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The Pharmaceutical Journal
Vol 268 No 7189 p349-354
16 March 2002

Related websites
National Institute for Clinical Excellence (www.nice.org.uk)

NICE limits use of colon cancer drugs

Irinotecan Irinotecan is a topoisomerase I inhibitor. It is licensed in the United Kingdom for use in chemotherapy-naive patients with advanced colorectal cancer in combination with 5FU/FA and as a single agent for second-line chemotherapy for patients in whom an established 5FU-containing regimen has failed.

Oxaliplatin Oxaliplatin is a platinum-based cytotoxic agent that cross-links DNA. It is licensed in the UK for the first-line treatment of adults with advanced colorectal cancer in combination with 5FU/FA.

Raltitrexed Raltitrexed is a thymidylate synthetase inhibitor. It is licensed in the UK for palliative treatment of advanced colorectal cancer where 5FU/FA-based regimens are either not tolerated or are inappropriate.

Neither irinotecan (Campto) nor oxaliplatin (Eloxatin) in combination with 5-fluorouracil and folinic acid (5FU/FA) should be used as routine first-line therapy for advanced colorectal cancer, according to the National Institute for Clinical Excellence. In addition, raltitrexed (Tomudex) is not recommended by NICE for treatment of the disease.

In guidance issued last week, NICE recommends that oxaliplatin should only be considered for use as first-line therapy in combination with 5FU/FA in patients who have metastases confined to the liver and whose cancer may become operable after treatment. Irinotecan monotherapy is recommended second-line for patients who have failed on an established 5FU-based treatment regimen or for whom 5FU is inappropriate. Raltitrexed should only be used as part of clinical studies, says NICE.

The guidance has received a mixed reception from pharmacists, oncologists and patient groups. Dr Maxwell Summerhayes, principal oncology pharmacist, Guy's and St Thomas' Hospital NHS Trust said: "NICE appears to have made its recommendations on cost grounds but fails to say what the limits are for cost effectiveness."

Dr Summerhayes said he is not sure how widespread the enthusiasm for combination therapy is. "In pharmacy terms, there may be some relief. With many chemotherapy services under a lot of strain, the idea of embracing the extra work involved in combination chemotherapy would be a significant problem."

He also posed the question of how investigators in the UK could contribute to or benefit from international studies, when treatments considered to be the gold-standard elsewhere in Europe and the United States are not used here.

NICE makes it clear in the guidance that it does not consider the available evidence to be robust enough to support the routine use of the three drugs. Professor Peter Littlejohns, clinical director, NICE, said: "We have recommended use of both irinotecan and oxaliplatin in specific circumstances where cancer patients will benefit. But the available data do not support widespread use of these drugs, and they should only be considered in the circumstances specified in the guidance."

However, patients who are already receiving irinotecan or oxaliplatin in combination with 5FU/FA or raltitrexed may continue treatment until it is considered appropriate to stop, the guidance adds.

In a release issued on behalf of Aventis Pharma, manufacturer of irinotecan, Dr Mark Saunders, Christie Hospital, Manchester said: "While this guidance may [eliminate post code prescribing], it will bring with it a new kind of rationing — social class prescribing — where only those patients who can afford private treatment will have access to modern, effective treatments."

Patient groups have also expressed concern over the guidance. Dr Rob Glynne-Jones, Colon Cancer Concern, said: "The [NICE] process is entirely inappropriate for a fast moving area such as colorectal oncology."

Copies of the full guidance are available on the NICE web site (www.nice.org.uk).