New practice changing clinical trial results show that for postmenopausal women with advanced or metastatic breast cancer, the drug palbociclib in combination with letrozole markedly improves progression free survival rates.
The results of the PALOMA-2 clinical trial were announced at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, USA, and published in the Journal of Clinical OncologyLetrozole is a standard treatment option for postmenopausal women with breast cancer that is hormone-sensitive and has returned or spread to other areas of the body (advanced or metastatic breast cancer). Palbociclib works differently than letrozole, in that it interferes with the cancer cell’s growth cycle. Both drugs are taken orally. Earlier research results in a smaller phase 2 clinical trial called PALOMA-1, showed that the combination of palbociclib and letrozole controlled the spread of breast cancer longer than when letrozole was administered alone.
The PALOMA-2 clinical trial, which is a larger phase 3 study, found that combining letrozole with the new drug palbociclib doubled progression free survival rates from 14 months to 24 months, when compared with letrozole treatment on its own. Overall survival rates are still immature and will be reported at a later date. The safety and tolerability of the combination of letrozole and palbociclib was very good overall with less than 10% of patients discontinuing treatment due to side effects.
PALOMA-2 is an international clinical trial that was coordinated in Australia and New Zealand by the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) and conducted with the Translational Research in Oncology (TRIO) group and Pfizer. More than 666 women participated in the study worldwide including 20 women from Australia and New Zealand.
The ANZBCTG’s Study Chair of the PALOMA-2 clinical trial, Dr Janine Lombard, said the results of the study were tremendous news for women with advanced breast cancer. “PALOMA-2 has produced practice changing results and provides a new treatment option for postmenopausal women with hormone sensitive breast cancer, whose disease is advanced or spread to other areas of the body,” Dr Lombard said.
“I would sincerely like to thank women who participated in this study and the institutions involved. This research has shown results that improves breast cancer progression free survival rates and as a result, improves the lives of women and their families.”
[hr] Source: ANZBCTG.
The ANZBCTG’s research program involves multicentre clinical trials, with 87 institutions and over 700 researchers throughout Australia and New Zealand. More than 14,000 women have participated in ANZBCTG breast cancer clinical trials. The fundraising department of the ANZBCTG is the Breast Cancer Institute of Australia (BCIA). For more information about the ANZBCTG, visit the website www.anzbctg.org.