【Abstract】 Objective To observe the Cha Duoxi paclitaxel (TXT) Joint PF regimen in the treatment of advanced esophageal cancer efficacy and feasibility. Methods 60 patients with advanced esophageal cancer by order of admission were randomly divided into a treatment group of 32 patients, 28 cases of the control group, the treatment group: TXT 75 mg/m2, day 1, DDP 35 mg/m2, days 1, 2, CF0. 2 g, 1 to 5 days, intravenous infusion, 5 Fu 2.5 g/m2 continuous infusion into the 120 h; control group: contains only DDP and 5-Fu, CF, usage, with the treatment group, 21 days for a cycle used in conjunction with more than two cycles. 0.05），RR差异有统计学意义（P">Treatment group CR rate was 6.25%, RR 71.9% CR rate of the control group was 3.57%, RR 42.9%, two groups of CR rate difference was not statistically significant (P> 0.05), RR difference was statistically significant (P 0.05）。">= 0.044), treatment group patients with previously untreated RR 73.6% retreatment in patients with RR was 69.2%, the difference was not statistically significant (P> 0.05). Treatment group, the incidence of leukopenia higher than that in control group, but the difference was not statistically significant, alopecia incidence was significantly higher than that in the control group (P = 0.000). Conclusion Docetaxel (TXT) the joint PF regimen in the treatment of advanced esophageal cancer the RR significantly improve toxicity increased slightly, but tolerated.
Key words PF side of docetaxel chemotherapy for advanced esophageal cancer
Esophageal cancer is one of the country’s common gastrointestinal malignancy, most patients already in the late stage, even early lesions, the recurrence rate is still higher 5-year survival rate is less than 20% , chemotherapy become the main treatment. Combined with fluorouracil (5 Fu) (PF scheme), cisplatin (DDP) is more commonly used chemotherapy has achieved 50% to 60% efficiency (RR) . Looking for more effective chemotherapy to control tumor growth and prolong the survival of the problems to be solved. From June 2004 to December 2006 on the basis of the PF regimen plus docetaxel (docetaxel, TXT) (TPF program) the treatment of 32 cases of advanced esophageal cancer, made a good effect, are as follows.
1 Materials and Methods
1.1 Clinical data
Hospitalized 60 cases of advanced esophageal cancer staging criteria in line with the national the esophageal working meeting in 1976 to develop the clinical staging. 3月，无化疗禁忌证，均有影像">Are clearly pathological diagnosis (51 cases of squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma cases), lost the chance of operation, KPS score more than 70 points, expected survival> March, no chemotherapy contraindications are images lesions learned measurable. Admission has randomly divided into a treatment group of 32 patients and the control group 28 cases. Treatment groups: 23 men and 9 females; aged 40 to 74, with a median age of 58 years old; pathological types: squamous cell carcinoma, 28 cases, 3 cases of adenocarcinoma, adenosquamous carcinoma; lesions: four cases of the previous paragraph, the middle in 17 cases, 11 cases of the lower segment; initial treatment in 19 cases, 13 cases of retreatment. Control group: 21 male and 7 females; aged 41 to 76 years, with a median age of 59 years old; pathological types: squamous cell carcinoma, 26 cases, 2 cases of adenocarcinoma; lesions: three cases of the previous paragraph, the middle of the 17 cases, eight cases under paragraph ; initial treatment of 17 cases, 11 cases of retreatment. The two sets of data are comparable (P> 0.05).
Treatment group: TXT 75 mg/m2, intravenous infusion of 1 h, 1 day, the day before chemotherapy dexamethasone 7.5 mg twice a day, once every three days; DDP 35 mg/m2, intravenous infusion, 1 , two days; Fu 2.5 g/m2 continuous pumped 120 h; leucovorin calcium (CF) 0.2 g intravenously, 1 to 5 days. Control group: DDP 35 mg/m2, intravenous infusion, days 1 and 2; 5-Fu 2.5 g/m2 continuous pumped 120 h; the CF0.2 g intravenous infusion, 1 to 5 days, 21 days for one cycle. The two groups of the conventional antiemetic symptomatic treatment, Ⅲ degree above neutropenia when given granulocyte colony-stimulating factor (G CSF) treatment. Chemotherapy during the weekly blood routine, a week before and after the review of the electrocardiogram, liver and kidney function, review after two cycles of esophageal barium meal X-ray film, esophageal endoscopy, chest CT, abdomen B ultrasonic, all cases were completed 2 to 6 cycles, the average four cycles.
1.3 Evaluation and drug toxicity indexing standards
Response Evaluation Criteria: recent efficacy standards prescribed by the International Union Against Cancer (UICC) is divided into full remission (CR): X-line the esophagus the barium meal tumors disappear, basically back to normal, physical examination no signs of tumor is present for more than a month; partial remission (PR esophageal barium meal examination): X line esophageal barium meal examination measurable tumor regression of more than 50%, and no new lesions, and continued for more than a month; stable (SD): X-line measurable tumor shrinkage of less than 50% tumor increase less than 25% for more than a month; Progress (PD): X line esophageal barium meal examination measurable tumor increased more than 25% of new lesions. CR + PR to CR, based on X-ray, physical examination, and esophageal endoscopy score, visceral and distant lymph node metastases were assessed according to WHO promulgated solid tumors measurable lesions Response Evaluation Criteria bone metastases based on X-ray and radionuclide scan and other tests results were assessed.
Drug toxicity: according to the 1991 WHO unified standard 0 ~ Ⅳ degrees.
