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Efficacy and safety of obinutuzumab for the first-line treatment of Follicular lymphoma:a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study

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Chinese Medical Journal 2022年第4期135卷 433-440页

作者： Xiaonan Hong Yuqin Song Yuankai Shi Qingyuan Zhang Wei Guo Gang Wu Junmin Li Jifeng Feng Anastasiia Kinkolykh Andrea Knapp Tongyu Lin Department of Medical Oncology Fudan University Shanghai Cancer CenterShanghai 200032China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education) Peking University Cancer Hospital and InstituteBeijing 100142China National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021China Department of Medical Oncology Harbin Medical University Cancer HospitalHarbin Medical UniversityHarbinHeilongjiang 150081China Department of Hematology The First Hospital of Jilin UniversityChangchunJilin 130015China Department of Medical Oncology Cancer CenterUnion HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei 430023China Shanghai Institute of Hematology State Key Laboratory of Medical GenomicsNational Research Center for Translational Medicine at ShanghaiRuijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai 200025China Department of Medical Oncology Jiangsu Cancer HospitalNanjing Medical University Affiliated Cancer HospitalNanjingJiangsu 210009China Consultant to F.Hoffmann-La Roche Ltd BaselSwitzerlandvia GCE Solutions-an IQVIA businessSwitzerland Product Development Oncology F.Hoffmann-La Roche LtdBaselSwitzerland Department of Medical Oncology Sun Yat-Sen University Cancer CenterState Key Laboratory of Oncology in South Chinaand Collaborative Innovation Center for Cancer MedicineGuangzhouGuangdong 510075China

Backgrounds:GALLIUM is a global phase Ⅲ study that demonstrated significant improvements in progression-free survival(PFS)for obinutuzumab plus chemotherapy(G-chemo)vs.rituximab plus chemotherapy(R-chemo)in previously untreated patients with Follicular lymphoma(FL).This study aimed to report the results of a subgroup of patients in China.Methods:Patients were randomized to G-chemo or R-chemo.Responders received maintenance therapy for 2 years or until disease progression.The primary endpoint was investigator(INV)-assessed PFS.Secondary endpoints included the overall response rate(ORR)and complete response rate(CRR)at the end of induction chemotherapy,overall survival(OS),and safety.Results:Overall,58 patients with FL were randomized to the G-chemo(n=25)and R-chemo arms(n=33).The INV-assessed PFS rate at 3 years was 81.8%in the G-chemo arm,vs.70.2%in the R-chemo arm(hazard ratio 0.35;95%confidence interval:0.09-1.34;P=0.1120).The INV-assessed CRRs(without positron emission tomography[PET])in these arms were 24.0%and 21.2%,respectively,whereas the ORRs were 80.0%and 90.9%,respectively.INV-assessed CRR-PET was 52.6%in the G-chemo,vs.60.9%in the R-chemo.Median OS was not reached in either arm.Grade 3 to 5 adverse events were more frequent in the R-chemo arm(97.0%vs.88.0%).Conclusions:The results of this subgroup analysis were consistent with those of the global population,and they suggest that G-chemo has a positive benefit-risk profile in patients from China with FL.Trial registration:ClinicalTrials.gov,No.NCT01332968.

关键词： Chinese Follicular lymphoma GALLIUM Obinutuzumab Rituximab

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Benefit of rituximab maintenance is associated with Follicular lymphoma International Prognostic Index in patients with Follicular lymphoma

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Blood Science 2023年第2期5卷 118-124页

作者： Ru Li Tingyu Wang Rui Lyv Yi Wang Ying Yu Yuting Yan Qi Sun Wenjie Xiong Wei Liu Weiwei Sui Wenyang Huang Huijun Wang Chengwen Li Jun Wang Dehui Zou Gang An Jianxiang Wang Lugui Qiu Shuhua Yi State Key Laboratory of Experimental Hematology National Clinical Research Center for Blood DiseasesHaihe Laboratory of Cell EcosystemInstitute of Hematology&Blood Diseases HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeTianjin 300020China Tianjin Institutes of Health Science Tianjin 301600China.

