[Abstract] Objective To compare the concept Cha Naida platinum (nedaplatin, NDP) combined with fluorouracil (5-Fu) and cis platinum (cisplatin, CDDP) combined with short-term effect of the 5 Fu treatment of advanced esophageal cancer. Acquisition of the 61 cases, the NDP +5 Fu group (NF) were 30, CDDP +5 Fu group (DF group) 31 cases, NF group using NDP 80 ~ 100mg/m2, intravenous infusion, d1, leucovorin calcium 200mg/m2, intravenous infusion, d1, 2,5 Fu 400mg/m2, intravenous bolus, then 5 Fu 600mg/m2 continuous intravenous infusion of approximately 22 h, d1, 2; the DF groups using CDDP 30mg/m2 intravenous infusion, d1, the use of other drugs with the NF group. 0.05)；NF组消化道不良反应小,肝肾毒性轻微。">The NF group and the DF group efficiency were 53.33% and 35.48%, respectively, no significant difference (P> 0.05); NF group gastrointestinal adverse reactions, liver and kidney toxicity was mild. Conclusion NDP treatment of advanced esophageal cancer is not lower than short-term effect of CDDP, easy to tolerate the side effects, especially for the elderly using CDDP treatment failed or can not tolerate the the CDDP adverse reaction cases there is still a certain effect.
Key words nedaplatin cisplatin in advanced esophageal cancer
Nedaplatin as second-generation platinum compound with a broad spectrum of anti-tumor, gastrointestinal reactions and renal toxicity than cisplatin light, no complete cross-resistance with other platinum-based drugs has received increasing attention in recent years in esophageal cancer treatment . We compare 2003 to 2006, the NDP joint program of 5 Fu and CDDP joint program of 5 Fu treatment of advanced esophageal cancer, the efficacy and adverse reactions, are as follows.
1 Materials and Methods
1.1 Case selection criteria
From 2003 to 2006, 61 cases of patients with advanced esophageal cancer, all patients with histopathological diagnosis and available for objective evaluation of tumor lesions, and all patients are newly diagnosed or recurrence and metastasis after not line rescue treatment programs. 3个月。">Before chemotherapy, patients with performance status ECOG score ≤ 2 points, liver and kidney function and ECG indicators are in line chemotherapy requirements, expected survival of> 3 months.
1.2 Clinical data
All patients were randomly divided into NF groups and DF group. NF group of 30 patients, including 23 males and 7 females; 27 cases of squamous cell carcinoma, adenocarcinoma, three cases; metastasis and recurrence in 8 cases, 22 cases of advanced inoperable. The DF group 31 cases, including 26 males and 5 females; 24 cases of squamous cell carcinoma, adenocarcinoma, small cell undifferentiated carcinoma; metastasis and recurrence in 12 cases, 19 cases of advanced inoperable. Basic Qi testing the two groups were the indicators are comparable, as shown in Table 1. Table 1 two sets of clinical data of patients with advanced esophageal cancer (cases)
NF group chemotherapy: NDP 80 100mg/m2 intravenous infusion, d1, calcium folinate 200mg/m2, intravenous infusion, d1, 2,5 Fu 400mg/m2 IV bolus, then 5 Fu 600mg / m2 continuous intravenous infusion of approximately 22 h, d1, continuous intravenous infusion using a portable infusion pump, the total capacity of 240ml; the DF group chemotherapy: of CDDP 30mg/m2 intravenous infusion, d1 ~ 3, conventional hydration diuretic, The use of other drugs with the NF group; repeated every 3 weeks.
1.4 Evaluation Criteria
Objective response by RECIST Response Evaluation Criteria, divided into complete remission (CR), partial remission (PR), no change (SD) and progress (PD), CR + PR effective (RR). Toxicity evaluation by WHO anticancer drug toxicity indexing standards.
1.5 statistical methods
Using SPSS13.0 software package for statistical analysis, χ2 test and Fisher exact test to compare two-tailed P <0.05 was considered statistically significant.
