6 results on '"Naseer Qayum"'
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2. Glofitamab Plus R-CHOP Induces High Response Rates and a Favorable Safety Profile in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): Results from a Phase Ib Study
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Max S. Topp, Monica Tani, Michael Dickinson, Nilanjan Ghosh, Armando Santoro, Antonio Pinto, Francesc Bosch, Christopher P. Fox, Armando López-Guillermo, Claudia Carlucci, Chun Wu, Kathryn Humphrey, Pauline Baumlin, Martin Barrett, Naseer Qayum, and Franck Morschhauser
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Immunology ,Cell Biology ,Hematology ,Biochemistry - Published
- 2022
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3. Mosunetuzumab Monotherapy Continues to Demonstrate Promising Efficacy and Durable Complete Responses in Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma
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Adam J. Olszewski, Abraham Avigdor, Sunil Babu, Itai Levi, Herbert Eradat, Uri Abadi, Houston Holmes, Matthew McKinney, Dariusz Woszczyk, Krzysztof Giannopoulos, Wojciech Jurczak, Diana Dunshee, Annie Yang, Mingzhu Zhou, Naseer Qayum, Gila Sellam, and Netanel A. Horowitz
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Immunology ,Cell Biology ,Hematology ,Biochemistry - Published
- 2022
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4. Single-Agent Mosunetuzumab Is a Promising Safe and Efficacious Chemotherapy-Free Regimen for Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma
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Uri Abadi, Ron McCord, Yuying Xie, Carol O'Hear, Itai Levi, Kati Sarouei, Houston Holmes, Cindy Chen, Abraham Avigdor, Adam J. Olszewski, Sunil Babu, Naseer Qayum, Herbert Eradat, Gila Sellam, and Matthew S McKinney
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medicine.medical_specialty ,Chemotherapy ,business.industry ,medicine.medical_treatment ,Immunology ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Gastroenterology ,Regimen ,Internal medicine ,medicine ,Single agent ,business ,Diffuse large B-cell lymphoma - Abstract
Introduction: Up to 30% of patients (pts) aged ≥75 years do not receive standard chemoimmunotherapy (CIT) as first-line (1L) treatment for diffuse large B-cell lymphoma (DLBCL) due to concerns about frailty and comorbidities. Poor outcomes are commonly reported for elderly/unfit pts with 1L DLBCL who receive no treatment, reduced-dose R-CHOP or other therapies such as R-CVP and R-bendamustine (Morrison, et al. J Geriatr Oncol 2020); less toxic, efficacious alternatives to full-dose CIT are needed. Mosunetuzumab (Mosun) is a full-length, fully humanized IgG1 CD20/CD3 bispecific antibody that redirects T cells to engage and eliminate malignant B cells. Single-agent Mosun has shown promising efficacy (including durable complete responses [CRs]) and tolerable safety in relapsed/refractory DLBCL pts in an ongoing Phase I study (GO29781; NCT02500407; Bartlett, et al. ASCO 2019, Schuster, et al. ASH 2019). Here we present early clinical data with Mosun as 1L therapy for elderly/unfit pts with DLBCL. Methods: GO40554 (NCT03677154) is a Phase I/II, open-label, multicenter study. We report data from Cohort B, designed to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of Mosun in pts with 1L DLBCL who are unable to tolerate full-dose CIT. Two safety evaluation cohorts were planned to receive Mosun at 13.5mg and 30mg, followed by an expansion phase. No safety concerns emerged following evaluation of the two safety cohorts. Eligible pts were aged ≥80 years or 60-79 years with impairment in ≥1 activity of daily living (ADL) or instrumental ADL, or with impairment in cardiac, renal or liver function precluding the use of full-dose CIT. After optional pre-phase treatment with prednisone with or without vincristine, pts received Mosun intravenously with step-up dosing on Day (D) 1, 8 and 15 of Cycle (C) 1, followed by a fixed dose on D1 of each subsequent 21-day cycle. Interim response assessment (IRA) occurred after C4 and primary response assessment (PRA) occurred after C8, with an option to continue up to maximum 17 cycles in case of partial remission (PR) following PRA. Results: As of May 27, 2020, 19 pts in Cohort B had received Mosun (1mg [C1 D1]/2mg [C1 D8]/13.5mg [C1 D15 