Vincristine (V), dactinomycin (A), and lower doses of cyclophosphamide (C) with or without radiation therapy for patients with newly diagnosed low-risk embryonal rhabdomyosarcoma (ERMS): A report from the Children’s Oncology Group (COG).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9509-9509 ◽  
Author(s):  
David Walterhouse ◽  
Alberto S. Pappo ◽  
Jane L Meza ◽  
John C. Breneman ◽  
Andrea Anita Hayes-Jordan ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Complete Response ◽  
Low Risk ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Group Iii ◽  
Group I ◽  
Phase Iii Study ◽  
Stage 1

9509 Background: Intergroup Rhabdomyosarcoma Study (IRS) trials showed improved survival with VAC compared with VA for patients with Stage 1 Group III (non-orbit) or Stage 3 Group I/II ERMS (see table). In COG ARST0331, we hypothesized that VA in combination with lower doses of C (total cumulative dose=4.8 g/m2) would produce the benefit of IRS-IV VAC with less toxicity for patients with Stage 1 Group III (non-orbit) or Stage 3 Group I/II low-risk ERMS. Methods: This single arm, non-inferiority, phase III study enrolled newly diagnosed patients with Stage 1 Group III (non-orbit) ERMS or Stage 3 Group I/II ERMS onto Subset 2. Therapy was 4 cycles of VAC followed by 12 cycles of VA over 46 weeks (total cumulative doses: V=54 mg/m2, A=21.6 mg/m2, C=4.8 g/m2). The radiation therapy dose was 36 Gy for Group IIA patients, 41.4 Gy for Group IIB/C patients, and 50.4 Gy for Group III patients. From 2004–2008 girls with Group III vaginal RMS did not receive radiotherapy if a complete response was achieved with chemotherapy with or without delayed resection. The primary endpoint was failure-free survival (FFS), and results were compared with a fixed expected outcome. Results: With a median follow-up of 3.0 yrs, we observed 16 failures vs. 7.8 expected failures. Estimated 3-yr FFS was 63% (95% CI: 46%, 75%) (n=60), and overall survival (OS) was 84% (95% CI: 68%, 93%). Estimated 3-yr FFS was 46% (95% CI: 23%, 67%) for girls with non-bladder genitourinary tract ERMS (n=21) and 75% (95% CI: 53%, 88%) for all other Subset 2 patients (n=39). Conclusions: We observed suboptimal FFS of patients with Subset 2 low-risk RMS using reduced total cyclophosphamide (4.8 g/m2). Results were complicated by the choice of no radiation therapy for girls with vaginal tumors. Future studies for low-risk RMS Subset 2 patients could investigate a dose of C between 4.8 and 26.4 g/m2 with VA and local radiotherapy. [Table: see text]

scholarly journals Shorter-Duration Therapy Using Vincristine, Dactinomycin, and Lower-Dose Cyclophosphamide With or Without Radiotherapy for Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma: A Report From the Soft Tissue Sarcoma Committee of the Children's Oncology Group

2014 ◽  
Vol 32 (31) ◽  
pp. 3547-3552 ◽  
Author(s):  
David O. Walterhouse ◽  
Alberto S. Pappo ◽  
Jane L. Meza ◽  
John C. Breneman ◽  
Andrea A. Hayes-Jordan ◽  
...  
Keyword(s):  
Residual Disease ◽  
Incidence Rates ◽  
Low Risk ◽  
Newly Diagnosed ◽  
Oncology Group ◽  
Group Iii ◽  
Group I ◽  
Risk Patients ◽  
Stage 1 ◽  
Length Of Therapy

