bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of combined resection of pancreas on long-term survival in patients with gastric cancer.
Authors: Hattori Taku , Terashima Masanori , Takahashi Kyota , Matsumoto Yosuke , Koseki Yusuke , Furukawa Kenichiro , Fujiya Keiichi , Tanizawa Yutaka , Bando Etsuro
Published: January 2025

359

Background:
In patients with advanced gastric cancer invading adjacent organs, extended multivisceral resection is required to achieve R0 resection. However, the survival benefit of combined resection of pancreas remains controversial. We investigated the safety and efficacy of combined pancreatic resection in gastric cancer.
Methods:
This study included 64 patients who underwent gastrectomy with pancreatectomy (pancreaticoduodenectomy (PD) or distal pancreatectomy with splenectomy (PS)) for primary gastric cancer with invasion to the pancreas by primary tumor or lymph node metastasis and invasion to the duodenum. Patients who underwent R2 resection were excluded. Short- and long-term outcomes were assessed.
Results:
PD was performed in 18 patients (28.1%) and PS in 46 patients (71.9%). Macroscopic invasion to the pancreas by primary tumor was observed in 47 patients (73.4%), by lymph node in 13 patients (20.3%), and the invasion to the duodenum by primary lesion was in 4 patients (6.3%). Pathologically, pancreatic invasion was confirmed in 27 out of 47 patients (57.4%). Postoperative intra-abdominal infectious complications (PIIC) of Clavien-Dindo (CD) Grade III or higher were observed in 33 patients (51.6%). The most common postoperative complication was pancreatic fistula, which was observed in 31 patients (48.4%). There was no mortality within 30 days after surgery. Univariate analysis revealed that invasion the duodenum was highly associated with PIIC (p=0.038). Twelve patients (18%) resulted in R1 resection due to positive peritoneal cytology in 11 patients and positive surgical margin in one patient. The 5-year overall survival (OS) rate was 42.9%, which was 53.6% in R0 resection and 0% in R1 resection. Multivariate analysis revealed R1 resection was an independent prognostic factor for OS (HR:5.315, p<0.001). The 5-year recurrence-free survival (RFS) rate was 44.5%. The 5-year RFS rate was significantly worse in patients with PIIC (28.7%) than in patients without it (58.7%). Multivariate analysis revealed that PIIC was an independent prognostic factor for RFS (HR:2.345, p=0.036).
Conclusions:
Pancreatic resection for gastric cancer is considered safe and effective when R0 resection is possible. However, surgeon should pay particular attention to avoid the postoperative complications.
Gastric cancer patient insights: Patient-reported outcomes and real-world perspectives from the gastric cancer patient community.
Authors: Raymond Martha , Simonetta Margaret-Ann ,   GI Cancers Alliance
Published: January 2025

362

Background:
According to the National Cancer Institute Surveillance, Epidemiology, and End Results Program, an estimated 26,890 patients in the United States will be diagnosed with gastric (stomach) cancer in 2024. Estimated deaths from the disease in 2024 will reach 10,880, with a five-year relative survival rate of 36%. Understanding the need for increased gastric cancer education and awareness, the GI Cancers Alliance created a 12-month series of engagement opportunities to better understand and listen to the gastric cancer patient voice and perspectives.
Methods:
Our 12-month patient-reported outcomes (PRO) research (September 2023 – August 2024) included an online survey, in person and virtual focus groups, and personalized follow-up interviews. 651 gastric cancer patients and survivors participated in these engagement opportunities, with 89% of participants asking for follow-up personalized interviews. One of our program goals was to reach and interact with patients who often experience barriers in receiving quality cancer care. Our PRO research provided an opportunity to amplify the patient voice and lived experience by engaging patients in medically underserved communities, rural and urban populations, diverse ethnic communities, and patients receiving care in community-based and federally funded oncology centers, and charity (indigent) care.
Results:
Overarching results from our study suggest that while advances have been made, health equity, racial disparities and barriers in cancer care remain a challenge. 651 patient participants (43% male, 54% female, 3% non-binary) identified their race/ethnicity as: 24% Black/African American, 22% Hispanic, 21% Multiracial, Non-Hispanic/White 19%, Asian/Pacific Islander 7%, Native American 2%, and 5% Other. 69% of patients reported that their clinician did not suggest biomarker testing, nor discuss the role of biomarkers to help make informed treatment decisions. 68% of patients were concerned that they lacked knowledge and options to make informed decisions regarding their treatment. 64% of patients reported they suffered from mental health concerns ranging from severe depression, feelings of hopelessness and anxiety; 63% of patients struggled to afford nutritious food to meet their changing dietary needs, especially post-surgery.
Conclusions:
Our PRO research underscores the need for increased education and outreach for gastric cancer patient communities experiencing barriers to high quality cancer prevention, early detection, and treatment. By partnering with our 100+ advocacy partner organizations, we will continue to amplify the gastric cancer patient voice by establishing new programming, initiatives, and enhanced outreach addressing the challenges and barriers to quality cancer care for all patients.
Anlotinib combined with penpulimab and nab-paclitaxel as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): A single-arm, open-label phase II clinical trial.
Authors: Chang Zhiwei , Wang Rui-Rui , Liu Xiao-Lei , Yu Dan-Dan , Han Hui-Qiong , He Jian , Qin Yanru
Published: January 2025

