scholarly journals Case report of the rapid achievement of sustained and long-term remission resulting from the use of ramucirumab plus paclitaxel in the second-line treatment of a patient with disseminated gastric adenocarcinoma

2018 ◽  
pp. 150-153
Author(s):  
T. A. Titova ◽  
N. S. Besova ◽  
V. A. Gorbunova ◽  
Yu. P. Kuvshinov ◽  
A. A. Filatov ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
High Efficiency ◽  
Performance Status ◽  
Gastroesophageal Junction ◽  
Growth Factor Receptor ◽  
Metastatic Gastric Cancer ◽  
Best Supportive Care ◽  
Serious Adverse Events ◽  
Endothelial Growth Factor

Ramucirumab is a monoclonal antibody targeting vascular endothelial growth factor receptor 2. In two randomised clinical trials Ramucirumab either alone or in combination with paclitaxel has been found to be safe and effective for patients with previously treated advanced gastric cancer. One of the serious adverse events associated with ramucirumab is bleeding.We report the case of a 56-year-old man with advanced gastric cancer located at the gastroesophageal junction with liver, pulmonary and multiple lymph node metastases, plevritis was treated with a paclitaxel plus Ramucirumab regimen. We demonstrate a case of a cardioesophageal junction bleeding due to the high efficiency of treatment. He was successfully treated with by applying only hemostatical therapy, but after stop the bleeding chemotherapy was not reintroduced. The partial response was maintained for approximately 10 months. The patient died on 28 November 2017.Chemotherapy with best supportive care for metastatic gastric cancer shown the improvement the performance status, help keep the cancer under control and help relieve symptoms during the time.

Safety and efficacy of apatinib as third or later line treatment for advanced gastric cancer or gastroesophageal junction adenocarcinoma: A post-marketing phase IV study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16034-e16034
Author(s):  
Jin Li ◽  
Shukui Qin ◽  
Lu Wen ◽  
Junsheng Wang ◽  
Wenying Deng ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Performance Status ◽  
Gastroesophageal Junction ◽  
Line Treatment ◽  
Ecog Performance Status ◽  
Safety And Efficacy ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Grade 3 ◽  
Phase Iv

e16034 Background: Apatinib, a small molecule multi-target tyrosine kinase inhibitor with high selectivity for VEGFR-2, has been approved for the treatment of advanced gastric cancer or gastroesophageal adenocarcinoma in China by significantly improving progression-free survival (PFS) and overall survival (OS). Here, we report safety and efficacy data from an open-label, single-arm, multicenter, phase IV trial of apatinib as a third-line or later line treatment for advanced gastric cancer. Methods: Eligible patients had histologically or cytologically confirmed advanced gastric cancer or gastroesophageal junction adenocarcinoma; and an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2; and adequate haematological and hepatic function; and failure of at least two lines of chemotherapy. Patients received oral apatinib until disease progression, death or unacceptable toxicity. The primary endpoint was safety, and secondary endpoints included PFS and OS. Results: The intention-to-treat population (ITT) included 2004 patients. At baseline, the median age was 59 (range, 19-85) years, ECOG performance status of 0/1/2 (%) was 15.4/68.8/15.1, and stage III/IV was 3.5/96.4; 98.8% had metastases, and among which metastatic foci≤2/ > 2 was 64.5/34.2 (%), respectively. 89.6% of the patients were given apatinib 500mg as the initial does and the median treatment duration was 56 days. After a median follow-up of 126.5 days, adverse events (AEs) occurred in 95.1% of the patients and 70.3% were grade ≥3. 87.9% of the patients experienced treatment-related AEs (TRAEs), of which 51% had grade ≥3, 12.3% and 16.8% reduced dose and discontinued the treatment, respectively. 57 (2.9%) TRAEs-related deaths were reported, mainly because of gastrointestinal bleeding (16 cases), upper gastrointestinal haemorrhage (7), cerebral haemorrhage (2), and gastric perforation (1). The incidence of TRAEs of special interest was 74.3%; 38.1% of patients developed grade≥3, mainly including hypertension (26.3%), bleeding (5.1%), proteinuria (4.5%), and hand-foot syndrome (3.1%). In an ITT population, median PFS was 2.7 months (95%CI 2.23-2.79) and median OS was 5.8 months (95% CI 5.42-6.11). Conclusions: This study confirms that apatinib has a well-established and manageable safety profile and survival benefit as third or later line therapy for patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma. Clinical trial information: NCT02426034.

