Campto^® (irinotecan) shown to offer new hope to colon cancer patients with early stage disease

16^th May 2005 American Society of Clinical Oncology:  Today, Pfizer announced promising interim results from the largest study of its kind showing Campto^® (irinotecan) significantly reduces the risk of recurrence when used with standard chemotherapy in the treatment of adjuvant colon cancer.

The Pan European Trial Adjuvant Colon Cancer (PETACC-3), evaluated the effect of irinotecan on the risk of recurrence among 3,278  patients with stage II or III colon cancer who were randomly assigned to receive, 5-fluorouracil (5-FU) and leucovorin (FA ) with or without irinotecan for six months.

After a median follow-up of 38 months, the encouraging results show the addition of irinotecan to infused 5-FU/FA significantly reduces the risk of colon cancer relapse in stage III patients by 14% (HR 0.86, p=0.045)

This study is the largest to evaluate this regimen in the adjuvant setting amongst early-stage patients and differs from previous investigations because it delivered 5-FU more slowly, via infusion, rather than as a “bolus” injection (a single large quantity of the drug delivered more quickly); the infusion approach is associated with fewer side effects.

“These are important new results demonstrating the benefit from irinotecan combined with 5-fluorouracil, given after surgery, in patients with colon cancer in reducing the risk of tumour recurrence,” said Professor David Cunningham, Royal Marsden Hospital , London and a Principal Investigator of the study. “We hope this will improve long-term outcomes for this group of patients”.

Note

Campto is a chemotherapeutic agent that has consistently demonstrated an overall survival advantage in patients with advanced colorectal cancer in both a first-line setting in combination with 5FU/FA (against the previous standard of 5-FU/FA) and as a single agent in the 2^nd line setting (again versus 5FU/FA and also palliative care).^1,2,3 More recent data has shown that sequential use of Campto in combination with 5-FU/FA can extend survival beyond 20 months.⁴ The provisional NICE Guideline recommendations, announced April 2005, suggest the use of 5FU/FA + Campto as a standard 1^st line treatment for advanced disease as well as Campto monotherapy as a 2^nd line option.⁵ These updated recommendations mirror the way these agents are used in most of the EU and the US.

Colorectal cancer is a malignant neoplasm in the large intestine and is the third most common cancer in the UK after breast and lung cancer.⁶ Over 34,000 new cases were registered in the UK in 2001, representing more than 14% and 12% of all new cancer cases in men and women, respectively.⁶ The annual incidence of colorectal cancer increases with age, from 25 per 100,000 in people aged between 45 and 55, to more than 300 per 100,000 in those older than 75 years.⁵  About 30% of patients with colorectal cancer present with advanced disease, which is defined as either metastatic or locally invasive to the extent that surgical resection with curative intent is unlikely to be carried out.⁵

References:

1. Douillard JY et al. Lancet 200;355:1041-1047

2. Rougier P et al. Lancet 1998;352:1407-1412

3. Cunningham D et al. Lancet 1998;352:1413-1418

4. Tournigand C et al. J Clin Oncol 2004;22(2):229-237

5. Provisional NICE guidance www.nice.org.uk/page.aspx?o=250494 Dated accessed 9/5/05

6. Cancer Research UK (2005). Large Bowel Cancer Fact Sheet

(www.cancerresearchuk.org/aboutcancer/statistics/factsheets/). Date accessed 9/5/05

  (25/5/05)