tbuckley/cabot-search huggingface dataset:
Neoadjuvant therapy in borderline resectable and resectable pancreatic cancer.
Authors: Kriti Dhamija, Kojo-Frimpong B. Awuah, Alexander Marwaha, Harmeet Kharoud, Dulabh K. Monga
Journal: Journal of Clinical Oncology (2025)

735 Background: To improve clinical outcomes in borderline resectable and resectable pancreatic cancer patients, preoperative chemotherapy with or without radiation can be administered. According to NCCN, there is limited evidence to recommend a specific neoadjuvant chemotherapy regimen. The Dutch randomized phase III PREOPANC trial showed that preoperative chemoradiotherapy led to improved disease free survival. We compared overall survival (OS) between two chemotherapy regimens; mFOLFIRINOX (mFOL) and Gemcitabine/nabPaclitaxel (Gem/nabP). Methods: We performed a retrospective analysis of biopsy-proven pancreatic cancer patients from 1/1/2019 to 2/1/2024. We included borderline resectable and resectable pancreatic cancer patients who received neoadjuvant chemotherapy and then underwent pancreatic resection. We divided them into two cohorts: those receiving mFOL and those receiving Gem/nabP. Kaplan-Meier and multivariate Cox regression analyses were performed to analyze OS and rates of R 0 resection amongst the two groups. A p-value &lt; 0.05 was deemed statistically significant. Results: From January 2019 to January 2024, 85 pancreatic cancer patients received preoperative chemotherapy prior to pancreatic resection. 50 patients received mFOL and 35 patients received Gem/nabP. The mean overall survival (OS) for the mFOL group was 1,137 days, while for the Gem/nabP group it was 876 days. The hazard ratio was estimated as 1.692 (confidence interval 0.901- 3.177, p-value 0.10). After matching for pathological stage and grade, preoperative radiation, postoperative chemotherapy, and presence of perineural and lymphovascular invasion, the hazard ratio was 1.981 (p-value 0.065). The R 0 resection rate was 92.1% for mFOL and 82.2% for Gem/nabP. The odds ratio for having negative margins with mFOL compared to Gem/nabP was 2.005 with a p-value of 0.37. Conclusions: Preoperative chemotherapy with mFOL did not demonstrate improved OS compared to Gem/nabP. The probability of achieving negative margins was also similar amongst the two groups. The SWOG S1505 which is a randomized phase II trial comparing perioperative chemotherapy with mFOL versus Gem/nabP in resectable pancreatic cancer patients has also shown similar OS and progression free survival in both groups.
Cost-effectiveness of NALIRIFOX compared to other first-line treatments for metastatic pancreatic cancer.
Authors: Chia Jie Tan, Haopeng Liu, Pegah Farrokhi, Ignacio Garrido-Laguna, David D. Stenehjem
Journal: Journal of Clinical Oncology (2025)

733 Background: NALIRIFOX was recently approved for first-line treatment of metastatic pancreatic cancer, where combination chemotherapy remains the main treatment modality. We conducted a cost-effectiveness analysis of NALIRIFOX compared to both FOLFIRINOX and gemcitabine/protein-bound paclitaxel (GP). Methods: A partitioned survival model with three health states (progression-free, post-progression and death) was constructed to model the disease course. Using published data from NAPOLI-3, parametric survival curves were generated for NALIRIFOX, from which survival curves for FOLFIRINOX and GP were extrapolated using pooled efficacy data reported by a network meta-analysis of clinical trials. Model inputs were retrieved from the literature or other publicly available resources. Specifically, drug acquisition costs were from average wholesale prices in the Red Book while administration, disease monitoring and supportive care costs were from the CMS Physician Fee Schedule. Utility values to estimate quality-adjusted life years (QALY) were from the CALGB80303 trial. Adverse effects that were considered included anemia, neutropenia, febrile neutropenia, thrombocytopenia, diarrhea, peripheral neuropathy, nausea and vomiting, and fatigue. Adverse effect rates were based on data pooled from clinical trials while costs and disutility were obtained from a secondary analysis of claims data and a clinician survey, respectively. The time horizon was 5 years and utilized a third-party payer perspective. Both costs ($USD 2024) and outcomes were discounted at 3% annually. A probabilistic sensitivity analysis was conducted by varying model parameters based on 95% confidence intervals if known or 10% in both directions otherwise. Results: The overall cost associated with NALIRIFOX was $129,314, followed by GP ($104,593) and FOLFIRINOX ($41,528). Among the 3 regimens, NALIRIFOX incurred the highest treatment-related cost ($105,533) but the lowest adverse effects management cost ($16,541). On average, patients on NALIRIFOX gained a total of 1.14 life years (LY) or after adjusting for utility, 0.86 QALY. FOLFIRINOX led to 1.09 LY or 0.82 QALY while GP resulted in 0.99 LY or 0.75 QALY. Due to its higher cost and lower survival benefit, GP was dominated by FOLFIRINOX. Compared to FOLFIRINOX, the incremental cost-effectiveness ratio (ICER) of NALIRIFOX was $1,952,062/QALY. In our sensitivity analysis, the probability of NALIRIFOX being cost-effective was 0% at all conventional ICER thresholds up to $200,000/QALY. Conclusions: Due to the high drug acquisition cost, the ICER of NALIRIFOX far exceeds currently acceptable thresholds for economic value and NALIRIFOX is considered not cost-effective. This is despite that in our model among first line treatments for metastatic pancreatic cancer, NALIRIFOX was associated with reduced costs for managing adverse effects.
