Docetaxel Plus Cisplatin vs Docetaxel Plus Gemcitabine Chemotherapy in Advanced Non–Small-Cell Lung Cancer: A Preliminary Analysis of a Multicenter Randomized Phase II Trial

August 2, 2000

Docetaxel (Taxotere)/cisplatin (Platinol) and docetaxel/gemcitabine (Gemzar) are active and well-tolerated chemotherapy regimens for the treatment of patients with advanced non–small-cell lung cancer (NSCLC). A phase II randomized trial was conducted in order to compare the efficacy and toxicity of these regimens.

Docetaxel (Taxotere)/cisplatin (Platinol) and docetaxel/gemcitabine (Gemzar) are active and well-tolerated chemotherapy regimens for the treatment of patients with advanced non–small-cell lung cancer (NSCLC). A phase II randomized trial was conducted in order to compare the efficacy and toxicity of these regimens.

A total of 315 chemotherapy-naive patients with stage IIIB and IV NSCLC were enrolled in the study. Patients were randomized to either arm A (docetaxel 100 mg/m², day 1, and cisplatin 80 mg/m², day 2), or arm B (gemcitabine 1,100 mg/m², days 1 and 8, and docetaxel 100 mg/m², day 8). Recombinant human granulocyte colony-stimulating factor (rhG-CSF) (150 µg/m² subcutaneously) was given in arm A (days 3–9) and in arm B (days 9–15). Both regimens were repeated every 3 weeks.

For arm A (docetaxel/cisplatin) the results are as follows: Number of patients treated/evaluated: 152/132; complete response (CR): 3 patients (2.3%); partial response (PR): 39 (30%); overall response rate: 32% (95% CI: 24%–40%); stable disease (SD): 42 (32%); progressive disease (PD): 48 (36%); duration of response: 5 months; time to progression: 8 months; median survival: 10 months; 1-year survival: 42%.

Arm B (docetaxel/gemcitabine) results are as follows: Number of patients treated/evaluated: 144/114; CR: 1 patient (0.9%); PR: 38 (33%); overall response rate: 34% (95% CI: 25%–43%); SD: 37 (32%); PD: 38 (33%); duration to response: 4 months; time to progression: 8 months; median survival: 9 months; 1-year survival: 38%.

The probability of response to docetaxel/cisplatin was significantly higher (P = .03) in patients with a nonadenocarcinoma, while the opposite was observed in patients with an adenocarcinoma (P = .002). A total of 1,161 cycles were administered (arm A = 595; arm B = 566) with a median of 3 (arm A) and 4 (arm B) cycles/patient. Toxicity by World Health Organization (WHO) criteria (arm A/arm B) was as follows: grade 3/4 anemia, 9 patients (6%)/6 patients (4%); grade 3/4 neutropenia, 50 (33%)/31 (22%); grade 3/4 thrombocytopenia, 4 (3%)/7 (5%); febrile neutropenia, 24 (16%)/20 (14%); grade 3/4 diarrhea, 18/4 (P = .00296); grade 3/4 fatigue, 45 (30%)/49 (33%); grade 2/4 neurotoxicity, 10 (7%)/6 (4%).

CONCLUSION: These preliminary results seem to indicate that the docetaxel/cisplatin and docetaxel/gemcitabine regimens have comparable activity and toxicity profiles in patients with advanced NSCLC.

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