Phase II trial of 9-aminocamptothecin as a 72-h infusion in cutaneous T-cell lymphoma.

摘要: Purpose: To evaluate the role of9-aminocamptothecin (9-AC), a syntheticcamptothecin analog, in advanced cutaneousT-cell lymphoma (CTCL). Methods: Eligible patientshad stage IIB-IV CTCL. 9-AC was infused over 72 h at adose of 1,100 μg/m2 per day (approximately46 μg/m2/h) every 2 weeks, withgranulocyte-colony stimulating factor(G-CSF) support. Results: Twelve patients received atotal 30 cycles 9-AC. Nine hadstage IV disease, 5 hadcirculating Sezary cells, and evidence tranformation to alarge cell lymphoma. Most patientswere heavily pretreated: 10 had receivedprior chemotherapy (83%), whom hadreceived or more prior regimens,including patient who receivedhigh-dose chemotherapy, 7 hadpreviously total-skin electronbeam therapy. The study prematurelyterminated due substantial toxicity. Sixpatients (50%) developed an indwellingcentral venous catheter-related infection,5 during period neutropenia. Threepatients died sepsis 4-8 weeks aftertheir last treatment. Two thesepatients previous history ofbacterial sepsis. Four (33%)developed grade thrombocytopenia. Twopartial responses were observed (responserate 17%), but duration responsewas brief, weeks. Conclusion: thisschedule route administration activity resultedin unacceptable rate complicatedneutropenia septic deaths heavilypretreated with CTCL whoare susceptible catheter-relatedinfections.