bluuebunny/crossref_metadata_2025_split huggingface dataset:
Real-world comparison of treatment outcomes between advanced esophagogastric junction adenocarcinoma and gastric adenocarcinoma.
Authors: Kadono Toru , Hirose Toshiharu , Hirano Hidekazu , Shoji Hirokazu , Okita Natsuko Tsuda , Takashima Atsuo , Kato Ken 
Published: January 2024

267 Background: The characteristics of esophagogastric junction adenocarcinoma (EGJA) differ from those of gastric adenocarcinoma (GA). Although chemotherapy for advanced GA has been adapted for advanced EGJA, its efficacy remains unknown. This study aims to elucidate the effectiveness of chemotherapy for advanced EGJA in real-world practice. Methods: This retrospective study compared treatment outcomes between advanced GA and EGJA in patients with performance status (PS) 0 to 2 who received doublet or triplet chemotherapy, including platinum agents, as first-line treatment at our hospital between 2010 and 2020. Patients with non-curative resection factors limited to positive peritoneal cytology, or those who relapsed during adjuvant chemotherapy or within 6 months after its completion, were excluded. Results: Out of the total 825 patients, 765 had GA and 60 had EGJA. The baseline characteristics of the GA and EGJA groups were as follows, respectively: median age 65.0 and 59.5 years (p = 0.02); PS 0, 35.9% and 33.3%; PS 1, 57.5% and 65.0%; PS 2, 6.5% and 1.7% (p = 0.28); HER2 positive, 16.1% and 26.7% (p = 0.06); diffuse histology, 52.7% and 26.7% (p < 0.01); lymph node metastasis, 74.0% and 93.3% (p < 0.01); peritoneal metastasis, 66.4% and 25.0% (p < 0.01); liver metastasis, 26.4% and 40.0% (p = 0.03); lung metastasis, 6.5% and 16.7% (p < 0.01). The proportions of fluoropyrimidine, taxanes, and irinotecan in all treatment lines did not differ between the two groups (fluoropyrimidine, 99.7% vs. 100%; taxanes, 70.1% vs. 73.3%; irinotecan, 23.0% vs. 23.3%). However, the EGJA group used ramucirumab, trastuzumab, and immune checkpoint inhibitors (ICIs) significantly more frequently than the GA group (ramucirumab, 27.8% vs. 43.3%, p = 0.02; trastuzumab, 15.4% vs. 26.7%, p = 0.03; ICIs, 21.0% vs. 41.7%, p < 0.01). Overall survival did not differ between the two groups (median, 14.8 months vs. 18.5 months, HR 0.80; 95% CI, 0.59-1.10, p = 0.17). Moreover, multivariate analysis revealed that EGJA and GA had a comparable prognosis (HR 1.23; 95% CI, 0.87-1.72, p = 0.24). HER2 positivity was a favorable prognostic factor in multivariate analysis, whereas diffuse histology, poor PS, lymph node metastasis, liver metastasis, and the presence of peritoneal metastasis were poor prognostic factors. There was no difference in time-to-treatment failure between the two groups for first-line (median, 6.1 vs. 4.9 months, HR 0.96; 95% CI, 0.73-1.28, p = 0.80), second-line (median, 2.9 vs. 3.5 months, HR 0.99; 95% CI, 0.73-1.34, p = 0.93), and third-line treatment (median, 1.9 vs. 2.7 months, HR 0.78; 95% CI, 0.53-1.13, p = 0.62). Conclusions: In real-world practice, the efficacy of chemotherapy for advanced EGJA was comparable to that for advanced GA.
Real-world experience with trastuzumab deruxtecan among patients with gastric cancer: 4 month-interim analysis of an all-patient post-marketing surveillance study in Japan.
