2020中国滤泡性淋巴瘤患者（FL）生存状况白皮书.pdf

中国滤泡性淋巴瘤患者生存状况白皮书White Paper on the Living Conditions of Follicular Lymphoma Patients in China 调查概况本次调查是由淋巴瘤之家、香港中文大学赛马会公共卫生与基层医疗学院和北京新阳光慈善基金会共同发起。针对滤泡性淋巴瘤患者，对基本人口学特征、诊断、治疗、疾病经济负担、用药情况和生存质量等做的线上调查。本次研究自2020年6月4日从组织意见预调研开始，患者和患者组织共同积极协助设计和修改问卷内容，贡献他们的经验与观察。问卷修改了7稿，预测试4轮。从2020年7月22日问卷正式发放到2020年9月14日正式截止总共收到有效问卷为326份（由患者自行填写的共计181份，由患者家属或其他主要照顾者代填的共计145份）。此报告即是根据这326份问卷分析、书写而成。This survey was jointly initiated by House086,the Jockey Club School of Public Health and Primary Care,The Chinese University of Hong Kong,and New Sunshine Charity Foundation.The main purpose of the survey was to explore the demographic characteristics,experience of diagnosis and treatment,disease burden and quality of life of follicular lymphoma patients in China.The pre-survey on question testing and consolidation started on June 4,2020.Patients and staffs from the patient organization,House086,devoted their time,experiences,and expertise to the design and refinement of the questionnaire.The questionnaire was modified for seven rounds and four pilot tests were conducted before the official launch of the survey.In total,326 valid responses were collected from July 22 to September 14,2020,among which,181 were from the patients themselves and 145 were from the patients family members or other main caregivers.This report is drafted based on answers from these 326 questionnaires.Overview-1-患者基础信息Demographics-2-性别年龄分布女性55.52%男性44.48%20 岁以下19-29 岁30-39 岁40-49 岁50-59 岁大于 60 岁0.31%3.07%23.31%34.05%24.85%14.42%性别与年龄在326名受访病友中，女性比例高于男性。受访患者的年龄主要在30岁或以上，中位年龄46岁。Gender and AgeOf all the 326 patients under survey,the proportion of females was higher than that of the males.A large majority of the patients surveyed were aged 30 years or above.The median age of the patients was 46 years.FemaleUnder 20yrs19-29yrs30-39yrs40-49yrsAge50-59yrsOver 60yrsMaleGender-3-全职就业退休/离休无业/待业料理家务丧失劳动力停职留薪兼职就业在校学生42.46%88.42%23.38%13.85%5.54%5.23%4.62%4.00%0.92%成年患者就业情况因滤泡淋巴瘤导致未就业情况11.58%非因病失业因病失业Due to other reasonsDue to follicular lymphoma在所有受访成年患者中，未就业占比 26.2%，因为滤泡性淋巴瘤而导致未就业的患者占绝大多数。未就业情况Employment Status More than 26%of the adult patients were unemployed,mostly due to follicular lymphoma.Full-time employedPart-time employedStudentsUnemployedHomemakersIncapacity for workTake unpaid leaveRetiredEmployment status of adult patientsUnemployment due to follicular lymphoma-4-城镇职工基本医疗保险城镇/城乡居民基本医疗保险新型农村合作医疗公费医疗、劳保医疗商业医疗保险没有参加以上医疗保险/救助其他学生/儿童大病医疗保险59.82%18.17%13.50%9.51%6.44%3.07%0.92%0.92%患者医疗保障覆盖情况（多选）医疗保障在所有受访者中，超过90%的滤泡性淋巴瘤患者享有我国三大基本医疗保险的保障，但也有 3.07%的受访者没有任何基本医疗保险/救助。Medical InsurancesMore than 90%of the follicular lymphoma patients under survey were covered by one of Chinas three basic medical insurances,while 3.07%of the patients were not covered by any.Urban employee basic medical insurance(UEBMI)Urban resident basic medical insurance(URBMI)New rural cooperative medical scheme(NRCMS)Free medical careCommercial medical insuranceNo medical insuranceOtherCritical illness insurance for student/ChildMedical insurance（Multiple choices）-5-患者社会保障覆盖情况其他社会保障（如失业保险、生育保险等）最低生活保障（城市或农村低保）没有以上任何保障/保险11.66%5.52%75.46%社会保障约有四分之三的滤泡性淋巴瘤患者表示未享有失业保险、养老保险、生育保险或者其他社会保障等。