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  • American Society of Clinical Oncology (ASCO)  (5)
  • 1
    Online Resource
    Online Resource
    Evaluating oncologists’ practice patterns and decision-making in locally advanced or metastatic urothelial carcinoma (la/mUC): The U.S. physician PARADIGM study (Part 2).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 4595-4595
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 4595-4595
    Abstract: 4595 Background: The treatment (tx) landscape for la/mUC has evolved with the use of immunotherapy (IO) for platinum-refractory la/mUC as well as first-line (1L) maintenance therapy (1LM). This cross-sectional survey explored practice patterns for 1L tx/1LM use and clinical decision-making. Methods: Community/academic US oncologists (n = 150) completed an online survey (Sept-Oct 2021) on demographics, 1L tx, 1LM use, attributes in 1L tx selection/1LM use, and factors associated with 1L tx/1LM use. Physicians were dichotomized into 4 pre-specified groups using the median percentage (%) as a cutoff: 1) more frequent 1L prescriber 2) less frequent 1L prescriber (% of pts treated with 1L tx in the past 6 months); 3) more frequent 1LM prescriber 4) less frequent 1LM prescriber (% of pts eligible and received 1LM). Descriptive and bivariate analyses assessing attributes (scored out of 100 points across 16 attributes) in 1L tx selection/1LM use were conducted. Multivariable logistic regression was used to assess factors associated with more/less frequent 1L tx/1LM use. Results: Median time in practice was 15 yrs (range, 2-31; 63% community vs 37% academic setting). The median % of la/mUC pts who received 1L tx was 46% (range, 25-89%). 72 physicians were categorized as more frequent 1L prescribers, while 78 were less frequent 1L prescribers. The median % of pts eligible and received 1LM was 71% (range, 0-100%). 71 physicians were categorized as more frequent 1LM prescribers, while 75 were less frequent 1LM prescribers. Attributes used in 1L tx selection differed among more vs less frequent 1L prescribers: mean scores for efficacy/overall survival (OS), disease control rate (DCR), or rate of grade 3/4 adverse events (AEs) were 23 vs 17, 10 vs 8, and 10 vs 5, respectively (all p 〈 0.05). Similarly, for more vs less frequent 1LM prescribers, mean scores for efficacy/OS, rate of grade 3/4 immune-mediated AEs, and inclusion in institutional guidelines/pathways were 23 vs 16, 6 vs 4, and 2 vs 4. Oncologists who stated OS, DCR, or rate of grade 3/4 AEs as important factors impacting tx selection were more likely to prescribe 1L tx (all p 〈 0.05). Regarding 1LM use, oncologists based in the academic setting, those who reported using RECIST 1.1 criteria to assess tx response or agreed 1LM is important to prolong OS were all more likely to prescribe 1LM (all p 〈 0.05). Those who reported that their institutional guidelines/pathways impact tx decisions or cited prior IO use before metastatic diagnosis as reason not to prescribe 1LM were less likely to prescribe 1LM (all p 〈 0.05). Conclusions: While several factors were found to be associated with offering 1L tx by US oncologists, including impact on OS and practice setting, variability exists in physicians’ attitudes to 1L tx/1LM use. Studies and interventions to explore shared decision-making for optimal 1L tx selection are needed.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.4595
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Assessment of treatment patterns and real-world outcomes following changes in the treatment paradigm for locally advanced/metastatic urothelial carcinoma (la/mUC) in the US.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 6_suppl ( 2023-02-20), p. 468-468
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 6_suppl ( 2023-02-20), p. 468-468
    Abstract: 468 Background: The standard-of-care first-line (1L) treatment for la/mUC is platinum-based chemotherapy (PBC) followed by avelumab 1L maintenance (1LM) in those who have not progressed following 1L PBC. This study aims to understand treatment patterns and real-world outcomes in patients with la/mUC in the US, including the early adoption of avelumab 1LM since its FDA approval in June 2020. Methods: Patients aged ≥18 years diagnosed with la/mUC between Jan 2015 and Jul 2021 were identified using electronic health records from the Flatiron Health database. Patient characteristics at baseline (la/mUC diagnosis) and clinical outcomes were described by 1L treatment received using the Kaplan-Meier method. Results: Of 4,387 patients included in this study, 3,706 (84.5%) received systemic treatments. Cisplatin-based therapy was the most common 1L therapy (33.3%), followed by carboplatin-based (30.9%) and immuno-oncology (IO) therapies (28.0%). Patients treated with cisplatin-based therapies had longer median progression-free survival compared with patients treated with carboplatin-based and IO therapies (8.0, 6.4, and 6.1 months, respectively). Median overall survival (mOS) in the treated cohort was 14.6 months from the initiation of 1L therapy. Patients treated with 1L cisplatin-based therapies had the longest mOS (18.3 months), followed by 1L IO therapies (14.6 months), and 1L carboplatin (13.2 months). Since July 2020, 89 patients received avelumab 1LM; the median follow-up time from the start of 1LM avelumab was 6.0 months and clinical outcomes data were immature. Of 1L-treated patients, 50.6% (n=1,874) moved onto second-line (2L) therapy during the study period. Notably, the cohort with the lowest 2L treatment rates were patients treated with 1L IO. The table demonstrates treatment sequences for this population. Conclusions: In this real-world cohort, most patients received standard-of-care platinum-based chemotherapy in 1L, with those on cisplatin-based therapy demonstrating the best outcomes. Early uptake of avelumab as 1LM was observed, and future analysis should examine the clinical outcomes of patients who received avelumab 1LM following 1L PBC. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.6_suppl.468
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 3
    Online Resource
    Online Resource
    Baseline characteristics from a retrospective, observational, US-based, multicenter, real-world (RW) study of avelumab first-line maintenance (1LM) in locally advanced/metastatic urothelial carcinoma (la/mUC) (PATRIOT-II).