Purpose Intergroup Rhabdomyosarcoma Study Group (IRSG) studies III and IV showed improved failure-free survival (FFS) rates with vincristine, dactinomycin, and cyclophosphamide (VAC; total cumulative cyclophosphamide dose, 26.4 g/m2) compared with vincristine and dactinomycin (VA) for patients with subset-one low-risk embryonal rhabdomyosarcoma (ERMS; stage 1/2 group I/II ERMS or stage 1 group III orbit ERMS). The objective of Children's Oncology Group ARST0331 was to reduce the length of therapy without compromising FFS for this subset of low-risk patients by using VA in combination with lower-dose cyclophosphamide (total cumulative dose, 4.8 g/m2) plus radiotherapy (RT). Patients and Methods This noninferiority prospective clinical trial enrolled newly diagnosed patients with subset-one clinical features. Therapy included four cycles of VAC followed by four cycles of VA over 22 weeks. Patients with microscopic or gross residual disease at study entry received RT. Results With a median follow-up of 4.3 years, we observed 35 failures among 271 eligible patients versus 48.4 expected failures, calculated using a fixed outcome based on the FFS expected for similar patients treated on the IRSG D9602 protocol. The estimated 3-year FFS rate was 89% (95% CI, 85% to 92%), and the overall survival rate was 98% (95% CI, 95% to 99%). Patients with paratesticular tumors had the most favorable outcome. Three-year cumulative incidence rates for any local, regional, or distant failures were 7.6%, 1.5%, and 3.4%, respectively. Conclusion Shorter-duration therapy that included lower-dose cyclophosphamide and RT did not compromise FFS for patients with subset-one low-risk ERMS.

An Update on the Role of Thalidomide (THAL) in Total Therapy 2 (TT2) for Newly Diagnosed Patients with Multiple Myeloma (MM): Analysis of Subgroups Defined by Standard Prognostic Factors (SPF) and Gene Expression Profiling (GEP)-Derived Subgroups.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3389-3389 ◽  
Author(s):  
John D. Shaughnessy ◽  
Jeffrey Haessler ◽  
Jerry Zeldis ◽  
Yongsheng Huang ◽  
Fenghuang Zhan ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Risk Groups ◽  
Complete Response ◽  
Low Risk ◽  
Phase Iii ◽  
Significant Difference ◽  
And Control ◽  
Standard Risk

Abstract Background: THAL, whose activity in MM was discovered in the setting of advanced and refractory disease in the late 1990’s (Singhal, NEJM, 2000), has become the standard front-line therapy in combination with dexamethasone (DEX). In a randomized phase III tandem transplant trial, TT2, a higher complete response (CR) rate and longer event-free survival (EFS) had been observed on the THAL arm (Barlogie, NEJM, 2006). The similar overall survival (OS) on THAL and control arms had been attributed to the routine use of THAL as salvage therapy for the patients randomized to the No-THAL arm and the shorter post-relapse OS among patients randomized to the THAL arm. Patients and Methods: With a median follow-up on TT2 of 53mo, 107 patients have relapsed and 219 died. Subset analyses were performed to determine whether THAL confers an OS advantage in any subgroup of patients. Results: 6-yr EFS and OS rates are 48%/63% on THAL and 38%/58% on control arm (p=0.01/0.67). Post-relapse OS is now similar with median durations of 5.3mo/4.3mo among control/THAL arms (p=0.11). According to multivariate analyses of 11 standard prognostic factors, EFS was shorter among patients treated without THAL, in the presence of cytogenetic abnormalities (CA), B2M and LDH elevations and low albumin, whereas CR was favorable; OS was inferior with CA, high LDH, low albumin and in patients not receiving 2nd transplant or not achieving CR. Randomization to THAL was beneficial only in the >2 risk factor group: 6-yr OS was 47% in 31 patients on THAL and 12% in 31 control patients (Figure 1, p=0.01). When examined in the context of GEP (70 gene model-based high versus low risk groups) and inter-phase FISH data (amp1q21), available in 260 patients, the 57 with GEP low risk and absence of amp1q21 receiving THAL had 5-yr OS of 90% compared to 74% among 73 controls (p=0.13). Conclusion: With longer follow-up of 53mo on TT2, EFS remains superior among patients randomized to THAL; post-relapse survival is no longer inferior among those randomized to THAL; THAL benefited a high-risk subgroup with >2 standard risk factors, whereas no significant `difference has yet emerged among genetically defined subgroups. Figure Figure

A phase III study of radiation therapy plus carmustine with or without recombinant interferon-? in the treatment of patients with newly diagnosed high-grade glioma

Cancer ◽  
2001 ◽  
Vol 92 (2) ◽  
pp. 420-433 ◽  
Author(s):  
Jan C. Buckner ◽  
Paula J. Schomberg ◽  
William L. McGinnis ◽  
Terrence L. Cascino ◽  
Bernd W. Scheithauer ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
High Grade Glioma ◽  
Phase Iii ◽  
High Grade ◽  
Newly Diagnosed ◽  
Recombinant Interferon ◽  
Phase Iii Study

scholarly journals Results of the Intergroup Rhabdomyosarcoma Study Group D9602 Protocol, Using Vincristine and Dactinomycin With or Without Cyclophosphamide and Radiation Therapy, for Newly Diagnosed Patients With Low-Risk Embryonal Rhabdomyosarcoma: A Report From the Soft Tissue Sarcoma Committee of the Children's Oncology Group

2011 ◽  
Vol 29 (10) ◽  
pp. 1312-1318 ◽  
Author(s):  
R. Beverly Raney ◽  
David O. Walterhouse ◽  
Jane L. Meza ◽  
Richard J. Andrassy ◽  
John C. Breneman ◽  
...  
Keyword(s):  
Survival Rates ◽  
Embryonal Rhabdomyosarcoma ◽  
Study Group ◽  
Free Survival ◽  
Group Iii ◽  
Group I ◽  
Risk Patients ◽  
Group Ii ◽  
Stage 1

Purpose Patients with localized, grossly resected, or gross residual (orbital only) embryonal rhabdomyosarcoma (ERMS) had 5-year failure-free survival (FFS) rates of 83% and overall survival rates of 95% on Intergroup Rhabdomyosarcoma Study Group (IRSG) protocols III/IV. IRSG D9602 protocol (1997 to 2004) objectives were to decrease toxicity in similar patients by reducing radiotherapy (RT) doses and eliminating cyclophosphamide for the lowest-risk patients. Patients and Methods Subgroup A patients (lowest risk, with ERMS, stage 1 group I/IIA, stage 1 group III orbit, stage 2 group I) received vincristine plus dactinomycin (VA). Subgroup B patients (ERMS, stage 1 group IIB/C, stage I group III nonorbit, stage 2 group II, stage 3 group I/II) received VA plus cyclophosphamide. Patients in group II/III received RT. Compared with IRS-IV, doses were reduced from 41.4 to 36 Gy for stage 1 group IIA patients and from 50 or 59 to 45 Gy for group III orbit patients. Results Estimated 5-year FFS rates were 89% (95% CI, 84% to 92%) for subgroup A patients (n = 264) and 85% (95% CI, 74%, 91%) for subgroup B patients (n = 78); median follow-up: 5.1 years. Estimated 5-year FFS rates were 81% (95% CI, 68% to 90%) for patients with stage 1 group IIA tumors (n = 62) and 86% (95% CI, 76% to 92%) for patients with group III orbit tumors (n = 77). Conclusion Five-year FFS and OS rates were similar to those observed in comparable IRS-III patients, including patients receiving reduced RT doses, but were lower than in comparable IRS-IV patients receiving VA plus cyclophosphamide. Five-year FFS rates were similar among subgroups A and B patients.

scholarly journals Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL: the HOVON-100 trial

2021 ◽  
Author(s):  
Anita W Rijneveld ◽  
Bronno van der Holt ◽  
Okke de Weerdt ◽  
Bart J Biemond ◽  
Arjan A Van de Loosdrecht ◽  
...  
Keyword(s):  
Older Patients ◽  
Residual Disease ◽  
Lymphoblastic Leukemia ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Serious Adverse Events ◽  
Hematopoietic Stem ◽  
Improve Outcome ◽  
Phase Iii Study

