Phase II study of nimustine hydrochloride (ACNU) plus paclitaxel for refractory small cell lung cancer

Isobe, Kazutoshi; Kobayashi, Kunihiko; Kosaihira, Seiji; Kurimoto, Futoshi; Sakai, Hiroshi; Uchida, Yuka; Nagai, Yoshiaki; Yamaguchi, Takefumi; Miyanaga, Akihiko; Ando, Makoto; Mori, Gaku; Hino, Mitsunori; Gemma, Akihiko

doi:10.1016/j.lungcan.2009.03.003

« Previous Next »Lung Cancer
Volume 66, Issue 3 , Pages 350-354, December 2009

Phase II study of nimustine hydrochloride (ACNU) plus paclitaxel for refractory small cell lung cancer

Kazutoshi Isobe
- Department of Respiratory Medicine, Toho University Omori Medical Center, Japan
Kunihiko Kobayashi
- Department of Respiratory Medicine, Saitama International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka City, Saitama, 350-1298, Japan
- Corresponding author. Tel.: +81 42 984 4111; fax: +81 42 984 4667.
Seiji Kosaihira
- Department of 4th Internal Medicine, Nippon Medical School, Tokyo, Japan
Futoshi Kurimoto
- Respiratory Section, Saitama Cancer Center, Saitama, Japan
Hiroshi Sakai
- Respiratory Section, Saitama Cancer Center, Saitama, Japan
Yuka Uchida
- Department of Respiratory Medicine, Saitama International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka City, Saitama, 350-1298, Japan
Yoshiaki Nagai
- Department of Respiratory Medicine, Saitama International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka City, Saitama, 350-1298, Japan
Takefumi Yamaguchi
- Department of Respiratory Medicine, Saitama International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka City, Saitama, 350-1298, Japan
Akihiko Miyanaga
- Division of Internal Medicine, Tsuboi Cancer Center Hospital, Fukushima, Japan
Makoto Ando
- Division of Internal Medicine, Tsuboi Cancer Center Hospital, Fukushima, Japan
Gaku Mori
- Division of Internal Medicine, Tsuboi Cancer Center Hospital, Fukushima, Japan
Mitsunori Hino
- Division of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Japan
Akihiko Gemma
- Department of 4th Internal Medicine, Nippon Medical School, Tokyo, Japan

Received 28 November 2008; received in revised form 25 February 2009; accepted 1 March 2009. published online 03 April 2009.

Abstract

Purpose

Bi-weekly administrations of nimustine hydrochloride (ACNU) plus paclitaxel were evaluated in this phase II study in patients with refractory small cell lung cancer (SCLC).

Methods

Patients who had disease progression within 3 months after treatment with irinotecan (CPT-11)-containing regimens were entered. They were treated with every other week administrations of ACNU 50mg/m² plus paclitaxel 110mg/m² on day 1 over 2 weeks.

Results

Twenty-four patients (20 males and 4 females, median age of 64 years, 17 patients with Eastern Cooperative Oncology Group [ECOG] performance status [PS] 0–1 and 7 patients with PS 2) participated in the trial. Of the 24 refractory patients after CPT-11 containing regimens, 17 patients had been given etoposide plus platinum. There were six partial responses, and an overall response rate of 25% (95% confidence interval, 10–46%) was obtained. The median time to progression and the median survival time after enrollment into this study were 2.8 and 5.8 months, respectively. The median overall survival from the first-line treatment was 19.5 months. The major toxicity was myelosuppression. Grade 4 neutropenia occurred in 13% of patients, and Grade 4 thrombocytopenia was observed in 13% of patients. There was one treatment-related death, attributed to pneumonitis.