Kooperativer Bibliotheksverbund

In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 8060-8060

Abstract: 8060 Background: ENKL is a rare and aggressive subtype of peripheral T-cell lymphoma. Due to its geographic predilection there is a paucity of data on clinical experiences from non-Asian countries. The purpose of this study was to analyze characteristics and outcomes of patients (pts) with ENKL identified from major academic centers in NA. Methods: Pts with newly diagnosed CD56+ ENKL were retrospectively identified. Analyses included disease characteristics, ethnicity, therapy, and outcomes. Results: 115 pts (63.5% Caucasian, 20% Asian, 16.5% other) were identified across 10 centers diagnosed between 5/1990-5/2011 (Era 1: pre-2000, n=16; Era 2: 2000-2005, n=45; Era 3: post-2005, n=54). Median age was 52 years (19-88). 75 (65%) had stage I/II disease and were treated with combined modality therapy (CMT) n=48, chemotherapy (CT) n=14 or radiotherapy (RT) n=14. 40 pts had stage III/IV disease and were treated with CT (n=23), CMT (n=12) or RT (n=5). CT regimens used alone or in CMT were either anthracycline-based (n=68) or other (n=29). 63% of stage I/II pts and 40% with stage III/IV achieved complete remission (CR). 30 pts underwent a stem cell transplant (SCT); 14 in first CR and 16 at progression/relapse (autologous, n=21; allogeneic, n=9). Pts with stage I/II disease had a better progression-free survival (PFS) and overall survival (OS) compared with stage III/IV (12 vs 5.2 months (p=0.003) and 41.5 vs 8.9 months (p 〈 0.0001), respectively). For all stages, treatment with CMT compared with CT or RT alone was also associated with better PFS and OS, 18.0 vs 3.9 months (p 〈 0.0001), and 41.5 vs 10.2 months (p=0.002) respectively. Non-anthracycline-based regimens were associated with better PFS (p=0.001) and OS (p=0.045). No survival differences were seen between Asian and non-Asian pts. Conclusions: This series represents one of the largest experiences of ENKL in NA. Our data are consistent with Asian studies in: 1) majority of pts present with early stage disease; 2) overall poor outcome; 3) superiority of CMT and non-anthracycline regimens. Advances in understanding biology and international collaborative efforts are required to improve outcome in this rare entity.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/jco.2012.30.15_suppl.8060

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2012

detail.hit.zdb_id: 2005181-5

In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 8507-8507

Abstract: 8507 Background: Therapies approved in US for R/R PTCL have overall response rates (ORR) of 25%-27%. The need for new therapies persists. BELIEF is a pivotal, single-arm study of belinostat in patients with R/R PTCL after failure of ≥1 prior systemic therapies. Methods: Entry criteria were measurable PTCL, platelets ≥ 50,000/µL, no prior HDACi therapy, and adequate organ function. PTCL was confirmed by central pathology review (CPRG). Belinostat 30 min IV infusion at 1000 mg/m 2 was administered on days 1–5 of a 3 week cycle until progression or unacceptable toxicity. Tumor response was assessed by Cheson 2007 criteria. The primary endpoint was ORR. Results: Patients with R/R PTCL (N=129, 53% male, median age 63 y) received belinostat a median of 2 cycles (range 1–33). The median number of prior therapies was 2 (1-8) including CHOP/CHOP-like (96%) and stem cell transplant (23%). The median administered dose intensity was 98%. One and two dose reductions of 25% occurred in 12% and 1% of patients, respectively, due to adverse events (AEs). For patients with CPRG confirmed PTCL (N=120), the ORR was 26% (n=31; 10% CR; 16% PR). The median time to response was 5.6 weeks (range 4.3-50.4). The median duration of response (DoR) was 8.3 months; longest DoR was 29.4 months. Seven patients remain on study in response. For the subgroup of patients with CPRG confirmed PTCL and baseline platelets ≥100,000/μL (N=100) ORR was 28% (CR 11%; PR 17%). The most frequent (≥ 5%) grade 3-4 treatment emergent AEs were thrombocytopenia (13%), neutropenia (13%), anemia (10%), dyspnea (6%), pneumonia (6%), and fatigue (5%). Patients with platelets 〈 100K tolerated belinostat, with 98% dose intensity. Belinostat was well tolerated with a low incidence of myelosuppression. Discontinuations were due to PD (64%), death (11%), AEs (7%), patient request (8%), and other (4%). Conclusions: Belinostat demonstrated a 26%-28% ORR in BELIEF and was well tolerated with a favorable safety profile in patients with R/R PTCL including those with low platelets. The low incidence of myelosuppression observed warrants further investigation of belinostat combination therapy to develop new treatment paradigms for R/R PTCL. Clinical trial information: NCT00865969.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/jco.2013.31.15_suppl.8507