Social SecurityAbout three quarters of the follicular lymphoma patients under survey were not covered by unemployment insurance,pension insurance,maternity insurance or any other social security.Minimum social security(urban or rural subsistence)Other social security(e.g.unemployment insurance,maternity insurance,etc.)Without any of the above security/insuranceSocial security-6-就诊与确诊情况Diagnosis-7-病理分级本次调查中滤泡性淋巴瘤患者的病理分级以 12 级为主，占比 47.55%，其次为 3a 级，占比 34.50%。Pathological GradeIn this survey,47.55%of the patients had a pathological diagnosis of grade 12,followed by grade 3a,accounting for 34.05%.Transformed（To DLBCL,etc.）UnknownGrade 12Grade 3aGrade 3bPathological grade-8-患者病理分级情况已发生转化（如弥漫大B或其他淋巴瘤）,5.21%不清楚,5.52%3b 级,7.67%3a 级,34.05%12 级,47.55%83.90%10.96%3.77%0.68%0.68%初次确诊滤泡性淋巴瘤的患者 245 位（占 83.90%），复发患者 47 位（占 16.10%），其中首次复发的人数最多，共 32 位。初诊与复发Treatment Stages About 83.9%of the patients（N=245）were newly diagnosed with follicular lymphoma and 16.10%were relapsed patients（N=47）.Among them,the largest proportion are patients relapsed once(N=32）.Newly diagnosedRelapse onceRelapse twiceRelapse thriceRelapse four timesNewly diagnosis and relapse-9-初诊与复发情况初诊（首次确诊）首次复发复发2次复发3次复发4次有 135 位患者被医生清楚告知并记录了危险分层，其中 47.41%为低危，34.81%为中危，17.78%为高危。危险分层Risk Stratification 135 patients were clearly informed by their doctors about their risk stratification.Among them,47.41%were at low-risk,34.81%were at intermediate-risk and 17.78%were at high-risk.Low-riskIntermediate-riskHigh-risk-10-47.41%34.81%17.78%低危中危高危相对于低危和中危组，高危组患者中病理分级为 3b 级和已经转化比例相对较高，且高危患者中有过复发经历的患者比例最高。危险分层Risk Stratification Compared with the low-risk and intermediate-risk groups,the proportion of patients with pathological grade 3b and transformation was relatively higher in the high-risk group,and proportion of patients who had experienced relapses was also higher.Low-riskLow-riskGrade 12Newly diagnosedRelapsed onceRelapsed twice or moreGrade 3aGrade 3bTransformedIntermediate-riskIntermediate-riskHigh-riskHigh-riskRisk stratification and pathological gradeRisk stratification and treatment stages-11-56.25%35.94%4.69%6.52%13.64%3.13%2.17%9.09%43.48%36.36%47.83%40.91%低危低危12级初治3a级复发1次3b级已发生转化复发2次或以上中危中危高危高危危险分层与病理分级情况危险分层与初诊复发患者占比情况92.19%80.85%70.83%1.56%4.26%8.33%6.25%14.89%20.83%无论是在确诊淋巴瘤还是进一步确诊亚型的过程中，大部分患者需要集中到北京、上海等医疗资源比较集中的城市，或省会地区，才能得到确诊。异地就诊Trans-local Hospital Visits and DiagnosisTo find a definitive diagnosis of their lymphoma or to further confirm the subtype,most patients had to go to the cities where high-quality healthcare resources are concentrated including municipalities such as Beijing and Shanghai or provincial capitals.BeiJingLiaoNingJiLinHeiLongJiangShangHaiJiangSuAnHuiHeNanNingXiaNeiMengGuGanSuQingHaiXinJiangXiZangSiChuanYunNanGuiZhouHuNanJiangXiZheJiangTaiWanFuJianGuangDongGuangXiHaiNanAoMenXiangGangChongQingShaanxiShanxi HeBeiShanDongHuBeiTianJin0-55-1515-2525-3035-4040-45More than 45Patients number-12-患者的平均确诊年限为 0.16 年（约为 2 个月），有 90.06%的滤泡性淋巴瘤患者都能在求医当年就得到确诊。