tbuckley/cabot-search huggingface dataset:
Understanding and comparing the views of specialty care providers and PCPs on addressing cancer survivorship needs via survivorship care plan portal.
Authors: David Andrew Haggstrom, Manasa Swaminathan, Claire E Donnelly, Ann H. Cottingham, Eric Vachon, Micah T. Faidley
Journal: Journal of Clinical Oncology (2024)

e13799 Background: Individuals with colorectal cancer (CRC) experience persistent and disabling symptoms across the care trajectory. Consequently, Survivorship Care Plans (SCPs) have been developed to assist patients in navigating these experiences. However, there are mixed results regarding its effectiveness and implementation in helping cancer survivors. The purpose of this qualitative study is to explore and compare the attitudes of cancer specialists and PCPs on current practices for survivorship care coordination, and to identify potential barriers and facilitators to implementing a SCP-PHR tool. Methods: Semi-structured interviews were conducted with 22 providers involved in cancer care, including specialty care providers (n=16) and primary care providers (n=6). The interview guide was based upon the Consolidated Framework for Implementation Research (CFIR). The current analysis focused solely on the “tension for change” domain. Two researchers analyzed individual transcripts using a combined thematic approach (inductive and deductive) to identify common themes and important findings. Results: While multiple barriers were identified, care coordination/communication among different specialties emerged as a notable challenge. Providers indicated that a lack of well-defined responsibilities between various specialties led to challenges in providing proper follow-up care. Most providers had not routinely utilized SCPs in their practice. Several specialty care providers expressed uncertainty about who handles follow-up care (n=11; 68.7%) while others believed that PCPs or nurses should bear that responsibility (n=5; 31.2%). In contrast, many PCPs voiced that follow-up care responsibility should fall to oncologists (n= 5, 83.3%) due to provider burden and lack of familiarity with cancer symptomatology. As a result, providers noted that patients are not receiving adequate information about their care and are unaware of their treatment needs. Specialty care providers expressed concerns that areas of non-cancer symptom management and preventive care are not being adequately addressed alongside cancer-specific symptoms. Primary care providers echoed similar concerns and noted that care tools, like SCP-PHRs and warm hand-offs, could be implemented to address these concerns. Conclusions: Barriers surrounding survivorship care coordination underscore the need for creating a efficient SCP-PHRs, as providers seek support in providing care information to patients. Providers suggested a virtual platform should be structured in a concise format that delivers comprehensive information tailored to individual needs and addresses symptoms across all stages of their cancer continuum. Future studies may focus on understanding differences in perspectives among those who have actively engaged with SCPs in their care practices.
TOURMALINE: A phase 3b study of durvalumab with gemcitabine-based chemotherapy regimens in advanced biliary tract cancer.
Authors: Arndt Vogel, Aiwu Ruth He, Do-Youn Oh, Teresa Macarulla, Aaron Dane, Binh Nguyen, Graham Wetherill, Boris Baur, Masafumi Ikeda
Journal: Journal of Clinical Oncology (2024)

TPS4188 Background: In the Phase 3 TOPAZ-1 study (NCT03875235), durvalumab plus gemcitabine + cisplatin (GC) significantly improved overall survival (OS) versus placebo + GC in participants with advanced biliary tract cancer (aBTC) with a manageable safety profile. To expand on TOPAZ-1, there is a need to further assess the safety and efficacy of durvalumab in combination with other gemcitabine (G)-based chemotherapy regimens used in aBTC, and in a more diverse population to reflect real-world clinical practice. Methods: TOURMALINE (NCT05771480) is a Phase 3b, single-arm, multicenter, international study. Approximately 140 adults with aBTC (intra- or extra-hepatic cholangiocarcinoma, gallbladder or ampulla of Vater carcinoma) will be enrolled. Key inclusion criteria include unresectable disease (advanced, metastatic), WHO/ECOG PS of 0–2, and no prior systemic therapy. Key exclusion criteria include any prior immune-mediated therapy and history of another primary malignancy. Participants will receive durvalumab 1500 mg IV plus an investigator-selected, G-based background chemotherapy; durvalumab will be administered Q3W when combined with a G-based chemotherapy Q3W (8 cycles of durvalumab) except for when combined with GC + S-1 Q2W, in which case durvalumab will be administered Q4W (4 cycles of durvalumab/8 cycles of chemotherapy). G-based chemotherapy will consist of G monotherapy, GC (for WHO/ECOG PS 2 participants only), G + oxaliplatin, G + carboplatin, GC + S-1, G + S-1, and GC + albumin-bound paclitaxel. Following the treatment period, durvalumab Q4W +/- chemotherapy (except for paclitaxel) may continue, at the investigator’s discretion, until discontinuation criteria are met. The primary endpoint is the incidence of Grade 3 or 4 adverse events, assessed by the investigator to be possibly related to any study treatment within 6 months after initiation of durvalumab. Secondary endpoints include OS, objective response rate, progression-free survival, and duration of response. Enrollment is ongoing and planned in France, Germany, United States, Spain, Italy, Japan, South Korea, and Singapore. Clinical trial information: NCT05771480 .
