scholarly journals An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202)

2020 ◽  
Vol 12 ◽  
pp. 175883592090542
Author(s):  
Xiang Wang ◽  
Ruixing Zhang ◽  
Nan Du ◽  
Mudan Yang ◽  
Aimin Zang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Progression Free Survival ◽  
High Dose ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Grade 3 ◽  
Gastric Cancer Patients ◽  
Noninterventional Study

Background: Apatinib has been proved to be effective and well tolerated among patients in phase II and III studies. Here, we evaluated the safety and effectiveness of apatinib in advanced gastric cancer patients in a real-world setting. Methods: This study enrolled advanced gastric cancer patients who had progressed or relapsed despite systemic chemotherapy. The primary outcome was safety and the secondary outcomes included overall survival (OS) and progression-free survival (PFS). Results: A total of 337 patients were included. In total, 62 (18.4%), 102 (30.3%), and 173 (51.3%) patients received first, second, and third or higher line apatinib therapy, respectively. Grade 3/4 treatment-emergent adverse events (AEs) were infrequent (<5%), with hypertension (6.8%) being the only grade 3/4 AE occurring in more than 5% of the patients and across the low-dose (250 mg, 7.3%), mid-dose (425–500 mg, 6.1%), and high-dose group (675–850 mg, 2/15, 13.3%). The median OS and PFS were 7.13 months (95% CI, 6.17–7.93) and 4.20 months (95% CI, 4.60–4.77), respectively, and were comparable among the low-, mid-, and high-dose groups. Conclusion: Lower daily doses of apatinib achieved comparable OS and PFS versus higher daily doses of apatinib while maintaining a more benign safety profile in advanced gastric cancer patients. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT02668380.

Postoperation chemotherapy with S1 and docetaxel in curatively resected gastric cancer of stage III (POST trial).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS4142-TPS4142
Author(s):  
Minkyu Jung ◽  
Seok Yun Kang ◽  
Bong-Seog Kim ◽  
Ki Hyang Kim ◽  
Kyung Hee Lee ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Open Label ◽  
Post Trial ◽  
Gastric Cancer Patients

TPS4142 Background: Complete surgical resections remains the only chance for cure in patients with gastric cancer, but approximately from 40% to 80% of patients still have recurrences and most patients ultimately die from their disease. The recent adjuvant trials in gastric cancer showed significantly improved survival in patients with adjuvant chemotherapy than those with surgery alone. However, further studies need for the effect of adjuvant chemotherapy following D2 dissected gastric cancer patients, especially in advanced gastric cancer. S-1 is an oral anticancer drug, a prodrug of fluorouracil, very effective in gastric cancer. Docetaxel is the first drug that showed survival benefits when added to the two drugs in advanced gastric cancer patients. And docetaxel is also synergistic anti-cancer effect with S-1 in advanced gastric cancer. Base on this background, the aim of this study is to detect a significant increase in 3 –year disease free survival (DFS) of adjuvant chemotherapy with docetaxel and S-1(DS) relative to those with S-1 and cisplatin (SP) in patients with stage III gastric cancer Methods: This study is an open-label, phase 3, randomized controlled trial, multicenter in South Korea. Patients with stage III (AJCC 7th edition) gastric cancer who had had curative D2 gastrectomy is randomly assigned to receive adjuvant chemotherapy of eight 3-week cycles of intravenous docetaxel (35 mg/m2 on day 1 and 8 of each cycle) plus oral S-1 (35 mg/m2 twice daily on days 1 to 14 of each cycle) for 6 months (DS) or chemotherapy of eight 3-week cycles of oral S1 plus intravenous cisplatin (60 mg/m2). After satisfying the screening criteria, patients have been randomized to the SD or SP arm in a 1:1 ratio. The randomization is stratified by institution and stage of disease (IIIA vs. IIIB vs. IIIC). The each stratum has been randomized by using the method of randomly permuted block. The primary endpoint is 3 year DFS, will analyze by intention to treat. A total of 290 patients will be enrolled, 67 patients have been treated to day, with continuing accrual. The trial is registered at ClinicalTrials.gov (NCT01283217).