Oxaliplatin/CF/5-FU versus paclitaxel/CF/5-FU in patients with advanced gastric cancer: A phase II clinical trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14014-14014
Author(s):  
T. Lin ◽  
F. Xu ◽  
S. Wang ◽  
Y. He ◽  
W. Tian ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Survival Time ◽  
Advanced Gastric Cancer ◽  
Median Survival ◽  
Median Survival Time ◽  
Performance Status ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Tumor Control ◽  
Tumor Control Rate

14014 Background: Although many randomized trials of chemotherapy for advanced gastric cancer have been reported during the past two decades, no standard regimens worldwide have been established yet. Now Paclitaxel and Oxaliplatin have shown promising activity in advanced gastric cancer. We prospectively evaluated toxicity, efficacy and survival of Oxaliplatin /CF/5-FU versus Paclitaxel/CF/5-FU. Methods: Metastatic or locally advanced gastric cancer; performance status (PS) 0–2. Patients (pts) were enrolled and randomized into arm A with Oxaliplatin 100mg/m2, 5-FU 400 mg/m2 bolus, FA 200 mg/m2 2h, 5-FU 2500 mg/m2 46h, q2w or into arm B with Paclitaxel 80 mg/m2, 5-FU 400 mg/m2 bolus, FA 200 mg/m2 2h, 5-FU 2500 mg/m2 46h, q2w. Results: From 2000 to 2005, (A/B) 46/43 pts were enrolled into this study. Median age (52/50 y), gender, PS, localization and numbers of metastatic sites were comparable for both arms. Pts who were not chemotherapy naive in A/B (% of pts) were 41.3/33.3. All pts were eligible and evaluable for toxicity and response. Overall response (CR+PR) rate for A/B (% of pts): 37.0/47.2 (p<0.05), tumor control rate (CR+PR+SD) 76.1/69.4(p<0.05). Median time to progression (TTP) were for A/B: 6.0 and 3.2 months. And median survival time for A/B were 13.4 and 13.8 months. Grade 3/4 toxicities were for A/B (% of pts): neutropenia 10.9/5.6, thrombocytopenia 4.3/2.8, anemia 0/2.8, vomiting 8.7/2.8, neurotoxic 0/2. No treatment-related death occurred in A/B. Conclusions: Oxaliplatin /CF/5-FU and Paclitaxel/CF/5-FU are both effective and safe in advanced or metastatic gastric cancer. Though Oxaliplatin /CF/5-FU had better tumor control rate and median TTP, there was no difference between the arms in the median survival time. No significant financial relationships to disclose.

scholarly journals RAMUCIRUMAB THERAPY IN PATIENTS WITH ADVANCED GASTRIC AND GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA: A SYSTEMATIC REVIEW

2017 ◽  
Vol 22 (3) ◽  
pp. 116-121
Author(s):  
V. A Gorbounova ◽  
N. S Besova ◽  
M. B Bychkov ◽  
S. V Orlov ◽  
L. M Kogoniya ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Growth Factor Receptor ◽  
Predictive Biomarkers ◽  
Antiangiogenic Agents ◽  
Gastroesophageal Cancer ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
American Society ◽  
Endothelial Growth Factor

Objective. Gastric cancer is the fifth most common malignancy and the third leading cause of the cancer mortality worldwide. It is most often diagnosed at a locally advanced or metastatic stage. Angiogenesis has become an important target in the treatment of solid tumors, and antiangiogenic agents are a promising approach to cancer therapy. In this review, we summarize the current literature on the treatment of gastric and gastroesophageal cancer with ramucirumab, an antiangiogenic agent specifically targeting vascular endothelial growth factor receptor-2 (VEGFR-2). Material and methods. We conducted a systematic search in May 2016 of PubMed and relevant congress proceedings including the American Society of Clinical Oncology, the European Society for Medical Oncology, and the European Cancer Congress. Included studies were aimed to prospectively evaluate the efficacy and safety of ramucirumab in advanced gastric or gastroesophageal cancer. Results. Our search yielded 91 publications including 5 manuscripts and 6 congress abstracts meeting the predefined inclusion criteria. Included studies reported outcomes were related to ramucirumab in gastric cancer, published within the past 5 years. Conclusion. Second-line treatment with ramucirumab, either as monotherapy or in combination with paclitaxel, significantly improves the survival of patients with advanced gastric cancer. Ramucirumab is well tolerated and has an acceptable safety profile. Furthermore, the patient quality of life is maintained with delayed both symptom worsening and deterioration of the functional status. Studies are required to identify potential predictive biomarkers of ramucirumab efficacy.

scholarly journals A Case Report of Ischemic Stroke in a Patient with Metastatic Gastric Cancer Secondary to Treatment with the Vascular Endothelial Growth Factor Receptor-2 Inhibitor Ramucirumab

2016 ◽  
Vol 9 (2) ◽  
pp. 317-320 ◽  
Author(s):  
Michael E. Christiansen ◽  
Timothy Ingall ◽  
Edward C. Lew ◽  
Ramesh K. Ramanathan ◽  
Harshita R. Paripati
Keyword(s):  
Gastric Cancer ◽  
Vascular Endothelial Growth Factor ◽  
Growth Factor ◽  
Case Reports ◽  
Growth Factor Receptor ◽  
Metastatic Gastric Cancer ◽  
Vascular Endothelial ◽  
First Case ◽  
Endothelial Growth Factor

Ramucirumab is an antiangiogenesis agent targeting the vascular endothelial growth factor receptor-2 (VEGFR-2), approved to treat advanced gastric and colon cancer. In clinical trials, it was shown to cause a small increase in arterial thromboembolism compared to placebo, including cerebral and myocardial ischemia, which was not statistically significant. Detailed case reports are lacking and we here present one of the first case reports of stroke secondary to ramucirumab-induced in situ thrombosis.

