[Abstract] Objective To investigate docetaxel combined with cisplatin, 5-Fu and Leucovorin in the clinical efficacy of advanced gastric cancer. Method the test group of 52 patients with chemotherapy: Dorsey docetaxel 75mg/m2 d1, 5-Fu 500mg/m2 d1 ~~ 5, leucovorin 200mg/m2 d1, cisplatin 20mg/m2 d1 5, 3 weeks; the control group, 47 cases of treatment with Table A neomycin (EPI) 35mg/m2 intravenous injection, cisplatin 40mg/m2, leucovorin calcium 250mg/m2  Fu 425mg/m2 intravenous infusion, 1 times / week once every eight weeks to assess efficacy. Results effective rate of 59.6%, no progress in the median survival of 7.8 months, 1-year, 2-year survival rate is 51% and 19%, respectively. The effective rate was 46.8% in the control group, no progress median survival of 6.0 months, 1 year, 2-year survival rate is 47% and 9%, respectively. Efficiency and 1-year survival rates compare the two groups showed no significant difference (P> 0.05); two groups effectively median progression-free survival and 2-year survival difference was statistically significant (P <0.05). The side effects are gastrointestinal reactions and bone marrow toxicity, but the majority of patients can tolerate. Conclusion Dorsey race combination with cisplatin and 5-Fu and calcium folinate is a safe and effective program for the treatment of advanced gastric cancer.

Key words gastric tumor; to docetaxel; fluorouracil; leucovorin; cisplatin

Effects of Docetaxel, Cisplatin Fluorouracil and Calcium Folinate in Treatment of Patients with Advanced Stomach Cancer

    LI Wen, JI De  lin, LIN Hua  ming

    Department of Oncology, People’s Hospital of Maoming City, Maoming 525000, ChinaAbstract: Objective To evaluate the efficacy and toxicity of the combination of docetaxel, 5  fluorouracil (5  Fu) and calcium folinate (CF) in the treatment of patients with advanced stomach cancer. Methods Group A: The 52 patients with advanced stomach cancer received Docetaxel 75mg/m2 iv, and 5  Fu 500mg/m2 dl ~ 5iv, CF200mg/m2dl ~ 5iv. Cisplatin (DDP) 20mg/m2 dl ~ 5, A cycle is 3 weeks. Group B: 47 patients received EPI 35mg/m2, DDP, CF 250mg/m2and 5  Fu 425mg/m2. A cycle is 1 weeks and 8 cycles is a course of treatment.Results The overall response rate of Group A was 59.6% and the overall response of the control of Group B was 46.8%. The progression free median duration of responsive patients was 7.8 months in Group A and 6.0 months in Group B.1  and 2  year survival rate in Group A was 0.05). The progression free median duration of responsive patients and">51% and 19%, and in Group B were 47% and 9%. There was no obvious difference between overall response rates and 1  year survival rate of two groups (P> 0.05). The progression free median duration of responsive patients and 2  year survival rate were significantly difference between two groups (P <0.05). The major side effects include phlebitis and peripheral neuritis can be accepted by most of the patients.Conclusion Combination of Docetaxel, CF and 5  Fu is an effective regimen in the treatment of patients with advanced stomach cancer.

    Key words: Stomach neoplasms; Docetaxel; Fluorouracil; Calcium folinate; Cisplatin

 Docetaxel for anti-cancer chemotherapy drug Taxol, by interfering with cell microtubule network phase cells in mitosis and split functions necessary to play the anti-tumor effect. Vitro studies have shown that docetaxel different degree of differentiation of gastric cancer are valid, the effective rate of 56%, the cytotoxicity of paclitaxel 1.3 to 12 times [1]. Since March 2002 to June 2005, our application docetaxel plus cisplatin, fluorouracil and leucovorin in the treatment of advanced gastric cancer 52 cases, and achieved good effect.

    1 Materials and methods

    1.1 The object of study

    Random number table, randomly selected hospital naive patients, 52 cases of the experimental group, the control group, 52 cases (the actual statistical analysis of 47 cases, three cases due to side effects withdrew from the study, 2 patients were lost to follow), all cases are untreated advanced 60分,预计生存期3月以上,化疗前肝、">patients with stage Ⅲ ~ Ⅳ were confirmed by pathology; by B-ultrasound, CT confirmed measurable the lesion, karnofsky score (KPS)> 60 points, expected survival of 3 months or more chemotherapy before liver with normal renal function, normal blood, were not used taxane. Test group of 52 patients, 34 males and 18 females, average age: 53.0 years; lesions: 28 cases of gastric antrum, cardia 16 cases, 8 cases of gastric body; pathological types: papillary adenocarcinoma, tubular adenocarcinoma, 17 cases, 15 cases of poorly differentiated adenocarcinoma, mucinous cell carcinoma of the five cases, the undifferentiated cell carcinoma in 6, 8 cases of mixed cell carcinoma. The control group, 47 patients, 30 males and 17 females, average age: 56.2 years; lesions: 23 cases of gastric antrum, cardia 14 cases, 10 cases of gastric body; pathological types: papillary adenocarcinoma, tubular adenocarcinoma, 16 cases, poorly differentiated adenocarcinoma in 14 cases, 4 cases of mucous cell carcinoma, undifferentiated cell carcinoma of the five cases, seven cases of mixed cell carcinoma. The two groups of gender, age differences were not statistically significant (P> 0.05).

    1.2 treatment programs

    (1) The test group: docetaxel 1d oral dexamethasone 16mg daily, and even served 3d. Docetaxel 75mg / m2, intravenously 1h, 1 day; Asia leucovorin 200mg / m2, intravenous injection, 1 to 5 days; fluorouracil 500 mg / m2 intravenously 3h, 1 to 5 days, cisplatin 20mg/m2, intravenous infusion, 1 to 5 days, 3 weeks, 1 cycle for three consecutive cycles for a course, a course of treatment efficacy was evaluated after.

