Phase II study of first-line sequential chemotherapy with gemcitabine-carboplatin followed by docetaxel in patients with advanced non-small cell lung cancer

Alberto Chiappori, George Simon, Charles Williams, Eric Haura, Caio Rocha-Lima, Henry Wagner, Gerold Bepler, Scott Antonia
Oncology 2005, 68 (4-6): 382-90

RATIONALE: Despite the use of novel chemotherapeutic agents, patients with advanced non-small cell lung cancer (NSCLC) continue to show a poor survival.

OBJECTIVES: To assess the safety and efficacy of a novel sequential and putatively non-cross-resistant chemotherapy regimen.

METHODS: Eligibility included: stages IV and IIIB (malignant pleural effusion), performance status 0-1, and adequate renal, hepatic and bone marrow function. Patients with previously treated and controlled brain metastases were not excluded. Responses were determined according to the Response Evaluation Criteria in Solid Tumors. Treatment consisted of gemcitabine, 1,000 mg/m2, on days 1 and 8, and carboplatin, AUC = 5, on day 1 every 4 weeks (2-4 cycles) followed by docetaxel, 75 mg/m2, on day 1 every 3 weeks (4 cycles). Docetaxel was given after four cycles of gemcitabine-carboplatin or if progression of disease occurred, after the first two cycles.

RESULTS: Forty patients were enrolled. All patients received at least one cycle of gemcitabine-carboplatin. Due to PD, 15 patients received fewer than four cycles and only 1 received docetaxel subsequently. Of the 25 patients who completed four cycles of gemcitabine-carboplatin, 23 received docetaxel. In total, 24 patients received at least one cycle of docetaxel, and 12 patients completed four cycles of both regimens. The overall response rate was 23.6% (9/38 patients, 95% confidence interval, CI, 11-40%), with 15.8% (6/38 patients, 95% CI, 6-31%) and 12.5% (3/24 patients, 95% CI, 3-32%) response rates to gemcitabine-carboplatin and docetaxel, respectively. No patient with PD on gemcitabine-carboplatin responded to docetaxel. Toxicities were tolerable and mostly hematologic. Median survival time and progression-free survival were 6.7 and 4.9 months, respectively, with a 1-year survival of 37.5%.

CONCLUSION: Sequential gemcitabine-carboplatin and docetaxel can be safely administered in advanced NSCLC. Our results are comparable to those achieved with other similar regimens and do not represent a significant improvement in the treatment of advanced NSCLC.

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