bluuebunny/crossref_metadata_2025_split huggingface dataset:
Real-world (rw) treatment (tx) patterns, sequencing, and outcomes in US patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC) treated with avelumab first-line maintenance (1LM).
Authors: Carson Kenneth Robert , Ike Chiemeka , Mahmoudpour Seyed Hamidreza , Monzon Sebastian , Fragkogianni Stamatina , Kearney Mairead 
Published: June 2024

e16621 Background: In June 2020, avelumab 1LM was approved in the US for pts with la/mUC without progressive disease (PD) after 1L platinum-based chemotherapy (PBC). This rw study describes pt characteristics, tx patterns, and outcomes in pts who received avelumab 1LM. We report exploratory analyses by baseline metastatic site. Methods: A retrospective cohort of pts diagnosed with la/mUC (T4b, N2/3, and/or M1) who received systemic tx after approval of avelumab 1LM was identified from deidentified records in the Tempus database. Pts with no evidence of PD after completing 1L PBC were considered eligible for 1LM. 1LM was differentiated from second-line (2L) tx based on recorded clinical intent or algorithmically based on immuno-oncology tx initiated within 180 days of 1L PBC completion without recorded PD. Rw overall survival (OS), progression-free survival (PFS), and time to next tx (TTNT) were estimated using Kaplan-Meier methods. Results: By data cutoff (Nov 2023), 1485 pts had received 1L tx after approval of avelumab 1LM. Median age at diagnosis was 70 y, 74% were men, 62% were White, 88% had transitional cell carcinoma, and 62% had metastatic/stage IV disease. 1L tx was PBC in 63% (942/1485), which included cisplatin in 62% (581/942), carboplatin in 34% (326/942), and oxaliplatin in 4% (35/942), alone or in combination. 87% (820/942) were eligible for 1LM after completing 1L PBC, of whom 38% (313/820) had recorded 1LM tx, which was avelumab in 58% (180/313). Median follow-up from 1LM start was 13.5 months. Median (95% CI) rwOS and rwPFS from avelumab 1LM start was 20.6 (17.6-25.3) and 6.2 (4.6-13.7) months, respectively. Analysis by metastatic site is shown in the table. After avelumab 1LM, 37% (67/180) received 2L tx, most commonly with enfortumab vedotin (EV; 64% [43/67]); median rwOS from start of 2L EV was 13.5 months (95% CI, 11.6-NE). Conclusions: Despite limited follow-up, this study demonstrates the rw effectiveness of avelumab 1LM in pts whose disease has not progressed on 1L PBC. Results corroborate JAVELIN Bladder 100 data and recent rw studies from multiple countries. Our study also provides early evidence of the use and effectiveness of 2L EV after the JAVELIN Bladder regimen of 1L PBC without PD followed by avelumab 1LM. Understanding OS outcomes in pts with specific metastatic patterns is important for improving individualized care. Future studies with longer follow-up are warranted to evaluate rw benefits of the avelumab 1LM in selected pt groups. [Table: see text]
Genetic analysis of metastatic castration resistant prostate cancer patients treated with Lu-177 PSMA radioligand therapy.
