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Gemcitabine/paclitaxel combination therapy effective in small cell lung cancer, but schedule appeared toxic
A gemcitabine/paclitaxel combination was linked to high disease control rates but high toxicity in patients with small cell lung cancer, according to recent results.
The phase 2 study evaluated a combination of gemcitabine and paclitaxel as second-line chemotherapy in 41 patients with relapsed or refractory small cell lung cancer. Eligibility criteria included an ECOG performance status of 0 to 2 and measurable disease. The median patient age was 65 years.
The treatment regimen was as follows: paclitaxel 135 mg/m2 on days 1 and 8, immediately followed by gemcitabine at 1,000 mg/m2 every 3 weeks for up to six courses.
The outcome measures were activity and toxicity, and restaging of disease was scheduled every three courses.
Nineteen patients had refractory disease, which the researchers defined as progressive disease during or within 90 days from completion of first-line treatment. Twenty-two patients were sensitive to chemotherapy.
Researchers administered 135 courses of the regimen (range, 1-6; median, 3).
The partial remission rate — also described as the partial response rate — was 22%. Ten patients (24%) had stable disease. The disease control rate, defined as partial response plus stable disease, was 46%.
The disease control rate was 55% among the 22 patients who were sensitive to chemotherapy and 37% among the 19 patients with refractory disease. All but one of the partial responses was observed in the chemotherapy sensitive group.
The median response duration was 5 months.
Grade-3 or grade-4 neutropenia occurred in 24% of the courses administered, and grade-3 neurologic toxicities were observed in 7% of the courses administered.
“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,” the researchers concluded.
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Dazzi C. Clin Lung Cancer. 2012;doi:10.1016/j.cllc.2012.03.003.