The Pharmaceutical Journal
Vol 278 No 7434 p42
13 January 2007

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Trastuzumab survival benefit seen after two years

Women given trastuzumab (Herceptin) for one year as adjuvant treatment for HER2-positive breast cancer have greater overall survival after two years' follow-up than those not given the monoclonal antibody, according to further results from the Herceptin adjuvant (HERA) trial published last week in The Lancet (2007;369:29).

The study, sponsored by Roche (manufacturer of Herceptin), followed 1,703 women who received trastuzumab for one year and 1,698 women from the control arm for a median of 23.5 months.

Investigators found the unadjusted hazard ratio for the risk of death in the trastuzumab compared with the observation group to be 0.66 (0.47–0.91; P=0.0115), corresponding to an absolute overall survival benefit of 2.7 per cent (92.4 per cent versus 89.7 per cent) after three years.

However, more side effects were experienced by women in the treatment arm: there were more occurrences of severe congestive heart failure, symptomatic congestive heart failure, confirmed significant drop in left ventricular ejection fraction and discontinuation of trastuzumab due to cardiac problems (P<0.0001) but not of cardiac-related deaths. Follow-up data for women who received two years of trastuzumab treatment in the HERA study are still awaited.

In an editorial (ibid, p3), Daniel Hind and colleagues from the University of Sheffield say that most trials of the adjuvant therapy, including HERA, are now confounded by a mass crossover of participants from the control arm and will never address whether trastuzumab prevents rather than delays recurrence and whether long-term harm will overturn early survival benefits.

They also question whether the National Institute for Health and Clinical Excellence would have endorsed the one-year HERA regimen (PJ, 26 August 2006, p241) if it had been compared with data from a Finnish study which found improvements in disease-free survival with only nine weeks’ treatment at one fifth of the usual dose (PJ, 4 March 2006, p259). However, they admit: “Unless catastrophic long-term side effects emerge for trastuzumab, HERA is good news for women with HER2-positive early breast cancer and adequate cardiac function.”