Multicenter Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Shah, Manish A.; Ramanathan, Ramesh K.; Ilson, David H.; Levnor, Alissa; D’Adamo, David R.; O’Reilly, Eileen M.; Tse, Archie; Trocola, R.; Schwartz, Lawrence; Capanu, Marinela; Schwartz, Gary K.; Kelsen, David P.

doi:10.1200/jco.2006.08.0887

Cited by 368 publications

(205 citation statements)

References 27 publications

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“…However, in order to further improve treatment results in this disease, the addition of targeted therapy to cytotoxic agents should be considered. In two recent phase II trials, the combination of irinotecan, cisplatin and bevacizumab (Shah et al, 2006), and cetuximab combined with FOLFIRI (Pinto et al, 2007), both produced encouraging results with TTP and OS remarkably improved over historical controls. In this context, the IDO regimen, with its activity and safety profile, could be a good candidate to enhance survival in metastatic gastric or GEJ cancer patients.…”

Section: Discussionmentioning

confidence: 99%

Irinotecan, docetaxel and oxaliplatin combination in metastatic gastric or gastroesophageal junction adenocarcinoma

Lauro¹,

Nunziata

Arena

et al. 2007

Br J Cancer

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This phase II study was designed to evaluate the activity and safety of a combination of irinotecan, docetaxel and oxaliplatin in metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Forty patients with measurable distant metastasis received irinotecan 150 mg m À2 and docetaxel 60 mg m À2 on day 1, and oxaliplatin 85 mg m À2 on day 2. Cycles were repeated every 3 weeks. The primary end point was to demonstrate a 50% improvement in time-to-progression (TTP) over historical controls. All patients were evaluable. Median TTP was 6.5 months (95% confidence interval (CI) 5.6 -7.4), the overall response rate was 50% (95% CI 35 -65%) and the median overall survival was 11.5 months (95% CI 8.7 -14.3). Grade 3/4 neutropaenia occurred in 47.5% of patients. There were four episodes of febrile neutropaenia in three patients. Other non-haematological grade 3 toxicities included diarrhoea in four patients (10%), vomiting in three patients (7.5%) and mucositis in two patients (5%). The irinotecan, docetaxel and oxaliplatin combination chemotherapy is an active and well-tolerated novel regimen for treating metastatic gastric or GEJ adenocarcinoma and deserves further evaluation in randomised trials and in combination with molecular targeting agents.

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Section: Discussionmentioning

confidence: 99%

Irinotecan, docetaxel and oxaliplatin combination in metastatic gastric or gastroesophageal junction adenocarcinoma

Lauro¹,

Nunziata

Arena

et al. 2007

Br J Cancer

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“…Most published data are from phase II studies, and no results from phase III multicenter randomized trials in this setting have been published. shah et al reported a phase II trial of cPt-11 combined with cisplatin and bevacizumab to treat patients with metastatic gastric cancer in 2005 (38). After a median follow-up of 47 patients for 12.2 months, the time to progression and overall survival were 8.3 and 12.3 months, respectively, and the overall response rate in evaluable patients (n=34) was 65% with no significant increase in adverse events.…”

Section: Target Therapy For Patients With Metastatic Gastric Cancermentioning

confidence: 99%

Gastric carcinoma in China: Current status and future perspectives (Review)

Zhu

Li²

2010

Oncology Letters

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Abstract. gastric cancer is one of the most frequently occurring cancers in china, with an estimated 380,000 new cases each year, accounting for more than 40% of the worldwide annual cancer incidence. there is geographical clustering of the distribution of gastric cancer in china, with most of the high-risk areas being rural. D2 resection is the standard lymphadenectomy for curative resection in china, but more extensive lymphadenectomy is conducted for selected patients. Perioperative chemotherapy, postoperative chemotherapy or chemoradiotherapy can be combined with surgery. It remains uncertain which option is best, but if surgery is insufficient, adjuvant chemoradiotherapy is recommended. In the palliative setting, although there is no standard first-line chemotherapy, regimens based on taxane, oxaliplatin or capecitabine, or the epirubicin, cisplatin, 5-fluorouracil regimen and its modifications are the most common options selected by chinese oncologists. several studies to evaluate target therapy are ongoing, but it is too early to draw any conclusions. However, the development of target therapy is likely to become a milestone in the treatment of gastric cancer. Contents1. epidemiology of gastric carcinoma in china 2. Methods of staging gastric cancer 3. surgery for gastric cancer 4. Perioperative chemotherapy and new adjuvant therapy 5. Adjuvant chemotherapy or chemoradiotherapy after surgery 6. Palliative and salvage chemotherapy for metastatic patients 7. target therapy for patients with metastatic gastric cancer 8. Future treatment for metastatic gastric cancer