Authors: Yilmaz Burcak , Chalker Cameron , Yu Yun , Kaempf Andy , Mittra Erik , Mallak Nadine , Sokolova Alexandra 
Published: June 2024

e17063 Background: We aim to elucidate associations between mutations, treatment response, and overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC) patients undergoing Lu-177 PSMA radioligand therapy (PSMA-RLT). Methods: We reviewed mCRPC patients who received at least 1 cycle of PSMA-RLT between May 2022 and October 2023, assessing mutations that included ATM, ATR, BRCA1/2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2/6, NBN, PALB2, PMS2, RAD51C, RAD51D, and TP53. Clinical variables were collected. Biochemical response (BR) was defined as PSA reduction ≥ 50% over the complete course of PSMA-RLT. PSMA PET segmentation was performed with MIM PUR PSMA (version 7.2.9). OS was measured from start of PSMA-RLT, estimated by the Kaplan-Meier method, and modeled with Cox regression; BR was modeled with logistic regression. Results:71 mCRPC patients with median age of 72 (range: 48-90) were included. 47 (66%) patients completed ≥ 4 PSMA-RLT cycles with 30% receiving all 6 cycles. 35 (49%) had a GS ≥ 8 (11 unknown) and 33 (46%) had metastases at diagnosis. 25 patients had somatic testing, 29 had germline testing, 16 had both, and 1 was unknown. All tumors were microsatellite stable. 6 had a BRCA 1/2 mutation, of which 3 were in the germline; 9 carried a non- BRCA homologous recombination deficiency (HRD) mutation. 17 had a mutation in p53, RB1, or PTEN. There was no correlation between mutation status and any pretreatment PET parameters, BR, or OS. BR was achieved in 48%. At median follow-up of one year, 41% of patients died; median OS was 12 months (95%CI: 10 – NA). No significant correlation was found when comparing prior therapy, mutation status, and any pretreatment PET parameter with BR or OS. Patients receiving all 6 cycles were 7 times more likely to achieve BR (p = 0.002). Conclusions: There was no significant association between PSMA-RLT outcomes and either mutation status or pretreatment PET parameters. This study is limited by the low number of patients with genomic alterations. [Table: see text]
Real-world treatment patterns with lutetium-177-PSMA-617 (177-Lu-PSMA) in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Authors: Dwabe Sami , Yazdanpanah Omid , Warnecke Brian , Benjamin David Joseph , Rezazadeh Arash , Mar Nataliya 
Published: June 2024

e17064 Background: The VISION study demonstrated improved outcomes with up to 6 doses of177-Lu-PSMA plus standard-of-care (SOC) therapy versus SOC alone in pre-treated mCRPC patients, which led to its regulatory approval on 03/23/22. This is our real-world experience with 177-Lu-PSMA at the University of California, Irvine and Hoag Hospital. Methods: This is a retrospective analysis of 22 patients with mCRPC treated with 177-Lu-PSMA at the University of California, Irvine and Hoag Hospital since 03/23/2022. Baseline demographic, pathologic, and genomic characteristics of all patients who received 177-Lu-PSMA (along with their outcomes) were analyzed. Results: Selected baseline characteristics of the study population are included in the table, which contrast treatment responders and non-responders. At the time of this analysis, 22.7% (5/22) of patients completed all 6 planned cycles of 177-Lu-PSMA, 40.9% (9/22) discontinued early due to disease progression, 18.2% (4/22) are still receiving therapy, 9.1% (2/22) stopped treatment due to toxicity, and 9.1% (2/22) discontinued for other reasons. PSA reduction by at least 50% (PSA50) was achieved in 59.1% (13/22) of patients, 27.3% (6/22) achieved < PSA50, and 3/22 (13.6%) had no PSA response at all. In PSA responders, the median time to PSA nadir was 11.7 weeks [range: 2.3 - 38.0], while the median time to second PSA rise above nadir was 6.0 weeks [range, 4.0 – 22.3]. Treatment related toxicities occurred in 54.5% (12/22) of patients, including 22.7% with dry mouth, 22.7% with fatigue, and 13.6% with nausea. Conclusions: This dataset highlightsreal-world treatment patterns with 177-Lu-PSMA, which is an active and well-tolerated therapy. Despite initial response, some patients appear to have quick PSA progression, which led to early treatment discontinuation. We set out to evaluate if there were any baseline characteristics predictive of response among our patients. Ultimately, our data did not show any factors predictive of response to therapy. Given its financial toxicity, further studies identifying which patients are most likely to respond to 177-Lu-PSMA are indicated. [Table: see text]
Interim analysis of clinical data and reasons for initiating relugolix on a cohort of US patients: The OPTYX study.
Authors: Spratt Daniel Eidelberg , McKay Rana R. , Ross Ashley , Lowentritt Benjamin H , Flanders Scott C , Zhu Yajun Emily , Nolley Susana , Hong Agnes , Gatoulis Sergio C , Dorff Tanya B. 
