Prognostic impact of immune-related adverse events with nivolumab in patients with advanced gastric cancer: A multicenter retrospective analysis.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 347-347
Author(s):  
Yuno Ohya ◽  
Takayuki Ando ◽  
Akira Ueda ◽  
Kohei Ogawa ◽  
Iori Motoo ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Practice ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Retrospective Analysis ◽  
Prognostic Impact ◽  
Significant Difference ◽  
Metastatic Sites ◽  
Practice Methods ◽  
Ecog Ps

347 Background: Nivolumab was established as one of the standard treatments for previously treated advanced gastric cancer (AGC). The aim of this study is to evaluate the frequency of immune-related adverse events (irAEs) with Nivolumab and its impact on treatment efficacy in clinical practice. Methods: We performed multicenter retrospective analysis, which included 90 patients with advanced gastric cancer who received Nivolumab treatment between October 2017 and September 2019. The frequency of irAEs and its treatment outcome were evaluated, and survival was compared during Nivolumab treatment. Results: The characteristics of 90 patients in this analysis were as follows: median age (range), 68 (36-85); male/female, 56/34; ECOG PS 0-1/≥2, 62/28; number of metastatic sites 1/≥2, 36/56; treatment line 3/≥4, 63/27. Median treatment cycle of nivolumab treatment was 3 (range 1-26). The overall response in 68 patients with target lesions was 6.3% (4/68), and the median PFS and OS was 1.5 and 4.3 months, respectively. IrAEs were observed in 8 patients (8.8%), including grade 4 pneumonitis, grade 2 or 3 adrenal insufficiency, and grade 2 hypothyroidism, encephalitis, and immune thrombocytopenia. Median time to onset of irAEs was 1.3 (range 0.6-10.5) months. Six were treated with systemic corticosteroid therapy, and all irAEs were relieved. The median PFS and OS were 4.7 months (95%CI, 1.2-9.3) and 12.2 months (95% CI, 3.2-not reached) in patient with irAEs, and 1.4 months (95%CI, 1.1-1.9) and 4.1 months (95%CI, 2.6-6.6) in those without, respectively. There was significant difference in the PFS (p=0.005) and OS (p=0.03). Conclusions: Nivolumab was effective and well tolerated even in clinical practice. Development of irAEs may be associated with better outcome of Nivolumab in patients with AGC.

scholarly journals Prognosis of Immune-related Adverse Events in Patients With Advanced Gastric Cancer Treated With Nivolumab or Pembrolizumab: A Multicenter Retrospective Analysis

In Vivo ◽  
2021 ◽  
Vol 35 (1) ◽  
pp. 475-482
Author(s):  
TAKAYUKI ANDO ◽  
AKIRA UEDA ◽  
KOHEI OGAWA ◽  
IORI MOTOO ◽  
SHINYA KAJIURA ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Retrospective Analysis

Multicenter retrospective analysis for elderly patients with advanced gastric cancer (AGC) received first-line chemotherapy in clinical practice.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 4046-4046
Author(s):  
Kenji Kunieda ◽  
Akitaka Makiyama ◽  
Masaaki Noguchi ◽  
Takeshi Kajiwara ◽  
Takao Tamura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Practice ◽  
Elderly Patients ◽  
Advanced Gastric Cancer ◽  
Retrospective Analysis ◽  
First Line ◽  
Line Chemotherapy

Safety and efficacy of trifluridine/tipiracil (FTD/TPI) plus bevacizumab in clinical practice for patients with chemorefractory metastatic colorectal cancer: A retrospective comparative study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 112-112
Author(s):  
Yoshinori Kagawa ◽  
Yohei Nose ◽  
Taishi Hata ◽  
Kenji Kawai ◽  
Takuya Sakamoto ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Practice ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Progression Free Survival ◽  
Combination Regimen ◽  
Safety And Efficacy ◽  
Significant Difference ◽  
Retrospective Comparative Study ◽  
Practice Methods

