Genitourinary Medical Oncology Research Articles

Alternative model to deliver germline genetic testing to patients with advanced prostate cancer (PCa).

123 Background: Genomic testing is now standard-of-care (SOC) for PCa patients with both therapeutic and hereditable consequences. National guidelines recommend germline testing in all high-risk and advanced PCa patients, regardless of age or family history. Yet, many systemic barriers prevent patients from receiving germline testing promptly, including the burden of appointments, comorbidities, transportation, provider knowledge of genetic testing, and insufficient genetics workforce that limits timely referral to genetic counselors. Methods: We developed a streamlined, alternative genetic care delivery model to improve rates of germline genetic testing for PCa patients. A multidisciplinary team (genitourinary medical oncologists, advanced practice RN, and genetic counselors) developed a tailored pre- and posttest counseling curriculum for PCa patients undergoing germline testing that was delivered by oncology providers. Pretest counseling was incorporated into SOC counseling for somatic tumor genomic testing performed to personalize therapeutics. Systematic posttest counseling was delivered by oncology providers, and men with germline pathogenic/likely pathogenic (P/LP) variants were referred to certified genetic counselors for formal genetic counseling. We retrospectively collected data on PCa patients treated at an academic oncology practice who underwent paired germline/somatic testing through a commercial lab accompanied by tailored pre/posttest counseling, including demographics, clinical characteristics, and germline test results. We performed quarterly audits to monitor quality metrics. Results: From September 2021 to May 2023, seventy-five PCa patients underwent paired germline/somatic tumor testing. The racial/ethnically diverse patient population (self-identified) included 81% Black, 13% Hispanic, and 6% non-Hispanic White men. At the time of analysis, 64 tests had resulted; 9.4% of patients (n=6) had a P/LP germline variant, and 31.2% of patients (n=20) tested negative. The majority of patients (59.4%, n=38) had a variant of unknown significance (VUS). Additional data will be available at the time of presentation. Conclusions: Providing paired germline/somatic tumor testing with tailored pre/posttest education delivered by oncology providers, and formal genetic counseling reserved for patients with P/LP germline variants, is an efficient way to provide guideline-directed genetic services for PCa patients. Given the frequency of VUS, education for pre/posttest counseling is essential, particularly in under-represented minority populations. The frequency of actionable mutations is reduced in underrepresented minority PCa patients compared with reports in the literature, reflecting limitations of current germline testing/bioinformatics platforms and the need for greater inclusion of diverse populations in future studies.

Adjuvant therapy for renal cell carcinoma: 2023 Canadian Kidney Cancer Forum consensus statement.

Several recent randomized trials evaluated the impact of adjuvant immune checkpoint inhibitor (ICI)-based therapy on post-surgical outcomes in renal cell carcinoma (RCC), with disparate results. The objective of this consensus statement is to provide data-driven guidance regarding the use of ICIs after complete resection of clear-cell RCC in a Canadian context. An expert panel of genitourinary medical oncologists, urologic oncologists, and radiation oncologists with expertise in RCC management was convened in a dedicated session during the 2022 Canadian Kidney Cancer Forum in Toronto, Canada. Topic statements on the management of patients after surgery for RCC, including counselling, risk stratification, indications for medical oncology referral, appropriate followup, eligibility and management for adjuvant ICIs, as well as treatment options for patients with recurrence who received adjuvant immunotherapy, were discussed. Participants were asked to vote if they agreed or disagreed with each statement. Consensus was achieved if greater than 75% of participants agreed with the topic statement. A total of 22 RCC experts voted on 14 statements. Consensus was achieved on all topic statements. The panel felt patients with clear-cell RCC at increased risk of recurrence after surgery, as per the Keynote-564 group definitions, should be counselled about recurrence risk by a urologist, should be informed about the potential role of adjuvant ICI systemic therapy, and be offered referral to discuss risks and benefits with a medical oncologist. The panel felt that one year of pembrolizumab is currently the only regimen that should be considered if adjuvant therapy is selected. Panelists emphasized current opinions are based on disease-free survival given the available results. Significant uncertainty regarding the benefit and harms of adjuvant therapy remains, primarily due to a lack of consistent benefit observed across similar trials of adjuvant ICI-based therapies and immature overall survival (OS) data. This consensus document provides guidance from Canadian RCC experts regarding the potential role of ICI-based adjuvant systemic therapy after surgery. This rapidly evolving field requires frequent evidence-based re-evaluation.