Clofarabine (CLO) is a nucleoside analogue with efficacy in relapsed/refractory acute lymphoblastic leukemia (ALL). This randomized phase III study aimed to evaluate whether CLO added to induction and consolidation would improve outcome in adults with newly diagnosed ALL. Treatment for younger (18-40 years) patients consisted of a pediatric inspired protocol and for older patients (41-70 years) of a semi-intensive protocol was used. 340 patients were randomized. After a median follow up of 70 months, 5-year EFS was 50% and 53% for arm A and B (CLO arm). For patients ≤40 years, EFS was 58% vs 65% in arm A vs B, while in patients >40 years EFS was 43% in both arms. CR rate was 89% in both arms and similar in younger and older patients. Minimal residual disease (MRD) was assessed in 200 patients (60%). Fifty-four of 76 evaluable patients (71%) were MRD negative after consolidation 1 in arm A vs 75/81 (93%) in arm B (p=0.001). Seventy (42%) patients proceeded to allogeneic hematopoietic stem cell transplantation in both arms. Five years OS was similar in both arms, 60% vs 61%. Among patients achieving CR, relapse rates were 28% and 24%, and non-relapse mortality was 16% vs 17% after CR. CLO treated patients experienced more serious adverse events, more infections, and more often went off-protocol. This was most pronounced in older patients. We conclude that, despite a higher rate of MRD-negativity, addition of CLO does not improve outcome in adults with ALL, which might be due to increased toxicity. The trial is registered at www.trialregister.nl as NTR2004.

Phase III randomized pilot study comparing interferon α- 2b in combination with radiation therapy versus radiation therapy alone in patients with stage III-B carcinoma of the cervix

2003 ◽  
Vol 13 (2) ◽  
pp. 164-169
Author(s):  
R. Yazigi ◽  
G. Aliste ◽  
R. Torres ◽  
A. M. Ciudad ◽  
M. Cuevas ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Pilot Study ◽  
Therapy Group ◽  
Combined Therapy ◽  
Randomized Study ◽  
Patient Characteristics ◽  
Complete Response ◽  
Phase Iii ◽  
Interferon Α

This randomized pilot study was designed to determine whether the addition of interferon α-2b to standard radiation therapy offered an advantage in loco-regional control and survival over radiation therapy alone in a homogeneous group of patients with stage IIIB carcinoma of the cervix. Thirty-six patients were treated with a combination of interferon α-2b plus radiation therapy, and 38 patients were treated with radiation therapy alone. Patients with evidence of ureteral obstruction were excluded from the study. Evaluation of loco-regional response was determined by pelvic examination, cervical cytology, biopsies and CT scans when indicated. Survival time was measured from initiation of treatment to date of death or last follow-up. Patient characteristics were comparable between both study arms. The objective complete response rate was 67% in the combined therapy group and 55% in the radiation alone group (P = 0.454). With a median follow-up of 17 months for all patients and 31 months for live patients, 50% of the combined group survived vs. 39.5% of the radiation alone group (P = 0.424). We conclude that the addition of interferon α-2b to standard radiation therapy did not significantly improve loco-regional response or survival, although such a trend was noted. We encourage the design of a larger randomized study with sufficient power to detect meaningful differences to prove whether the tendency observed in the present investigation holds any promise to improve the outcome of these patients.

Dactinomycin (A) and vincristine (V) with or without cyclophosphamide (C) and radiation therapy (RT) for newly diagnosed patients with low-risk embryonal/botryoid rhabdomyosarcoma (RMS). An IRS-V report from the Soft Tissue Sarcoma Committee of the Children’s Oncology Group (STS COG)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 9001-9001 ◽  
Author(s):  
D. O. Walterhouse ◽  
J. L. Meza ◽  
R. B. Raney ◽  
J. Anderson ◽  
E. S. Wiener ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Therapy ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Primary Endpoint ◽  
Low Risk ◽  
Newly Diagnosed ◽  
Oncology Group ◽  
Free Survival

