tbuckley/cabot-search huggingface dataset:
Continuous remote monitoring of performance status in patients with NSCLC through fitness tracker–derived life-log data.
Authors: Yeong Hak Bang, Suyeon Lee, Taehee Kim, Hongyiel Suh, Mansu Kim, Sehhoon Park
Journal: Journal of Clinical Oncology (2024)

1568 Background: Traditional methods for assessing the performance status of cancer patients often rely on clinical evaluations and patient-reported histories. This study utilizes life-log data derived from fitness trackers (FTs) in patients with non-small cell lung cancer (NSCLC) to offer a comprehensive and dynamic perspective on performance status throughout their treatment. Methods: Patients with NSCLC scheduled for a minimum of 12 weeks of treatment were enrolled. Custom software facilitated the remote collection of life-log data from participants' FTs (Fitbit Inspire 3), encompassing step count, calories burned, heart rate, sleep patterns, etc. Quality of life surveys assessing patient-reported outcomes (PROs) were completed during regular visits (every 3 weeks) and unscheduled visits (USV), in addition to collecting clinical data such as laboratory parameters and body composition metrics. An end-of-monitoring survey assessed participants' familiarity with this monitoring approach. The study aimed to correlate FT data with clinical parameters and identify patterns predictive of treatment related USVs. Results: Of the 98 enrolled patients, 69 patients (70.4%) completed the 12-week follow-up. The cohort predominantly consisted of older adults (≥65 years) (55.1%) and patients in palliative care (75.5%), with most undergoing cytotoxic chemotherapy (66.3%) and some receiving oral agents (20%). FT-based remote monitoring revealed that older patients had a comparable 12-week completion rate to younger patients. (69.2% vs. 76.2%, P=0.604). Analysis of life-log data from three days before a visit (D-3) to the visit day (D0) showed significant reductions in average step counts ( P=0.022) and walking distance ( P=0.021) for USVs compared to regular visits, while resting heart rate (HR) showed a significant increase for USVs ( P=0.049). PRO-based PROMIS physical function scores and EQ-5D-3L scores showed a significant correlation with both D-3 to D0 acquired resting HR ( P&lt;0.001, P=0.002) and average step counts ( P=0.011, P=0.013), respectively. End of monitoring survey was done from 72 participants indicating high satisfaction and familiarity with the FT-based remote monitoring system, median score of 90 out of 100. Conclusions: FT-derived life-log data effectively captured dynamic performance status in NSCLC patients, correlating with clinical outcomes and PRO. These findings support further research into FT data's predictive value for clinical interventions, underscoring its potential in personalized remote patient management.
Performance of an artificial intelligence/machine learning model designed to identify hospitalized patients with cancer who could benefit from timely specialized palliative care delivery.
Authors: Jacob J. Strand, Alisha A Morgan, Deirdre R. Pachman, Curt B Storlie, Patrick M Wilson
Journal: Journal of Clinical Oncology (2024)

1559 Background: Timely access to specialty Palliative Care (SPC) services provides significant benefits to hospitalized patients with cancer, including improvements in quality of life. However, many patients with cancer who could benefit from SPC suffer from lack of timely referral or do not receive SPC services. A previously published trial of an artificial intelligence/machine learning (AI/ML) model to predict need for SPC at Mayo Clinic increased timely SPC consultation of hospitalized patients overall. We sought to review the performance of this algorithm in patients with cancer across an expanded hospitalized population. Methods: The study population consisted of all patients admitted into a Mayo Clinic hospital in Minnesota, Wisconsin, Arizona and Florida between January 2020 and September 2023. Due to the size of the cohort a case-control sample of three controls for every case was created. Patients were considered to be a patient with cancer if they had at least one billing diagnosis up to 1 year prior to their index hospitalization from any of the 5 HCC categories denoting cancer: Metastatic Cancer and Acute Leukemia (HCC 8); Lung and Other Severe Cancers (HCC 9); Lymphoma and Other Cancers (HCC 10); Colorectal, Bladder, and Other Cancers (HCC 11); and Breast, Prostate, and Other Cancers and Tumors (HCC 12). The training data set consisted of 107,076 patient encounters with a total of 8,355,090 time periods of constant risk. An AI/ML model using gradient boosting methods which contained 269 variables (both static and time-varying) of various classes with SPC consultation treated as a time-to-event outcome was trained. Results: Due to the longitudinal nature of the prediction, performance was assessed using the max score AUC (using the max score a patient received during a given encounter prior to an event or discharge) to produce the AUC. The model had an overall AUC of 0.932 (0.929, 0.935 – 95% CI). We saw a decrease in performance of the AI/ML model in the Oncology population with an overall performance of 0.818 (0.806, 0.83). Some of the most influential variables were previous SPC visit, age, metastatic disease, acute leukemia diagnosis, and pain scores. Conclusions: An AI/ML model can effectively predict the need for an inpatient PC consult in a population of hospitalized patients with cancer. [Table: see text]
Survival outcomes associated with first-line PCV or temozolomide in combination with radiotherapy in IDH-mutant 1p/19q-codeleted grade 3 oligodendroglioma.
