tbuckley/cabot-search huggingface dataset:
Selection of active surveillance in Medicaid patients: Results from the Michigan Urological Surgery Improvement Collaborative.
Authors: Arnav Srivastava, Stephanie Daignault-Newton, Sabir Meah, Kassem S Faraj, Kevin Ginsburg, Keow Goh, Brent K. Hollenbeck, Vahakn Shahinian, Lindsey A. Herrel, Tudor Borza
Journal: Journal of Clinical Oncology (2024)

302 Background: Active surveillance (AS) is the preferred treatment for low-risk prostate cancer. Insurance coverage and cost sharing often influence treatment choices for providers and patients. The impact of insurance payer, specifically Medicaid, on treatment selection in prostate cancer remains understudied. Methods: We identified patients with biopsy-proven prostate cancer from the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry, a statewide quality improvement collaborative, from 2016-2021. We captured risk category, insurance payer (Medicaid vs. private insurance), and treatment (AS vs. primary treatment). Watchful waiting rates were under 2% in both payer groups; these patients were excluded from analysis. We used logistic regression to assess the correlation between payer status and treatment choice by prostate cancer risk group. Results: We identified 38,663 patients. Most patients had private insurance (51%), followed by Medicare (45%) and Medicaid (3%). Median age was 62 (IQR 58 – 66) for privately insured patients and 60 (IQR 56 – 63) for Medicaid patients. Among patients with low-risk disease, 65% of privately insured patients and 67% of Medicaid patients elected for AS. AS for favorable intermediate-risk prostate cancer was also similar across the payer groups (private 20%, Medicaid 19%). In an adjusted analysis Medicaid and privately insured patients did not demonstrate different odds of AS (OR 0.99 (95%CI 0.71 – 1.40), p &gt; 0.9). No significant differences in treatment selection were noted in favorable or unfavorable intermediate-risk patients (Table). Conclusions: Our analysis, from a granular statewide registry, suggests that Medicaid patients undergo similar treatment patterns to commercially insured patients. This suggests that insurance status may not drive AS selection in our cohort. Our work points towards not only the increased adoption of AS, but also its adoption across payers. [Table: see text]
Phase II trial of ArtemiCoffee for men with biochemical recurrence of prostate cancer after local therapy.
Authors: Zin Myint, William H St. Clair, Stephen Strup, Patrick J. Hensley, Donglin Yan, Carleton Scott Ellis, Jill Kolesar
Journal: Journal of Clinical Oncology (2024)

TPS350 Background: The optimal timing for initiating androgen deprivation therapy (ADT) in biochemical recurrent (BCR) prostate cancer (PC) patients, specifically those with PSA doubling time &gt; 10 months, remains uncertain. Therefore, there is a compelling need for clinical trials exploring alternatives to ADT. Artesunate, derived from Artemisinin which is extracted from Artemisia annua (Aa), shows anti-cancer effects. Aa comprises several active constituents including dihydroartemisinic acid, artemisinic acid, and artemisinin. Our research group assessed the sensitivity of prostate cancer cells to Artesunate using established PC cell lines such as LNCaP, C4-2, CWR-22Rv1 and PC-3. Two cell lines, LNCaP (PSA and AR positive, hormone naïve) with an IC50 of 3.30 µM (95% CI 2.28-4.79) and C4-2 (PSA and AR positive, castration resistant) with an IC50 of 3.99 µM (3.13-5.10 µM) demonstrated sensitivity to Artesunate. Wang et. al (2017) reported that Artesunate, administered at varying doses, effectively suppressed tumor growth, inhibited cell viability and enhanced apoptosis in a mouse xenograft model using the 22rv1 PC cell line. Based on these promising preclinical findings, we hypothesize that Aa decaf coffee has the potential to decrease rising PSA levels in patients with BCR PC. Our research group previously conducted a phase I dose escalation of ArtemiCoffee in ovarian cancer (NCT04805333) and preliminary results indicated no grade ≥3 toxicities at the proposed dose (unpublished data). In this study, we aim to conduct a phase II study of Aa decaf coffee in men with BCR PC. Methods: An open-label, single center, phase II study targets men with BCR PC following primary definitive local therapy and a PSA doubling time &gt; 10 months. Commercially available Aa decaf coffee pods supplied by ArtemiLife Inc. will be utilized. These decaf coffee pods adhere to FDA food-grade quality standards and Aa plants used for ArtemiLife coffee are cultivated in Kentucky, USA. Aa decaf coffee will be self-administered three times daily (total of 1,350mg Aa) on an outpatient basis for 24 weeks. The primary endpoint is to determine the proportion of patients achieving a ≥50% decline in PSA levels within 24 weeks of Aa decaf coffee treatment in BCR population. A total of 30 patients will be enrolled in this study, ensuring a maximum margin of error of approximately 16% in the 95% confidence interval for the primary endpoint. Secondary endpoints include safety and tolerability. Correlative endpoints include 1) changes in downstream biomarkers of the NRF2/KEAP1 signaling pathway and 2) changes in plasma concentrations of artemisinin and dihydroartemisinin by comparing pre- and post-treatment with Aa decaf coffee using non-parametric paired test. The study commenced accrual in August 2023. Clinical trial information: NCT05478239 .