Phase III Study of Docetaxel and Cisplatin Plus Fluorouracil Compared With Cisplatin and Fluorouracil As First-Line Therapy for Advanced Gastric Cancer: A Report of the V325 Study Group

2006 ◽  
Vol 24 (31) ◽  
pp. 4991-4997 ◽  
Author(s):  
Eric Van Cutsem ◽  
Vladimir M. Moiseyenko ◽  
Sergei Tjulandin ◽  
Alejandro Majlis ◽  
Manuel Constenla ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Risk Reduction ◽  
Cancer Patients ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Iii ◽  
First Line Therapy ◽  
Grade 3 ◽  
Gastric Cancer Patients

Purpose In the randomized, multinational phase II/III trial (V325) of untreated advanced gastric cancer patients, the phase II part selected docetaxel, cisplatin, and fluorouracil (DCF) over docetaxel and cisplatin for comparison against cisplatin and fluorouracil (CF; reference regimen) in the phase III part. Patients and Methods Advanced gastric cancer patients were randomly assigned to docetaxel 75 mg/m2 and cisplatin 75 mg/m2 (day 1) plus fluorouracil 750 mg/m2/d (days 1 to 5) every 3 weeks or cisplatin 100 mg/m2 (day 1) plus fluorouracil 1,000 mg/m2/d (days 1 to 5) every 4 weeks. The primary end point was time-to-progression (TTP). Results In 445 randomly assigned and treated patients (DCF = 221; CF = 224), TTP was longer with DCF versus CF (32% risk reduction; log-rank P < .001). Overall survival was longer with DCF versus CF (23% risk reduction; log-rank P = .02). Two-year survival rate was 18% with DCF and 9% with CF. Overall response rate was higher with DCF (χ2 P = .01). Grade 3 to 4 treatment-related adverse events occurred in 69% (DCF) v 59% (CF) of patients. Frequent grade 3 to 4 toxicities for DCF v CF were: neutropenia (82% v 57%), stomatitis (21% v 27%), diarrhea (19% v 8%), lethargy (19% v 14%). Complicated neutropenia was more frequent with DCF than CF (29% v 12%). Conclusion Adding docetaxel to CF significantly improved TTP, survival, and response rate in gastric cancer patients, but resulted in some increase in toxicity. Incorporation of docetaxel, as in DCF or with other active drug(s), is a new therapy option for patients with untreated advanced gastric cancer.

Outcome of advanced gastric cancer patients with disseminated intravascular coagulation and bone marrow metastasis is improved by weekly 24-Hour infusional high-dose 5-fluorouracil and leucovorin (HDFL)-based chemotherapy

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14132-14132
Author(s):  
T. Huang ◽  
C. Hsu ◽  
A. Cheng ◽  
K. Yeh
Keyword(s):  
Gastric Cancer ◽  
Bone Marrow ◽  
Treatment Outcome ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Disseminated Intravascular Coagulation ◽  
High Dose ◽  
Disease Entity ◽  
Bone Marrow Metastasis ◽  
Gastric Cancer Patients

14132 Background: Advanced gastric cancer (AGC) patients manifesting with acute disseminated intravascular coagulation (DIC) and diffuse bone marrow metastasis have inevitably led a fatal outcome within a median of 2–4 weeks. We previously reported that weekly 24-hour infusional high-dose 5-fluorouracil (5-FU) and leucovorin (LV) (HDFL: 5-FU of 2,000–2,600 mg/m2/wk and LV 300 mg/m2/wk) chemotherapy with negligible myelosuppression has been successfully used in the treatment of these patients (Yeh KH & Cheng AL, Br J Haematol 1998;100:769–72). The study planned to determine the treatment outcome in a larger group of this disease entity being treated with HDFL-based chemotherapy. Methods: This is a retrospective study. Bone marrow study is routinely done for gastric cancer patients with DIC in our institute. We searched for gastric cancer patients with DIC or bone marrow metastasis from 1994 to 2005. Results: A total of 21 AGC patients (M: 13, F: 8) who had unequivocal evidence of DIC or biopsy-proven bone marrow metastasis have been diagnosed at National Taiwan University Hospital between 1994 and 2005. At initial presentations, 18 patients had evident laboratory findings of DIC. Nine of them had symptomatic DIC and 8 patients had significant thrombocytopenia (< 50,000/mm3). All patients received HDFL-based chemotherapy as the initial treatment. Seventeen of them showed significant improvement in both clinical symptoms and laboratory abnormalities of DIC. The median overall survival (OS) of the whole group of patients since the diagnosis of DIC or bone marrow metastasis was 7 months (range: 1 week–3 years). Conclusions: Manifestations with acute DIC and bone marrow metastasis in AGC patients constitute a rare disease entity with a grave prognosis. Before introduction of HDFL for the treatment of AGC at our institute, this group of patients was extremely difficult to treat, and usually died within 2–4 weeks. Current analysis revealed that OS of this group of patients has been improved up to a median of 7 months, suggesting a significant improvement in the treatment outcome. No significant financial relationships to disclose.

