Phase I study of Nedaplatin, a platinum based antineoplastic drug, combined with nab-paclitaxel in patients with advanced squamous non-small cell lung cancer.

Abstract

Background This study was designed to determine the recommended dose of a combination of nedaplatin (NED) and nab-paclitaxel (nab-PTX) in chemotherapy-naive patients with advanced squamous non-small-cell lung cancer (NSCLC). Methods Patients received escalating doses of NED on day 1 and nab-PTX on days 1, 8, and 15 every 4 weeks by an intravenous infusion for up to six cycles. Results A dose of 100 mg/m2 NED and 100 mg/m2 nab-PTX was determined to be the recommended dose for patients with advanced squamous NSCLC. The study had an overall response rate of 66.7% (95% confidence interval [CI]: 38.4-88.2) and disease control rate of 93.3% (95% CI: 68.1-99.8). The median progression-free survival time and survival time was 7.0 months (95% CI: 5.9-8.1) and 13.1 months (95% CI: 6.2-20.1), respectively. The most common adverse events were neutropenia (grade 3/4, 33%) and leukopenia (grade 3/4, 27%). Although peripheral neuropathy was observed in 5 patients (grade 1/2), non-hematological toxic effects were relatively mild. Febrile neutropenia, pneumonitis, and treatment-related death were not observed. Conclusions The combination of NED and nab-PTX was a tolerable and effective regimen and its recommended dose was 100 mg/m2 and 100 mg/m2, respectively, in chemotherapy-naive patients with advanced squamous NSCLC (UMIN000010963).

• Authors: Satoshi Igawa, Sakiko Otani, Yoshiro Nakahara, Shinichiro Ryuge, Yasuhiro Hiyoshi, Tomoya Fukui, Hisashi Mitsufuji, Masaru Kubota, Masato Katagiri, Yuichi Sato, Jiichiro Sasaki, Noriyuki Masuda
• Journal: Investigational new drugs (Invest New Drugs) Vol. 36 Issue 1 Pg. 45-52 (02 2018) ISSN: 1573-0646 [Electronic] United States
• PMID: 28466376 (Publication Type: Clinical Trial, Phase I, Journal Article)

Chemical References

• 130-nm albumin-bound paclitaxel
• Albumins
• Antineoplastic Agents
• Organoplatinum Compounds
• nedaplatin
• Paclitaxel

Topics

• Aged
• Albumins (therapeutic use)
• Antineoplastic Agents (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy)
• Carcinoma, Squamous Cell (drug therapy)
• Female
• Humans
• Kaplan-Meier Estimate
• Lung Neoplasms (drug therapy)
• Male
• Middle Aged
• Organoplatinum Compounds (therapeutic use)
• Paclitaxel (therapeutic use)
• Progression-Free Survival