Evaluation of Trends in Treatment of Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Across Canada During the COVID-19 Pandemic.

In metastatic hormone sensitive prostate cancer (mHSPC), treatment intensification with either docetaxel or an androgen-receptor-axis targeted therapy (ARAT), added to androgen deprivation therapy (ADT) is the new standard of care. To better understand patterns of treatment intensification in Canada and specifically how it has been influenced by the COVID-19 pandemic, we conducted a national survey of genitourinary medical oncologists from across Canada. Using SurveyMonkey, we conducted an online survey of 119 medical oncologists in Canada from January 15 to January 27, 2021. The survey consisted of 16 questions, including demographics, and asked specifically about their approach to managing mHSPC before and during the pandemic. Overall there were 50/119 (42%) respondents. Most were male (65%), from Ontario (35%), practicing in academic centers (71%), with 45% reporting their practices focused primarily on genitourinary malignancies and one other tumor site. The majority were in practice 1 to 5 years (34%). Overall 65% indicated their practice patterns had changed since the pandemic, with 51% offering more ARATs and less docetaxel chemotherapy. In low volume mHSPC, the use of ARATs increased from 73% to 79%, while the use of docetaxel remained unaltered at 2%. In high volume disease, the use of ARATs increased from 63% to 84%, while the use of docetaxel decreased from 37% to 14%. Use of granulocyte colony stimulating factor (G-CSF) with docetaxel chemotherapy increased by 35%. Post-pandemic, 45% reported they intend to maintain these changes. Only 18% reported they had prostate cancer patients test positive for COVID-19, and all patients recovered. Management of patients with mHSPC in Canada has changed during the pandemic, with increased uptake of ARATs and reduced use of docetaxel, a trend expected to continue beyond the pandemic. How this trend will impact uptake of triplet therapy (ADT+ARAT+Docetaxel), downstream treatment choices and overall outcomes remains to be seen.

Oncologist-driven development of an electronic health record (EHR) clinical data visualization tool for prostate cancer.

267 Background: Clinical information management is a burdensome process for oncology providers owing to the complexity of modern cancer data. The results that a clinician needs to review are often spread across several areas within the EHR, making it cumbersome to sense a broad overview of patient status. The purpose of this study is to describe a framework for oncologist-driven development of a data visualization tool to trend cancer biomarkers and assess the feasibility of this tool to query and display EHR data relevant for the treatment of prostate cancer. Methods: A clinical sponsor is selected to identify data elements necessary to make treatment decisions for patients receiving therapy for prostate cancer and to provide rapid feedback for the clinical tool interface. The commercial EHR database is queried to determine identifying codes for relevant laboratory tests, medications, and procedures. Data elements are assembled using the EHR platform for clinical synopsis and the clinical tool is made available to five genitourinary medical oncologists for initial pilot. Results: Oral prostate cancer medications were queried based on medication therapeutic and pharmaceutical class. In addition, androgen deprivation therapy (ADT) injections were separately identified based on route of administration. Prostate specific antigen (PSA) and testosterone result values were queried using laboratory base and/or common name codes. However, many duplicate entities are found varying by hospital/laboratory site and test assay. The assembled clinical data visualization tool can overlay temporal trends in PSA and testosterone over medication start/stop dates to convey treatment response and signs of early medication resistance. The clinician also has the option to overlay vital signs or other laboratory information to visualize treatment related adverse events (ex. weight gain related to ADT, anemia related to PARP inhibitor therapy, etc.) Lastly, the tool can also highlight the dates of the patient’s last imaging tests to allow clinicians to determine if the patient is due for any follow up imaging. Conclusions: The EHR can support novel data visualization tools for cancer biomarkers that can reasonably support clinical workflows. Development requires an intimate knowledge of EHR data but may still be limited by duplicate or erroneous codes for laboratory results. This issue may be addressed by using standard nomenclature for laboratory results such as LOINC codes but is not currently supported by the commercial EHR. Future work in this area will include formal usability testing from the perspective of oncology providers and patients.

Reliability of real-world data for diagnosis of metastatic prostate cancer.

