The TRAIN-2 randomized trial investigated whether in this patient population the addition of anthracyclines would improve pathological complete response (pCR) compared with a carboplatin-taxane regimen, when combined with dual ERBB2 blockade (trastuzumab and pertuzumab).
The primary analysis, reported in The Lancet Oncology in 2018 (https://bit.ly/3uintyA), showed similarly high pCR rates after treatment with or without anthracyclines (67% vs. 68%).
The three-year follow-up of the TRAIN-2 study showed high event-free survival (92.7% vs. 93.6%) and overall survival (97.7% vs. 98.2%) in patients treated with or without anthracyclines.
"In addition, we found no indication that patients with a higher risk of breast cancer recurrence derive benefit from anthracyclines," the TRAIN-2 study team reports in JAMA Oncology.
In addition, Dr. Gabe Sonke with the Netherlands Cancer Institute, in Amsterdam, and colleagues note that anthracycline use led to a higher incidence of febrile neutropenia and cardiotoxic effects, leading to premature discontinuation of trastuzumab. Two patients developed chemotherapy-related acute leukemia after receiving anthracyclines.
The TRAIN-2 study adds to other clinical trials indicating that patients with ERBB2- positive breast cancer may not require anthracyclines, the investigators conclude.
Dr. Sara Hurvitz, with the Jonsson Comprehensive Cancer Center in Los Angeles, weighs in on the new data in an editorial in JAMA Oncology.
"One may rightly argue that there has not been a large randomized trial with a noninferiority end point to prove that nonanthracyclines have equal efficacy to anthracycline-based regimens," she writes. "While that is true, there has also been no demonstration from any randomized trial showing that anthracyclines are superior to nonanthracycline-based regimens in the trastuzumab era."
And as the TRAIN-2 authors point out, "we now have access to an expanding armamentarium of biologically targeted therapies for those patients at highest risk of relapse. Although these recently approved drugs are not void of adverse effects, their risk of life-threatening toxic effects is smaller than that seen with anthracyclines," Dr. Hurvitz says.
"The stand against routine use of anthracyclines in ERBB2-positive disease was recently endorsed by the National Comprehensive Cancer Network when anthracycline-based regimens were removed from the preferred list and placed into the category of useful in certain situations."
"Data from studies like TRAIN-2 have played a critical role in redefining how we approach the use of anthracyclines in this setting, challenging us to carefully consider whether we have enough evidence to justify their inclusion in treatment for the patient sitting before us," Dr. Hurvitz concludes.
TRAIN-2 was an investigator-initiated study sponsored by the Dutch Breast Cancer Research Group. Roche Netherlands provided pertuzumab and financial support for the study.
SOURCE: https://bit.ly/3wBtBn2 and https://bit.ly/3wBttny JAMA Oncology, online May 20, 2021.
By Reuters Staff
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