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

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.

Conclusion

Bi-weekly administrations of ACNU plus paclitaxel provided a practical and well-tolerated regimen that was active for CPT-11-refractory SCLC.

Keywords: Lung neoplasms, Small cell lung cancer, Nimustine, ACNU, Paclitaxel

a Department of Respiratory Medicine, Toho University Omori Medical Center, Japan

b Department of Respiratory Medicine, Saitama International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka City, Saitama, 350-1298, Japan

c Respiratory Section, Saitama Cancer Center, Saitama, Japan

d Division of Internal Medicine, Tsuboi Cancer Center Hospital, Fukushima, Japan

e Division of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Japan

f Department of 4th Internal Medicine, Nippon Medical School, Tokyo, Japan

Corresponding author. Tel.: +81 42 984 4111; fax: +81 42 984 4667.

PII: S0169-5002(09)00127-5

doi:10.1016/j.lungcan.2009.03.003

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