Authors: Kawakami Hisato , Uchino Kazuhiro , Hashimoto Wataru , Muro Kei 
Published: January 2024

273 Background: Interstitial lung disease (ILD) is an important identified risk in the Japanese risk management plan of trastuzumab deruxtecan (T-DXd). In Japan, all-patient post-marketing surveillance (PMS) is underway to investigate the risk of ILD among patients with gastric cancer treated with T-DXd in a real-world setting. We present an interim analysis of the large-scale all-patient PMS. Methods: This is an observational, multicenter, all-patient PMS (jRCT2001200001) with an observation period of 12 months that enrolled all patients treated with T-DXd for HER2-positive unresectable advanced or recurrent gastric cancer between Sep 2020 and Dec 2021. This interim analysis is based on safety data from the first 4 months of all enrolled patients. All potential ILD (identified based on the pre-specified list of AE terms) reported by physicians were adjudicated by an independent ILD adjudication committee (ILD-AC). The incidence of ILD was calculated from adjudicated drug-related ILD. Results: The interim analysis set included 1074 patients with median age of 70 years (range: 23-100). Of the 1074 patients, 1051 (97.9%) received T-DXd as third-line or later treatment. One hundred and eight patients (10.1%) had an Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or greater, and 32 (3.0%), 3 (0.3%), and 23 (2.1%) patients had severe renal impairment (15≤ creatinine clearance (CL) <30 mL/min), end-stage renal disease (CL <15 mL/min), and ILD/radiation pneumonitis at baseline, respectively (all of which were defined as exclusion criteria in clinical trials of T-DXd). Median initial dose of T-DXd was 6.4 mg/kg (range: 3.1-6.4). Median treatment duration of T-DXd was 4.0 months (range: 0.7-4.0). During the first 4 months from the initial treatment, T-DXd was discontinued in 50.9% (547/1074) of patients. The most common reasons for treatment discontinuation were disease progression (n=390, 71.3%), adverse events other than ILD (n=76, 13.9%), and ILD (n=56, 10.2%). All potential ILD that occurred during the first 4 months were adjudicated by ILD-AC, and the incidence of all grades, grade ≥3, and grade 5 adjudicated drug-related ILD were 5.2% (n=56), 1.5% (n=16) and 0.7% (n=7), respectively. Of the 56 patients with adjudicated drug-related ILD, 54 (96.4%) discontinued T-DXd. The incidence of adjudicated drug-related ILD by time from initial treatment of T-DXd were 0.7% (7/1074) at ≤ 1 month, 2.0% (19/949) at 1-2 months, 2.7% (22/829) at 2-3 months, and 1.2% (8/652) at 3-4 months. Conclusions: The interim analysis revealed patient experiences and treatment profiles of T-DXd and the incidence of ILD during the first 4 months since initial treatment in a real-world setting in Japan. The final analysis including a risk factor analysis for ILD of the ongoing PMS is planned.
Quality of life (QOL) for patients with esophageal cancer receiving trimodality therapy with induction chemotherapy, chemoradiation, and surgery: Results from CALGB 80803 (Alliance).
Authors: Goodman Karyn A. , Dueck Amylou C. , Fruth Briant , Noonan Anne M. , Shergill Ardaman , Bekaii-Saab Tanios S. , O'Reilly Eileen Mary , Meyerhardt Jeffrey A. , Ilson David H. , Deshields Teresa L. 
Published: January 2024

283 Background: The randomized phase II CALGB 80803 trial evaluated use of PET imaging for early assessment of induction chemotherapy (iCT) responsiveness to tailor therapy for patients with esophageal and gastroesophageal junction adenocarcinomas (EC) undergoing trimodality therapy. The primary endpoint of improving pathologic complete response rates using PET-adapted therapy was met. A companion QOL study aimed to characterize patients’ experience through iCT, chemoradiation (CRT) and surgery (S). Methods: Between 11/2011 and 5/2015, 241 eligible patients were randomized to an iCT regimen: modified oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) or carboplatin/paclitaxel (CP), followed by PET scan then CRT, either continuing on the same CT for PET-responders (PET-R) or crossing over to the alternative CT for PET-nonresponders (PET-NR). We prospectively collected QOL domains and symptoms at baseline (T1), after iCT (T2), after CRT (T3), and 3- (T4) and 6- months (T5) after S using the EORTC QLQ-C30, The Esophageal Cancer subscale (EORTC OES18), FACT Neurotoxicity Scale (FACT-NTX), and 6 questions from the PRO-CTCAE. QOL scores were compared between iCT groups and between PET-R and PET-NR at each time point using mixed models. The association of QOL scores at enrollment with overall survival (OS) was tested using Cox regression. Results: 189 patients enrolled on the QOL sub-study, 92 received induction FOLFOX and 97 induction CP. Of those, 110 were PET-R and 79 were PET-NR. 97.9% went on to CRT, and 83.6% underwent S. Global QOL and symptoms statistically significantly worsened from T1 to T2 in 14 of 25 domains, and remained significantly worsened from T1 at: T3 for 19 of 25 domains, T4 for 17 of 25 domains, and T5 for 6 of 25 domains. Changes from T1 significantly favored iFOLFOX (vs iCP) for ability to eat (at T3 and T4), GI symptoms (at T3 and T4), and talking (at T5). Changes from T1 significantly favored iCP (vs iFOLFOX) for neuropathy (at T2, T3, and T4) and coughing (at T5). Proportion of patients reporting worsened PRO-CTCAE scores did not differ between PET-R or PET-NR groups . Multiple QOL domains and symptoms were associated with OS including role functioning, global health status/QOL, appetite loss, pain, dysphagia, and ability to eat (all p<0.002). Conclusions: QOL was impacted most by CRT but returned to baseline 6 months after surgery for most domains. Observed symptom differences did not consistently favor one iCT regimen. Early interventions such as nutritional support and prehabilitation should be studied to improve QOL and OS. Clinical trial information: NCT01333033 .
