Annals of Oncology 12:923-927, 2001
© 2001 European Society for Medical Oncology
research-article |
Paclitaxel plus topotecan treatment for patients with relapsed or refractory aggressive non-Hodgkin's lymphoma
1Department of Lymphomna and Myeloma Houston, Texas, USA
2Division of Radiology Houston, Texas, USA
3Department of Biostatistics, The University of Texas M. D.Anderson Cancer Center Houston, Texas, USA
A. Younes. MD Department of Lymphoma and Myeloma The University of Texas M.D. Anderson Cancer Center 1515 Holcombe Boulevard Houston, TX 77030 USA E-mail ayounes{at}mail.mdanderson.org
Background. Used as single agents, paclitaxel and topotecan have demonstrated promising activity in treating patients with relapsed aggressive non-Hodgkin's lymphoma (NHL). We conducted a phase II clinical trial to investigate the activity and tolerabilit of the combination both drugs.
Patients and methods: Patients with refractory or relapsed aggressive NHL who had previously been treated with a maximum of two prior chemotherapeutic regimens were given intravenous infusions of paclitaxel 200 mg/m2 over three hours on day one and topotecan 1 mg/m2 over 30 minutes daily from days one to five. All patients received daily subcutaneous injections of fligrastim (granulocyte colony-stimulating factor) 5 .µg/kg starting 24 hours after the last dose of chemotherapy until neutrophil recovery. Treatments were repeated every three weeks for a maximum of six courses. Patients who achieved partial remission or complete remission (CR) after at least two courses were offered stem cell transplantation, if eligible.
Results: Of the 71 patients eligible for this trial, 66 (93%) were evaluable for treatment response. The median age was 53 years (range 23 to 74 years). Thirty-six percent of the patients h previously been treated with ara-C/platinum based regimens, and 48% failed to achieve CR after primary induction therapy. Sixty-seven percent of the patients had elevated lactate dehydrogenase levels at the time of treatment initiation. The overall response rate was 48% (95% confidence interval (95% CI): 36%–61%). Patients who had primary re fractory disease had a response rate of 31%, compared with 65% for patients who did not. Similarly, the response rate of patients who failed to achieve CR after their most recent previous therapy was 37%, compared with a 65% response rate in patients who relapsed from a first or second CR. The median duration of response was six months. A total of 199 courses were given, with a median of three courses per patient. Neutropenia at levels 
500 leukocytes per microliter was observed after 32% of the courses, and thrombocytopenia at levels 20,000 platelets per microliter was observed after 17% of the courses. Grade 3–4 neutropenic fever occurred after 6% of the courses. Non-hematologic toxic effects were pre dominantly grade 1%2.
Conclusion: The combination of paclitaxel and topotecan is an effective first or second line salvage therapy for patients with relapsed or refractory aggressive NHL who had prior anthracycline-or platinum-based chemotherapy.
G-CSF, lymphoma, therapy