Prescription Drug Information: DOCETAXEL (Page 10 of 17)

Head and Neck Cancer

Combination therapy with docetaxel in head and neck cancer

Table 11 summarizes the safety data obtained from patients that received induction chemotherapy with docetaxel 75 mg/m 2 in combination with cisplatin and fluorouracil followed by radiotherapy (TAX323; 174 patients) or chemoradiotherapy (TAX324; 251 patients). The treatment regimens are described in Section 14.6.

Table 11: Clinically Important Treatment-Emergent Adverse Reactions (Regardless of Relationship) in Patients with SCCHN Receiving Induction Chemotherapy with Docetaxel in Combination with Cisplatin and Fluorouracil Followed by Radiotherapy (TAX323) or Chemoradiotherapy (TAX324)
TAX323 (n=355) TAX324 (n=494)
Docetaxel arm (n=174) Comparator arm (n=181) Docetaxel arm (n=251) Comparator arm (n=243)
Adverse Reaction (by Body System) Any % Grade 3/4 % Any % Grade 3/4 % Any % Grade 3/4 % Any % Grade 3/4 %
Clinically important treatment-emergent adverse reactions based upon frequency, severity, and clinical impact.
*
Febrile neutropenia: grade ≥2 fever concomitant with grade 4 neutropenia requiring intravenous antibiotics and/or hospitalization.
Related to treatment.
Includes superficial and deep vein thrombosis and pulmonary embolism
Neutropenia 93 76 87 53 95 84 84 56
Anemia 89 9 88 14 90 12 86 10
Thrombocytopenia 24 5 47 18 28 4 31 11
Infection 27 9 26 8 23 6 28 5
Febrile neutropenia * 5 N/A 2 N/A 12 N/A 7 N/A
Neutropenic infection 14 N/A 8 N/A 12 N/A 8 N/A
Cancer pain 21 5 16 3 17 9 20 11
Lethargy 41 3 38 3 61 5 56 10
Fever in the absence of infection 32 1 37 0 30 4 28 3
Myalgia 10 1 7 0 7 0 7 2
Weight loss 21 1 27 1 14 2 14 2
Allergy 6 0 3 0 2 0 0 0
Fluid retention 20 0 14 1 13 1 7 2
Edema only 13 0 7 0 12 1 6 1
Weight gain only 6 0 6 0 0 0 1 0
Dizziness 2 0 5 1 16 4 15 2
Neurosensory 18 1 11 1 14 1 14 0
Altered hearing 6 0 10 3 13 1 19 3
Neuromotor 2 1 4 1 9 0 10 2
Alopecia 81 11 43 0 68 4 44 1
Rash/itch 12 0 6 0 20 0 16 1
Dry skin 6 0 2 0 5 0 3 0
Desquamation 4 1 6 0 2 0 5 0
Nausea 47 1 51 7 77 14 80 14
Stomatitis 43 4 47 11 66 21 68 27
Vomiting 26 1 39 5 56 8 63 10
Diarrhea 33 3 24 4 48 7 40 3
Constipation 17 1 16 1 27 1 38 1
Anorexia 16 1 25 3 40 12 34 12
Esophagitis/dysphagia/ Odynophagia 13 1 18 3 25 13 26 10
Taste, sense of smell altered 10 0 5 0 20 0 17 1
Gastrointestinal pain/cramping 8 1 9 1 15 5 10 2
Heartburn 6 0 6 0 13 2 13 1
Gastrointestinal bleeding 4 2 0 0 5 1 2 1
Cardiac dysrhythmia 2 2 2 1 6 3 5 3
Venous 3 2 6 2 4 2 5 4
Ischemia myocardial 2 2 1 0 2 1 1 1
Tearing 2 0 1 0 2 0 2 0
Conjunctivitis 1 0 1 0 1 0 0.4 0

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