Phase I trial of nedaplatin and S‑1 in patients with advanced squamous cell lung cancer

Kanaji,Nobuhiro; Ishii,Tomoya; Ueda,Yutaka; Ichikawa,Hirohisa; Kishimoto,Nobuhito; Kadowaki,Norimitsu

doi:10.3892/mco.2020.2159

Phase I trial of nedaplatin and S‑1 in patients with advanced squamous cell lung cancer

Authors:
- Nobuhiro Kanaji
- Tomoya Ishii
- Yutaka Ueda
- Hirohisa Ichikawa
- Nobuhito Kishimoto
- Norimitsu Kadowaki
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Affiliations: Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 761‑0793, Japan, Department of Respiratory Medicine, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa 760‑8557, Japan, Department of Internal Medicine, Federation of National Public Service Personnel Mutual Aid Associations Takamatsu Hospital, Takamatsu, Kagawa 760‑0018, Japan, Department of Pulmonary Medicine, Takamatsu Municipal Hospital, Takamatsu, Kagawa 761‑8538, Japan
Published online on: October 23, 2020 https://doi.org/10.3892/mco.2020.2159
Article Number: 90
Copyright: © Kanaji et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

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Abstract

The platinum doublet is considered to be the standard cytotoxic chemotherapy for advanced lung cancer. It has been previously reported that nedaplatin and S‑1 have clinical efficacy against squamous cell lung cancer. As the combination of nedaplatin and S‑1 has never been studied for advanced squamous cell lung cancer, a phase I trial of this combination in the first‑line setting was conducted. Patients who had not received chemotherapy previously, aged ≤75 years and with advanced squamous cell lung cancer were recruited. Nedaplatin was administered intravenously (day 1), and S‑1 was orally administered (days 1‑14) at a fixed dose based on the body surface area (BSA) <1.25 m², 80 mg/day; BSA=1.25‑1.5 m², 100 mg/day; and BSA ≥1.5 m², 120 mg/day. A total of 9 patients were enrolled. The maximum tolerated dose was 80 mg/m² for nedaplatin. At this dosage, dose‑limiting toxicity was observed in 2 of the 6 patients. A total of one patient experienced grade 3 thrombocytopenia, and the other patient experienced grade 3 anorexia and grade 3 nausea. The recommended dose for phase II studies was determined as being 70 mg/m2 for nedaplatin (clinical trial registration no. UMIN‑CTR UMIN000036387).

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