367

Background:
Recently, PD-1 blockades combined with dual chemotherapy regimens in first-line setting exhibited encouraging efficacy for patients with ESCC. However, the safety profile of conventional dual chemotherapy remained unsatisfactory. Therefore, PD-1 blockades combined with anti-angiogenic tyrosine kinase inhibitors (TKIs) and single chemotherapy regimen might offer a promising strategy. Anlotinib, a novel multitarget TKI primarily targeting VEGFR1-3, demonstrated promising therapeutic activity as first-line combination therapy or second-line monotherapy for ESCC patients in China clinically. Therefore, this study was designed to explore the efficacy and safety of anlotinib combined with penpulimab (PD-1 blockade) and nab-paclitaxel as first-line therapy in advanced ESCC.
Methods:
Patients with previously untreated metastatic or locally advanced ESCC were recruited and treated with anlotinib (12mg, po, d1~14, q3w) and penpulimab (200mg, iv, d1, q3w) plus nab-paclitaxel (220mg/m
2
, iv, d1, q3w) until disease progression or unacceptable toxicity. The tumor response was assessed according to RECIST 1.1 using CT scans every two cycles. Adverse events were recorded by severity in accordance with the NCI CTC AE Version 5.0. The predefined sample size was 30. Primary endpoint was PFS and secondary endpoints included safety, ORR, DCR and OS.
Results:
From Jul 2022 to Sep 2024, a total of 30 patients were enrolled, with 29 patients who had received first tumor response were included in this analysis. The best overall response indicated that there were 1 CR (3.4%), 23 PR (79.3%), 2 SD (6.9%) and 3 NE (10.3%). Therefore, the preliminary ORR was 82.8% (95%CI: 64.2%-94.2%), DCR was 89.7% (95%CI: 72.6%-97.8%). The primary median PFS of the 29 patients was 10.84 months (95%CI: 7.57-14.11). Additionally, safety profile exhibited that the regimen was tolerable. The most common treatment-emergent adverse events among the 29 patients with the incidence >20% were anemia (62%), leukopenia (31%), peripheral neurotoxicity (28%) and rash (21%). Common grade ≥3 treatment-emergent adverse events were leukopenia (7%), glutamic-pyruvic transaminase was elevated (3%), glutamic oxalacetic transaminase increased (3%), hypertension (3%), diarrhea (3%) and rash (3%).
Conclusions:
The combination of anlotinib plus penpulimab and nab-paclitaxel as first-line therapy for advanced ESCC demonstrated promising efficacy and manageable safety profile. And the conclusions needed to be confirmed in subsequent trials.
Clinical trial information: ChiCTR2400089133
.
Efficacy and safety of intraperitoneal paclitaxel based regimens in patients with gastric cancer and peritoneal metastasis: A systematic review and meta-analysis.
Authors: Bakhtiar Muhammad , Ilerhunmwuwa Nosakhare Paul , Ahmed Rabeea , Mahnoor Mahnoor , Ismail Ahmad , Sahin Ibrahim Halil , Saeed Anwaar
Published: January 2025

373

Background:
Peritoneal metastasis (PM) occurs in about 5% - 20% of patients with gastric cancer (GC) at the time of diagnosis, and prognosis remains poor with limited treatment options. There are conflicting results on the efficacy of intra-peritoneal (IP) paclitaxel in patients with gastric cancer with PM. We performed a meta-analysis to examine the current evidence on the effectiveness of IP paclitaxel-based regimens in this patient population.
Methods:
A comprehensive search was conducted across Pubmed, EMBASE, Cochrane library, and Clinicaltrials.gov, resulting in the initial identification of 253 articles. Following screening, 35 articles, comprising only clinical trials (CT) and Randomized Controlled Trials (RCTs), were selected for detailed analysis. Screening and data extraction were conducted by two reviewers concurrently, with quality assessment performed using RoB (Risk of Bias) 2.0 tool and NIH quality assessment questionnaire. Proportional meta-analysis was done to estimate the pooled efficacy of IP paclitaxel based on the Median Survival Time (MST) and 1-year Overall Survival (OS), and tumor response was assessed using RECIST criteria. Subgroup analysis was conducted for patients who underwent conversion gastrectomy. Safety was assessed through the analysis of adverse events.
Results:
A total of 855 patients were included in the evaluation of MST, revealing an overall pooled MST of 20.21 months for GC patients with PM treated with IP paclitaxel-based regimens. Additionally, 1-year OS data was available for 785 patients, revealing an overall cumulative 1-year OS of 71% (95% CI: 66-76). Furthermore, among the 332 patients who underwent conversion gastrectomy, the pooled overall MST was 27 months. For 168 participants who underwent conversion gastrectomy after receiving therapy with IP PAC-based regimens, the 1-year OS was 84% (95% CI: 77-89). The most common adverse events (AE) observed were alopecia (75%) and anemia (60%). Overall, most studies exhibited low RoB, with only a few demonstrating poor quality.
Conclusions:
IP paclitaxel-based regimens demonstrate both safety and encouraging efficacy in the treatment of GC patients with PM. Subsequent conversion gastrectomy in eligible patients can further improve the survival outcomes.
The incidence and risk of cardiovascular events among gastroesophageal cancer patients receiving immune-checkpoint inhibitors.
Authors: Bahar Furkan , Ibis Betul , Cakir Colak Sena , Banga Akshat , Song Junmin , Chi Kuan-Yu , Chang Yu , Chiang Cho Han
Published: January 2025