112 Background: Trifluridine/tipiracil (FTD/TPI) significantly improves overall survival (OS) in patients with chemorefractory metastatic colorectal cancer (mCRC). The phase I/II C-TASKFORCE study of FTD/TPI + bevacizumab (Bev) for patients with mCRC who are refractory to standard chemotherapy demonstrated promising efficacy results. FTD/TPI + Bev were linked to significant and clinically relevant improvements in progression-free survival (PFS) and OS compared with FTD/TPI monotherapy and a favorable safety profile in a Danish randomized trial. This retrospective study investigated the safety and efficacy of FTD/TPI alone or in combination with Bev for patients with refractory mCRC in clinical practice. Methods: We reviewed the outcomes of patients with chemorefractory mCRC who received FTD/TPI alone (monotherapy; 35 mg/m2, twice daily on days 1–5 and 8–12 in a 28-day cycle) or FTD/TPI + Bev (combination; 5 mg/kg, days 1 and 15) in our institution since 2014. We compared the safety and efficacy of the monotherapy and combination regimens. Adverse events were evaluated using Common Terminology Criteria for Adverse Eventsv4.0. Median PFS and OS were analyzed using the Kaplan–Meier method. Results: In total, 56 patients received chemotherapy containing FTD/TPI. Twenty-four patients were treated with monotherapy, and 32 patients received the combination regimen. The median PFS was 1.8 months in the monotherapy arm, versus 4.7 months in the combination arm (hazard ratio [HR] = 0.28; 95% confidence interval [CI] = 0.15–0.51; P < 0.0001). The median OS was 6.3 months for the monotherapy arm, versus 11.7 months for the combination arm (HR = 0.25; 95% CI = 0.13–0.48; P < 0.0001). There was no significant difference in the rates of adverse events between the groups excluding neutropenia. Neutropenia (Grade 3 or worse) developed in five patients (20.8%) in the monotherapy arm and 17 patients (53.1%) in the combination arm ( P = 0.030). There were no treatment-related deaths. Conclusions: In patients with chemorefractory mCRC, FTD/TPI + Bev significantly improved PFS and OS versus FTD/TPI monotherapy.

scholarly journals Prognostic Impact of Sarcopenia and Radiotherapy in Patients With Advanced Gastric Cancer Treated With Anti-PD-1 Antibody

2021 ◽  
Vol 12 ◽  
Author(s):  
Nalee Kim ◽  
Jeong Il Yu ◽  
Do Hoon Lim ◽  
Jeeyun Lee ◽  
Seung Tae Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Negative Impact ◽  
Multivariable Analysis ◽  
Immune Checkpoint Blockade ◽  
Prognostic Impact ◽  
Skeletal Muscle Index ◽  
Entire Cohort ◽  
Significant Difference ◽  
History Of

BackgroundWe explored the combined effects of sarcopenia (SAR) and radiotherapy (RT) on outcomes in patients with advanced gastric cancer (AGC) treated with immune-checkpoint blockade (ICB).MethodsAmong 185 patients with AGC treated with ICB, we defined SAR as skeletal muscle index &lt;49 cm2/m2 for men and &lt;31 cm2/m2 for women; 93 patients met criteria. We defined high neutrophil-to-lymphocyte ratio (hNLR) as NLR≥3. Palliative RT was performed in 37 patients (20%) before ICB.ResultsWe frequently observed hNLR in patients with SAR (53% vs. 35%, p = 0.02). The median overall survival (OS) for the entire cohort was 5 months. Stratification by risk factors of SAR or hNLR revealed a significant difference in median OS (0 [N = 60] vs. 1 [N = 76] vs. 2 [N = 49]: 7.6 vs. 6.4 vs. 2.2 months, p &lt; 0.001). Patients with microsatellite instability-high (MSI-H, N = 19) or Epstein-Barr virus (EBV)-positive tumors (N = 13) showed favorable outcomes compared to those with microsatellite stable (MSS, N = 142) tumors (median OS, not reached vs. 16.8 vs. 3.8 months, respectively). The benefit of RT was evident in patients with both SAR and hNLR (median OS, 3.1 vs. 1.3 months, p = 0.02) and MSS/EBV-negative tumor (median OS, 6.5 vs. 3.5 months, p = 0.03), but outcomes after RT in MSI-H tumor were not significantly different. In multivariable analysis, SAR/hNLR, molecular subtypes, and a history of RT were associated with OS (all p &lt; 0.05).ConclusionsWe demonstrated the negative predictive value of SAR/hNLR on outcomes after ICB for AGC, and the history of RT could overcome the negative impact of SAR/hNLR and the MSS/EBV-negative subtype.

