tbuckley/cabot-search huggingface dataset:
Oral oncolytics medically integrated dispensing: Impact on medical spending compared to non-integrated dispensing.
Authors: Ben Urick, Landon Marshall, Patrick P. Gleason, Brady Atherton, Joseph W. Leach
Journal: Journal of Clinical Oncology (2024)

e23098 Background: Medically integrated dispensing, consisting of multidisciplinary care teams dispensing drugs within clinics, has been associated with reduced medical spending for members receiving oral oncolytics (OO). However, there is little understanding of how medical spending differs across sites of care by dispensing channel. Objective: To compare 6-month pre/post all-cause medical spending by site of care between integrated and non-integrated dispensing channels among commercially insured members initiating OO therapy. Methods: Prime Therapeutics’ integrated pharmacy and medical claims database was used to identify members newly initiating an OO of interest between 1/1/2019 and 12/1/2022. Members were required to be continuously enrolled 6 months before and after index, had a cancer diagnosis, and had &gt; $0 medical spending. Dispensing channel Integrated Health System Specialty Pharmacy (Int-HSSP), Integrated Physician Office (Int-Phys), Non-Integrated (Non-Int) was assigned using index OO fill. The primary outcomes were change in all-cause medical spending, medical drug spending, and non-drug medical spending divided into five site of care categories: inpatient, outpatient facility, emergency department, provider office visits, and other. Regression analysis was used to compare change in spending across channels, adjusting for demographics, health status, and cancer type. Results: A total of 30,928 (Int-HSSP: N = 5,500; Int-Phys: N = 2,550; Non-Int: N = 22,878) commercially insured members met all study criteria. Mean age ranged from 53.9 (Int-HSSP) to 56.1 years (Int-Phys). Compared to Non-Int (Unadjusted All Medical Pre: $56,214, Post: $67,050), significant cost savings were observed in the Int-Phys (Unadjusted All Medical Pre: $64,794 Post: $64,670; adj. diff -$5,672 [-9,384 to -1,960; p = 0.003]). Across categories of medical spending, the largest decreases were observed for inpatient medical spending (adj. diff -$2,663 [-5,000 to -326; p = 0.026]) and medical drug spending (adj. diff -$2,082 [-$4,248 to 84; p = 0.060]) with the remaining $927 in savings coming from differences across all other sites of care combined. No significant differences were observed for other medical spending categories or for Int-HSSP compared to Non-Int. Conclusions: Int-Phys dispensing channel for OO drugs was associated with a $5,672 reduction in medical spending compared to Non-Int, nearly half of which was driven by changes in inpatient non-drug medical spending alone. These findings support managed care models which include integrated oncology dispensing as a potential opportunity to reduce medical spending. Future work should assess the impact of dispensing channel on total cost of care and differences in healthcare utilization and in patient care experiences by dispensing channel.
Immune response to SARS-CoV-2 vaccine administered to patients with solid cancers under systemic treatment: A prospective, monocentric study (Immunocovid-19).