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2013

detail.hit.zdb_id: 2005181-5

In: European Journal of Cancer, Elsevier BV, Vol. 148 ( 2021-05), p. 411-421

Type of Medium: Online Resource

ISSN: 0959-8049

URL: Article

DOI: 10.1016/j.ejca.2021.01.054

Language: English

Publisher: Elsevier BV

Publication Date: 2021

detail.hit.zdb_id: 1120460-6

detail.hit.zdb_id: 1468190-0

detail.hit.zdb_id: 82061-1

In: Journal of the American Academy of Dermatology, Elsevier BV, Vol. 56, No. 2 ( 2007-2), p. 317-326

Type of Medium: Online Resource

ISSN: 0190-9622

URL: Article

DOI: 10.1016/j.jaad.2006.09.005

Language: English

Publisher: Elsevier BV

Publication Date: 2007

detail.hit.zdb_id: 2001404-1

In: Clinical Lymphoma Myeloma and Leukemia, Elsevier BV, Vol. 14, No. 4 ( 2014-08), p. e137-e140

Type of Medium: Online Resource

ISSN: 2152-2650

URL: Article

DOI: 10.1016/j.clml.2014.02.005

Language: English

Publisher: Elsevier BV

Publication Date: 2014

detail.hit.zdb_id: 2540998-0

detail.hit.zdb_id: 2193618-3

In: Blood, American Society of Hematology, Vol. 132, No. Supplement 1 ( 2018-11-29), p. 1646-1646