Published: June 2024

e17072 Background: Relugolix is an oral GnRH receptor antagonist indicated for advanced prostate cancer treatment. The OPTYX study is prospectively collecting clinical and patient outcomes data from US patients initiating relugolix in routine care settings to evaluate the long-term outcomes of relugolix therapy. An interim analysis of key baseline variables, reasons for starting relugolix therapy and treatment patterns is presented. Methods: The multi-center observational OPTYX study aims to enroll 1,000 patients with prostate cancer starting relugolix therapy. The current study population includes diverse disease states, treatment circumstances (eg, monotherapy, combination therapy, or intermittent therapy) and clinical settings representative of real-world patterns of care. Baseline demographics, clinical characteristics, reasons for initiating treatment, and treatment patterns from Oct 2022 to Oct 2023 are described. Results: As of October 2023, 394 men were enrolled in the OPTYX study and received relugolix with a median treatment duration of 114 days. The median age was 71 years; 78.7% of patients self-reported as White, 14.2% as Black. Enrollment occurred through Urology, Oncology and Radiation Oncology practices. Most patients (61.2%) had baseline PSA <20 ng/ml. Mean (SD) baseline testosterone was 317.7 (238.5) ng/dL. At baseline, 15.2% of patients had received prior radiotherapy and 20.0% had prior androgen deprivation therapy. Known distant metastases were found in 24.6% of patients. A total of 135 patients (34.3%) received relugolix in combination with other therapies (Table). Top 3 reasons physicians prescribed relugolix were oral instead of injection (40.6%), rapid testosterone suppression (37.6%) and safety (25.1%), while patient reasons were physician recommendation (74.6%), oral instead of injection (35.5%) and safety (8.9%). In 10.7% of patients who discontinued therapy for any reason, 3.3% completed the planned regimen while 3.6% discontinued due to adverse events. No new serious safety signals have been identified. Conclusions: The OPYTX study is evaluating real-world experience with relugolix, including diverse disease states, practice settings and physician specialties. More than a third of patients and physicians favored oral versus injectable formulation, and more than a third used relugolix in combination with other therapies. There was low unplanned discontinuation of relugolix at data cut-off. Clinical trial information: NCT05467176 . [Table: see text]
Association of very deep prostate-specific antigen (PSA) decline with longer radiologic-progression-free survival (rPFS) in patients with metastatic castration-sensitive prostate cancer.
Authors: Kapar Caner , Tuğcu Volkan , Şahin Selçuk , Güler Haydar , Kilickap Saadettin , Tural Deniz 
Published: June 2024

e17074 Background: Previous studies have shown rare PSA and rapid reduction in PSA to be associated with survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with ADT, docetaxel, abiraterone, or enzalutamide. The ability to accurately rate nadir PSA level may help inform treatment intensification or de-escalation decisions. PSA nadir level was determined as 0.2 ng/mL for mCSPC in previously reported. However, the deeper the reduction in PSA level, the better the survival outcomes in prostate cancer may be. In the current study, we evaluated the association between a very deep PSA decline and rPFS in patients treated with mCSPC. Methods: Patients with mCSPC treated with ADT, Abiraterone acetate, Enzalutamide, or Docetaxel in the first line setting were included in the study. Serum PSA values were recorded at baseline, 1st, 3rd, and 6th months (mo ). Based on the lowest reached PSA level, patients were divided into four subgroups (PSA <=0.02 ng/mL, PSA 0.02–0.2ng/mL, PSA 0.2-4ng/mL, PSA >4 ng/mL). Median follow-up and rPFS were estimated using the Kaplan-Meier method. Results: Data from 151 patients were analyzed. 11 patients were excluded due to insufficient data, and 7 patients were not included due to inadequate follow-up. The median age was 68 (38–91) years, and the majority of patients (51.1%) had Eastern Cooperative Oncology Group performance status (ECOG PS) scores of 1≥. Of the patients, 54.1% had high-volume disease, and 65.4% had synchronous metastasis. Additionally, 82% of the patients had bone metastasis, 15% had lung metastasis, and 7% had liver metastasis. When patients were stratified into 4 subgroups based on their lowest PSA levels, the distribution was as follows: PSA<=0.02 ng/mL, 15% (n=20); PSA 0.02–0.2 ng/mL, 20.3% (n=27); PSA 0.2–4 ng/mL, 48.9% (n=65); PSA >4 ng/mL, 15.8% (n=21). The median follow-up time was 32.3 (3–86) mo. The median rPFS for all populations was calculated as 18.1 mo [15.1–20.9 mo, 95% CI]. In the PSA<=0.02 ng/mL group, the median rPFS was 49.8 mo [38–61.6 mo, 95% CI]; PSA 0.02–0.2 ng/mL group, 27 mo [16.8–37.2 mo, 95% CI]; PSA 0.2–4 ng/mL group, 16 mo [13.5–18.8 mo, 95% CI]; PSA >4 ng/mL group, 8 mo [1.4-14.6 mo, 95% CI]. The statistical analysis revealed a significant relationship between very deep PSA levels and rPFS [p<0.01]. 5-year rPFS were %78, %16, %8 and %0 for each group, respectively(p<0.01). Conclusions: Very deep prostate-specific antigen decline is associated with longer rPFS in patients with mCSPC. Very deep prostate-specific antigen decline is a more potent surrogate marker for longer rPFS and it can be used new primary endpoint for clinical trials.
