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Trial results challenge tamoxifen as first-line treatment for breast cancer

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The Pharmaceutical Journal Vol 265 No 7117 p508
October 07, 2000 Clinical

Trial results challenge tamoxifen as first-line treatment for breast cancer

Letrozole (Femara) is superior to tamoxifen for the treatment of breast cancer in postmenopausal women, according to data from two international trials presented at the European breast cancer conference (EBCC) in Brussels, on September 28. The phase III randomised, controlled trials compared the efficacy of letrozole with tamoxifen both as first-line treatment in postmenopausal women with advanced breast cancer and as pre-operative treatment in postmenopausal women with primary breast cancer.
In the first-line treatment trial, 907 postmenopausal women with hormone-sensitive locally advanced or metastatic breast cancer were treated orally with either letrozole (2.5mg daily) or tamoxifen (20mg daily). Efficacy was assessed by measuring time to progression (TTP), tumour response rate and duration, rate and duration of clinical benefit, time to treatment failure (TTF), overall survival and tolerability. Overall survival rates for the two drugs will be analysed once an extension to the trial has been completed at the end of 2001.
The median TTP was 9.4 months in the letrozole group compared with 6.0 months in the tamoxifen group. Patients receiving letrozole showed a better objective response rate than patients receiving tamoxifen (30 per cent compared with 20 per cent). There were no significant differences in the duration of response or duration of clinical benefit for either drug. The median TTF for letrozole was 9.1 months compared with 5.7 months for tamoxifen.
In the second trial, 337 postmenopausal women with hormone-sensitive large, localised or locally advanced breast cancers not amenable to breast-conserving surgery were included. Patients were treated orally with either letrozole (2.5mg daily) or tamoxifen (20mg daily) for four months before surgery to reduce tumour size. The number of clinical responses was significantly higher for letrozole than for tamoxifen (55 per cent compared with 36 per cent) and more women underwent breast-conserving surgery in the letrozole group (45 per cent compared with 35 per cent). In both studies, letrozole and tamoxifen were equally well tolerated; the three most common adverse events for both drugs were hot flushes, nausea and hair thinning.
Commenting on the trial results, Dr Stephen Johnston (consultant oncologist, Royal Marsden hospital, and member of the trial team) told The Journal on October 2, that, until now, no studies had shown that letrozole was better than tamoxifen but that these data did. “The benefits for patients could be enormous,” he said. Dr Johnston added that it was important that the message to patients was clear: “Tamoxifen is the best drug we have had and at the moment if a tumour fails with tamoxifen then patients receive this drug [letrozole] anyway.” A spokesman for Novartis, manufacturer of Femara, told The Journal on October 3, that an application to extend letrozole’s licensed indications to include first-line treatment in advanced breast cancer had been submitted to the Medicines Control Agency. He said that the company hoped to receive a positive response before the end of this year.
Ms Kate Law (head of clinical programmes, Cancer Research Campaign) told The Journal on October 4 that these results looked encouraging. “The meta-analyses on tamoxifen have shown us how effective it is. If this drug can do the same, without tamoxifen’s side effects, then this is positive news.”

Citation: The Pharmaceutical Journal URI: 20003163

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