Pembrolizumab (pembro) versus standard of care chemotherapy (chemo) in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Asian subgroup analysis of KEYNOTE-062.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4523-4523 ◽  
Author(s):  
Hironaga Satake ◽  
Keun Wook Lee ◽  
Hyun Cheol Chung ◽  
Jeeyun Lee ◽  
Kensei Yamaguchi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Performance Status ◽  
Gastroesophageal Junction ◽  
Objective Response ◽  
Asian Population ◽  
Progression Free Survival ◽  
Ecog Performance Status ◽  
End Points ◽  
Asian Patients

4523 Background: First-line treatment with pembro or pembro + chemo vs chemo alone was evaluated in patients with PD-L1 combined positive score (CPS) ≥1, HER2-negative advanced gastric cancer in the randomized, active-controlled, phase 3 KEYNOTE-062 study (NCT02494583). We present results from the Asian subpopulation receiving pembro monotherapy or chemo. Methods: Eligible patients were randomly assigned 1:1:1 to pembro 200 mg, pembro + chemo (cisplatin + 5-FU or capecitabine), or placebo + chemo every 3 weeks for ≤35 cycles (~2 years). Randomization was stratified by region, disease status, and fluoropyrimidine treatment. Primary end points for this analysis were overall survival (OS) in patients with CPS ≥1 and patients with CPS ≥10; progression-free survival (PFS) and objective response rate (ORR) were exploratory end points. Data cutoff was March 26, 2019. Results: Globally, 256 patients received pembro monotherapy and 250 received chemo. Pembro was noninferior to chemo for OS in CPS ≥1 per prespecified margins (median OS, 10.6 vs 11.1 months, respectively; HR [99.2% CI], 0.91 [0.69-1.18]). In the Asian population 62 patients received pembro and 61 received chemo; 26 and 22 had CPS ≥10 (Table). Compared with the global population, Asian patients had a higher proportion of ECOG performance status 0, more diagnoses of stomach cancer, and a greater proportion with 0-2 metastatic sites. Median OS was longer with pembro than chemo using both CPS cutoffs (HR [95% CI]: CPS ≥1, 0.54 [0.35-0.82]; CPS ≥10, 0.43 [0.21-0.89]); 12- and 24-month OS rates were higher for pembro using both CPS cutoffs (12-month OS: CPS ≥1, 69% vs 54%; CPS ≥10, 81% vs 68%; 24-month OS: CPS ≥1, 45% vs 23%; CPS ≥10, 54% vs 27%). The HR (95% CI) for PFS was 1.11 (0.76-1.64) for CPS ≥1 and 0.71 (0.36-1.39) for CPS ≥10. Conclusions: In Asian patients with advanced gastric cancer, OS favored pembro in patients with CPS ≥1 and CPS ≥10. Clinical trial information: NCT02494583 . [Table: see text]

S-1+oxaliplatin with pembrolizumab for advanced gastric cancer: The cohort 1 in a phase IIb KEYNOTE-659 study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 382-382
Author(s):  
Hisateru Yasui ◽  
Akihito Kawazoe ◽  
Kensei Yamaguchi ◽  
Yuji Negoro ◽  
Mizutomo Azuma ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Performance Status ◽  
Growth Factor Receptor ◽  
Progression Free Survival ◽  
Median Number ◽  
First Line ◽  
Ecog Performance Status ◽  
Duration Of Response ◽  
Grade 3