Provider perspectives on non-medical barriers to GI cancer care at a regional cancer center.
Authors: Trisha Lal, Richard Hoehn, Christina Boutros, Anand Kathardekar, Jordan Michael Winter
Journal: Journal of Clinical Oncology (2025)

807 Background: Disparities in care for patients with gastrointestinal (GI) cancers are well-documented, but solutions remain elusive. Understanding the barriers faced by healthcare providers is essential to improving care equity. This study explored the perceptions of healthcare providers at a regional academic health system regarding barriers to care for GI cancer patients. Methods: A cross-sectional survey was conducted among healthcare providers, including physicians, advanced care providers (APPs), nurses, dietitians, social workers, care coordinators, and physical/occupational therapists who directly care for patients with GI malignancies. Survey items assessed specific barriers encountered in clinical practice and suggestions for improving care. Descriptive statistical analysis evaluated the quantitative data from the closed-ended questions across professional roles. A thematic analysis was performed on open-response items and assessed to further identify key barriers to care based on respondents' clinical roles and experiences. Results: Seventy-nine healthcare providers responded to the survey. Initial treatment planning was consistently identified as the phase with the most significant barriers across all disciplines. Health literacy was cited as the most critical barrier to diagnosis, while insurance coverage, financial constraints, geographic location, lack of transportation, and social support were the primary obstacles to treatment. The importance of these barriers varied by profession: physicians noted geographic and transportation limitations, while nurses and social workers emphasized gaps in health literacy, insurance, and social support. Systemic issues such as limited access to specialized care and healthcare personnel shortages were also noted. Notably, 55% of physicians spent 10-30% of their time addressing non-medical barriers to treatment, while 38% of nurses spent 30-50%. Care coordination across disciplines was commonly cited as a challenge, with many calling for improved communication and establishing multidisciplinary clinics. Food insecurity, housing stability, and language/cultural barriers were less prominent concerns at this institution. Conclusions: Oncology providers at a large regional cancer center spend significant time addressing non-medical barriers to treatment for GI cancer patients, particularly during initial treatment planning. The most common challenges reported were insurance, transportation, health literacy, and social support. We will use these findings to guide in-depth provider and patient interviews and develop a team-based, equity-focused intervention. These efforts aim to improve care delivery at our institution and serve as a model enhancing GI cancer care in broader healthcare settings.
Clinical utility of nurses’ telephone follow-up program (Tsukiji Call) for resectable locally advanced esophageal squamous cell carcinoma patients received neoadjuvant DCF therapy.