Rituximab maintenance(RM)prolongs the progression-free survival(PFS)of responding patients with Follicular lymphoma(FL),but the maintenance efficacy in different Follicular lymphoma International Prognostic Index(FLIPI)risk group is still confusing.We performed a retrospective analysis of the effect of RM treatments in patients with FL responding to induction therapy based on their FLIPI risk assessment carried out prior to treatment.We identified 93 patients between 2013 and 2019 who received RM every 3 months for≥4 doses(RM group),and 60 patients who did not accept RM or received rituximab less than 4 doses(control group).After a median follow-up of 39 months,neither median overall survival(OS)nor PFS was reached for the entire population.The PFS was significantly prolonged in the RM group compared to the control group(median PFS NA vs 83.1 months,P=.00027).When the population was divided into the 3 FLIPI risk groups,the PFS differed significantly(4-year PFS rates,97.5%vs 88.8%vs 72.3%,P=.01)according to group.There was no significant difference in PFS for FLIPI low-risk patients with RM compared to the control group(4-year PFS rates,100%vs 93.8%,P=.23).However,the PFS of the RM group was significantly prolonged for FLIPI intermediate-risk(4-year PFS rates,100%vs 70.3%,P=.00077)and high-risk patients(4-year PFS rates,86.7%vs 57.1%,P=.023).These data suggest that standard RM significantly prolongs the PFS of patients assigned to intermediate-and high-risk FLIPI groups but not to low-risk FLIPI group,and pending larger-scale studies to validate.

关键词： Follicular lymphoma Follicular lymphoma international prognostic index Induction therapy Maintenance Progressionfree survival Rituximab

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Follicular lymphoma:the diminishing role of chemotherapy

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Journal of Cancer Metastasis and Treatment 2022年第1期8卷 393-411页

作者： Beatrice Casadei Laura Nanni Ginevra Lolli Pier Luigi Zinzani IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia“Seràgnoli”Bologna 40138Italy Dipartimento di Medicina Specialistica Diagnostica e SperimentaleUniversitàdi BolognaBologna 40138Italy

Follicular lymphoma(FL)is the most common indolent non-Hodgkin lymphoma,accounting for 70%of cases in Western countries.Despite this unique name,FL is an extremely heterogeneous disease,both clinically and biologically.The basis of FL heterogeneity lies in the different biological pathways which can be activated,because of the variety of gene mutations that can occur.Today,there is a growing interest in the knowledge of these activated pathways,which is also testified by the presence of a new model that incorporates FL mutations to define patient’s prognosis(m7-FLIPI).These evaluations are also appealing because of the recent possibility of using“targeted therapies”.Targeted therapies are new tools,currently applicable in the setting of relapse/refractory(R/R)disease,where we can find a great variety of“chemo-free”combinations.As in other hematologic malignancies,“cellular therapy”enriches FL drug scenario,including T-cell dependent bispecific antibodies and chimeric antigen receptor(CAR)T-cell.Since FL heterogeneity is the basis of the difference in therapeutic efficacy and disease course among patients,the hope for the future is to understand FL biology more deeply,to better comprehend how to obtain more representative samples and pre-treatment prognostic information in order to individualize the treatment strategy as early as frontline therapy.

关键词： Follicular lymphoma POD24 target therapies chemo-immunotherapy biological heterogeneity

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Follicular lymphoma with cardiac involvement in a 90-year-old patient:A case report

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World Journal of Clinical Cases 2022年第28期10卷 10208-10213页

作者： Yi-Xuan Sun Jia Wang Ji-Heng Zhu Wei Yuan Lin Wu Department of Geriatrics Zhongshan HospitalFudan UniversityShanghai 200032China Department of Pathology Zhongshan HospitalFudan UniversityShanghai 200032China

BACKGROUND The incidence of cardiac lymphoma is low,and it mainly occurs secondary to nonHodgkin’s lymphoma,particularly diffuse large B-cell lymphoma.Here,we report a case of Follicular lymphoma with cardiac involvement and severe heart failure as the sole clinical manifestation.CASE SUMMARY A 90-year-old male patient was first admitted to our hospital due to an accidentally discovered painless mass in the right lower abdomen.A biopsy of the mass revealed a Follicular lymphoma.Positron emission tomography-computed tomography confirmed mild pericardial effusion,and echocardiography showed no structural abnormalities with normal ejection fraction at the time of diagnosis.The patient refused our recommendation of chemotherapy and was re-admitted 4 mo later due to heart failure.A series of subsequent echocardiographic examinations showed thickening of the left ventricular walls and increasing pericardial effusion over the following 2 mo.His heart failure exacerbated despite all symptomatic and supportive treatments.He passed away after an episode of aspiration pneumonia.CONCLUSION The diagnosis of cardiac lymphoma is difficult as its clinical manifestations are nonspecific,and prognosis is poor.