382 Background: The KEYNOTE-059 study showed the preliminary antitumor activity and tolerability of chemotherapy with pembrolizumab (P) for advanced gastric cancer (AGC). In Japan, S-1 + platinum regimen is a standard chemotherapy for AGC. The KEYNOTE-659 study (NCT03382600) investigated the efficacy and safety of S-1 + oxaliplatin (SOX; cohort 1) or cisplatin (SP; cohort 2) with P as the first line treatment in patients (pts) with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1 (PD-L1)-positive AGC. Here, we report the results of cohort 1. Methods: The key inclusion criteria were as follows: age ≥18 to ≤75 years; an ECOG performance status of 0 or 1; and chemotherapy-naïve, HER2-negative and PD-L1-positive AGC. PD-L1 positivity was defined as a combined positive score of ≥1 using the IHC 22C3 PharmDx assay. An S-1 dose of 40-60 mg per dose was orally administered, twice daily, for the first 2 weeks of a 3-week cycle. P (200 mg) and oxaliplatin (OX; 130 mg/m2) were administered on day 1 of each cycle. The primary endpoint was overall response rate (ORR) that was assessed by a blinded independent central review (BICR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety. Results: From April to September 2018, 54 pts were enrolled at 25 sites in Japan. The median follow-up time was 10.1 months. The median number of P doses and cycles in SOX were 9 (range, 2-18) and 6 (range, 2-13), respectively. The relative dose intensities of S-1 and OX were 73% and 60%, respectively. The ORR and DCR assessed by BICR were 72.2% (95% CI 58.4-83.5) and 96.3% (95% CI 87.3-99.5), respectively. The median PFS was 9.4 months (95% CI 6.6-NR). Median DOR and OS were not reached. Grade ≥3 adverse events (AEs) were reported in 31 pts (57.4%). The most common treatment-related AEs of grade ≥3 were thrombocytopenia (14.8%), neutropenia (13.0%), colitis (7.4%), and adrenal insufficiency (5.6%). There were no treatment-related deaths. Conclusions: This study showed the encouraging efficacy and manageable safety of SOX with P therapy as a first line in pts with HER2-negative, PD-L1-positive AGC. Clinical trial information: NCT03382600.

Recent Strategies for Treating Stage IV Gastric Cancer: Roles of Palliative Gastrectomy, Chemotherapy, and Radiotherapy

2016 ◽  
Vol 25 (1) ◽  
pp. 87-94 ◽  
Author(s):  
Kunihiko Izuishi ◽  
Hirohito Mori
Keyword(s):  
Gastric Cancer ◽  
Performance Status ◽  
Locally Advanced ◽  
Growth Factor Receptor ◽  
Stage Iv ◽  
Stage Iv Gastric Cancer ◽  
Palliative Gastrectomy ◽  
Advanced Tumor ◽  
Esophagogastric Cancer ◽  
Previously Treated

Recently, many strategies have been reported for the effective treatment of gastric cancer. However, the strategy for treating stage IV gastric cancer remains controversial. Conducting a prospective phase III study in stage IV cancer patients is difficult because of heterogeneous performance status, age, and degree of cancer metastasis or extension. Due to poor prognosis, the variance in physical status, and severe symptoms, it is important to determine the optimal strategy for treating each individual stage IV patient. In the past decade, many reports have addressed topics related to stage IV gastric cancer: the 7th Union for International Cancer Control (UICC) TNM staging system has altered its stage IV classification; new chemotherapy regimens have been developed through the randomized ECF for advanced and locally advanced esophagogastric cancer (REAL)-II, S-1 plus cisplatin versus S-1 in RCT in the treatment for stomach cancer (SPIRITS), trastuzumab for gastric cancer (ToGA), ramucirumab monotherapy for previously-treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD), and ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously-treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW) trials; and the survival efficacy of palliative gastrectomy has been denied by the reductive gastrectomy for advanced tumor in three Asian countries (REGATTA) trial. Current strategies for treating stage IV patients can be roughly divided into the following five categories: palliative gastrectomy, chemotherapy, radiotherapy, gastric stent, or bypass. In this article, we review recent publications and guidelines along with above categories in the light of individual symptoms and prognosis. Abbreviations: APC: argon plasma coagulation; AVAGAST: anti-angiogenic antibody bevacizumab, the avastin in gastric cancer; BSC: best supportive care; CF: cisplatin and fluorouracil; CRP: C-reactive protein; DCF: docetaxel, cisplatin, and 5-FU; FISH: fluorescent in-situ hybridization; GJ: gastrojejunostomy; GPS: Glasgow Prognostic Score; HER: human epidermal growth factor receptor; HR: hazard ratio; NLR: neutrophil-to-lymphocyte ratio; OS: overall survival; PS: performance status; QOL: quality of life; RAINBOW: ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously-treated advanced gastric or gastro-oesophageal junction adenocarcinoma; RCTs: randomized controlled trials; REAL: randomized ECF for advanced and locally advanced esophagogastric cancer; REGARD: ramucirumab monotherapy for previously-treated advanced gastric or gastro-oesophageal junction adenocarcinoma; REGATTA: reductive gastrectomy for advanced tumor in three Asian countries; SEER: Surveillance Epidemiology and End Results; SEMS: self-expandable metal stents; SPIRITS: S-1 plus cisplatin versus S-1 in RCT in the treatment for stomach cancer; ToGA: trastuzumab for gastric cancer; TTP: time-to-progression; VEGFR: vascular endothelial growth factor receptor.

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