A phase II study of biweekly paclitaxel (P) and gemcitabine (G), followed by maintenance weekly paclitaxel in elderly patients with advanced non-small cell lung cancer (NSCLC).
BACKGROUND
This phase II study was conducted to evaluate the efficacy and safety of a novel combination of paclitaxel (P) and gemcitabine (G) in an every 2 weeks schedule followed by weekly paclitaxel (P) as first-line treatment in elderly patients with locally advanced or metastatic NSCLC.


METHODS
Elderly patients (> or =65 years of age) with 1997 TNM stage IIIB (pleural effusion)/stage IV NSCLC, performance status (PS) of 0-2 and normal organ function were eligible. Therapy consisted of P at 150 mg/m(2) and G at 2000 mg/m(2) administered every 2 weeks for 3 cycles followed, in progression-free patients, by P at 80 mg/m(2) every week for 6 consecutive weeks every 8 weeks for 2 cycles.


RESULTS
Fifty-three eligible patients were enrolled: M/F 51/2; stage IIIB/IV 8/45; PS 0, 40%, PS 1 51%, PS 2 9%; median age, 73 years (range 67-82). The overall response rate was 32% (95% confidence interval [CI]: 19-45). The median overall survival was 7 months (95% CI: 5-9); the median progression-free survival was 5 months (95% CI: 3-6); and the 1- and 2-year survivals were 28.3% and 10.1%, respectively. Both phases of the treatment protocol were well tolerated.


CONCLUSIONS
Biweekly P/G followed by weekly P is well tolerated and active as first-line therapy for elderly NSCLC patients.
Pino
Maria Simona
MS
Division of Medical Oncology A, Regina Elena National Cancer Institute, Via Chianesi 53, Rome 00144, Italy. pino@ifo.it
Gamucci
Teresa
T
Mansueto
Giovanni
G
Trapasso
Tiziana
T
Narducci
Filomena
F
Giampaolo
Maria Anna
MA
Fariello
Anna Maria
AM
Sperduti
Isabella
I
Ceribelli
Anna
A
Cognetti
Francesco
F
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage*; D000093542:Gemcitabine
D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine