| Objective:Compare the clinical efficacy,toxicity and adverse reactions between irinotecan and docetaxelin in the second-line treatment of advanced esophageal cancer and investigate the factors influencing the prognosis of the patients.Methods:134 patients with advanced esophageal cancer were treated as the research objects from January 2012 to December 2014 in the department of oncologyof Subei People's Hospital of Jiangsu province.All the patients were ineffective or progressin first-line treatment.The patients were randomly divided into irinotecan group(n=68)and docetaxel group(n=66).Irinotecan group was treated with irinotecan combined with other chemotherapeutic drugs,and docetaxel group was treated with docetaxel combined with other chemotherapeutic drugs.Patients with efficacy evaluated received at least 2 cycles of systemic chemotherapy,and it could not stop until the disease progression or intolerable toxicity.The clinical efficacy was evaluated by imaging every two cycles at least.The short-term effect complete remission(CR),partial remission(PR),stable disease(SD),progressive disease(PD)was evaluated according to the evaluation criteria of solid tumor.The determination of toxicity and adverse reactions were based on the national cancer institution common terminology criteria.Progress-free survival(PFS),overall survival(OS),clinical benefit rate(DCR)and objective remission rate(ORR)in patients were observed and analyzed.The follow-up period was 1 years after the death of the patient or the end of the treatment.The clinical data of two groups were analyzed retrospectively.Univariate analysis was performed to the factors influencing the prognosis including TNM stage(the depth of tumor invasion,lymph node metastasis and distant metastasis),patients status(sex,age,ECOG score,the length of the tumor,the recurrence and metastasis time).The impact was estimated of the factors on OS.Results:(1)There is no significant difference in the two group in the sex,age,location,BMI,PS score,length,TNM stage and metastasis time.(2)Clinical efficacy analysis:The average period of chemotherapy in two groups was similar,respectively(3.8±0.77)months and(3.7±0.92)months(P=0.923).After the treatment,there was no CR case in the two groups.In the irinotecan group and docetaxel group,the PR cases were 15(22.0%)and 14(21.2%),the SD cases were 14(20.6%)and 18(27.2%),the PD cases were 39(57.4%)and 34(51.5%).The ORR of irinotecan group was 22.0%slightly higher than that of docetaxel group 21.2%,and there was no significant difference between the two groups(P=0.905).The DCR of irinotecan group was 48.5%slightly higher than that of docetaxel group 42.6%,and there was no significant difference between the two groups(P=0.498).The median OS of irinotecan group and docetaxel group were 6.3 months(95%Cl:5.42-7.27 months)and 6.5months(95%CI:5.49-7.42months).The median PFS of irinotecan group and docetaxel group were 2.2 months(95%CI:1.60-2.84 months)and 2.4months(95%CI:1.63-2.96months).There were no significant differences between the two groups in the median OS and median PFS(P=0.872,0.790).(3)Toxicity and adverse reactions:No one died due to the toxicity and adverse reactions.The main toxicity and adverse reactions were myelosuppression(neutrophil decrease,thrombocytopenia,hemoglobin levels decreased),gastrointestinal toxicity(diarrhea,nausea and vomiting),liver function abnormalities and hair loss.Most of the patients were able to tolerate,and there was no significant effect on the course of treatment.A small number of patients were remission of disease after symptomatic treatment.The incidences of severe anemia and alopecia(III-IV)of irinotecan group were 5.9%,5.9%which significantly lower than that of docetaxel group 27.3%,36.4%(P=0.001,0.000).The incidence of severe diarrhea of docetaxel group was 12.1%significantly lower than that of docetaxel group 41.2%(P=0.000).(4)Influencing factors of prognosis:It was the significantly correlation between the OS of patients with advanced esophageal cancer with the factors of TNM stage(the depth of tumor invasion,lymph node metastasis and distant metastasis),patients status(ECOG score,the length of the tumor,the recurrence and metastasis time).They were the risk factors including high depth of tumor invasion,lymph node metastasis,distant metastasis of tumor,ECOG scores of patients more than 2,the longest diameter of the tumor more than 3 cm,recurrence time less than 6 months had the negative correlation with OS in patients with advanced esophageal cancer.Conclusions:(1)The clinical efficacy of irinotecan and docetaxel is quite similar in second-line treatment of advanced esophageal cancer,and the median OS were 6.3 months and 6.5 months,the median PFS were 2.2 months and 2.4 months,the ORR were 22.0%and 21.2%respectively.(2)The major toxicity and adverse reaction of irinotecan and docetaxel in second-line treatment of advanced esophageal cancer were bone marrow suppression,gastrointestinal toxicity and abnormal liver function.No patient died of toxicity and adverse reaction.Irinotecan and docetaxel have the good safety and tolerance.And compared with irinotecan,the incidence rate of severe anemia and alopecia of docetaxel was significantly higher and the incidence rate of severe diarrhea was significantly lower.(3)The factors of the depth of tumor invasion,lymph node metastasis,distant metastasis,ECOG score,the longest diameter of the tumor,recurrence and metastasis time a have a significant impact on the survival of patients.The prognosis of patients is good with shallow depth of tumor invasion,small volume,no distant metastasis and lymph node matastasis,good physical condition,recurrence and metastasis time more than 6 months. |
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