Phase II study of the combination of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer.

Abstract

BACKGROUND:

To date, no phase II trial of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer (NSCLC) has been published. The safety and efficacy of the combination of nedaplatin and weekly paclitaxel in patients with NSCLC was examined.

PATIENTS AND METHODS:

Patients with previously untreated NSCLC, either stage IIIB with pleural effusion or stage IV, were eligible if they had a performance status of 0 to 2, were 75 years or younger and had adequate organ function. Patients were treated with nedaplatin (80 mg/m(2) on day 1) and weekly paclitaxel (90 mg/m(2) on days 1, 8 and 15).

RESULTS:

From March 2005 through March 2008, 47 patients (31 men and 16 women; median age, 66 years; age range, 38 to 75 years) were enrolled. The overall response rate was 53.2% (95% confidence interval, 38.1% to 67.9%). The median survival time was 13 months (range, 1 to 36 months), the 1-year survival rate was 62% and the median time to disease progression was 5 months (range, 1 to 19 months). Grade 3 to 4 hematologic toxicities included neutropenia in 38.3% of patients, thrombocytopenia in 2.1% and anemia in 23.4% . Although frequent non-hematologic toxicities were nausea, hepatic dysfunction and peripheral neuropathy, all cases were of only mild to moderate severity. Although 1 patient had grade 3 pulmonary toxicity due to drug-induced pneumonia, this patient recovered after receiving steroid therapy.

CONCLUSION:

This combination chemotherapy is effective and well tolerated and is an acceptable therapeutic option for patients with untreated advanced NSCLC.

• Authors: Takashi Hirose, Tomohide Sugiyama, Sojiro Kusumoto, Takao Shirai, Masanao Nakashima, Toshimitsu Yamaoka, Kentaro Okuda, Keiichi Ogura, Tsukasa Ohnishi, Tohru Ohmori, Mitsuru Adachi
• Journal: Anticancer research (Anticancer Res) Vol. 29 Issue 5 Pg. 1733-8 (May 2009) ISSN: 0250-7005 [Print] Greece
• PMID: 19443395 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Organoplatinum Compounds
• nedaplatin
• Paclitaxel

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy)
• Female
• Humans
• Lung Neoplasms (drug therapy)
• Male
• Middle Aged
• Organoplatinum Compounds (administration & dosage)
• Paclitaxel (administration & dosage)