Phase II trial of weekly paclitaxel and gemcitabine for previously untreated, stage IIIB-IV nonsmall cell lung cancer.
BACKGROUND
The purpose of the current study was to evaluate the efficacy and tolerance of the noncisplatin-based combination of paclitaxel and gemcitabine administered weekly for patients with untreated metastatic nonsmall cell lung cancer (NSCLC).


METHODS
Patients with Stage IIIB/IV or recurrent NSCLC, a performance status of 0-2, and no prior chemotherapy exposure were eligible. Patients received gemcitabine 1000 mg/m2 and paclitaxel 85 mg/m2 on Days 1, 8, 15, 22, 29, 36 of an 8-week cycle until progression.


RESULTS
Thirty-nine eligible patients were enrolled. The median age was 66 years and 14 patients were > or =70 years old. Performance status was 2 in 13 (33%) and 29 patients (75%) had Stage IV. Five patients (12.8%) developed interstitial pneumonitis and 2 of these were responsive to steroid therapy. The overall response rate was 23.1%, with no complete responses. The median survival was 32 weeks and the 1-year survival was 32%.


CONCLUSIONS
This regimen of weekly paclitaxel and gemcitabine has modest activity in advanced NSCLC.
Akerley
Wallace
W
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah 84115, USA. akerley@HCI.utah.edu
Safran
Howard
H
Zaner
Ken
K
Ready
Neal
N
Mega
Tony
T
Kennedy
Teresa
T
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008168:Lung / Q000187:drug effects; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D016879:Salvage Therapy; D015996:Survival Rate; D000093542:Gemcitabine
D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine