily for 12 weeks prior to surgery. The primary outcome was objective response rate. Secondary outcomes included safety, tolerability, feasibility of administration of axitinib and quality of life (using FKSI-15). A dedicated radiologist independently reviewed all CT scans to evaluate for response using RECIST. Results: Twenty-four patients were treated between 2011 and 2013. All patients had biopsy-proven clear cell RCC. Twenty-three patients continued axitinib for 12 weeks, and underwent surgery as planned without delay. One patient stopped treatment before 12 weeks due to adverse events (AEs) and was taken to surgery early. Median reduction of primary renal tumor size was 28.3% (range 5.3-42.9%). Eleven patients (45.8%) experienced a partial response by RECIST, and 13 patients had stable disease. There was no progression of disease while on axitinib. The most common AEs were hypertension, fatigue, oral mucositis, hypothyroidism, and hand-foot syndrome. No grade 4 AEs were observed. Intraoperatively, no complications or unusual bleeding were encountered. Postoperatively, 2 grade 3 and 13 grade 2 complications were noted, while no grade 4 or 5 complications occurred. FKSI-15 did change over time (p < 0.0001), with quality of life worsening in comparison to the screening assessment by week 7 (p = 0.0004). However, by week 19, quality of life was not found to be statistically different from screening (p = 0.3344). Conclusions: Axitinib was clinically active and well tolerated in the neoadjuvant setting in patients with locally advanced non-metastatic ccRCC. Clinical trial information: NCT01263769.
Journal of gastrointestinal oncology, Dec 1, 2017
Background: Over the last 15 years, large randomized controlled studies have validated the benefi... more Background: Over the last 15 years, large randomized controlled studies have validated the benefit of preoperative therapy for patients with resectable gastric cancer. Computed tomography (CT) and endoscopic ultrasonography (EUS) are commonly used to select patients for preoperative treatment, but studies of preoperative staging accuracy that focus on patient selection for preoperative therapy are rare; therefore, whether CT or EUS can reliably identify patients eligible for preoperative therapy is still unclear. Our purpose was to determine the accuracy of EUS and CT for preoperative staging of gastric cancer and to identify factors that may affect their usefulness in selecting patients for preoperative therapy. We reviewed the medical records of 8,260 patients with gastric or gastroesophageal adenocarcinoma treated at our institution from 1995 to 2013, identifying those who underwent gastrectomy without preoperative treatment. We compared T stage and N status from preoperative EUS and CT reports with those drawn from surgical pathology reports. Clinicopathologic and demographic variables associated with incorrect preoperative staging were investigated using univariate and multivariate analyses. Results: We identified 187 patients who underwent preoperative staging by EUS (n=145) and/or CT (n=134) before gastrectomy. The accuracy, sensitivity, and specificity of EUS in distinguishing stage T1 from more advanced tumors were 82%, 78%, and 85%, respectively. Variables associated with underestimation of EUS T stage were lymphovascular invasion [odds ratio (OR), 7.51; 95% confidence interval (CI), 1.91-29.50; P<0.01] and white race (OR, 3.75; 95% CI, 1.31-10.75; P=0.01). The accuracies, sensitivities, and specificities for determining N status were, respectively, 65%, 49%, and 79% with CT and 66%, 29%, and 95% with EUS. Lymphovascular invasion was associated with a false negative result (OR, 3.79; 95% CI, 1.34-10.70; P=0.01), and well-or moderately differentiated histology was associated with a false positive result for CT N status (OR, 7.14; 95% CI, 2.00-25.44; P<0.01). Conclusions: EUS is accurate in distinguishing T1 from T2-T4 lesions; both CT and EUS have low sensitivities and high specificities in determining N status. These accuracies and variables associated with inaccurate staging, including race, should be considered when selecting gastric cancer patients for preoperative therapy.