Abstract: Background: A histologic finding of large cell transformation (LCT) in Mycosis fungoides (MF) is often associated with an aggressive clinical course and inferior prognosis (Arulogun et al. Blood 2008). In patients (pts) with advanced MF (stage IIB-IV), LCT has been established as an independent prognostic factor (Scarisbrick et al. JCO 2015). Although CD30 expression is observed more frequently in MF with LCT vs without LCT, a wide range of CD30 expression levels is observed in LCT lesions and the level of expression lacks prognostic value for MF (Vergier et al. Blood. 2000). The ALCANZA study (NCT01578499) demonstrated significantly better rates of objective response lasting ≥4 months (ORR4) (∆43.8%; p 〈 0.0001) and progression-free survival (PFS) (16.7 months vs 3.5 months; p 〈 0.0001) with brentuximab vedotin vs physician's choice (PC) of oral methotrexate or bexarotene in adults with previously treated CD30+ MF or primary cutaneous anaplastic large-cell lymphoma (Prince et al. Lancet 2017). Despite variability in CD30 expression, significant improvements in ORR4 and PFS were consistently seen with brentuximab vedotin over PC, across all CD30 expression levels in pts with MF. This post-hoc analysis characterized the proportion of pts with LCT, efficacy of brentuximab vedotin in pts with LCT and relationship to CD30 expression. Methods: Analyses were performed on skin biopsies taken from 98 pts with previously treated CD30+ MF who were randomized 1:1 to receive brentuximab vedotin or PC. CD30 expression levels were measured by immunohistochemistry on samples obtained during screening of pts for the ALCANZA study. LCT status at baseline was assessed using ≥2 biopsies obtained at screening; pts were deemed to have LCT if any biopsy showed presence of LCT (large cells - with nuclei ≥4 times larger than those of normal lymphocytes - present in 〉 25% of total dermal infiltrate or forming microscopic nodules). Objective response rates lasting ≥4 months (ORR4), PFS, and safety endpoints were assessed according to LCT and CD30 expression. Results: Baseline demographics and LCT status by disease stage are described in Table 1. In both arms, 17/49 pts (35%) pts had LCT, and LCT was found more frequently in stage IIB pts (59% [brentuximab vedotin] and 41% [PC] ). Brentuximab vedotin improved ORR4 vs PC in pts with LCT (11/17 [64.7%] vs 3/17 [17.6%] ; p=0.006) and without LCT (12/31 [38.7%] vs 2/31 [6.5%] ; p=0.003) (Table 2). Median PFS improved with brentuximab vedotin vs PC in pts with LCT (15.5 vs 2.8 months; HR=0.304; 95% CI 0.139, 0.668; p=0.002) and without LCT (16.1 vs 3.5 months; HR=0.364; 95% CI 0.200, 0.662; p 〈 0.001). Median PFS follow-up times were 26.0 months (both arms, pts without LCT), 36.0 months (brentuximab vedotin arm, pts with LCT), and not estimable (PC arm, pts with LCT). Grade ≥3 adverse event (AE), drug-related grade ≥3 AE and serious AE rates were similar across LCT status groups (Table 2), and CD30 expression levels and were not associated with treatment-emergent AEs in the brentuximab vedotin arm. In pts with LCT, median average CD30 expression was 50% of total dermal infiltrate (range 3-95%) in the brentuximab vedotin arm and 35% (6.3-97.5%) in the PC arm (Figure 1), although pts with high baseline average CD30 expression (upper tercile of all enrolled MF pts) were more likely to have LCT; in the high CD30 expression sub-group, 56% and 64% of pts had LCT in the brentuximab vedotin and PC arms, respectively. Globally, pts with LCT treated with brentuximab vedotin who achieved an ORR4 had higher median average baseline CD30 levels (65%) vs pts who did not attain ORR4 (20%). Of the pts with LCT who achieved an ORR4, 9/11 pts in the brentuximab vedotin arm had baseline average CD30 expression levels ≥40%, but responses were also noted in the 2 pts with low average CD30 levels (10% and 17.5%). Conclusions: Previously, there were limited data on the relationship between LCT status and clinical outcome or CD30 expression in MF pts treated with brentuximab vedotin. Our analyses demonstrated that pts with MF benefitted from brentuximab vedotin regardless of LCT status. A wide range of CD30 expression levels was observed in pts with MF and LCT. In these pts, high baseline CD30 expression levels were generally predictive of a good response to treatment with brentuximab vedotin although meaningful responses were observed in those with lower CD30 levels. Disclosures Kim: Merck: Research Funding; Eisai: Membership on an entity's Board of Directors or advisory committees, Research Funding; Tetralogic: Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees; Innate Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; miRagen: Research Funding; Medivir: Membership on an entity's Board of Directors or advisory committees; Kyowa-Kirin-Pharma: Membership on an entity's Board of Directors or advisory committees, Research Funding; Horizon Pharma: Consultancy, Research Funding; Portola: Research Funding; Soligenix: Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Galderma: Research Funding; Forty Seven Inc: Research Funding; Neumedicine: Consultancy, Research Funding. Prince:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen Cilag: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Whittaker:Galderma: Research Funding. Horwitz:Trillium: Consultancy; ADC Therapeutics: Consultancy, Research Funding; Millennium/Takeda: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Spectrum: Research Funding; Infinity/Verastem: Consultancy, Research Funding; Kyowa-Hakka-Kirin: Consultancy, Research Funding; Aileron Therapeutics: Consultancy, Research Funding; Forty Seven: Consultancy, Research Funding; Portola: Consultancy; Mundipharma: Consultancy; Innate Pharma: Consultancy; Seattle Genetics: Consultancy, Research Funding; Corvus: Consultancy. Duvic:UT MD Anderson Cancer Center: Employment; Shape: Research Funding; Concert Pharmaceuticals, Inc.: Consultancy; Forty Seven, Inc.: Membership on an entity's Board of Directors or advisory committees; Precision Oncology, LLC: Membership on an entity's Board of Directors or advisory committees; Aclaris Therapeutics Int'l Ltd.: Honoraria, Membership on an entity's Board of Directors or advisory committees; MEDACorp: Consultancy; Cell Medica Inc.: Consultancy, Honoraria; Medscape: Other: Speaker/Preceptor; Array Biopharma: Consultancy, Honoraria; American Council on Extracorporeal Photopheresis (ACE): Membership on an entity's Board of Directors or advisory committees; Medivir AB: Membership on an entity's Board of Directors or advisory committees; Spatz Foundation: Research Funding; Rhizen Pharma: Research Funding; Dr. Reddy's Laboratories (A.K.A. Promius Pharma): Consultancy; Mallinckrddt Pharmaceuticals (formerly Therakos): Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Kiniksa Pharmaceuticals: Consultancy; The Lynx Group: Consultancy; MiRagen Therapeutics: Consultancy; Guidepoint Global: Consultancy; Soligenix, Inc.: Membership on an entity's Board of Directors or advisory committees, Research Funding; Huya Bioscience Int'l: Consultancy; Seattle Genetics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Millennium Pharmaceuticals, Inc.: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Evidera, Inc.: Consultancy; Huron Consulting Group: Consultancy; Defined Health: Consultancy; Taiwan Liposome Company LTD: Consultancy; Jonathan Wood & Associates: Other: Speaker; Celgene Corp: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Eisai: Research Funding; Allos: Research Funding; Oncoceuticals: Research Funding; Tetralogics: Research Funding; Kyowa Hakko Kirin, Co: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Clinical Care Options: Consultancy. Bechter:MSD: Consultancy; Pierre Fabre: Consultancy; Sanofi: Consultancy; Bristol Myers Squibb: Consultancy; Novartis: Consultancy. Stadler:ICN: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy; Millennium Pharmaceuticals, Incmited: Consultancy; Johnson and Johnson: Membership on an entity's Board of Directors or advisory committees. Scarisbrick:Takeda harmaceuticals: Consultancy. Zinzani:Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Verastem: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Bayer: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Speakers Bureau; Takeda: Membership on an entity's Board of Directors or advisory committees; MSD: Honoraria, Speakers Bureau; PFIZER: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees; Astra Zeneca: Speakers Bureau; TG Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; SERVIER: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; PFIZER: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celltrion: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TG Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Eradat:Novartis: Research Funding; Celgene: Research Funding; Gilead: Honoraria, Research Funding; Roche: Consultancy, Honoraria, Research Funding; Genentech: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy, Honoraria, Research Funding; Pharmacyclics: Research Funding. Ortiz-Romero:Actelion: Consultancy; Innate Pharma: Consultancy; 4SC: Consultancy; Takeda: Consultancy; MEDA: Research Funding; Patent of PLG1 mutation for diagnostic or treatment of cutaneous lymphomas: Patents & Royalties: Patent of PLG1 mutation for diagnostic or treatment of cutaneous lymphomas; Janssen: Other: Travel Expenses; Roche: Other: Travel Expenses; Abbvie: Other: Travel Expenses. Akilov:Kyowa Kirin: Consultancy; Seattle Genetics: Consultancy; Pfizer: Research Funding; Trillium Therapeutics: Research Funding; Actelion Pharmaceuticals: Consultancy. Trotman:PCYC: Research Funding; Jassen: Research Funding; Celgene: Research Funding; Roche: Research Funding; Janssen: Research Funding; Beigene: Research Funding. Weichenthal:Takeda: Consultancy; Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Research Funding; TEVA: Other: Grant. Fisher:Genetech: Membership on an entity's Board of Directors or advisory committees; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics Inc.: Membership on an entity's Board of Directors or advisory committees. McNeeley:Quest Diagnostics: Employment, Equity Ownership. Gru:Seattle Genetics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees. Wang:Seattle Genetics, Inc.: Employment, Equity Ownership. Palanca-Wessels:Seattle Genetics, Inc.: Employment, Equity Ownership. Lisano:Seattle Genetics: Employment, Equity Ownership. Li:Seattle Genetics, Inc.: Employment. Lin:Takeda Pharmaceutical Company Limited: Employment, Equity Ownership. Little:Takeda: Employment, Equity Ownership. Trepicchio:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Dummer:Bristol-Myers Squibb (BMS): Consultancy, Membership on an entity's Board of Directors or advisory committees; Sun Pharma: 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; Pierre Fabre: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Merck Sharp & Dhome (MSD): Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood-2018-99-112847