Real-world observation of the efficacy and prognostic factors analysis of apatinib for patients with advanced gastric cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15508-e15508
Author(s):  
Qiwen Shen ◽  
Mingyun WANG ◽  
Xiaobao Peng ◽  
Siyi Tan ◽  
Jiaqi Xie ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Prognostic Factors ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Clinical Decision ◽  
Factors Analysis ◽  
One Year ◽  
Metastatic Sites

e15508 Background: Apatinib is the first oral anti-angiogenic agent approved for the treatment of advanced gastric cancer in China. With the development of marketing promotion, the real world observation of the efficacy and prognostic factors analysis of apatinib become the urgent need for clinical decision. The aim of this study is to evaluate the efficacy and safety of apatinib in patients with advanced gastric cancer, and the association between some prognostic factors and clinical outcomes. Methods: We collected the data of 153 patients with advanced gastric cancer, who were treated with apatinib after failure of at least one regimen chemotherapy from December 2014 to June 2019. Treatment response, progression-free survival(PFS), overall survival(OS) and treatment-related adverse events were evaluated. Results: The median PFS for 153 patients was 3.1m (95% confidence interval, CI 2.863-3.337). The median OS was 6.0m (95% CI 4.392-7.608). Adverse events of grade 3 or above happened in 47.6 percent of patients and 61.7 percent of whom stopped treatment. Multivariate analysis showed that the number of metastatic sites was the independent factor simultaneously predicting DCR (disease control rate, P = 0.008) and OS (P = 0.007). Patients spending more than one year from diagnosis to treatment with apatinib had better DCR (P = 0.032) and longer PFS (P = 0.015). Liver metastasis (P = 0.007) and combined systemic therapy (P = 0.036) were significantly associated with DCR, but not associated with PFS or OS. Conclusions: Some patients with advanced gastric cancer can benefit from apatinib. This study help us to identify patients who has potential benefit from apatinib.

Efficacy and safety of nivolumab and irinotecan as third-line chemotherapy for advanced gastric cancer: A multi-institutional retrospective study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 396-396
Author(s):  
Ryosuke Kumanishi ◽  
Seiichiro Mitani ◽  
Shigenori Kadowaki ◽  
TOMOHIRO MATSUSHIMA ◽  
Naoki Takahashi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Group Performance ◽  
Interaction Analysis ◽  
Eastern Cooperative Oncology Group ◽  
Lower Grade ◽  
Efficacy And Safety ◽  
Clinical Factors ◽  
Ecog Ps