Authors: Salah Eddine O. Kacimi, Caroline Dehais, Loïc Feuvret, Olivier L. Chinot, Catherine Carpentier, Charlotte Bronnimann, Elodie Vauleon, Apolline Djelad, Elizabeth L. Cohen-Jonathan Moyal, Olivier Langlois, Mario Campone, Mathilde Ducloie, Georges Noel, Stefania Cuzzubbo, Damien Ricard, Thierry Faillot, Pierre-Yves Boelle, Dominique Figarella-Branger, Francois Ducray, Mehdi Touat
Journal: Journal of Clinical Oncology (2024)

2004 Background: Patients with IDH-mutant 1p/19q-codeleted grade 3 oligodendroglioma (O3 IDHmt/Codel ) benefit from adding alkylating chemotherapy to radiotherapy (RT). However, the optimal chemotherapy regimen between Procarbazine, CCNU, and Vincristine (PCV) and Temozolomide (TMZ) remains unclear given the lack of randomized trial data comparing both regimens. Methods: The objective was to assess the overall (OS) and progression-free (PFS) survival associated with first-line PCV/RT versus TMZ/RT in patients diagnosed with O3 IDHmt/Codel . We included patients with histologically-proven O3 IDHmt/Codel (according to WHO criteria) from the French national prospective cohort study POLA. All tumours underwent central pathological review. OS and PFS from surgery were estimated using Kaplan-Meier method and Cox regression model. Results: 305 newly-diagnosed O3 IDHmt/Codel patients treated with RT and chemotherapy between 2008 and 2022 were included. 67.9% of patients (n=207) were treated with PCV/RT and 32.1% with TMZ/RT (n=98). Median follow-up was 78.4 months (IQR=44.3-102.7). Median OS was not reached (95%CI: NR-NR) and 140 months (95%CI: 110-NR) in the PCV/RT and TMZ/RT groups, respectively (log-rank P&lt;0.0001). On univariable analysis, there was a significant difference in favor of PCV/RT in both 5-year (PCV/RT: 89%, 95%CI: 85-94; TMZ/RT: 75%, 95%CI: 66-84) and 10-year OS (PCV/RT: 72%, 95%CI: 61-85; TMZ/RT: 60%, 95%CI: 49-73), which was confirmed in the multivariable Cox model adjusted for age, type of surgery, gender, ECOG performance status and CDKN2A homozygous deletion (HR 0.53 for PCV/RT, 95%CI: 0.30-0.92, P=0.025). Conclusions: In patients with newly-diagnosed O3 IDHmt/Codel from the POLA cohort, first line PCV/RT was associated with better OS outcomes compared to TMZ/RT. Our data suggest that the improved safety profile associated with TMZ comes at the cost of inferior efficacy in this population. Further investigation using prospective randomized studies is warranted.
Efficacy and safety of the vebreltinib in patients with previously treated, secondary glioblastoma/IDH mutant glioblastoma with PTPR<i>Z</i>1-<i>METFU</i>sion <i>GEN</i>e (FUGEN): A randomised, multicentre, open-label, phase II/III trial.
Authors: Tao Jiang, Zhaoshi Bao, Feng-Dong Yang, Qing Mao, Shouwei Li, Yan Qu, Liang Wang, Yonggao Mou, Ru-tong Yu, Jinsong Wu, Guangyuan Hu, Wenbin Li, Xiaoguang Qiu, Yun-Qian Li, Linbo Cai
Journal: Journal of Clinical Oncology (2024)

2003 Background: Although gliomas with mutated IDH have an improved prognosis compared to gliomas with wild-type IDH, IDH-mutant gliomas carry a high risk of malignant transformation from low-grade gliomas into high-grade gliomas within 10 years, resulting in poor prognosis. However, effective targeted drugs for high-grade gliomas are still lacking. Here, we report data from the FUGEN study of Vebreltinib, the first completed phase II/III trial of sGBM / IDH mutant glioblastoma patients with previously treated, PTPRZ1-MET Fusion gene positive. Methods: In this open-label, phase II/III trial, we randomly assigned, in a 1:1 ratio, 84 patients with Histologically confirmed secondary GBM or IDH-mutant GBM to receive twice-daily oral vebreltinib in 300 mg dose or the investigator's choice of chemotherapy (temozolomide [100-150 mg/m 2 /day, 7days on followed by 7 days off ] or cis-platinum [80-100 mg/m 2 for 3 days] combined with etoposide [100mg/m 2 /day for 3 days]) every 28 days. The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS) and objective response rate (ORR). Results: 42 patients of the vebreltinib group and 39 patients of the chemotherapy group were included in the full analysis set. After a median follow-up of 4.44 months, the median OS in the vebreltinib group and chemotherapy group was 6.31 months (95% CI, 4.44-8.77) and 3.38 months (95% CI, 2.37-4.27), respectively. The HR for OS was 0.52 (90% CI, 0.32-0.85; P = 0.009). The median PFS in the vebreltinib group and chemotherapy group was 1.87 months (95% CI, 1.41-2.76) and 1.05 months (95% CI, 0.95-1.77), respectively. The HR for PFS was 0.54 (95% CI, 0.33-0.88; P = 0.014). No significant differences were observed in ORR (9.5% vs. 2.6%) for the vebreltinib group and chemotherapy group. Treatment-related adverse events of grade 3 or 4 were reported in 7% of the patients in the vebreltinib group, as compared with 12.2% of those in the chemotherapy group. No treatment-related deaths were observed. Conclusions: These results of the FUGEN trail support the use of vebreltinib as the first target therapy in patients with previously treated, PTPRZ1-MET fusion gene positive, secondary glioblastoma / IDH-mutant glioblastoma, and shed light on a novel therapeutic pathway in the landscape of IDH-mutant high-grade gliomas. Clinical Trials Information: NCT06105619 and ChiCTR2300077783 Research Funding:Beijing Pearl Biotechnology Co., Ltd. and Avistone Biotechnology Limited. Clinical trial information: NCT06105619 .
ACE-BREAST-03: A phase 2 trial evaluating ARX788, an anti-HER2 antibody drug conjugate (ADC), for the treatment of HER2+ metastatic breast cancer (mBC) in patients who have been previously treated with trastuzumab deruxtecan (T-DXd).
Authors: Debashish Tripathy, Kashif Ali, Laila Agrawal, Sami M. Ali, Sibel Blau, Margaret Block, Michael A. Danso, Denise Yardley, Jay Andersen, Adrienne Gropper Waks, Priya Jayachandran, Igor Makhlin, Petros Nikolinakos, Richard Zuniga, Joyce O'Shaughnessy, Sandra Aung, Janice M. Lu, Kevin Kalinsky, William John Gradishar, Hope S. Rugo
Journal: Journal of Clinical Oncology (2024)

TPS1123 Background: HER2-targeted ADCs revolutionized treatment for patients with HER2+ mBC. The HER2-targeted ADC, T-DXd, improved PFS and OS vs T-DM1 (trastuzumab emtansine) as second-line treatment for HER2+ mBC and is now the preferred treatment option in this setting. However, new treatment options are needed for patients with disease progression on T-DXd. Novel technological advances in design of the antibody, linker, and payload of ADCs may further improve the safety/tolerability and efficacy, widening the therapeutic window to address resistance to other anti-HER2 therapies. ARX788 is a next-generation anti-HER2 ADC stably conjugated to AS269 (a potent tubulin inhibitor). Proprietary site-specific oxime conjugation chemistry, enabled by incorporation of synthetic amino acids into the antibody construct, maximizes the delivery of the cytotoxic payload to tumor cells and minimizes systemic exposure of free payload. ARX788 has shown antitumor activity in heavily pretreated patients with HER2+ and HER2-low mBC, including those with prior T-DXd exposure. Methods: ACE-Breast-03 (NCT04829604) is a Phase 2 trial evaluating ARX788 in patients previously treated with T-DXd. The primary efficacy endpoint is response rate by RECIST v1.1. Approximately 40 patients will be enrolled. Eligible patients have HER2+ mBC and up to 5 prior treatment regimens for mBC, including T-DXd. Patients must have central laboratory-confirmed HER2+ mBC; new pre-treatment biopsies may be required. Patients with treated and stable brain metastases who are off steroids are eligible. Treatment includes 1.5 mg/kg Q3W ARX788 for up to 26 cycles or until disease progression. Tumor status is assessed every 9 weeks through 27 weeks and every 12 weeks thereafter. The study is currently enrolling in the US. Clinical trial information: NCT04829604 .
Feasibility and satisfaction level of caregivers with telemedicine in childhood cancer: A mixed-methods study.
Authors: Sameer Bakhshi, Shuvadeep Ganguly, Manraj Singh Sra, Archana Sasi, Shubhangi Sharma, Swetambri Sharma
Journal: Journal of Clinical Oncology (2024)

1549 Background: Telemedicine has emerged as a crucial solution to addressing health care disparities, especially in countries like India where healthcare disparities are pronounced and specialist care is concentrated in urban areas. Methods: We conducted a mixed-methods study among caregivers of children with cancer who had utilised telemedicine in the past 6 months. Telephonic quantitative interviews collected information on diagnosis, current treatment status, residence and socio-economic parameters. A logistic regression model was created to assess patient and caregiver related factors associated with satisfaction with telemedicine. In-depths interviews were conducted in a sub-set of participants followed by thematic analysis. Results: Caregiver of 465 patients [median (range) age: 8 (0.1-18) years; 70.04% male; 82.54% with haematological malignancy] participated in this study. Patients had a median (range) of 2 (1-30) telemedicine in the past year, with parents being the most common care giver being involved [n=326 (70.10%)]. Telemedicine was reported to be more convenient than in-person visits and helpful in saving time and money by 90.54% (n=421) patients and 88.6% (n=421) patients reported easier follow up and access to care using telemedicine. Difficulty in explaining issues over telephones or emails was the reason for dissatisfaction for 47.53% (n=221) patients, additionally 22.37% (n=104) patients felt they received inadequate attention during telemedicine. Majority of the patients (85.38%, n=397) planned to continue teleconsultation and 88.39% (n=411) would recommend teleconsultation to others. Socioeconomic status of upper and upper-middle class upper and upper-middle socioeconomic status [OR (95%CI): 2.14 (1.38-3.32), p: &lt;0.001; aOR (95%CI): 2.11 (1.35 - 3.31), p: 0.001] was significantly associated with caregiver satisfaction with telemedicine. Qualitative interview showed themes of monetary and time savings with telemedicine, ease of consultations for minor complaints, delay in responsiveness of doctors, language barriers and difficulty in using telemedicine platforms due to low literacy levels. Conclusions: Telemedicine has emerged as a valuable tool for paediatric cancer care offering convenience and accessibility. While most caregivers expressed satisfaction, challenges remain in communication and limited access among caregiver of lower socio-economic strata. Further studies should aim at developing more patient friendly telemedicine platforms.
Geriatric assessment in older patients with non-small cell lung cancer: Insights from a cluster-randomized, phase III trial—ENSURE-GA study (NEJ041/CS-Lung001).