397 Background: Real-world data (RWD) is playing an increasingly important role in cancer research. Surrogate endpoints such as metastasis-free survival play an important role in prostate cancer research, leading to interest in its computational extraction, typically with use of International Classification of Disease (ICD) metastatic codes. While prior studies have suggested that ICD codes are valid for identification of patients (pts) with metastatic prostate cancer (MPC), delays in coding may impact their accuracy. The objective of this informatics-based study is to quantify the time delay between diagnosis of MPC and entry of ICD MPC-related code and its interaction with changing institutional healthcare processes. Methods: A single institutional EHR data warehouse was queried to identify a random sample of 100 pts with MPC diagnosis based on ICD codes (ICD10 C79 or ICD9 198.5) from 2013-2021 who were also seen in the genitourinary medical oncology program (GUMOP). Of note, in 6/2018, the GUMOP adopted EHR-specific MPC visit diagnosis identifiers (Dx ID) to improve MPC coding during clinic independent of ICD codes typically used by RWD researchers. Thus, the study cohort was designed to include pts whose first follow up after being diagnosed with MPC was before (n = 50) or after (n = 50) Dx ID implementation. Date of first MPC ICD code entry at any point in the EHR was compared against true date of MPC, based on physician review of definitive imaging or pathology. Data analysis was performed with Wilcox Signed rank test, bivariate analyses, and multivariable linear regression. Covariates included modality of diagnosis confirmation and timing with Dx ID implementation. Results: One hundred pts with MPC ICD coded in the EHR were included, with 29 pts diagnosed by PSMA PET and 71 by conventional imaging. Median time from true MPC diagnosis to first subsequent clinic follow up was < 1 month (IQR 0-2), while median time from true MPC diagnosis to entry of ICD MPC-related code was longer at 4mo (IQR 0-15). 5 pts had C79 applied for N1 disease and 10 pts for work-up of biochemical recurrence. On multivariable analysis of potential factors affecting time interval to MPC ICD entry, Dx ID implementation (b = -6.5 mo [95% CI -1.8 to -11.2], p = 0.007) and non-PSMA based diagnosis (b = -5.7 mo [95% CI -0.5 to -10.8], p = 0.03) were independently associated with shorter time to ICD coding. In subset analysis of the cohort after Dx ID implementation, use of both ICD and Dx ID to identify pts with MPC reduced the median time from true MPC diagnosis to EHR coding (1mo, IQR 0-6.3) compared to ICD alone (2mo, IQR 0-8) (p = 0.003). Conclusions: Timing of MPC ICD entry is highly variable and may carry biases derived from healthcare processes, including data entry and diagnostic testing. This may be improved with EHR workflow interventions. It is essential to have domain knowledge of clinical coding practices to improve information retrieval and recognize potential limitations and biases.

Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC).

4577 Background: Treatment (tx) landscape has evolved significantly for cisplatin-ineligible mUC patients (pts). Carboplatin and gemcitabine followed by avelumab (Av) maintenance is the current preferred standard. Although pembrolizumab (P) and atezolizumab (At) were approved as 1L therapy for these pts in 2017, the FDA has now restricted the use of 1L P to “platinum ineligible” mUC pts. We previously suggested a consensus definition for “platinum-ineligible” pts with mUC (Gupta et al. ASCO GU 2019). We now updated the consensus definition for standard therapy and clinical trial eligibility in the current tx era. Methods: We surveyed 60 genitourinary medical oncologists in the US (similar cohort to 2019) using an online tool consisting of several clinical parameters used in our initial survey with additional questions related to current available tx options. Different age and creatinine thresholds in combination with ECOG PS along with other clinically relevant established criteria were analyzed. We compiled the responses to generate a consensus definition. Results: All 60 respondents provided 100% responses. Respondents (94%) reported using a carboplatin-based regimen followed by Av and 6% reported using carboplatin-based regimen followed by P for cisplatin-ineligible mUC pts. 17/60 (28.3%) and 29/60 (48.3%) checked PD-L1 status prior to using P or At respectively. Survey results for the most common responses are presented in the Table. Conclusions: Based on the survey, any mUC pt meeting one the following 5 parameters should be considered "platinum-ineligible”: ECOG PS > / = 3; Cr Cl < 30 ml/min; peripheral neuropathy > / =Grade 2; NYHA Heart Failure Class > 3; ECOG PS 2 AND Cr Cl < 30 ml/min. These criteria are proposed to guide treatment recommendations and standardization of eligibility criteria. [Table: see text]

Practice Changing Results in RCC come from ASCO 2021

For the second year in a row, the annual meeting of the American Society of Clinical Oncology (ASCO) was held virtually due to the ongoing COVID-19 pandemic. Nonetheless, the meeting was hailed as a great success and brought much practice changing data in the field of genitourinary medical oncology, including kidney cancer.