1.4 statistical methods
The establishment of a database, using χ2 test with SPSS10.0 package.
2.1 The short-term effect
Treatment group CR rate was 6.25% (2/32), RR was 71.9% (23/32); CR rate of the control group was 3.57% (1/28), the RR was 42.9% (12/28). 0.05），RR差异有统计学意义（P=0.044），见表1。">Two sets of the CR rate difference was not statistically significant (P> 0.05), RR difference was statistically significant (P = 0.044), as shown in Table 1. Treatment group in patients with previously untreated RR was 73.6% (14/19) in patients with retreatment RR was 69.2% (9/13); control group were 47.1% (8/17), 36.4% (4/11). 0.05），初治和复治患者的RR治疗组均高于对照组，但差异未见统计学意义（P>0.05），见">Initial treatment and retreatment patients RR of treatment group, the difference was not statistically significant (P> 0.05), the initial treatment and retreatment of patients with RR treatment group were higher, but the difference was not statistically significant (P> 0.05), see Table 2. Two groups in Table 1 Table 2 Comparison of the two programs compare two groups in Table 3 toxicities efficacy in patients with initial treatment and retreatment
The two sets of toxicity is bone marrow toxicity, gastrointestinal reactions, and hair loss, as shown in Table 3. Treatment group, neutropenia was 71.9% (23/32), 12.5% (4/32) Ⅲ ~ Ⅳ degree; control group were 53.6% (15/28), 3.57% (1/28), treatment 0.05），Ⅲ度以上白细胞减少患者经G－CSF治疗后均能按时完成化疗周期，无相关死亡病例。">The group was higher, but the difference was not statistically significant (P> 0.05), Ⅲ degree above neutropenia patients after G-CSF treatment could be completed on time cycle of chemotherapy, no related deaths. 0.05），均未见Ⅲ度以上贫血。">Anemia occurred in the treatment group was 43.8% (14/32), 17.9% (5/28) in the control group, the difference was not statistically significant (P> 0.05), and were no more Ⅲ degree of anemia. Treatment group, nausea and vomiting incidence was 71.9% (23/32), grade Ⅲ ~ Ⅳ 9.38% (3/32), diarrhea 62.5% (20/32), stomatitis 50% (16/32); control group followed by 67.9% (19/28), 14.3% (4/28), 64.3% (18/28), 50% (14/28), two groups of gastrointestinal reaction quite incidence was no significant difference. Treatment group alopecia incidence of 96.9% (31/32), significantly higher than 42.9% (12/28) (P = 0.000). Other toxicities, including liver and kidney dysfunction, cardiac toxicity, both groups the incidence is low, and no difference was found. In addition, the treatment group, 1 case of chest tightness, suffocation, facial flushing, and remission after slow infusion.
Since the DDP clinical application, various joint programs for the treatment of esophageal cancer is gradually increasing. Had the DDP, Bo to neomycin (BLM), vindesine (VDS) of three drugs used in combination treatment of advanced esophageal cancer, but only about 30% RR, and later found, CF/5-Fu and DDP the joint RR higher, up to 50% to 60%, therefore CF/5-Fu + PDD synergistic therapy of esophageal cancer has become the standard program . But still about half of patients with chemotherapy poor efficacy, therefore, some scholars try in this program on the basis of a new drug, such as paclitaxel (PTX) , TXT , vinorelbine (NVB) [5 ], gemcitabine (GEM) , irinotecan , in order to achieve a higher efficacy.
TXT by promoting microtubule protein assembly into microtubules and prevents their depolymerization, so that the cell’s microtubule loss of normal function and lead to cell death. As cell mitosis inhibitor blocking the cancer cells in the G2 / M phase of the cell cycle; addition, in vitro tests showed that there are anti-tumor angiogenesis and inducing apoptosis of tumor cells. The main toxicity was myelosuppression and alopecia, bone marrow suppression correctable G CSF support. Much attention due to its unique mechanism of action, broad spectrum anti-cancer, TXT, approved in the major countries of the global breast cancer, non-small cell lung cancer, prostate cancer, three kinds of indications , in 2006 the FDA approved in the treatment of advanced gastric cancer. TXT for the treatment of esophageal cancer less Japan a TXT treatment of metastatic esophageal cancer research  TXT 70 mg/m2 single drug to obtain a 20% partial response rate, median survival time was 8.1 months, one year survival rate was 35%, so accordingly TXT study was approved in January 2004 for treatment of esophageal cancer.
In this paper, TPF regimen in the treatment of 32 cases of advanced esophageal cancer, the overall RR of 71.9%, significantly higher than the PF regimen, 42.9% (P = 0.044), and TPF program is equally effective initial treatment and retreatment of advanced esophageal cancer, some patients with previously untreated radical surgery opportunity. The small sample size may be between the two programs on the efficiency the main reason was no significant difference in the initial treatment or retreatment patients. The TPF regimen toxicities were neutropenia, gastrointestinal reactions and alopecia, leukopenia incidence compared to the PF regimen, but not statistically significant, but did not affect the normal conduct of chemotherapy. The TPF regimen only significantly higher than the PF regimen toxicity is alopecia (P = 0.000), but patients can accept.
Therefore, we believe, the TPF regimen for advanced or recurrent esophageal cancer is safe and effective, and patients can tolerate is a better application prospects chemotherapy. However, in this study the small sample size, its efficacy and toxicity needs further study, and its long-term effect needs further study.