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 6_suppl ( 2023-02-20), p. 465-465
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 6_suppl ( 2023-02-20), p. 465-465
    Abstract: 465 Background: The JAVELIN Bladder 100 clinical trial demonstrated a significant overall survival and progression-free survival benefit with avelumab 1LM + best supportive care (BSC) vs BSC alone for la/mUC not progressing on platinum-based chemotherapy (PBC). PATRIOT-II aims to describe RW data for avelumab 1LM treatment (tx) of patients (pts) with la/mUC. Methods: PATRIOT-II collected data from pts with la/mUC treated in 37 geographically dispersed oncology practices/communities and academic centers in the US. Pts who initiated avelumab 1LM following PBC were retrospectively enrolled and will be followed up via medical record review for 52 weeks post avelumab 1LM initiation. This analysis focused on pt characteristics and tx data from la/mUC diagnosis through the PBC period and at avelumab 1LM initiation. Disease and PBC tx characteristics, as well as response to PBC, were assessed. All analyses were descriptive. Results: A total of 160 pts were enrolled (Table), 118 (74%) were white, non-Hispanic, 16 (10%), were Black, Asian, or Hispanic, and the rest unknown; 102 (64%) were current or former smokers. 77 (48%) were tested for PD-L1 via various assays, with 44 (57%) of those tumor samples reported as positive. 1L PBC was cisplatin-based in 100 (63%) of pts and carboplatin-based in 60 (38%). Pts received a median of 4 PBC cycles (interquartile range [IQR], 3-6) for a median of 13 weeks (IQR, 10-17). 31 (19%) discontinued PBC due to unacceptable side effects/toxicity. Best observed response was complete response in 21 (13%), partial response in 109 (68%), and stable disease in 17 (11%), with the remainder unknown. Median time to first imaging was 10 weeks (IQR, 5-14) after PBC initiation. 23 (14%) were hospitalized while receiving PBC, and 25 (16%) were seen in the emergency department. Pts proceeded to avelumab 1LM at a median of 4 weeks (IQR, 3-6) following PBC completion. Avelumab was administered at 800 mg every 2 weeks in 130 (81%), 10 mg/kg in 15 (9%), 〈 800 mg in 8 (5%), and 〉 800 mg in 7 (4%) pts. Conclusions: This ‘RW’ study offers valuable insights into characteristics and outcomes of pts with la/mUC treated in the US. Baseline factors, tx patterns and response to PBC were consistent with usual therapy paradigms in the 1L induction setting. Ongoing trials are evaluating the optimal number of PBC cycles and predictive biomarkers. Limitations include the retrospective nature, lack of randomization and central review, potential selection and confounding biases. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.6_suppl.465
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 4
    Online Resource
    Online Resource
    Disease management and frontline treatment of locally advanced or metastatic urothelial (la/mUC) carcinoma: The U.S. physician PARADIGM study.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 6_suppl ( 2022-02-20), p. 456-456
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. 456-456
    Abstract: 456 Background: The treatment landscape for la/mUC is evolving. Data on current real-world treatment trends in la/mUC are limited. This study assessed US physician treatment decision-making and prescribing patterns using qualitative interviews (QIs). Methods: First, a targeted literature search (TLS) evaluated published abstracts from January 2018 to March 2021. Then, in July 2021, QIs with 15 US medical oncologists/urologists were conducted based on the TLS findings. Physicians were recruited for a 60-minute, 1-on-1 phone interview. Physicians had to be in practice ≥1 year post fellowship, a board-certified oncologist/urologist, and managed ≥1 la/mUC patients who received first-line (1L) systemic therapy in the past 6 months. Results: Seven published US retrospective studies found relatively low utilization of 1L systemic therapy with 40%-65% of la/mUC patients not treated; high attrition rates reported with only 15%-40% of 1L patients receiving second-line (2L) therapy. The TLS included patient data collected primarily through 2017 and did not capture current systemic treatment patterns for recently approved therapies. QI respondents were community oncologists (n = 8), academic oncologists (n = 4), and community urologists (n = 3). The average number of la/mUC patients seen in the past 6 months was 23 per physician. Physicians estimated that ≥75% la/mUC patients are currently being treated with systemic therapy, with all oncologists prescribing 1L immunotherapy (IO) maintenance to eligible patients (n = 10 prescribing avelumab for ≥90%). According to 11 respondents (73%), the proportion of systemic-treated patients