9001 Background: The STS COG defines patients with low-risk RMS as those with localized tumors of embryonal histology that occur in favorable sites or occur in unfavorable sites and are grossly resected. Intergroup Rhabdomyosarcoma Studies (IRS)-III (1984–1991) and -IV (1991–1997) found that these patients had a 5-year failure-free survival (FFS) of 83% and an overall survival of 95%. Methods: Two subsets were identified for the IRS-V low-risk RMS study (D9602) (1997–2004) based on the hypothesis that they required different treatment intensities to achieve similar excellent outcomes. Patients assigned to Subset A (Stage [Sg] 1 Group [Gp] I/IIA, Sg 1 Gp III orbit, Sg 2 Gp I) received VA (cumulative doses over 1 year of treatment: V: 54 mg/m2, A: 24 mg/kg) ± local RT. Patients assigned to Subset B (Sg 2 Gp IIB/C, Sg 1 Gp III non-orbit, Sg 2 Gp II, Sg 3 Gp I/II) received VA + C (C: 28.6 g/m2) ± RT. The RT dose was reduced to 36 Gy (instead of 41.4 Gy on IRS-IV) for Gp IIA patients and to 45 Gy (instead of 50.4 or 59.4 Gy on IRS-IV) for Gp III orbit patients. The primary endpoint was FFS. Results: Estimated 3-yr FFS was 89% (95% CI 84%, 93%) for Subset A (n=263) and 89% (95% CI 77%, 95%) for Subset B (n=79). Median follow-up was 2.9 years. Estimated 3-yr FFS was 80% (95% CI 64%, 89%; n=59) for patients with Sg 1 Gp IIA disease and 88% (95% CI 77%, 94%; n=76) for Gp III orbit disease. Conclusions: There is not evidence to suggest that outcome for these patients differs from outcomes observed in similar patients treated on IRS-III and IRS-IV. No significant financial relationships to disclose.

Effect of consolidation with arsenic trioxide (As2O3) on event-free survival (EFS) and overall survival (OS) among patients with newly diagnosed acute promyelocytic leukemia (APL): North American Intergroup Protocol C9710

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
B. L. Powell
Keyword(s):  
Disease Free Survival ◽  
Patient Characteristics ◽  
Phase Iii ◽  
Remission Induction ◽  
Cooperative Groups ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Phase Iii Study ◽  
To Receive

2 Background: This randomized phase III study was designed to evaluate the benefit and toxicity of two 25-day courses of As2O3 as first post-remission therapy for newly diagnosed patients with APL. Methods: Adult patients were randomized to receive 2 courses of As2O3 (0.15 mg/kg/d for 5d each wk for 5 wk) as a first consolidation if they achieved remission (CR or PR) after induction with oral tretinoin (ATRA; 45 mg/m2/d), daunorubicin (50 mg/m2 IV × 4d), and cytarabine (200 mg/m2 CIV × 7d); by study design, all but 2 children were assigned to the non-As2O3 arm. Subsequent consolidation on both arms included 2 courses of ATRA (45 mg/m2 × 7d) + daunorubicin (50 mg/m2 × 3d; 2d for age < 15 yr). CR patients were then randomized to 1 yr of ATRA maintenance (7d repeated every other wk) with or without 6- mercaptopurine (daily) + methotrexate (weekly). Results: 518 adults (15–79 yr) and 64 children (<15 yr; 11%) with untreated APL were enrolled by 5 cooperative groups (CALGB, ECOG, SWOG, COG, NCIC-CTG). Eligibility required demonstration of PML-RARA in one of 3 central labs; 37 adults and 7 children were ineligible and not included in the analyses. Patient characteristics and toxicity data have been reported (ASH 2006; Blood 108:171a). Median follow up is now 29 mos. Overall CR rate for adults was 89% and did not differ by treatment arm; CR rate for children was 89%. There were 41 deaths (8%) within 60 days. EFS, the primary endpoint, was 77% at 3 yrs on the As2O3 arm (median, not reached) compared to 59% at 3 yrs on the standard arm (median, 63 mos; p=0.0013). Overall, 84% of adults were alive at last follow up. OS was 86% at 3 yrs on the As2O3 arm compared to 77% at 3 yrs on the standard arm (medians not reached; p=0.029); EFS and OS for pediatric patients did not differ statistically from the adult arm without As2O3. Among 452 CR pts, there have been only 71 post-CR events (16%) so disease- free survival has not yet been analyzed by treatment arm. Conclusion: The addition of 2 courses of As2O3 consolidation following remission induction significantly improves EFS and OS in adults with APL. No significant financial relationships to disclose.