396 Background: Although nivolumab (NIVO) and irinotecan (IRI) are currently used as third- or later-line therapy for advanced gastric cancer (AGC), few direct comparisons between them have been available. The present study therefore aims to compare the efficacy and safety of NIVO with IRI and explore clinical factors that predict efficacy. Methods: Patients with AGC who underwent NIVO or IRI treatment between November 2016 and June 2018 at three institution were retrospectively examined, subsequently evaluating response rates (RR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs). The main inclusion criteria were patients pretreated with fluoropyrimidines and taxanes, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0–2, and no previous NIVO or IRI treatment. Results: A total of 71 and 61 patients received NIVO and IRI, respectively, with both groups having similar baseline characteristics, except for gender. Efficacies were as follows (NIVO/IRI): RR, 20%/6% (p = 0.17); median PFS, 1.6 months (m)/1.8 m (HR 0.93, p = 0.67); median OS, 6.4 m/6.4 m (HR 0.91, p = 0.61); 1-year survival rate, 24.9%/19.3% (p = 0.61), respectively. Interaction analysis found no significant interaction between drugs and various factors such as ECOG PS (p = 0.59) and neutrophile/lymphocyte ratio (p = 0.33) related to OS. Subsequent chemotherapy agents were administered to 32 patients (45%) in the NIVO group (17 patients out of them received IRI) and 36 patients (59%) in the IRI group (23 patients out of them received NIVO) (p = 0.12). NIVO tended to have lower grade 3 or more AEs than IRI, especially neutropenia (3% vs. 28%, respectively; p < 0.01) and febrile neutropenia (1% vs. 8%, respectively; p = 0.09), as well as neutropenia, nausea, diarrhea, constipation, fatigue, and anorexia of any grade. Five patients developed immune-related adverse events in the NIVO group: pneumonitis (n = 1) and rash (n = 4). Conclusions: Although no remarkable differences in efficacy were found between NIVO and IRI for AGC, NIVO had a better safety profile compared to IRI. This study found no clinical factors that predicted efficacy.

Randomized, Open-Label, Phase III Study Comparing Irinotecan With Paclitaxel in Patients With Advanced Gastric Cancer Without Severe Peritoneal Metastasis After Failure of Prior Combination Chemotherapy Using Fluoropyrimidine Plus Platinum: WJOG 4007 Trial

2013 ◽  
Vol 31 (35) ◽  
pp. 4438-4444 ◽  
Author(s):  
Shuichi Hironaka ◽  
Shinya Ueda ◽  
Hirofumi Yasui ◽  
Tomohiro Nishina ◽  
Masahiro Tsuda ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Phase Iii ◽  
Significant Difference ◽  
Paclitaxel Group ◽  
Phase Iii Study ◽  
Third Line ◽  
Line Chemotherapy

Purpose This phase III study compared treatment with weekly paclitaxel and biweekly irinotecan in patients with advanced gastric cancer refractory to treatment with fluoropyrimidine plus platinum. Patients and Methods Patients were randomly assigned to receive either paclitaxel (80 mg/m2 on days 1, 8, and 15, every 4 weeks) or irinotecan (150 mg/m2 on days 1 and 15, every 4 weeks). Primary end point was overall survival (OS), and secondary end points were progression-free survival (PFS), response rate, adverse events, and proportion of patients who received third-line chemotherapy. Results Of 223 patients, 219 were eligible for analysis. Median OS was 9.5 months in 108 patients allocated to the paclitaxel group and 8.4 months in 111 patients allocated to the irinotecan group (hazard ratio [HR], 1.13; 95% CI, 0.86 to 1.49; P = .38). Median PFS was 3.6 months in the paclitaxel group and 2.3 months in the irinotecan group (HR, 1.14; 95% CI, 0.88 to 1.49; P = .33). Response rate was 20.9% in the paclitaxel group and 13.6% in the irinotecan group (P = .24). Common grade 3 to 4 adverse events were neutropenia (paclitaxel group, 28.7%; irinotecan group, 39.1%), anemia (21.3%; 30.0%), and anorexia (7.4%; 17.3%). Treatment-related deaths occurred in two patients (1.8%) in the irinotecan group. Third-line chemotherapy was administered in 97 patients (89.8%) after paclitaxel treatment and in 80 patients (72.1%) after irinotecan treatment (P = .001). Conclusion No statistically significant difference was observed between paclitaxel and irinotecan for OS. Both are reasonable second-line treatment options for advanced gastric cancer.

scholarly journals Comparison of prognostic impact of anatomic location of the pancreas on postoperative pancreatic fistula in laparoscopic and open gastrectomy