Clinical outcomes of frontline GemFLP in advanced urachal and non-urachal adenocarcinomas of the urinary tract: The MD Anderson Cancer Center (MDACC) experience.
Authors: Mohammad Jad Moussa, Adrienne H. Chen, Allison K. Grana, Jianjun Gao, Amishi Yogesh Shah, Paul Gettys Corn, Nizar M. Tannir, Sangeeta Goswami, Jianbo Wang, John C. Araujo, Ashish M. Kamat, Neema Navai, Curtis Alvin Pettaway, Mehrad Adibi, Bogdan Czerniak, Charles C. Guo, Arlene O. Siefker-Radtke, Matthew T Campbell, Omar Alhalabi
Journal: Journal of Clinical Oncology (2024)

630 Background: Adenocarcinomas of the urinary tract, including urachal (UA) and non-urachal (NUA) subtypes, are rare tumors. Triplet regimens combining gemcitabine, a taxane or 5-fluorouracil (5-FU)/leucovorin (L), and cisplatin (P), have been developed. Methods: We retrospectively reviewed records of patients receiving frontline (1L)GemFLP (Gemcitabine 200 mg/m 2 IV on days 1 and 5; 5-FU 200 mg/m 2 IV on days 1, 2, 3, 4, 5; L 10mg/m 2 IV on days 1, 2, 3, 4, 5; P 20mg/m 2 IV on days 1, 2, 3, 4, 5) in advanced UA and NUA at MDACC between 2003 and 2023. Advanced disease is defined as Sheldon stages IVA/IVB in UA and TNM stage IV in NUA. Imaging-based best overall responses (BOR) were complete (CR), partial (PR), stable (SD), progressive (PD) or non-evaluable (NE). Overall response rate (ORR) covers CR + PR, while disease control rate (DCR) covers CR + PR + SD. We report overall survival (OS) and progression-free survival (PFS) from GemFLP start. Results: Baseline characteristics of UA (n=40) and NUA (n=28) are in Table. In UA, bladder dome was primary location in 39 (97.5%). NUA pts had either bladder (11, 39.3%) or urethral (17, 60.7%) origin. BOR in 1L GemFLP are shown in Table. In UA, ORR is 20% and DCR is 72.5%. Median OS (mOS) is 19.8 months (95% CI: 12.2 - 30.6) and median PFS (mPFS) is 5.3 mo (95% CI: 3.1 – 6.3). In UA, pts with CR, PR, or SD have a significantly longer mOS than pts with PD [26 mo (16.2 – 35.6) vs. 7.7 mo (2.67 – 11.9), log-rank p &lt;0.0001]. Meanwhile, in NUA, ORR is 35.7% and DCR is 75%. mOS is 12.95 mo (95% CI: 7.1-20.2) and mPFS is 5.3 mo (1.93 – 7.6). A similar significant survival benefit is seen in NUA pts with disease control versus pts with PD [17.6 mo (12.6 – 25.9) vs. 5 mo (2.63 – 7.1), p &lt;0.0001]. Surgical consolidation was offered for 6 UA pts (3 PR, 3 SD), 3 of whom were regional N+ only, and for 4 NUA pts (1 CR, 1 PR, 2 SD) who were all regional N+ only. All except one showed residual pathological disease. Conclusions: 1L GemFLP is an active regimen in advanced UA and NUA, with a DCR of &gt;70%. Pts with disease control (CR, PR, or SD) have a clear survival benefit compared to non-responders. 1L GemFLP might offer chances at surgical consolidation after disease control for pts with regional node-positive only disease, with larger cohorts needed to confirm findings. [Table: see text]
Safety of pegfilgrastim in patients with metastatic germ-cell tumor receiving combination chemotherapy containing bleomycin.
