| Purpose:To understand the characteristics of bone marrow safety after the application of docetaxel chemotherapy in real cases in China,and to summarize the effects of different leukocyte-raising protection modes,different chemotherapy methods,different doses of chemotherapy,and different factors of bone marrow toxicity on patients with differentiated effects.Sexual whitening protects the drug.Methods:This study screened the enrolled patients according to the following criteria:(1)patients with breast cancer diagnosed by histopathology;(2)The patient has not received chemotherapy before,plan to assist or neoadjuvant chemotherapy,and at least two cycles of chemotherapy with docetaxel;(3)More detailed hematology data can be analyzed after chemotherapy.(4)No obvious signs of hematological diseases,baseline ANC≥1.5×10~9/L,PLT≥80×10~9/L,Hb≥75g/L,WBC≥3.0×10~9/L,and no bleeding tendency.Any of the following are excluded:(1)There are uncontrollable infections during treatment;(2)Patients received systemic antibiotics within 72 hours prior to chemotherapy;(3)Any patient with abnormal bone marrow hyperplasia and other hematopoietic dysfunction;(4)Patients who have received bone marrow or hematopoietic stem cell transplantation;(5)Patients who received radiation therapy within 4 weeks prior to the start of treatment.According to the different modes of leukocyte-raising protection measures received in the first cycle of chemotherapy,patients were divided into three groups:unprotected group(referred to as“unprotected group”)who received no leukocyte-raising protection,A long-acting leukocyte-raising group(referred to as"long-acting group")that received a single fixation of 6 mg of PEG-rhG-CSF and the short-acting leukocyte-raising group(referred to as the"short-acting group"),which received 300 ug/time of rhG-CSF protection.According to different chemotherapy regimens,it can be divided into three-week regimen with docetaxel monotherapy T-chemotherapy,TA regimen and TC regimen with docetaxel-containing regimen,all in accordance with CSCO guidelines.All of them have completed the complete cycle of chemotherapy,and there are more detailed blood routine data in our department during the chemotherapy cycle.General information of 3 groups of patients and post-chemotherapy hematology data were collected for analysis.Results:A total of 412 patients were enrolled,and the three groups were 153 in the unprotected group,161 in the long-acting group,and 98 in the short-acting group.The general data and treatment information characteristics of the three groups were similar:the average of the KPS scores of the unprotected,short-acting,and long-acting groups,the age composition,and the average body weight and body surface area were similar;the neutrophil absolute count(ANC)baseline of the 3 groups.They were all maintained at a level of about 4.×10~9/L;There were a small number of patients with mildly low liver function before treatment,and the unprotected,short-acting,and long-acting groups accounted for 13.7%,16.1%,and 14.3%,respectively.There are cases renal function was low in the group,all of which are mild.According to the treatment plan,the unprotected group TA program,TC program,single drug T program were 63 cases,70 cases,20 cases;the long-acting group was 64cases,76 cases,21 cases;the short-acting group was respectively There were 28 cases,55 cases,and 15 cases.According to the standard dose of Docetaxel in the CSCO guidelines,the unprotected,long-acting,and short-acting groups were 43(26.1%)and 46(28.6%),respectively.29 cases(29.6%);90 cases(58.8%),98 cases(60.9%),59 cases(60.2%),respectively,reached the standard dose intensity of 90%-110%;There were 20 patients(13.1%),17 patients(10.5%),and 10 patients(10.2%).A significant proportion of patients had a gap with the standard docetaxel dose intensity required by the CSCO guidelines.(1)The incidence of grade III/IV neutropenia:The unprotected group was as high as94.8%,which was much higher than the two groups with white protection(P=0),the long-acting group was 30.4%,and the short-acting group was 45.9%.The long-term and short-acting groups reached the statistics.The difference in academic significance(P=0.012).The incidence of IV neutropenia was also the same:the incidence of grade IV neutropenia in the unprotected,short-acting,and long-acting groups was 68.6%,33.7%,and 17.4%,respectively,and the blank group was much higher.The other two groups also had statistical differences between the two groups(P=0.013).In the second cycle of chemotherapy,the long-acting group using PEG-rhG-CSF in both cycles had a two-cycle III/IV degree neutropenia with an incidence of 30.4%and 19.9%,respectively,and the second cycle was lower than the first cycle.The cycle(P=0.028).(2)The duration of III/IV neutropenia:The median duration of the unprotected group reached 4 days,which was much longer than the protected group(P<0.001).The median time of the long and short-acting groups was 2 days.The duration average was shorter,but no Statistical difference(P=0.696).(3)The incidence of febrile neutropenia(FN):was 28.8%in the unprotected group,exceeding 20%.After the different chemotherapy regimens,the incidence of AT,TC,and single drug T was 30.2%,25.7%,and 35%.The long-acting and short-acting groups receiving leukocyte-raising protection had 4 cases(2.48%)and 2 cases(2.04%)with FN,which were significantly lower than the unprotected group(P<0.01).Long-acting and short-acting groups.There is no difference between them.