但有过无法及时确诊*经历的患者，从看病到最终确诊所用的时间显著长于可以及时获得确诊的患者。*无法及时确诊：特指因病理分型不明确或存在误诊，而导致患者无法及时得到明确或正确诊断*Un/under/misdiagnosed refers to various conditions when patients were unable to be diagnosed timely or accurately确诊时长Diagnosis Lag TimeOn average,it took 0.16 years(nearly 2 months)for a follicular lymphoma patient to have a definite diagnosis.Of all patients under survey,90.06%were diagnosed in the first year.Nevertheless,a few patients were un/under/misdiagnosed*,which resulted in an obviously longer interval for them to have a definite diagnosis than those who were not.Less than 1 yearNot timely diagnosedTimely diagnosed1 year23 years46 yearsUnit：year-13-90.06%0.39单位：年0.087.14%1.86%0.93%当年确诊曾经无法及时获得确诊的患者可以及时获得确诊的患者1年23年46年本次调查中，23.01%的患者无法及时得到确诊。其中的 86.67%的淋巴瘤患者曾被怀疑为其他非淋巴瘤疾病，另有 14.67%则曾有被诊断为其他淋巴瘤亚型。无法及时确诊Un/under/misdiagnosedIn this survey,23.01%of the follicular lymphoma patient had experienced un/under/misdiagnosis,of whom 86.67%were suspected of having non-lymphoma diseases,and 14.67%were diagnosed with other lymphoma subtypes.Other lymphoma subtypesTimelyNot timelyNon-lymphoma diseasesPrevious diagnosisPercentage of timely diagnosed or not-14-76.99%14.67%86.67%23.01%其他淋巴瘤亚型其他疾病（非淋巴瘤疾病）及时不及时患者无法及时确诊比例患者曾被诊断的疾病在高危组和病理3b级的患者中，未及时确诊的患者比例分别较其他危险组/病理分级更高。无法及时确诊Un/under/misdiagnosedAt the the high-risk group or with pathological diagnosis of grade 3b group,un/under/misdiagnosed patients took a higher proportion than other groups respectively.Un/under/misdiagnosed and risk stratification Un/under/misdiagnosed and pathological grade Low-riskGrade 12Grade 3aGrade 3bTransformedIntermediate-riskHigh-risk-15-各病理分级无法及时确诊的比例各危险分层无法及时确诊的比例25.00%19.15%33.33%11.76%36.00%25.23%20.65%低危中危高危已经转化3b级3a级12级治疗情况Treatment-16-参与调查的患者中，有 64.42%的患者正在接受治疗，从来都没有治疗过的患者占 19.63%。和从未治疗的患者相比，正在治疗和没有在治疗的患者患者组中复发患者比例均更高。治疗情况Treatment Status and Stage Of all the patients,64.42%were currently under treatment at the time of survey.Yet 19.63%were never treated.Compared with those who had never been treated,there was a higher proportion of relapsed patients of those who were currently being treated or had been treated before.Treated-currentlyTreated-currentlyNever treatedNever treatedNon treated-currentlyNewly diagnosed patientsRelapsed patientsNon treated-currentlyTreatment statusTreatment status and stage-17-各治疗阶段初诊复发患者占比情况各治疗阶段患者占比情况64.42%100.00%64.29%35.71%16.84%83.16%19.63%15.95%正在治疗从未治疗过没有治疗正在治疗从未治疗没有在治疗初诊患者复发患者治疗情况和从未治疗患者相比，正在治疗或没有在治疗的患者中的病理 3 级和发生转化的患者、中高危的患者更多。Treatment Status and Stage Compared to those who had never been treated,there was a higher proportion of patients with pathological grade 3 or at intermediate-high risk in the groups of patients who were currently being treated or had been treated before.Never treatedNever treatedNon treated currentlyNon treated currentlyTreated-currentlyTreated-currentlyPathological grade and treatment statusRisk stratification and treatment statusGrade 12Grade 3aGrade 3bTransformedLow-riskIntermediate-riskHigh-risk-18-从未治疗过没有在治疗正在治疗从未治疗过没有在治疗正在治疗80.95%39.30%43.43%83.33%40.70%25.58%36.84%16.67%52.63%33.72%40.91%40.43%17.46%12.77%8.51%5.56%10.10%1.59%10.53%各治疗阶段患者病理分级情况各治疗阶段危险分层情况12级低危3a级中危3b级发生转化高危初诊患者中使用 RCHOP 的人数最多，医生推荐给初诊患者的平均诱导疗程为 7.41 个，超过 80%的患者根据医生的建议完成了所有疗程，患者实际完成的平均诱导疗程与医生推荐的疗程数相近，为 6.51 个疗程。