Language: English

Publisher: American Society of Hematology

Publication Date: 2018

detail.hit.zdb_id: 1468538-3

detail.hit.zdb_id: 80069-7

In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 8028-8028

Abstract: 8028 Background: Effective treatment for relapsed/refractory cHL is lacking. The oral mammalian target of rapamycin inhibitor EVE showed promising efficacy and acceptable toxicity in cHL. We conducted a study to confirm EVE safety and efficacy in relapsed/refractory cHL. Methods: In this multicenter, open-label, 2-step, phase 2 study, adults with cHL that progressed after high-dose chemotherapy with autologous hematopoietic stem cell transplant (AHSCT) or a gemcitabine-, vinorelbine-, or vinblastine-containing regimen received EVE 10 mg/d until disease progression or unacceptable toxicity. Response was assessed every 12 wk via integrated positron emission tomography/computed tomography (CT) with contrast or CT with contrast. Primary endpoint was overall response rate (ORR) per modified response criteria for malignant lymphoma. Adverse events (AEs) were assessed during, and for ≥4 wk after, EVE treatment. Results: 55 patients were enrolled. Of the 38 currently evaluable patients, 37% were men, median age was 32.5 y, 53% were pretreated with AHSCT, and 95% were pretreated with gemcitabine, vinorelbine, or vinblastine; 71% had disease progression during previous therapies or discontinued previous treatment due to progression. 23 patients discontinued treatment, most commonly due to disease progression (n = 11). ORR was 37% (Table). Median progression-free survival (PFS) was 7.2 mo. The most common hematologic AEs were thrombocytopenia (39%) and anemia (24%); the most common nonhematologic AEs were fatigue (47%), cough (29%), dyspnea (26%), headache (21%), and rash (21%). Grade 3/4 AEs, most commonly thrombocytopenia (18%), were observed in 45% of patients. Conclusions: EVE showed a favorable ORR and median PFS in the first 38 evaluable patients with highly pretreated, relapsed/refractory cHL. The AE profile was consistent with that previously observed for EVE. These preliminary results confirm those of an earlier study and support further evaluation of EVE in cHL. [Table: see text]

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/jco.2012.30.15_suppl.8028

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2012

detail.hit.zdb_id: 2005181-5

In: The Journal of Clinical Endocrinology & Metabolism, The Endocrine Society, Vol. 91, No. 6 ( 2006-06), p. 2205-2208

Type of Medium: Online Resource

ISSN: 0021-972X , 1945-7197

URL: Article

DOI: 10.1210/jc.2005-2839

Language: English

Publisher: The Endocrine Society

Publication Date: 2006

detail.hit.zdb_id: 2026217-6

In: Expert Opinion on Investigational Drugs, Informa UK Limited, Vol. 17, No. 12 ( 2008-12), p. 1883-1887