374

Background:
Immune checkpoint inhibitors (ICIs) have been associated with an increased risk of cardiovascular events. However, these data were mostly derived from patients with lung cancer or melanoma. To date, there is limited data describing the incidence and risk of cardiovascular adverse events associated with the use of ICIs among patients with gastroesophageal cancers.
Methods:
We performed a propensity score-matched cohort study using the TriNetX Analytics Network database, which comprises de-identified data from over 120 participating institutions and 101 million individuals. We defined the ICI cohort as patients who received any of the ICIs and chemotherapy. We defined the control cohort as patients who received only chemotherapy but not an ICI. We matched 2 cohorts based on predetermined variables including age, race, gastroesophageal cancer-directed therapy, cardiovascular agents, underlying comorbidities, and surgical history. The outcomes were myocarditis, pericarditis, myocardial infarction, heart failure, cerebral ischemia/infarction, atrial fibrillation, conduction disorders, and venous thromboembolism (VTE). All outcomes were captured within 1-year of the start of ICI therapy and identified using the International Classification of Diseases (ICD)-10 codes.
Results:
We identified 2005 patients who received ICI and chemotherapy (ICI cohort) and 14048 patients who received chemotherapy only (control cohort). We matched 952 patients in 2 cohorts. The mean age was 62.8 ± 12.7 and 62.8 ± 12.3 for the ICI and chemotherapy cohorts, respectively. We observed a significant increase in cardiovascular events in the ICI cohort compared to the chemotherapy cohort. In particular, the risk of myocarditis (4 cases in the ICI cohort and no cases in the chemotherapy cohort), pericarditis (Hazard ratio (HR), 2.53 [95% CI: 1.52-4.19]), conduction disorders (HR, 1.64 [95% CI: 1.04-2.59]), and VTE (HR, 1.56 [95% CI: 1.17-2.10]) were higher in the ICI cohort than the chemotherapy cohort.
Conclusions:
The use of ICI was associated with an increased risk of cardiovascular events, particularly myocarditis, pericarditis, conduction disorders, and VTE among patients with gastroesophageal cancer. Further studies are needed to identify strategies to stratify patients at high risk of developing ICI-associated cardiovascular events.

Outcomes
ICI + Chemotherapy(ICI cohort)
Chemotherapy only(Control cohort)
Hazard ratio(95% CI)

Cases
At risk patients
Cases
At risk patients

Myocarditis
4
952
0
952
-

Pericarditis
52
952
21
952
2.53 (1.52-4.19)

Myocardial infarction
18
952
12
952
1.49 (0.72-3.11)

Cerebral Ischemia/Infarction
22
952
17
952
1.30 (0.69-2.44)

Atrial fibrillation
56
952
48
952
1.16 (0.79-1.71)

Conduction disorder
49
952
30
952
1.64 (1.04-2.59)

Venous thromboembolism
112
952
73
952
1.56 (1.16-2.10)

Heart Failure
118
952
114
952
1.04 (0.80-1.34)
Effect of adjuvant radiotherapy after endoscopic resection of early esophagus cancer to prevent new intraluminal mucosal recurrence.
Authors: Fukushima Hirofumi , Takahito Awatsu , Adachi Shunsuke , Yuzawa Arisa , Murakami Takashi , Ueyama Hiroya , Shibuya Tomoyoshi , Hojo Mariko , Nagahara Akihito
Published: January 2025

381

Background:
Endoscopic resection (ER) is effective for treating T1a early esophageal squamous cell carcinoma (ESCC). Occasional distant metastasis and recurrence are inevitable invasion in depth of muscularis mucosa(MM). Additional surgical resection is an effective means for cure and prevent recurrence, but it imposes a heavy physical burden. Chemoradiation therapy (CRT) is a comparable alternative to surgery. Not all patients will want those additional treatment. Another problem is the occurrence of new esophagus intraluminal mucosal recurrence. After endoscopic treatment, there is an increased risk of scarring and deformity. But there are few reports of the effectiveness of additional RT in suppressing new lesions. This study was designed to verify the efficacy of not only curability but also suppressive effect the occurrence of new lesions additional treatment of T1a(MM) ESCC.
Methods:
This study was a retrospective study. We reviewed 71 consecutive patients who underwent ER followed by clinical stage I (T1a: MM) ESCC. We compared patients in the radiotherapy group or non-radiotherapy group after ER. Patients of radiotherapy group received radiation within 3 months after ER. All patients underwent regular follow-up. Recurrence, recurrence-free survival, cancer-specific survival, overall survival, and complications were evaluated.
Results:
There were 34 cases of radiotherapy group and 37 cases of non-radiotherapy group. 3 patients (8.9 %) in the radiotherapy group experienced intraluminal mucosal recurrence, and 2 patients (6.6 %) experienced local recurrence. On the other hand, in the non-radiotherapy group, 9 patients (24.3 %) experienced intraluminal mucosal recurrence, and 7 patients (18.9 %) experienced local recurrence (intraluminal mucosal recurrence: p< 0.05, local recurrence p=0.14). The recurrent group received chemotherapy. The 3-year cumulative recurrence-free survival was 97 % in the radiotherapy group and 83.7 % in the non-radiotherapy group (p< 0.05). No severe radiation toxicities were recorded.
Conclusions:
The radiotherapy after ESD reduced the risk of lymph nodes recurrence not only local lymph node recurrence but also new intraluminal mucosal recurrence, and safe and effective therapeutic strategy.
Optical coherence tomography and elastography for the visualization of architecture and stiffness differences in gastric cancer and dysplasia.
Authors: Gonzales Alana , Ruhland Caitlin , Mitstifer Ryan , Rice Photini , Sawyer Travis , Barton Jennifer
Published: January 2025