Authors: Francesco Caputo, Martina Rotolo, Edoardo Carretto, Laura Albertazzi, Giamaica Ciardiello, Silvio Cavuto, Luisa Savoldi, Eleonora Ferretti, Mattia Lombardi, Silvia Soncini, Cristina Galimberti, Stefania Di Girolamo, Gabriella Moretti, Francesco Iachetta, Francesca Zanelli, Silvia Fanello, Elisa Gasparini, Angela Damato, Antonino Neri, Carmine Pinto
Journal: Journal of Clinical Oncology (2024)

e23093 Background: Despite vaccination, COVID-19 could still cause severe disease in immunocompromised patients (pts). While subsequent vaccine doses increase immune response in the general population, few data concerning cancer pts under systemic treatment are reported. Methods: This study will be conducted on blood samples from 1000 pts admitted to Reggio Emilia AUSL-IRCCS Cancer Center and undergoing systemic therapies who received ≥ 2 vaccine doses. The samples will be analyzed at Clinical Microbiology and Chemistry Laboratories of Reggio Emilia AUSL-IRCCS. We will perform antibody IgM-IgG serology by means of COVID-19 VIRCLIA® Monotest and anti-spike antibodies evaluation using LIAISON® SARS CoV-2 Trimerics IgG. We will also investigate cell immune response (B and T lymphocyte counts) and analyze specific lymphocyte subsets on the first 200 pts treated with chemo- (CT) or immunotherapy (IO). Then, we will evaluate the T-cell response on the first 50 pts and those with an inadequate anti-spike serologic response through the T-SPOT.COVID test. Statistical analyses will be conducted by the Clinical Studies and Statistical Unit Staff. Results: Here, we report preliminary data on the first 240 pts enrolled and treated with CT (55.4%), IO (26.3%), or other therapies (18.3%). Most of the pts were male (58%), had metastatic cancer (82%), and no previous COVID-19 infection (60%). 84% of pts were affected by gastrointestinal, lung, urogenital and breast cancer. We stratified pts in three groups according to the time from the last vaccine dose (0-6/6-12/ &gt; 12 months). We showed no significant decrease in cellular and humoral immune response over time from the last vaccine dose, independent of the specific treatment received, also if CT (Table 1). Furthermore, clinical characteristics as gender, treatment, and primary tumor site appear not to influence immune response, even if a trend to a higher response in pts previously affected by COVID-19 has been observed. The T-SPOT.COVID test performed on the first 27 pts showed that 19% had no T-cell activation, even with good IgG response. Conclusions: This feasible and cost-effective study has a potential impact on public health. Although these are preliminary data, the immune response to COVID-19 vaccines remains good after 12 months from the last dose administered in cancer pts. The enrollment is ongoing, and we could provide relevant information on the influence of clinical factors on the immune response and identify specific subgroups that could benefit from different vaccine approaches. [Table: see text]
National Comprehensive Cancer Network guideline compliance in an oncology value-based care program serving Medicare members.
Authors: Edward Thompson, Kevin Hastings, Robert Cullum, Shirisha Reddy, Rogelio Alberto Brito, Brooke Byrd, Elisea Avalos-Reyes, Kjel Andrew Johnson
Journal: Journal of Clinical Oncology (2024)

e23095 Background: Value-based care (VBC) focuses on improving patient health outcomes while reducing the overall cost of healthcare. National Comprehensive Cancer Network (NCCN) cancer treatment guidelines standardize and improve quality of care. While studies have shown that compliance to NCCN guidelines improves survival, little information exists regarding the impact of compliance in VBC arrangements. This study aimed to evaluate compliance to NCCN regimen guidelines in Medicare members being treated for cancer under a VBC arrangement. Methods: This is a cohort study of individuals receiving care, in a single state, enrolled in a VBC contract within a large national insurer from February 2023 to October 2023. Medicare members with bladder, colon, lung, melanoma, breast, hepatocellular, rectal, pancreatic, multiple myeloma, gastric, ovarian, esophageal, lymphoma, kidney, leukemia, head and neck, biliary tract and uterine cancer with at least one oncology claim within the contract year were included. NCCN compliance was a quality measure of the VBC. NCCN regimen compliance was identified from pharmacy and medical claims and defined as concordant if the entire prescribed treatment regimen matched an NCCN regimen (Level 1 and 2a); members not receiving an NCCN recommended regimen were deemed to be non-concordant. Results: This study included 561 patients, the mean [SD] age was 75.7 [8.2] years and 286 [51.0%] members identified as male. The total population captured through the automated prior authorization platform yielded 100% NCCN compliance. Conclusions: In this study, individuals receiving chemotherapy participating in a shared savings VBC demonstrated 100% compliance to NCCN guidelines.
Molecular and genomic testing in Native American patients with metastatic lung and colorectal cancers: A retrospective chart review.
