A phase II study of S‑1 in relapsed small cell lung cancer

Kudo,Keita; Ohyanagi,Fumiyosi; Horiike,Atsushi; Miyauchi,Eisaku; Tahanaka,Hisashi; Yanagitani,Noriko; Saito,Ryouta; Kaburaki,Kyouhei; Sakatani,Toshio; Horai,Takeshi; Nishio,Makoto

doi:10.3892/mco.2013.67

A phase II study of S‑1 in relapsed small cell lung cancer

Authors:
- Keita Kudo
- Fumiyosi Ohyanagi
- Atsushi Horiike
- Eisaku Miyauchi
- Hisashi Tahanaka
- Noriko Yanagitani
- Ryouta Saito
- Kyouhei Kaburaki
- Toshio Sakatani
- Takeshi Horai
- Makoto Nishio
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Affiliations: Thoracic Oncology Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Koto-ku, Tokyo 135-8550, Japan
Published online on: January 14, 2013 https://doi.org/10.3892/mco.2013.67
Pages: 263-266

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Abstract

S‑1 is a new oral fluoropyrimidine derivative designed to enhance anticancer activity and reduce gastrointestinal toxicity. This phase II trial aimed to evaluate S‑1 in patients with relapsed small cell lung cancer (SCLC). SCLC patients who had experienced treatment failure with ≥1 prior chemotherapies were eligible. Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0‑2 and adequate organ function. Treatment consisted of oral S‑1 at 40 mg/m2 twice/day for 28 days every 6 weeks. Twenty-six patients were enrolled, 85% of whom were males. The median age was 68 years (range, 33‑79) and 81% of the patients had a performance status of 0‑1, and 46% of the patients had relapse‑sensitive SCLC. An objective response was obtained in only 1 patient (3.8%), and the median progression‑free survival (PFS) was 1.1 months. The median overall survival was 5.3 months, and the 1‑year survival rate was 23%. The most common grade 3/4 toxicities included neutropenia (7.7%), leukopenia (7.7%), anemia (7.7%), hyponatremia (7.7%), rash (7.7%), infection (7.7%) and diarrhoea (3.8%). None of the patients developed febrile neutropenia and no deaths were attributed to treatment. In conclusion, S‑1 has minimal single‑agent activity in relapsed SCLC.

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