Kathryn Fortune , Soham Ali , Jack Masur , Paul Viscuse , Michael Devitt , Robert Dreicer , William Paul Skelton IV
{"title":"Impact of Renin-Angiotensin System Inhibitors on Response to PD1/L1 Inhibitors in Patients With Metastatic Renal Cell Carcinoma","authors":"Kathryn Fortune , Soham Ali , Jack Masur , Paul Viscuse , Michael Devitt , Robert Dreicer , William Paul Skelton IV","doi":"10.1016/j.clgc.2024.102256","DOIUrl":"10.1016/j.clgc.2024.102256","url":null,"abstract":"<div><h3>Background</h3><div>The renin-angiotensin-aldosterone system (RAAS), traditionally associated with blood pressure and fluid regulation, also plays a role in tumorigenesis. Renin-angiotensin-aldosterone system inhibitors (RAASI), including angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs), have been shown to improve outcomes in various malignant neoplasms. In metastatic urothelial cancer, the use of RAASI have been associated with higher rates of tumor regression in patients receiving immunotherapy (IO) with PD1/L1 inhibitors. This is thought to be due to RAASI-induced downregulation of TGF-beta, for which increased expression is a known mechanism of PD1/L1 inhibitor resistance. We hypothesized that concurrent RAASI in patients with mRCC receiving IO is associated with increased tumor regression.</div></div><div><h3>Methods</h3><div>We conducted a retrospective analysis of patients with mRCC receiving IO as a first- or second-line therapy from 2016-2023 at the University of Virginia. A logistic regression model was used to evaluate the impact of concurrent RAASI on tumor regression. The primary endpoint was any regression of tumor on imaging.</div></div><div><h3>Results</h3><div>Data were available for 128 patients with mRCC who received IO as a first- (n = 91, 71.0%) or second- (n = 37, 28.9%) line treatment. Patients who received RAASI during IO were more likely to have tumor regression compared to patients who were not on concurrent RAASI (OR 3.84 [95% CI 1.81-8.47, <em>P</em> =< .001). This held true regardless if patients received IO as a first-line (OR 2.83 [95% CI 1.2-6.94], <em>P</em> = .0173) or second-line (OR 9.5 [95% CI 1.89-73.1], <em>P</em> = .005) treatment.</div></div><div><h3>Conclusions</h3><div>Our hypothesis generating study suggests that in our mRCC population, concurrent use of RAASI in patients receiving IO was associated with a significantly increased likelihood of tumor regression. These findings highlight the potential therapeutic advantage of RAASI in combination with IO for mRCC patients. Further exploration of this association is warranted in prospective studies to improve treatment outcomes for this patient population.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102256"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142721626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shawn Dason , Rajvi Goradia , Victor Heh , Akshay Sood , Matthew Lee , Young Son , Yuanquan Yang , Shang-Jui Wang , Elshad Hasanov , Tasha Posid , Eric A. Singer
{"title":"Impact of Preoperative Systemic Therapy on Cytoreductive Nephrectomy Outcomes in the National Surgical Quality Improvement Program (NSQIP)","authors":"Shawn Dason , Rajvi Goradia , Victor Heh , Akshay Sood , Matthew Lee , Young Son , Yuanquan Yang , Shang-Jui Wang , Elshad Hasanov , Tasha Posid , Eric A. Singer","doi":"10.1016/j.clgc.2024.102258","DOIUrl":"10.1016/j.clgc.2024.102258","url":null,"abstract":"<div><h3>Introduction</h3><div>Management of metastatic renal cell carcinoma (mRCC) is highly individualized and often involves cytoreductive nephrectomy (CN) and systemic therapy (ST). The optimal sequencing of CN and ST is uncertain. A difference in perioperative outcomes based on sequence of CN and ST could influence decisionmaking. We analyzed the National Surgical Quality Improvement Program (NSQIP) database to assess whether preoperative systemic therapy adversely impacted perioperative outcomes in patients receiving deferred CN.