Immunotherapy-based therapy versus chemotherapy for the neoadjuvant treatment of locally advanced dMMR/MSI-H gastric cancer.
Authors: Pengfei Zhang, Hongfeng Gou
Journal: Journal of Clinical Oncology (2024)

e16121 Background: Growing evidences have suggested that immunotherapy represents a promising treatment for the neoadjuvant treatment of mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) gastric cancer. The study aimed to compare the efficacy of neoadjuvant chemotherapy and immune checkpoint inhibitor (ICI)-based therapy in locally advanced, dMMR/MSI-H gastric cancer. Methods: Patients with MSI-H/dMMR locally advanced gastric cancer who received neoadjuvant chemotherapy, or ICI-based therapy between December 2018 and June 2023 at West China Hospital, Sichuan University were included. Patient data were collected from the prospectively database program of gastric cancer at our Hospital. Demographic and clinicopathologic data of patients were collected, including age, sex, ECOG performance status, primary tumor site, tumor staging, Lauren’s classification, tumor response, tumor regression grade (TRG), R0 resection, disease-free survival (DFS) and overall survival (OS). Results: A total of 21 patients treated with ICIs-based regimens and 18 patients treated with chemotherapy were included. In the ICI-based therapy group, 10 patients (47.6%) received dual PD-1 and CTLA-4 blockade, 1 patient (4.8%) received PD-1 blockade, and 10 patients (47.6%) received PD-1 blockade combined with chemotherapy. The median age of chemotherapy group and ICI-based group were 63 years (range, 36-76 years) and 59 years (range, 34-74 years), respectively. The rates of T4b and limited metastases were significantly higher in the ICI-based therapy group compared to chemotherapy group (T4b: 11.1% vs. 23.8%; limited metastases: 0% vs. 19.0%). 17 patients (94.4%) in the chemotherapy group and 20 patients (95.2%) in the ICI-based therapy group underwent R0 radical gastrectomy. One patient in the chemotherapy group did not undergo surgery due to disease progression. One patient in the ICI-based therapy group refused radical gastrectomy. For patients undergoing surgery, TRG 0-1 rate was obviously lower in patients receiving chemotherapy compared to those treated with ICI-based regimen (0.0% vs. 78.9%). The pCR rates in the chemotherapy group and ICI-based group were 0.0% and 57.9%, respectively. The pCR rates in patients treated with dual PD-1/CTLA-4 blockade and PD-1 blockade with chemotherapy were 66.6% and 50.0% (P = 0.65). Median DFS and OS have not yet been achieved due to the short follow-up time. Conclusions: Improvements in TRG 0-1 rate and pCR rate suggested that ICI-based treatments are favorable in the neoadjuvant setting of locally advanced, dMMR/MSI-H gastric cancer compared to chemotherapy. However, within the overall favorable group, there was no differences between dual PD-1/CTLA-4 blockade and PD-1 blockade with chemotherapy in term of pCR rate. Whether high pCR rates can translate into long-term survival benefits requires longer follow-up time.
Schwannomas: Experience from a single center reference in Peru.