Authors: Jennifer King, Rebecca Hassoun, Sandra K. Althouse, Stephanie Schneck, Nasser H. Hanna, Lawrence H. Einhorn, Nabil Adra
Journal: Journal of Clinical Oncology (2024)

513 Background: There are conflicting reports on the impact of growth factor support in combination with bleomycin on the development of bleomycin associated lung toxicity in various malignancies. In addition, theories remain surrounding the possibility of worsened hematologic toxicity when receiving pegfilgrastim too close to the time of subsequent chemotherapy that is given in consecutive weeks. Here, we aim to evaluate the safety of the use of pegfilgrastim in patients with germ-cell tumor (GCT) undergoing combination chemotherapy containing bleomycin. Methods: The prospectively maintained Indiana University testicular cancer database was queried for patients with metastatic GCT treated between 2010-2023 at Indiana University with chemotherapy containing bleomycin. Safety in patients who received at least one dose of pegfilgrastim were compared to patients who did not receive any doses. Bleomycin lung toxicity was per the discretion of treating physician. Comparison between groups was done using Chi-square tests for categorical variables or Wilcoxon test for continuous variables. Results: 196 patients met eligibility. Median age at diagnosis was 26.7 (range, 20.2-50). Primary site was testis in 95.4%, retroperitoneum in 2.6%, and mediastinum in 2%. 79% of patients included had nonseminomatous germ-cell tumor (NSGCT). IGCCCG risk was good in 146, intermediate in 19, and poor in 31 patients. First-line chemo was BEPX3 in 71% of patients, BEPX3 with EPX1 in 9% of pts, BEPX4 in 10% of patients, and other in 10% of patients. There were 49 patients (25%) who received at least one dose of pegfilgrastim with chemotherapy. There was no statistically significant difference in the type of chemotherapy received, metastatic sites of disease at time of diagnosis, or IGCCCG risk in patients who received pegfilgrastim vs. those who did not. The median number of pegfilgrastim doses received was 2. The median number of doses of bleomycin received was 9 for both patients who received pegfilgrastim and those who did not. In those who received pegfilgrastim, 4 patients developed bleomycin lung toxicity vs. 13 patients who did not receive pegfilgrastim (p=1.000). Of these 17 pts, 9 were diagnosed on symptoms and exam alone, 2 by imaging with symptoms, 2 by imaging without symptoms, 3 on PFTs ordered because of symptoms, and 1 on PFTs alone without symptoms. 3 patients required steroids. There were no fatalities related to pulmonary toxicity. Median nadir ANC in those who received pegfilgrastim was 3350 vs. 800 in those who did not (p&lt;0.0001). Conclusions: The administration of pegfilgrastim with combination chemotherapy containing bleomycin for metastatic GCT did not increase the risk for bleomycin associated lung toxicity. Hematologic toxicity, demonstrated by nadir ANC, was worse in pts who did not receive pegfilgrastim.
Trends and disparities in hospice care utilization in testicular cancer in the United States of America from 2003 to 2020: Analysis of CDC WONDER database.
Authors: Karan Jatwani, Mahnoor Sukaina, Atulya Aman Khosla, Rohit Singh, Tulika Garg, Rutvi Chahal, Archit Patel, Vasanthan Muthusamy Kumarasamy, Dharmesh Gopalakrishnan
Journal: Journal of Clinical Oncology (2024)

504 Background: Testicular cancer (TC) is a malignancy with five-year survival reaching up to 95%. It is estimated that 470 deaths from this disease will occur in the United States in 2023. Even with exceptional survival rates, it is important to recognize the need of hospice in these patients. Enrollment in hospice is associated with lower healthcare costs, symptom burden, and psychological distress and improved quality of life. We used publicly available CDC WONDER (Centers for Disease Control and Prevention for Wide-ranging Online Data for Epidemiologic Research) database with the aim to explore the trends of hospice utilization in patients with testicular cancer nationwide in the US. Methods: The search and analysis were conducted using the CDC WONDER database from January 01, 2003, to December 31, 2020. The data for deaths due to TC were pooled using the International Classification of Diseases-10th Revision codes C62, C62.0, C62.1 and C62.9. The inclusion criteria included males aged &gt;15 years. The demographic data was obtained to calculate descriptive statistics using age, census region, and utilization of hospice mortality accordingly over the past two decades. Results: The analysis demonstrated that overall mortality due to TC were 6,969 from 2003-2020. Of these deaths, 520 (7.46%) were recorded in hospice facilities. According to the US census regions, the highest number of hospice deaths were recorded in Census Region 3: South (CENS-R3) 8.99%, followed by Census Region 1: Northeast (CENS-R1) 8.03%, and Census Region 2: Midwest (CENS-R2) 7.23%. While the lowest number of deaths were observed in Census Region 4: West (CENS-R4) at 5.30%. The lowest hospice mortality was 1.9% in 2005 and increased over the years to the highest of 10.4% in 2019, with a slight decline in 2020 which is 7.9%. Moreover, when stratified by age groups, the lowest hospice mortalities are recorded in the age group 15-34 years (6.32%), 35-54 years (7.08%), 55-74 years (10.10%), 75-85+ years (8.72%). Conclusions: To our knowledge this is the first study utilizing CDC WONDER database to demonstrate hospice care utilization in TC related deaths. We observed a steady increase in hospice utilization from 2005-2019 throughout the US with a decline in 2020 possibly related to COVID pandemic. Age stratification further revealed lower utilization in 15-34 years age group compared to 55-74 highlighting the need to improve hospice discussions early in this age group. This study highlights the disparities in end-of-life care in TC and should promote policy-level changes in the states with lower utilization of hospice services to improve access of care in TC patients.