Very late recurrence in germ cell tumor of the testis: Lessons and implications.

5030 Background: Up to 30% of patients with germ cell tumor of the testis (TGCT) develop recurrent disease after initial treatment. The majority of recurrences occur in the first 2 years after treatment. Very late recurrence (LR), i.e. > 5 years after initial presentation, occurs in about 1% of patients with TGCT and is associated with poor prognosis. Current guideline does not require follow-up after 5 years to detect LR, except in those presenting with metastatic NSGCT. Methods: We retrospectively reviewed the records of patients from the Genitourinary Medical Oncology clinic at the M. D. Anderson Cancer Center, who developed recurrent disease > 5 years after their initial diagnosis of TGCT. Specifically, we examined the pathology and location of their primary and recurrent tumors, treatments rendered (e.g., surgery, radiotherapy, chemotherapy), and overall survival after LR. Overall survival from the time of LR was estimated using Kaplan-Meier estimates and compared for patient subgroups with log rank tests. Fisher’s exact test was used to compare proportions in patient subgroups. Results: We identified 25 patients who developed LR between July 2007 and August 2020. Age at time of LR: median 46 years (range, 29-61); time of late LR: median 16.1 years (range, 6.8-33.1 years) after diagnosis. Stage at time of diagnosis: I – 5, II-IIIA – 13, IIIB-C – 7. Pathology of primary: nonseminoma with yolk sac tumor or teratoma – 15, nonseminoma without yolk sac tumor or teratoma – 1, not available – 9. Pathology of LR: somatic transformation to carcinoma – 9, somatic transformation to sarcoma – 2, nonseminoma with yolk sac tumor or teratoma – 10, nonseminoma without yolk sac tumor or teratoma – 2, not available – 2. Overall, 5 patients (20%) had LR in retroperitoneum alone, 6 patients (24%) had non-retroperitoneal nodal or pulmonary metastases, and 14 patients (56%) had non-pulmonary visceral metastases. Nine patients (36%) are deceased, ten patients (40%) are alive without evidence of disease (NED), and 6 patients are alive with disease (24%). With a median follow-up of 42 months, 68% of patients are alive 3 years after LR. Patients with prior post-chemotherapy consolidation surgery have longer survival, 80% vs. 53% at 3 years, respectively (p = 0.01). Additionally, at their last follow-up 9/12 vs. 1/13 patients were NED with vs. without prior post-chemotherapy consolidation surgery, respectively (p = 0.001). Conclusions: Patients with LR > 5 years after initial presentation tend to harbor nonseminoma (with yolk sac tumor and or teratoma). Among these patients, a majority who did not undergo surgery to remove residual disease after chemotherapy developed somatic transformation and succumbed to their LR. Further investigation into rates of LR among all patients may be warranted given the poor survival after LR.

The impact and collateral damage of COVID-19 on prostate MRI and guided biopsy operations: Society of Abdominal Radiology Prostate Cancer Disease-Focused Panel survey analysis.

The Coronavirus disease 2019 (COVID-19) pandemic has significantly affected health care systems throughout the world. A Qualtrics survey was targeted for radiologists around the world to study its effect on the operations of prostate MRI studies and biopsies. Descriptive statistics were reported. A total of 60 complete responses from five continents were included in the analysis. 70% of the responses were from academic institutions. Among all participants, the median (range) number of prostate MRI was 20 (0, 135) per week before the COVID-19 pandemic versus 10 (0, 30) during the lockdown period; the median (range) number of prostate biopsies was 4.5 (0, 60) per week before the COVID-19 versus 0 (0, 12) during the lockdown period. Among the 30% who used bowel preparation for their patients prior to MRI routinely, 11% stopped the bowel preparation due to the pandemic. 47% reported that their radiology departments faced staff disruptions, while 68% reported changes in clinic schedules in other clinical departments, particularly urology, genitourinary medical oncology, and radiation oncology. Finally, COVID-19 pandemic was found to disrupt not only the clinical prostate MRI operations but also impacted prostate MRI/biopsy research in up to 50% of institutions. The impact of this collateral damage in delaying diagnosis and treatment of prostate cancer is yet to be explored.

Implementation of clinician-facing prostate cancer therapeutic clinical trial decision tool at a comprehensive cancer center.

