Comparison of a Rotary Powered Bone Marrow Aspiration and Biopsy Device to the Traditional Manual Device in an Adolescent

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4718-4718 ◽  
Author(s):  
Maria G. Falcon ◽  
Chatchawin Assanasen ◽  
Paul Thomas ◽  
Victor Saldivar
Keyword(s):  
Bone Marrow ◽  
Pain Score ◽  
Core Biopsy ◽  
Research Funding ◽  
Iliac Crest ◽  
Bone Marrow Aspiration ◽  
Bone Marrow Examination ◽  
Procedural Pain ◽  
Bone Marrow Biopsies ◽  
Biopsy Device

Abstract Abstract 4718 Bone marrow examination is important for the diagnosis of hematological malignancies and nonmalignant diseases in children. In patients with newly diagnosed lymphoproliferative diseases and certain non-hematopoietic malignancies, bone marrow examination is also part of the staging process. Core biopsy length has been found to be critical in diagnosing, predicting relapse or identifying residual disease following chemotherapy in patients. The larger the amount of marrow obtained increases the chance of finding a focal lesion. Unfortunately, the current practice of obtaining trephine biopsies and bone marrow aspirates in children via the manual method has a poor success rate for obtaining adequate specimens. In 2007, an FDA-cleared battery powered bone marrow aspiration and biopsy system (OnControl™ by Vidacare) was developed. Multiple studies have evaluated the use of the powered device in adults and found decreased time of procedure, decreased pain, and improved core biopsy specimens. Here we present a direct comparison of the rotary powered device versus the traditional manual device (e.g. Jamshidi) when obtaining bilateral bone marrow aspirates and biopsies in a 17 year-old female with relapsed alveolar rhabdomyosarcoma. This patient required bilateral bone marrow biopsies to stage her disease and evaluate for bone marrow involvement. One aspirate and biopsy was obtained using the powered device from the right posterior superior iliac crest, and specimens were obtained from the left iliac crest using the traditional manual device. The endpoints measured were quality of the biopsy, length and width of the biopsy, time to obtain aspirate and biopsy, number of attempts to obtain the biopsy, post-procedural pain, and operator satisfaction with the device (O.S.). Device Quality Rating Length (mm) Width (mm) Aspirate Time (sec) Biopsy Time (sec) Attempts Pain Score (0–10) O.S. (0–10) Powered 2 9 1.5 20 108 1 0 10 Manual 1 14 2 25 225 1 0 9 In conclusion, the powered device was superior to the manual device in terms of time to obtain the aspirate and biopsy and operator satisfaction with the device. It was found to be equivalent to the manual device in regards to number of attempts to obtain the biopsy, and post-procedural pain score. The manual device produced a biopsy that was longer, wider, and of higher quality than the biopsy obtained via the powered method. A randomized controlled trial in the pediatric population comparing the rotary powered device to the traditional device is currently underway as further studies are needed to evaluate the use of the powered bone marrow aspiration and biopsy device in children. Disclosures: Falcon: Vidacare Corporation: Research Funding. Assanasen:Vidacare Corporation: Research Funding.

A New Rotary Powered Device for Bone Marrow Aspiration and Biopsy Yields Superior Specimens with Less Pain: Results of a Randomized Clinical Study

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1529-1529 ◽  
Author(s):  
Ronan Swords ◽  
Javier Anguita ◽  
Russell A. Higgins ◽  
Andrea Yunes ◽  
Michael Naski ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Biopsy ◽  
Research Funding ◽  
Bone Marrow Aspiration ◽  
Morbidity And Mortality ◽  
Procedure Time ◽  
Medullary Bone ◽  
Biopsy Device ◽  
The Mean