Short-term and long-term results of robot-assisted esophagectomy in cT3br/T4b esophageal cancer at initial diagnosis: Comparison with conventional thoracoscopic surgery.
Authors: Fujita Takeo , Sato Kazuma , Fujiwara Naoto , Daiko Hiroyuki 
Published: January 2024

284 Background: Conversion surgery in patients with locally advanced esophageal cancer that is not resectable at first time and has responded to prior therapy remains unclear. Recently, the usefulness of RAMIE for locally advanced esophageal cancer has begun to be discussed. In this study, we first analyzed the short- and long-term results of RAMIE, then examined the results of conversion RAMIE in T3br/T4b patients, and compared them with those of conversion using conventional MIE. Methods: Short-term and long-term postoperative outcomes were analyzed in 203 cases of robot-assisted esophageal cancer resection between 2020/1 and 2023/08. In addition, 33 patients with T3br/T4b who were initially diagnosed with cT3br/T4b and who underwent RAMIE after prior treatment were selected and compared to 48 cT3br/T4b cases with conventional MIE performed at the same time. Results: The mean age of RAMIE patients was 66.2 years, male to female ratio 170:33, preoperative treatment including NAC 150:53, and Clinical Stage I:II:III:IV 41:27:97:38. Surgical outcomes included thoracic surgery time of 200.3 min and total blood loss of 154.4 ml. Perioperative outcomes were Clavien-Dindo Grade 1 or higher: suture failure 4.4%, pneumonia 13.3%, and recurrent nerve palsy 16.7%. Long-term prognostic analysis (MST: 483.6days) showed 3yOS:97.6/94.1/80.3/70.9% and 3yDFS:96.2/87.2/66.2/52.4% in cStage I/II/III/IV. Especially in cStage II/III patients, 3yOS: 81.5%, 3yDFS: 71.4%. Long-term outcomes were not significantly different from those of conventional thoracoscopic procedures performed at the same time. Perioperative outcomes in cT3br/cT4b patients at initial presentation were pneumonia: 18.1%, recurrent nerve palsy rate: 12.1% (excluding complicated resection cases), and these 3yOS:66.2% and 3yDFS:48.7%. The 3yOS:52.7% and 3yDFS:40.3% of cT3br/T4b cases in the usual MIE showed a favorable trend in RAMIE (p=002). Of the 38 patients with recurrence after RAMIE surgery, 19 were local/regional and 19 were distant. Of these, 5/6/5/3 were brain/lung/liver/LN+others as the first site of distant metastasis. Conclusions: The short- and long-term results of RAMIE in our department, including T3br/T4, were described, and the short-term and long-term results of RAMIE were considered acceptable. In terms of recurrence, local/regional disease control was considered to be relatively good.
Prognostic impact of ectopic fat deposition within psoas muscle in patients undergoing systemic chemotherapy for stage IV gastric cancer.