19 Background: The conventional model for clinical trial (CT) recruitment relies on clinicians to identify potential CTs for patients. Internet technology can be leveraged as a decision tool to enhance the CT recruitment process. Methods: An internet-based, clinician-facing decision tool was developed in genitourinary medical oncology clinic at a Comprehensive Cancer Center (CCC). The tool provided access to a real-time, tailored list of treatment CTs actively recruiting patients with PCa at the CCC based on clinical characteristics inputted by user. The clinical data was summarized. All clinicians (n = 9) with access to the decision tool completed a survey to assess effectiveness and satisfaction. Results: During a 9-month pilot period, user engagement increased from a baseline of 36 to 136 cases per month, with a total of 644 cases overall. Among cases, 525 had metastatic disease, 436 of which were metastatic castration resistant PCa (mCRPC). Overall, 145 cases were classified as having oligo-metastatic ( < = 3) PCa, 93 of whom were also mCRPC. Prior treatments received included abiraterone in hormone-sensitive PCa (HSPC 19.3%, CRPC 48.7%); enzalutamide (HSPC 3.7%, CRPC 34.9%) apalutamide (HSPC 1.3%, CRPC 6.9%), taxane (HSPC 17.2%, CRPC 27.8%), radium-223 (6.1%), sipuleucel-T (18.3%), parp inhibitors (4%), or check-point inhibitors (6%). Clinician-inputted genomics of cases included CDK12 (20.9%), MSI-high disease (13.6%), BRCA1/2 (32.7%), ARID1a (7.3%), ATM (21.8%), FANCA (4.5%), or CHEK2 (6.4%) and HDAC2 (0.9%). Among survey respondents, use of tool in clinic was reported sometimes (22%), often/always (78%). Results of decision tool were reported to inform treatment sometimes (22%) or often/always (78%). Respondents confidence in often/always knowing all available CTs increased from a baseline of 0% to 89%, and 89% of users reported very/complete satisfaction with decision tool. Conclusions: An internet-based CT decision tool for provides detailed clinical characteristics of patients for whom CTs are being considered at a CCC. Clinicians using the decision tool report high levels of satisfaction. The tool was effective in increasing confidence in knowledge of current available CTs. Data gathered in the decision tool may inform future CT development. Future research with expanded use of decision tool among referring clinicians will assess its impact in promoting diversity among CT participants.

Genitourinary Medical Oncology Expert Opinion Survey Regarding Treatment Management in the COVID-19 Pandemic.

BackgroundThe worldwide Coronavirus disease 2019 (COVID-19) public health pandemic has restructured clinical care of patients with cancer throughout the world. The specific changes in the management of genitourinary (GU) cancers in different cancer centers owing to COVID-19 are not known, and some clinical scenarios remain controversial. We conducted an opinion survey to determine what changes in cancer treatment strategies are occurring owing to the COVID-19 pandemic.Materials and MethodsA 20-item online survey was sent on May 25, 2020 to 170 expert GU medical oncologists from Europe and North America. The survey solicited responses to changes in GU cancer management in the setting of the COVID-19 pandemic. Data was collected and managed via a secure REDCap Database.ResultsSurveys were completed by 78 (45.8%) of 170 GU oncologists between May 25, 2020 and June 25, 2020. Clinical practice changes owing to COVID-19 in at least one scenario were reported by 79.1% of responders, most pronounced in prostate cancer (71.8%) and least pronounced in urothelial cancer (23%). Preferences for change in management varied by country, with 78% (37/47) of United States oncologists indicating a change in their practice, 57% (4/7) of Canadian oncologists, and 79% (19/24) of European oncologists.ConclusionsThis study suggests international practice changes are occurring in GU cancer care during the COVID-19 pandemic. The variability in practice changes between countries may reflect differences in COVID-19 case load during the time point of data collection. These results, based on expert opinion during this rapidly changing crisis, may inform the oncologic community regarding the effects of COVID-19 on GU cancer care.