onwards], n=8; 1/2/30mg, n=11). Eight pts were enrolled in the 13.5mg safety evaluation cohort and 11 enrolled in the 30mg safety cohort and expansion (7+4 respectively). Median age was 84 (range: 67-100) years, 14 (74%) pts were women, 10 (53%) had Ann Arbor stage III-IV and 17 (90%) had an IPI score ≥2. Median Mosun cycles received was 6 (range: 2-9; one pt in PR continued treatment). Among 19 pts, 16 (84%) had ≥1 adverse event (AE), 13 (68%) had ≥1 AE related to Mosun and 7 (37%) experienced a Grade (Gr) 3-4 AE, of which 4 were related to Mosun. No fatal AEs were observed. The most common (>10%) treatment-emergent AEs were cytokine release syndrome (CRS; n=9, 47%), rash (n=4, 21%), neutropenia, nausea, decreased appetite, dry mouth, fatigue, pain and muscle spasms (all n=2, 11%). All CRS events were Gr 1 by ASTCT consensus criteria (Lee, et al. Biol Blood Marrow Transplant 2019); no pts experienced hypotension, hypoxia or required tocilizumab or steroid treatment. No severe (Gr ≥3) neurologic AEs were observed. Gr 2 (ICAN) neurotoxicity was observed in one (5%) pt on C1D2 with symptoms of inability to answer questions, drowsiness, weakness and somnolence, combined with Gr 1 CRS (fever and tachycardia). The event resolved after 2 days and was considered related to Mosun. Eight (42%) pts discontinued Mosun early due to progressive disease (PD) between C2-C6. No pts discontinued Mosun due to an AE. Among all treated pts, the overall response rate was 58% (11/19) and CR rate was 42% (8/19). At Mosun dose 13.5mg, 3/8 pts (38%) achieved a CR, 2 (25%) had a PR and 3 (38%) had PD at the PRA. At Mosun dose 30mg, response was available at IRA: 5/11 pts (45.5%) achieved a CR, 1 (9%) had a PR and 5 (45.5%) had PD. Of the 8 pts with PD (from both dosing cohorts), 5 have received salvage therapy post progression. Figure 1 shows a durable response of almost a year for the first responder. Correlative studies of T-cell response by flow cytometry and cytokine expression, and PK analyses are ongoing and will be provided. Conclusions: Early clinical data indicate that single-agent Mosun confers notable efficacy and remarkable tolerability for previously untreated elderly/unfit DLBCL pts. Mosun is a promising chemotherapy-free regimen for patients who otherwise have limited options. Disclosures Olszewski: Spectrum Pharmaceuticals: Research Funding; TG Therapeutics: Research Funding; Adaptive Biotechnologies: Research Funding; Genentech, Inc.: Research Funding. Avigdor:Takeda, Gilead, Pfizer: Consultancy, Honoraria; Janssen, BMS: Research Funding. Babu:Amgen: Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Fort Wayne Medical Oncology & Hematology: Current Employment, Current equity holder in publicly-traded company; Lilly: Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Sanofi: Research Funding; Janssen Oncology: Research Funding; Lutheran Hospital: Other; Bayer: Honoraria; AstraZeneca: Consultancy, Honoraria; AstraZeneca/MedImmune: Research Funding; Boehringer Ingelheim: Consultancy; Alexion Pharmaceuticals: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding, Speakers Bureau; Argenx: Consultancy, Research Funding; Novartis: Research Funding; Genentech, Inc./ F. Hoffmann-La Roche: Research Funding; Syndax: Research Funding; Nektar: Research Funding; Merck: Research Funding; AbbVie: Research Funding; TG Therapeutics: Research Funding. Levi:Abbvie Inc: Consultancy, Research Funding. Abadi:Abbvie Inc: Research Funding; Roche, Gilead, Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Holmes:Texas Oncology PA: Current Employment; Gilead/Kite, Celgene/Juno, Rigel, Karyopharm, Janssen, Dova: Consultancy; Gilead/Kite, Novartis, Autolus, Celgene/Juno/bluebird, Genentech, Inc., Rigel, Janssen, Unum, ADC Therapeutics, Seattle Genetics, Incyte, Verastem: Research Funding; Kite, Karyopharm, Seattle Genetics, Rigel, Dova: Speakers Bureau. McKinney:UNUM, Molecular Templates, Incyte, Beigene, Denovo Biopharma, Pharmacyclics, Nordic Nanovector, BMS, Genentech, Inc., Celgene: Research Funding; Kite/Gilead: Honoraria, Speakers Bureau; Kite/Gilead, Seattle Genetics, Molecular Templates, BTG, Pharmacyclics, Verastem, Genentech, Inc., Celgene: Consultancy. McCord:F. Hoffmann-La Roche: Current equity holder in publicly-traded company; Genentech, Inc.: Current Employment. Xie:F. Hoffmann-La Roche: Current