| IntroductionMelanoma is one of the most common malignant tumors that originated from melanocytes.In the past 50 years,the incidence of melanoma among Caucasian population has increased by 10 times.The incidence of melanoma among the Chinese population is also growing at a relatively low rate of 3%-5%.The most common type of melanoma is the cutaneous melanoma(CM)which is one of the most highly malignant tumors in the skin tumors.And its death toll is almost 90%.The main clinical feature of melanoma can be summarized as “ABCDE”: Asymmetry,border irregularity,color variegation,diameter and evolving.ObjectiveWe analyzed the clinical data of patients with melano ma in recent 9 years in this study retrospectively.In order to investigate the clinical and epidermiological characteristics of melanoma on the one hand and on the other hand evaluate the effect and adverse reaction of high-dose interferon alpha-1b(IFNα-1b)with advanced melanoma patients as postoperative adjuvant treatment,to provide references for the treatment and prognosis.MethodsThe clinical data of 375 cases of melanoma patients diagnosed by pathology were collected from September 2006 to October 2015 in Xijing Hospital.361 patients aged 18-80 years old without serious chronic disease were included in the study and followed up until October 2016.SPSS19.0 statistical software was used to evaluate the clinical efficacy of high-dose IFNα-1b in the treatment of patients with advanced melanoma.Evaluation indexes include median survival time,progression-free survival(PFS),1-year,3-year and 5-year survival rate and the incidence of adverse reactions.Results361 cases of melanoma were included in the study,in which there were 61 cases of in situ melanoma,101 cases of early stage melanoma(stage IA-II A),and 199 cases of advanced melanoma(stage II B-IV),including 52 patients with stage IV melanoma.By October 2016,a total of 36 death and 3 people lost to follow-up.The follow-up period for the patients who lost the follow-up was more than 12 months.All patients died of melanoma progression.The median follow-up period was 31 months(range,3-121 months).Male 142(39.3%),female(60.7%),the ratio is approximately 1:1.5.The average onset age of all patients is(53.82±13.25).The distribution of primary tumor site: 54 cases in head and neck(15%),32 cases in the trunk(8.9%),26 cases in limbs(7.2%),215 cases in the extremities(hands and feet)(59.6%),27 cases of mucosa(7.5%)and 7 cases in eyes(9%).Patients with in situ melanoma were treated extended 0.5 cm resection.After surgery,only 2 patients received IFNα-1b adjuvant therapy,the rest of the patients did not receive any adjuvant therapy.The courses of disease in 61 patients were ranged from 12 months to 116 months.All patients were followed up until October 2016,and no disease progression or recurrence occurred.The 5-year survival rate is 100%.Early stage melanoma patients were treated with enlarged 1-2 cm resection according to tumor Breslow thickness.There are 2 patients with stage Ⅰhad disease progression,one had pulmonary metastasis and the other had liver metastasis.At the end of the follow-up period,the two patients were still alive for a period of 28 months and 21 months,respectively.6 patients with phase ⅡA showed disease progression,4 of them progressed to phase Ⅲ,and the other 2 progressed to stage Ⅳ.Three patients died during the follow-up.The 5-year survival rate of patients with early stage is 97.1%.A total of 199 patients with advanced melanoma were enrolled,including 8 patients with advanced disease from early stage to advanced stage during the follow-up period.All the advanced melanoma patients were treated with enlarged 2 cm resection,and the patient with stage Ⅲ and the above underwe nt lymph node dissection.Base on the above,high-dose IFNα-1b postoperative adjuvant therapy were given with a starting dose of 300-600 μg / time,subcutaneous,once every other day.A total of 66 patients developed disease progression,the median PFS of them is 44 months(95% confidence interval [CI],42.603-45.397)and the median survival has not reached.3-year and 5-year survival rates are 82.4% and 77.2%,respectively.170 patients with stage ⅡB-ⅡC and ⅢB-ⅢC had a median PFS of 43 months(95% confidence interval [CI],28.005-57.995),and the median survival has not reached,3-year and 5-year survival rates are 87% and 80.9%,respectively.52 patients with stage Ⅳ had a median survival of 16 months(95% confidence inter val [CI],5.106-26.894),1-year,3-year and 5-year survival rates are 69.1%、30.9% and 23.3%,respectively.Using Log-rank test to analyze the relationship between the location in initially diagnosed with metastatic and the survival of the patients with stage Ⅳ,the results showed that the median survival of the patients with M1 a was significantly longer than patients with M1c(P=0.028);But between patients with M1 a and M1 b,or between patients with M1 b and M1 c,the survival tine did not showed significant differences(P>0.05),the P-values are respectively 0.922 and 0.191.The main side effects of adjuvant therapy for high-dose IFNα-1b were fever,fatigue,alopecia,gastrointestinal reaction,white blood cell decrease,transaminase ele vation,abnormal thyroid function and so on.The incidence of fever is the highest(72.4%),followed by fatigue(17.1%),the occurrences of grade 3 or grade 4 severe adverse reaction include fever(15.6%),abnormal thyroid function(5%),abnormal autoantibodies(2%),alpecia,fatigue and white blood cell reduction in each of 1 case.Toxicity was assessed according to the National Cancer Institute Common Toxicity Criteria(National Cancer Institute,NCI)2.0.The dosage of IFNα-1b was forced to be reduced in one patient when receiving IFNα-1b(400 g/ time)injection because of the insupportable adverse reactions.The patient felt much well when the dosage reduced to 200 g/ time and continued using the drug.Conclusion:1.The incidence of melanoma increased year by year in C hina.Extremity is the predilection site and the elderly is the predilection population.2.In situ melanoma patients do not need any adjuvant therapy after appropriate extended resection.3.High-dose IFNα-1b adjuvant therapy can prolong the median overall survival and the progression-free survival of patients with advanced melanoma;the side effects of IFNα-1b are relatively mild and reversible. |
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