Authors: Jianmartin Galecio Viera, Victor Paitan Amaro, Victor Castro Oliden
Journal: Journal of Clinical Oncology (2024)

e14043 Background: Schwannomas are nerve sheath tumors that originate in Schwann cells. They are usually solitary and sporadic and manifest on peripheral, spinal or cranial nerves. It is the most common type of benign peripheral nerve tumor in adults. These tumors represent a diagnostic challenge due to their rarity and difficult differential diagnosis. Our objective was to determine the clinical and pathological characteristics, as well as the therapeutic management of patients with Schwannoma admitted to our institution over a period of time. Methods: A retrospective, cross-sectional and descriptive study was carried out on the cases of patients with Schwannoma over 14 years of age, diagnosed at the National Institute of Neoplastic Diseases from 2009 to 2023. Medical records and pathology reports were reviewed. Results: A total of 225 patients were diagnosed with schwannoma on anatomopathology. Median age was 44 years, with a range of 15 to 92 years. 135 (60%) patients were female and 90 (40%) male, with a ratio of 1.5:1. 19 (8.4%) patients had a second cancer before or after the diagnosis of schwannoma. 6 (2.66%) patients were previously diagnosed with neurofibromatosis. According to anatomical origin: 27 (12%) patients had schwanommas of the abdominal region, 36 (16%) of the head and neck, 42 (18.66%) of the spinal cord, 17 (7.55%) of the extremities, 83 ( 36.88%) of the intracranial region and 20 (8.88%) of the thorax. At the intracranial level, 71 patients had location at the cerebellopontine angle, 5 at the orbital level, 2 at the level of the cerebellum and 5 in another location. At the abdominal level, 13 patients had a retroperitoneal location, 8 at the gastric level, 2 at the renal level and 4 in another location. In 130 patients we can obtain the ki67, median score was 2% (1-50%). Regarding treatment, 156 (69.33%) patients underwent surgery, and 42 (18.66%) patients received radiation treatment. During their follow-up, only 5 (2.22%) patients had local recurrence. Conclusions: Schwannomas are rare benign tumors. In many cases, its suspected diagnosis is difficult due to its similarity to other tumors that must be part of the differential diagnosis. Its treatment is surgical, with the objective of complete macroscopic resection. Radiotherapy is a complementary treatment in case of residual disease.
Neuro-oncology anywhere: A decentralized approach to clinical trials in brain tumors and beyond.
Authors: Bryan Neth, Mason Webb, Taylor Galloway, Lynn M Flickinger, Katrina Chan, Sue Steinmetz, William Breen, Sani Haider Kizilbash, Jian Li Campian, Joon H. Uhm, Michael W. Ruff, Stacy D. D'Andre, Terry C. Burns, John L Stricker, Susan Michelle Geyer, Eva Alden, Nikki Stricker, Ugur Sener
Journal: Journal of Clinical Oncology (2024)

TPS1647 Background: The majority of patients with primary and secondary central nervous system (CNS) malignancy develop cognitive impairment, fatigue, and mood-related symptoms. Radiotherapy has been shown to contribute to symptom burden often limiting quality of life and functional status. The development of interventions mitigating neurocognitive toxicity requires an accurate assessment of function and symptom burden. Formal neuropsychological evaluation is resource and time intensive, and often challenging to incorporate in routine clinical practice. There is a critical need to accurately assess cognition without causing undue burden to cancer patients while evaluating the efficacy of interventions that can be scaled and implemented at a population level. Methods: To adequately assess the neurocognitive function and related symptoms in patients with CNS malignancy we have designed an open-label decentralized clinical trial that will randomize patients who received intracranial radiation for primary or metastatic brain tumors in a 1:1 allocation to a therapy targeting radiation-related toxicity (metformin shipped to patient home) plus health promotion with a wearable device vs. health promotion with a wearable device alone. Participants will be stratified based on tumor type (glioblastoma vs. other glioma vs. brain metastases vs. meningioma) and age (&lt;70 vs. 70+ years). Participants will be provided a wearable device for monitoring health status. Participants will undergo serial remote cognitive assessments with the Mayo Test Development Through Rapid Iteration, Validation and Expansion platform (Mayo Test Drive). Remote reported symptom collection via patient surveys and remote neurologic examination by telehealth will also be incorporated. Cognitive assessments and symptom surveys will be designed for completion on a smartphone, tablet, or computer device. Health data will be collected from the wearable device, including the number of steps per day and sleep quality/duration. Participants receiving metformin will utilize device apps to report medication adherence and adverse events. Study-related laboratory assessments will be completed remotely and transmitted electronically. This decentralized clinical trial will provide real-world cognitive and quality-of-life data for patients with primary and metastatic brain tumors while providing preliminary data on the effectiveness of device-based health promotion with or without metformin for treating radiation-related cognitive decline. Results gained from this study will guide future trials in neuro-oncology and other fields. This study is expected to open in March 2024.