</div></div><div><h3>Methods</h3><div>This analysis was conducted using the American College of Surgeons NSQIP Participant Use Data File for years 2019 and 2020. Groups were stratified by their receipt of preoperative systemic therapy within 90 days before CN. The primary outcome of our study was overall major complication rate. Secondary outcomes included overall complication rate, length of stay, operative time, discharge to home, adjunctive procedures, conversion from minimally-invasive to open surgery and infectious complications. Multivariate logistic regression was used to assess the role of preoperative systemic therapy and other predictors on the primary and secondary outcome(s).</div></div><div><h3>Results</h3><div>The study cohort comprised of 752 patients (586 upfront vs. 166 deferred) undergoing cytoreductive nephrectomy from 2019-2021. There were no significant differences in major complication rate (8% upfront vs. 5% deferred, <em>P</em> = .188) or overall complication rate (33% upfront vs. 39% deferred, <em>P</em> = .152). On multivariate analysis, bleeding diathesis, adjunctive procedures, and higher ASA class were predictive of major complications. Patients receiving preoperative ST were more likely to be on steroids (23% vs. 7%, p</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102258"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142745143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yeuk-lam Hong , Chi-fai Ng , Kenneth Chun-wai Wong , Wing-yan Kong , Peter Ka-Fung Chiu , Jeremy Yuen-Chun Teoh , Chi-ho Leung , Pui-tak Lai
{"title":"Patient Preferences for Metastatic Prostate Cancer Treatment: A Discrete Choice Experiment","authors":"Yeuk-lam Hong , Chi-fai Ng , Kenneth Chun-wai Wong , Wing-yan Kong , Peter Ka-Fung Chiu , Jeremy Yuen-Chun Teoh , Chi-ho Leung , Pui-tak Lai","doi":"10.1016/j.clgc.2024.102254","DOIUrl":"10.1016/j.clgc.2024.102254","url":null,"abstract":"<div><h3>Background</h3><div>To examine the preference weightings for risk/benefit attributes of therapy in metastatic prostate cancer (mPC) patients, encompassing hormone-sensitive (mHSPC) and castration-resistant (mCRPC) settings.</div></div><div><h3>Patients and Methods</h3><div>A noninterventional cross-sectional survey employing a discrete choice experiment was conducted, recruiting 200 mHSPC and 100 mCRPC patients within 5 years of diagnosis from the urology and oncology specialty clinics between Feb 2023 and Jul 2023. Patients were randomized into 2 blocks of 9 questions, choosing 1 out of 2 medication profiles consisting 5 attributes, each with 3 levels, determined from a group interview of 5 patients. A mixed logit model estimated attribute-level preference weightings, with tradeoff points calculated.</div></div><div><h3>Results</h3><div>Median age was 75 (IQR:71-81), 170 (56.7%) had no income, 245 (81.7%) cared for themselves, mean maximum out-of-pocket treatment cost was US$20,456 (SD:43,568), and 160 (53.3%) claimed not to consider further treatment when cost exceeding their affordability. Patients favoured self-care ability (4.37, <em>P</em> < .001) and life expectancy extension (2.83, <em>P</em> < .001), disfavoured adverse effects (−6.97, <em>P</em> < .001) and treatment cost (in HK$million or USD$128,205) (−3.14, <em>P</em> < .001). mCPRC patients was more sensitive to treatment cost (−3.61 vs. −2.97), life expectancy extension (3.47 vs. 2.55) and adverse effects (−7.55 vs. −6.80) compared to mHSPC patients. Higher financial affordability patients exhibited higher sensitivity to self-care ability (4.89 vs. 4.02) and adverse effects (−7.57 vs. −6.70).</div></div><div><h3>Conclusion</h3><div>The chance of adverse effects was pivotal in treatment decisions, followed by self-care ability, with cost remaining a major access barrier.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102254"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142696156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giulia Giannini , Mona Kafka , Hannes Neuwirt , Nastasiia Artamonova , Gianpaolo di Santo , Irene Virgolini , Robert Dotzauer , Emil Deiss , Pia Paffenholz , Axel Heidenreich , Sazan Rasul , Igor Tsaur , Steffen Rausch , Holger Einspieler , Christian la Fougère , Nils F. Trautwein , Fabio Zattoni , Matteo Sepulcri , Isabel Heidegger
