Gemcitabine and Paclitaxel Combination as Second-Line Chemotherapy in Patients With Small-Cell Lung Cancer: A Phase II Study

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• 作者：Claudio Dazzi ; ^{c.dazzi@ausl.ra.it} ; Anna Cariello ; Claudia Casanova ; Alberto Verlicchi ; Marco Montanari ; Giorgio Papiani ; Eva Freier ; Valentina Mazza ; Carlo Milandri ; Alessandro Gamboni ; Maximilian Papi ; Maurizio Leoni ; Giorgio Cruciani ; Bernadette Vertogen
• 关键词：Gemcitabine ; Paclitaxel ; Second-line chemotherapy ; Small-cell lung cancer
• 刊名：Clinical Lung Cancer
• 出版年：2013
• 出版时间：January, 2013
• 年：2013
• 卷：14
• 期：1
• 页码：28-33
• 全文大小：326 K

文摘

Background

Although small-cell lung cancer is a chemosensitive malignancy, most patients rapidly relapse. Results of second-line treatment are generally poor. We conducted a phase II study to evaluate the activity and toxicity of a combination of gemcitabine and paclitaxel as second-line chemotherapy.

Patients and Methods

Eligible patients were refractory or relapsed small-cell lung cancer, with an Eastern Cooperative Oncology Group performance status of 0-2 and measurable disease. Paclitaxel was administered at 135 mg/m² days 1 and 8 immediately followed by gemcitabine at 1000 mg/m² every 3 weeks up to 6 courses. Restaging of disease was scheduled every 3 courses.

Results

Forty-one patients were enrolled. The median age was 65 years. Nineteen patients were considered refractory (progressive disease during or within 90 days from completion of first-line treatment), whereas 22 patients were chemotherapy sensitive. A total of 135 courses was administered (range, 1-6; median, 3). Nine patients achieved a partial remission (partial response, 22 % ), and 10 patients had stable disease (24 % ), with a disease control rate (partial response + stable disease) of 46 % : in 12 (55 % ) of 22 patients who were sensitive and in 7 (37 % ) of 19 patients with refractory disease, respectively. All partial responses but one were observed in the sensitive group. The median duration of response was 5 months. The most-frequent severe toxicities were neutropenia grade 3-4 and neurologic grade 3 in 24 % and 7 % of delivered courses, respectively.

Conclusions

The combination of gemcitabine and paclitaxel investigated in our study achieved a high disease control rate, but the schedule we adopted appeared to be quite toxic.