The Pharmaceutical Journal
Vol 270 No 7252 p785
7 June 2003

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Promising results for oxaliplatin from three colorectal cancer trials at ASCO

Adding oxaliplatin (Eloxatin) to conventional colorectal cancer therapy increases tumour response rates and reduces the chance of cancer recurrence, results of three phase III studies presented at the American Society of Clinical Oncology annual meeting show.

All of the studies tested the effects of a regimen known as FOLFOX (5-fluorouracil [5-FU], folinic acid [FA] and oxaliplatin) against standard therapy (5-FU/FA).

The first showed that patients with locally advanced colorectal cancer who were treated using the FOLFOX regimen as adjuvant therapy were more likely to be free of cancer three years after the start of treatment than those who received standard therapy. Addition of oxaliplatin decreased the risk of cancer recurrence by 23 per cent, Dr Aimery de Gramont, Saint Antoine Hospital, Paris, told conference participants. "We are very encouraged by these results and expect that they will change the standard of care for many patients with colorectal cancer," he said.

The study involved 2,248 patients who had already undergone surgery to remove their tumours. Of those randomised to receive FOLFOX, 77.8 per cent had no signs of cancer recurrence following three years of treatment. This compared with 72.9 per cent of the patients who received standard therapy (hazard ratio 0.77, P<0.01). Dr de Gramont estimated that as many as 5,000 lives could be saved each year in Europe should this treatment regimen be adopted.

Presenting a discussion paper about the trial data, Dr Robert Mayer, Dana-Farber Cancer Institute, Boston, Massachusetts, said FOLFOX represented an "acceptable option" for standard adjuvant therapy. However, he added: "It is potentially worrisome that 47 per cent of patients [treated with FOLFOX] experienced some kind of neurotoxicity."

A second trial, involving 821 patients with metastatic colorectal cancer compared FOLFOX with standard therapy (and with oxaliplatin alone). Patients enrolled in the trial had progressive colorectal cancer and had initially been treated with irinotecan (Campto) and 5-FU/FA. The researchers, led by Dr Mace Rothenberg, Vanderbilt-Ingram Cancer Centre, Nashville, Tennessee, found that 9.6 per cent of patients responded to FOLFOX whereas 0.7 per cent of patients responded to standard therapy. The delay in time to tumour progression was longer among patients treated with FOLFOX (5.6 months versus 2.6 months, P<0.001). Dr Rothenberg added: "Both components of therapy — oxaliplatin and 5FU/FA — appear to be needed to achieve this effect."

The final study evaluated FOLFOX as first-line therapy in advanced colorectal cancer. Dr Richard Goldberg, Mayo Clinic, Rochester, Minnesota, said patients treated with FOLFOX lived an average of 19.5 months compared with 14.8 months for the standard regimen (17.4 months for oxaliplatin plus irinotecan). "Furthermore, patients on the FOLFOX regimen showed on average no signs of their cancer worsening for 8.7 months compared with 6.9 months in patients on the standard treatment," he said.

Generally, the FOLFOX regimen was well tolerated. However, in the adjuvant chemotherapy trial grade three-neuropathy was experienced by 12 per cent of patients treated with FOLFOX. One year after treatment the percentage of patients with this grade of neuropathy had fallen to 1 per cent.

The Journal attended the 39th annual meeting of the American Society of Clinical Oncology, held in Chicago, Illinois, from 31 May until 3 June, courtesy of Eli Lilly. Our report continues next week