Authors: Ikegami Takako , Yamaguchi Toshifumi , Yukami Hiroki , Kadono Toru , Okemoto Dai , Kameishi Shin , Goto Masahiro , Nishikawa Hiroki 
Published: January 2024

285 Background: Sarcopenia is a progressive condition characterized by loss of skeletal muscle mass, muscle strength, and physical function, and is identified as an important prognostic factor in malignant tumors. The patients of gastrointestinal (GI) malignancies are often poor nutrition, weight loss, and loss of skeletal muscle mass due to pathophysiology such as the dysfunction of nutritional absorption and GI obstruction. The prevalence of sarcopenia is high in GI malignancies, especially in advanced gastric cancer (GC), which is reported to be 30%. Recently, in assessing sarcopenia, muscle quality as well as skeletal muscle mass has been considered important and some studies suggest that intramuscular adipose tissue is useful in assessing muscle quality. In this study, we focused on the fat ratio within psoas muscle (FRPM) and sought to clarify the impact of FRPM on overall survival (OS) in GC patients undergoing systemic chemotherapy. Methods: We retrospectively analyzed the patients with histologically confirmed stage IV GC receiving at least one systemic chemotherapy between February 2017 and March 2021 in our hospital. We measured PMI (Psoas Muscle Index: bilateral muscle mass (cm2)/height squared(m2)) and FRPM both at the lumber three level on the CT images before chemotherapy. PMI and FRPM values were classified into two groups, High and Low, according to whether they were higher or lower than the median, and differences in OS were analyzed for each group. Results: The analysis included 79patients (median age: 69 years, 59 males). The median FRPM was 1.67%. The FRPM-high group and the FRPM-low group were 40/39patients, respectively. The median PMI in male and female patients was 4.35 cm2/m2 and 2.88 cm2/m2. Thirty male patients and ten female patients were defined as the PMI-high group, and the remaining 39 patients were in the PMI-low group. The 1, 2 and 3year cumulative OS rate in patients with FRPM-high and FRPM-low was 67.3%, 14.3% and 7.6% in the FRPM-high group and 74.8%, 40.5% and 32.4% in the FRPM-low group ( P = 0.0341). The 1, 2 and 3year cumulative OS rate in patients with PMI-high and PMI-low was 86.7%, 40.4% and 30.0% in the PMI-high group and 55.8%, 12.8% and 6.4% in the PMI-low group ( P < 0.0001). In the multivariate analysis of factors associated with OS, PMI ( P = 0.0047) and FRPM ( P = 0.0019) were independent predictors for the OS. Conclusions: High-FRPM may be associated with declined physical activity, suggesting that skeletal muscle function may be an important prognostic factor in patients with GC receiving systemic chemotherapy.
Tislelizumab (TIS) plus chemotherapy (Chemo) vs placebo (PBO) plus chemo as first-line (1L) treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC): Health-related quality of life (HRQoL) outcomes in the RATIONALE-305 study.
Authors: Cruz-Correa Marcia , Xu Rui-Hua , Moehler Markus H. , Oh Do-Youn , Kato Ken , Spigel David R. , Arkenau Hendrik-Tobias , Tabernero Josep , Zimina Anastasia V. , Bai Yuxian , Shi Jianhua , Lee Keun-Wook , Hirano Hidekazu , Wyrwicz Lucjan S. , Pazo Cid Roberto , Xu Hui , Sheng Tao , Barnes Gisoo 
Published: January 2024

290 Background: RATIONALE-305 (NCT03777657), demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) with TIS + chemo (n=501) over PBO + chemo (n=496) as 1L treatment in patients (pts) with advanced G/GEJC. This analysis examined HRQoL outcomes of the RATIONALE-305 study at final analysis. Methods: Adults with previously untreated, unresectable, or metastatic GC/GEJC, were randomized (1:1) to TIS 200 mg or PBO IV once every 3 weeks plus investigator-choice of chemo. HRQoL was assessed using EORTC QLQ-C30 and the QLQ-STO22. A mixed model for repeated measures using PRO endpoints at clinical Cycles 4 and 6 was performed. Time to deterioration was examined. Results: TIS + chemo had improved outcomes than PBO + chemo (Table) as indicated by least-squares mean change from baseline to Cycle 6 for QLQ-C30 GHS/QoL (2.52 [95% CI:0.29 to 4.74]), physical functioning (2.46 [95% CI: 0.49 to 4.43]), fatigue (-3.01 [95% CI: -5.78 to -0.24]), and the STO22 index score (-1.62 [95% CI: -3.12 to -0.12]), as well as maintaining upper gastrointestinal (GI) symptoms (-1.74 [95% CI: -3.55 to 0.06)] and pain (-1.88 [95% CI: -4.03 to 0.27]). Pts receiving TIS + chemo had a lower risk for deterioration of GHS/QoL (0.77 [95% CI: 0.60 to 0.98]), physical functioning (0.72 [0.57 to 0.92]), STO22 index score (0.64 [0.45 to 0.92]), pain/discomfort (HR: 0.74 [0.58-0.96]), and upper GI symptoms (0.73 [0.56 to 0.95]). Conclusions: Pts treated with TIS + chemo had better HRQoL outcomes vs pts treated with PBO + chemo, particularly for GHS/QoL, physical functioning, fatigue, GC/GEJC symptoms, pain/discomfort, and upper GI symptoms These results, along with prolonging of OS and other secondary efficacy endpoints, as well as a tolerable safety profile, support the benefit of TIS + chemo as a potential 1L treatment option for GC/GEJC. Clinical trial information: NCT03777657 . [Table: see text]
Association of intensifying supportive care with improved survival in patients with gastric cancer with malignant ascites.
Authors: Karalis John D , Ju Michelle R , Feig Rachel , Estrella Raechelle , Pettigrew Morgan F , Alterio Rodrigo , Abreu Andres A , Farah Emile , Sawas Tarek , Sanford Nina Niu , Sanjeevaiah Aravind , Reznik Scott , Hammer Suntrea , Porembka Matthew R. , Wang Sam C. 