Authors: Ai Tanaka, Rikako Tanaka, Shun Yamamoto, Junko Tauchi, Kazuhiro Shiraishi, Hiroshi Imazeki, Ken Kato, Nozomi Asai
Journal: Journal of Clinical Oncology (2025)

384 Background: The standard neoadjuvant treatment in Japan for resectable locally advanced esophageal squamous cell carcinoma (ESCC) is docetaxel (DTX) + cisplatin (CDDP) + 5-fluorouracil (5-FU) (DCF) based on the results of the JCOG1109 study. Neoadjuvant DCF therapy is administrated triweekly; in the first week in a hospital, and the remaining two weeks at hom. After the administration of neoadjuvant DCF therapy, patients might suffer from febrile neutropenia or gastrointestinal symptoms such as nausea, vomiting, constipation, diarrhea, and stomatitis even during remaining two weeks at home. Therefore, nurses in our hospital teach self-care at home for these patients who received neoadjuvant DCF therapy. However, some patients experienced emergency admission due to worsening adverse events. To prevent these events, nurses in our hospital conducted a telephone follow-up program (Tsukiji Call) for patients at home. Methods: This retrospective analysis included locally advanced ESCC patients who received neoadjuvant DCF therapy in our hospital between Feb 2023 and Jul 2024. Three courses of DCF (DTX [day 1]: 70 mg/m2, CDDP [day 1]: 70 mg/m2, 5-FU [continuous infusion on days 1-5]: 750 mg/m2, every three weeks) were planned as neoadjuvant treatment. On days 8-14 of the first course of neoadjuvant DCF therapy, Tsukiji Call was conducted by nurses in our hospital to check fever and nausea, vomiting, constipation, diarrhea, and stomatitis based on the CTCAE ver. 5.0 for patients at home before the first outpatient clinic. Eligible patients were divided into the Tsukiji Call and non-Tsukiji Call groups. We used Fisher's exact test to evaluate the frequency of grade 2 (Gr.2) or more adverse events (AEs) between two groups at the first outpatient clinic. Results: This study identified 90 patients (Tsukiji Call: 20, non-Tsukiji Call: 70). The median age (range) and gender male/female, PS 0/1/2, cStage I/II/III/IVA/IVB were 66.5 years (45-76 years) and 15 (75%)/5(25%), 19(95%)/1(5%)/0, 1(5%)/4(20%)/11(55%)/1(5%)/3(15%) in Tsukiji Call group, and were 64 years (46-79 years) and 49(70%)/21(30%), 67(95%)/2(2%)/1(1%), 1(1%)/13(18%)/50(71%)/0/6(8%) in non-Tsukiji Call group, respectively. In the first outpatient clinic, the frequency of Gr.2 or more AEs on fever, nausea, vomiting, constipation, diarrhea, stomatitis and any events between in Tsukiji Call and non-Tsukiji Call groups were 0/0(p = 1), 2(10%)/1(1%) (p = 0.123), 0/0 (p = 1), 0/0 (p = 1), 0/4(5%) (p = 0.572), and 0/10(14%) (p = 0.109), 2(10%)/15(21%) (p = 0.342), respectively. One patient in each group was emergently admitted within 7 days after discharge. Conclusions: Non-hematologic toxicities during DCF therapy may be reduced by Tsukiji Call by nurses in the hospital, which seemed to be in preventing the worsening of adverse events.
Disparities in clinical trial enrollment among LGBTQ+ individuals and its impact on cancer treatment and management: A systematic review.
Authors: Akshit Chitkara, Fnu Anamika, Atulya Aman Khosla, Akshee Batra, Rushin Patel, Sakshi Bai, Sohiel Deshpande, Rohit Singh
Journal: Journal of Clinical Oncology (2025)

805 Background: There is a significant gap in oncologic research, which arises from the exclusion of LGBTQ+ individuals from cancer clinical trials, compromising the development of personalized cancer therapies and limiting the generalizability of findings. Despite known health disparities in this population, including higher cancer risk factors and unique psychosocial stressors, data on clinical trial participation remains sparse. This study aims to elucidate the extent of underrepresentation of LGBTQ+ individuals in cancer clinical trials and examine its impact on treatment efficacy, safety, and overall management. Methods: We conducted a systematic review of literature and clinical trial databases, including PubMed, ClinicalTrials.gov, and other registries, focusing on cancer trials from 2010 to 2024. We extracted data on LGBTQ+ enrollment, analyzed demographic inclusivity criteria, and identified barriers to participation. Subgroup analyses evaluated the correlation between LGBTQ+ representation and treatment outcomes, considering variables such as trial design, recruitment strategies, and data collection on sexual orientation and gender identity. The review also examined policy changes and inclusivity initiatives aimed at improving trial access for this community. Results: The review identified a significant underrepresentation of LGBTQ+ individuals in cancer trials, with sexual orientation and gender identity data reported in only 6.2% of trials. Structural and sociocultural barriers, including heteronormative trial designs, lack of inclusive recruitment strategies, and pervasive discrimination, were frequently cited as impediments. Trials that included LGBTQ+ participants rarely conducted stratified analyses to assess differential treatment responses, leading to a paucity of data on drug safety, efficacy, and toxicity profiles specific to this population. The absence of these data may contribute to suboptimal therapeutic decision-making and potential adverse outcomes in clinical practice. Conclusions: The substantial underrepresentation of LGBTQ+ individuals in cancer clinical trials impairs the ability to develop inclusive, evidence-based oncology care. Addressing this gap requires systematic changes, including the integration of sexual and gender minority data collection, implementation of LGBTQ+-specific recruitment frameworks, and stratified analyses of treatment outcomes. Enhancing trial inclusivity will not only improve the external validity of oncologic research but also support the development of tailored therapeutic approaches that address the unique needs of LGBTQ+ cancer patients, ultimately advancing health equity in cancer care.
