Treatment patterns, effectiveness, and safety of Trastuzumab in Chinese patients with metastatic gastric cancer: Interim analysis of the EVIDENCE registry study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15595-e15595 ◽  
Author(s):  
Shukui Qin ◽  
Shen Lin ◽  
Ruihua Xu ◽  
Wuyun Su ◽  
Yong Tang ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Gastroesophageal Junction ◽  
Metastatic Gastric Cancer ◽  
Treatment Patterns ◽  
Chinese Patients ◽  
Registry Study ◽  
Her2 Positive ◽  
Real World Data ◽  
First Line Therapy ◽  
Gastroesophageal Junction Adenocarcinoma

e15595 Background: Trastuzumab (TRA) was approved for HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma (mGC) in China in August 2012. However, real-world data on the treatment patterns, effectiveness, and safety of TRA in Chinese patients (pts) with mGC are limited. Methods: EVIDENCE is a prospective, multicenter, non-interventional, registry study of 5 cohorts (NCT01839500). Cohort I enrolled pts with HER2-positive mGC (IHC3+ or IHC2+/ISH+) diagnosed up to 6 months previously. This interim analysis evaluated the effectiveness and safety of TRA in the first 95 pts of cohort I who were treated at 33 hospitals in China between April 2013 and August 15, 2016. Results: 71 of the 95 pts (74.7%) were male and the median age at diagnosis was 61 years (range 21-87 years). At the data cut-off date, the preliminary median PFS was 9.5 months (95% CI 7.6-11.8 months), and the preliminary median overall survival (OS) was 30.0 months (95% CI 18.6-38.7 months). 90 pts were treated with TRA + chemotherapy; XELOX (capecitabine + oxaliplatin) (28 pts, 31.1%) and capecitabine (20 pts, 22.2%) were the mostly commonly used regimens with TRA for first-line therapy, while paclitaxel was most commonly used with TRA for second-line (7.8%) and third-line (2.2%) therapy. TRA was also used in neoadjuvant (7 pts) and adjuvant (8 pts) settings prior to recurrence. During follow-up, 48 pts had progressive disease, and 21 (43.8%) received TRA beyond progression; 7 pts (14.6%) continued TRA after their 2nd disease progression. TRA-related adverse events (AEs) were observed in 26 pts (27.4%), including neutropenia in 10 pts (10.5%), thrombocytopenia in 9 (9.5%), and a decreased white blood cell count in 7 (7.4%). Only 6 pts (6.3%) experienced grade > = 3 TRA-related AEs (which included neutropenia and thrombocytopenia). Conclusions: In routine clinical practice in China, TRA combined with various chemotherapy regimens proved effective and well tolerated for treating mGC HER2+ pts. In addition to its use in palliative settings, TRA was also used as neoadjuvant/adjuvant treatment. Clinical trial information: NCT01839500.

Phase II study of trastuzumab and cisplatin as first-line therapy in patients with HER2-positive advanced gastric or gastroesophageal junction cancer

2011 ◽  
Vol 13 (3) ◽  
pp. 179-184 ◽  
Author(s):  
Cristina Grávalos ◽  
Carlos Gómez-Martín ◽  
Fernando Rivera ◽  
Inmaculada Alés ◽  
Bernardo Queralt ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Gastroesophageal Junction ◽  
First Line ◽  
Her2 Positive ◽  
First Line Therapy ◽  
Gastroesophageal Junction Cancer ◽  
Line Therapy

scholarly journals Differences in outcome according to chemotherapy backbone and maintenance treatment in HER2 positive metastatic gastric cancer (GC) or gastroesophageal junction (GEJ)

2018 ◽  
Vol 29 ◽  
pp. viii225
Author(s):  
N. Martinez Lago ◽  
S. Candamio Folgar ◽  
C. Grande Ventura ◽  
M. Salgado Fernandez ◽  
J. De la Camara Gomez ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Maintenance Treatment ◽  
Gastroesophageal Junction ◽  
Metastatic Gastric Cancer ◽  
Her2 Positive

Cisplatin and capecitabine as first-line therapy for advanced gastric or gastroesophageal junction adenocarcinoma

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 4187-4187
Author(s):  
A. Viteri ◽  
R. Barcelo-Galindez ◽  
I. Rubio ◽  
R. Fernandez ◽  
A. Muñoz ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
First Line ◽  
First Line Therapy ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Line Therapy

ZW25, an anti-HER2 bispecific antibody, plus chemotherapy with/without tislelizumab as first-line treatment for patients with advanced HER2-positive breast cancer or gastric/gastroesophageal junction adenocarcinoma: A phase 1B/2 trial-in-progress.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS3145-TPS3145
Author(s):  
Do-Youn Oh ◽  
Hyun Cheol Chung ◽  
Young Hyuck Im ◽  
Chia Jui Yen ◽  
Yee Chao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Antitumor Activity ◽  
Gastroesophageal Junction ◽  
Single Agent ◽  
Tolerability Profile ◽  
First Line ◽  
Her2 Positive ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Treatment Naïve ◽  
Phase 1B

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 .