has increased in recent years with the availability of IO and novel therapies. Top reasons for not prescribing systemic therapy were poor performance status (73%), old age (67%), patient preference (53%), and comorbidities (47%). Physician-reported 1L regimens administered were 41% carboplatin-based, 37% cisplatin-based, 17% single-agent IO, and 4% nonplatinum chemotherapy. Top criteria impacting 1L regimen choice were renal function (100%), performance status (75%), neuropathy (75%), and age (50%). IO was typically reserved for patients who were platinum ineligible or refused chemotherapy. Ten oncologists reported that 60%-80% of 1L la/mUC patients received a 2L treatment. Conclusions: From the QIs, physicians reported higher treatment rates compared to the TLS; however, our physician sample was small, and the TLS included patient data through 2017 and thus did not capture current systemic treatment patterns. Findings suggest that, over time, the proportion of US la/mUC patients treated with/eligible for 1L systemic therapy has increased, including IO maintenance, as well as for subsequent lines due to increased treatment options after 2017. A quantitative survey of 150 medical oncologists is planned next for this study.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.6_suppl.456
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 5
    Online Resource
    Online Resource
    PATRIOT II: An ambispective, observational, multicenter, 2-cohort study of avelumab (Ave) first-line maintenance (1LM) in locally advanced/metastatic urothelial carcinoma (la/mUC) in the United States.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 6_suppl ( 2022-02-20), p. TPS578-TPS578
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. TPS578-TPS578
    Abstract: TPS578 Background: The randomized phase 3 JAVELIN Bladder 100 trial demonstrated overall and progression-free survival (OS and PFS) benefit with Ave 1LM for la/mUC not progressed with platinum-containing chemotherapy (PCT). PATRIOT II aims to understand real-world treatment (tx) patterns, patient-reported outcomes (PRO), and healthcare resource utilization (HCRU; eg, hospitalizations and emergency department visits) before and during Ave 1LM treatment. Methods: PATRIOT II is an ongoing, real-world, observational study in ≤25 US oncology centers with 1) an ambispective cohort of patients (pts) initiating PCT (n = 100), a subset of whom may continue to Ave 1LM and 2) a retrospective cohort initiated on Ave 1LM (n = 150). Sample size assumes noninferiority in HCRU and PRO pre and post 1LM initiation using paired t-tests with effect size of ≤0.3 as noninferior: ≥71 patients continuing to 1LM. In the ambispective cohort, pts with histologically confirmed la/mUC newly initiating 1L PCT are enrolled. While pts are receiving PCT and 1LM (for those who receive it), data will be collected on disease characteristics, response to tx, survival, adverse events (AEs), and HCRU for ≤52 wks after study initiation. PROs are captured using Rand SF-36 question 1, FACT Bladder Symptom Inventory – 18 and Cancer Treatment Satisfaction Questionnaire. Primary outcomes include OS and PFS from both PCT and 1LM initiation; secondary outcomes are changes in PROs and HCRU from PCT to 1LM. Analysis will be conducted at following time points: 1) baseline characteristics after full enrollment; 2) 6 months after study initiation to assess tx changes and rationale, OS, PFS, HCRU, and PRO changes from baseline; 3) at study conclusion (wk 52 after study initiation). In the retrospective cohort, pts with la/mUC who initiated Ave 1LM are enrolled. Chart data encompasses PCT and 1LM periods. Disease characteristics, response to tx, survival, AEs, and HCRU are collected. Primary outcomes are OS and PFS from initiation of PCT and 1LM start. Secondary outcomes are changes in HCRU before and after 1LM. Analysis will be conducted at following time points: 1) baseline characteristics after full enrollment, PCT, and response to tx; 2) 6 months after study initiation to assess tx changes since baseline, including dose changes, tx discontinuation/change rationale, survival rates (censoring for differential duration of follow-up), and HCRU outcomes; 3) at study conclusion to analyze endpoints up to wk 52 following study initiation. Analyses for both cohorts include Kaplan-Meier and Cox regression for time-to-event endpoints and paired t-tests for pre/post 1LM. Enrollment commenced in June 2021. 5 and 18 pts are enrolled to date in the ambispective and retrospective cohorts, respectively, from 6 of 11 activated sites. Initial results are anticipated in May 2022.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.6_suppl.TPS578
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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