382

Background:
Individuals at high risk for gastric cancer may be recommended to undergo risk-reducing gastrectomy, which leads to life-long morbidity. Surveillance with endoscopy can be an appropriate and effective option for avoiding unnecessary surgery. Gastric cancer is commonly characterized by changes in tissue architecture and increased tissue stiffness, but visualization of these alterations is challenging for white light endoscopy methods. We utilized optical coherence tomography (OCT), a non-destructive imaging modality that uses reflected near-infrared light to generate cross-sectional images of tissue, to visualize microstructure and relative tissue stiffness.
Methods:
We utilized two modes of OCT for visualization of
ex vivo
tissue samples collected from patients undergoing gastrectomy for gastric cancer, endoscopic mucosal resection, or endoscopic biopsy. Images were collected with a benchtop OCT system (Thorlabs Telesto TEL221). Structural OCT was used to visualize changes in tissue architecture including thickened mucosa and irregular put structure of the mucosa. Optical coherence elastography (OCE) was used to extract relative measures of tissue stiffness using an optical palpation method. A phantom of known mechanical properties was placed on the tissue and an axial force was applied. The resulting deformation (strain) of the phantom provided relative measurements of tissue stiffness. Classification of normal and cancerous tissue was confirmed by histology.
Results:
Structural OCT imaged architectural features of tissue with high resolution (<10 um) and depth of imaging up to 1.5 mm. Strain maps generated with OCE data showed that normal gastric tissue had relatively consistent stiffness, whereas stomach cancer and dysplasia exhibited increased tissue stiffness compared to normal.
Conclusions:
Structural OCT and OCE captured changes in tissue architecture and increased stiffness in patient samples of gastric cancer and dysplasia. These tissue features are classic characteristics of cancer, making this technique a useful screening tool for several cancer types. Future work aims to implement endoscopic OCT and OCE to detect cancer at early stages
in vivo
.
Young onset gastrointestinal cancer: A needs analysis.
Authors: Keohane Nicola , Reynolds John V , Harrold Emily , Gallagher David James , King Sinead , Gleeson Chris , Deac Oana , Warner Nikolett , Enright Cathy , McCormick Paul , Kelly Michael E , Lowery Maeve Aine
Published: January 2025

383

Background:
The global incidence of Young Onset ( YO) cancers diagnosed in adults under 50 years, is increasing for unknown reasons. YO Gastrointestinal (GI) cancers, which account for approximately 27% of newly diagnosed cancer cases and 37% of cancer deaths present distinct challenges in areas including sexual health, finance, career and family. We assessed the holistic needs of these patients through a mixed methods approach.
Methods:
A single institution needs analysis study was undertaken in YO GI patients diagnosed 2014-2024 through an anonymous survey and Focus Group Discussions (FGD). The surveys asked about their experiences of sexual health and function, psychosocial concerns, financial concerns, career developments and when in their cancer journey would they prefer to speak to a health care professional about these. FGD's used nominal group technique to deepen the analysis.
Results:
88 participants responded via survey and 10 participated in a FGD. The average age at diagnosis was 43 years. 80% of participants reported they would have benefitted from a conversation about fertility, sexual health/function (82%) and financial supports (98%) at diagnosis. 93% of patients were out of work during cancer treatment with average length of time > 1 year.
Conclusions:
This needs analysis highlights the importance of specialised clinical pathways for young onset GI cancer patients focusing on these unique and complex needs. Financial supports, conversations regarding sexual health/function, fertility preservation and psychosocial support are critical areas requiring structured intervention.

2014-2024 young onset SJH.

UGI ( N=233)
Colorectal (N=275)

Clinical Stage at diagnosis
Oeso Stage 4 = 39% Gastric stage 4 = 26%
Stage 3= 46% Stage 4 = 20%

Treatment intent %
Radical =54% Palliative =38% Radical/Palliative = 8%
Radical =75% Palliative 25%

Mortality rate
66%
25%

GI Survey results ( N=236)
Support offered Y/N
Preferred timing of support

Sexual health/ function
No=85% Yes =15%
82% At diagnosis

Financial support
No=95%Yes= 5%
98% At diagnosis

Fertility preservation
No = 65% Yes=35%
80% At diagnosis
Clinical utility of nurses’ telephone follow-up program (Tsukiji Call) for resectable locally advanced esophageal squamous cell carcinoma patients received neoadjuvant DCF therapy.
Authors: Tanaka Ai , Tanaka Rikako , Yamamoto Shun , Tauchi Junko , Shiraishi Kazuhiro , Imazeki Hiroshi , Kato Ken , Asai Nozomi
Published: January 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.
The impact of nutritional status on recurrence-free survival (RFS) in patients with locally advanced oesophagogastric adenocarcinoma (LA-OGA) treated with FLOT therapy.
Authors: Sugiyama Keiji , Kumar Sacheen , Chaudry M. Asif , Patel Nikhil , Patel Pranav , Cunningham David , Starling Naureen , Rao Sheela , Fribbens Charlotte Victoria , Chau Ian
Published: January 2025