2.1 recently efficacy analysis
The whole group of 61 patients completed at least two cycles of chemotherapy. 0.05，差异无统计学意义。">The total efficiency compared the NF groups are more efficient than the DF group, P> 0.05, the difference was not statistically significant. Three cases of failed or can not tolerate the the CDDP adverse reaction in patients treated with CDDP to switch to the NDP treatment, there are two cases of PR cases the PD, as shown in Table 2. Table 2 Comparison of two groups Note: χ2 test, P = 0.1612.2 adverse reactions.
All two groups of patients could be evaluated adverse reactions, the NF group hematologic toxicity than the DF group serious gastrointestinal reactions light, compared to the results shown in Table 2. Table 3 groups of adverse comparison
Of the incidence of esophageal cancer in the world and one of the countries with the highest mortality. The multi combination chemotherapy, its effect than a single agent for remission has been extended. CDDP after the introduction of combination chemotherapy efficacy of a certain improvement in the effective rate of 30% to 50%. DF for the treatment of esophageal cancer chemotherapy . Cisplatin toxicity, some patients can not tolerate. Nedaplatin that Shun glycolic acid, diamine-platinum (cis diammincgly colatoplatinum, nedaplatin), is a second-generation Japanese pharmaceutical company Shionogi developed organic platinum anti-cancer drugs, the first in Japan in June 1995 The times approved listing . Clinical studies have demonstrated Ming Naida platinum in head and neck cancer, esophageal cancer, non-small cell lung cancer, small cell lung cancer, cervical cancer, ovarian cancer, bladder cancer and testicular cancer and other solid tumors. Clinical reports suggest that the the nedaplatin either drug alone, and other chemotherapy drugs and radiotherapy combination of radiation sensitizing effect. Nedaplatin anticancer mechanism of cisplatin mainly to generate nucleoside and nucleoside reaction a platinum conjugates in combination with cisplatin in the same way with DNA and inhibition of DNA replication, its dissolution is about 10 times the cisplatin . During the administration without hydration. Lower renal toxicity and gastrointestinal toxicity, and showed a good synergy with other chemotherapy drugs in combination with CDDP between completely cross-resistance , nedaplatin therapeutic index, toxicity, dose-limiting toxicity to bone marrow suppression caused by thrombocytopenia, renal toxicity and gastrointestinal reactions were low .
In recent years, many foreign clinical studies reported nedaplatin-based treatment of advanced esophageal efficiency majority of its effectiveness in more than 50%, higher than or similar to conventional cisplatin-based treatment programs, and adverse reactions can be predicted, tolerance . The domestic similar study reported . The results of this study show that: recent efficacy, NF group efficiency of 53.33%, 35.48% higher than the DF group, but the difference was not statistically significant, and CDDP treatment failed or can not tolerate the of CDDP adverse reaction cases there is still a certain effect, The results showed that the NDP-based combination chemotherapy is effective in patients with advanced esophageal cancer, and its efficacy is not less than CDDP-based chemotherapy; adverse reactions, the NF group the incidence of nausea and vomiting was significantly lower than the DF group, which NF group occurred Ⅰ ~ Ⅱ degree and 5 HT3 receptor antagonist the antiemetic treatment can ease soon, while the higher incidence of nausea and vomiting DF group Ⅲ ~ Ⅳ degree. Kidney toxicity NF group, the incidence is lower than the DF group and Ⅰ ~ Ⅱ. The incidence of liver toxicity NF group and the DF group was no significant difference. Bone marrow suppression, the two groups of white blood cells decline are grade Ⅰ ~ Ⅱ-based, and the incidence of NF group is slightly lower than the DF group, but the difference was not statistically significant, platelets decreased NF group compared with the DF group significantly, grade Ⅰ ~ Ⅱ platelet down 43.33%, the level in Ⅲ ~~ Ⅳ thrombocytopenia 16.13%, and reduce occurred in 7 to 10 days after treatment, and 14 days after treatment all returned to normal. The results show that the NF group, nausea, vomiting and other gastrointestinal reactions DF group was significantly lower than the incidence of liver and kidney toxicity was mild, and its main dose-limiting toxicity was myelosuppression, especially thrombocytopenia, give symptomatic and supportive treatment and adjust dosage processing after can be restored. Therefore the NDP for the elderly and the poor physical condition of the cases can be better tolerated.