Impact of EOB-MRI on the outcome of patients with pancreatic cancer in real-world settings.
Authors: Atsushi Oba, Tomoyuki Taguchi, Naoto Fujikawa, Suguru Okami, Takashi Tsuji, Alexander Michel, Yuki Kado, Satoshi Goshima
Journal: Journal of Clinical Oncology (2024)

e16298 Background: Contrast-enhanced computed tomography (CE-CT) is a commonly used imaging modality for the preoperative detection of local extension and distant metastasis in patients (pts) with pancreatic cancer (PaC). There have been cases where surgical treatment was deemed unsuitable due to unexpected distant metastases discovered during surgery, which had not been detected by CE-CT. While studies have reported gadoxetate disodium-enhanced MRI (EOB-MRI) improves the detection of liver metastases, it is not clear whether adding EOB-MRI to CE-CT provides clinical benefits, e.g. improved outcomes through the early access to appropriate treatments by avoiding unnecessary surgery (open-close surgery) in pts with PaC. This study aimed to assess the effectiveness of adding EOB-MRI before surgical or non-surgical treatment on overall survival (OS) in pts with PaC in real world settings. Methods: This was a retrospective cohort study using a nationwide hospital-claims database in Japan. Pts aged ≥18 years diagnosed with PaC with a record of surgery, radiotherapy, or chemotherapy, who had an imaging modality were identified between January 1, 2011 to October 31, 2021. Pts were grouped into EOB-MRI and no EOB-MRI groups, and further grouped into surgery, no surgery and open-close laparotomy. OS was compared between propensity-score matched EOB-MRI and no EOB-MRI groups using the Cox regression model. Results: 39,624 pts were included in the study, of them, 4,477 (11.3%) underwent EOB-MRI prior to the initial treatment. 2,061 (46.0%) pts in EOB-MRI group underwent surgery, 2,346 (52.4%) had no surgery and 70 (1.6%) had open-close laparotomy. In 35,147 (88.7%) pts in no EOB-MRI group, 13,182 (37.5%) underwent surgery, 21,506 (61.2%) had no surgery, and 459 (1.3%) had open-close laparotomy. The OS results in subgroups are shown in the Table. Conclusions: In real-world settings, EOB-MRI performed prior to the initial treatment was associated with significantly higher OS than those without EOB-MRI in pts who did not undergo surgery, but there was no difference in OS in pts who underwent surgery. These results suggest that the early detection of micro hepatic metastases through EOB-MRI and multidisciplinary treatment that enables EOB-MRI may contribute to improved outcomes in pts with PaC. [Table: see text]
Efficacy of next-generation genomic sequencing (NGS) applied to cerebrospinal fluid (CSF) in the identification of actionable mutations in Mexican patients.
Authors: Iván Romarico González Espinoza, Sergio Sánchez-Sosa, Abraham Castro-Ponce, Gabriela Sandoval-Amaro, Gabriela Juárez-Salazar, Ana Isabel Nieva, Galo Ismael Íñiguez López, Eric Acosta Ponce de León, Jorge Esteban Aranda, Julio Cesar Garibay Diaz, Mariana Chiquillo-Domínguez
Journal: Journal of Clinical Oncology (2024)

e14000 Background: Among the benefits offered by NGS from liquid biopsy are the molecular classification of neoplasms as well as the identification of therapeutic targets, without the need to obtain a biopsy of the tumor when it is not feasible. Since 2016, the World Health Organization has included these biomarkers as part of its classification for better management. Additionally, in the case of metastatic tumors, it allows the identification of therapeutic targets as well as resistance mutations and even driver mutations to better understand their biology. In this study, we evaluated the efficacy of CSF NGS in the identification of actionable mutations in patients with CNS neoplasms, and its potential impact on the personalization of cancer treatments for patients in our center. Methods: A retrospective analysis of nine cases was performed in which CSF was used to identify NGS-actionable mutations, collecting, and descriptively analyzing clinical and molecular data from these patients. Results: Mean age was 51.89 years; 55.56% were men and 44.44% women; 66.67% had family history of cancer, of which 83.33% were first-degree relatives; 88.89% had neurological symptoms prior to the study; 33.33% were primary CNS tumors; 55.56% were secondary tumors metastatic to the CNS; 11.11% were indicated due to suspected CNS metastasis. At least 1 genomic alteration was found in 89% of the cases; the most frequently altered gene in primary tumors was TP53 (66.67%). In secondary tumors, the most frequently altered genes were AR and EGFR with 40% incidence each; Approved therapies were found in 55.56% of the cases, therapies approved in other neoplasms in 44.44%, and phase 2 or 3 clinical trials were available in 88.89%. Specific alterations found in are listed in the table. Survival rate at 6-month follow-up was 55.56%. Conclusions: In our patients, the study of CSF through NGS effectively identified actionable mutations with approved treatment in the analyzed neoplasms, other neoplasms, or clinical trials available for enrollment in most cases. In one case, it was possible to rule out the presence of metastasis in CNS, avoiding unnecessary toxicity. To our knowledge, this is the first study in our country that reports the findings of this technique in medical practice, however, more research is needed in bigger populations to optimize and validate the implementation of this study as part of the approach to patients with CNS tumors. [Table: see text]
Assessment of<i> CDKN2A</i> homozygous and hemizygous deletion status in gliomas.