Sequential ADT and abiraterone acetate plus prednisone versus combined ADT with abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer: A propensity score-matched study.
Authors: Yang Zhenyu , Zhao Diwei , Wang Jun , Long Xingbo , Chen Dong , Zhou Fangjian , Li Yonghong 
Published: June 2024

e17075 Background: Previous studies showed that combination of androgen deprivation therapy (ADT) with abiraterone acetate plus prednisone was associated with longer survival than ADT alone in patients with metastatic castration-sensitive prostate cancer (mCSPC). The aim of this retrospective propensity score-matched study was to compare the effects of sequential treatment of ADT and abiraterone acetate plus prednisone (sequential treatment cohort), and combination treatment of ADT with abiraterone acetate plus prednisone (combination treatment cohort), in men with newly diagnosed mCSPC. Methods: The sequential treatment cohort received ADT or ADT plus first-generation nonsteroidal antiandrogen (NSAA) as first-line therapy, then ADT and abiraterone acetate plus prednisone after progression. The combination treatment cohort received ADT and abiraterone acetate plus prednisone as first-line therapy. Patients with newly diagnosed mCSPC treated with ADT, ADT plus first-generation NSAA, or ADT plus abiraterone acetate in our center between June 2014 and July 2022, were respectively identified. Patients treated with sequential treatment or combination treatment were evaluated through propensity score matching (PSM) based on baseline clinical characteristics. The primary outcome was abiraterone failure-free survival (aFFS). Secondary outcomes including overall survival (OS), PSA response. Results: Clinical characteristics were balanced after PSM and 117 patients were included in each cohort. The aFFS was 30.7 and 30.6 months in sequential and combination treatment cohort, respectively, no statistically significant difference was observed (hazard ratio [HR] 0.90, 95% confidence interval [CI] 0.64 -1.27; p = 0.526). Similarly, there was no statistically significant difference in overall survival (OS, HR 0.92, 95% CI 0.57 -1.49; p = 0.388) between sequential and combination treatment. Conclusions: Patientswith newly diagnosed mCSPC treated with sequential ADT and abiraterone acetate plus prednisone, had similar aFFS and OS, compared to men treated with combined ADT and abiraterone acetate plus prednisone, according to our preliminary results. Our data indicate that sequential treatment of ADT and abiraterone acetate might be considered as an alternative to newly diagnosed mCSPC.
Clinical characteristics and outcomes of veterans with metastatic hormone-sensitive prostate cancer (mHSPC) based on volume of disease and site of metastases.
Authors: Stackable Kaitlin , Pickett Carley , Riekhof Forest , Fedele Nicholas , Baxi Priya , Ingram Kara , Karunanandaa Krishny , Govindan Srinivas , Cheranda Nina , Agarwal Rohan , Schoen Martin W. 
