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NICE rules on chemotherapy drugs for colon and breast cancer

London Susan Mayor

Capecitabine and oxaliplatin, two relatively new cancer drugs, should be considered for the adjuvant treatment of stage III (Dukes’s type C) colon cancer after surgery, the National Institute for Health and Clinical Excellence (NICE) has recommended. Separate appraisals of docetaxel and paclitaxel for early breast cancer after surgery found insufficient evidence to make recommendations.

Previous NICE guidance said that the standard treatment for stage III (Dukes’s type C) colon cancer after surgery was a six month course of 5-fluorouracil and folinic acid given intravenously. NICE also said that this treatment should be offered to all patients who are fit enough to tolerate it after surgery for Dukes’s type C colon cancer (in which the tumour has spread to lymph nodes) and that it should begin within six weeks of surgery.

NICE’s new appraisal reviewed the clinical and cost effectiveness data for two of the newer drugs. Capecitabine is an orally administered precursor of the cytotoxic moiety 5-fluorouracil, and NICE considered its use as monotherapy. Oxaliplatin is a platinum based cytotoxic drug that prevents DNA replication and is used in combination with 5-fluorouracil and folinic acid.

The guidance recommends that either drug should be considered for adjuvant treatment and that the patient and their doctor should make the choice jointly after discussion. They should consider any contraindications to the treatments, their side effects, and the different ways that they are given. The decision should also take into account the patient’s clinical condition and individual preferences.

Andrew Dillon, NICE’s chief executive, said, “This appraisal is another example of NICE working to ensure that new treatments that are clinically and cost effective are made available to patients across the NHS. These drugs are not a cure, but they can improve quality of life and increase progression-free survival, and as such they are an important addition to the treatment options available to people with this cancer.”

The first guidance developed under NICE’s new rapid appraisal process was draft recommendations on the clinical and cost effectiveness of two taxanes, docetaxel and paclitaxel, for the treatment of early breast cancer after surgery. NICE has not recommended either drug because of lack of information on clinical and cost effectiveness compared with chemotherapy regimens currently used in the NHS.

The guidance, which was published last week, did not recommend use of docetaxel in the treatment of early breast cancer after surgery because the appraisal committee found that there was “too much uncertainty about the evidence to make a clear judgment on its clinical and cost effectiveness compared with current practice in England and Wales.”

Andrea Sutcliffe, the deputy chief executive of NICE and executive lead for the appraisal, said, “[NICE] has asked the manufacturer of docetaxel to further clarify the evidence before our independent appraisal committee next meets to make its final recommendations.” This meeting will take place in June, and the guidance is available for comment until 22 May.

NICE has asked for information on the clinical and cost effectiveness of docetaxel in combination with doxorubicin and cyclophosphamide compared with combination regimens of 5-fluorouracil, epirubicin, and cyclophosphamide that include doses of epirubicin at the higher end of the range currently used in the NHS in England and Wales.

NICE also wants more information on the clinical and cost effectiveness of docetaxel in combination with doxorubicin and cyclophosphamide compared with the block sequential regimen of epirubicin and then a combination of cyclophosphamide, methotrexate, and 5-fluorouracil.

The guidance also said that paclitaxel should not be recommended after surgery for early breast cancer when the cancer has spread into the lymph nodes. This is for similar reasons—lack of evidence of the clinical and cost effectiveness compared with current standard practice in the NHS.

The committee agreed that evidence provided by the manufacturer showed clinical benefit of adding four cycles of paclitaxel to four cycles of cyclophosphamide compared with four cycles of cyclophosphamide alone. But it said that four cycles of cyclophosphamide was not a commonly used chemotherapy regimen for adjuvant treatment of breast cancer in the NHS. The committee considered that the magnitude of the benefit of six cycles of cyclophosphamide compared with four cycles was at least as high as adding four cycles of paclitaxel to four cycles of cyclophosphamide. The guidance, Capecitabine and Oxaliplatin in the Adjuvant Treatment of Stage III (Dukes’ C) Colon, is available at www.nice.org.uk/TA100.The appraisal consulation document Docetaxel for the Adjuvant Treatment of Node-Positive Breast Cancer (Appraisal Consultation) is available at www.nice.org.uk/page.aspx?o=309609, and Breast Cancer (Early): Paclitaxel—Single Technology Appraisal is at www.nice.org.uk/page.aspx?o=309608.

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