The Impact of Special Access Programs (SAP) on Prescribing Patterns in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Background: Special access programs provide physicians in Canada access to new drugs before they are publicly funded, but little is known about how they impact prescribing practices. For men with metastatic castration-resistant prostate cancer post-docetaxel chemotherapy, a special access program for enzalutamide was open from June-December 2013. To better understand how this impacted prescribing practices, we surveyed medical oncologists at our institution. Methods: All four genitourinary medical oncologists at the Princess Margaret Cancer Centre completed an anonymous paper or electronic survey for each patient enrolled. The survey consisted of seven multiple-choice questions (with free text option) asking about disease characteristics, prior treatments, and reasons for prescribing enzalutamide. Results: Surveys were completed on all 155 patients; 92% (142/155) had metastatic disease, with 20% (28/142) having visceral disease; 8% (13/155) had non-metastatic disease; and the majority (92%) had progressive disease. All patients were on androgen deprivation therapy, 60% had prior prednisone, 30% had prior abiraterone, and 34% had prior docetaxel. Most (50%) used enzalutamide because it was supported by available data; 35% reported free drug was the motivating factor; 10% indicated their patients were unfit for chemotherapy; and in 5%, all other options were exhausted. Over half reported feeling enzalutamide was the appropriate treatment option for their patient at that time. Conclusions: During the special access program, most patients received enzalutamide in settings supported by available evidence. A minority did, however, received enzalutamide outside of the formally studied setting, suggesting that funding and accessibility can impact prescribing practices.

Current Management of Localized Muscle-Invasive Bladder Cancer: A Consensus Guideline from the Genitourinary Medical Oncologists of Canada

BACKGROUND: Despite recent advances in the management of muscle-invasive bladder cancer (MIBC), treatment outcomes remain suboptimal, and variability exists across current practice patterns. OBJECTIVE: To promote standardization of care for MIBC in Canada by developing a consensus guidelines using a multidisciplinary, evidence-based, patient-centered approach who specialize in bladder cancer. METHODS: A comprehensive literature search of PubMed, Medline, and Embase was performed; and most recent guidelines from national and international organizations were reviewed. Recommendations were made based on best available evidence, and strength of recommendations were graded based on quality of the evidence. RESULTS: Overall, 17 recommendations were made covering a broad range of topics including pathology review, staging investigations, systemic therapy, local definitive therapy and surveillance. Of these, 10 (59% ) were level 1 or 2, 7 (41% ) were level 3 or 4 recommendations. There were 2 recommendations which did not reach full consensus, and were based on majority opinion. This guideline also provides guidance for the management of cisplatin-ineligible patients, variant histologies, and bladder-sparing trimodality therapy. Potential biomarkers, ongoing clinical trials, and future directions are highlighted. CONCLUSIONS: This guideline embodies the collaborative expertise from all disciplines involved, and provides guidance to further optimize and standardize the management of MIBC.

Management of Germ Cell Tumors During the Outbreak of the Novel Coronavirus Disease-19 Pandemic: A Survey of International Expertise Centers.

The coronavirus disease 2019 (COVID-19) pandemic has become a public health emergency affecting frail populations, including patients with cancer. This poses the question of whether cancer treatments can be postponed or modified without compromising their efficacy, especially for highly curable cancers such as germ cell tumors (GCTs). To depict the state-of-the-art management of GCTs during the COVID-19 pandemic, a survey including 26 questions was circulated by e-mail among the physicians belonging to three cooperative groups: (a) Italian Germ Cell Cancer Group; (b) European Reference Network-Rare Adult Solid Cancers, Domain G3 (rare male genitourinary cancers); and (c) Genitourinary Medical Oncologists of Canada. Percentages of agreement between Italian respondents (I) versus Canadian respondents (C), I versus European respondents (E), and E versus C were compared by using Fisher's exact tests for dichotomous answers and chi square test for trends for the questions with three or more options. Fifty-three GCT experts responded to the survey: 20 Italian, 6 in other European countries, and 27 from Canada. Telemedicine was broadly used; there was high consensus to interrupt chemotherapy in COVID-19-positive patients (I = 75%, C = 55%, and E = 83.3%) and for use of granulocyte colony-stimulating factor primary prophylaxis for neutropenia (I = 65%, C = 62.9%, and E = 50%). The main differences emerged regarding the management of stage I and stage IIA disease, likely because of cultural and geographical differences. Our study highlights the common efforts of GCT experts in Europe and Canada to maintain high standards of treatment for patients with GCT with few changes in their management during the COVID-19 pandemic. Despite the chaos, disruptions, and fears fomented by the COVID-19 illness, oncology care teams in Italy, other European countries, and Canada are delivering the enormous promise of curative management strategies for patients with testicular cancer and other germ cell tumors. At the same time, these teams are applying safe and innovative solutions and sharing best practices to minimize frequency and intensity of patient contacts with thinly stretched health care capacity.