Employment. Chen:Janssen Pharmaceuticals: Current equity holder in publicly-traded company; Bristol-Myer Squibb: Current equity holder in publicly-traded company, Ended employment in the past 24 months; Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company. Sarouei:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company. Qayum:F. Hoffmann-La Roche: Current Employment. O'Hear:Genentech, Inc.: Current Employment; F. Hoffmann-La Roche: Current equity holder in publicly-traded company. Sellam:F. Hoffmann-La Roche: Current Employment. Eradat:UCLA Medical Center, David Geffen school of Medicine at UCLA: Current Employment; Genentech, Inc.: Consultancy, Honoraria, Research Funding, Speakers Bureau; F. Hoffmann-La Roche: Consultancy, Research Funding; Abbvie: Consultancy, Honoraria, Research Funding, Speakers Bureau; Astrazeneca, Atara, Kite, Juno, Acerta, BeiGene, Celgene: Research Funding. OffLabel Disclosure: Mosunetuzumab (RG7828; CD20-TDB) is a full-length, fully humanized immunoglobulin G1 (IgG1) bispecific antibody targeting both CD3 (on the surface of T cells) and CD20 (on the surface of B cells). Mosunetuzumab redirects T cells to engage and eliminate malignant B cells. Mosunetuzumab is an investigational agent.
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- 2020
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5. Glofitamab Plus R-CHOP Induces High Response Rates with Minimal Cytokine Release Syndrome (CRS) in Patients (pts) with Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL) and Previously Untreated (1L) Diffuse Large B-Cell Lymphoma (DLBCL): Preliminary Results from a Dose-Escalation and Safety Run-in Phase Ib Study
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Steven Le Gouill, Naseer Qayum, William Townsend, Max S. Topp, Nilanjan Ghosh, Monica Tani, Armando Santoro, Michael Dickinson, Michael Crump, Kathryn Humphrey, Martin Barrett, Amitkumar Mehta, Franck Morschhauser, Chun Wu, Martin Hutchings, and Anesh Panchal
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business.industry ,Immunology ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Cytokine release syndrome ,Relapsed refractory ,medicine ,Cancer research ,Dose escalation ,Hodgkin lymphoma ,In patient ,business ,Diffuse large B-cell lymphoma - Abstract
Background: Over a third of pts with 1L DLBCL do not respond to, or relapse after, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP; [Sarkozy and Sehn. Ann Lymphoma 2019]). Despite recent advances, pts with R/R NHL have limited curative options. Glofitamab (Glofit) is a novel, T-cell-engaging bispecific antibody with a 2:1 molecular configuration that allows bivalent binding to CD20 on B cells and monovalent binding to CD3 on T cells. Unlike other CD20xCD3 bispecific antibodies, this format uniquely enables combination with anti-CD20 antibodies, including rituximab. Glofit monotherapy induces high response rates in R/R B-cell NHL (Hutchings et al. J Clin Oncol 2021). We present results of the ongoing NP40126 study (NCT03467373), designed to assess the feasibility and safety of Glofit + R-CHOP in R/R NHL (dose-escalation phase) and 1L DLBCL (safety run-in phase). Methods: R/R NHL dose-escalation: Pts (Eastern Cooperative Oncology Group performance status [ECOG PS] 0-2) received increasing Glofit doses in separate cohorts (70µg, 1800µg, 10mg and 30mg) plus standard R-CHOP for 6-8 cycles (each 21-day). To mitigate CRS risk, R- or obinutuzumab (G)-CHOP was given in Cycle (C)1, with the aim of tumor debulking. Glofit was given from C2 onwards. For 70µg and 1800µg cohorts, fixed-dose Glofit was given on C2 Day (D)8 and onwards. For 10mg and 30mg cohorts, step-up dosing was used to further mitigate CRS risk (2.5mg C2D8, 10mg C2D15, target dose C3D8 and onwards). Optional Glofit maintenance was permitted (every 2 months for 1L DLBCL safety run-in: Pts (ECOG PS 0-3) received Glofit 30mg plus standard R-CHOP for 6-8 cycles (each 21-day). Pts received R-CHOP in C1; Glofit step-up dosing began in C2 (2.5mg C2D8, 10mg C2D15, 30mg C3D8 and onwards). Response rates were assessed by PET-CT (Lugano criteria; [Cheson et al. J Clin Oncol 2014]). CRS events were graded by ASTCT criteria [Lee et al. Biol Blood Marrow Transplant 2019]. Results: R/R NHL dose-escalation: At data cut-off (June 10, 2021), 31 pts (23 follicular lymphoma [FL]; 6 transformed FL; 1 