A three-week schedule of gemcitabine–cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels: A phase II randomized trial

• Published in: Annals of oncology Vol. 11; no. 10; pp. 1295 - 1300
• Main Authors: Rinaldi, M., Crinò, L., Scagliotti, G. V., Mosconi, A. M., De Marinis, F., Gridelli, C., Selvaggi, G., Della Giulia, M., Darwish, S., Porrozzi, S., Novello, S., Cipri, A., Bartolucci, R., Calandri, C., Tonato, M.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.10.2000
• Subjects: Adult; advanced NSCLC; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Chemotherapy; Cisplatin - administration & dosage; Cisplatin - adverse effects; cisplatin dose level; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Drug Administration Schedule; Female; gemcita-bine–cisplatin combination; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Antineoplastic agent; Human; Lung disease; Drug combination; Gemcitabine; Respiratory disease; Toxicity; Treatment efficiency; Administration schedule; Malignant tumor; Survival; Bronchopulmonary; Cisplatin; Chemotherapy; Randomization; Treatment; Phase II trial; Bronchus disease; Advanced stage; Fluorine Organic compounds; Dose; Pyrimidine nucleoside; Non small cell carcinoma; Platinum II Complexes
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1023/A:1008334610955

Background: To explore a new schedule of gemcitabine–cisplatin (GP) combination therapy using two different cisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: From May to December 1997, 92 chemonaive patients entered the study and 88 (28 with locally advanced and 60 with disseminated NSCLC) were evaluable for response and toxicity (45 in arm A and 43 in arm B). Patients were randomly assigned to arm A or arm B. Gemcitabine 1000 mg/m2 was given on days 1–8 plus cisplatin 100 mg/m2 in arm A and cisplatin 70 mg/m2 in arm B on day 2 of every 21-day cycle. Results: The overall response rates in arms A and B were 42% (95% confidence interval (CI): 27.8%–56.7%) and 47% (95% CI: 31.6%–61.5%), respectively. Median duration of response was 9.7 months (range 1.8 to 30.9 months; 13.1 and 9.5 months for arm A and B, respectively), and median survival was 12 months (range 0.2 to 31.1 months; 15.4 and 11.5 months for arm A and B, respectively). Major WHO grade 3–4 toxicities in arm A vs. arm B included: thrombocytopenia (23% vs. 17% of courses), leukopenia (15% vs. 4% of courses), anemia (7% vs. 6% of courses), and nausea-vomiting (20% vs. 7% of patients). Grade 1–2 nephrotoxicity occurred in 20% of patients in arm A and in 7% of patients in arm B, with one grade 4 episode in arm A. Six patients discontinued treatment because of toxicities, 5 in arm A and 1 in arm B. Conclusions: Results of this trial indicate that both schedules are feasible and active, with a milder toxicity in the arm with the lower cisplatin dose.