Journal of Clinical Oncology, May 20, 2013
4516 Background: Previous studies have shown minimal impact of TKIs on primary renal tumor downsi... more 4516 Background: Previous studies have shown minimal impact of TKIs on primary renal tumor downsizing. Axitinib is a VEGFR TKI that has been recently approved for use in patients with metastatic clear cell renal cell carcinoma (RCC). In this prospective phase II trial, we sought to investigate the safety and role of axitinib in downsizing tumors in patients with non-metastatic renal cell carcinoma, prior to undergoing surgical resection. Methods: Patients with locally advanced (clinical stage T2-T3b N0 M0) biopsy-proven clear cell RCC were eligible for this phase II clinical trial. The primary outcome was objective response rate (using RECIST) following the administration of axitinib for 12 weeks prior to undergoing radical nephrectomy. Secondary outcomes included safety, tolerability, and feasibility of administration of axitinib in this patient population. Patients were given axitinib 5mg PO BID, and dose titration was allowed. Axitinib was continued until 36 hours prior to surgery. A dedicated radiologist independently reviewed all CT scans to evaluate for response using RECIST. Results: The study goal of enrolling 24 patients has been recently reached. At present, nineteen patients have completed the studies required for assessment of the primary outcome and are hereby reported. Fifteen patients were males, and four were females. Median age was 61 years (range 42-83 years). All patients had biopsy-proven clear cell RCC. All 19 patients continued axitinib for 12 weeks, and underwent surgery as planned without delay. Adverse events of any grade were: arthralgia in 6, hypothyroidism in 14, fatigue in 15, and hypertension in 16 patients. No wound complications occurred after surgery. Nine patients (47%) experienced a partial response by RECIST, and 10 patients had stable disease. There was no progression of disease while on axitinib. Conclusions: Axitinib is well tolerated in the neoadjuvant setting in patients with planned surgery for locally advanced non-metastatic clear cell RCC. The drug showed tumor downsizing activity when given for 12 weeks prior to surgery. Adverse events of any grade were common and easily manageable with routine care. Clinical trial information: NCT01263769.
Journal of Clinical Oncology, May 20, 2018
4563Background: TEM has level 1 evidence in aRCC with poor-risk disease. No previous trial compar... more 4563Background: TEM has level 1 evidence in aRCC with poor-risk disease. No previous trial compared a VEGFR-TKI with TEM as first-line (1L) therapy. Methods: We randomly assigned (1:1) treatment-na...
Journal of Clinical Oncology, Feb 20, 2018
583 Background: TEM has level 1 evidence in aRCC with poor-risk disease. No trial compared a VEGF... more 583 Background: TEM has level 1 evidence in aRCC with poor-risk disease. No trial compared a VEGFR-TKI with TEM as first-line (1L) therapy in this disease state. Methods: We randomly assigned (1:1) treatment-naïve pts with aCCRCC and &gt; = 3 risk factors (as per Hudes et al., NEJM 2007) to receive PAZ 800 mg po qd or TEM 25 mg iv qw. Pts were offered to receive the alternative agent at disease progression (PD). The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR) and safety. A blinded radiologist assessed the radiographic response using RECIST v1.1. A sample size of 90 pts was based on an assumption of improved median PFS from 3.8 mo with TEM to 6.1 mo with PAZ. Pts were stratified by prior nephrectomy (Nx). The Kaplan-Meier method was used for PFS and OS analysis, and the Fisher’s exact test was used for comparison of ORR between PAZ and TEM. Results: The study was closed to new patient enrollment when the results of the CheckMate 214 and CABOSUN studies were presented at ESMO 2017. A total of 69 pts were eligible and evaluable (median age 61, 52 males [75%], 44 [64%] had poor-risk by IMDC criteria). Thirty pts [43%] had prior Nx. Thirty-five pts received PAZ (intermediate-risk 13, poor-risk 22) and 34 pts received TEM (intermediate-risk 12, poor-risk 22). Of the 69 pts, 67 had PD or died. The median PFS was 5.2 mo (95% CI: 3.6 –7.4) for PAZ and 2.6 mo (95% CI: 1.9 –4.2) for TEM (p = 0.16). In 1 pt, no date of death was available. Of the remaining 68 pts, 58 (85.3%) have died. The median OS was 12.0 mo (95% CI: 8.3–20.1) for PAZ and 7.4 mo (95% CI: 5.3–17.4) for TEM (p = 0.61). Sixty-eight pts were evaluable for response: 9/35 pts (26%) who received PAZ and 2/33 pts (6%) who received TEM had partial response (p = 0.046). Adverse events (AEs) were consistent with the known safety profiles of PAZ and TEM. Only 2 pts in each arm discontinued treatment due to AEs. Conclusions: PAZ extended PFS and OS and yielded a significantly higher ORR than TEM as 1L therapy in pts with aCCRCC and intermediate/poor-risk disease. Clinical trial information: NCT01392183.
Cancers
Diffuse type of gastric adenocarcinoma (dGAC) generally confers a poor prognosis compared to inte... more Diffuse type of gastric adenocarcinoma (dGAC) generally confers a poor prognosis compared to intestinal type. Some dGACs are not avid on fluorine-18 fluoro-2-deoxy-D-glucose PET (FDG-PET) while others seem to consume glucose avidly. We analyzed the outcomes based on the avidity (high with standardized uptake value (SUV) > 3.5 or low with SUV ≤ 3.5) of the primary on baseline FDG-PET. We retrospectively selected 111 localized dGAC patients who had baseline FDG-PET (all were treated with preoperative chemotherapy and chemoradiation). FDG-PET avidity was compared with overall survival (OS) and response to therapy. The mean age was 59.4 years and with many females (47.7%). The high-SUV group (58 (52.3%) patients) and the low-SUV group (53 (47.7%) patients) were equally divided. While the median OS for all patients was 49.5 months (95% CI: 38.5–98.8 months), it was 98.0 months (95% CI: 49.5–NE months) for the low-SUV group and 36.0 months for the high-SUV (p = 0.003). While the median...
Cancers, 2021
Methods: Keyword searches of Medline, PubMed, and the Cochrane Library for manuscripts published ... more Methods: Keyword searches of Medline, PubMed, and the Cochrane Library for manuscripts published in English, and searches of references cited in selected articles to identify additional relevant papers. s sponsored by various societies including the American Urological Association (AUA), European Association of Urology (EAU), and European Society for Medical Oncology (ESMO) were also searched. Background: Bladder cancer is the sixth most common cancer in the United States, and one of the most expensive in terms of cancer care. The overwhelming majority are urothelial carcinomas, more often non-muscle invasive rather than muscle-invasive. Bladder cancer is usually diagnosed after work up for hematuria. While the workup for gross hematuria remains CT urography and cystoscopy, the workup for microscopic hematuria was recently updated in 2020 by the American Urologic Association with a more risk-based approach. Bladder cancer is confirmed and staged by transurethral resection of bladder...
PET Clinics, 2018
This paper will provide an overview of PET in cervical cancer, primarily with regard to the use o... more This paper will provide an overview of PET in cervical cancer, primarily with regard to the use of FDG PET/CT. A brief discussion of upcoming technologies, such as PET/MRI, will be presented.
European Urology Focus, 2019
The decision to perform a partial nephrectomy (PN) relies largely upon the complexity of the rena... more The decision to perform a partial nephrectomy (PN) relies largely upon the complexity of the renal mass and its surrounding anatomy. The presence of adherent perinephric fat (APF) can increase surgical complexity and extend operative times. The accurate prediction of APF may improve surgical planning and aid in decision making for the surgical approach. Objective: We sought to develop and externally validate a score that predicts APF based on preoperative clinical and radiological prognostic factors. Design, setting, and participants: We retrospectively analyzed 495 consecutive patients who underwent open or minimally invasive PN. APF was defined as the presence of "dense," "adherent," or "sticky" perinephric fat at the time of dissection by the surgeon, and this did not require subcapsular dissection. Additionally, we analyzed an independent cohort of 285 patients for external validation. Outcome measurements and statistical analysis: A score model was developed using multivariate logistic regression analysis. Calibration of the fitted model was assessed graphically with a plot of the predicted versus the actual probability of APF, and discrimination was assessed by calculating the area under the receiver operating characteristic curve. Results and limitations: Of the 495 patients, 95 (19%) had APF. Patients with APF had longer operative (p = 0.02) and arterial clamp (p = 0.01) times than non-APF patients. On multivariate analyses, diabetes mellitus (p = 0.009), posterior perinephric fat thickness (p < 0.001), and perinephric stranding (p < 0.001) were predictors of encountering APF in PN. A risk score ranging from 0 to 4 was developed based on these three variables to predict APF. The scoring system demonstrated good discrimination of 0.82 and 0.84 for the development and external validation cohorts, respectively. Conclusions: The APF score can accurately predict the presence of APF in patients with a small renal mass who are planning to undergo PN. This score could aid in pre-and intraoperative planning and impact the surgical approach. Patient summary: The presence of "sticky" fat surrounding the kidney in patients undergoing partial nephrectomy has previously been linked to longer operative times, intraoperative complications, and surgical conversion. In our study, we found that this feature is more often presented in patients with diabetes mellitus, and thicker and more inflammatory fat on renal imaging. Based on these findings, we developed a risk score that can accurately predict this feature before surgery, in order to improve surgical planning and better counsel the patients.