Abstract Abstract 1529 Introduction: The importance of bone marrow aspiration and biopsy in the evaluation of hematopoietic and non-hematopoietic disorders is well established. However, this technique is associated with morbidity and mortality risks.1 Recently, a battery-powered bone marrow biopsy system was developed to allow operators to safely, quickly and efficiently access the marrow space. We previously evaluated this device in swine models and in patients needing routine hematology outpatient evaluation.2 In the current study we compared the powered device to the traditional manual technique by relatively assessing pain scores, procedure times, biopsy capture rates, quality of material retrieved, safety and operator satisfaction. Methods: Two large academic medical centers participated in this trial (San Antonio, TX and Madrid, Spain). The study protocol was approved by each center's institutional review board. Adult patients requiring bone marrow biopsies were considered for the study. Following informed consent, patients were randomized to have procedures using a manual biopsy device (T-handle Jamshidi bone marrow biopsy and aspiration set, Cardinal Health, Dublin, OH) or the Powered device (OnControl 11 gauge/102mm Bone Marrow Biopsy System, Vidacare Corporation, Shavano Park, TX). After infiltration of the skin and medullary bone with local anesthesia, a visual analog scale (VAS) pain score was recorded immediately following skin puncture and once again at the end of the procedure for each patient. Procedure time was measured from skin puncture to core specimen ejection from the needle. Pathologic assessment of 30 randomized samples was carried out. Operator satisfaction with devices was measured on a scale of 0–10, with 10 as the highest rating. Statistics were calculated using t-test and chi-square, with an alpha-level of 0.05. Results: Five operators from 2 sites enrolled 50 patients (Powered, n=25; Manual, n=25). Of those patients, 58% were male and 42% were female; and had a mean age of 56.0±18.0 years. The mean height was 167.5 ± 10.5cm and the mean weight was 78.7 ± 22.7kg. Forty percent were lymphoma patients—the largest diagnostic group. Between patient groups, there were no significant differences in the means for these variables. See Table below for quantitative results, including pathology analysis. For the pathology qualitative analysis, there was no difference between groups for hemorrhage, clot/particle spicules, or smear spicules. Conclusions: Results of this trial suggest that the use of a Powered bone marrow biopsy device significantly reduces needle insertion pain. While not reflected in the results, overall pain may be better tolerated due to the important difference in procedure time. Moreover, the superior size and overall quality of core specimens retrieved by the Powered device provides more material for pathologic evaluation, thereby increasing diagnostic yield and reducing the need for repeat procedures. Cohesiveness of the medullary bone sampled was comparable for both techniques; however, the Powered system was less likely to recover non-hematopoietic tissue (e.g. cortical bone and soft tissue). Artifact was slightly more common with the Powered device (aspiration, hemorrhage and crush) but this did not impact on the diagnostic quality of the sample. No differences in safety data were noted for either technique and operator satisfaction favored the Powered device. 1. Bain BJ. Bone marrow biopsy morbidity and mortality. British Journal of Haematology 2003;121:949-51. 2. Swords RT, Kelly KR, Cohen SC et al. Rotary powered device for bone marrow aspiration and biopsy yields excellent specimens quickly and efficiently. J Clin Pathol 2010;63:562-5. Disclosures: Swords: Vidacare Corporation: Research Funding. Anguita:Vidacare Corporation: Research Funding. Kelly:Vidacare Corporation: Research Funding. Philbeck:Vidacare Corporation: Employment. Miller:Vidacare Corporation: Employment, Equity Ownership. Brenner:Vidacare Corporation: Research Funding.

Evaluation of a Powered Intraosseous Device for Bone Marrow Sampling.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5150-5150
Author(s):  
Stephen C. Cohen ◽  
Jill M. Soroka
Keyword(s):  
Bone Marrow ◽  
Pain Score ◽  
Bone Marrow Aspiration ◽  
Bone Marrow Examination ◽  
Ease Of Use ◽  
Course Of Disease ◽  
Patient Pain ◽  
The Mean ◽  
Accepted Practice ◽  
Ultimate Purpose

Abstract The importance of bone marrow examination in the evaluation of leukemia, multiple myeloma, anemia, pancytopenia, and other disorders is well established. The objective for this study was to evaluate the ability of a powered bone marrow aspiration device to penetrate the intraosseous medullary space of the iliac crest, and to aspirate bone marrow samples for the ultimate purpose of diagnosing disease and monitoring the course of disease and medical therapy. The device was used to obtain bone marrow samples in accordance with accepted practice guidelines and device’s directions for use. Among other data, insertion success, time to insertion, and complications were recorded. Patient pain levels were rated from 0 to 10 (10=extreme pain). Device operators rated the use of the device from 0 to 10 (10=outstanding). There were 55 patients in the study from three centers. Successful insertion and aspiration of bone marrow samples were achieved in 54 of the 55 patients (98.1%). Mean insertion time was 4.9±3.0 seconds; significantly faster than the 7.3 minutes reported by Kuball et al* (one-sample t-test, p<0.001). There were no complications. The mean insertion pain score was 2.5±2.2 and the mean aspiration pain score was 3.7±2.5. On a scale of 0 to 10, the six operators rated the ease of use of the device at a mean score of 8.3±1.7. Findings suggest that the powered aspiration device is safe and effective for bone marrow aspirations.

