3 research outputs found
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HIDRATE-PRO: A prospective pilot study evaluating a digital behavioral health intervention to improve bladder-filling compliance in patients with prostate cancer receiving radiation
70 Background: Prostate cancer (PCa) patients undergoing radiation therapy (RT) need comfortably full bladders during RT to reduce toxicities. Awareness of this state is lacking, and poor compliance is common with standard of care written/verbal instructions, leading to wasted patient value (PV) and inefficient throughput (TE). Herein, we assessed the feasibility and acceptability of a digital behavioral intervention (DBI) to improve bladder filling compliance, methods for quantifying PV, IT, and behavioral biomarkers. Methods: We enrolled 18 non-metastatic PCa patients in a prospective, single-arm pilot study using a DBI. The DBI consists of a smart water bottle and companion app that tracks water consumption. Additionally, visual alerts (water bottle glow and phone notifications) remind the patient to empty his bladder and drink a personalized volume goal (VG) at a set time. The VG is based on simulation bladder volume and reminders are initially set 1.25 hours prior to scheduled RT. Patients were trained to adjust their VG and notification times to achieve comfortably full bladders. Primary endpoint was met if qualitative (QLC) and quantitative compliance (QNC) were both >80%. Other endpoints include acceptability assessed via Service User Technology Acceptability Questionnaire (SUTAQ), engagement (>80% of patients used the device > 50% of the time) and impact of DBI on PV and TE. For QLC, patients were asked if they prepared their bladders before daily RT. QNC was met if bladder volumes on daily CBCT were > 75% of the simulation’s volume. The SUTAQ was given pre- and post-DBI. PV and TE were measured by time spent in clinic and on the linear accelerator (linac), respectively. Biometric data was probed for insights on optimal drinking behaviors. Results: All endpoints were met. QLC was 100% on 375/398 (94.2%) of total treatments, while QNC was 88.9% on 341/398 (85.7%) total treatments. Patients were accepting of DBI with few privacy concerns (4.33/5.00), believe in benefits (4.00/5.00), high satisfaction (4.56/5.00) and high usability (4.24/5.00). Most patients, 15/18 (83.3%), used the DBI on >50% of treatments and met the engagement requirements. Patients with empty bladders (n=43) spent significantly more time (75.14 vs 50.59 minutes, p=0.007) in clinic than patients who came with full bladders (n=355). Similarly, these patients spent nearly twice as long on the linac (21.63 v 12.50 minutes, p<0.001). Shorter time spent drinking correlated with empty bladders (17.07 vs 27.85 min, p=0.027). Conclusions: This digital intervention trial showed high rates of bladder filling compliance and engagement. High patient-value and throughput efficiency was feasibly quantified by shortened clinic times and linac usage, respectively. Future studies are needed to evaluate clinical outcomes, patient experience and cost benefit. Clinical trial information: NCT04946214
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Complete pathological response after neoadjuvant treatment in soft tissue sarcoma: A single-institution experience.
e23526 Background: Pathological complete response (pCR) to preoperative treatment has been reported as a prognostic factor for survival in the soft tissue sarcoma (STS) population. pCR evaluation has been demonstrated in breast and head and neck cancers widely associated with improved outcomes, including overall survival (OS). The assessment to pathological response is not easily subject to variability, can be globally equitable, and has the potential to serve as a surrogate endpoint for research and survival outcomes. Methods: This is a retrospective, single institution study. The inclusion criteria were: patients with STS diagnosed between 2011–2021, s/p neoadjuvant treatment, and pCR (defined as necrosis rate on surgical specimen ≥ 90%). This study was approved by the University of Miami-Sylvester IRB. Results: We identified a total of 39 patients that met our inclusion criteria. 43% of the population were women. Mean age at diagnosis was 59 years old (range 20-84). 90% of the population remains alive, with mean overall survival of 6.6 years. Disease recurrence (local and distant) was present only in 11 patients (28%) and 4 of these patients (36.3%) progressed to death. Median progression free survival (PFS) was 42.5 months (95% CI 33.9-53.1). 34% of the cohort had the myxofibrosarcoma histology, and this group had mean OS of 7.2 years and mean PFS of 5.8 years. 