Primary retroperitoneal germ-cell tumours (pR-GCT): Evaluation of treatment outcomes of an international retrospective collaboration (PRIMERE study).
Authors: Patrizia Giannatempo, Nazzani Sebastiano, Ida Taglialatela, Bernasconi Valentina, Michal Mego, Davide Bimbatti, Simona Secondino, Melanie Claps, Davide Biasoni, Mario Catanzaro, Matteo Zimatore, Tullio Torelli, Silvia Stagni, Alberto Macchi, Antonio Tesone, Paolo Pedrazzoli, Umberto Basso, Giuseppe Procopio, Nicola Nicolai
Journal: Journal of Clinical Oncology (2024)

510 Background: pR-GCT corresponds to the clinical case of retroperitoneal ascertained GCT without radiological evidence of primary testicular tumor and accounts for up to 40% of extragonadal GCTs. An occult primary testicular tumor is often missed at diagnosis. Treatment modalities and outcomes have not been specifically addressed, preventing robust recommendations. We performed an international call to assess prognosis of treatment outcomes of these patients. Methods: Clinical, pathological and treatment data pts with pR-GCT between 04/1988 and 01/2022 were retrospectively collected across 4 referral centers. Kaplan Meier methods, univariable and multivariable Cox regression models (MCRMs) were used. Results: Ninety-nine patients (median age 37 yrs - IQR: 29-45) were collected. Ninety-three (94%) had histological diagnosis by biopsy or primary retroperitoneal lymph-node dissection (RPLND): 60 (62.5%) had non-seminomatous pR-GCTs (pR-NSGCTs) and 33 (34.4%) had seminomatous pR-GCTs (pR-SGCTs). IGCCCG prognostic allocation was possible in 91 pts: 34 (35.8%) were good, 23 (24.2%) intermediate and 34 (35.8%) poor risk, respectively. All pts underwent cisplatin-based chemotherapy, usually BEP regimen (94.9%). After chemotherapy, 25 (25.3%) pts underwent orchiectomy: viable tumor was present in 8 (32%), burn-out lesions in 6 (24%) and no lesion in 11 (44%) cases. After a median follow-up of 45 mos (IQR:15-90), the 5-years OS was 58%, being 85% in case of pR-SGCT and 46% in case of pR-NSGCT. According to IGCCCG classification 5-years OS was 83.3% for good, 57% for intermediate and 42% for poor risk patients, respectively. No difference in term of OS (60% vs 56%, p-value 0.81) was observed between patient who had or not radical orchiectomy. At MCRMs only IGCCCG poor risk category (HR 3.2, CI: 1.18-8.84, p-value 0.02) was independent predictors of a worse OS. Conclusions: Eventually, a significant proportion of pts with a pR-GCT had a misclassified primary testicular tumor. 5 yrs-OS according to IGCCCG classification is worse than expected. The role of a surgical exploration of the suspected primary tumor remains controversial and the existence of a real category of p-GCT cannot be excluded.
PEMBROBLAD: Real world effectiveness and safety of immune checkpoint inhibitors in patients with advanced urothelial carcinoma with histological variants.