Polymorphism of nucleotide excision repair genes as predictors for clinical outcome in advanced gastric cancer patients treated with oxaliplatin-based chemotherapy

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4565-4565
Author(s):  
H. Hur ◽  
K. Song ◽  
C. Park ◽  
Y. Hong ◽  
H. Chun ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Excision Repair ◽  
Predictive Marker ◽  
Hematologic Toxicity ◽  
Nucleotide Excision ◽  
Grade 3 ◽  
Gastric Cancer Patients ◽  
Repair Genes

4565 Background: The individual variations in treatment response and the toxicity of combination regimen of oxaliplatin and 5-fluorouracil with leucovorin (FOLFOX) for advanced gastric cancer patients have been reported. The aim of this study is to evaluate the influence of polymorphism of nucleotide excision repair genes that are involved in the metabolism of cisplatin on the clinical outcomes of gastric cancer patients treated with modified FOLFOX-6 chemotherapy. Methods: From March 2006 to December 2007, eighty-two patients with advanced gastric cancer were treated with modified FOLFOX-6 as the primary chemotherapy in our institution. Of these patients, 55 patients who were available for peripheral blood sampling before starting chemotherapy were enrolled in this study. Genomic DNA was extracted from mononuclear cells of patients’ blood. Four polymorphisms were investigated in three genes, ERCC, GSTP and XRCC. Results: The overall response rate (RR) was 40.0%. Median time to progression (TTP) and overall survival (OS) was 6 months (C.I.: 5.0 - 7.0 months) and 15.0 months (C.I.: 9.7 - 20.3 months). Grade 3 or 4 hematologic toxicities were presented in 17 patients (30.9%), gastrointestinal toxicities in 5 patients (9.1%), peripheral neuropathy in 5 patients (9.1%) and hepato-toxicity in 4 patients (7.3%). Most common types of polymorphism were G/G (67.3%) in XRCC1 Arg399Gln, A/A (74.5%) in GSTP1 Ile105Val, C/C (60.0%) in ERCC1 Asn118Asn and C/A (49.1%) in ERCC1 C8092A. The RR was significantly lower in patients with C/C type in ERCC1 C8092A gene than those with other type (25.0% vs 51.6%, p=0.046). However, there were no differences of TTP and OS among the polymorphisms in three genes. The rate of grade 3 or 4 hematologic toxicity was higher in patients with C/T or T/T in ERCC1 codon 118 gene than those with C/C type (45.5% vs 21.2%, p=0.057). Conclusions: We demonstrated that modified FOLFOX-6 chemotherapy was effective and tolerable. The polymorphism of C/C type in ERCC1 C8092A gene was found to be a predictive marker of the poor response and C/C type in ERCC1 Asn118Asn gene was to be a predictive marker of the hematologic toxicity. No significant financial relationships to disclose.