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“…In particular, early data from phase II trials [49 -52, 55, 56] show encouraging response rates and overall survival times for first-and second-line combinations of cytotoxic agents and the EGFRor vascular endothelial growth factor (VEGF)-targeted monoclonal antibodies cetuximab and bevacizumab (Table 2). In particular, high response and/or disease control rates have been reported for EGFR-targeted cetuximab combined with irinotecan and infusional 5-FU and leucovorin [50,51] and VEGF-targeted bevacizumab combined with irinotecan and cisplatin [56].…”

Section: Targeted Biological Agentsmentioning

confidence: 99%

“…A number of different classes of targeted agents have shown promising activity in clinical studies of advanced gastric cancer, including epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor (HER)-2-targeted monoclonal antibodies and tyrosine kinase inhibitors (TKIs) [49 -54], antiangiogenic and antiangiogenic/antitumor compounds [53,55,56], and the proteasome inhibitor bortezomib [57]. In particular, early data from phase II trials [49 -52, 55, 56] show encouraging response rates and overall survival times for first-and second-line combinations of cytotoxic agents and the EGFRor vascular endothelial growth factor (VEGF)-targeted monoclonal antibodies cetuximab and bevacizumab (Table 2).…”

Section: Targeted Biological Agentsmentioning

confidence: 99%

Is There an Optimal Chemotherapy Regimen for the Treatment of Advanced Gastric Cancer That Will Provide a Platform for the Introduction of New Biological Agents?

Pozzo

Barone

2008

The Oncologist

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Globally, gastric cancer is the second most common cause of cancer-related death. The majority of gastric cancer patients will have at presentation or will ultimately develop overt metastatic disease. Meta-analysis has demonstrated not only that systemic chemotherapy can improve survival in patients with advanced disease but also that the best survival results in earlier randomized studies have been achieved with three-drug regimens containing a fluoropyrimidine, an anthracycline, and cisplatin. Although there has been little progress historically in improving median overall survival times beyond the 9-month plateau achievable with the standard epirubicin–cisplatin–infusional 5-fluoropyrimidine (ECF) combination, the availability of newer cytotoxic anticancer agents has provided some measure of optimism that current outcomes can be improved. A number of new triplet and doublet combinations incorporating docetaxel, oxaliplatin, irinotecan, capecitabine, and S-1 have been explored in randomized trials. Although some combinations, such as epirubicin–oxaliplatin–capecitabine, have been shown to be as effective as (or perhaps more effective than) ECF, and although promising early data have been derived for S-1 in combination with cisplatin, a lack of studies in which direct comparisons have been made currently hinders the identification of the optimal regimen in this setting. One factor that might contribute to the lack of clear progress is the absence of consensus on the utility of second-line cytotoxic treatments. It can therefore be concluded that, although there is no first-line regimen that is clearly the most appropriate platform for the investigation of biological agents, there are a number of combinations that have been shown to be effective and therefore good candidates.

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Multicenter Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Cited by 368 publications

References 27 publications

Irinotecan, docetaxel and oxaliplatin combination in metastatic gastric or gastroesophageal junction adenocarcinoma

Irinotecan, docetaxel and oxaliplatin combination in metastatic gastric or gastroesophageal junction adenocarcinoma

Gastric carcinoma in China: Current status and future perspectives (Review)

Is There an Optimal Chemotherapy Regimen for the Treatment of Advanced Gastric Cancer That Will Provide a Platform for the Introduction of New Biological Agents?

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