Authors: Niveditha Popuri, Minh Duc Phan, Ryan David Nipp, Mark Philip Doescher, Amanda Janitz, Justin Dvorak, Sheryl Buckner, Amber Anderson-Buettner, Dorothy Alison Rhoades
Journal: Journal of Clinical Oncology (2024)

e23136 Background: The Native American (NA) population has the poorest cancer survival of all racial groups in the U.S. A long history of research misconduct has caused many tribal communities to hold unfavorable views toward genomic data collection. Routine molecular and genomic testing is standard of care for most metastatic lung and colorectal cancers but the frequency of such testing in NA patients is unknown. Many NA patients have limited financial resources and must rely on coverage for health care from an Indian Health Service, Tribal Health Service, or Urban Indian Health (ITU) program. However, ITU programs do not operate their own cancer treatment services and must refer their patients elsewhere for such care. Methods: A Native American Navigation program (NANP) was established at the Stephenson Cancer Center (SCC) in Oklahoma to promote cancer health equity and provide high-quality cancer care by facilitating access to care for ITU patients from across the state. The NANP interfaces with ITU programs to obtain approvals for care as well as to coordinate clinical and supportive services, such as transportation or food assistance. We conducted a retrospective chart review of patients referred from an ITU program to the SCC NANP in Oklahoma from 1/2014 to 6/2023. Among patients with metastatic colorectal cancer (CRC), we investigated the frequency of testing for KRAS, NRAS, BRAF as well as MSS/MSI. In patients with metastatic non-small cell lung cancer (NSCLC), we identified the frequency of EGFR, ALK, ROS1, and PD-L1 testing. Results: A total of 305 NA patients were referred to SCC for colorectal and lung cancers. Of these, 68 patients had metastatic disease and qualified for molecular and genomic testing per National Comprehensive Cancer Network guidelines. The mean age of our cohort was 63 with a male-to-female ratio of 1.6:1. Most (85.3%) patients eligible for testing had testing for at least one biomarker. In patients with metastatic CRC, 100% received MSS/MSI as well as KRAS testing and the frequency of NRAS and BRAF testing was 69.6% and 84.8% respectively. In patients with metastatic NSCLC, the frequency of EGFR, ALK, and ROS1 testing was 95.8%, 87.5%, and 79.1%, with PD-L1 testing frequency being 83.3%. Conclusions: The overall frequency of molecular and genomic testing in these navigated NA patients (85.3%) was comparable to the range reported in the general population (66-90%). By facilitating access to cancer care, programs such as the NANP may help NA patients receive appropriate testing to guide treatment. Larger studies are needed to further assess the role of navigation programs in reducing cancer disparities by facilitating access to appropriate molecular and genomic testing for NA patients with metastatic cancers.
Eribulin and irinotecan for refractory or recurrent Ewing sarcoma: A retrospective study.
Authors: Jie Xu, Lu Xie, Xin Sun, Kuisheng Liu, Xin Liang, Xiaodong Tang
Journal: Journal of Clinical Oncology (2024)

e23502 Background: The effectiveness of eribulin and irinotecan in treatment of xenograft models of Ewing sarcoma is well-established but little clinical data has been reported. Encouraging results from preclinical models and a shortage of temozolomide in our hospital have prompted the administration of the eribulin as substitute for temozolomide and vincristine in combination of irinotecan at our institution from 2022 to 2023 in an off-label way. Methods: We retrospectively reviewed the medical records of patients treated for refractory or recurrent Ewing sarcoma with 1.4mg/m 2 D 1,8 eribulin and 20mg/m 2 /d D 1-5,8-12 irinotecan at 21 day intervals (ERII) at Peking University People’s Hospital. Results: Finally, a total of 17 patients with median age 18.6 years were treated with a total of 77 courses of ERII between February 2022 and February 2023. The objective response rate was 35.3%, the disease control rate 58.9% and the median event-free survival (EFS) 2.07 months. 35.3% patients had 6 months EFS and overall survival was 66.9%. Grade 3 or 4 toxicities were observed in 37.6% courses and in 64.7% of the patients, with myelosuppression, especially neutropenia, being the most common and diarrhea / abdominal pain the second most common. In the dx5x2 VIT protocol the later portion was given two days after the end of early portion. However, in this substitute regimen of eribulin, the median time interval between the end of the early portion to the start of later portion was 5 days. The dose intensity of the regimen was reduced by 21% per cycle. The later portion was delayed mostly because of unrecovered myelosuppression. Conclusions: The efficacy and safety of eribulin and irinotecan as a second-line regimen was inferior to historical reports of temozolomide and irinotecan in the same institute. There was no need for further prospective trials on this combination unless mechanisms of synergy and biomarkers are identified. [Table: see text]
Perspectives of facilitators and barriers to cancer clinical trial participation: A mixed-methods study.