Abstract A081: Trial Library: A pilot study to examine feasibility, acceptability, and preliminary estimates of efficacy for an online clinical trial matching website on patient-prompted conversations for prostate cancer clinical trials

Abstract Background: The ability of clinical trials to effectively translate into therapeutic interventions for the general population can be limited by a lack of representative participants in these trials. There is an acute need to develop informational resources regarding cancer clinical trials that meet the linguistic and literary needs of under-represented and vulnerable populations. Current practices utilize a one-size-fits-all approach that may be inaccessible to a diverse audience. Given the increased utilization of online resources for health information among a diverse patient population and across age groups, we developed a website, called Trial Library, which may serve as a prostate cancer clinical trial matching tool. We hypothesize that use of the Internet-based clinical trial matching tool in clinic will increase the number of patient-initiated conversations with physicians about clinical trial options, and by extension, improve enrollment to therapeutic cancer clinical trials among a diverse participant pool. Procedures/Design/Aims: This is a nonrandomized, nontherapeutic interventional pilot study. The study will be performed in genitourinary medical oncology clinic at UCSF Helen Diller Family Comprehensive Cancer Center. We will measure the feasibility and acceptability of a clinical trial matching tool that includes two unique features: user-validated clinical trial content and navigation schema. We will measure preliminary estimates of efficacy of the online clinical trial matching tool in triggering patient-promoted conversations regarding clinical trials and ultimately clinical trial enrollment. Discussion: Trial Library is designed to be an accessible informational resource for patients from diverse levels of health literacy and English proficiency. This pilot study will provide important preliminary results to inform the design of the website and subsequent testing outside of clinic. Additionally, this website will ultimately serve as a model for clinical trial information that can be translated across tumor types. Note: This abstract was not presented at the conference. Citation Format: Hala T. Borno, Brian Bakke, Anke Hebig Prophet, Yoon-Ji Kim, Jan Yaeger, Jessica Chao, Pelin Cinar, Celia Kaplan, Eric Small, Christy Boscardin, Ralph Gonzales. Trial Library: A pilot study to examine feasibility, acceptability, and preliminary estimates of efficacy for an online clinical trial matching website on patient-prompted conversations for prostate cancer clinical trials [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A081.

Management of urachal cancer: A consensus statement by the Canadian Urological Association and Genitourinary Medical Oncologists of Canada.

The urachus is a fibrous remnant of the allantois. After birth, it remains throughout life as the medial umbilical ligament running from the apex of the bladder to the umbilicus but without any further physiological role. First described by Begg in 1931, urachal cancer is a rare pathology representing less than 1% of bladder cancers.1 Usually located on the serous side of the bladder apex, these tumors are classically silent because of their extravesical and extraperitoneal location. Therefore, most patients present with local invasion or metastatic disease and, thus, are detected at a higher stage. Based on its rarity, there have been no large, prospective, randomized trials in urachal cancer and there are no evidence-based guidelines on the management of this disease. The existing evidence in the medical literature is derived from case series. In this article, led by the Genitourinary Medical Oncologists of Canada (GUMOC), we aim to review the literature of this rare disease in order to establish a Canadian consensus statement on the management of urachal cancer. To our knowledge, there is no other consensus statement available.

Canadian Urological Association/Genitourinary Medical Oncologists of Canada consensus statement: Management of unresectable locally advanced and metastatic urothelial carcinoma.

In Canada, bladder cancer ranks as the fifth most common cancer, with an estimated 8900 new cases and 2400 deaths in 2018.1 Approximately 15% of patients have locally advanced or metastatic disease at presentation. A further 40–50% of those with muscle-invasive, early-stage disease will relapse after initial treatment. The majority of patients with advanced-stage disease will succumb to their disease. Cancers of the ureter, renal pelvis, and proximal urethra constitute approximately 5–10% of cases of urothelial carcinoma and are treated with similar systemic therapy as bladder cancer. GUMOC (Genitourinary Medical Oncologists of Canada) is comprised of Canadian medical oncologists who specialize in the treatment of genitourinary cancers. With recent advances in systemic therapy, especially due to the emergence of immunotherapy as a therapeutic option, a consensus opinion has become necessary to guide the management of unresectable, locally advanced and metastatic urothelial carcinoma.

