Weekly chemotherapy with cisplatin and paclitaxel in advanced NSClC: a phase II study.
BACKGROUND
This phase II study was designed to assess the activity and toxicity of administration of the cisplatin/paclitaxel combination in advanced non-small cell lung cancer (NSCLC).


METHODS
Eligibility criteria included: age up to 70 years, pathological diagnosis of NSCLC, inoperable disease or post-operative tumour recurrence, performance status < or =2, no severe co-morbidity, no previous chemotherapy, and informed consent. Treatment consisted of intravenous infusion of cisplatin, 25 mg/m2, and paclitaxel, 80 mg/m2, every week. Chemotherapy was continued until completion of a 22-week treatment plan, disease progression, persistent toxicity, or patient refusal.


RESULTS
Forty-nine patients entered the study. They received a median of 14 cycles (range 0-22). For both drugs, the median dose-intensity was 75% of projected. Toxicity was generally acceptable, and never life threatening. Alopecia was the most common side effect, followed by anemia, leukopenia, and nausea/vomiting. Twenty patients responded (40.8% response rate), with three complete, pathologically documented responses. The estimated median time to progression was 35 weeks (95% CI: 29-41); the median survival time was 56 weeks (95% CI: not calculable), with a 2-year survival rate of 46.1%.


CONCLUSIONS
When given on a weekly basis, the cisplatin/paclitaxel combination is well tolerated, active, and associated to remarkably long survivals.
Buccheri
G
G
Cuneo Lung Cancer Study Group, Struttura Complessa di Pneumologia, Ospedale A. Carle, Azienda Ospedaliera S. Croce e Carle, Cuneo, 1-12100, Italy. buccheri@culcasg.org
Ferrigno
D
D
Giordano
M C
MC
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D015331:Cohort Studies; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D016896:Treatment Outcome
D017239:Paclitaxel; D002945:Cisplatin