Jamshidi needle Biopsy of the Sternal Bone Marrow.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4548-4548
Author(s):  
Enrique Davila
Keyword(s):  
Bone Marrow ◽  
Iliac Crest ◽  
Conflicts Of Interest ◽  
Metastatic Cancer ◽  
Bone Marrow Aspiration ◽  
Final Diagnosis ◽  
External Diameter ◽  
Iliac Crest Biopsy ◽  
Bone Marrow Biopsies ◽  
Posterior Iliac Crest

Abstract Abstract 4548 The aspiration and biopsy of the bone marrow is one of the most valuable and important tests in hematology, oncology and medicine. It is a high yield, safe, fast and informative test performed frequently in medical practice with minimal complications. For reasons of ease and safety, bone marrow aspiration and biopsy are usually obtained from the posterior iliac crest. I reviewed my experience in obtaining 37 consecutive bone marrow biopsies from the sternum using a Jamshidi needle (gauge 11; external diameter 3.048 mm) in 36 consecutive patients (twice in one patient) over a 9 year period, in whom a posterior iliac crest study could not be done. Technique After performing the sternal bone marrow aspiration in the usual manner, a small skin incision is made over the sternum with a scalpel. The Jamshidi needle is introduced at approximately a 90 degree angle in the middle of the sternum at the level of the 3rd intercostal space. After a ”give” is felt, indicating that the needle has reached the bone marrow cavity, the tip of the needle is angled downwards at 45 degrees or less and with a clockwise - counterclockwise movement, the needle is advanced for 3 to 10 mm. After a slight change of angle aiming at “breaking” the distal attachment of the bone marrow piece, the needle is slowly withdrawn with the same rotatory movements. In no case did I feel that I had reached the inner table of the sternum. All patients were observed and examined 20 minutes and 24 hours after the procedure. Results There were 22 inpatient and 15 outpatient procedures. The reasons that precluded the performance of the preferred posterior iliac crest bone marrow biopsy were: immobility in 17 patients, obesity in 13, prior radiation in 3 and other in 4. The final diagnosis was a malignant disorder in 17 patients (leukemia, lymphoma, myelodysplasia, plasma cell dyscrasia or metastatic cancer). All but one were new diagnoses. In 20 cases the final diagnosis was a benign hematological disorder or a non diagnostic bone marrow examination. In 9 occasions (mostly obese patients and patients with prior radiation therapy) a previous attempt at performing a posterior iliac crest biopsy had failed. The only complications were the development of a tumor nodule in the needle tract in one patient with an aggressive, Burkitt's type lymphoma and a small superficial hematoma in a patient with a highly vascular metastatic breast cancer. The bone marrow core biopsy of the sternum, performed as described, in the hands of an experienced practitioner is a safe and helpful test in the evaluation of the bone marrow cytology, architecture and anatomy in selected patients in whom the performance of the preferred posterior iliac crest biopsy cannot be done. Disclosures: No relevant conflicts of interest to declare.

Nitrous oxide analgesia for bone marrow aspiration and biopsy – A randomized, controlled and patient blinded study

2015 ◽  
Vol 7 (1) ◽  
pp. 28-34 ◽  
Author(s):  
Anna-Maria Kuivalainen ◽  
Freja Ebeling ◽  
Eira Poikonen ◽  
Per H. Rosenberg
Keyword(s):  
Bone Marrow ◽  
Nitrous Oxide ◽  
Cognitive Function ◽  
Side Effects ◽  
Bone Marrow Aspiration ◽  
Bone Marrow Examination ◽  
Procedural Pain ◽  
Randomized Controlled ◽  
Pain Scores ◽  
Blinded Study