388

Background:
Malnutrition and weight loss were reported as poor prognostic factors in operable OGA. This study examines the relationship between oncological outcomes and nutritional status in LA-OGA patients under the current standard of care, perioperative FLOT therapy.
Methods:
From 2017 to 2023, 423 patients who had radical resection at Royal Marsden Hospital were screened. Inclusion criteria included LA-OGA (cT2≤ and Nany or Tany and N+), at least one cycle of neoadjuvant chemotherapy (NAC), and ECOG PS 0–2. Nutritional status was assessed by body weight and prognostic nutritional index (PNI), with significant weight loss defined as a 5% loss within six months before diagnosis or during NAC. PNI was calculated as serum albumin (g/L) + 0.005 × lymphocyte count /μL, with categories of severe (<45), mild to moderate (45–49.9), and normal (≥50). The primary endpoint was 3-year recurrence-free survival (3y-RFS). Restricted mean survival time (RMST) at 36 months was calculated to analyze survival time. Multivariate analyses were performed to identify prognostic factors for RFS. The pathological response was assessed using tumour regression grade (TRG) (Mandard criteria).
Results:
Of the 423 patients, 210 met the inclusion criteria. Primary tumour sites were the oesophagus (52.4%), the oesophagogastric junction (18.1%), and the stomach (29.5%). The median follow-up was 26.5 months. Weight loss at baseline and after NAC, as well as PNI, did not significantly impact RFS (p=0.13, p=0.91, p=0.69, p=0.45). However, a PNI decrease from baseline was associated with significantly shorter 3y-RFS (46% vs. 69%, p<0.001), and the RMST difference was 5.46 months (p<0.001). Multivariable analyses showed ypN positivity (p<0.001), R1 resection (p<0.001), and PNI decrease (p=0.03) as negative prognostic factors for RFS. Pathological response did not differ regardless of PNI change (28.2% vs. 30.4%, p=0.75).
Conclusions:
A decrease of PNI is a significant poor prognostic factor for RFS in LA-OGA patients undergoing FLOT, suggesting that maintaining nutritional status during NAC could enhance survival outcomes.
Assessment of nutritional status in elderly patients with gastroesophageal cancer: A post hoc analysis.
Authors: Kaur Jasmeet , Wookey Vanessa , Meeker Caitlin R. , Meghan Connors Meghan , Handorf Elizabeth A. , Tejani Mohamedtaki Abdulaziz , Williams Grant Richard , Winer Arthur , Arora Sukeshi Patel , Mittal Juhi , Filchner Kelly A. , Vijayvergia Namrata , Dotan Efrat
Published: January 2025

389

Background:
Elderly patients with gastroesophageal cancer (GEC) frequently suffer from malnutrition due to tumor location and treatment-related toxicity. Malnutrition is associated with increased morbidity and mortality in this population. This study investigates the relationship between body mass index (BMI), Mini Nutritional Assessment (MNA) scores, unintentional weight loss (UWL), and chemotherapy toxicity while identifying key factors influencing nutritional status.
Methods:
This post hoc analysis utilized data from a prospective, multicenter study of patients aged 65 and older with all stages of GEC undergoing chemotherapy. Nutritional assessments were conducted using validated tools, focusing on BMI, MNA, and UWL over three months post enrollment. We defined malnourished patients as those with abnormal BMI (<18.5 or >30), low MNA (0-11), and significant UWL (≥10%). We analyzed associations between nutritional status and geriatric assessment comorbidities, depression score, functional status, cognition, hospitalization, treatment toxicity, and social support using Fisher’s exact tests.
Results:
Eighty-two patients were enrolled, with a median age of 73 years (range 65-91 years). The cohort was predominantly male (74%) and primarily presented with stage III-IV disease (82%), most receiving first-line therapy (79%). Primary sites included gastric (32%), esophageal (43%), and gastroesophageal junction (26%). Notably, 34% of patients had abnormal BMI, with 2 patients classified as underweight (BMI <18.5) and 19 as obese (BMI >30). Approximately 69% reported UWL, of 10% or greater. MNA scores indicated malnutrition in about 66% of patients (severe (0-7): 15 patients; moderate (8-11): 37 patients), while 31% scored within the normal range (12-14).Hospital admissions were significantly higher in patients with low MNA (33% vs. 3%; p=0.002) and UWL (29% vs. 8%; p=0.047). No significant correlations were observed between nutritional status and treatment type, treatment toxicity, or other geriatric assessment variables, including functional status and social support.
Conclusions:
MNA and UWL are effective indicators of nutritional status in elderly GEC patients, while BMI is not a reliable measure. Malnutrition significantly correlates with increased hospital admissions, highlighting the need for reliable tools to measure malnutrition to implement necessary interventions. Further research is required to explore the broader implications of malnutrition on treatment outcomes and quality of life in this vulnerable population.
Survival associated with metastatic early-onset colorectal cancer among Black patients: A real-world account.
Authors: Mehravar Sepideh , Mahipal Amit , Chakrabarti Sakti
Published: January 2025

39

Background:
Early-onset colorectal cancer (EOCRC), defined as colorectal cancer (CRC) diagnosed under the age of 50, is a growing health concern. The current study explored the racial differences in EOCRC survival in the United States (US).
Methods:
This retrospective cohort study was conducted using the TriNetX database, a platform that provides access to deidentified medical records on more than 130 million patients across 94 healthcare organizations in the US. The study cohort included patients with metastatic CRC (mCRC), aged 20 to 50, diagnosed between January 1, 2002, and January 1, 2020, and received frontline chemotherapy with oxaliplatin and 5- fluorouracil or capecitabine. The cohort was divided into Black or African American cohort and White cohort. The primary endpoint, 5-year overall survival (OS), was compared between these cohorts after performing 1:1 propensity score matching (PSM) for baseline demographics and comorbid conditions (Table). Kaplan-Meier curves, log-rank chi-square statistics, and hazard ratios (HR) were used to compare the outcome.
Results:
The entire cohort consisted of 2,923 patients with a mean age of 44 (±6) years; 48.58% were female. The majority were white (56.38%), followed by 15.56% of unknown race, Black/African American (9.16%), Hispanic (9.34%), and Asian (8.96%). After propensity score matching (PSM), there were 262 patients in both the Black and White groups. In the matched population, the Kaplan-Meier survival curves showed that Black patients had significantly lower 5-year OS rates (24.84%) compared to White patients (33.76%) [Hazard Ratio (HR): 1.39, 95% CI (1.06, 1.85), p<0.05]. There is no significant difference between Black and White population over age of 50 [ HR: 1.06, 95% CI (0.966-1.179), P=0.2].
Conclusions:
Survival among Black patients with EOCRC appears to be worse than White patients despite adjustment for confounding variables, supporting further research focusing onto this patient population.