Authors: Karim Amrane, Luca Campedel, Mostefa Bennamoun, Pierre-Etienne Gabriel, Nicolas Brouchet, Damien Pouessel, Matthieu Roulleaux Dugage, Constance Thibault, Mathilde Cancel, Mathilde Gout, Aude Flechon, Olivier Huillard, Baptiste Abbar, Delphine Borchiellini, Louis Doublet, Laetitia Augusto-Pelegrin, Boughalem Elouen, Fabien Moinard-Butot, Clement Dumont, Philippe Barthelemy
Journal: Journal of Clinical Oncology (2024)

624 Background: A non-negligible portion of bladder cancers have non-pure UC histology; these tumors are often underdiagnosed and represent an unmet treatment need. Efficacy of immune checkpoint inhibitors (ICI) in non-pure UC remains unknown. We report preliminary data form the PEMBROBLAD study assessing ICI in pretreated mixed variants (UC-V) or pure non-UC (NUC) in real life condition. Methods: PEMBROBLAD is a retrospective multicenter study conducted in 24 French GETUG centers. Eligible patients had advanced UC with UC-V or NUC. All patients received ICI as a second line treatment. We excluded patients with ICI maintenance therapy. The primary endpoint was overall survival (OS); secondary endpoints included overall response rate (ORR), progression free survival (PFS), time to treatment failure (TTF) and safety. Results: A total of 139 patients (pts) were analyzed. Median age was 70 years (range 44-88), 70.8 % were male with ECOG PS 0/1, 2 and 3 in 57.7%, 26.6% and 10.1% of cases respectively. The most common variants of UC-V (n=96, 69.0%) were squamous cell differentiation (n=25, 26.0%), sarcomatoid (n=12, 12.5%), micropapillary (n=9, 9.3%), neuroendocrine (n=8, 8.3%), nested (n=7, 7.3%) and adenocarcinoma (n=5, 5.2%); squamous cell carcinoma (n=23, 53.4%) represented the majority of NUC (n=43, 31.0%). At data cutoff (August 15, 2023), median follow-up was 35.1 months (mo) (range 3.7-86.9). The most administered ICI was pembrolizumab in 85.6% of cases followed by durvalumab in 12.2% of cases. Median OS was 6.1 mo for all pts, 6.1 and 5.9 for UC-V and NUC respectively. In pts with UC-V and NUC, ORR was 31.2 % (n=30) and 18.6% (n=8) and DCR was 41.6% (n=40) and 23.2% (n=10) respectively. In all 139 pts, median TTF was 2.2 mo (95% CI, 0.1-50.0 mo). Serious TRAE occurred in 13 pts (9.3%). Discontinuation due to TRAEs occurred in 5.0% of pts. Conclusions: Our results suggest some efficacy of ICI in pretreated advanced UC-V and NUC. No new safety concerns were identified. Updated results with subgroup analysis will be reported at the meeting. [Table: see text]
The pretreatment neutrophil-to-lymphocyte ratio to predict clinical response to maintenance avelumab therapy in patients with metastatic urothelial cancer.
Authors: Satoshi Inoue, Hiroki Sai, Akira Hayakawa, Koya Morishita, Yuri Yuguchi, Tomohide Suzuki, Hirotaka Matsui, Motohiro Maeda, Akiyuki Asano, Kosuke Tochigi, Shusuke Akamatsu
Journal: Journal of Clinical Oncology (2024)

620 Background: It has not been elucidated how preceding first-line chemotherapy affects neutrophil-to-lymphocyte ratio (NLR) and maintenance avelumab therapy. We investigated the relationship between NLR levels just before the initiation of treatment with maintenance avelumab therapy and clinical outcomes in metastatic urothelial cancer (mUC) patients. Methods: This retrospective study was analyzed for patients with mUC who received maintenance avelumab therapy between February 2021 and July 2023 at Nagoya University and several affiliated hospitals in Japan. We investigated the relationship between NLR levels just before avelumab therapy and clinical outcomes. All patients were divided into two groups according to NLR levels just before avelumab therapy. A NLR level of ≥3.00 was defined as elevated according to a calculation by a receiver-operation curve analysis. Progression-free survival (PFS) and overall survival (OS) rates were estimated using Kaplan–Meier curves and Cox proportional hazards models. Results: The median age and follow-up duration were 73 years (range 49-83 years) and 11.6 months (range 2.4-26.5 months), respectively. The high NLR group consisted of 29 patients (45.3%). Patients in the high NLR group had significantly shorter PFS and OS than those in the low NLR group (p=0.018 and p=0.027, respectively). Similarly, PFS and OS was significantly shortened in patients with NLR levels that had increased during first-line chemotherapy than their counterparts (p=0.018 and p=0.008, respectively). Furthermore, patients in the high NLR group had a significantly lower disease control rate than those in the low NLR group (58.6% vs 91.4%, p=0.003). While there was not a significant association between OS and NLR at the start of first-line chemotherapy (p = 0.763). Multivariate analyses revealed that stable disease as best response to first-line chemotherapy was significantly associated with PFS [hazard ratio (HR), 4.55; p=0.001] and OS (HR, 21.58; p=0.001). Conclusions: High NLR levels just before avelumab therapy might be a prognostic factor for mUC patients undergoing maintenance avelumab therapy.