初诊方案：诱导治疗*RCHOP：利妥昔单抗+环磷酰胺+多柔比星+长春新碱+泼尼松*RCHOP:rituximab+cyclophosphamide+doxorubicin+vincristine+prednisone*BR：苯达莫司汀和利妥昔单抗*BR:bendamustine+rituximab*R2：利妥昔单抗+来那度胺*R2:Rituximab+LenalidomideFirst Line Treatment Regimens:Induction StageR-CHOP was the most commonly used initial treatment option during the induction stage.On average,7.41 cycles were recommended by doctors and more than 80%of the patients were compliant with their doctors recommendations.The actual average induction cycles(N=6.51)completed by the patients were close to the numbers recommended by their doctors.Induction regimens for first line treatmentNumber of cycles recommended and completedOther regimens*RCVP：利妥昔单抗+环磷酰胺+强的松+长春新碱*RCVP:rituximab+cyclophosphamide+prednisone+vincristine*CHOP：环磷酰胺+多柔比星+长春新碱+泼尼松龙*CHOP:cyclophosphamide+doxorubicin+vincristine+prednisolone-19-初诊患者诱导治疗方案选择医生推荐及患者实际完成疗程的情况患者实际完成疗程医生推荐疗程60.00%13.33%9.09%7.88%7.27%1.82%0.61%RCHOP*利妥昔单抗BR*R2*其他方案RCVP*CHOP*单位：人Unit：patientsCycles completedCycles recommendedRituximab初诊方案：维持治疗正在做维持治疗或已经完成了维持治疗的初诊患者中，使用利妥昔单抗的人占绝大多数。对已经完成维持治疗的患者，医生推荐给他们的平均维持疗程为 9.38 个，而他们平均实际完成的疗程为 6.50 个。较多患者的医生建议疗程多于 6 个；63%的患者完成了 6 个或以上疗程。First Line Treatment Regimens:Maintenance StageRituximab was the first line maintenance treatment option to the newly diagnosed patients.For patients who had completed the maintenance treatments,the average completed cycles were 6.50,while an average of 9.38 cycles were recommended by their doctors.For most patients,their doctors suggested more than 6 cycles and 63%of them had completed 6 or above.Maintenance regimens for first line treatmentNumber of cycles recommended and completed-20-医生推荐及患者实际完成疗程情况患者实际完成疗程医生推荐疗程单位：人初诊患者维持治疗方案选择84.81%8.86%5.06%1.27%利妥昔单抗R2其他方案来那度胺RituximabOther regimenslenalidomideCycles completedCycles recommendedUnit：patients复发治疗方案：诱导治疗复发患者使用最多的前三位诱导治疗方案是：R2、RCHOP、BR。已经完成诱导治疗的复发患者里，医生推荐使用多于 6 个治疗疗程，大部分患者实际完成了 6 个疗程或多于 6 个疗程。Treatment Regimens for Relapsed Patients:Induction StageThe three most common induction treatment regimens used by relapsed patients were:R2,RCHOP and BR.To the relapsed patients who had completed induction stage,more than 6 cycles were recommended by doctors,and most patients had completed 6 or more cycles.Induction regimens for relapsed treatmentNumber of cycles recommended and completed-21-医生推荐及患者实际完成疗程情况患者实际完成疗程医生推荐疗程单位：人患者治疗方案选择情况27.03%24.32%18.92%13.51%13.51%2.70%R2RCHOPBR其他方案来那度胺利妥昔单抗RituximabOther regimensLenalidomideCycles completedCycles recommendedUnit：patients目前正在进行维持治疗或已经完成维持治疗的复发患者使用的方案是 R2、来那度胺或利妥昔单抗等。完成维持治疗患者 5 例，其维持治疗平均疗程数为 5.20 个；正在进行维持治疗的患者 11 例，其目前所处平均疗程数 6.55 个。