MANILA, Philippines - The results of the international phase III study NO16968 (XELOXA), an open-label, randomized trial of Xelox (oral capecitabine in combination with intravenous oxaliplatin) versus 5-fluorouracil/leucovorin (5-FU/LV) as adjuvant therapy for patients with stage III colon cancer who have undergone surgery, showed the superiority of Xelox versus 5-FU/LV in terms of disease-free survival (DFS).
The trial demonstrated that Xelox offered significantly superior DFS at three, four and five years. The three-year DFS for patients taking oxaliplatin in patients aged 65 or over was superior to those patients receiving 5-FU/LV (71 percent versus 67 percent).
The superiority of oxaliplatin over 5-FU/LV was also demonstrated in terms of DFS at four and five years, respectively (68.4 percent versus 62.3 percent and 66 percent versus 60 percent).
The trial, conducted in previously untreated patients who have undergone surgery for colon cancer, studied use of Xelox for six months.
The study, the largest-ever study of patients with stage III colon cancer, included 1,886 patients and was conducted at 226 study sites across 29 countries.
A subgroup analysis from the NO16968 (XELOXA) study, presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, demonstrated the benefits of capecitabine for patients over 65 or 70 years old.
The data show that patients older than 65 and 70 taking capecitabine with oxaliplatin (Xelox) immediately after surgery live disease-free longer compared with those treated with commonly-used chemotherapy regimen 5-FU/LV.
Although overall survival data are currently immature, the analysis shows a trend toward superiority for Xelox in patients aged over 65 or 70.
The subgroup analysis in patients over 65 or 70 years old follows on from the main study results which were presented at ECCO/ESMO in 2009.
Capecitabine is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs.
Capecitabine uniquely activates the cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells. Capecitabine tablets can be taken by patients in their own home, reducing the number of hospital or clinic visits.
Licensed and marketed by Roche in more than 100 countries worldwide, capecitabine has over 11 years of proven clinical experience providing an effective and flexible treatment option to over 1.8 million people with cancer.