Phase II study of oral doxifluridine in elderly patients with advanced non-small-cell lung cancer.
Elderly patients with advanced non-small-cell lung cancer (NSCLC) are usually excluded from most clinical trials because of the toxicity associated with chemotherapy. About 50% of the new cases of lung cancer occur in patients older than 65 years. Doxifluridine is a fluoropyrimidine derivate which can be administered orally with very low toxicities. This phase II study evaluates the toxicity and activity of a home therapy with oral doxifluridine in elderly advanced NSCLC patients. Thirty-three advanced NSCLC patients, aged 70 years or more, entered the study; median ECOG performance status was 1 (0-2) and 22 patients (66.6%) had metastatic disease. Doxifluridine was given orally in three divided doses, for a total daily dose of 2,250 mg, for 4 consecutive days every week. The treatment was well tolerated; five patients (15%) experienced a grade 3 diarrhea which required doxifluridine dose reduction to 1,500 mg daily. Thirty-one patients are evaluable for response; four partial responses (12.9%) have been observed (95% confidence limit interval 3.6-29.8%); 17 patients (54.8%) had a stabilization of the disease. This study demonstrates that a home therapy with oral doxifluridine in elderly NSCLC patients is feasible and well tolerated and should encourage further studies.
Baldini
E
E
Division of Medical Oncology, St. Chiara Hospital, Pisa, Italy.
Tibaldi
C
C
Pfanner
E
E
Ricci
S
S
Falcone
A
A
Ceribelli
A
A
Sarcina
R
R
Comella
G
G
Stampino
C G
CG
Conte
P F
PF
D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005240:Feasibility Studies; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006699:Home Care Services; D006801:Humans; D007536:Isomerism; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D012074:Remission Induction
D000970:Antineoplastic Agents; D005467:Floxuridine; C025034:doxifluridine