Authors: Lovoria B. Williams, Jessica L. Burris, Tia N. Borger, Tianna Acree, Bassema M. Abufarsakh, Susanne M. Arnold
Journal: Journal of Clinical Oncology (2024)

e23206 Background: Inclusive clinical trials (CT) are integral to ensure that all patients benefit from advancements in cancer treatment. Having a diverse makeup of CT participants is imperative. Yet nationally, only 5% of trial participants are racial/ethnic minorities despite persistent disparities in cancer incidence and mortality. Determining the barriers and facilitators to CT participation will inform strategies to advance CT diversity, and cancer care equity. Methods: We conducted a mixed methods study exploring perceived barriers and facilitators to CT participation. We asked CT staff and Black adult cancer patients who enrolled in a CT to engage in semi-structured focus groups or interviews via Zoom. Based on emergent themes and data from extant literature we developed and deployed to CT staff a 24 item 5-point Likert style (strongly disagree – strongly agree) survey regarding clinician, institution, and patient-level factors impacting CT participation; one item ranked overall CT participation barriers. Results: Ten patients and thirteen CT staff participated in the focus groups and interviews. Table 1 presents major themes that emerged. CT survey respondents (N = 30) included clinicians (40%) and research associates (43%) and roughly half (55%) were White, non-Hispanic. The majority (80%) responded that their personal skills and confidence with enrolling diverse patients were high. The top ranked barriers to CT enrollment were travel distance (77%) and added financial burden (60%). Facilitators were altruism (70%) and clinician awareness of available trials (73%). Most (60%) endorsed perceptions that enrolling racial/ethnic patients was more challenging than White and that patient attributes (e.g., higher education, timeliness to appointments increased adherence to CTs protocols. Conclusions: Complex, multi-level factors influence CT enrollment and diversity with patient level factors of most concern. Multi-level approaches both internally and community-focused are necessary for CT participation and diversity. Efforts are necessary to mitigate implicit bias among CT staff, particularly as it relates to perceptions of patient attributes. To advance cancer care, CT participation equity must remain a priority.
Assessing response and adherence to neoadjuvant treatment in soft tissue sarcomas of the extremities.
