PHASE-II STUDY OF PACLITAXEL IN RELAPSED NON-HODGKINS-LYMPHOMAS

Purpose: To assess the efficacy and toxicity of paclitaxel administere d as a 96-hour infusion to patients with relapsed non-Hodgkin's lympho mas (NHLs). Patients and Methods: Eligible patients had relapsed NHL a nd measurable disease and were considered incurable. Paclitaxel was in fused at a dose of 140 mg/m(2) every 3 weeks. Premedications to preven t paclitaxel hypersensitivity reactions were not administered and no p atients received corticosteroids. Expression of the multidrug resistan ce (mdr-1) gene was determined in tumor from 17 patients by mRNA quant itative polymerase chain reaction (PCR). Results: Thirty-one patients received a total of 99 cycles of paclitaxel. Two patients were not ass essable for response. The median age was 50 years, 71% had stage IV di sease, and intermediate/high-grade histology was present in 65% of pat ients. Patients had received a median of three prior chemotherapy regi mens, and 68% of patients had responded to the previous chemotherapy ( chemotherapy-sensitive). Of 29 assessable patients, five (17%) achieve d a partial response (PR). With a median potential follow-up time of 1 7 months, the median even-free and overall survival durations were 1.6 and 7.5 months, respectively. No correlation was found between respon se to paclitaxel and extent of prior treatment or response. The mdr-1 gene wets easily detectable in 14 of 17 tumor biopsies, but was low in all but one sample. The most serious toxicity was grade 4 neutropenia , which occurred during 14% of cycles. Conclusion: Paclitaxel was well tolerated, but had a low response rate in patients with relapsed NHLs . There was no clear association between response to paclitaxel and ex tent of or response to prior treatment. Most patients had chemotherapy -sensitive disease, which suggests that the low response rate to pacli taxel was probably not due to general chemotherapy resistance. Paclita xel provided good palliation in a minority of patients and is a reason able agent to consider for use in patients who have failed to respond to standard chemotherapy.