Phase II study of paclitaxel in relapsed non-Hodgkin's lymphomas.
OBJECTIVE
To assess the efficacy and toxicity of paclitaxel administered as a 96-hour infusion to patients with relapsed non-Hodgkin's lymphomas (NHLs).


METHODS
Eligible patients had relapsed NHL and measurable disease and were considered incurable. Paclitaxel was infused at a dose of 140 mg/m2 every 3 weeks. Premedications to prevent paclitaxel hypersensitivity reactions were not administered and no patients received corticosteroids. Expression of the multidrug resistance (mdr-1) gene was determined in tumor from 17 patients by mRNA quantitative polymerase chain reaction (PCR).


RESULTS
Thirty-one patients received a total of 99 cycles of paclitaxel. Two patients were not assessable for response. The median age was 50 years, 71% had stage IV disease, and intermediate/high-grade histology was present in 65% of patients. Patients had received a median of three prior chemotherapy regimens, and 68% of patients had responded to the previous chemotherapy (chemotherapy-sensitive). Of 29 assessable patients, five (17%) achieved a partial response (PR). With a median potential follow-up time of 17 months, the median event-free and overall survival durations were 1.6 and 7.5 months, respectively. No correlation was found between response to paclitaxel and extent of prior treatment or response. The mdr-1 gene was 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.


CONCLUSIONS
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 extent of our response to prior treatment. Most patients had chemotherapy-sensitive disease, which suggests that the low response rate to paclitaxel was probably not due to general chemotherapy resistance. Paclitaxel provided good palliation in a minority of patients and is a reasonable agent to consider for use in patients who have failed to respond to standard chemotherapy.
Wilson
W H
WH
Medicine Branch, National Cancer Institute, Bethesda, MD 20892.
Chabner
B A
BA
Bryant
G
G
Bates
S
S
Fojo
A
A
Regis
J
J
Jaffe
E S
ES
Steinberg
S M
SM
Goldspiel
B R
BR
Cheson
B D
BD
D000328:Adult; D000368:Aged; D018572:Disease-Free Survival; D018432:Drug Resistance, Multiple; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D010166:Palliative Care; D016133:Polymerase Chain Reaction; D012333:RNA, Messenger / Q000235:genetics; D012008:Recurrence
D012333:RNA, Messenger; D017239:Paclitaxel