Safety, Efficacy, and Clinical Impact of Penicillin Skin Testing in Immunocompromised Cancer Patients

Use of penicillin skin testing (PST) to rule out penicillin (PCN) allergies is safe and effective in immunocompetent patients; however, data on immunocompromised patients are limited. We aimed to determine safety, efficacy, and clinical impact of PST in immunocompromised patients with cancer. A quality improvement process establishing a PST service was implemented at MD Anderson Cancer Center. Adult patients admitted to leukemia and genitourinary medical oncology (GUMO) services with history of possible type I reactions to PCN were eligible for testing. Between April and October 2017, 218 patients with reported PCN allergies were screened; 100 met inclusion criteria and underwent PST (67 leukemia, 33 GUMO). The most common reported allergy was to PCN (64%), with 61% reporting cutaneous reactions and 79% reporting reactions more than 20 years ago. PST with oral challenge results were overwhelmingly negative (95%); only 4% tested positive, and 1 test result was indeterminate (negative histamine control). After negative PST and oral challenge results, 51% patients were transitioned to PCN-based antibiotics during the same hospitalization. During the follow-up period (median 177 days), 65 of 95 patients were readmitted (185 total readmissions), and 51 patients required antibiotic therapy, with 37 receiving a PCN-based antibiotic (accounting for 336 days of therapy). No patient who received PCN-based antibiotics experienced an immediate-type allergic reaction. Our findings support PST use in immunocompromised hosts. The widespread use of PST in patients with cancer will allow for optimal use of antimicrobial therapy and stewardship, which are vital in a population at increased risk for infections.

Expectations of cure among patients with advanced genitourinary cancer treated with immunotherapy.

591 Background: Over the past 15 years, considerable progress has been made in systemic therapy options for genitourinary (GU) cancers. In diseases such as metastatic renal cell carcinoma (RCC) and urothelial cancer (UC), immunotherapeutic strategies such as programmed death-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibition have elicited durable responses, albeit in a minority of patients. We examined expectations for clinical outcome with immunotherapy among patients with advanced GU cancers. Methods: A survey study was conducted in patients with advanced GU cancers initiating PD-1/PD-L1 inhibitors from October 2017 to September 2018. Patients were screened prior to initiation of immunotherapy for their expectation of cure (divided into 4 quartiles), symptoms of anxiety and depression (PROMIS-A and PROMIS-D), and quality of life (QOL; FACT-G). For purposes of the survey, cure was equated to a durable complete response. Differences in frequency of anxiety, depression and QOL were compared amongst subsets of patients divided by expectation of cure. Results: Among 60 patients, median age was 67, 72% were male and 81% were married. Types of cancer included RCC (69%), UC (19%) and prostate cancer (12%). The majority were in the 1st or 2nd line of therapy (40% and 31%, respectively). Despite extensive counseling from GU medical oncologists, 23% of patients thought that cure was “very likely”, defined as in the range of 76-100%. Approximately 70% of patients estimated cure in the range of 0-25%, in line with clinical counseling. These patients had higher rates of anxiety (P = 0.01), depression (P = 0.002) and poorer QOL (P = 0.003) compared to patients who felt cure was very likely. Conclusions: A considerable proportion of patients with advanced GU malignancies harbor unrealistic expectations around the potential benefit of immunotherapy. Although a first instinct may be to remedy these expectations, it is important to bear in mind that these patients had better emotional well-being and QOL. We will validate these findings and assess these parameters longitudinally in an upcoming SWOG trial for patients with mRCC receiving upfront immunotherapy.

Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC).

451 Background: Patients (pts) with mUC who are ineligible to receive cisplatin have limited treatment options. Pembrolizumab and atezolizumab were approved as 1st-line therapy in these pts, but their use is now restricted in pts with tumors with high PD-L1 expression, or platinum-ineligible. “Platinum-ineligible” mUC (cisplatin and carboplatin ineligible), remains undefined, and a clear definition is needed for determining treatment and clinical trial eligibility. Methods: We surveyed 56 genitourinary medical oncologists in the US using an online tool consisting of several clinical parameters (Round 1) and based on the responses, we refined the survey (Round 2) and then compiled the responses to generate a consensus definition. Results: Responses were received from 43/56 (77%) of those surveyed in Round 1 and 44/56 (78.5%) in Round 2. Based on the results shown in the Table, we recommend 1 of the following 5 parameters be used to define "platinum-ineligible” mUC: ECOG PS > 3; Cr Cl < 30 ml/min; Peripheral neuropathy > 3; NYHA Heart Failure Class > 3; ECOG PS 2 and Cr Cl < 30 ml/min. Conclusions: “Platinum-ineligible” mUC is a new and undefined category with a substantial definition variability among investigators. Results from consensus definition are proposed for standardization of this mUC category. [Table: see text]