{"title":"Safety and Efficacy of 177Lu-PSMA Therapy Following 223Radium Treatment: A Retrospective Multinational Real-World Analysis","authors":"Giulia Giannini , Mona Kafka , Hannes Neuwirt , Nastasiia Artamonova , Gianpaolo di Santo , Irene Virgolini , Robert Dotzauer , Emil Deiss , Pia Paffenholz , Axel Heidenreich , Sazan Rasul , Igor Tsaur , Steffen Rausch , Holger Einspieler , Christian la Fougère , Nils F. Trautwein , Fabio Zattoni , Matteo Sepulcri , Isabel Heidegger","doi":"10.1016/j.clgc.2024.102260","DOIUrl":"10.1016/j.clgc.2024.102260","url":null,"abstract":"<div><h3>Background</h3><div><sup>177</sup>Lu PSMA therapy is increasingly used for metastatic castration-resistant prostate cancer (mCRPC) treatment. However, data on its efficacy and safety in patients previously treated with <sup>223</sup>Ra remain limited.</div></div><div><h3>Methods</h3><div>This retrospective, multicenter study evaluated 233 mCRPC patients treated with <sup>177</sup>Lu PSMA at 5 European centers. The cohort included 27 patients previously treated with <sup>223</sup>Ra and 206 Radium-naive patients. Statistical analyses, including Chi-squared, Mann-Whitney U tests, and multivariate logistic regression, were used to assess response and mortality. Predictors of response and mortality were identified using multivariate models.</div></div><div><h3>Results</h3><div>Patients who experienced a longer interval between castration resistance and the initiation of <sup>177</sup>Lu PSMA therapy demonstrated better responses (median 17 months in responders vs. 8.5 months in progressors, <em>P</em> = .001). Platelet counts were significantly lower in the progressive group compared to the responsive group (<em>P</em> = .01). Multivariate regression confirmed lower platelet levels as a predictor of poor response (<em>P</em> = .029). The overall response rate to <sup>177</sup>Lu PSMA was 54%, similar between the <sup>223</sup>Ra-pretreated and Radium-naive groups. However, mortality was significantly higher in the <sup>223</sup>Ra-pretreated group (86%) compared to the Radium-naive group (51%, <em>P</em> = .003). ECOG performance status (<em>P</em> = .004) and ALP levels (<em>P</em> = .030) were significant predictors of mortality, while CRP showed a trend towards significance (<em>P</em> = .064). Tolerability of <sup>177</sup>Lu PSMA was comparable to the safety profile reported in the literature, with 44% of <sup>223</sup>Ra-pretreated patients experiencing AEs and 22% experiencing severe AEs (Grade ≥ 3).</div></div><div><h3>Conclusions</h3><div><sup>177</sup>Lu PSMA therapy is effective and well-tolerated in mCRPC patients pretreated with <sup>223</sup>Ra. However, higher mortality was observed in the <sup>223</sup>Ra-pretreated group. ECOG PS, ALP, and platelet counts were significant predictors of response and mortality, and a longer interval between therapies was associated with better outcomes. These findings underscore the importance of treatment sequencing and monitoring prognostic markers.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102260"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142721625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Isabella Saporita , Mariangela Calabrese , Stefano Poletto , Fabio Turco , Rosario Francesco Di Stefano , Orazio Caffo , Antonio Russo , Ugo De Giorgi , Marcello Tucci , Massimo Di Maio , Saverio Cinieri , Consuelo Buttigliero
{"title":"Testing BRCA 1-2 Mutations in Metastatic Prostate Cancer: Results of a Survey of the Italian Association of Medical Oncology","authors":"Isabella Saporita , Mariangela Calabrese , Stefano Poletto , Fabio Turco , Rosario Francesco Di Stefano , Orazio Caffo , Antonio Russo , Ugo De Giorgi , Marcello Tucci , Massimo Di Maio , Saverio Cinieri , Consuelo Buttigliero","doi":"10.1016/j.clgc.2024.102255","DOIUrl":"10.1016/j.clgc.2024.102255","url":null,"abstract":"<div><h3>Background</h3><div>20% of prostate cancer (PC) patients harbor germinal or somatic alterations in homologous recombination repair (HRR) genes, including BRCA1/2. BRCA mutations represent predictive biomarkers for treatment with polyadenosine diphosphate-ribose inhibitors (PARPi). Olaparib has shown efficacy in metastatic castration-resistant PC (mCRPC) and is currently approved in Italy for mCRPC with BRCA1/2 mutations. National and international guidelines strongly recommend BRCA testing in PC. However, genetic testing presents challenges in clinical practice that may limit access to PARPi.