Authors: Naoki Furuya, Nobuhiro Kanaji, Keiki Yokoo, Takashi Yanagawa, Hiroshi Yamamoto, Koichi Takayama, Shigeo Kawase, Kazuto Matsunaga, Kenichi Takeda, Hiromi Nagashima, Tomohiro Sakamoto, Takamasa Hotta, Yuichi Takiguchi, Hitomi Nogawa, Yasuhiko Nishioka, Kunihiko Kobayashi, Takeshi Isobe, Yukari Tsubata
Journal: Journal of Clinical Oncology (2024)

1502 Background: To determine optimal treatment in older cancer patients, it is recommended to conduct a geriatric assessment (GA) before chemotherapy. The ENSURE-GA study, which focused on patients aged 75 and older with non-small cell lung cancer (NSCLC), reported that the implementation of GA not only enhanced patient satisfaction with regards to communication with their physicians, but also improve the patients’ quality of life. Additionally, we assessed whether GA could improve overall survival and serve as a predictor for severe adverse events. Methods: Patients aged ≥75 with NSCLC who were unable undergo radical treatment were enrolled. All patients underwent a standardized GA before treatment. The participating institutions were cluster-randomized into either intervention group or control group. For the intervention group, GA summaries and recommendations for GA-guided interventions were provided to guide physicians in selecting treatments and interventions. The control group did not provide physicians with GA summaries. Geriatric 8 (G8) and CARG scores were calculated at enrollment, and we investigated whether adverse events during a 3-month follow-up could be predicted. Results: Between 2019 and 2022, 1,021 patients were enrolled from 78 institutions in Japan. No significant differences were observed in patient characteristics or for GA domains between intervention and control groups. Additionally, there were no significant differences seen in 1-year overall survival (20.7m vs 18.8m, p = 0.414), or the incidence of grade 3 or higher adverse events in patients treated with medical treatment (36.8% vs 38.1%, p = 0.732). The ROC curve for G8 regarding the occurrence of grade 3 or higher adverse events in cases receiving cytotoxic chemotherapy yielded an AUC of 0.525, indicating no discriminatory ability. Furthermore, there was no difference in the incidence of adverse events between low-risk and high-risk patients based on the CARG score. Conclusions: The implementation of GA and interventions based on its results enhances patient satisfaction. However, additional studies are needed before incorporating GA into an adverse event prediction system. Developing risk scoring tools specific to cancer types and races may prove useful. Clinical trial information: UMIN0000037590 .
Identifying states for targeted alloHCT access initiatives using social vulnerability, physician density, and unmet need.
Authors: Samantha Watters, Christa Meyer, Jaime Preussler, Mary Senneka
Journal: Journal of Clinical Oncology (2024)

1528 Background: Access to allogeneic hematopoietic cell transplantation (alloHCT) is limited by many factors, with only 1 in 3 patients who may need a transplant receiving one. This study examined associations between social vulnerability index (SVI), physician density (PD), and alloHCT unmet need across the United States (U.S.) to identify geographic areas that may be most at-risk of access challenges. Methods: A retrospective analysis aggregated public data across 3,141 U.S. counties, including: SVI [Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry]; National Provider Identifier [Center for Medicare and Medicaid Services] data for all registered hematology-oncology and HCT physicians; and 2017 – 2021 alloHCT unmet need [Center for International Blood and Marrow Transplant Research (CIBMTR), NMDP]. PD was defined as providers per 10,000 population. All variables were collapsed into ordinal categories (very low, low, moderate, high) based on quartiles. Counties with moderate/high SVI and unmet need and low/very low PD were defined as at-risk. By state, linear regression and mediation analysis assessed exploratory relationships. Results: Among 396 counties defined as at-risk, top states are shown (Table). State (n=51) percent unmet need was correlated with SVI (r=0.494, p&lt;0.001) and PD (r=-0.295, p=0.036). Univariate analysis revealed SVI (b=0.223, p&lt;0.001) and PD (b=-0.187, p=0.036) as predictors of unmet need. However, multivariate regression showed only SVI as significant when included with PD. Race/ethnicity as 1 of 4 SVI subthemes (socioeconomic status [SES], household characteristics [including age], race/ethnicity, and housing/transportation) was not correlated with PD, but all other themes were. SES and household characteristics were found to fully mediate the relationship between PD and unmet need. Conclusions: This study can help prioritize targeted initiatives through a better understanding of how SVI, PD, and unmet need relate to alloHCT access. This study cannot draw causal conclusions and uses multiple population-level data sources. However, data can examine trends on a regional level within at-risk states to allocate resources to overcome barriers to alloHCT, with special attention on SES and household factors like age. Relationships between variables should be further examined. [Table: see text]