Neoadjuvant chemoradiotherapy with ipilimumab and nivolumab in rectal cancer (CHINOREC): A prospective randomized, open-label, multicenter, phase II clinical trial.
Authors: Johannes Laengle, Irene Kuehrer, Askin Kulu, Julijan Kabiljo, Daphni Ammon, Rebecca Zirnbauer, Anton Stift, Friedrich Herbst, Bernhard Dauser, Matthias Monschein, Peter Razek, Matthias Biebl, Hans Geinitz, Wolfgang Hulla, Leonhard Muellauer, Joachim Widder, Clemens Bittermann, Friedrich Laengle, Rainer Schmid, Michael M Bergmann
Journal: Journal of Clinical Oncology (2025)

139 Background: Immune checkpoint inhibitors (ICIs) seem only effective in a primed tumor immune microenvironment (TIME). Neoadjuvant radiotherapy (RT) has been shown to induce an immunogenic cell death (ICD) and thereby restores the susceptibility to ICI. This study evaluates the safety of neoadjuvant chemoradiotherapy (CRT) with concomitant ipilimumab (IPI) and nivolumab (NIVO) in curative rectal cancer (RC) patients. Methods: The CHINOREC study (ClinicalTrials.gov identifier NCT04124601) is a prospective, randomized (ratio 50:30), open-label, multicenter, phase II investigator-initiated trial (IIT). Patients with RC received neoadjuvant CRT (50 Gy in 2 Gy fractions with concurrent capecitabine 1650 mg/m 2 /d) alone or in combination with IPI (1 mg/kg IV at day 7), following 3 cycles of NIVO (3 mg/kg IV Q2W, starting on day 14). Surgical resection was performed 10-12 weeks post CRT. The primary endpoint was surgical safety and feasibility (Clavien-Dindo Classification) of neoadjuvant CRT with sequential IPI and NIVO following surgical resection. Secondary outcome was complete response rate (clinical and pathological). Results: Between June 2020 and November 2023, 145 patients were screened and 80 randomly assigned to CRT (n=30) or CRT+IPI/NIVO (n=50). The primary endpoint (any surgical complication) did not differ between the 2 groups (78% vs. 77%). The reoperation rate (≥Grade IIIb) was comparable low in both groups (8% vs. 7%). No new safety signals were identified. The rate of major pathological response (MPR) and complete response (CR) was also comparable high in both arms (38% vs. 37% and 30% vs. 22%, respectively). Conclusions: Neoadjuvant IPI/NIVO can be safely applied concomitant with CRT in patients with RC, as it does not increase the rate of reoperation or surgical complications. The validity of the encouraging CR rate needs to be elucidated over time. Further translational analyses will elucidate mechanistic insight regarding improved fraction, dosing and timing of CRT and ICI. Clinical trial information: NCT04124601 .
Safety and efficacy of conversion therapy for metastatic esophageal cancer: Exploratory analysis of JCOG1314.
