[A randomized comparative trial of three combined regimens containing cisplatin for treatment of advanced non-small cell lung cancer].
Parole chiave
Astratto
OBJECTIVE
Vinorelbine (NVB), paclitaxel (TAX), and gemcitabine (GEM) are first-line chemotherapeutic drugs in the treatment for non-small cell lung cancer (NSCLC) currently. There are many domestically retrospective studies to compare efficacies and adverse reactions among these three regimens, all of which has composed of cisplatin (DDP). This randomized study was to investigate the efficacies and toxicities of these three regimens in NSCLC treatment, in order to choose a feasible regimen for NSCLC patients.
METHODS
A total of 276 NSCLC patients were randomly assigned to a regimen of NP (NVB plus DDP ), or TP (TAX plus DDP), or GP (GEM plus DDP). Efficacies and toxicities were analyzed and compared after two cycles.
RESULTS
The response rates were 42.3% (41/97) in NP arm, 43.0% (40/93) in TP arm, and 43.4% (36/83) in GP arm, and complete remission rates were 1.0% (1/97), 2.2% (1/93) and (0/83) respectively, without significant difference. The median survival time, disease-free survival time and 1-year survival rate were 8.5 months, 4.1 months and 31.9%; 8.8 months, 3.8 months and 33.3%, and 9.2 months, 3.9 months, 31.3%, respectively in NP, TP and GP arms without significant difference. The major adverse reactions were stage 3 to 4 myelo-suppression, nausea/vomiting, fatigue and phlebitis. There were highest incidences of leucopenia (42.2%), neutropenia (36.2%) and lowest incidence of thrombocytopenia (53.0%) in GP arm compared to NP arm (77.8%, 67.7%, 12.1%) or TP arm (71.0%, 57.0%, 13.0%) statistically (P<0.01 for all). The rates of nausea/vomiting in GP arm (16.8%) and TP arm (25.8%) were significantly lower than in NP arm (41.4%)(P<0.05); and the rate of fatigue in GP arm (38.5%) or phlebitis in NP arm was most frequent among the three arms (P=0.000, 0.008 respectively).
CONCLUSIONS
There is no significant difference in short-term efficacy of chemotherapy regimen NP, TP and GP. TP and GP regimens, both of which possesses its own advantage, are more tolerable than NP regimen which has the most side effects.
