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adverse reactions
ADVERSE REACTIONS Most patients treated for hairy cell leukemia in the five NCI-sponsored Phase 2 studies and the Phase 3 SWOG study experienced an adverse event. The following table lists the most frequently occurring adverse events in patients treated with pentostatin (both frontline and IFN-refractory patients) compared with IFN (frontline only), regardless of drug association. The drug association of some adverse events is uncertain as they may be associated with the disease itself (e.g., infection, hematologic suppression), but other events, such as the gastrointestinal symptoms, rashes, and abnormal liver function tests, can in many cases be attributed to the drug. Most adverse events that were assessed for severity were either mild or moderate, and diminished in frequency with continued therapy. Percent of Patients All Adverse Events a Frontline, TreatedWith Pentostatin N=180 Frontline, TreatedWith IFN N=176 IFN-Refractory, Treated With Pentostatin N=197 Nausea and/or Vomiting 63 22 53 b Fever 46 59 42 Rash 43 30 26 Fatigue 42 55 29 Leukopenia 22 15 60 Pruritus 21 6 10 Coughing/Increased Cough 20 15 17 Myalgia 19 36 11 Chills 19 34 11 Headache 17 29 13 Diarrhea 17 17 15 Abdominal Pain 16 15 4 Anorexia 13 10 16 Upper Respiratory Infection 13 8 16 Asthenia 12 13 10 Stomatitis 12 7 5 Rhinitis 11 15 10 Dyspnea 11 13 8 Anemia 8 5 35 Pain 8 19 20 Pharyngitis 8 11 10 Sweating/Increased Sweating 8 21 10 Viral Infection 8 17 NR Infection 7 c 2 c 36 Arthralgia 6 14 3 Thrombocytopenia 6 6 32 Skin Disorder 4 5 17 Allergic Reaction 2 1 11 Hepatic Disorder/Elevated Liver Function Tests d 2 2 19 Neurologic Disorder, CNS/CNS Toxicity 1 NR 11 Lung Disorder/Disease NR 1 12 Nausea NR NR 22 Genitourinary Disorder NR NR 15 NR = Not Reported a Occurring in more than 10% of patients, in any group, regardless of drug association b Includes only nausea with vomiting c These figures represent only unspecified infections. Refer to infection table. d Elevated liver enzymes and liver disorder for SWOG The total incidence for all types of infections is considerably higher for both treatment groups in the SWOG 8691 study than is listed in the table above. An intent-to-treat analysis of infections found that 38% of patients treated with pentostatin and 34% of patients treated with IFN averaged 2.4 and 1.9 documented infections during treatment, respectively. The following table lists the different types of infections that were reported as adverse events during the initial phase of the SWOG study. There were no apparent differences in the types of infection between the 2 treatment groups, with the possible exception of herpes zoster which was reported more frequently for pentostatin (8%) than for IFN (1%). Percent of Patients Type of Infection Frontline, Treated With Pentostatin N=180 Frontline, Treated With IFN N=176 Upper Respiratory Infection 13 8 Rhinitis 11 15 Herpes Zoster 8 1 Pharyngitis 8 11 Viral Infection 6 17 Infection (Unspecified) 7 2 Sinusitis 6 4 Cellulitis 6 3 Bacterial Infection 5 4 Pneumonia 5 7 Conjunctivitis 4 2 Furunculosis 4 <1 Herpes Simplex 4 1 Bronchitis 3 2 Sepsis 3 2 Urinary Tract Infection 3 3 Abscess, Skin 2 4 Moniliasis, Oral 2 <1 Mycotic Infection, Skin <1 3 Osteomyelitis 1 0 The drug relatedness of the adverse events listed below cannot be excluded. The following adverse events occurred in 3% to 10% of pentostatin-treated patients in the initial phase of the SWOG study: Body as a Whole —Chest Pain, Death, Face Edema, Peripheral Edema Cardiovascular System —Hemorrhage, Hypotension Digestive System —Dental Abnormalities, Dyspepsia, Flatulence, Gingivitis Hemic and Lymphatic System —Agranulocytosis Laboratory Deviations —Elevated Creatinine Musculoskeletal System —Arthralgia Nervous System —Confusion, Dizziness, Insomnia, Paresthesia, Somnolence Psychobiologic Function —Anxiety, Depression, Nervousness Respiratory System —Asthma Skin and Appendages —Skin Dry, Urticaria The remaining adverse events which occurred in less than 3% of pentostatin-treated patients during the initial phase of the SWOG study: Body as a Whole —Flu-like Symptoms, Hangover Effect, Neoplasm Cardiovascular System —Angina Pectoris, Arrhythmia, A-V Block, Bradycardia, Extrasystoles Ventricular, Heart Arrest, Heart Failure, Hypertension, Pericardial Effusion, Phlebitis, Pulmonary Embolus, Sinus Arrest, Tachycardia, Thrombophlebitis Deep, Vasculitis Digestive System —Constipation, Dysphagia, Glossilis, Ileus Hemic and Lymphatic System —Acute Leukemia, Anemia-Hemolytic, Aplastic Anemia Laboratory Deviations —Hypercalcemia, Hyponatremia Musculoskeletal System —Arthritis, Gout Nervous System —Amnesia, Ataxia, Convulsions, Dreaming Abnormal, Dysarthria, Encephalitis, Hyperkinesia, Meningism, Neuralgia, Neuritis, Neuropathy, Paralysis, Syncope, Twitching, Vertigo Psychobiologic Function —Decrease/Loss Libido, Emotional Lability, Hallucination, Hostility, Neurosis, Thinking Abnormal Respiratory System —Bronchospasm, Larynx Edema Skin and Appendages —Acne, Alopecia, Eczema, Petechial Rash, Photosensitivity Reaction Special Senses —Amblyopia, Deafness, Earache, Eyes Dry, Labyrinthitis, Lacrimation Disorder, Nonreactive Eye, Photophobia, Retinopathy, Tinnitus, Unusual Taste, Vision Abnormal, Watery Eyes Urogenital System —Amenorrhea, Breast Lump, Impotence, Kidney Function Abnormal, Nephropathy, Renal Failure, Renal Insufficiency, Renal Stone One patient with hairy cell leukemia treated with pentostatin during another clinical study developed unilateral uveitis with vision loss. Nineteen (5%) patients withdrew from the Phase 3 SWOG 8691 study because of adverse events, 9 during initial pentostatin treatment, 4 during pentostatin crossover, 5 during initial IFN treatment, and 1 during both initial IFN treatment and pentostatin crossover. In the Phase 2 studies in IFN-refractory hairy cell leukemia, 11% of patients withdrew from treatment with pentostatin due to an adverse event.