Serum VEGF Per Platelet Count as a Prognosis Predicting Factor in Advanced Gastric Cancer Patients

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5467-5467
Author(s):  
Byung Soo Kim ◽  
Chul Won Choi ◽  
Seok Jin Kim
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Platelet Count ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
Free Survival ◽  
Control Serum ◽  
Gastric Cancer Patients

Abstract Background: New blood vessel formation is a crucial step in the process of tumor growth and systemic metastasis. Recent studies have shown that VEGF expression not in tissues but in serum sample is correlated with tumor vascularity, and the high serum VEGF levels could predict poor prognosis in cancer patients. However there has been no data regarding the clinical and prognostic significance of serum VEGF levels per platelet count in advanced gastric cancer. In this study, we conducted a study to evaluate the prognostic implication of serum VEGF per platelet count in the patients with advanced gastric cancer. Methods: 111 patients with histologically confirmed gastric cancer, 35 patients with early gastric cancer were included and control serum samples were acquired from 25 healthy volunteers. The levels of VEGF were measured using human VEGF quantitative enzymelinked immunosorbent assay (ELISA). Survival curves were calculated using the Kaplan-Meier method and survival comparisons were made by the log rank test in metastatic gastric cancer. The Cox proportional hazards regression model was utilized for multivariate analyses after univariate analysis defined relevant prognostic variables. Results: The mean serum VEGF level was higher in the patients of AGC compared to those with EGC and controls (AGC 465 ± 315.8pg/ml; EGC 306 ± 97.8 pg/ml controls 230.8 ± 53.2 pg/ml, P&lt; 0.033). A trend toward a significant positive correlation between serum VEGF and platelet counts was observed in patients of AGC (r = 0.477, P = 0.000, Fig 2) and there was a significant correlation between serum VEGF levels and differentiation of tumor (p = 0.014), stage (p = 0.036). The overall survival (log rank, p =0.0432) and the progression free survival (median 4.5 vs. 8.9 months; log rank, p =0.0116) were significantly shorter in patients with high VEGF per platelet count (≥1.626 pg/106). In the multivarivate analysis, performance status (P=0.025), the presence of peritoneal carcinomatosis (P=0.006), serum VEGF per platelet (P=0.005) were found to be significantly associated with the short progression free survival Conclusions: This study demonstrated that serum VEGF per platelet count is correlated with short overall survival and progression free survival in advanced gastric cancer patients. Therefore, serum VEGF per platelet may be a useful marker for predicting the prognosis of advanced gastric cancer patients.

scholarly journals Prognostic Role of RASSF1A, SOX17 and Wif-1 Promoter Methylation Status in Cell-Free DNA of Advanced Gastric Cancer Patients

2021 ◽  
Vol 20 ◽  
pp. 153303382097327
Author(s):  
Evangelos I. Karamitrousis ◽  
Ioanna Balgkouranidou ◽  
Nikolaos Xenidis ◽  
Kyriakos Amarantidis ◽  
Eirini Biziota ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Methylation Status ◽  
Progression Free Survival ◽  
Cell Free Dna ◽  
Free Survival ◽  
Free Dna ◽  
Gastric Cancer Patients

Epigenetic modification of several genes is a key component in the development of gastric cancer. The methylation status of RASSF1A, SOX17 and Wif-1 genes was evaluated in the cell free circulating DNA of 70 patients with advanced gastric cancer, using methylation-specific PCR. Patients with higher cell-free DNA concentration seem to have lower PFS, than patients with lower cell-free DNA concentration (p = 0.001). RASSF1A was the tumor suppressor gene, most frequently methylated in metastatic gastric cancer patients, followed by SOX17 and Wif-1 (74.3%, 60.0% and 47.1%, respectively). Patients having the SOX17 promoter methylated, had lower progression free survival and overall survival, than unmethylated ones (p < 0.001). Patients having the Wif-1 promoter methylated, had lower progression free survival and overall survival, than unmethylated ones (p = 0.001). Patients having the RASSF1A promoter methylated, had lower progression free survival and overall survival, than unmethylated ones (p = 0.004). Promoter methylation of the examined genes was significantly associated with a decrease in progression free survival and overall survival, comparing to that of patients without methylation. Simultaneous methylation of the above genes was associated with even worse progression free survival and overall survival. The methylation of RASSF1A, SOX-17 and Wif-1 and genes, is a frequent epigenetic event in patients with advanced gastric cancer.

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