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
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 nonsmall-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 39) and in arm B (days 915). 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. Millers commentary on this abstract.
Eric Ko on Combining Radiation Therapy With Immunotherapy to Treat Non–Small-Cell Lung Cancer
September 18th 2018ONCOLOGY spoke with Eric Ko, MD, PhD, who recently published a review article with his colleagues on strategies for combining radiation therapy with immunotherapy for the treatment of non–small-cell lung cancer.