Published: June 2024

e17083 Background: Metastatic hormone-sensitive prostate cancer (mHSPC) is categorized by volume of disease and high tumor volume is associated with worse outcomes. Assessment of volume of disease and site of metastases at diagnosis may help risk stratify patients with mHSPC. This study describes patient characteristics and survival in U.S. veterans treated for mHSPC. Methods: Veterans were identified with initial diagnosis of SEER stage ‘distant’ prostate cancer. All veterans had androgen deprivation therapy (ADT) initiated within 4 months of diagnosis and followed until September 2023. Veterans treated with ADT alone during 2018, ADT+docetaxel (DOC) from 7/2016-6/2021 or androgen receptor pathway inhibitors (ARPIs) abiraterone, enzalutamide, apalutamide, and darolutamide from 7/2017-6/2021 were included if initiated within 4 months after ADT. Veterans were categorized as high or low volume of disease by chart review. If patients had more than one site of metastasis, they were categorized as follows: any liver, any lung, any high volume bone. Age, PSA, and body mass index (BMI) were collected at diagnosis and compared by ANOVA or Kruskal-Wallis with Bonferroni correction for multiple comparisons. Results: 1520 veterans were identified with 886 high volume bone metastases, 154 lung metastases, 70 liver metastases, and 410 low volume patients. Mean age of patients was 72.3 years (SD 0.4) with median PSA of 103.2 ng/mL and mean BMI of 27.4. There was no difference in mean age between high volume and low volume (72.3 vs. 72.5 years, p=0.28), however median PSA was higher in high volume (152.0 vs. 48.8 ng/mL, p<0.001) and median BMI was lower in high volume (26.5 vs. 27.5, p=0.002). High volume metastasis was associated with shorter survival (31.2 vs. 56.3 months, p<0.001). For site of metastases, there was no difference in age between location (p=0.365), PSA was higher in liver, lung, and high volume bone compared to low volume while for BMI, only liver metastasis was associated with significantly lower BMI. Liver metastasis was associated with shorter survival compared to low volume, high volume bone, and lung metastasis (all p<0.001 by log-rank). Conclusions: High volume disease and liver metastases were associated with shorter survival in veterans with mHSPC. Presence of liver metastasis was independently associated with decreased overall survival compared to high volume bone or lung metastases. Volume of disease and location of metastases may provide information for prognostication in mHSPC. [Table: see text]
Descriptive analysis of patients on active surveillance escalating to treatment for localized prostate cancer.
Authors: Son Young , Wu Edward , Akanda Shawon , Klimowich Katelyn , Mueller Thomas , Brown Gordon Andrew 
Published: June 2024

e17092 Background: It is predicted that 1 in 8 men will be diagnosed with prostate cancer and 1 in 41 men will die of prostate cancer, making it the second leading cause of death in men. However, not all diagnosis of prostate cancer is clinically significant and active surveillance (AS) can be an option. Although AS is an option, an estimated 50% of patients will progress to treatment within 5-10 years. In this study, we aim to characterize those patients that required escalation to treatment from AS. Methods: A multicenter retrospective review was performed of patients that were had biopsy proven prostate cancer that elected to undergo AS. The cohort was subdivided into those that progressed to treatment (radiation, surgery, or hormonal therapy) and those that continued AS. Patient demographics, prostate biopsy characteristics, and biomarker usage was analyzed between the two groups. Descriptive analysis was performed and a multivariate logistic regression was performed. Results: A total of 158 patients were reviewed from 2021-2023. Among the cohort, 55 (34.2%) progressed to treatment while 106 (65.8%) remained on AS. The treated cohort were younger (63.2 vs. 68.6), had lower initial PSA (1.6 vs. 4.7), lower % free PSA (10.5 vs. 20.6), and higher number of cores positive (3.9 vs. 2.7) on biopsy. There was no difference in biomarker testing including Prolaris, Decipher, and Oncotype Dx between the treated and AS group. On adjusted analysis, age (OR 0.9, 0.81 – 0.99, P=0.035) and initial PSA (OR 0.38, 0.22 – 0.59, P<0.001) were predictive covariates into treatment (Table). Conclusions: AS is an option for favorable prostate cancer. We show that there was no difference in Biomarkers, PIRADS, and PSAD between the treated and the AS group. Escalation to treatment from AS should be a shared decision making between provider and patient. Our multicenter, real-world analysis shows that younger patients and lower initial PSA were factors that were associated with escalation to treatment. [Table: see text]