ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(十三)
isorders Peripheral neuropathya 48 3 64 12
General disorders
and administration
site conditions Edema peripheral 10 0 4 <1
Respiratory
thoracic and
mediastinal
disorders Epistaxis 7 0 2 0
Musculoskeletal
and connective
tissue disorders Arthralgia 13 <1 25 2
Myalgia 10 <1 19 2
For the ABRAXANE plus carboplatin treated group, 17/514 (3%) patients developed Grade 3 peripheral neuropathy and no patients developed Grade 4 peripheral neuropathy. Grade 3 neuropathy improved to Grade 1 or resolved in 10/17 patients (59%) following interruption or discontinuation of ABRAXANE.
6.3 Clinical Trials Experience in Adenocarcinoma of the Pancreas
Adverse reactions were assessed in 421 patients who received ABRAXANE plus gemcitabine and 402 patients who received gemcitabine for the first-line systemic treatment of metastatic adenocarcinoma of the pancreas in a multicenter, multinational, randomized, controlled, open-label trial. Patients received a median treatment duration of 3.9 months in the ABRAXANE/gemcitabine group and 2.8 months in the gemcitabine group. For the treated population, the median relative dose intensity for gemcitabine was 75% in the ABRAXANE/gemcitabine group and 85% in the gemcitabine group. The median relative dose intensity of ABRAXANE was 81%.
Table 9 provides the frequency and severity of laboratory-detected abnormalities which occurred at a higher incidence for Grades 1-4 (≥ 5%) or for Grade 3-4 (≥ 2%) toxicity in ABRAXANE plus gemcitabine-treated patients.
Table 9: Selected Hematologic Laboratory-Detected Abnormalities with a Higher Incidence (≥ 5% for Grades 1-4 or ≥ 2% for Grades 3-4 Events) in the ABRAXANE/Gemcitabine Arm a 405 patients assessed in ABRAXANE/gemcitabine-treated group
b 388 patients assessed in gemcitabine-treated group
c 404 patients assessed in ABRAXANE/gemcitabine-treated group
d Neutrophil growth factors were administered to 26% of patients in the ABRAXANE/gemcitabine group.
ABRAXANE(125 mg/m2)/
Gemcitabined Gemcitabine
Grades 1-4
(%) Grade 3-4
(%) Grades 1-4
(%) Grade 3-4
(%)
Neutropeniaa,b 73 38 58 27
Thrombocytopeniab,c 74 13 70 9
Table 10 provides the frequency and severity of adverse reactions which occurred with a difference of ≥ 5% for all grades or ≥ 2% for Grade 3 or higher in the ABRAXANE plus gemcitabine-treated group compared to the gemcitabine group.
Table 10: Selected Adverse Reactions with a Higher Incidence (≥5% for All Grade Toxicity or ≥2% for Grade 3 or Higher Toxicity) in the ABRAXANE/Gemcitabine Arm a Peripheral neuropathy is defined by the MedDRA Version 15.0 Standard MedDRA Query neuropathy (broad scope).
b Urinary tract infections includes the preferred terms of: urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, and urinary tract infection enterococcal.
System Organ Class Adverse Reaction ABRAXANE (125 mg/m2) and
gemcitabine (N=421) Gemcitabine (N=402)
All Grades Grade 3 or
Higher All Grades Grade 3 or
Higher
General disorders and
administration site conditions Fatigue 248 (59%) 77 (18%) 183 (46%) 37 (9%)
Peripheral edema 194 (46%) 13 (3%) 122 (30%) 12 (3%)
Pyrexia 171 (41%) 12 (3%) 114 (28%) 4 (1%)
Asthenia 79 (19%) 29 (7%) 54 (13%) 17 (4%)
Mucositis 42 (10%) 6 (1%) 16 (4%) 1 (<1%)
Gastrointestinal disorders Nausea 22 |
