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United States: Adding Trastuzumab to Standard Cisplatin-Based Chemotherapy Provides Benefits for Patients With Advanced Gastric Cancer: Presented at ECCO-ESMO.


Trastuzumab, in combination with standard cisplatin-based chemotherapy, is well tolerated and provides significant survival benefits over chemotherapy alone for patients with human epidermal growth factor receptor This article is about a cell suface receptor. For estimated measure of kidney function (eGFR), see Glomerular filtration rate.
The epidermal growth factor receptor
 2 (HER2)-positive advanced gastric cancer, researchers stated at the joint 15th Congress of the European Cancer Organisation (ECCO An earlier Windows PIM from NetManage, Inc., Cupertino, CA (www.netmanage.com). ECCO provided a phone book, calendar, to-do list, outlining and notetaking. It was noted for its tightly integrated and sophisticated functions. ) and 34th Congress of the European Society for Medical Oncology (ESMO ESMO European Society for Medical Oncology
ESMO European Student Moon Orbiter
ESMO Earth Science Mission Operations
ESMO Excited-State Molecular Orbital
).

"Gastric cancer is a difficult disease to treat, and the median survival with advanced or metastatic gastric cancer is poor, at around 10 or 11 months, when treated with a reference cytotoxic combination," said principal investigator Eric Van Cutsem, MD, PhD, Gastrointestinal Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium. There is, thus, an unmet need for better treatment options in advanced gastric/gastro-oesophageal junction (GEJ GEJ Gastroesophageal Junction ) cancer, he explained during his presentation of a multicentre, randomised Adj. 1. randomised - set up or distributed in a deliberately random way
randomized

irregular - contrary to rule or accepted order or general practice; "irregular hiring practices"
, open-label phase 3 trial here on September 24.

The main entry criteria for the study were adenocarcinoma of the stomach or GEJ, with inoperable locally advanced disease and/or metastatic disease. Subjects were required to have measurable or evaluable disease, a HER2-positive tumour, an Eastern Cooperative Oncology Group The Eastern Cooperative Oncology Group (ECOG) was established in 1955 as one of the first cooperative groups launched to perform multi-center cancer clinical trials. A cooperative group is a large network of researchers, physicians, and health care professionals at public and  (ECOG ECOG Eastern Cooperative Oncology Group ) performance status of 2 or less, and adequate organ function.

In all, 584 patients had advanced gastric cancer, and were randomised to receive 5-fluorouracil or capecitabine plus cisplatin (FC; n = 290) or 5-fluorouracil or capecitabine plus cisplatin plus trastuzumab every 3 weeks for 6 cycles (FCT; n = 294).

The main baseline demographics were evenly matched across the FC and FCT arms for median age (59.0 vs 61.0 years); gender (male, 75% vs 77%); type of gastric cancer (about 75% intestinal and 15% mixed); and prior gastrectomy gastrectomy

Surgical removal of all or part of the stomach to treat peptic ulcers. It eliminates the cells that secrete acid and halts the production of gastrin, the hormone that stimulates them. Once a common operation, it is now a last resort.
 (21.4% vs 24.1%).

For the stratification factors, Dr. Van Cutsem noted the main primary tumour site (80% stomach), the ECOG performance status (90% 0/1), and prior capecitabine treatment (almost 90%).

The primary endpoint of median overall survival showed significant benefit for the addition of trastuzumab to FC: median overall survival was 11.1 months for the FC group versus 13.8 months for the FCT group (hazard ratio HR , 0.74; 95% confidence interval CI , 0.60-0.91; P = .0046). Similarly, the secondary endpoint of median progression-free survival was 5.5 months for the FC group versus 6.7 months for the FCT group (HR, 0.71; 95% CI, 0.59-0.85; P = .0002).

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Date:Oct 6, 2009
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