Prognostic Implication of Somatic Mutations By Next Generation Sequencing: An Analysis from the Mmrf Commpass Study in Newly Diagnosed Multiple Myeloma Patients

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2079-2079
Author(s):  
Mattia D'Agostino ◽  
Stefania Oliva ◽  
Alessandra Larocca ◽  
Stefano Spada ◽  
Manuela Gambella ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Board Of Directors ◽  
Cox Model ◽  
Newly Diagnosed ◽  
Advisory Committees ◽  
Group Iii ◽  
Mutational Status ◽  
Group I ◽  
Group Ii

Abstract Introduction: High throughput techniques, such as massively parallel sequencing, are becoming an attractive approach to characterize multiple myeloma (MM) genomic profiles. However, the clinical relevance and contribution to risk assessment of such approaches need to be established. The Multiple Myeloma Research Foundation (MMRF)CoMMpass trial (NCT01454297) has collected data from 1000 newly-diagnosed MM patients enrolled worldwide and observed through an expected follow-up of up to eight-years. Comprehensive analysis of somatic mutations detected in purified MM cells could reveal disease features with prognostic value, which may not have been detected using traditional approaches. Materials and methods: We analyzed data from the interim analysis 8 cohort. CD138+ purified MM specimens from bone marrow aspirates and mononuclear cells from peripheral blood were collected at diagnosis. Whole exome libraries from both tumor and constitutional DNA samples were created. Somatic single nucleotide variants (SNV) were identified using three different variant callers (Seurat,Strelka andMutect), only nonsynonymous SNV calls made from at least two callers were included in the analysis. Patients were analyzed on an intention-to-treat basis. We evaluated the impact on progression free survival (PFS) of recurrently mutated genes (with at least a nonsynonymous SNV in more than 10 patients) in a Cox model adjusted for international staging system (ISS) and cytogenetic profile (high risk, standard risk and missing). An additive score related to mutated genes was calculated on the basis the level of each coefficient estimated using a Cox Model with backward selection based on theAkaikeInformation Criterion (AIC). Results: 517 patients with baseline somatic mutation data were included in the analysis. Median age at diagnosis was 64 years (range 27-93). All patients received novel agents as first line treatment; 236 (45.6%) received autologous stem cell transplantation (ASCT). Each patient showed a median number of 55 nonsynonymous somatic SNV (range 8-1970) in a median number of 47 genes (range 5-1741). Excluding immunoglobulin genes, the most recurrent mutated genes were KRAS (25%), NRAS (19.5%), TTN (12.1%), MUC16 (9.1%) and DIS3 (9.1%). Based on the results of a multivariable Cox model corrected for ISS and cytogeneticprofile, we created a scoring system determined by the mutational status of 9 genes identified in a nonbiased manner (Table 1). Three groups were identified: group I (score 0-2, 17%); group II (score=3, 51%), and group III (score >3, 32%). After a median follow-up of 371 days, the 18-month PFS rate was 93% for group I, 85% for group II, and 67% for group III. In a Cox model adjusted for ISS and cytogeneticprofile, the hazard ratio was 2.34 (p=0.112) for group II versus group I, and 5.96 (p<0.001) for group III versus I. The prognostic trend of the score was confirmed in different patient subgroups including ASCT/no ASCT, standard/high risk cytogenetic profile, ISS I, II, or III. Of note, 23.3% of patients in group I had an ISS III and 30.4% of patients in group III had an ISS I. Conclusion: The use of a prognostic model based on the mutational status of 9 recurrently mutated genes could improve risk assessment of newly-diagnosed MM patients. To our knowledge, this is the largest study correlating nonsynonymous somatic SNV with MM patients' outcome. Longer follow-up and validation in independent cohorts are needed to confirm our findings. Disclosures Larocca: Amgen, Celgene, BMS, Janssen-Cilag: Honoraria. Gay:Amgen: Honoraria; Bristol-Myers Squibb: Honoraria; Celgene: Honoraria; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Mundipharma: Membership on an entity's Board of Directors or advisory committees. Palumbo:Janssen Cilag: Honoraria; Takeda: Employment, Honoraria.

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