Using Herceptin ( Trastuzumab ) with chemotherapy, instead of after, clearly improves treatment of women with HER2+ breast cancer, and should be the new standard of care.

Patients using Herceptin and chemotherapy at the same time had a relative 25 percent reduction in the risk of recurrence of cancer or death, compared with women who used Herceptin after chemotherapy, says Edith Perez, North Central Cancer Treatment Group ( NCCTG ) Breast Committee and at the Mayo Clinic campus in Jacksonville ( US ).

In the United States, for example, Herceptin is approved for use on either a sequential or concurrent treatment schedule with adjuvant chemotherapy. In much of the rest of the world, Herceptin is used sequentially.

This could mean that up to 10,000 women around the world each year may have a better outcome if Herceptin is used along with chemotherapy.

Every year, approximately 250,000 women worldwide are eligible to be treated with Herceptin for invasive HER2+ breast cancer.

Some data on part of the study, the clinical trial N9831, have been released before, such as in 2005 in the New England Journal of Medicine. But this is the first time that mature outcome information on patients given sequential versus concurrent treatment is available. The trial enrolled women who had surgery to treat stage I-III invasive HER2+ breast cancer.

The study is the only phase III randomized clinical trial to assess chemotherapy alone ( Arm A ) versus either sequential ( Arm B ) or concurrent ( Arm C ) incorporation of Herceptin in patients. Chemotherapy used in the study was Doxorubicin and Cyclophosphamide then Paclitaxel, and was administered for approximately six months. Herceptin was given for 52 weeks.

Two different comparisons were made in the study. The first looked at outcomes in Arm A ( 1,087 women ) compared to Arm B ( 1,097 women ) and found that five-year disease-free survival ( defined as no cancer recurrence ) was increased from 72 percent ( Arm A ) to 80 percent ( Arm B ). Researchers also tabulated 222 events ( cancer recurrence or death ) in Arm A compared to 164 events in Arm B.

The second comparison looked at 954 women enrolled in Arm B with 949 women enrolled in Arm C. Researchers found that patients in Arm C fared the best overall. Their five-year disease-free-survival increased to 84 percent, compared to 80 percent in Arm B.

The study demonstrated that adding Herceptin clearly improves disease-free survival, with improvement if given after chemotherapy, but even more improvement if started concurrent with taxane-based chemotherapy.

Source: Mayo Clinic, 2009

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