Multicenter phase II study of pemetrexed and oxaliplatin as first-line therapy in advanced gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14045-14045
Author(s):  
L. Celio ◽  
S. Sachetta ◽  
S. Mosconi ◽  
I. La Torre ◽  
C. Barone ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Interim Analysis ◽  
Single Agent ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Primary Objective ◽  
Vitamin Supplementation ◽  
Stage Design ◽  
First Line Therapy

14045 Background: We have previously reported that single-agent pemetrexed is active in metastatic gastric cancer. On the basis of the potential synergism of pemetrexed and oxaliplatin, we explored the combination in patients with locally advanced/metastatic gastric carcinoma. Methods: The primary objective was activity of the combination. Eligible patients had to ≥1 measurable lesion according to RECIST. Pemetrexed 500 mg/m2 was given intravenously over 10 minutes, and oxaliplatin 120 mg/m2 was given over 2 hours; both drugs were given on day 1 of a 21-day cycle. Patients were to receive ≥6 (maximum of 8) cycles unless disease progression occurred. Vitamin supplementation was given as well as dexamethasone. A total of 43 patients were planned in a two-stage design with 13 patients in the first stage. An interim analysis was planned at the end of the first stage, so the trial could be stopped if ≤3 responses were observed. Results: Between May 2004 and January 2005, 13 patients (6 females) entered the study. Median age was 52 years (range, 27–75). One patient (7.8%) had locally advanced disease, and 5 patients (38.5%) retained primary gastric cancer. Main disease sites included lymph nodes (100%) and liver (23.1%). A total of 60 cycles were administered (median 6; range, 2–6). All 13 patients were evaluable for efficacy with 3 complete and 2 partial responses (ORR 38.5%; 95% CI, 13.9%-68.4%). Stable disease occurred in 3 patients (23.1%). G3 toxicities were neutropenia (30.8%), vomiting, hepatic toxicities and leucopenia (7.7%) each; no G4 toxicity were found. Conclusions: This interim analysis suggests that the activity and tolerability of the combination in advanced gastric cancer is very promising. Study accrual was ended in October 2005, and final results will be presented at the meeting. No significant financial relationships to disclose.

Camrelizumab combined with capecitabine and oxaliplatin followed by camrelizumab and apatinib as first-line therapy for advanced or metastatic gastric or gastroesophageal junction cancer: Updated results from a multicenter, open label phase II trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4031-4031 ◽  
Author(s):  
Lin Shen ◽  
Zhi Peng ◽  
Yan-Qiao Zhang ◽  
Jia Wei ◽  
Feng Wang ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
Objective Response ◽  
Progression Free Survival ◽  
Sequential Therapy ◽  
Metastatic Gastric Cancer ◽  
First Line ◽  
Open Label ◽  
First Line Therapy ◽  
Line Therapy ◽  
Open Label Phase

4031 Background: Capecitabine plus oxaliplatin (CAPOX) is one of the standard first-line treatments for advanced or metastatic gastric cancer. Camrelizumab (SHR-1210, an anti–PD-1 antibody) shows promising anti-tumor activity in patients (pts) with advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer. Camrelizumab combined with CAPOX for untreated G/GEJ cancer was assessed as a part of an ongoing multicenter, open-label phase 2 trial (cohort 1), and encouraging preliminary results were reported. Here, we present the updated safety and efficacy data. Methods: In this cohort, systemic treatment naïve pts with HER2– advanced or metastatic G/GEJ adenocarcinoma were given camrelizumab 200 mg on Day 1, capecitabine 1000 mg/m2 bid on Days 1–14 and oxaliplatin 130 mg/m2 on Day 1 of each 21-day-cycle for 4 to 6 cycles followed by camrelizumab 200 mg every 3 weeks plus apatinib 375 mg qd until disease progression or intolerable toxicity. The primary endpoint was objective response rate. Results: At data cutoff (Jan 20, 2019), 43 of the 48 enrolled pts were evaluable. Partial response was observed in 28 pts (65%), and 19 (44%) were confirmed. Stable disease in 14 pts and progressive disease in 10 pts were reported. Median estimates for duration of response and progression-free survival were not reached. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 9 pts (21%), included neutropenia, diarrhea, rash and elevated ALT, whereas none of the TRAEs was fatal. Ten pts without progression after 4–6 cycles of camrelizumab and CAPOX combination therapy all received camrelizumab plus apatinib as sequential therapy, and no new safety signals were observed. Conclusions: The updated results confirmed that camrelizumab plus CAPOX followed by camrelizumab plus apatinib was well tolerated with noteworthy responses as first-line therapy in advanced or metastatic G/GEJ cancer pts. Expansion of this cohort in a phase 3 study are under way. Clinical trial information: NCT03472365.

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