</div></div><div><h3>Methods</h3><div>we conducted a survey directed towards members of the Italian Association of Medical Oncology to highlight the level of implementation of national recommendations and issues associated with genetic testing. Through an anonymous questionnaire, the survey collected clinical data of PC patients undergoing BRCA testing and the main difficulties to face in conducting the analysis.</div></div><div><h3>Results</h3><div>The survey was completed by 108 participants (5% of AIOM members). 52.8% of respondents test BRCA in all metastatic PC patients. If tissue analysis is invalid, only 17% use liquid biopsy, and 15.7% always consider a re-biopsy of a metastatic lesion. A quarter of respondents have to outsource genetic testing to another center and 17.6% have a split process between different institutions. Long timelines, lack of a predefined procedure, and unavailability of liquid biopsy represent the main issues based on respondents' opinions.</div></div><div><h3>Conclusions</h3><div>BRCA testing in PC still presents several difficulties in clinical practice that can limit access to PARPi treatment. Better implementation of molecular testing to identify BRCA-mutated patients is crucial for tailored treatment in mCRPC.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102255"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142745144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Qiong Bao , Yan Li , Yu Chen , Ji Zheng , Jiang Zhao , Ting Hu
{"title":"Transcriptome-Based Network Analysis Related to Histone Deacetylase Genes and Identified EMP1 as a Potential Biomarker for Prognosis in Bladder Cancer","authors":"Qiong Bao , Yan Li , Yu Chen , Ji Zheng , Jiang Zhao , Ting Hu","doi":"10.1016/j.clgc.2024.102262","DOIUrl":"10.1016/j.clgc.2024.102262","url":null,"abstract":"<div><h3>Background</h3><div>Abnormal expression and function of histone deacetylases (HDACs) are closely associated with the development of bladder cancer (BCa). Systematic elucidation of the role of HDACs in BCa is expected to improve BCa prognosis and treatment strategies.</div></div><div><h3>Methods</h3><div>We explored the correlation and expression patterns of HDAC family genes in BCa. Consensus clustering was employed to categorize BCa into subtypes based on HDAC expression profiles. Differential analysis, pathway enrichment analysis, and drug responsiveness evaluation were conducted to characterize HDAC subtypes. Then, a prognostic model based on HDAC cluster related genes was constructed and validated across multiple cohorts.</div></div><div><h3>Results</h3><div>We identified distinct HDAC expression patterns and correlations with immune cell infiltration and enrichment of pathways in cancer, highlighting their role in BCa. Consensus clustering revealed 2 HDAC gene subtypes. Gene cluster 1 showed worse survival, higher clinical stage, and lower immune cell infiltration compared to gene cluster 2. Additionally, pathway enrichment analysis revealed differences in tumor-promoting pathways between the clusters. Moreover, gene cluster 1 exhibited higher resistance to Rho kinase inhibitor drugs. Multi-omic analysis unveiled unique mutation and CNV profiles between the clusters, indicating distinct molecular features. Furthermore, a HDAC gene-related prognostic model demonstrated robust predictive accuracy and identified EMP1 as a key prognostic gene associated with poor survival and enriched metastatic pathways.</div></div><div><h3>Conclusion</h3><div>Our study provides comprehensive insights into the landscape of HDACs in BCa, elucidating their roles in tumor heterogeneity, immune modulation, drug responsiveness, and molecular features. EMP1 is a potential therapeutic target and prognostic marker for BCa.