Abstract 97P
Background
In the phase II PHranceSCa study (NCT03674112), 85% of patients preferred the fixed-dose combination of pertuzumab (P) and trastuzumab (H) for subcutaneous injection (PH FDC SC) over PH infused intravenously (IV) as adjuvant treatment for HER2-positive early breast cancer, with no new safety signals with PH FDC SC. We present efficacy and safety data after continuation of treatment and follow-up.
Methods
Patients with locally advanced, inflammatory, or early breast cancer who had completed neoadjuvant PH + chemotherapy and surgery were randomised 1:1 to 3 cycles of PH FDC SC (600 mg P/600 mg H in 10 mL) followed by 3 cycles of PH IV (P 420 mg; H 6 mg/kg) or 3 cycles of PH IV followed by 3 cycles of PH FDC SC. If needed, loading doses were P 1200 mg /H 600 mg in 15 mL for PH FDC SC and P 840 mg/H 8 mg/kg for PH IV. After the crossover period, patients continued treatment by their preferred method (continuation period, up to 18 cycles total). Efficacy (invasive disease-free survival [IDFS]) and overall survival (OS), safety and quality of life (EORTC QLQ-C30) were assessed after 3 years.
Results
159/160 patients were treated in the continuation period (138 PH FDC SC, 21 PH IV, median 8 cycles for both) and 148 completed follow-up. The table shows safety in the continuation period. Most adverse events (AEs), including all cardiac AEs (n = 2) and anaphylaxis/hypersensitivity (n = 2), were grades 1/2. No grade 4/5 AEs occurred. There were six IDFS events (3.8%: 3-year IDFS 97.4%, 95% confidence interval [CI] = 94.9, 99.9) and two deaths (1.3%: 3-year OS 98.7%, 95% CI = 96.9, 100.0). Mean changes from baseline in EORTC QLQ-C30 were generally minimal.
Conclusions
PH FDC SC was well tolerated, with safety consistent with that of PH IV (except injection-site reactions) and no grade ≥3 anaphylaxis/hypersensitivity or new safety signals in the continuation period. Efficacy data are immature but show high IDFS and OS rates at 3 years.
For the latest information on IDFS data, please consult the Poster.
Table: 97P
| Patients, n (%) | PH FDC SC (n = 138) | PH IV (n = 21) |
| Any AE | 92 (66.7) | 14 (66.7) |
| Grade 3–5 AE | 7 (5.1) | 2 (9.5) |
| Serious AE | 4 (2.9) | 0 |
| Cardiac AE | 1 (0.7) | 1 (4.8) |
| Anaphylaxis/hypersensitivity | 2 (1.4) | 0 |
| Administration-related reaction | 16 (11.6) | 1 (4.8) |
| Local injection-site reaction | 13 (9.4) | 0 |
| Systemic injection reaction | 2 (1.4) | 0 |
| Systemic infusion reaction | 0 | 1 (4.8) |
| AE leading to interruption or dose reduction | 8 (5.8) | 1 (4.8) |
| AE leading to treatment discontinuation | 0 | 1 (4.8) |
Clinical trial identification
NCT03674112.
Editorial acknowledgement
Support for third-party writing assistance for this abstract, furnished by John Carron, PhD, of Health Interactions, was provided by F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd.