AbstractBackground and aims Bone marrow aspiration and/or biopsy (BMAB), performed under local anaesthesia in adults, is a common and often painful procedure. Anxiety is known to intensify pain during the procedure. Nitrous oxide (N2O), known for its sedative and analgesic benefit in various short medical procedures and labour pain, could be advantageous also for pain relief during bone marrow examination. N2O acts rapidly and is eliminated in a couple of minutes once the inhalation is stopped, and occasional side effects (e.g. dizziness and nausea) are mild. The aim of this study was to compare the analgesic effects of inhaled 50% mixture of nitrous oxide and oxygen to 50% oxygen during bone marrow examination.MethodsIn this randomized, controlled, patient and observer blinded study patients received either 50% mixture of nitrous oxide and oxygen or 50% mixture of oxygen in air during bone marrow examination, in addition to local analgesia. Both patient groups comprised 35 adult patients. Pre-procedural anxiety and procedural pain were rated on the Numeral Rating Scale (NRS 0‒10). Cognitive function was measured before and 30 min after the procedure. Possible side effects were recorded. A telephone interview was performed 24 h later.ResultsThere were no statistically significant differences in pain scores of the procedural steps (median NRS ranging 3.0‒4.0) between the study groups. High pain scores of 8‒10 comprised 0% vs. 8.6% of the scores during infiltration, 2.9% vs. 5.7% during puncture, 11.4% vs. 14.3% during aspiration and 2.9% vs. 2.9% during biopsy in N2O and 50% O2 groups, respectively (NS). Pre-procedural anxiety (median NRS 3.5 in both groups), measured in the outpatient clinic just prior to procedure, correlated with pain intensity during bone marrow aspiration (P = 0.045). There were no significant differences between side effects. During the BMAB four patients (3 in N2O group, 1 in 50% O2 group) reported dizziness and one patient in the N2O group reported nausea. Gas inhalation did not affect the cognitive function of the participants. In both groups the majority (>80%) of the patients was satisfied with the inhalation technique. During the 24 h interview, most of the participants were pain free and they did not report any serious adverse effects.ConclusionsIn spite of similar moderate to strong procedural pain in both groups and no benefit of N2O, most patients were satisfied with the inhalational techniques. We assume that the bedside presence of an anaesthesiologist and the distraction caused by the inhalational arrangements introduced positive context-sensitive therapeutic effect independent of the gas used. Pre-procedural anxiety predicted pain associated with bone marrow aspiration.ImplicationsInhaled 50% nitrous oxide was not an effective analgesic during bone marrow examination in our unselected outpatient population. Further studies should concentrate on its use with patients predicted to be at increased risk of suffering intense pain during the procedure, such as very anxious patients or those who have a painful history of previous bone marrow examinations.

scholarly journals Bone Marrow Clot Section a Useful Tool for Diagnosis of Haematological Diseases- A Case Series

2021 ◽  
Author(s):  
Parul Garg ◽  
Harjot Kaur ◽  
Ishwer Tayal ◽  
Aradhana Singh Hada
Keyword(s):  
Bone Marrow ◽  
Diagnostic Tool ◽  
Core Biopsy ◽  
Case Series ◽  
Bone Marrow Aspiration ◽  
Bone Marrow Examination ◽  
Biopsy Material ◽  
Haematological Disorders ◽  
Neoplastic Disorders

Bone marrow examination is required for diagnosis of various haematological disorders. It includes both neoplastic and non-neoplastic disorders. Usually, bone marrow examination includes Bone Marrow Aspiration (BMA), bone marrow biopsy and bone marrow imprints. Bone marrow clot sections can also be an adjuvant of bone marrow examination. The bone marrow clot sections are prepared from the left-over blood after aspirate smears have been prepared. An adequate bone marrow clot section can be valuable for diagnosis of various diseases, especially in cases in which the aspirate and core biopsy material are inadequate or non contributory or it can be an adjuvant procedure. Little has been published about usefulness of bone marrow clot section. Studies are going on to evaluate the role of bone marrow clot section as an adjuvant or a diagnostic tool. This study includes a series of three cases in which bone marrow clot section was diagnostic.