Authors: Satoru Matsuda, Hirofumi Kawakubo, Takahiro Tsushima, Shuichi Hironaka, Yasuhiro Tsubosa, Katsuyuki Sakanaka, Junya Oguma, Shigenori Kadowaki, Shigeru Tsunoda, Hiroki Hara, Kazuo Koyanagi, Toshifumi Yamaguchi, Kazuaki Harada, Masanobu Takahashi, Keiko Minashi, Eishi Baba, Keita Sasaki, Ryunosuke Machida, Hiroya Takeuchi
Journal: Journal of Clinical Oncology (2025)

401 Background: Patients with esophageal cancer (EC) with distant metastasis were treated with systemic chemotherapy. Recent advances in multimodal treatments have made conversion therapy (CT) a viable option for patients with metastatic EC. JCOG1314 was a randomized phase III trial to confirm the survival benefit of docetaxel plus cisplatin plus 5-fluorouracil (DCF) versus cisplatin plus 5-fluorouracil (CF) as initial treatment for unresectable or recurrent esophageal cancer. The purpose of this study was to evaluate the safety and survival impact of CT in patients enrolled in JCOG1314. Methods: CT was defined as surgery or chemoradiotherapy (CRT) aiming at cure after initial treatment for tumors that were initially unresectable due to distant metastasis. Clinicopathologic factors, surgical outcomes, toxicities during CRT, and survival were compared between CT and non-CT groups. CTCAE v4.0-JCOG was used to evaluate postoperative complications and adverse events during CRT. Results: Between September 2014 and April 2021, 240 patients were randomized to CF or DCF. Excluding patients with recurrent disease, 154 patients with initially unresectable esophageal cancer due to distant metastasis were selected for this study. Among them, 21 patients received CT which included conversion surgery (n=5) and conversion CRT (n=16). There was no significant difference in the number of metastatic organs, depth of invasion of the primary tumor, lymph node metastasis, and chemotherapy regiment between CT and non-CT groups. The most common M1 factor in CT group was the thoracic lymph node, followed by abdominal lymph node and cervical node. In conversion surgery group, there was no incidence of Grade 3 or higher pneumonia/leakage. Regarding the Grade 3 or higher non-hematological toxicities during conversion CRT, the incidence of appetite loss/ oral mucositis/pneumonia was 2 (13%)/2 (13%)/1 (6%), respectively. The 3-year overall survival (OS) of CT and non-CT groups was 52.4% and 14.3%, respectively. On multivariable analysis, patients with CT showed significantly better OS compared with the non-CT group (HR 0.36, 95% CI 0.19-0.67, p&lt;0.01). In patients who underwent CT, there was no significant difference in OS between conversion surgery and CRT groups. Conclusions: This study demonstrated that CT was safely performed with favorable prognosis. A prospective study is warranted to investigate whether CT would improve survival in metastatic esophageal cancer.
Use of molecular residual disease (MRD) testing with measurement of circulating tumor DNA (ctDNA) post-operatively in stage II colon cancer (SIICC) in the community-based setting.
Authors: Kiran Foster, Sameer P. Desai, Jake Canavan, Ellen A. Ronnen
Journal: Journal of Clinical Oncology (2025)

53 Background: 80% of adult oncology patients (pts) are treated in the community-based setting. Data on the implementation of emerging technologies such as ctDNA testing is scant in this population. Use of adjuvant chemotherapy in SIICC pts historically was based on clinical/pathological risk factors however new data presented in mid 2022 utilizes the presence or absence of ctDNA 6-8 weeks post operatively to help risk stratify pts. The absence of ctDNA predicts a high chance of disease-free survival. Use of ctDNA was incorporated into the NCCN Colon Cancer guidelines as of 2023. In a private practice setting, we retrospectively looked at the use of ctDNA assay for adjuvant chemotherapy decision-making in SIICC pts. Methods: We conducted a retrospective study to quantify ctDNA testing frequency in SIICC pts in our community based oncology practice. The historical cohort was comprised of pts diagnosed prior to the NCCN guideline inclusion of ctDNA; the current cohort included pts diagnosed after the NCCN guideline change. For all pts, we reviewed clinicopathologic risk factors deemed to be high risk (positive margin, &lt; 12 LN removed, tumor budding, lymphovascular invasion, poorly differentiated features; perforation or obstruction) and used this for stratification. Low-risk pts had no high risk features. Medical record data (office notes, pathology, molecular testing) was evaluated to determine ctDNA results including timing and use of adjuvant chemotherapy. Primary endpoint was the percent (%) of current pts who were low-risk with ctDNA testing sent compared to historical control. Secondary endpoint was the % of ctDNA testing sent within 8 weeks of curative surgery in both cohorts. Results: In a private practice setting, we identified low-risk SIICC pts spanning a 36-month period and categorized them into two groups: the historic cohort (A) pts were diagnosed between July 2021-Dec 2022, and the active cohort (B) pts were diagnosed between Jan 2023-July 2024. 26 pts were identified in cohort A and 36 pts were identified in cohort B to have SIICC. Out of 26 pts in cohort A, we identified 13 low risk SIICC pts; for cohort B, out of 36 pts, we identified 25 low-risk SIICC pts. The percentage of pts in each group that had ctDNA testing sent was 79.6% (10/13 pts) in cohort A and 92% (23/25 pts) in cohort B. In cohort A, 80% (8/10 pts) and in cohort B, 90.9% (20/22 pts) had ctDNA sent within 8 weeks of surgery. Conclusions: Incorporation of ctDNA testing in low-risk SIICC pts in a community-based setting occurred quickly. As ctDNA testing was implemented into practice, a majority of pts had the testing sent in the appropriate time frame. Future best practices, especially in the community, should incorporate tumor specific clinician oversight with use of updated pathways to ensure any recent changes to standard of care are followed.