(4)The neutrophil absolute count(ANC)trend:The unprotected group ANC showed a"single valley"with time,and the ANC began to decrease significantly on the 7th day.On the 8th-10th day,the median 9th day reached the lowest ANC value for about 5-7days.Recovered on the 14th day.The long-term and short-acting groups showed a"double peak"change with time.Compared with the unprotected group,the number of days in which the lowest ANC appeared occurred,and the long-acting and short-acting groups were the median 7th and median.8 days appeared,which was earlier than the median 9th day of the unprotected group(P<0.001).There was also a statistical difference between the long and short-acting groups.After that,the recovery rate of ANC was faster than that of the unprotected group,and severe neutropenia was observed.The duration is shortened.The preventive leukocyte-raising protection measures have better protection effect on the single-agent docetaxel regimen than the docetaxel-containing chemotherapy regimen.The short-acting group grade IV neutropenia has a single-agent and joint regimen of 13.3%and 37.3%,respectively;the incidence of granulocytopenia in the long-acting group of single-agent and combination regimens was 0%and 20.0%,respectively,and the single-drug and combined regimen of different leukocyte-raising protection measures reached statistical difference(P<0.05)..In the comparison of different leukocyte-raising protection measures,the long-acting group under the docetaxel single-agent regimen was completely protected,while the short-acting group had a prevalence of grade IV neutropenia still 13.3%;under the docetaxel combination regimen The long-acting and short-acting groups achieved statistical differences(P<0.01).In the docetaxel combination regimen with long-lasting leukocyte-raising protection,the different dose strengths of docetaxel were compared:only 2 of the 31patients who were significantly lower than the standard dose intensity chemotherapy(<90%standard dose intensity).In the case of IV neutrophil deficiency,the incidence rate was only 6.5%;relative to the standard dose intensity range(90%-110%standard dose intensity),the incidence of IV granulocyte deficiency reached 22.8%,significantly exceeding the lower than Standard dose-strength chemotherapy(P=0.04).Especially in cases exceeding the standard dose intensity(>standard dose intensity 110%),the incidence rate reached 29.4%,the incidence increased further,and significantly exceeded the patients below the standard dose intensity chemotherapy(P=0.03).Among other bone marrow safety risk factors in breast cancer patients,in the long-acting group also fixed 6 mg long-acting leukocyte-raising protection:(1)Baseline ANC level:the incidence of IV neutropenia was 33.3%when the baseline ANC was low,baseline ANC the incidence of IV neutropenia was 15.0%at normal time,and the incidence of IV neutropenia was lower when the ANC baseline was normal compared with baseline,and the difference was statistically significant(P=0.04).(2)Different weight grouping:in patients with significantly lower body weight,the incidence of IV neutropenia was the lowest in patients<50 kg,and no granulocyte deficiency in 13 patients;and IV granulocytes in group 50-70 kg body weight,The incidence of deficiency increased gradually,reaching 17.1%.Especially in patients with significantly larger body weight,and the incidence of IV neutropenia was 25.8%in patients>70 kg,which was statistically different compared with cases with light weight(P=0.04).(3)The effect on the lack of severe granulocytes,which is not clinically required and allows for mild hepatic dysfunction of chemotherapy,grouping of different ages,and different KPS scores.Conclusion:1.In real-world patients receiving chemotherapy with docetaxel,there is a high probability of serious bone marrow toxicity,and the risk of FN is high.Primary prevention should be given the use of leukocyte-raising protective drugs in patients receiving docetaxel-containing chemotherapy.2.Preventive use of leukocyte-raising protective drugs in patients.Prophylactic long-acting,short-acting leukocyte-raising drugs have a significant effect on improving neutropenia when treated with chemotherapy drugs with high bone marrow toxicity.The long-acting leukocyte-raising drug PEG-rhG-CSF is superior to the short-acting leukocyte-raising drug rhG-CSF.3.The single-agent docetaxel regimen has better protection than the docetaxel combination scheme under the same leukocyte-raising protection.In the comparison of different leukocyte-raising protection measures,whether for the single-agent docetaxel or docetaxel combination,the long-term protection is better than the short-acting protection.4.In real-world patients receiving non-standard dose-strength chemotherapy,the safety is lower than the standard dose intensity,the incidence of severe neutropenia can be controlled at a lower level;and the bone marrow safety is significantly reduced at significantly higher than the standard dose intensity.5.If breast cancer patients have low baseline ANC levels or high body weight,which may affect the safety of bone marrow and the risk factors of leukocyte-raising protective drugs,even if standard long-term leukocyte-raising protection has been adopted,it is necessary to be alert to the occurrence of chemotherapy bone marrow safety events. |
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