Phase II study of nedaplatin and amrubicin as first-line treatment for advanced squamous cell lung cancer.

Abstract

BACKGROUND:

The first-line treatment for squamous cell lung cancer (SCC) has not necessarily been established; however, our previous exploratory study suggested that the combination of nedaplatin and amrubicin would be a promising treatment approach for patients with SCC. Therefore, a phase II study of this chemotherapeutic combination was designed to evaluate its efficacy and safety for treatment-naïve patients with advanced SCC.

METHODS:

A total of 21 treatment-naïve patients with stage IIIB/IV or postoperative recurrent SCC were enrolled from six institutions. Nedaplatin (100 mg/m2 ) on day 1 and amrubicin (25 mg/m2 ) on days 1-3 were administered intravenously every 4 weeks. The primary endpoint was overall response rate (ORR), while the secondary endpoints included overall survival (OS), progression-free survival (PFS), and drug toxicities.

RESULTS:

Partial response was observed in seven of 21 cases (ORR, 33.3%; 95% confidence interval [CI], 14.5-52.2). Disease control rate, which includes stable disease, was 71.4%. Median OS and PFS was 14.6 and 4.1 months, respectively. This regimen did not cause any treatment-related deaths. Grade 3/4 neutropenia developed in 8 of 21 cases (38.1%); however, febrile neutropenia developed in only 9.5% of the cases. Grade 3/4 gastrointestinal or neuromuscular toxicities were not observed.

CONCLUSION:

The efficacy of the combination of nedaplatin and amrubicin was comparable to that of other conventional chemotherapeutic regimens for treatment-naïve patients with advanced SCC, and no severe gastrointestinal or neuromuscular toxicities were observed. This combination therapy may be an alternative treatment approach, particularly in patients who cannot tolerate gastrointestinal or neuromuscular toxicities.

• Authors: Hirokazu Taniguchi, Hiroyuki Yamaguchi, Yosuke Dotsu, Midori Shimada, Hiroshi Gyotoku, Hiroaki Senju, Shinnosuke Takemoto, Takeshi Kitazaki, Masaaki Fukuda, Daiki Ogawara, Hiroshi Soda, Katsumi Nakatomi, Nanae Sugasaki, Akitoshi Kinoshita, Seiji Nagashima, Takaya Ikeda, Yoichi Nakamura, Noriho Sakamoto, Yasushi Obase, Minoru Fukuda, Hiroshi Mukae
• Journal: Thoracic cancer (Thorac Cancer) Vol. 10 Issue 9 Pg. 1764-1769 (09 2019) ISSN: 1759-7714 [Electronic] Singapore
• PMID: 31309738 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: © 2019 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

Chemical References

• Anthracyclines
• Organoplatinum Compounds
• nedaplatin
• amrubicin

Topics

• Aged
• Anthracyclines (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, pathology)
• Drug-Related Side Effects and Adverse Reactions
• Female
• Follow-Up Studies
• Humans
• Lung Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Organoplatinum Compounds (administration & dosage)
• Prognosis
• Survival Rate