marginal-zone lymphoma; 1 mantle-cell lymphoma) had received Glofit with R/G-CHOP. Median age was 62 years, median prior lines of therapy was 2 (range: 1-5). In efficacy-evaluable pts (n=31), after a median 9.0 months' (range: 0-29) follow-up, the overall response rate (ORR) was 90% (n=28) and complete response rate (CRR) was 77% (n=24). Median duration of response was not reached. The Figure shows change in tumor size. Grade (Gr) ≥3 adverse events (AEs) occurred in 28 (90%) pts, serious AEs in 21 (68%) pts and CRS in 17 (55%) pts (mostly low grade; majority after the first 2.5mg Glofit dose; Table). One (3%) pt had a Gr 5 AE (COVID-19 pneumonia not related to study treatment). AEs led to Glofit dose modification/interruption in 2 (6%) pts and Glofit withdrawal in 1 (3%) pt. Neurologic AEs (NAEs) occurred in 20 (65%) pts: Gr 1-2 (16 pts, 52%); Gr 3 (4 pts, 13%). Immune effector cell-associated neurotoxicity syndrome (ICANS)-like AEs were uncommon; a serious AE was reported in 1 pt only (Gr 3 epilepsy during the maintenance phase; resolved in 3 days). Neutropenia occurred in 24 (77%) pts. Median dose intensity was 100% for all R-CHOP components. 1L DLBCL safety run-in: At data cut-off, 13 pts were enrolled (safety population); of these, 4 pts received Glofit 30mg with R-CHOP and were efficacy-evaluable. Median age was 68 years, all pts had Ann Arbor Stage 3/4 disease. At interim assessment (C3), CRR was 100% (4/4). Of 13 pts, 1 (8%) had a CRS event (Gr 1 with fever only) after the first 2.5mg Glofit dose; no other CRS events observed. Gr ≥3 AEs occurred in 8 (62%) pts and Gr ≥3 AEs related to Glofit in 1 (8%) pt only. One (8%) pt had a serious AE and 1 (8%) pt had a Gr 5 AE (infusion-related reaction related to rituximab on C1D1). No AEs led to Glofit or R-CHOP dose interruptions. NAEs occurred in 3 (23%) pts (all Gr 1-2; none were ICANS-like). Neutropenia occurred in 6 (46%) pts. Median dose intensity was 100% for all R-CHOP components. Conclusions: Initial data show that Glofit + R-CHOP has tolerable safety in R/R NHL and 1L DLBCL. R-CHOP dose intensity was maintained in all pts. The very low CRS rate and no neurotoxicity in 1L DLBCL may render Glofit particularly suitable for the outpatient setting without the need for hospitalization. Updated data, including end-of-treatment responses from the 1L DLBCL safety run-in phase, will be presented. Figure 1 Figure 1. Disclosures Ghosh: Seattle Genetics: Consultancy, Honoraria, Speakers Bureau; Gilead: Consultancy, Honoraria, Research Funding, Speakers Bureau; Pharmacyclics LLC, an AbbVie Company: Consultancy, Honoraria, Research Funding, Speakers Bureau; AbbVie: Honoraria, Speakers Bureau; Karyopharma: Consultancy, Honoraria; AstraZeneca: Consultancy, Honoraria, Speakers Bureau; ADC Therapeutics: Consultancy, Honoraria; Adaptive Biotech: Consultancy, Honoraria; TG Therapeutics: Consultancy, Honoraria, Research Funding; Genmab: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding, Speakers Bureau; Epizyme: Honoraria, Speakers Bureau; Incyte: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Speakers Bureau; Genentech: Research Funding. Townsend: Celgene (Bristol-Myers Squibb): Consultancy, Honoraria; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria. Dickinson: Amgen: Honoraria; Celgene: Research Funding; Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau; Takeda: Research Funding; Gilead Sciences: Consultancy, Honoraria, Speakers Bureau; MSD: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Roche: Consultancy, Honoraria, Other: travel, accommodation, expenses, Research Funding, Speakers Bureau. Topp: Celgene: Consultancy, Research Funding; Janssen: Consultancy; Universitatklinikum Wurzburg: Current Employment; Kite, a Gilead Company: Consultancy, Research Funding; Novartis: Consultancy; Roche: Consultancy, Research Funding; Gilead: Research Funding; Regeneron: Consultancy, Research Funding; Macrogeniecs: Research Funding; Amgen: Consultancy, Research Funding. Santoro: Sandoz: Speakers Bureau; Eli-Lilly: Speakers Bureau; Pfizer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AstraZeneca: Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Servier: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Speakers Bureau; Amgen: Speakers Bureau; AbbVie: Speakers Bureau; Roche: Speakers