atients treated with Nipent was similar to that in Nipent-treated frontline patients. At a median follow-up duration of 46 months, there was no statistically significant difference in survival between hairy cell leukemia patients initially treated with Nipent and those initially treated with IFN. However, no definite conclusions regarding survival can be made from these results because they are complicated by the fact that the majority of IFN patients crossed over to Nipent treatment.
In the Phase 3 SWOG study, 25 patients with hairy cell leukemia died during treatment or follow-up: 18 patients had last received Nipent (3 of whom had crossed over from IFN), and 7 patients had last received IFN (1 of whom crossed over from Nipent). Eleven of the 25 deaths occurred within 60 days of the last dose of treatment. Of these, hairy cell leukemia was cited by the investigators as a contributory cause for 1 death in the Nipent group and 3 deaths in the IFN group. Additionally, infection contributed to the deaths of 3 patients in the Nipent group and 2 patients in the IFN group. Approximately 4% of hairy cell leukemia patients, in each arm, died more than 60 days after the last dose of either treatment and there was no outstanding cause of death among these patients.
Indications and Usage for Nipent
Nipent is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
Contraindications
Nipent is contraindicated in patients who have demonstrated hypersensitivity to Nipent.
Warnings
See Boxed Warning.
Patients with hairy cell leukemia may experience myelosuppression primarily during the first few courses of treatment. Patients with infections prior to Nipent treatment have in some cases developed worsening of their condition leading to death, whereas others have achieved complete response. Patients with infection should be treated only when the potential benefit of treatment justifies the potential risk to the patient. Efforts should be made to control the infection before treatment is initiated or resumed.
In patients with progressive hairy cell leukemia, the initial courses of Nipent treatment were associated with worsening of neutropenia. Therefore, frequent monitoring of complete blood counts during this time is necessary. If severe neutropenia continues beyond the initial cycles, patients should be eva luated for disease status, including a bone marrow examination.
Elevations in liver function tests occurred during treatment with Nipent and were generally reversible.
Renal toxicity was observed at higher doses in early studies; however, in patients treated at the recommended dose, elevations in serum creatinine were usually minor and reversible. There were some patients who began treatment with normal renal function who had evidence of mild to moderate toxicity at a final assessment. (See DOSAGE AND ADMINISTRATION.)
Rashes, occasionally severe, were commonly reported and may worsen with continued treatment. Withholding of treatment may be required. (See DOSAGE AND ADMINISTRATION.)
Acute pulmonary edema and hypotension, leading to death, have been reported in the literature in patients treated with pentostatin in combination with carmustine, etoposide and high dose cyclophosphamide as part of the ablative regimen for bone marrow tr