Published: January 2024

294 Background: Gastric cancer patients with malignant ascites often have poor functional status and malnutrition that precludes receipt of systemic therapies. Thus, these patients have a very poor prognosis. Beginning in 2019, our multidisciplinary gastric cancer disease-oriented team implemented a more aggressive supportive care plan for gastric cancer patients with malignant ascites. The initiative included measures such as supplemental enteral nutrition, ascites drainage, and initiation of chemotherapy on an inpatient basis. We compared outcomes for gastric cancer patients who presented with synchronous malignant ascites treated before and after the implementation of the care plan. Methods: We performed a retrospective review of our institutional database to identify patients diagnosed with gastric adenocarcinoma and synchronous malignant ascites between 2010-2022. We compared survival between patients diagnosed from 2010-2018, which will be referred to as the historical control era and patients diagnosed from 2019-2022, which will be called the aggressive supportive care era. Results: 54 patients were included in our analysis; 31 patients were treated in the historical control time frame and 23 patients treated during the aggressive supportive care era. Demographic, clinical, and pathologic characteristics were similar between groups. 3% of historical controls received supplemental tube feeds at diagnosis as compared to 30% of the aggressive supportive care cohort (p=0.008). 3% of historical controls received their first cycle of chemotherapy in the inpatient setting versus 39% of patients treated during the aggressive supportive care era (p=0.001). The median number of chemotherapy cycles received was 5 among historical controls and 9.5 among aggressive supportive care era patients (p = 0.02). There was no difference in the number of days spent as an inpatient between the two groups. The median overall survival for historical control patients was 5.4 months as compared to 10.4 months for patients treated during aggressive supportive care era (p=0.035). Conclusions: Gastric cancer patients with synchronous malignant ascites treated during a timeframe when our multidisciplinary team implemented more aggressive supportive care measures had improved OS as compared to historic controls.Our results suggest that aggressive supportive measures for these patients with highly challenging clinical issues and poor prognosis can prolong survival. Specifically, initiation of chemotherapy in the inpatient setting and supplemental nutrition should be considered for patients at high risk for treatment intolerance.
Does routine clinical assessment of older adults with gastroesophageal cancer tell the whole story?
Authors: Connors Meghan , Meeker Caitlin R. , Handorf Elizabeth , Filchner Kelly A. , Tejani Mohamedtaki Abdulaziz , Williams Grant Richard , Winer Arthur , Arora Sukeshi Patel , Vijayvergia Namrata , Dotan Efrat 
Published: January 2024

297 Background: Geriatric Assessment (GA) can help oncologists determine fitness of their older patients (pt) for anti-cancer therapy. Our objective was to compare routine provider assessment (PA) and GA of older adults with gastroesophageal cancer (GEC). Methods: Patients ≥65 with any stage of GEC completed a GA. The pt’s provider completed a PA and abnormalities detected by both assessments were centrally reviewed and compared. GA and PA assessed functional status, nutrition, comorbidities, psychological distress, cognition, social support, and chemotherapy toxicity risk. Validated assessment tools were used for the GA. Data collected 3 months post-enrollment included hospitalization, ≥ grade 3 toxicities, and treatment delays. We compared the proportions detected/not detected abnormalities by PA vs GA using McNemar’s test for paired data, and we measured agreement using Kappa statistics (1=full, 0=no, -1=disagreement). Results: 82 pts were enrolled, majority male (74%), median age 73 (65-91), stage III/IV (82%) disease on first line therapy (79%). Cancer sites included gastric (32%), esophageal (43%), GEJ (26%). Pts’ demographic and clinical characteristics did not predict for the identification of GA abnormalities. GA detected 196 abnormalities and PA detected 86. Majority of pts (84%) had ≥ 1 unidentified abnormality by PA. Providers identified more pts with clinically significant comorbidities as compared to GA. However, the GA identified more abnormalities compared to PA in all other evaluated domains (Table). Low agreement was found between PA and GA in any of the domains. Pts scoring high on the CARG chemotherapy toxicity prediction tool (p=0.004) and pts with evidence of psychological distress (p=0.049) had more ≥ grade 3 toxicity. Pts with abnormalities in functional status, nutrition, psychological distress, and a high CARG score were more likely to be hospitalized during therapy. Conclusions: Clinical characteristics of older pts with GEC are not predictive of GA abnormalities. While providers were better at identifying comorbidities, the GA resulted in a comprehensive evaluation of all domains and identified significant abnormalities that affect treatment outcomes in this population. [Table: see text]