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Capecitabine Plus Cisplatin Combination Effective in Patients With Advanced Gastric Cancer

First Ever phase 3 Trial with Oral Xeloda Combination as First-Line Treatment in Gastric Cancer Reduces Clinic Visits by 80% Compared to Standard of Care

ATLANTA, GA -- June 19, 2006 -- In the first-ever phase 3 trial of oral Xeloda (capecitabine) as first-line treatment for gastric cancer, Xeloda plus cisplatin (XP) was found to be at least as effective and safe in achieving progression-free survival as the current standard of care for gastric cancer -- intravenous 5-fluorouracil (IV 5-FU) plus cisplatin (FP) -- with higher overall response rates, according to final data presented today at the 42nd Annual American Society of Clinical Oncology (ASCO) Annual Meeting in Atlanta, GA.

Gastric (or stomach) cancer is the fourth most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide. The American Cancer Society estimates that more than 22,000 Americans will be diagnosed with gastric cancer in 2006. The 5-year relative survival rate for the disease is only 23%; however, if diagnosed early the 5-year relative survival rate increases to 58%. Unfortunately, patients with stomach cancer are often asymptomatic until the disease has progressed to an advanced stage.

"Patients diagnosed with advanced gastric cancer have a poor prognosis and treatment can be very cumbersome," said Howard Burris, MD, Sarah Cannon Research Institute. "With the combination of Xeloda and cisplatin, we're seeing the promise of a treatment option that is as effective as standard therapy, well-tolerated and has the added benefit of reducing the amount of time needed for treatment at a clinic or hospital, which may help some patients continue to spend valuable time with family and friends."

About the Study
This international, randomized, phase 3 non-inferiority study, conducted by Professor Y. K. Kang of the Asan Medical Center, Seoul, South Korea, in patients with advanced gastric cancer compared progression-free survival with Xeloda and cisplatin (XP) versus the current standard treatment, intravenous 5-fluorouracil (IV 5-FU) plus cisplatin (FP).

The study included 316 patients from 46 centers in 13 countries who were previously untreated and had advanced or metastatic gastric cancer. Patients in the XP arm lived at least as long without the cancer progressing as those treated with FP (median progression-free survival 5.6 vs. 5 months, HR= 0.81, P =<.001 showing strong evidence of non-inferiority), and also lived at least as long overall (10.5 vs. 9.3 months, HR=0.85, P =.008 showing strong evidence of non-inferiority).

The XP overall response rate was superior to standard therapy (41% vs. 29%, P =.030). Further, XP reduced the amount of time patients need to spend in the clinic by 80% (one day vs. five days every three weeks).

Both study arms had acceptable and similar safety profiles, with no unexpected toxicities; XP was as least as well tolerated as FP. The most common grade 3-4 adverse events (greater than or equal to 3%) in both arms included neutropenia, vomiting, stomatitis, diarrhea and anemia. Hand-foot syndrome was more frequent in the XP arm; stomatitis and vomiting were more frequent in the FP arm. Both arms had similar rates of withdrawal due to adverse events, 60-day all-cause mortality, and treatment-related mortality.

"Xeloda has become a foundational treatment for breast and colon cancer and Roche
Oncology is committed to exploring its potential beyond its current indications to enhance patient survival and quality of life," said Lars Birgerson, Vice President, Medical Affairs, Roche.

About Xeloda
Xeloda is the only FDA-approved oral chemotherapy for both metastatic breast cancer and adjuvant and metastatic colorectal cancer. Inactive in pill form, Xeloda is enzymatically activated within the body; when it comes into contact with a naturally occurring protein called thymidine phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic (cell-killing) drug. Because many cancers have higher levels of TP than does normal tissue, more 5-FU is delivered to the tumor than to other tissue.

A clinically important drug interaction between Xeloda and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported.

Clinically significant increases in prothrombin time (PT) and INR have been observed within days to months after starting Xeloda, and infrequently within one month of stopping Xeloda. For patients receiving both drugs concomitantly, frequent monitoring of INR or PT is recommended. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.

Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil, and in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. Xeloda is contraindicated in patients with severe renal impairment. For patients with moderate renal impairment, dose reduction is required.

The most common adverse events (>/= 20%) of Xeloda monotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome. As with any cancer therapy, there is a risk of side effects, and these are usually manageable and reversible with dose modification or interruption.


SOURCE: Roche

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