Rebecca A. Shatsky, MD, discusses the outcomes of the phase 3 FeDeriCa study of subcutaneous trastuzumab and pertuzumab in patients with HER2-positive breast cancer.
Rebecca A. Shatsky, MD, associate professor of medicine at UC San Diego School of Medicine, discusses the outcomes of the phase 3 FeDeriCa study (NCT03493854) of subcutaneous (SC) trastuzumab and pertuzumab (Phesgo) in patients with HER2-positive breast cancer.
The randomized, multicenter, open-label phase 3 trial investigated the SC formulation in comparison with intravenous (IV) trastuzumab (Herceptin) and pertuzumab (Perjeta). Investigators enrolled patients with operable or locally advanced HER2-positive breast cancer. Patients received neoadjuvant dose-dense doxorubicin plus cyclophosphamide for 4 cycles, followed by either docetaxel or paclitaxel. They then received the SC fixed-dose combination or IV combination of trastuzumab/pertuzumab for 4 cycles followed by surgical resection, then 14 more cycles of trastuzumab/pertuzumab.
The primary end point of the trial was noninferior pharmacokinetics of the SC method of administration. Looking at cycle 7 pertuzumab serum trough concentration, noninferiority was defined as the lower bound of the 90% CI of the geometric mean ratio being 0.8 or higher. The study found that the geometric mean ratio of pertuzumab serum trough concentration of the SC vs IV was 1.22 (90% CI, 1.14-1.31). A secondary end point, the geometric mean ratio of trastuzumab serum trough concentration at cycle 7, was 1.33 (90% CI, 1.24-1.43). The pathological complete response rate was 59.5% in the intravenous group and 59.7% in the SC group, and safety outcomes were also similar between the 2 groups.
TRANSCRIPTION:
0:08 | This trial was designed for noninferiority evaluation to look at the combination of IV pertuzumab/trastuzumab vs Phesgo to see if efficacy of Phesgo was noninferior to IV pertuzumab/trastuzumab and they looked at their primary end point was actually the pharmacokinetics of the Phesgo vs the IV pertuzumab/trastuzumab. And in the trial, they found that the pharmacokinetics were noninferior. The trial was considered noninferior if the lower limit of the 90% confidence interval was greater than or equal to 0.8. For all of the pharmacokinetic data, the lower limit of the confidence interval was actually higher than 1.0.
Leslie Reviews Relevant Data for Treatment of Relapsed/Refractory CLL
May 8th 2024During a Case-Based Roundtable® event, Lori A. Leslie, MD, discussed Bruton tyrosine kinase inhibition options for a patient with relapsed/refractory chronic lymphocytic leukemia in the first article of a 2-part series.
Read More
NGS and ctDNA Considered in Advanced Breast Cancer After Progression
May 3rd 2024During a Case-Based Roundtable® event, Ruth M. O'Regan, MD, led a discussion on whether to order next-generation sequencing and/or circulating tumor DNA testing for a patient with hormone receptor–positive breast cancer after progression in the first article of a 2-part series.
Read More
Comparing Choices for IO/TKI Combinations in Advanced RCC
May 2nd 2024During a Case-Based Roundtable® event, Shilpa Gupta, MD, led a discussion on the combination of immunotherapy and tyrosine kinase inhibitors for patients with advanced renal cell carcinoma in the second article of a 2-part series.
Read More