Understanding bone safety zones during bone marrow aspiration from the iliac crest: the sector rule

2014 ◽  
Vol 38 (11) ◽  
pp. 2377-2384 ◽  
Author(s):  
Jacques Hernigou ◽  
Laure Picard ◽  
Alexandra Alves ◽  
Jonathan Silvera ◽  
Yasuhiro Homma ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Iliac Crest ◽  
Bone Marrow Aspiration

scholarly journals TO DETERMINE THE FREQUENCY OF VISCERAL LEISHMANIASIS IN PERIPHERAL CYTOPENIC PATIENT IN PATHOLOGY DEPARTMENT HAYATABAD MEDICAL COMPLEX.

1969 ◽  
Vol 4 (2) ◽  
pp. 560-566
Author(s):  
ZARD ALI KHAN ◽  
MOHAMMAD SAJJAD ◽  
IMRAN UD DIN ◽  
MUKAMIL SHAH ◽  
SHAH JEHAN
Keyword(s):  
Bone Marrow ◽  
Visceral Leishmaniasis ◽  
Case Series ◽  
Bone Marrow Aspiration ◽  
Bone Marrow Examination ◽  
Total Leukocyte Count ◽  
Full Blood Count ◽  
Female Ratio ◽  
Pathology Department ◽  
Case Series Study

BACKGROUND: Visceral Leishmaniasis is a chronic disease and was first described in 1903, byLIESHMAN and DONOVAN. The disease is common in tropical and sub tropical areas of the worldwith various hematological manifestations. It is characterized by fever, visceromegaly, weight loss,pancytopenia and hypergammaglobulenemia. The disease is silent killer, invariably killing almost alluntreated patients, but curable with hematological improvement within 4-6 weeks of treatment.OBJECTIVE: To determine the frequency of Visceral Leishmaniasis in patints with cytopenias .MATERIAL AND METHODS: A descriptive study conducted in Pathology department, HayatabadMedical Complex, Hayatabad from September 1, 2012 to August 31, 2013. This study comprises of 126patients, subjected to complete blood counts. Diagnosis were confirmed by finding Amastigote( L/Dbody) from bonemarrow aspirate. All the patients who were referred to pathology Department of thehospital for bone marrow examination, with the results of peripheral blood using automatedHaematology analyzer, Sysmex KX 21 showing cytopenia were included in the study. Consent wastaken from the patient for bone-marrow aspiration procedure. After consent detailed history, physicalexamination was done.Laboratory investigations i.e. full blood count, which includes hemoglobin estimation, white blood cell,red blood, and platelet count.Bone marrow cytology (Giemsa stain) was recorded on the designed profroma.Posterior superior iliac spine (PSIS) was used as the site for aspiration in adults and children over 2years of ageRESULT: Descriptive case series study of 126 patients of peripheral cytopenia. In which 77 (61.1%)patients were males and 49 (38.9%) were female with male to female ratio of 1.57: 1 It was also foundin this study that visceral leishmaniasis was present in 29 (23%) of cases and the male: female were 1.6:1. Result of the automated hematology analyzer of peripheral cytopenic patients in visceralleishmaniasis show that all of the patients were having total leukocyte count less than 4000/cmm(100%). The hemoglobin level wass less than lOgm/dl in 26 cases (87.7%) and more than lOgm/dl inthree cases (10.3%). In case of platelets count, 27 cases (93.1%) were having platelets count less than150000/cmm.CONCLUSION: Incidence of visceral leishmaniasis is highier in children age group 1-10 years, alsomales are more prone than females. Leukopenia is recorded in all (100%) of the cases, followed bythrombocytopenia (93.1%) and anemia (Hb <10gm %) 87.7% cases.KEY WORD: Visceral Leishmaniasis, Kala Azar, Amastigote (L/D body)

scholarly journals The Necessary for Long-Term Follow-up of Mutated Genes and Clonal Evolutions in Multiple Myeloma Combined with cfDNA Assay

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5515-5515
Author(s):  
Yuko Mishima ◽  
Yuji Mishima ◽  
Masahiro Yokoyama ◽  
Noriko Nishimura ◽  
Yoshiharu Kusano ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Bone Marrow ◽  
Genomic Dna ◽  
Research Funding ◽  
Somatic Mutations ◽  
Clinical Course ◽  
Bone Marrow Aspiration ◽  
Long Term Follow Up