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102262"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142721643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Dose Per Body Weight Predicts Incidence and Severity of Apalutamide-Related Skin Rash in Metastatic Castration-Sensitive Prostate Cancer","authors":"Kotaro Suzuki, Yusuke Shiraishi, Yasuyoshi Okamura, Yukari Bando, Takuto Hara, Keisuke Okada, Tomoaki Terakawa, Yoji Hyodo, Koji Chiba, Jun Teishima, Yuzo Nakano, Hideaki Miyake","doi":"10.1016/j.clgc.2024.102250","DOIUrl":"10.1016/j.clgc.2024.102250","url":null,"abstract":"<div><h3>Background</h3><div>A survival advantage with apalutamide (APA) combined with androgen deprivation therapy for metastatic castration-sensitive prostate cancer (mCSPC) has been demonstrated in the clinical trial, irrespective of race. However, the incidence of APA-induced skin rash in the Japanese subpopulation is higher than that in the global population. In the present study, we investigated the predictive value of APA dose per body weight for the incidence of skin rash.</div></div><div><h3>Methods</h3><div>A total of 128 patients with mCSPC treated with APA between January 2018 and December 2022 were retrospectively reviewed. A receiver operating characteristic analysis was performed to identify the optimal APA cutoff dose. In addition to comparing the status of APA-induced skin rash, the progression-free survival (PFS) was compared after propensity score matching.</div></div><div><h3>Results</h3><div>The optimal cutoff dose predicting the occurrence of skin rash was 3.33 mg/kg. Our cutoff value significantly stratified the 2 groups in time to occurrence of APA-induced skin rash and discontinuation of APA due to skin rash (<em>P</em> = .005 and <em>P</em> = .009, respectively). The incidence of a ≥G3 skin rash in patients receiving ≥3.33 mg/kg was significantly higher than in others (6.5% vs. 19.7%, <em>P</em> = .037). There was no significant difference in the PFS between patients administered <3.33 mg/kg and those administered ≥3.33 mg/kg.</div></div><div><h3>Conclusions</h3><div>Our data suggest that the drug dosage per body weight may predict the incidence and severity of APA-induced skin rash. Further large-scale prospective studies are needed to validate the predictive value of drug dosage per body weight and identify the optimal cutoff value.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102250"},"PeriodicalIF":2.3,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142690143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hersh Trivedi , Hannah Kay , Katy Reines , Julie Hartzell , Eiman Newcomer , Shannon Myers , Richard S. Matulewicz , Adam O. Goldstein , Kimberly A. Shoenbill , Marc A. Bjurlin
{"title":"Efficacy of Inpatient, Evidence-Based Tobacco Use Treatment of Patients With Bladder Cancer After Radical Cystectomy","authors":"Hersh Trivedi , Hannah Kay , Katy Reines , Julie Hartzell , Eiman Newcomer , Shannon Myers , Richard S. Matulewicz , Adam O. Goldstein , Kimberly A. Shoenbill , Marc A. Bjurlin","doi":"10.1016/j.clgc.2024.102252","DOIUrl":"10.1016/j.clgc.2024.102252","url":null,"abstract":"<div><h3>Purpose</h3><div>Despite a 3-fold increase in risks of bladder cancer (BC) among current smokers, smoking cessation therapy for patients undergoing treatment is significantly underutilized. Inpatient admission after surgery provides a teachable moment to pursue tobacco treatment. We conducted a 12-month prospective quality improvement initiative to increase tobacco treatment program (TTP) consultations with BC patients who smoke and underwent radical cystectomy (RC).</div></div><div><h3>Materials and Methods</h3><div>From 6/2022 to 6/2023, patients admitted after RC for BC who were identified to be current smokers were referred to our institution's inpatient TTP. A baseline standardized assessment of tobacco dependence was conducted postoperatively, and nicotine replacement therapy (NRT) was prescribed both inpatient and upon discharge. Study endpoints included the percentage of patients receiving inpatient TTP consultation, inpatient and 1-month NRT prescription fill rates, tobacco usage, cessation rates, quit attempts, and patient and provider satisfaction. Postintervention outcomes were compared to historical controls.</div></div><div><h3>Results</h3><div>Of the 16 inpatients (of 63 RCs) who smoked and received a TTP referral, 15 accepted. Referrals to TTP increased from 20% at baseline to 100% after implementation of the intervention (<em>P</em> = .01). NRT was prescribed for 40% of inpatients, and 60% of patients filled NRT after discharge. At 1-month follow-up, a significant decrease occurred in cigarette use (12.6 cigarettes/day to 6.8 cigarettes/day; <em>P</em> = .001). The majority, 86%, reported attempts to quit, and 29% reported that they successfully quit smoking. Patients reported high levels of stress reduction, confidence to quit, desire to quit, and willingness to use NRT. Most (83%) providers were very satisfied with the TTP and felt recommendations were easy to implement.