Type of Medium: Online Resource

ISSN: 1354-3784 , 1744-7658

URL: Article

DOI: 10.1517/13543780802493440

Language: English

Publisher: Informa UK Limited

Publication Date: 2008

detail.hit.zdb_id: 2030114-5

SSG: 15,3

In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 4150-4150

Abstract: Introduction: Outcomes for patients with aggressive T cell lymphomas who are not cured by frontline therapies are poor. A Canadian retrospective analysis showed median overall survival (OS) to be 6.5 months combined for peripheral T-cell lymphoma (PTCL) patients in first relapse (Rel) and patients with primary refractory (Ref) disease (Mak, et al. JCO 2013). There have been no prospective studies that have examined the differences between Rel and Ref patients. In this analysis, we examined clinical features and outcomes for 285 patients prospectively enrolled in the COMPLETE Registry who completed frontline therapy and identified 119 patients with either Rel or Ref disease. We describe differences in clinical features, treatment, and outcomes between Rel and Ref patients. Methods: Patients with all subtypes of PTCL from 72 sites in the US were prospectively enrolled in the COMPLETE registry at initial diagnosis. Clinical and histopathologic features, treatment regimens, goals of therapy, toxicities, and outcomes were recorded. For this analysis, Ref disease was defined as no response to initial treatment or progression during or within 1 month of completing frontline therapy. Rel disease was defined as progression at least 1 month from completion of frontline therapy in patients who achieved a complete response (CR) or partial response (PR). Results: Of 285 patients in COMPLETE who had locked treatment and follow-up records required for this analysis, 50 met the criteria for Rel and 69 for Ref PTCL. Demographics (age, gender, race) and key clinical characteristics at initial diagnosis (histology [Table 1], bone marrow involvement, LDH, ECOG performance status) did not significantly differ between Rel and Ref patients. According to the treating physician, the primary goal of second-line therapy was cure in over half of both groups (52% for Rel, 60% for Ref); the remainder were managed with palliative intent. Rel patients received novel therapies (see Table 2 for definition) more frequently than Ref patients (58% vs. 28%) (P = 0.005) and were less likely to receive multi-agent regimens (24% vs. 45%; P = 0.04) [Table 2] . In the 55 Rel and Ref patients who received single-agent therapy, the most common agents were brentuximab vedotin (20%), romidepsin (15%), pralatrexate (9%) and gemcitabine (7%). In the 30 patients who received multi-agent therapy, the most common regimens were ICE (ifosfamide, carboplatin and etoposide) (17%), GemOx (gemcitabine and oxaliplatin) (17%), and CHOP or CHOP-like plus etoposide (13%). Despite similar frontline therapy with combination chemotherapy regimens, more Rel patients underwent high dose therapy and transplant compared to the Ref group (30% vs. 4%; P = 0.0005). Although single agent versus combination therapy showed similar objective response rates (ORR= CR+PR), the ORR of novel vs. traditional chemotherapy showed a trend favoring novel agents for the entire cohort (57% vs. 38%; P = 0.07). The ORR to second-line therapy was higher in Rel patients (63% vs. 38%; P = 0.02) as was the proportion achieving a CR (38% vs. 15%; P = 0.02). Further, Rel patients had longer OS compared Ref patients, with a median OS of 31 months (95% CI: 22.1 months to not reached) versus 10.2 months (95% CI: 6.5 - 15.9 months) from first diagnosis (Figure 1a) and 14.6 months versus 6.1 months (P = 0.048) from the time of relapse or progression (Figure 1b). For both Rel and Ref patients, there was no difference in survival by PTCL subtype. In both the Rel group and Ref groups, survival was significantly longer in patients treated with curative vs. palliative (as determined by the treating physician) intent (P = 0.01). Conclusions: Our analysis of real world outcomes in patients with aggressive T cell lymphomas demonstrates that outcomes are significantly worse for patients with Ref compared to those with Rel disease. Interestingly, novel single agent therapies were used most often as second-line therapy in Rel patients while multi-agent chemotherapy was used more frequently in Ref patients, despite the demonstration of activity of novel single agents in the Ref setting in other studies. The high proportion of patients with Rel or Ref disease in COMPLETE, and the demonstrated activity of novel agents in the Rel and Ref settings, supports initiatives to incorporate novel agents into frontline therapy for PTCL. Disclosures Lansigan: Spectrum: Consultancy, Research Funding; Pharmacyclics: Consultancy; Teva: Research Funding; Celgene: Consultancy. Horwitz:Huya: Consultancy; Celgene: Consultancy; Takeda: Consultancy, Research Funding; Infinity: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy; Kyowa Hakka Kirin: Consultancy, Research Funding; Spectrum: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; ADCT Therapeutics: Research Funding. Pinter-Brown:Celgene: Consultancy; Spectrum Pharmaceuticals: Consultancy; Seattle Genetics: Consultancy. Carson:American Cancer Society: Research Funding. Pro:Seattle Genetics: Honoraria; Takeda: Honoraria; Celegene: Honoraria. Hsi:Onyx Pharmaceuticals: Honoraria; Seattle Genetics: Honoraria; Eli Lilly: Research Funding; Cellerant: Honoraria, Research Funding; Abbvie: Honoraria, Research Funding; HTG Molecular Diagnostics: Consultancy. Federico:MedNet Solutions: Consultancy. Gisselbrecht:Roche/Genentech: Research Funding, Speakers Bureau. Schwartz:MedNet Solutions: Employment. Bellm:Merck: Equity Ownership; Johnson & Johnson: Equity Ownership; BMS: Equity Ownership; MedNet Solutions: Consultancy, Other: Reimbursement of travel-related expenses. Acosta:Spectrum Pharmaceuticals: Employment, Equity Ownership. Foss:Celgene: Consultancy, Research Funding, Speakers Bureau; Seattle Genetics: Consultancy, Speakers Bureau; Spectrum Pharmaceuticals: Consultancy; Eisai: Consultancy.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood.V128.22.4150.4150

Language: English

Publisher: American Society of Hematology

Publication Date: 2016

detail.hit.zdb_id: 1468538-3

detail.hit.zdb_id: 80069-7