Characteristics of the cohorts before and after matching.

Black cohort (n = 265) and White cohort (n = 1,632) characteristics before propensity score matching

Black cohort (n = 262) and White cohort (n = 262) characteristics after propensity score matching

Black patients, n (%)
White patients, n (%)
Sth diff.

Black Patients, n (%)
White patients, n (%)
Sth diff.

Age (Mean ± SD)
36.2 ± 6.18
36.3 ± 6.01
0.022

36.1 ± 6.17
36.2 ± 6.43
0.013

Female
144 (54.5%)
774 (47.4%)
0.142

143 (54.5%)
143 (54.5%)
<0.0001

Tobacco use
15 (5.6%)
96 (5.8%)
0.0087

15 (5.7%)
11 (4.2%)
0.0703

Hypertensive diseases
67 (25.3%)
214 (13.12%)
0.3147

65 (24.8%)
64 (24.4%)
0.0089

Ischemic heart diseases
10 (3.7%)
40 (2.4%)
0.0769

10 (3.8%)
10 (3.8%)
< 0.0001

Type 2 diabetes mellitus
24 (9%)
89 (5.4%)
0.1403

22 (8.3%)
19 (7.2%)
0.0426

Diseases of arteries, arterioles and capillaries
12 (4.5%)
47 (2.8%)
0.0881

11 (4.1%)
10 (3.8%)
0.0195
A randomized phase II trial of systemic chemotherapy with or without trastuzumab followed by surgery in HER2 positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis: 3-year follow-up data of the Japan Clinical Oncology Group study JCOG1301C (Trigger study).
Authors: Aizawa Masaki , Tokunaga Masanori , Machida Nozomu , Kajikawa Riku , Mitome Noriko , Hirao Motohiro , Nishida Masato , Kinoshita Takahiro , Yasuda Atsushi , Kawase Tomono , Kano Mikihiro , Kurokawa Yukinori , Boku Narikazu , Yoshikawa Takaki , Terashima Masanori ,   Japan Clinical Oncology Group
Published: January 2025

393

Background:
We previously reported better objective and pathological response with the addition of trastuzumab to preoperative chemotherapy in the randomized phase II trial comparing the efficacy of systemic chemotherapy with or without trastuzumab followed by surgery in HER2 positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis. Here, we report 3-year follow-up data.
Methods:
Eligible patients with HER2-positive gastric cancer having extensive lymph node metastasis were randomized to receive preoperative chemotherapy with S-1/cisplatin (SP: S-1 80–120 mg/body on days 1–14, and cisplatin 60 mg/m2 on day 1, q21 days, 3-4 courses) in arm A or SP plus trastuzumab (first course 8 mg/kg followed by 6 mg/kg, day 1 on each course) in arm B. After gastrectomy, adjuvant chemotherapy with S-1 was added for 1 year in both arms. The primary endpoint was overall survival (OS), and the sample size was planned to be 130 patients in total, expecting a 10% increase in the 3-year OS (70% vs 80%) with a 1-sided alpha of 0.2, a power of 0.75.
Results:
The study was terminated in March 2021 due to slow patient accrual. In total, 46 patients were randomized to either arm A (22 patients) or arm B (24 patients). Patient characteristics were well balanced between the arms. Planned preoperative chemotherapy was completed in 20 patients (90.9%) in arm A and in 23 patients (95.8%) in arm B. Objective response rate tended to be higher in arm B (66.7% [16/24]) than in arm A (36.4% [8/22], p=0.08), and R0 resection was achieved in 20 patients (90.9%) in arm A and 22 patients (91.7%) in arm B. The adjuvant chemotherapy was completed in 54.6% (12/22) in arm A and in 54.2% (13/24) in arm B. With the median observation period of 4.1 years, the 3-year OS was 68.2% in arm A and was 78.9% in arm B with a hazard ratio of 0.698 (95% confidence interval (CI), 0.221-2.209). The 3-year progression-free survival of arm A and arm B was 39.3% and 62.3%, respectively, with a hazard ration of 0.562 (95% CI, 0.229-1.377).
Conclusions:
Preoperative chemotherapy with SP plus trastuzumab was feasible, and tended to improve the objective response rate, OS and progression-free survival. An integrated analysis with other clinical trials evaluating perioperative trastuzumab is being planned. Clinical trial information: s031180006.
Does chemotherapy regimen matter for first-line immunochemotherapy in low programmed cell death ligand 1 (PD-L1)-expressing esophageal squamous cell carcinoma (ESCC)? A systemic review and meta-analysis.
Authors: Guo Jhe-Cyuan , Lin Pei-Shan , Shau Wen-Yi , Shao Yu-Yun , Chen Chi-Ling , Hsu Chih-Hung
Published: January 2025