Bureau; BMS: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Eisai: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Speakers Bureau; Sanofi: Consultancy; Arqule: Consultancy, Speakers Bureau; Novartis: Speakers Bureau; Bayer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; MSD: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Crump: Novartis: Membership on an entity's Board of Directors or advisory committees; Kyte/Gilead: Membership on an entity's Board of Directors or advisory committees; Epizyme: Research Funding; Roche: Research Funding. Morschhauser: Epizyme: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech, Inc.: Consultancy; Genmab: Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Speakers Bureau; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Chugai: Honoraria; Incyte: Membership on an entity's Board of Directors or advisory committees; Servier: Consultancy; AstraZenenca: Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria. Mehta: Kite/Gilead; Roche-Genetech; Celgene/BMS;Oncotartis; Innate Pharmaceuticals; Seattle Genetics;Incyte; Takeda; Fortyseven Inc/Gilead; TG Therapeutics;Merck; Juno Pharmaceuticals/BMS: Research Funding; Seattle Genetics; Incyte; TG Therapeutics: Consultancy; Seattle Genetics; Incyte; TG Therapeutics: Membership on an entity's Board of Directors or advisory committees. Panchal: F. Hoffmann-La Roche Ltd: Current Employment. Wu: F. Hoffmann-La Roche Ltd: Current Employment, Current equity holder in publicly-traded company. Barrett: Roche Products Ltd: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company. Humphrey: Roche: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Qayum: F. Hoffmann-La Roche Ltd: Current Employment, Current equity holder in publicly-traded company. Hutchings: Novartis: Research Funding; Janssen: Honoraria, Research Funding; Incyte: Research Funding; Genentech: Honoraria, Research Funding; Celgene: Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria, Research Funding; Genmab: Consultancy, Honoraria, Research Funding. OffLabel Disclosure: Glofitamab is a full-length, humanized immunoglobulin G1 bispecific antibody with a 2:1 molecular format that facilitates bivalent binding to CD20 on B-cells, and monovalent binding to CD3 on T-cells. Glofitamab redirects T cells to engage and eliminate malignant B cells. Glofitamab is an investigational agent. Rituximab (Rituxan) is a CD20-directed cytolytic antibody indicated for the treatment of adult pts with: relapsed or refractory, low grade or follicular, CD20-positive, B-cell NHL as a single agent; previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy (chemo) and, in pts achieving a CR or PR to a rituximab product in combination with chemo, as single-agent maintenance therapy; non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line CVP chemo; previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP or other anthracycline-based chemo regimens; previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide.
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- 2021
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6. Comparable Overall Survival with Rituximab-Bendamustine (R-Benda) and Rituximab-Gemcitabine-Oxaliplatin (R-GemOx) When Used As Second-Line (2L) Treatment for Diffuse Large B-Cell Lymphoma (DLBCL): A Real-World Study Using US Veterans Health Administration Data
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Aijing Shang, Lizheng Shi, Raluca Ionescu-Ittu, Naseer Qayum, Yilu Lin, Sherry Shi, Nancy Vander Velde, and Annie Guerin
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Bendamustine ,Oncology ,medicine.medical_specialty ,Gemcitabine/oxaliplatin ,business.industry ,Immunology ,Cell Biology ,Hematology ,GemOx ,Veterans health ,medicine.disease ,Biochemistry ,03 medical and health sciences ,0302 clinical medicine ,Second line ,030220 oncology & carcinogenesis ,Internal medicine ,Overall survival ,Medicine ,Rituximab ,business ,Diffuse large B-cell lymphoma ,030215 immunology ,medicine.drug - Abstract
