DOCETAXEL (Page 9 of 20)

Combination therapy with docetaxel in chemotherapy-naive advanced unresectable or metastatic NSCLC

Table 8presents safety data from two arms of an open label, randomized controlled trial (TAX326) that enrolled patients with unresectable stage IIIB or IV non-small cell lung cancer and no history of prior chemotherapy. Adverse reactions were described using the NCI Common Toxicity Criteria except where otherwise noted.

Table 8: Adverse Reactions Regardless of Relationship to Treatment in Chemotherapy- Naive Advanced Non-small Cell Lung Cancer Patients Receiving Docetaxel in Combination with Cisplatin
Adverse Reaction Docetaxel 75 mg/m 2 + Cisplatin 75 mg/m 2 n=406 % Vinorelbine 25 mg/m 2 + Cisplatin 100 mg/m 2 n=396 %
*
Replaces NCI term “Allergy”
COSTART term and grading system
Neutropenia
Any 91 90
Grade 3/4 74 78
Febrile Neutropenia 5 5
Thrombocytopenia
Any 15 15
Grade 3/4 3 4
Anemia
Any 89 94
Grade 3/4 7 25
Infection
Any 35 37
Grade 3/4 8 8
Fever in absence of infection
Any 33 29
Grade 3/4 < 1 1
Hypersensitivity Reaction *
Any 12 4
Grade 3/4 3 < 1
Fluid Retention
Any 54 42
All severe or life-threatening events 2 2
Pleural effusion
Any 23 22
All severe or life-threatening events 2 2
Peripheral edema
Any 34 18
All severe or life-threatening events <1 <1
Weight gain
Any 15 9
All severe or life-threatening events <1 <1
Neurosensory
Any 47 42
Grade 3/4 4 4
Neuromotor
Any 19 17
Grade 3/4 3 6
Skin
Any 16 14
Grade 3/4 <1 1
Nausea
Any 72 76
Grade 3/4 10 17
Vomiting
Any 55 61
Grade 3/4 8 16
Diarrhea
Any 47 25
Grade 3/4 7 3
Anorexia
Any 42 40
All severe or life-threatening events 5 5
Stomatitis
Any 24 21
Grade 3/4 2 1
Alopecia
Any 75 42
Grade 3 <1 0
Asthenia
Any 74 75
All severe or life-threatening events 12 14
Nail Disorder
Any 14 <1
All severe events <1 0
Myalgia
Any 18 12
All severe events <1 <1

Deaths within 30 days of last study treatment occurred in 31 patients (7.6%) in the docetaxel+cisplatin arm and 37 patients (9.3%) in the vinorelbine+cisplatin arm. Deaths within 30 days of last study treatment attributed to study drug occurred in 9 patients (2.2%) in the docetaxel+cisplatin arm and 8 patients (2.0%) in the vinorelbine+cisplatin arm.

The second comparison in the study, vinorelbine+cisplatin versus docetaxel+carboplatin (which did not demonstrate a superior survival associated with docetaxel [see Clinical Studies (14.3)] ) demonstrated a higher incidence of thrombocytopenia, diarrhea, fluid retention, hypersensitivity reactions, skin toxicity, alopecia and nail changes on the docetaxel+carboplatin arm, while a higher incidence of anemia, neurosensory toxicity, nausea, vomiting, anorexia and asthenia was observed on the vinorelbine+cisplatin arm.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.