关键词： Follicular lymphoma Cardiac lymphoma Chemotherapy Heart failure Elderly patient Case report

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Clinical features and prognostic factors in 49 patients with Follicular lymphoma at a single center:A retrospective analysis

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World Journal of Clinical Cases 2023年第14期11卷 3176-3186页

作者： Hao Wu Hui-Cong Sun Gui-Fang Ouyang Department of Hematology Ningbo First HospitalNingbo 315010Zhejiang ProvinceChina Adult Internal Medicine Ningbo Women and Children's HospitalNingbo 315012Zhejiang ProvinceChina

BACKGROUND Follicular lymphoma(FL)is a type of B-cell lymphoma that originates at the germinal center and has a low malignancy rate.FL has become the most common inert lymphoma in Europe and America but has a relatively low incidence in Asia.AIM To explore the clinical features,curative effects,and prognostic factors of FL.METHODS Completed medical records of 49 patients with FL who were admitted to the Ningbo First Hospital from June 2010 to June 2021 were examined.These patients were definitively diagnosed by pathological biopsy or immunohistochemical staining.The diagnostic criteria were based on the 2008 World Health Organization classification of lymphomas.Ann Arbor staging was performed according to the imaging and bone marrow examination results.Risk stratification of all patients was performed based on the International Prognostic Index(IPI),age-adjusted IPI,Follicular lymphoma International Prognosis Index(FLIPI),and FLIPI2 to compare the efficacy of different treatment regimens and analyze the related prognostic factors.RESULTS The age of onset in patients ranged from 24 to 76 years,with a median age of 51 years.Most patients developed the disease at 40–59 years of age,and the male:female ratio was 1.6:1.No significant difference was noted in the curative effect between the non-chemotherapy,combined chemotherapy,and other chemotherapy regimens(P>0.05).Hemoglobin(Hb)level50%,bone marrow involvement,and clinical stagesⅢ–IV were associated with a poor prognosis of FL(P<0.05).However,the influence of other indicators was not statistically significant.Risk grouping was performed using the FLIPI,and the results showed that 24.5%,40.8%,and 34.7%of patients were in the low-,moderate-,and high-risk groups,respectively.According to the survival analysis results,the survival rate of patients was lower in the high-risk group than in the other low-risk and moderate-risk groups(P<0.05).CONCLUSION FL mainly occurs in middle-aged and elderly men,primarily affecting lymph nodes and bone marrow.Hb le

关键词： Follicular lymphoma Clinical feature Curative effect Prognosis Survival analysis Follicular lymphoma International Prognosis Index

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Follicular lymphoma presenting like marginal zone lymphoma:A case report

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World Journal of Clinical Cases 2022年第17期10卷 5877-5883页

作者： Hao-Yu Peng Ying-Jie Xiu Wei-Hong Chen Qing-Li Gu Xin Du Department of Hematology Shenzhen Second People’s HospitalThe First Affiliated Hospital of Shenzhen UniversityShenzhen 518035Guangdong ProvinceChina Department of Pathology Shenzhen Second People’s HospitalThe First Affiliated Hospital of Shenzhen UniversityShenzhen 518035Guangdong ProvinceChina

BACKGROUND Follicular lymphoma(FL),a common type of indolent lymphoma,carries markers of the germinal center,and the rearrangement of the BCL-2 gene is regarded as an initiating event and a hallmark of the neoplasm.When FL has marginal zone differentiation,some marginal zone features are carried by the neoplasm.CASE SUMMARY A 54-year-old male with lymphadenopathy,splenomegaly and hyperlymphocytosis was diagnosed with FL with marginal zone differentiation.The tumor demonstrated different features in the bone marrow(BM)compared with the follicle of the lymph node(LN).Some component of the neoplasm mimicked marginal zone lymphoma,such as infiltrating the marginal zone of the LN,displaying a monocytoid shape and lacking the expression of CD10 in the BM.The diagnosis of FL was made due to the concurrent detection of BCL-2 rearrangement in the LN and BM.CONCLUSION Discordant pathological features in LN and BM could mislead diagnosis.When clinical and pathological manifestations are confusing in diagnosis,typical genetic abnormalities are decisive.

