Shorter trastuzumab treatment feasible for HER2-positive early breast cancer
medwireNews: Reducing adjuvant treatment with trastuzumab from the current standard of 12 months to 6 months does not have a negative impact on disease-free survival (DFS) in women with HER2-positive early breast cancer, PERSEPHONE trial data show.
In addition, the shorter treatment duration was associated with fewer cardiac side effects, reported Helena Earl (University of Cambridge, UK) at a press conference for the ASCO Annual Meeting 2018 in Chicago, Illinois, USA.
The phase III study included 4088 patients, from 152 sites in the UK, with HER2-positive early breast cancer who were randomly assigned to receive 6 or 12 months of adjuvant treatment with trastuzumab. The majority (69%) of women were also estrogen receptor positive, and all received additional chemotherapy with an anthracycline, taxane, or both.
During a median follow-up period of 4.9 years, 512 (12.5%) women experienced disease progression or death.
The 4-year disease-free survival rate was similar between the two groups, at 89.4% for the women who received trastuzumab for 6 months and 89.8% for those who received it for 12 months. This gave a hazard ratio of 1.07, which was below the noninferiority threshold of 1.29, indicating that 6 months of treatment with trastuzumab is at least as effective as 12 months of treatment.
Moreover, the proportion of women stopping treatment due to cardiotoxicity was significantly lower in the 6-month group than the 12-month group, at 4% versus 8%, with cardiac function recovering significantly faster in the women who received the shorter duration of treatment.
Assessments of quality of life, patient experience, and heath economics are currently underway, Earl noted.
Discussing the findings in a press release, she said: “The PERSEPHONE trial’s researchers worked closely with patient advocates. Everyone involved in this study is very excited by these results.”
She added: “We are confident that this will mark the first steps towards a reduction of the duration of trastuzumab treatment to 6 months in many women with HER2-positive breast cancer.”
Commenting on the study, ASCO president Bruce Johnson said: “The use of trastuzumab has been a major advance for women with HER2-positive breast cancer by increasing the cure rate, but no treatment is free of side effects, and heart damage has always been a concern with this treatment.
“This new trial shows that a shorter length of treatment can benefit patients just as much as a longer treatment, with less risk of cardiac side effects. This is a win-win for patients with breast cancer who are receiving this common treatment.”
By Laura Cowen
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