Dr Joyce O’Shaughnessy of the Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX, USA reported at ESMO Breast Cancer Virtual Meeting 2020 (23-24 May 2020) the results from an interim analysis of the PHranceSCa study. The study investigators found that over 80% of patients preferred a subcutaneous fixed-dose combination of pertuzumab and trastuzumab over pertuzumab plus trastuzumab given intravenously and chose subcutaneous formulation to complete their treatment. Subcutaneous treatment was generally well tolerated, and the safety profile was consistent with intravenous treatment. No new safety signals were seen. Subcutaneous injection combines pertuzumab plus trastuzumab in one ready-to-use fixed-dose combination vial. Primary study analysis is expected in Q4 2020.
Dr O’Shaughnessy said that a subcutaneous fixed-dose combination of pertuzumab plus trastuzumab may offer patients less invasive treatment in comparison to same drugs combination given intravenously. Subcutaneous treatment may reduce patients time in the clinic and free up resources at the practice. Furthermore, patient reported outcomes are increasingly important for decision making. PHranceSCa provides insights into patients’ perspective on subcutaneous treatment with pertuzumab plus trastuzumab and provides supportive information to the pivotal FeDeriCa pharmacokinetic study.
PHranceSCa (NCT03674112) is an open-label, randomised cross-over study evaluating patient preference and satisfaction with subcutaneous vs intravenous treatment with pertuzumab plus trastuzumab. Patients with histologically confirmed, HER2-positive early breast cancer who completed neoadjuvant therapy with pertuzumab plus trastuzumab plus chemotherapy and had surgery are enrolled and 1:1 randomised to group A who received 3 cycles of pertuzumab plus trastuzumab given intravenously every 3 weeks then 3 cycles of the subcutaneous fixed-dose combination of pertuzumab and trastuzumab every 3 weeks or Group B who received 3 cycles of the subcutaneous fixed-dose combination of pertuzumab and trastuzumab every 3 weeks and then 3 cycles of pertuzumab plus trastuzumab given intravenously every 3 weeks. Patients then choose the subcutaneous fixed-dose combination of pertuzumab and trastuzumab or pertuzumab plus trastuzumab given intravenously to complete anti-HER2 therapy up to 18 cycles. The primary objective was to evaluate patient preference for the subcutaneous fixed-dose combination of pertuzumab and trastuzumab.
At clinical cut-off of 19 August 2019, 118 patients were randomised: 56 patients in group A and 62 patients in group B. All were female. Median age was 49 years. In total 42 of 51 patients (82%) who completed the cross-over therapy preferred the subcutaneous fixed-dose combination of pertuzumab and trastuzumab. Main reasons for preference of subcutaneous treatment were spending less time in the clinic and
more comfortable therapy administration. In total 46 of 51 patients (90%) were very satisfied or satisfied with subcutaneous treatment in comparison to 34 of 51 patients (67%) who were treated with intravenous combination. Majority of patients (84%) chose the subcutaneous fixed-dose combination of pertuzumab and trastuzumab to complete their therapy.
In total 81 of 116 patients had 1 adverse event. One patient had a serious adverse event (pyrexia) and 5 patients had a grade 3 adverse event, in particular 3 patients with subcutaneous treatment had ejection fraction decrease, diarrhoea, device-related infection, while 2 patients who received intravenous treatment had ejection fraction decrease and lymphopenia. However, there were no deaths and no adverse events led to study discontinuation. In total 16 of 116 patients (13.8%) had diarrhoea, mainly low grade. Systemic administration-related reaction rates were reported in 2 of 116 patients (1.7%) for subcutaneous treatment and 3 of 116 patients (2.6%) for intravenous treatment. In total 21 of 116 patients (18.1%) had local injection site reactions. There were no local infusion-related reactions.
The authors concluded that most patients preferred subcutaneous over intravenous treatment. Main reasons for preference of subcutaneous treatment in the PHranceSCa study are consistent with findings from PrefHer. Most patients also chose the subcutaneous fixed-dose combination of pertuzumab and trastuzumab to complete their treatment. Subcutanous treatment was generally well tolerated with safety profile consistent to intravenous treatment. No new safety signals were observed, including when switching formulations.
The study was funded by F. Hoffman-La Roche.
Reference
Abstract 80O - O’Shaughnessy J, Sousa SP, Cruz J, et al. Patient (pt) preference and satisfaction with the subcutaneous fixed-dose combination of pertuzumab (P) and trastuzumab (H) in pts with HER2-positive early breast cancer (HER2+ eBC): Interim analysis of the open-label, randomised cross-over PHranceSCa study. ESMO Breast Cancer Virtual 2020 (23-24 May 2020).