Risk factors and characteristics of bacterial infection during first-line chemotherapy for metastatic gastric or gastroesophageal junction adenocarcinoma

Author(s):  
Xuan Jin ◽  
Shikai Wu ◽  
Yu Bai
2019 ◽  
Vol 08 (02) ◽  
pp. 085-087
Author(s):  
K. Govind Babu ◽  
Tamojit Chaudhuri ◽  
K. C. Lakshmaiah ◽  
Lokanatha Dasappa ◽  
Linu Abraham Jacob ◽  
...  

Abstract Background: Epirubicin, cisplatin, and 5-FU (ECF) is one of the most commonly used first-line chemotherapy regimens in metastatic gastric cancer. However, due to protracted infusion schedule, need for special infusion pumps, and catheter-related complications, the practical utility and acceptability of standard ECF regimen are limited, particularly in resource-constrained settings including India. Materials and Methods: In the present study, we have used a more convenient modification of the standard ECF protocol (using 5 days intravenous infusion of 5-FU at a dose of 750 mg/m2/day, given over 6 h through a peripheral venous line), in Indian patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The primary endpoint was overall survival (OS). The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), and toxicity profile. Results: Between January 2014 and December 2017, 107 patients were assigned and treated with this modified ECF regimen. The median age was 52 years (range, 34–62); 66.3% were males and 36.5% of the patients had ≥ 3 metastatic disease site involvement at baseline. Dose reductions due to toxicity were required in 14.9% of the patients. The ORR was 32.7%; median PFS and OS were 5.9 months (95% confidence interval [CI]: 4.7–6.9) and 10.4 months (95% CI: 8.4–11.8), respectively. Both the hematological and nonhematological toxicities were manageable, and there was no toxicity-related death. The most frequent Grade 3–4 adverse events were neutropenia (18.7%), febrile neutropenia (13.1%), mucositis (5.6%), and diarrhea (5.6%). Conclusions: In the present study, the modified ECF regimen demonstrated significant efficacy with an acceptable toxicity profile in Indian patients with metastatic gastric and GEJ adenocarcinoma. The survival outcomes of this modified schedule were comparable with those of the standard ECF regimen, as reported earlier. Clearly, this modified and more convenient ECF protocol should be explored and validated through large prospective randomized trials.


2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Hongqiong Yang ◽  
Yaojun Zhou ◽  
Liangzhi Wang ◽  
Tianyi Gu ◽  
Mengjia Lv ◽  
...  

Five electronic databases were searched for eligible records. Outcomes were presented and analyzed according to the objective response rate (ORR), progression-free survival (PFS) rate, and overall survival (OS) rate. Five records involving 2,024 participants were included in the study. The pooled analysis of OS and PFS were longer with ramucirumab (RAM) therapy than without RAM for OS (odds ratio OR = 0.90 , 95% confidence interval CI = 0.82 – 1.00 , p = 0.05 ) and PFS ( OR = 0.74 , 95 % CI = 0.57 – 0.96 , p = 0.02 ). Moreover, compared with the current first-line chemotherapy, the OS ( OR = 0.93 , 95 % CI = 0.83 – 1.04 , p = 0.19 ) and PFS ( OR = 0.82 , 95 % CI = 0.64 – 1.06 , p = 0.13 ) results were not significantly higher with RAM. The ORRs of the patients in the RAM therapy groups were significantly higher than those in the groups without RAM ( OR = 1.40 , 95 % CI = 1.14 – 1.73 , p = 0.001 ).


2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 4187-4187
Author(s):  
A. Viteri ◽  
R. Barcelo-Galindez ◽  
I. Rubio ◽  
R. Fernandez ◽  
A. Muñoz ◽  
...  

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9569-9569
Author(s):  
A. Salar ◽  
B. Sanchez-Gonzalez ◽  
A. Alvarez-Larran ◽  
J. Comin ◽  
J. R. Gonzalez ◽  
...  

