TY - JOUR
T1 - Phase II trial of 9-aminocamptothecin as a 72-h infusion in cutaneous T-cell lymphoma
AU - Argiris, Athanassios
AU - Heald, Peter
AU - Kuzel, Timothy
AU - Foss, Francine M.
AU - Distasio, Susan
AU - Cooper, Dennis L.
AU - Arbuck, Susan
AU - Murren, John R.
PY - 2001/9/5
Y1 - 2001/9/5
N2 - Purpose: To evaluate the role of 9-aminocamptothecin (9-AC), a synthetic camptothecin analog, in advanced cutaneous T-cell lymphoma (CTCL). Methods: Eligible patients had stage IIB-IV CTCL. 9-AC was infused over 72 h at a dose of 1,100 μg/m2 per day (approximately 46 μg/m2/h) every 2 weeks, with granulocyte-colony stimulating factor (G-CSF) support. Results: Twelve patients received a total of 30 cycles of 9-AC. Nine patients had stage IV disease, 5 patients had circulating Sezary cells, and 2 patients had evidence of tranformation to a large cell lymphoma. Most of the patients were heavily pretreated: 10 had received prior chemotherapy (83%), 5 of whom had received 2 or more prior regimens, including a patient who had received high-dose chemotherapy, and 7 had previously received total-skin electron beam therapy. The study was prematurely terminated due to substantial toxicity. Six patients (50%) developed an indwelling central venous catheter-related infection, 5 during a period of neutropenia. Three patients died due to sepsis 4-8 weeks after their last 9-AC treatment. Two of these patients had a previous history of bacterial sepsis. Four patients (33%) developed grade IV thrombocytopenia. Two partial responses were observed (response rate 17%), but the duration of response was brief, 4-8 weeks. Conclusion: 9-AC at this schedule and route of administration had activity but resulted in an unacceptable rate of complicated neutropenia and septic deaths in heavily pretreated patients with advanced CTCL who are susceptible to catheter-related infections.
AB - Purpose: To evaluate the role of 9-aminocamptothecin (9-AC), a synthetic camptothecin analog, in advanced cutaneous T-cell lymphoma (CTCL). Methods: Eligible patients had stage IIB-IV CTCL. 9-AC was infused over 72 h at a dose of 1,100 μg/m2 per day (approximately 46 μg/m2/h) every 2 weeks, with granulocyte-colony stimulating factor (G-CSF) support. Results: Twelve patients received a total of 30 cycles of 9-AC. Nine patients had stage IV disease, 5 patients had circulating Sezary cells, and 2 patients had evidence of tranformation to a large cell lymphoma. Most of the patients were heavily pretreated: 10 had received prior chemotherapy (83%), 5 of whom had received 2 or more prior regimens, including a patient who had received high-dose chemotherapy, and 7 had previously received total-skin electron beam therapy. The study was prematurely terminated due to substantial toxicity. Six patients (50%) developed an indwelling central venous catheter-related infection, 5 during a period of neutropenia. Three patients died due to sepsis 4-8 weeks after their last 9-AC treatment. Two of these patients had a previous history of bacterial sepsis. Four patients (33%) developed grade IV thrombocytopenia. Two partial responses were observed (response rate 17%), but the duration of response was brief, 4-8 weeks. Conclusion: 9-AC at this schedule and route of administration had activity but resulted in an unacceptable rate of complicated neutropenia and septic deaths in heavily pretreated patients with advanced CTCL who are susceptible to catheter-related infections.
KW - 9-aminocamptothecin (9-AC)
KW - Cutaneous T-cell lymphoma
KW - Indwelling catheter-related infection
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U2 - 10.1023/A:1010613912335
DO - 10.1023/A:1010613912335
M3 - Article
C2 - 11561692
AN - SCOPUS:0034870085
SN - 0167-6997
VL - 19
SP - 321
EP - 326
JO - Investigational New Drugs
JF - Investigational New Drugs
IS - 4
ER -