European Urology Oncology, 2019
Radiologia brasileira
To determine whether there are substantive differences between the initial interpretations of mag... more To determine whether there are substantive differences between the initial interpretations of magnetic resonance imaging (MRI) scans acquired at outside facilities and the second-opinion interpretations of radiologists specializing in gynecologic oncology at a tertiary cancer center, among patients referred for endometrial cancer staging. This was a retrospective, comparative analysis of 153 initial and second-opinion MRI reports for endometrial cancer staging officially submitted for review by radiologists specializing in gynecologic oncology. For each case, the relationship between the initial and second-opinion reports, regarding the suggested diagnosis and the clinically relevant MRI findings reported, was categorized as "agreement" or "disagreement". Histopathology was used in order to establish the definitive diagnosis. Disagreement was found in 58 (37.9%) of the 153 cases. Second-opinion interpretations reported findings that affected the preoperative canc...
Journal of Clinical Oncology, 2016
34 Background: Because gastric cancers stage ≥ T2 or ≥ N1 are considered for neoadjuvant treatmen... more 34 Background: Because gastric cancers stage ≥ T2 or ≥ N1 are considered for neoadjuvant treatment, accuracy of preoperative staging is critical. The purpose of this study was to identify preoperative staging accuracies of computed tomography scan (CT) and endoscopic ultrasound (EUS) in gastric cancer and their utilities in selecting patients for neoadjuvant therapy. Methods: Medical records of 8,260 patients with gastric or gastroesophageal adenocarcinoma (presented 1995-2013) were reviewed to identify those who underwent gastrectomy but not neoadjuvant treatment. We reviewed preoperative EUS reports and CT images to identify detailed T stage (based on AJCC 7thedition) and lymph node positivity (short axis diameter ≥ 6mm). T stage and N status were compared with those from the surgical pathology report. Clinicopathologic variables associated with incorrect preoperative staging were also examined. Results: We identified 187 patients who underwent preoperative staging by EUS (n = 145...
The Journal of Clinical Endocrinology & Metabolism, 2014
Context: Sorafenib, a tyrosine kinase inhibitor, is a common first-line therapy for advanced diff... more Context: Sorafenib, a tyrosine kinase inhibitor, is a common first-line therapy for advanced differentiated thyroid cancer (DTC). However, responses are not durable and drug toxicity remains a problem. The objective of the study was to determine the efficacy of salvage therapy after first-line sorafenib failure.
The Journal of Urology, 2014
P ¼ 0.180) or when adjusting for thrombus level, age, sex, T stage, N stage, presence of metastas... more P ¼ 0.180) or when adjusting for thrombus level, age, sex, T stage, N stage, presence of metastasis, and time under surgery (P ¼ 0.734). Median cancer-specific survival was 29.1 months (95% CI [21.2, 48.3]) in non-CPB patients and 39.4 months in CPB patients (95% CI [29.3, 80.0]). Cancer-specific survival did not differ significantly based on CPB, either in the univariate analysis (P ¼ 0.704) or in the multivariate analysis (P ¼ 0.888). In univariate analysis, length of stay (LOS) was estimated to be 26% higher in CPB patients (P ¼ 0.002) and the complication rate was marginally lower in CPB patients (P ¼ 0.053). However, in multivariable analysis, no significant difference was seen in hospital LOS (P ¼ 0.439) or complication rate with the use of CPB (P ¼ 0.457). CONCLUSIONS: In our multi-institutional analysis, the use of cardiopulmonary by-pass did not significantly impact cancer specific survival or overall survival in patients undergoing nephrectomy and level III or IV tumor thrombectomy. Higher surgical complications or longer hospital stay were not independently associated with the used of CPB.
BJUI, Jun 29, 2015
Objective-To evaluate how many patients could have undergone PN instead of RN before and after ne... more Objective-To evaluate how many patients could have undergone PN instead of RN before and after neoadjuvant axitinib therapy, as assessed by 5 independent urologic oncologists, and to study the variability of inter-observer agreement. Patients and Methods-Preand post systemic treatment CT scans from 22 patients with ccRCC in a phase II neoadjuvant axitinib trial were reviewed by 5 independent urologic oncologists. RENAL score and Kappa statistics were calculated. Results-Median RENAL score changed from 11 pre-treatment to 10 post-treatment, p=0.0017. Five tumors with moderate-complexity pre-treatment remained moderate-complexity posttreatment. Of 17 tumors with high-complexity pre-treatment, 3 became moderate-complexity posttreatment. Overall kappa statistic was 0.611. Moderate-complexity kappa was 0.611 vs. highcomplexity kappa of 0.428. Pre-treatment kappa was 0.550 vs. post-treatment of 0.609. After treatment with axitinib, all 5 reviewers agreed that only 5 patients required RN (instead of 8 pretreatment) and that 10 patients could now undergo PN (instead of 3 pre-treatment). The odds of PN feasibility were 22.8-times higher after treatment with axitinib.
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Papers by Catherine Devine