Authors: Gabriela Alamilla-Garcia, Haydée Williams, Dorian Yarih Garcia-Ortega
Journal: Journal of Clinical Oncology (2024)

e23559 Background: The standard treatment for large, intermediate, and high-grade extremity soft tissue sarcoma (ESTS) involves surgery and radiotherapy. The addition of chemotherapy has improved oncological outcomes, such as reduced recurrence and prolonged survival. However, the relationship between neoadjuvant treatment and tumor response in ESTS is not well understood. Pathological evaluation of viable tumor cells after treatment is an indicator of tumor response, yet the proportion of viable tumor cells remains high, particularly in high-risk sarcomas. Combining radiotherapy with chemotherapy may enhance the response of tumor cells. Objective: This study aims to evaluate the effects of neoadjuvant chemotherapy (NCT) and chemoradiotherapy (CRT) on patients with high-risk ESTS and to determine its impact on the pathological response. Methods: We enrolled adult patients with high-risk ESTS (SARCULATOR OS &lt; 60%) at a single center in Latin America. The study was designed to analyze the pathological response in patients with high-risk sarcomas who underwent neoadjuvant CRT and resection and to correlate these responses with various variables. The treatment response was evaluated using the EORTC–STBSG criteria. Results: Thirty-four patients were recruited, with a median age of 44 years (IQR 23-74). Fifty-two percent had T3 tumors (mean size 18 cm), and 79.4% were diagnosed at stage III. The predominant histological subtypes were synovial sarcoma (35.3%) and dedifferentiated liposarcoma (29.4%). The most used NCT regimen was doxorubicin/ifosfamide (84.4%), with 62.5% receiving a dosage intensity of Q4W, affected by overcapacity, and 25% received Q3W. Concurrent CRT was administered to 64.7% of patients, with a median delay to onset of 36 days due to overcapacity (43.5%). Only 79.4% completed three preoperative cycles of treatment. As for the response, 41.2% had an EORTC-E response, and 17.6% had an EORTC-D response. Grade 3 neutropenia and anemia occurred in 17.2% and 8.8% of patients, respectively. Disease progression during NCT was observed in six patients. No significant difference was found in the pathological response between the Q4W and Q3W dosage intensities (p = 0.62). Conclusions: The impact of NCT on pathological responses was not significantly high, which may be due to the predominant histological type in our series. The main cause of treatment delay at our center was due to overcapacity; however, this did not influence the pathological response relative to dose intensity. Additional follow-up assessments are required to determine the influence on relapse-free and overall survival based on the response after preoperative CRT.
Factors influencing the clinical added value (CAV) in France over more than a decade.
Authors: Lucas Duriez
Journal: Journal of Clinical Oncology (2024)

e23102 Background: The rise of cancer drug prices has raised alarm over the need to base pricing decisions on the clinical added value (CAV). The French National Authority for Health (HAS) is responsible for health technology assessment (HTA) in France. For each indication retained for reimbursement, the HAS assesses the CAV on a 5-point scale ranging from I (Major) to V (absence of clinical added value). This assessment is primarily based on medical evidence. The CAV score is one of the factors contributing to price negotiations between the French ministry and pharmaceutical companies. Methods: A retrospective and descriptive study analysis of all indications in oncology (hematology and solid tumors), excluding accelerated approvals for innovative treatments, was conducted by the HAS comparing the 2010-2015 and 2016-2022 periods. For each assessment, information relative to the level of evidence and the clinical effect of the drug from the HAS opinion were collected and focused on the study’s conclusive endpoints and design. Results: The global distribution of CAV score between the two studied periods (2010-2015 and 2016-2022) was similar. However, the distribution of CAV score based on study design differed between the two periods. Regarding non comparative studies, the proportion of indications that were attributed a CAV score V increased 1.7 times between 2010-2015 and 2016-2022 and those with a CAV score I-III was nearly divided by 3. Differences were equally observed for the distribution of CAV score between the two periods based on the conclusive endpoints in the pivotal study. For the studies with a conclusive endpoint on overall survival, the rate of CAV I-III was multiplied by 1.68 (an increase from 6 to 36 cases). Concerning the cases with a progression-free survival endpoint, an observed increase of 1.3 times was noted for the CAV I-III. Lastly, studies with a conclusive overall response rate (ORR) saw an increase of 1.4 times for the CAV V as well as a decrease of 0.76 times for the CAV I-III. Over the most recent period (2016-2022), the conclusive endpoints identified in the evaluated studies were predominantly the overall response rate (93%, n = 42/45) for phase II studies. For phase III studies, progression-free survival and overall survival were respectively identified in 45% and 30% of the cases. Conclusions: Thisstudy shows that the number of indications evaluated has increased and that the assessment of the CAV is closely correlated with the choices of the study design (comparative or not) and the primary endpoint (clinically relevant or not). However, other elements underpin and qualify its valuation such as the medical need. These elements are reviewed in the HAS Guidance which emphasises overall survival as a primary endpoint and comparative data.