395

Background:
Anti-programmed death 1 (PD-1) therapy plus chemotherapy has become standard first-line therapy for patients with high PD-L1-expressing advanced ESCC. The benefit for patients with low PD-L1-expressing ESCC remains debatable.
Methods:
Eligible studies were phase III trials investigating anti-PD-1/PD-L1 therapy plus chemotherapy (immunochemotherapy) vs chemotherapy as first-line therapy of advanced ESCC. Study-level pooled analyses of hazard ratios (HR) for progression-free survival (PFS) and overall survival (OS) with corresponding 95% confidence intervals (CI), were used to compare the different groups in random-effects model. PD-L1 expression levels with tumor proportion score (TPS) ≥ 1% vs < 1%, tumor area positivity (TAP) ≥ 10% vs < 10%, and combined positive score (CPS) ≥ 10 vs < 10 were collectively categorized as high vs low PD-L1 expression. The impact of two different chemotherapy regimens, TP (paclitaxel plus platinum) and PF (platinum pus fluoropyrimidine), stratified by PD-L1 expression levels, on the survival benefit of immunochemotherapy vs chemotherapy was investigated.
Results:
Eight randomized controlled trials including 4733 subjects were enrolled. Immunochemotherapy vs chemotherapy was associated with significantly improved PFS and OS irrespective of PD-L1 expression levels or chemotherapy regimens (Table). The PFS and OS benefits were more pronounced in high PD-L1 group than low PD-L1 group. In patients with high PD-L1 expression, the PFS and OS benefits were not significantly different between two chemotherapy regimen subgroups. However, in patients with low PD-L1 expression, the PFS benefit was more significant in TP subgroup than PF subgroup, and OS benefit trended to be in favor of TP subgroup.
Conclusions:
The addition of anti-PD-1/PD-L1 therapy to TP chemotherapy may associate with more significant survival benefit than to PF chemotherapy in advanced ESCC with low PD-L1 expression.

Population
PFS (immunochemotherapy vs chemotherapy)
OS (immunochemotherapy vs chemotherapy)

HR(95% CI)
P value(subgroup differences)
HR(95% CI)
P value(subgroup differences)

All patients
0.63 (0.57-0.69)

0.69 (0.64-0.74)

High PD-L1 group
0.54 (0.49-0.60)
P < 0.01
0.60 (0.53-0.67)
P < 0.01

Low PD-L1 group
0.71 (0.62-0.81)
0.78 (0.70-0.87)

TP group
0.56 (0.50-0.62)
P < 0.01
0.66 (0.59-0.74)
P = 0.32

PF group
0.68 (0.62-0.75)
0.72 (0.65-0.79)

Among high PD-L1 patients

TP subgroup
0.56 (0.45-0.69)
P = 0.75
0.60 (0.46-0.78)
P = 0.90

PF subgroup
0.53 (0.45-0.62)
0.59 (0.50-0.69)

Among low PD-L1 patients

TP subgroup
0.59 (0.48-0.74)
P = 0.01
0.72 (0.55-0.93)
P = 0.32

PF subgroup
0.82 (0.72-0.94)
0.84 (0.72-0.97)
The role of immunotherapy for real-world patients with HER2-negative advanced gastric cancer between 2011-2023.
Authors: Shimozaki Keitaro , Ooki Akira , Yoshino Koichiro , Tamba Mikako , Udagawa Shohei , Osumi Hiroki , Wakatsuki Takeru , Ogura Mariko , Shinozaki Eiji , Chin Keisho , Yamaguchi Kensei
Published: January 2025

404

Background:
Although the appearance of immunotherapy has apparently brought benefits for all patients (pts) with advanced gastric cancer (AGC), the magnitude of the benefit in real-world pts with HER2-negative AGC has not been fully investigated.
Methods:
We conducted a retrospective study on pts with HER2-negative AGC who received first-line platinum-based chemotherapy between 2011 and 2023. We evaluated the clinical outcomes across different periods of immunotherapy approval in Japan: Group A (pre-immunotherapy approval): 2011-2017, Group B (approved for third-line treatment or later): 2018-2021, and Group C (approved for first-line treatment): 2022-2023.
Results:
A total of 949 pts were enrolled (A: n = 477; B: n = 344; C: n = 128). Patient's characteristics were comparable except for the proportion of those with age ≥75 years (P = 0.002), prior gastrectomy (P = 0.03), and liver metastases (P < 0.001). The median overall survival (OS) was 16.2, 15.2, and 21.3 months in group A, B, and C, respectively, with no significant difference between groups (log-rank P = 0.50). Pts who had received first-line immunotherapy plus chemotherapy (n = 173) showed significantly improved OS compared with pts without having received any immunotherapy-containing treatment at 2011-2017 (n = 382) (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.61-0.99; P = 0.04). In the multivariate analysis, the use of immunotherapy at first-line treatment was not significantly associated with worse OS, whereas the use of immunotherapy at any lines was prognostic (HR, 0.54; 95% CI, 0.41-0.71; P < 0.0001). The proportion of pts who had received any second-line treatment was comparable among groups: 76%, 80%, and 71%, respectively.
Conclusions:
Our study suggests that the immunotherapy might partially have an impact on the survival improvement of real-world pts with HER2-negative AGC, which calls for the need for appropriate treatment strategies, including other agents.
Clinical outcomes and changes in body composition following endoscopic submucosal dissection versus total gastrectomy in patients with proximal early gastric cancer.
Authors: Kim Ga Hee , Kim Hyoung-Il , Park Sung Hyun , Cho Minah , Jung Da Hyun , Kim Yoo Min , Park Jun Chul , Shin Sung Kwan , Lee Sang Kil , Hyung Woo Jin , Lee Yong Chan
Published: January 2025