Introduction: DLBCL is the most common subtype of non-Hodgkin lymphoma. R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) is established as the standard of care for patients (pts) with previously untreated DLBCL, but ~40% of pts will eventually relapse. For relapsed/refractory pts who are ineligible for transplant, clinical guidelines propose a broad spectrum of therapeutic options. However, little is known about treatment patterns and outcomes associated with 2L therapy in routine practice, particularly for pts less suitable for intensive therapy. Therefore, using real-world data, we evaluated 2L treatment patterns in DLBCL pts and overall survival (OS) in those pts who received 2L R-Benda or R-GemOx. We focused on these 2 treatments as they are typically used in the non-transplant setting in pts less suitable for aggressive therapy, and can typically be administered in an outpatient setting. Methods: DLBCL pts receiving care from the US Veterans Health Administration were identified through their electronic medical records and raw oncology domain. Pts diagnosed with DLBCL (and no prior other types of malignancies) between 2004-2016, with ≥1-month follow-up and who received 2L treatment were included. OS (defined as time from the start of 2L therapy until death) was analyzed in pts who received 2L R-Benda or R-GemOx using the Kaplan-Meier method. Surviving pts were censored at data cutoff (December 31, 2017). Univariate and multivariate Cox regression analyses were undertaken to assess the impact of 2L treatment (in particular, R-GemOx vs R-Benda) on OS. Results: A total of 2600 DLBCL pts were identified: 2039 received 1L and 702 received 1L and 2L therapy. Among the 702 pts treated with 2L therapy, regimens included R-ICE (n=77; 11.0%), R-CHOP (n=75; 10.7%), rituximab monotherapy (n=34; 4.8%), R-Benda (n=32; 4.6%), methotrexate (n=24; 3.4%), R-ESHAP (n=23; 3.3%), R-DHAP/R-EPOCH/R-GDP (n=18; 2.6%), rituximab plus cyclophosphamide-doxorubicin-vinblastine-vincristine (n=14; 2.0%), R-CVP (n=11; 1.6%), rituximab plus cyclophosphamide-etoposide-vincristine (n=11; 1.6%), and R-GemOx (n=10; 1.4%). Of the remaining pts, 267 (38.0%) received regimens with agent(s) included in the NCCN guidelines, while 106 (15.1%) received regimens with at least 1 agent not guideline-recommended. Baseline characteristics for pts treated with 2L R-Benda (n=32) or R-GemOx (n=10) are shown in Table 1. There was an imbalance between the 2 cohorts with regard to race, number of involved lymph nodes, B symptoms, Charlson Comorbidity Index score, and abnormal lactate dehydrogenase results. After 24 deaths in the R-Benda cohort and 7 deaths in the R-GemOx cohort, median OS was estimated at 11 and 13 months, respectively (Figure 1). Median follow-up time after start of 2L treatment was 11.3 and 11.7 months, respectively. The Kaplan-Meier curves of the 2 cohorts overlapped at multiple timepoints during follow-up. Respective 1-year OS rates (95% confidence interval [CI]) with R-Benda and R-GemOx were 50.0% (31.9%, 65.7%) and 60.0% (25.3%, 82.7%). Compared with R-Benda, R-GemOx did not significantly predict longer OS in either the univariate (hazard ratio [HR]: 0.94; 95% CI: 0.41, 2.19; p=0.893) or multivariate (HR: 1.07; 95% CI: 0.46, 2.50; p=0.873) analyses. Conclusions: This real-world study highlights the diversity of 2L treatment regimens used in DLBCL pts. There was no apparent difference in OS between R-Benda- and R-GemOx-treated pts and, with a median OS of approximately 1 year after 2L initiation with either regimen, there is clearly an unmet need in this setting. The main limitation of the study relates to the small sample size of each treatment cohort. Further research using other real-world data sources is warranted. Disclosures Ionescu-Ittu: Analysis Group, Inc.: Employment; F. Hoffman-La Roche Ltd: Consultancy, Other: I am an employee of Analysis Group, Inc., which received consulting fees from Roche for the conduct of this study. Shang:F. Hoffmann-La Roche Ltd.: Employment, Other: Ownership interests non-PLC. Guérin:F. Hoffman-La Roche Ltd: Other: I am an employee of Analysis Group, Inc., which received consulting fees from Roche for the conduct of this study; Analysis Group, Inc.: Employment. Shi:F. Hoffman-La Roche Ltd: Research Funding; Bravo4Health: Other: Ownership interests non-PLC; Genentech: Research Funding; Chiasma: Research Funding; Intuitive Surgical: Consultancy. Shi:F. Hoffman-La Roche Ltd: Other: I am an employee of Analysis Group, Inc., which received consulting fees from Roche for the conduct of this study; Analysis Group, Inc.: Employment. Qayum:F. Hoffmann-La Roche Ltd: Employment.
- Published
- 2018
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