A phase II trial of weekly paclitaxel and gemcitabine in non-small cell lung cancer patients previously treated with platinum and vinorelbine.

Abstract

This study evaluated the activity and toxicity of a weekly paclitaxel plus gemcitabine combination as second-line treatment in patients with advanced non-small cell lung cancer (NSCLC). Paclitaxel 80 mg/m2 on days 1, 8 and 15 and gemcitabine 1000 mg/m2 on days 1 and 8 every 3 weeks were administered to 34 consecutive, advanced NSCLC patients uniformly pretreated with cisplatin or carboplatin and vinorelbine. The median time interval from first- to second-line treatment was 8 weeks (range 1-72). A total of 124 cycles with a median of 3 cycles per patient were administered (range 1-6). Four patients (12%) achieved a partial response (95% confidence interval: 1-23%), 17 had stable disease (50%) and 12 progressed (37%). Three responses were observed in 14 patients showing disease response or stabilization to previous platinum therapy. The median survival was 28 weeks (range 3-91), the median progression-free survival was 12 weeks (range 3-50) and the 1-year survival rate was 23%. The toxicity profile was favorable. In conclusion, a weekly schedule of paclitaxel plus gemcitabine as a second-line regimen has moderate activity and good tolerability in NSCLC patients not refractory to previous platinum-vinorelbine treatment.

• Authors: Vincenzo Dongiovanni, Alfredo Addeo, Alfredo Berruti, Lucio Buffoni, Diego Dongiovanni, Maria Antonia Polimeni, Camilla Fissore, Carla Barone, Oscar Bertetto
• Journal: Anticancer research (Anticancer Res) 2004 Jul-Aug Vol. 24 Issue 4 Pg. 2567-72 ISSN: 0250-7005 [Print] Greece
• PMID: 15330216 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Deoxycytidine
• Vinblastine
• Paclitaxel
• Cisplatin
• Vinorelbine
• Gemcitabine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy)
• Cisplatin (administration & dosage)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Drug Administration Schedule
• Female
• Humans
• Lung Neoplasms (drug therapy)
• Male
• Middle Aged
• Paclitaxel (administration & dosage, adverse effects)
• Vinblastine (administration & dosage, analogs & derivatives)
• Vinorelbine
• Gemcitabine