20% of the myxofibrosarcoma patients developed metastatic disease versus 21% among patient with different histology (p = 0.89). Among the neoadjuvant treatments delivered, 93% of the patients received a combination of chemotherapy and radiation. The most common neoadjuvant chemotherapy regimen was the combination of Doxorubicin with Ifosfamide (66% of the patients) and their mean OS was 6.2 years vs 2.9 for the other regimens (p = 0.08). Among patients that received neoadjuvant chemotherapy, the median number of preoperative cycles was 4 (SD = 1.1). The median time from the start of chemotherapy to surgery was 5 months (SD = 1.4 months). Conclusions: Treatment induced pathologic necrosis has been proven as a predictor of survival in patients with STS in multiple studies. Interestingly, the most common histology present was myxofibrosarcoma, suggesting a good response to neoadjuvant treatment in this group with a lower rate of metastatic disease after pCR, when compared to the literature (35%). Chemotherapy associated with radiation in the neoadjuvant setting was the most common treatment and Doxorubicin with Ifosfamide was associated with a longer OS. The rate of necrosis after surgery has been shown to be a prognostic factor for STS, therefore there is a need to evaluate which associated factors lead to pCR. Further research with the evaluation of the molecular profiling of STS with pCR is underwork to better understand the mechanisms behind treatment responses. </jats:p
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Ancestral characterization of the genomic landscape, comprehensive genomic profiling utilization, and treatment patterns may inform disparities in advanced prostate cancer: A large-scale analysis
5003
Background: Prostate cancer (PCa) incidence, mortality, and outcomes vary widely across race/ethnicity. The underlying drivers of these differences are multifactorial, including systemic barriers that lead to wide variation in access to care including genomic and precision medicine. Men of African ancestry (AFR) are particularly underrepresented in genomic and precision medicine studies. Therefore, we sought to comprehensively assess patterns of gene alterations, comprehensive genomic profiling (CGP) utilization, and treatment patterns in a large, diverse advanced PCa cohort. Methods: 11,741 PCa patients with CGP, as part of routine clinical care (Foundation Medicine Inc., FMI) were evaluated for their genomic landscape. Predominant ancestry was inferred using a SNP-based approach (Connelly et al, AACR 2018). Independently, the US-based de-identified Flatiron Health (FH)-FMI clinico-genomic database (CGDB) of 897 evaluable PCa patients was also queried. Clinical characteristics and treatment selections were described for patients who received metastatic or castrate-resistant diagnosis between 1/2011 and 6/2020. Results: The FMI cohort included 1,422 (12%) men of AFR and 9,244 (79%) men of European ancestry (EUR). Median age was lower in AFR compared with EUR men (64 vs. 67, p < 0.001). TP53 and PTEN alterations and TMPRSS2-ERG rearrangements occurred less frequently in AFR than EUR men (35% vs. 43%, 21% vs. 33%, 15% vs. 33% respectively, p < 0.05). In contrast, alterations in SPOP (11.9% vs. 7.3%), CDK12 (10.0% vs. 5.2%), CCND1 (6.0% vs. 3.8%), KMT2D (7.7% vs. 5.1%), HGF (4.1% vs. 2.5%), and MYC (13.4% vs. 10.6%) were enriched in the AFR cohort (p < 0.05). Alteration frequency in BRCA1/2, AR, DNA damage response pathway genes, and actionable genes with therapy implications, were similar across ancestry. Of note, BRAF alterations were slightly enriched in AFR (5.0% vs. 3.2%, p < 0.05). In the CGDB cohort (79 AFR, 762 EUR), AFR men received a median of 2 lines of therapy prior to CGP, compared to 1 line for EUR men. Notably, the proportion of patients receiving immunotherapy and PARPi was similar across ancestry, however AFR men were less likely to receive clinical study drug compared with EUR men (11% vs 30%, p < 0.001), even among men with actionable alterations (1% vs 6%, p < 0.001). Conclusions: To our knowledge, this study encompasses the largest cohort, particularly of AFR men in a genomic study, that defines CGP utilization, the genomic landscape and therapeutic implications of CGP in PCa across ancestry. Overall, there were largely similar rates of actionable gene alterations across ancestry. Notably, AFR men were less likely to receive CGP earlier in their treatment course, and less likely to be treated on clinical trials, which could impact the genomic landscape, outcomes, and ultimately disparities