| Purpose: Lung cancer is one of the most common malignacies in China, and approximately 80%～85% is non-small-cell lung cancer (NSCLC). Multidisciplinary therapy are the major therapeutic methods for the patients with early-stage disease, but most of patients are diagnosed with advanced or metastatic disease at the time of initial diagnosis.Even among patients with early-stage disease, most will develop recurrence or metastasis . Patients with advanced or metastatic disease will require systemic chemotherapy. Systemic chemotherapy could improve survival and ameliorate quality of life of NSCLC patients, but the efficacy and survival of these patients remain poor and the toxicity of chemotherapy still severe. How to enhance the efficacy of the chemotherapy and to improve survival and quality of life are hotspots of research. The use of antioxidants during cancer treatment could reduce toxicity of the chemotherapy, improve quality of life,however,if this practice could enhance efficacy of chemotherapy remains controversial. Tiopronin, an antioxidant, is one of the most widely used drugs for the prevention and treatment of liver injury. In this study ,we evaluated the potential benefits of tiopronin during chemotherapy in patients with advanced or metastatic NSCLC.Materials and Methods: Study subjects included patients with advanced or metastatic NSCLC diagnosed and treated between June2004 and January 2008 in Jiangsu Cancer Hospital & Research Institute.Patients treated with tiopronin and chemotherapy are defined Group A . Same number of patients with advanced or metastatic NSCLC who were not treated with tiopronin during chemotherapy are randomly selected as the control (Group B). All data were analyzed using the State 8.0 statistical software.Results: A total of 452 patients were enrolled in this study. The objective response rate of Group A versus Group B were 20.35 % versus 18.58% (P = 0.635) , and disease control rate were 73.01% versus 70.35 % (P = 0.531) , respectively. Incidence, type and severity of adverse events except myelosuppression were similar between the two groups. In Group B patients had higher grade 2/3/4 neutropenia (55.31%) than those in Group A (46.02%) (P = 0.048) , but the distinction of grade 2/3/4 thrombocytopenia and anemia showed no statistical significance between the two groups (Group A vs. Group B 16.81% vs. 20.80% and 11.95% vs. 15.49% , respectively). The median progression-free survival of two groups were 5.2 and 4.3 months (P = 0.48) , respectively , with corresponding the median overall survival were 10.5 and 9.5 months (P = 0.18). 1-year overall survival for patients in Group A and Group B were 37.61% and 30.53% (P = 0.11),respectively.However, the patients with first-line chemotherapy in Group A (46.43% ) had higher 1-year overall survival than those in Group B (34.97%) in subgroup analyses ( P = 0.049).Conclusions: Tiopronin is an effective drug for the prevention and treatment of liver injury.The use of tiopronin during chemotherapy did not improve response rates and disease control rate and prolonge survival , but it could reduce the toxicity in patients with advanced or metastatic NSCLC. It could increase 1-year overall survival in subtype patients with first-line chemotherapy. Future research is needed to validate the concurrent use of antioxidant (tiopronin) and chemotherapy with larger sample size and prospective disign. |
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