</div></div><div><h3>Conclusions</h3><div>This study successfully increased the use of inpatient TTP in patients with BC who smoked and were undergoing RC. The positive outcomes, including high acceptability among patients, increased rates of TTP consultations, reduced cigarette usage postintervention, and notable satisfaction among healthcare providers, suggest that these strategies can be readily adopted by urologic care teams.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102252"},"PeriodicalIF":2.3,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142694006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ronac Mamtani , Nobuaki Matsubara , Alvaro Montesa Pino , Urbano Anido Herranz , Mehmet A. N. Şendur , Gwenaelle Gravis , Olivier Huillard , Hyo Jin Lee , Rustem Gafanov , Florence Joly , Jens Bedke , Avishay Sella , Yen-Hwa Chang , Kentaro Imai , Blanca Homet Moreno , Jin Zhi Xu , Ajjai Alva , Thomas Powles
{"title":"Outcomes by Retrospective Eligibility for Maintenance Therapy of Patients With Advanced Urothelial Carcinoma: Post Hoc Analysis of the Phase 3 KEYNOTE-361 Trial","authors":"Ronac Mamtani , Nobuaki Matsubara , Alvaro Montesa Pino , Urbano Anido Herranz , Mehmet A. N. Şendur , Gwenaelle Gravis , Olivier Huillard , Hyo Jin Lee , Rustem Gafanov , Florence Joly , Jens Bedke , Avishay Sella , Yen-Hwa Chang , Kentaro Imai , Blanca Homet Moreno , Jin Zhi Xu , Ajjai Alva , Thomas Powles","doi":"10.1016/j.clgc.2024.102248","DOIUrl":"10.1016/j.clgc.2024.102248","url":null,"abstract":"<div><h3>Introduction</h3><div>The phase 3 KEYNOTE-361 trial of first-line pembrolizumab with or without chemotherapy versus chemotherapy alone in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) completed enrollment before the approval of postchemotherapy maintenance avelumab for patients without progressive disease. This post hoc analysis evaluated the outcomes of patients who received chemotherapy alone in KEYNOTE-361 by retrospective eligibility for subsequent maintenance therapy.</div></div><div><h3>Patients and Methods</h3><div>Patients in the chemotherapy alone arm were retrospectively categorized as maintenance eligible (received ≥4 cycles of chemotherapy and did not die or experience disease progression within 10 weeks of chemotherapy completion), maintenance ineligible (received <4 cycles of chemotherapy or had progressive disease or died within 0-10 weeks after completion of ≥4 cycles of chemotherapy), and indeterminate eligibility for maintenance therapy (if neither maintenance eligible or ineligible). End points included progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent central review and overall survival from randomization (start of chemotherapy).</div></div><div><h3>Results</h3><div>Median follow-up was 31.7 months (range, 22.0-42.3). Among 342 patients who received chemotherapy alone, 172 (50.3%) were maintenance eligible, 108 (31.6%) were maintenance ineligible, and 62 (18.1%) had indeterminate eligibility for maintenance therapy. The median progression-free survival was 9.0 months (95% CI 8.4-10.4) in maintenance-eligible patients, 5.1 months (4.2-6.0) in maintenance-ineligible patients, and 2.3 months (1.9-3.8) in the indeterminate group; median overall survival was 23.3 months (95% CI 19.4-26.1), 10.2 months (9.1-11.6), and 5.5 months (3.7-8.5), respectively.</div></div><div><h3>Conclusion</h3><div>This post hoc analysis suggests that a majority of patients with untreated la/mUC who initiated chemotherapy in a clinical trial may have been considered eligible for maintenance therapy and had favorable survival outcomes compared with those considered maintenance ineligible.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102248"},"PeriodicalIF":2.3,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142696149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}