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jun Kinoshita ◽  
Takahisa Yamaguchi ◽  
Hiroto Saito ◽  
Hideki Moriyama ◽  
Mari Shimada ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Pancreatic Fistula ◽  
Left Gastric Artery ◽  
Postoperative Pancreatic Fistula ◽  
Open Gastrectomy ◽  
Amylase Level ◽  
Prognostic Impact ◽  
Anatomic Location ◽  
Significant Difference ◽  
Preoperative Ct

Abstract Background Postoperative pancreatic fistula (POPF) is a serious complication after gastric cancer surgery. The current study aimed to investigate the significance of the anatomic location of the pancreas as a predictor for POPF in both laparoscopic gastrectomy (LG) and open gastrectomy (OG). Methods In total, 233 patients with gastric cancer were assessed retrospectively. We measured the maximum vertical (P-L height; PLH) and horizontal length (P-L depth; PLD) between the upper border of pancreas and the root of left gastric artery on a preoperative CT in the sagittal direction. The maximum length of the vertical line between the surface of the pancreas and the aorta (P-A length), previously reported as prognostic factor of POPF, was also measured. We investigated the correlations between these parameters and the incidence of POPF in LG and OG groups. Results Among the patients in this study, 118 underwent OG and 115 underwent LG. In LG, the median PLH and P-A length in patients with POPF were significantly longer compared with those without POPF (p = 0.026, 0.034, respectively), but not in OG. There was no significant difference in the median PLD between the patients with or without POPF in both LG and OG. The multivariate analysis demonstrated that PLH (odds ratio [OR] 4.19, 95% confidence interval [CI] 1.57–11.3, P = 0.004) and P-A length (OR 4.06, 95%CI 1.05–15.7, P = 0.042] were independent factors for predicting POPF in LG. However, intraoperative blood loss (OR 2.55, 95%CI 1.05–6.18, P = 0.038) was extracted as an independent factor in OG. The median amylase level in the drained fluid (D-Amy) were significantly higher in patients with high PLH(≥12.4 mm) or high P-A length (≥45 mm) compared with those with low PLH or low P-A length in LG. However, there were no differences in the D-Amy levels by PLH or P-A length in OG patients. Conclusions The anatomic location of the pancreas is a specific and independent predictor of POPF in LG but not in OG. PLH is a simple parameter that can evaluate the anatomic position of the pancreas, and it may be useful for preventing POPF after LG.

scholarly journals The Relation between Stress of Clinical Practice and Burnout among Nursing Students: The Mediation Effect of Spiritual Well-being

2017 ◽  
Vol 23 (3) ◽  
pp. 300-308
Author(s):  
Do Young Lee ◽  
Jin Kyoung Park ◽  
Mi Young Choi
Keyword(s):  
Clinical Practice ◽  
Nursing Students ◽  
Negative Correlation ◽  
Well Being ◽  
Self Report ◽  
Mediation Effect ◽  
Mediating Effects ◽  
Significant Difference ◽  
Spiritual Well Being ◽  
Practice Methods

Purpose: The purpose of this study is to examine the factors that influence the clinical practice of nursing students and to identify the mediating effects of spiritual well-being in the relation between stress of clinical practice and burnout caused by clinical practice. Methods: Data were collected by self-report questionnaires targeting 420 nursing students in three nursing colleges located in Gyeonggi and Chungnam province. Results: Burnout of clinical practice according to general characteristics of the study subjects showed significant difference in religion (t=1.895, p=.049). Stress of clinical practice and burnout of clinical practice showed positive correlation (r=.42, p<.001), existential spiritual well-being showed negative correlation between stress of clinical practice (r=-.17, p<.001) and burnout of clinical practice (r=-.47, p<.001). In addition, religious spiritual well-being in spiritual well-being showed no mediating effects and existential spiritual well-being showed mediating effects between burnout in clinical practice stress. Conclusion: In order to alleviate the stress of clinical practice for burnout of clinical practice prevention of nursing students, solutions to improve the existential spiritual well-being will be required in the future.

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