关键词： Follicular lymphoma Marginal zone differentiation Discordant immunophenotypes Gene rearrangement Case report

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Treatment strategies for nodal and gastrointestinal Follicular lymphoma:Current status and future development

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World Journal of Gastroenterology 2010年第44期16卷 5543-5554页

作者： Takuya Watanabe Department of Internal Medicine and Gastroenterology Medical HospitalThe Nippon Dental University School of Life Dentistry at Niigata

In recent years,therapies for Follicular lymphoma (FL) have steadily improved.A series of phase Ⅲ trials comparing the effect of rituximab with chemotherapy vs chemotherapy alone in treating FL have indicated significant improvements in progression-free survival (PFS) and overall survival.Recent studies have found that prolonged response durations and PFS were obtained with maintenance therapy using rituximab or interferon after completion of first line therapy.For patients with relapsed or refractory FL,phase Ⅱ studies have assessed the effectiveness of combination therapies using a Toll-like receptor-9 agonist (1018ISS),oblimersen sodium (a Bcl-2 antisense oligonucleotide),bendamustine,and rituximab,as well as veltuzumab,a new humanized anti-CD20 antibody,and epratuzumab.In addition,the effectiveness of yttrium-90 ibritumomab tiuxetan and iodine-131 tositumomab as radioimmunotherapies has been reported.Furthermore,three phase Ⅲ studies on an idiotype vaccine are near completion.Unfortunately,these vaccines,which appeared highly effective in phase Ⅰ and Ⅱ trials,do not appear to result in prolonged PFS.This report will summarize the current knowledge on therapies for treatment of FL,and will conclude with a brief discussion of feasiblefuture options for effective treatments.Lastly,we added descriptions of the management of gastrointestinal FL,which is considered to be controversial because it is rare.

关键词： Anti-CD20 monoclonal antibody (rituximab) Follicular lymphoma Idiotype vaccines Immunoradiotherapy Treatment strategies

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Primary Follicular lymphoma in the renal pelvis:A rare case report

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World Journal of Clinical Cases 2021年第21期9卷 6026-6031页

作者： Xun-Ze Shen Chen Lin Fang Liu PET/CT Center Shaoxing People's Hospital(Shaoxing HospitalZhejiang University School of Medicine)Shaoxing 312000Zhejiang ProvinceChina Department of Pathology Shaoxing People's Hospital(Shaoxing HospitalZhejiang University School of Medicine)Shaoxing 312000Zhejiang ProvinceChina

BACKGROUND Follicular lymphoma(FL)is more common in lymph nodes,while primary extranodal lymphomas are rare.Urinary tract lymphoid neoplasms are extremely rare,accounting for less than 5%of all extranodal lymphomas.Only one case of FL from the renal pelvis has previously been reported.CASE SUMMARY A 70-year-old male patient with a history of esophageal cancer visited our hospital for follow-up examination.Abdominal computed tomography revealed a malignant mass in the right renal pelvis.The whole-body positron emission tomography/computed tomography showed a significant increase in fluorodeoxyglucose uptake of this soft tissue mass and no abnormal fluorodeoxyglucose uptake in the esophageal wall.The patient underwent radical resection of a malignant tumor in the right kidney,which was confirmed by postoperative pathology to be FL.The patient received no radiation or chemotherapy after surgery,and no recurrence of lymphoma or other malignant tumors was found at the 1-year follow-up.CONCLUSION Extranodal FL is more common in the skin and gastrointestinal tract but rarely occurs in the urinary tract.This is the second report of primary renal FL.Localized extranodal FL is expected to have a favorable prognosis and can be cured by local resection.

关键词： lymphoma Follicular lymphoma Renal pelvis Imaging Resection Case report

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Clinical significance of the loss of CD20 antigen on tumor cells in patients with relapsed or refractory Follicular lymphoma

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Cancer Drug Resistance 2021年第3期4卷 710-718页

作者： Jean-Marie Michot Alice Buet-Elfassy Maxime Annereau Julien Lazarovici Alina Danu Clémentine Sarkozy Claude Chahine Camille Bigenwald Jacques Bosq Julien Rossignol Patricia Romano-Martin Capucine Baldini David Ghez Peggy Dartigues Christophe Massard Vincent Ribrag Gustave Roussy UniversitéParis-SaclayDépartement des Innovations Thérapeutiques et Essais PrécocesVillejuif 94800France Gustave Roussy UniversitéParis-SaclayPharmacy DepartementVillejuif 94800France Gustave Roussy UniversitéParis-SaclayDepartement of HematologyVillejuif 94800France Gustave Roussy UniversitéParis-SaclayDepartement of PathologyVillejuif 94800France