复发治疗方案：维持治疗Treatment Regimens for Relapsed Patients:Maintenance StageThe regimens used by relapsed patients who were undergoing maintenance treatment at the time of survey or who had completed maintenance treatment were R2,lenalidomide or rituximab.For the 5 patients who had completed maintenance treatment,the average cycles of their maintenance treatment were 5.20;for the 11 patients who were undergoing maintenance treatment,their average cycles were 6.55.Maintenance regimens for relapsed treatment-22-31.25%31.25%18.75%18.75%R2来那度胺其他方案利妥昔单抗复发患者维持治疗方案选择RituximabOther regimensLenalidomide经济负担Disease Burden-23-受访的初诊患者，平均每个诱导治疗疗程花费为 3.05 万元，自费占总支出的 53.55%。平均每个维持治疗疗程的花费为 1.7 万元，自费占总支出的 70.56%。完成全疗程治疗的初诊患者总花费约为 32.23 万元，自费占总支出的 54.94%。初诊患者的医疗支出Medical Expenditure of Newly Diagnosed Patients The average cost of each induction cycle for newly diagnosed patients was 30,500 CNY,of which 53.55%was self-pay.The average expenditure of each maintenance cycle was 17,000 CNY,of which 70.56%was self-pay.The aggregate expenditure for newly diagnosed patients to complete the full treatment cycles once was nearly 322,300 CNY,of which 54.94%was self-pay.Expenditure of each cycle for first line treatmentOverall expenditure for first line treatment-24-1.41，46.45%14.52，45.06%0.5，29.44%1.63，53.55%17.70，54.94%1.21，70.56%诱导治疗维持治疗全疗程初诊患者单疗程费用初诊患者全疗程费用InductionMaintenance单位：万元Unit：10,000CNY报销自费Self-pay medical expenditureReimbursable expenditureWhole treatment course复发患者的医疗支出受访的复发患者，复发后平均每个诱导治疗疗程花费为 2.27 万元，自费占总支出的56.18%。平均每个维持治疗疗程的花费为 1.53 万元，自费占总支出的 60.92%。受访患者中已完成一次全疗程治疗的复发患者总花费约为 19.22 万元，自费占总支出的 58.35%。Medical Expenditure of Relapsed Patients To the relapsed patients who received the re-treatment,the average cost of each induction was 22,700 CNY,of which 56.18%was self-pay.The average expenditure of each maintenance cycle was 15,300 CNY,of which 60.92%was self-pay.The aggregate expenditure for relapsed patients who completed the full treatment cycles once was nearly 192,200 CNY,of which 58.35%was self-pay.Expenditure of each cycle for relapsed patientsOverall expenditure for relapsed patients to complete the full treatment cycles once-25-0.99，43.82%0.59，39.08%1.27，56.18%0.93，60.92%诱导治疗维持治疗复发患者复发后单疗程费用情况8.01，41.65%11.21，58.35%全疗程复发患者复发后一次全疗程费用情况InductionMaintenance单位：万元Unit：10,000CNY报销自费Self-pay medical expenditureReimbursable expenditureWhole treatment course2019 年度，滤泡性淋巴瘤患者家庭收入均值约为 12.07 万元。其中，初诊患者的家庭收入均值为 12.84 万元，复发患者的家庭收入均值仅 8.69 万元。家庭年收入Annual Household Income in 2019 The average household income of follicular lymphoma patients under survey was about 120,700 CNY in 2019.The average household income of newly diagnosed patients was 128,400 CNY,while that of the relapsed patients was merely 86,900 CNY.-26-没有收入5 千以下5 千-1 万1-3 万3-5 万5-10 万10-20 万20-30 万30-50 万50 万以上1.84%0.61%2.15%8.59%18.10%30.67%24.23%8.59%4.29%0.92%2.13%0.00%4.26%12.77%23.40%31.91%21.28%4.26%0.00%0.00%1.63%7.76%17.14%29.39%25.71%9.39%5.31%1.22%1.63%0.82%患者家庭年收入情况初诊患者家庭收入所有患者家庭收入 复发患者家庭收入All patientsNewly diagnosed pati