Authors: Hainan Li, Chongzhu Fan, Lijun Dai, Zhi Li, Ningning Luo, Xing Zhang, Lei Ye, Tiantian Han
Journal: Journal of Clinical Oncology (2024)

e14021 Background: Homozygous deletion of CDKN2A (Homdel) has been included in the WHO CNS5 classification as a grade 4 definition in IDH mutated gliomas without the 1p-/19q-codeletion ( IDH mu-noncodel). Hemizygous CDKN2A deletion (Hemdel) has also been reported to be associated with poor prognosis. The identification methods for CDKN2A deletion include next generation sequencing (NGS), methylation array, fluorescence in situ hybridization (FISH), and immunohistochemistry (IHC). However, at present, there is no gold standard threshold for FISH to judge the homozygous and hemizygous deletion. Methods: We collected formalin fixed paraffin-embedded (FFPE) tissue samples from 99 patients with adult-type diffuse glioma and all samples were tested using DNA-based NGS profiling (Simceredx). In addition, CDKN2A status was also detected by FISH and IHC (P16 and MTAP). Based on the CDKN2A status determined by NGS, the FISH were evaluated using ROC curves, including Area Under Curve (AUC), sensitivity, specificity, and cut-off values of Homdel and Non-Homdel, and deletion (Homdel and Hemdel) and non-deletion. The consistency of CDKN2A status identified by NGS, FISH IHC-P16 and IHC-MTAP was compared by Kappa test and Cramer V coefficient. Results: In 99 enrolled patients, NGS results showed 49 patients with CDKN2A Homdel, 18 patients with CDKN2A Hemdel, and 32 patients with CDKN2A Normal. There were no significant differences in age, gender, location of occurrence, IDH mutation status, or receiving chemoradiotherapy among the three groups. There were statistically significant differences in cancer subtype (p value=0.015) and grade (p value=0.010) among the three groups: oligodendroglioma and 2-3 grade was more likely to be normal in CDKN2A and grade 4 significantly predisposed to be Homdel. The ROC curve determines that cutoff of Homdel and Non- Homdel by FISH is 23%, and greater than 23% is Homdel. The ROC curve showed that the AUC of FISH method using 23% cutoff is 0.958, and the sensitivity and specificity were 85.11% and 100%, respectively. The consistency between FISH and NGS was 0.854. For the inconsistent samples, all NGS results were Homdel, and all FISH were deletion except one. Compared the results with FISH, we found that the results of NGS and IHC-P16 were more consistent. The ROC curve determines that the cutoff of deletion and non- deletion by FISH is 39%, and greater than 39% is deletion. The ROC curve showed that the AUC of FISH method with 39% cutoff is 0.962 and the sensitivity and specificity were 95.31% and 90.62%, respectively. Consistency comparison of the four methods showed that the consistency between FISH and NGS in determining Homdel and Non-Homdel, and deletion and non-deletion were the highest, 0.841 and 0.86, respectively. Conclusions: In our study, four methods were used to determine the status of CDKN2A, and results showed that the consistency between FISH and NGS was the highest.