Aim:Anti-CD20 monoclonal antibody is a cornerstone therapy for Follicular lymphoma.Following anti-CD20 therapy,a potential decrease in CD20 antigen,and therefore a loss of the tumor target might be expected.However,the incidence and clinical significance of CD20 loss on tumor cells in patients with relapsed or refractory Follicular lymphoma are unknown.This study aims to investigate the incidence and outcome of patients with relapsed or refractory Follicular lymphoma patients harboring the loss of the tumor target,CD20.Methods:All consecutive adult patients with relapsed or refractory Follicular lymphoma referred to the Early Drug Department at Gustave Roussy were included.The main objectives were to assess the incidence and prognosis of the loss in expression of CD20 antigen on the surface of tumor cells on patient outcome.Results:Over the study period 2013-2018,131 patients were screened for clinical trials with B-cell malignancies in the early drug department of Gustave Roussy in France.Forty-four patients presented with relapsed or refractory Follicular lymphoma and 32 had tumor biopsies at the time of relapse that were retained for analysis.The median(range)age was 67.5 years(55.3-75.3)and the median number of prior anti-cancer systemic therapies was 3(2-4).At the time of relapse,CD20 expression was positive in 84%of tumors(n=27)and negative in 16%of tumors(n=5).At a median follow-up of 18.3(0.6-83.3)months,CD20 negativity was associated with a poorer prognosis with a median overall survival of 8.9 months(95%CI:2.4-19.1)in comparison to CD20 positive patients(28.3 months,95%CI:25.1-75.3 months,P=0.019).Conclusion:The loss of the tumor target antigen,CD20,occurred in 16%of patients with relapse or refractory Follicular lymphoma.Due to confounding factors in patients who received anti-CD20 immunotherapy,it was not possible to formally establish the prognostic significance of CD20 negativity.However,we suggest that a check for CD20 antigen positivity nevertheless be performed to adapt subsequent therapies for p

关键词： Follicular lymphoma CD20 tumor antigen anti-CD20 monoclonal antibody cancer drug resistance

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Low symptomatic COVID-19 in an elderly patient with Follicular lymphoma treated with rituximab-based immunotherapy:A case report

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World Journal of Clinical Cases 2021年第18期9卷 4859-4865页

作者： StanisławŁącki Kinga Wyżgolik MichałNicze Sylwia Georgiew-Nadziakiewicz Jerzy Chudek Kamil Wdowiak Department of Internal Diseases and Oncological Chemotherapy Medical University of SilesiaKatowice 40-027Silesian VoivodeshipPoland Imaging and Isotope Diagnostics Department Chorzów General HospitalChorzów 41-500Silesian VoivodeshipPoland

BACKGROUND Follicular lymphoma is an indolent lymphoma that may progress to a highly aggressive form requiring immunochemotherapy.Most regimens utilize rituximab,an anti-CD20 monoclonal antibody,which may affect the clinical course of novel coronavirus,severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infections[coronavirus disease 2019(COVID-19)].Here we describe the first case of mild COVID-19 during ongoing oncological treatment without significant deterioration after rituximab administration.CASE SUMMARY A 74-year-old female with an enlargement of her right palatine tonsil was diagnosed with Follicular lymphoma following tonsillectomy and started immunochemotherapy according to the rituximab,cyclophosphamide,vincristine,prednisone regimen.At home before the fourth cycle,she developed nonspecific symptoms(excessive fatigue,loss of appetite and nausea),misdiagnosed as adverse effects of chemotherapy.Unexpectedly,interim positron emission tomography-computed tomography scan,performed shortly before rituximab administration,revealed previously nonexistent pulmonary changes,potentially of infectious etiology.SARS-CoV-2 infection was confirmed by a nasopharyngeal swab(with reverse transcriptase polymerase chain reaction test)performed the following day.Despite rituximab infusion,the patient remained oligosymptomatic and was discharged home for self-isolation.Having reached a negative SARS-CoV-2 status before the subsequently scheduled regimen,the patient successfully received six cycles of rituximab,cyclophosphamide,vincristine,prednisone and obtained complete remission by positron emission tomographycomputed tomography.CONCLUSION Our case shows that rituximab-based immunotherapy due to Follicular lymphoma may have no evident negative effect on the COVID-19 clinical course.

关键词： COVID-19 SARS-CoV-2 Follicular lymphoma Rituximab Case report

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