HER
SafeHER was a prospective, two-cohort, non-randomized, multi-center, multinational, open-label study to assessthe safety of HERCEPTIN HYLECTA in patients with operable HER2-positive breast cancer. In SafeHER, 1864patients were enrolled and treated with 600 mg of HERCEPTIN HYLECTA administered subcutaneously onceevery three weeks for 18 cycles.
The median age of patients was 54 (range: 20-88 years), 99.8% were female, and a majority were white (76%).
A majority of the patients received HERCEPTIN HYLECTA concurrently with a chemotherapy regimen (58%).
The median number of HERCEPTIN HYLECTA cycles administered was 18 and the median duration ofHERCEPTIN HYLECTA exposure was 11.8 months. The median duration of follow-up was 23.7 months.
During the treatment period, the most common adverse reactions of any grade (occurring in ≥10% of patients)were ARRs (39%), diarrhea (21%), fatigue (21%), arthralgia (21%), nausea (15%), myalgia (14%), headache(13%), asthenia (12%), pain in extremity (11%), cough (11%), pyrexia (11%), hot flush (10%), and rash(10%). The most common Grade ≥3 adverse reactions (occurring in >1% of patients) were neutropenia (4%),febrile neutropenia (2%), hypertension (2%), leukopenia (1%), and diarrhea (1%). Adverse reactions that ledto study drug discontinuation (≥0.5% of patients) were ejection fraction decreased (2%) and left ventriculardysfunction (1%).
The incidence of ARRs was 39%, with Grade ≥3 ARRs reported in 1% of patients treated with HERCEPTINHYLECTA. The most frequently reported Grade ≥3 ARRs were dyspnea (<1%), cough (<1%), erythema (<1%),rash (<1%), and drug hypersensitivity (<1%). ISRs were reported in 20% of patients treated with HERCEPTINHYLECTA. The most common ISRs were injection-site erythema (7%) and injection-site pain (6%). All ISRswere Grade 1 or 2, except for one (<1%) Grade 3 injection site discomfort.
The data in Table 4 were obtained from the SafeHER trial for adverse reactions that occurred in ≥5% of thepatients treated with HERCEPTIN HYLECTA.
Table 4
Adverse Reactions* (≥ 5% Incidence) Reported in SafeHER
Adverse Reactions *,†
HERCEPTIN HYLECTA
600 mg (once every 3 weeks)
n=1864
All Grades
%
Grades 3 to 5
%
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Fatigue* 33 < 1
Injection Site Reaction*,‡ 20 < 1
Edema* 12 < 1
Pyrexia* 11 < 1
Pain* 8 < 1
Mucosal Inflammation 6 < 1
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Arthralgia* 21 < 1
Myalgia* 17 < 1
Pain in Extremity 11 < 1
Back Pain* 8 < 1
Pain* 7 < 1
GASTROINTESTINAL DISORDERS
Diarrhea* 21 1
Nausea 15 < 1
Abdominal Pain* 10 < 1
Constipation 9 < 1
Stomatitis* 8 < 1
Vomiting 7 < 1
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rash* 17 < 1
Nail Disorder* 10 < 1
Alopecia* 9 < 1
Erythema* 9 < 1
Pruritus* 6 -
INFECTIONS AND INFESTATIONS
Upper Respiratory Tract Infection* 19 < 1
Urinary Tract Infection* 6 < 1
Viral Infection* 5 -
NERVOUS SYSTEM DISORDERS
Neuropathy Peripheral* 14 < 1
Headache* 13 < 1
Dizziness* 6 < 1
Paresthesia 6 < 1
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Cough* 11 < 1
Dyspnea* 8 < 1
Epistaxis 6 -
Nasal Inflammation/Discomfort* 6 -
VASCULAR DISORDERS
Flushing* 12 < 1
Hypertension* 8 2
BLOOD AND LYMPHAT |
