Background
Pyrotinib is an innovative cancer drug targeting EGFR, HER2, and HER4 which are components expressed on cell surface.
Pyrotinib plus Xeloda has shown meaningful benefits and acceptable side effects in patients with HER2+ metastatic breast cancer in phase 1 and phase 2 clinical trials.
In the PHOEBE phase III clinical trial, extension in the time to disease progression was demonstrated with the Pyrotinib plus Xeloda versus the Tykerb plus Xeloda.
Either combination was given to patients with HER2-positive metastatic breast cancer who received prior treatment with Herceptin and chemotherapy.
About PHOEBE trial
PHOEBE was a multicenter phase III study which enrolled patients with HER2-positive metastatic breast cancer after Herceptin and taxanes and/or anthracyclines (chemotherapies).
267 patients participated in the study. 134 patients entered the Pyrotinib plus Xeloda group and 133 entered the Pyrotinib and Tykerb group.
Study results
The results were presented as part of the annual American Society of Clinical Oncology, ASCO, meeting which was virtually held on May 29-31, 2020.
- Among Herceptin-resistant patients, time to disease progression with Pyrotinib plus Xeloda was 12.5 months versus 6.9 months with Tykerb plus Xeloda.
- 67.2% of patients in the Pyrotinib group had their tumor either stopped from growing or shrunk by 30-50% in size versus 51.5% of patients in the Tykerb group.
- 61.9% of patients in the Pyrotinib group had their tumor either stopped from growing or shrunk by up to 30% in size versus 50.8% of patients in the Tykerb group.
- Complete remission of disease was seen in 5.2% of patients in the Pyrotinib group versus 0.8% of patients in the Tykerb group.
- Overall, Pyrotinib plus Xeloda was effective in 73.1% of patients versus 59.1% of patients in the Tykerb group.
- Further, the duration of response was 11.1 months in the Pyrotinib group versus 7.0 months in the Tykerb group.
- Survival data were not yet mature to conclude anything at the time of the analysis, but a strong trend toward prolonged survival was observed in the Pyrotinib group, 91.3%, versus 77.4% in the Tykerb group.
Side effects
- 57.5% of patients in the Pyrotinib group suffered severe side effects and 34.1% of patients in the Tykerb group.
- The most common side effects were diarrhea and hand-foot syndrome.
- No lethal side effect occurred in either group.
- In the Pyrotinib group, 61 patients discontinued treatment versus 101 patients In the Tykerb group.
Important note,
Pyrotinib plus Xeloda was approved as a second-line standard-of-care therapy for metastatic HER2-positive breast cancer in China in 2018.
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