A new treatment option will help more colon cancer patients in Europe to benefit from treatment with capecitabine (Xeloda; Roche), highly effective targeted oral chemotherapy uniquely activating cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells.

The new treatment, a combination of capecitabine with oxaliplatin (Eloxatin; Sanofi-Aventis), a combination also known as XELOX, has been approved by the European Commission for the adjuvant (post-surgery) treatment of patients with early colon cancer. The approval was based on results from the pivotal NO16968 (XELOXA) study.

NO16968 was one of the largest randomized, phase III studies of XELOX (oral Xeloda in combination with intravenous oxaliplatin) in patients with stage III (early) colon cancer versus 5-FU/LV as adjuvant therapy for patients with stage III colon cancer who have undergone surgery. The study included 1886 patients and was conducted at 226 study sites across 29 countries. The primary objective of the study was to assess the superiority of XELOX versus 5-FU/LV in terms of 3 year disease-free survival (DFS). The trial demonstrated that patients taking XELOX immediately after surgery lived disease-free for longer compared to those treated with chemotherapy regimen 5-fluorouracil/leucovorin (5-FU/LV).1 The 3 year disease-free survival (DFS) for patients receiving XELOX was superior to the 5-FU/LV arm (71.0% versus 67.0%, HR 0.80, p=0.0045).

“The approval of XELOX for the adjuvant treatment of early colon cancer is great news for patients, who now have the added benefits and convenience of oral Xeloda in combination therapy for this disease, which is potentially curable if diagnosed and treated promptly,? said Pascal Soriot, Chief Operating Officer (COO), Roche Pharmaceutical Division.

Following approval in the European Union, label extensions for capecitabine in other regions of the world are expected. Xeloda monotherapy is already approved for use immediately after surgery in patients with colon cancer throughout the world including Europe, the US and Japan.

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?I am delighted that XELOX will now be made available to patients with early colon cancer, particularly as it is at this stage of the disease that we have the best chance of curing them,? said Professor Hans-Joachim Schmoll, Martin Luther University Clinic for Internal Medicine IV, Halle, Germany and one of the lead investigators. ?Having a range of treatment options means more patients are given the chance to live without their disease returning, potentially enabling them to be cured,? he added.

Colorectal cancer is the second most common cause of death from cancer across all tumor types in Europe2 and is the third most commonly reported cancer in the world.3

  1. Haller D, Tabernero J, Maroun J, De Braud F, Price T, et al. 5LBA First efficacy findings from a randomized phase III trial of capecitabine + oxaliplatin vs. bolus 5-FU/LV for stage III colon cancer (NO16968/XELOXA study) Eur J Cancer Supplements. 2009 Sep; 7 (3): 4 (abstract 5LBA)
  2. Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol.2007 Mar;18(3):581-92. Epub 2007 Feb 7.
  3. Parkin DM, Bray F, Ferlay J, Pisani P, Global cancer statistics, 2002 CA cancer J Clin 2005; 55:74

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