    (2) control group: epirubicin (EPI) 35mg/m2, IV bolus weekly cisplatin 40mg/m2, the calcium folinate 250mg/m2, intravenous infusion once a week, and 5  Fu 425mg/m2, intravenous (after the CF), once a week, all treatment once every eight weeks to the end, and then to assess the clinical follow-up time of 8 to 25 months, with a median follow-up time of 16.3 months. Appropriate use of antiemetic treatment process liters of white blood cell drug use, and the condition of patients.

    1.3 Evaluation Standards

    For efficacy assessment in accordance with the WHO solid tumor objective response criteria: complete remission (CR), partial remission (PR), stable (SD), (PD), calculated according to CR + PR efficient. Tumor size by endoscopy, barium meal and CT assessment of toxic side effects, according to the WHO anticancer drug toxicity standards for integrated assessment [2]. Survival calculated from the start of chemotherapy, progression-free survival from the determination of the effective date of start

    1.4 statistical methods

    SPSS11.5 software package for statistical analysis, the group used to compare the efficiency of the χ2 test, survival analysis by Kaplan  merier between the two groups was used to compare the Log  rank test.

    2 Results

    2.1 clinical efficacy

    (1) the test group, 52 cases of CR 3 cases, PR 28 cases, efficiency (CR + PR) 59.6% (31/52), the SD 10, PD 11 cases, 28 cases were PR patients 8 patients received 2 surgery, these patients out of the group. Effective in patients with a median progression-free survival was 7.8 months, median survival time was 14.6 months; 1 – and 2-year survival rates were 57% and 19%.

    (2) control group, 47 cases were analyzed, including the CR 2 cases, PR 20 the efficient (CR + PR) 46.8% (22/47), SD 12, PD 13, the group of patients without undergoing surgery treatment. Efficient patient progression-free survival was 6.0 months, median survival of 13.6 months, and 2-year survival rates were 47% and 9%.

    The inspection efficiency differences between the two groups was not statistically significant (P> 0.05); two groups effectively in median progression-free survival difference was statistically significant (P <0.05). Two sets of 1-year survival rate difference was not statistically significant (P> 0.05), and 2-year survival difference was statistically significant (P <0.05).

    2.2 toxicity

    All patients in the experimental group completed 3 cycles of chemotherapy, not the occurrence of intolerable toxicity, no water and sodium retention, allergic reactions and brain damage, no treatment-related deaths. In the control group, 47 patients completed treatment, three cases suffered from Ⅲ Ⅳ neutropenia and thrombocytopenia, treatment is not completed on time to withdraw from the trial. The two main groups of toxicity performance leukopenia, the incidence in the two groups were 68% (35/52) and 83% (39/47), which grade Ⅲ ~ Ⅳ were 17.3% (9/52) and 21.27 % (10/47) by the G  CSF treatment can complete the chemotherapy cycle; addition to gastrointestinal toxicity (nausea, vomiting, mucositis, diarrhea), the incidence of the two groups were 44.2% (23/52 ) and 55.3% (26/47), antiemetic drug dexamethasone treatment can ease the level III each cases, alopecia incidence of 100%.

    3 Discussion

    Worldwide, the incidence of gastric cancer among all malignancies 2, the mortality rate of cancer deaths in the first four; ranks the first of a variety of malignant tumors in the incidence of gastric cancer in China, 75% of patients with advanced diagnosis early gastric cancer after 2 years from 50% to 60% of the transfer, and therefore has an important significance chemotherapy for patients with gastric cancer. And abroad typically 5  Fu + cisplatin or ECF (epirubicin, cisplatin, 5-Fu) program as conventional treatment options, but short clinical remission, complete remission rate [3]. Still Yuhong [4] reported applications combined with cisplatin, epirubicin, fluorouracil treatment of advanced gastric total effective rate of 52%, but the toxicity. Docetaxel as a next-generation taxane anticancer drugs, after years of clinical studies have shown that advanced gastric cancer have better efficacy and efficiency in the 17% to 24% of the single-agent. Based on the above characteristics, prompting people to begin to explore the treatment of advanced gastric cancer with docetaxel, more clinical application of docetaxel plus cisplatin or 5-Fu, foreign scholars reported better efficacy [5  8]. Domestic Shao-water [9] reported Dorsey docetaxel plus cisplatin, 5  Fu treatment of advanced gastric total effective rate of 56.5%. Kong Fan macros [10] reported that docetaxel combined with leucovorin, fluorouracil and cisplatin in the treatment of advanced gastric cancer total effective rate of 59.3%. We apply the docetaxel treatment of advanced gastric cancer in combination with cisplatin, fluorouracil and leucovorin effective rate of 59.6%, reported in the literature are similar, higher than that of the control group (46.8%), but the difference was not statistically significant (P> 0.05). However, the median progression-free survival of 7.8 months, significantly greater than in the control group, 6.0 months (P <0.05). The toxicity analysis shows that the two main groups of adverse reactions were myelosuppression, which mainly leukopenia, neutropenia was the control group 83% higher than 68% of the test group, but was tolerated under the support of the G  CSF , and no accumulation of short duration; non-hematologic toxicity mainly nausea, vomiting, mucositis, diarrhea, control group of nausea and vomiting was 55.3%, higher than the 44.2% of the test group, before treatment line antiemetic drugs and dexamethasone pretreatment can be prevented; alopecia incidence of 100%, and no difference in the two groups. Through this study, we believe that the docetaxel plus cisplatin, fluorouracil and calcium folinate advanced gastric cancer is more effective program, well tolerated, and worthy of further study.