9569 Background: NT-Pro BNP provides diagnostic and prognostic information in many heart syndromes, but its role in oncologic patients is not established. Methods: We studied the association between NT-ProBNP levels and the risk of major toxicity associated with chemotherapy and death from all causes in 116 consecutive patients with lymphoma treated with curative intent. High resolution ultrasound echocardiography and serum NT-ProBNP levels were prospectively done previous the start of chemotherapy. Charlson Comorbidity Index was retrospectively calculated. A major toxicity event was defined as: when chemotherapy had to be discontinued, when chemotherapy had to be changed to a less intensive regimen, and treatment-related death. Results: High blood levels of NT-proBNP were associated with previous cardiologic history but not with left ventricular ejection fraction. With a median follow-up of 16 moths (0–49 months), 25 patients had a major toxic event with first line chemotherapy and 16 had died at last follow-up. The threshold of NT-ProBNP with better predictive accuracy for major toxicity-free and overall survival was 900 pg/mL. Patients with levels of NT-proBNP greater of 900 pg/mL had an adjusted hazard ratio (HR) for major toxicity after first-line chemotherapy for lymphoma of 6.4 (95%CI, 2.7–15.1). Two additional independent factors predicting higher major toxicity associated with chemotherapy were albumin < 3.5 g/mL (HR 3.5, P=0.008) and number of extranodal sites ≥ 2 (HR 3.1, P<0.007). For prediction of death from all causes, patients with a NT-ProBNP greater of 900 pg/mL had an HR of death of 15.3 (95%CI, 4.8–48.8; P<0.001). ECOG ≥ 2 was also significant for predicting death (HR 3.6; 95%CI, 1.1–11.6; P=0.03). The NT-Pro BNP added prognostic information beyond that provided by conventional risk factors, including IPI, left ventricular ejection fraction and Charlson comorbidity index. Conclusions: NT-ProBNP is the stronger marker for predicting major toxicity after first-line chemotherapy and death from all causes in patients with lymphoma and provides prognostic information beyond that provided by conventional lymphoma risk factors and comorbidity indexes. No significant financial relationships to disclose.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS3145-TPS3145
Author(s):  
Do-Youn Oh ◽  
Hyun Cheol Chung ◽  
Young Hyuck Im ◽  
Chia Jui Yen ◽  
Yee Chao ◽  
...  

TPS3145 Background: ZW25 is a novel HER2-targeted antibody that binds two distinct extracellular domains of HER2, allowing for multiple mechanisms of action, including activation of ADCC and inhibition of ligand-dependent and -independent cellular growth. ZW25 is well tolerated and showed single-agent antitumor activity in patients (pts) with advanced HER2-positive cancers. Previous reports suggested that tislelizumab, an investigational anti-PD-1 antibody engineered to minimize binding of FcgR on macrophages in order to abrogate antibody-dependent phagocytosis, was generally well tolerated and had antitumor activity alone and in combination with chemotherapy in pts with advanced solid tumors. Combining HER2-targeted agents with chemotherapy has resulted in improved survival; the highly immunogenic nature of HER2 tumors has led to the development of therapies combining anti-HER2 therapies with immune checkpoint blockade. Methods: This open-label, two cohort phase 1B/2 study is designed to evaluate ZW25 plus chemotherapy ± tislelizumab as first-line therapy in pts (n≈50) with HER2-positive metastatic breast cancer (mBC; cohort 1) or advanced gastric/gastroesophageal junction adenocarcinoma (GC/GEJC; cohort 2). In cohort 1, pts with HER2-positive (IHC3+ or ISH amplified) mBC must be treatment-naïve for metastatic disease and will receive intravenous (IV) ZW25 30 mg/kg plus docetaxel 75 mg/m2 IV once every 3 weeks (Q3W). In cohort 2, treatment-naïve pts with HER2-positive (IHC3+ or IHC2+ with ISH amplification) advanced GC/GEJC will receive ZW25 30 mg/kg plus tislelizumab 200 mg IV and chemotherapy (CAPOX regimen: capecitabine 1000 mg/m2 twice daily and oxaliplatin 130 mg/m2 IV) Q3W. A safety lead-in phase is designed for the first six pts in cohort 2, followed by dose expansion after a safety monitoring committee review. Primary endpoints are the safety/tolerability profile and objective response rate; secondary endpoints include duration of response, time to response, progression-free survival, disease control rate, and overall survival. Clinical trial information: Registered, NCT number pending will provide as soon as available .


2021 ◽  
Author(s):  
Josep Tabernero ◽  
Yung-Jue Bang ◽  
Eric Van Cutsem ◽  
Charles S Fuchs ◽  
Yelena Yuriy Janjigian ◽  
...  

Current guidelines recommend two-drug cytotoxic chemotherapy with a fluoropyrimidine (fluorouracil or capecitabine) and a platinum-based agent (oxaliplatin or cisplatin) as first-line treatment for advanced gastric cancer. Pembrolizumab monotherapy has demonstrated durable antitumor activity in patients with advanced programmed death ligand 1-positive (combined positive score ≥1) gastric/gastroesophageal junction adenocarcinoma. Accumulating evidence indicates that combining pembrolizumab with standard-of-care chemotherapy for the treatment of advanced or metastatic cancer improves clinical outcomes. We describe the rationale for and the design of the randomized, double-blind, placebo-controlled, Phase III KEYNOTE-859 study, which is investigating pembrolizumab in combination with chemotherapy as first-line treatment for patients with human epidermal growth factor receptor 2-negative advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma. The planned sample size is 1542 patients, and the primary end point is overall survival. Clinical trial registration: NCT03675737 (ClinicalTrials.gov)


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