Funding
F. Hoffmann-La Roche Ltd.
Disclosure
J. O'Shaughnessy: Financial Interests, Personal, Advisory Board: AbbVie, Agendia, Amgen, Aptitude Health, AstraZeneca, Bristol Myers Squibb, Celgene, Eisai, G1 Therapeutics, Genentech, Immunomedics, Ipsen Biopharmaceuticals, Lilly, Merck, Myriad, Novartis, Ondonate, Pfizer, Puma, Prime Oncology, Roche, Seattle Genetics, Syndax, Carrick Therapeutics, Daiichi Sankyo, Gilead Sciences, Ontada, Pierre Fabre Pharmaceuticals, Samsung Bioepis, Sanofi. S.P. Sousa: Financial Interests, Invited Speaker: Roche, Novartis, Pfizer, MSD Oncology, AstraZeneca, Merck, GSK, Gillead. J. Cruz Jurado: Financial Interests, Personal, Advisory Board: PharmaMar, Roche, Lilly, Pfyzer, Novartis, Gilead, AstraZeneca, Daiichi, Seagen, GSK, Bayer; Financial Interests, Personal, Invited Speaker: PharmaMar, Roche, Lilly, Pfyzer, Novartis, Eisai, Gilead, AstraZeneca, Daiichi, Seagen, Esteve, Roche. L.J. Fallowfield: Financial Interests, Personal, Invited Speaker, Genomic Health Nurses ForumMAY 2019/ DEC 2019: Genomic Health; Financial Interests, Personal, Invited Speaker, MAR 2021. Understanding the quality of survival in metastatic breast cancerOCT 2020. Novartis Virtual Summit: Novartis; Financial Interests, Personal, Advisory Board, Lilly Oncology Breast Cancer European Advisory BoardAPR 2019: Lilly; Financial Interests, Personal, Invited Speaker, NOV 2019. PrIME Masterclass in NET Neuroendocrine Tumours: prIME A Medscape Oncology Company; Financial Interests, Personal, Invited Speaker, SEP 2020. Chair national Pfizer virtual meeting: Pfizer; Financial Interests, Personal, Invited Speaker, OCT 2020. CATCH Collaborate and address treatment challenges in haemophilia Workshop Talk: Patient Engagement: Sobi; Financial Interests, Personal, Invited Speaker, SEP 2020. Communicating Risk - Virtual Consultations MSD speaker meeting: MSD; Financial Interests, Personal, Invited Speaker, OCT 2020. Financial Toxicity In Oncology From Worldwide To Italy: 3P SOLUTION; Financial Interests, Personal, Invited Speaker, NOV 19. Prosigna Event: Communicating risk to patients incorporating aspects of the recent Prosigna videos.: Veracyte; Financial Interests, Personal, Invited Speaker, SEP 2021. Step Ahead - 4th Biennial Breast Cancer Summit AZ: AstraZeneca; Financial Interests, Personal, Advisory Board: Voluntis; Financial Interests, Institutional, Funding, PI: Veracyte; Financial Interests, Institutional, Research Grant, PI: Eli Lilly, Roche, Bristol Myers Squibb. P. Auvinen: Non-Financial Interests, Personal, Funding, Research funding: Support for third-party writing assistance: F. Hoffmann-La Roche Ltd. C. Pulido: Non-Financial Interests, Funding, Research funding: Support for third-party writing assistance from F. Hoffmann-La Roche Ltd.: F. Hoffmann-La Roche Ltd. A.S. Cvetanovic: Financial Interests, Invited Speaker, Speaker honoraria: Roche, Novartis, Pfizer, MSD Oncology, AstraZeneca, Merck. S.T. Wilks: Non-Financial Interests, Funding, Research funding: Support for third-party writing assistance from F. Hoffmann-La Roche Ltd.: F. Hoffmann-La Roche Ltd. L.A. Ribeiro: Financial Interests, Personal, Advisory Board: Novartis Farma. M. Burotto: Financial Interests, Other, Consulting fees: F. Hoffmann-La Roche Ltd., Genentech , Bristol Myers Squibb, MSD Oncology, Novartis, AstraZeneca; Financial Interests, Speaker’s Bureau: F.Hoffmann-La Roche Ltd., Genentech, MSD Oncology, Bristol Myers Squib, AstraZeneca. T. Boulet: Financial Interests, Personal, Full or part-time Employment, Employee from Parexel which is contracted by F.Hoffmann – La Roche Ltd. for statistical services in the conduct of the study: Parexel. V. Revelant: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd. N. Theron: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd.; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd.; Non-Financial Interests, Personal, Funding, Research funding: Support for third-party editing assistance from F. Hoffmann-La Roche Ltd.: F. Hoffmann-La Roche Ltd. P. Trask: Financial Interests, Personal, Full or part-time Employment, Employed by Genentech and hold stock in Roche.: F. Hoffmann-La Roche Ltd. L.A. Wahyudi: Non-Financial Interests, Funding, Research funding: Support for third-party writing assistance from F. Hoffmann-La Roche Ltd.: F. Hoffmann-La Roche Ltd. Z. Machackova: Financial Interests, Stocks/Shares: F. Hoffmann-La Roche Ltd. L. Stamatovic: Financial Interests, Personal, Invited Speaker: AstraZeneca, F. Hoffmann-La Roche Ltd., Novartis, Pfizer, MSD , Eli Lilly; Non-Financial Interests, Personal, Funding, Research Funding: Support for third-party writing assistance: F. Hoffmann-La Roche Ltd.