Cisplatin/Gemcitabine/Paclitaxel in the Treatment of Advanced Non–Small-Cell Lung Cancer: A Southern Italy Cooperative Oncology Group (SICOG) Phase II Study

The purpose of this study was to define the antitumor activity of the PGT (cisplatin [Platinol]/gemcitabine [Gemzar]/paclitaxel [Taxol]) combination in chemonaive non–small-cell lung cancer patients.

Patients with locally advanced or metastatic NSCLC were considered eligible if they were £ 70 years old and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. They received cisplatin 50 mg/m², paclitaxel 125 mg/m², and gemcitabine 1,000 mg/m² days 1 and 8, every 3 week.

Beginning in April 1997, 39 patients with stage IIIB (13 patients) or IV (26) disease were enrolled for a total of 158 cycles delivered. The ECOG performance status was 0–1 in 31 patients and 2 in 8 patients. Of the 39 patients, 38 were evaluable for response on an intent-to-treat basis. Two complete responses and 24 partial responses have been recorded for a 68% (95% CI: 51%–82%) overall response rate. Major responses were 10/13 (77%) in stage IIIB patients and 16/25 (64%) in stage IV patients.

Patients’ quality-of-life (QoL) score improved in 27/38 (71%) patients. At a 13-month (range: 1–23 months) median follow-up the median survival time was 13.5 months, with a 1-year projected survival of 70%.

Toxicity was generally manageable. Grade 4 neutropenia and thrombocytopenia were observed in 9 (23%) and 3 (8%) patients, respectively, and in 6 cases a packed red blood cell transfusion was required. Severe nonhematologic toxicity occurred in 8 patients.

CONCLUSION: The PGT combination yields very high clinical response and QoL improvement in chemonaive advanced NSCLC patients, at a price of manageable toxicity. A large phase III trial comparing this new regimen to standard combinations is underway.

Click here for Dr. Vincent A. Miller’s commentary on this abstract.