415

Background:
Sarcopenia is associated with poor surgical outcomes and prognosis in patients with gastric cancer. However, the relationship between changes in skeletal muscle following endoscopic submucosal dissection (ESD) versus total gastrectomy (TG) in patients with proximal early gastric cancer (EGC) remains unclear. This study aimed to investigate the clinical outcomes and skeletal muscle mass changes between ESD and TG in patients with proximal EGC.
Methods:
We retrospectively reviewed 329 patients who underwent either ESD (n=127) or TG (n=202) for cT1N0M0 gastric cancer in the upper third of the stomach between 2015 and 2019 at a tertiary care center. The skeletal muscle index (SMI), visceral/subcutaneous fat, and abdominal circumference were measured preoperatively, and at 1 and 3 years after surgery, using cross-sectional computed tomography. We compared these parameters between the two groups and assessed both short- and long-term outcomes, as well as prognostic factors.
Results:
No significant differences were observed between the two groups with respect to overall survival (P=0.266), recurrence-free survival (P=0.079), or disease-specific survival (P=0.24). The recurrence rate was four (3.1%) in the ESD group and two (0.9%) in the TG group. Of the four recurrences in the ESD group, two were cured by gastrectomy, and two by ESD. Two recurrences in the TG group died of cancer progression. In the ESD group, all deaths were unrelated to gastric cancer, compared to 83.3% in the TG group (P=0.376). Patients in the ESD group showed more preserved SMI (P<0.001), visceral/subcutaneous fat (P<0.001), and abdominal circumference (P<0.001) at 1 and 3 years after surgery, compared to the TG group. The incidence of sarcopenia was significantly lower in the ESD group at postoperative years 1 (22.2% vs. 34.7%, P=0.02) and years 3 (25.7% vs. 40.6%, P=0.001). Sarcopenia had a significant impact on survival, with 5-year OS rates being lower in patients with preoperative sarcopenia (85.3% vs. 95.6%, P=0.005). Multivariate analysis revealed that the prognostic nutritional index was significantly associated with OS (hazard ratio, 0.86; 95% confidence interval: 0.75–0.99, P=0.03).
Conclusions:
Although OS was comparable between the ESD and TG groups, ESD was associated with better preservation of skeletal muscle and visceral/subcutaneous fat. These results suggest that ESD should be considered for patients with proximal EGC who are at high risk for sarcopenia.
Outcomes of neoadjvuant chemotherapy versus chemoradiation for esophageal adenocarcinoma: A National Cancer Database analysis.
Authors: Shridhar Ravi , Meredith Kenneth Lee , Huston Jamie
Published: January 2025

416

Background:
While neoadjuvant chemoradiation (NCRT) has been the acceptable standard of care for esophageal adenocarcinoma (EAC), there has been a paradigm shift from recent trials have shown that neoadjuvant chemotherapy (NAC) is either equivalent or superior to NCRT. We sought to examine the outcomes of NAC versus NCRT in esophageal cancer from the National Cancer Database (NCDB).
Methods:
Utilizing the NCDB, we identified esophagectomy patients with EAC who underwent multiagent NCT versus multiagent NCRT. Overall Survival (OS) was analyzed with the Kaplan-Meier method and multivariate analysis (MVA) was performed to identify predictors of OS. Propensity score matching (PSM) was used to correct for baseline differences between groups.
Results:
After PSM, we identified 1007 patients in each group. Groups were equally balanced in age, gender, T/N stage, grade, and facility volume. There was improved lymphadenectomy and higher use of adjuvant therapy in NCT patients. There were significant improvements in R0 resection and pathologic response associated with NCRT patients. There was a significant improvement in OS in NCT versus NCRT. The median and 5-year OS was 42.7 months and 42% in NCT patients versus 34.2 months and 35% in NCRT patients (p = 0.001). For pathologic complete responders, median and 5-year OS was 101 months and 64% in NCT patients versus 71.2 months and 53% in NCRT patients (p = 0.04). On MVA, improved mortality was associated with female gender, pathologic N0, >10 nodes removed, pathologic partial or complete response, R0, well/moderate grade, NCT, adjuvant chemotherapy, and higher facility volume. There was also no survival benefit to adjuvant chemoradiation.
Conclusions:
Despite higher R0 and pathologic response associated with NCRT, NCT was superior to NCRT for OS in EAC patients. NCRT needs to be re-examined in its role as a treatment recommendation for operable EAC patients.

Multivariate analysis for overall survival.

Variable
HR
95% CI

P
value

Age
1.01
1.00 – 1.02
0.004

SexMaleFemale
Reference0.79
0.64 – 0.98
0.03

Charlson Deyo score01
Reference1.05
0.91 – 1.21
0.54

Pathologic N-stageN0N+
Reference1.82
1.58 – 2.10
<0.001

LN removed<10>10
Reference0.81
0.68 – 0.97
0.02

ResponseNonePartialComplete
Reference0.810.61
0.69 – 0.940.50 – 0.75
0.008<0.001

Margin statusR0R1
Reference1.24
1.01 – 1.52
0.04

GradeWell/moderatePoor
Reference1.35
1.18 – 1.54
<0.001

Preop radiationYesNo
Reference0.77
0.67 – 0.88
<0.001

Adjuvant therapyNoneChemotherapyChemoradiation
Reference0.770.83
0.65 – 0.920.64 – 1.08
0.0040.17

Facility volumeLow (≤10/year)Medium (11-19/year)High (≥20/year)
Reference0.860.78
0.72 – 1.030.67 – 0.90
0.10<0.001