Introduction)Somatic mutations in multiple myeloma (MM) are strongly related to the clinical outcome and clonal evolution over the clinical course, and are a major problem. From a clinical viewpoint, although numerous novel drugs have been utilized, achieving long-lasting and complete remission remains difficult. Recent studies have elucidated the mutated genes using next-generation sequencing, and have examined how clonal change can be acquired in myeloma. In this study, we traced the transition of the somatic mutations of bone marrow tumor cells in patients with MM over a long-term follow-up. Furthermore, we compared the somatic mutations found in serum cell-free DNA (cfDNA) and mutated genes obtained from bone marrow myeloma cells. Material and Methods)Patients diagnosed with multiple myeloma who provided written informed consent to participate in the study were enrolled. Patients were treated by immuno-chemotherapy with or without radiation between 2000 and 2017 at our institute. Bone marrow aspiration and biopsy were performed at the time of diagnosis and upon disease progression. Around the time of bone marrow aspiration, serum was obtained from a peripheral blood sample for cfDNA analysis. Myeloma cells were separated from bone marrow samples with MicroBeads of CD138 antibody and genomic DNA was extracted. The peripheral blood samples derived from myeloma patients. The cfDNA was extracted from the serum using a Maxwell RSC cfDNA Plasma kit. Using genomic DNA derived from cfDNA and bone marrow, multiplex polymerase chain reaction (PCR) was performed, and a sequence library was then constructed with an Ion Custom Amplicon panel. The panel for the sequence library was designed using an Ion AmpliSeq DesignerTM. 126 targeted genes were selected. The genomes were sequenced using the Ion ProtonTM System. This protocol was approved by the institutional review board and the Genomic Review Board of the Japanese Foundation for Cancer Research. Result)We followed 7 patients' long term-clinical course and the transition of mutations (8.5 year average). The expression of myeloma driver genes, such as RAS, BRAF, and MYC, were not critical. We did, however, detect a relationship between an increase in the dominant mutated gene, such as TP53, DIS3, FAM46C, KDM6B, and EGR1 and poor prognosis in patients with myeloma. Next, we calculated the cfDNA concentrations from 34 cases. The cfDNA concentrations were significantly higher than 10 control cases (average 62.0 ng/mL (0-200 ng/mL) and 8.18 ng/mL (4.3-14.1 ng/mL), P=0.0046). The 2.5 year-progression free survival (PFS) during the first treatment of MM were tend to be poorer in the group with cfDNA>50 ng/mL (72.9%) than the group with cfDNA<50 ng/mL(25.9%), however there are no statistical significance (P = 0.15).We caluculated concordance rate of derived mutations from bone marrow MM cells and cfDNA in 7 cases. The somatic mutations found in serum cell-free DNA (cfDNA) and bone marrow MM cells were determined the correlation coefficients. However, there are few difference expression pattern in each source. In cfDNA assay, CREEP, EGR1, HDAC4, HDAC6, and JMJD1C were highly expressed as 57.1% (4/7) - 85.7% (6/7), and these results were almost the same as those for bone marrow MM cells. On the other hand, KDM1A (85.7%), PI3KCD (71.4%), and KDM3B (57.1%) were highly detected in cfDNA, although those were not frequently expressed in bone marrow. Discussion)Our data demonstrate the importance of the long-term follow-up of somatic mutations during the clinical course of myeloma. Serum cfDNA is a useful alternative source for detecting somatic mutations in MM patients during long-term follow-up. Disclosures Mishima: Chugai-Roche Pharmaceuticals Co.,Ltd.: Consultancy. Yokoyama:Chugai-Roche Pharmaceuticals Co.,Ltd.: Consultancy. Nishimura:Chugai-Roche Pharmaceuticals Co.,Ltd.: Consultancy; Celgene K.K.: Honoraria. Hatake:Celgene K.K.: Research Funding; Janssen Pharmaceutical K.K.: Research Funding; Takeda Pharmaceutical Co.,Ltd.: Honoraria. Terui:Bristol-Myers Squibb K.K.: Research Funding; Bristol-Myers Squibb, Celgene, Janssen, Takeda, MSD, Eisai, Ono, and Chugai-Roche Pharmaceuticals Co.,Ltd.: Honoraria.

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