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• W2951683868 abstract "Introduction: CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone) is a common upfront regimen for peripheral T-cell lymphoma (PTCL). Lenalidomide (len) is an immunomodulatory agent with 22% single agent response rate in relapsed and refractory PTCL. Here we report the phase II results of len-CHOEP including consolidation outcomes of those proceeding to len maintenance or autologous stem cell transplantation (ASCT). Methods: Eligible patients (pts) had newly diagnosed PTCL with adequate hematologic and organ function. Based on phase I results10 mg of len was deemed the recommended phase II dose. CHOEP was administered at standard doses with len given on days 1-10 of 21-day cycle for 6 planned cycles. Pts received thromboprophylaxis and growth factor support. The primary endpoint was complete response (CR) by PET/CT after 6 cycles. Secondary endpoints included toxicity, overall response rate (ORR), progression free survival (PFS), 2-year PFS, and overall survival (OS). Pts who had CR or partial response (PR) at the end of therapy had the option of len maintenance (10 mg/day for 21 out of 28 days) for 1-year or consolidative ASCT without len maintenance. Results: 39 pts with PTCL-NOS (n = 19), ALK negative ALCL (n = 4) and AITL (n = 16) enrolled into the phase II portion. Median age was 63 years (range 24-79) and 20 were male. Stage III/IV was seen in 89%. Prognosis by international prognostic index was 0-1 (15%), 2 (41%), and 3-5 (44%). 29 (75%) pts completed all 6 cycles. One pt was re-classified as Hodgkin lymphoma post completion of len-CHOEP and is included in toxicity analysis. Reasons for discontinuing len-CHOEP early were toxicity (n = 7) and progressive disease (PD; n = 5). The primary endpoint of CR by an intent to treat (ITT) analysis was 48% (19/40; 95CI—33-64%) with an ORR of 69%. Responding pts (CR/PR; n = 30) proceeded either to an ASCT (n = 16), len maintenance (n = 10) or neither (investigator/pts preference; n = 1). At a median follow up of 18 months (range: 2-30 months), the 1-year estimated PFS and OS is 67% [95% CI: 50-79%] and 90% [95%CI: 73-96%] respectively. There is no difference in 1-year PFS by PTCL subtype or between the len maintenance or ASCT. There were 5 grade (G) 5 events including PD (n = 1), secondary malignancy (n = 1; AML), sepsis (n = 2), and cardiac arrest (n = 1). Serious or recurrent adverse events (SAEs or AEs; G 3-4) of interest occurring during any cycle included 38% febrile neutropenia despite mandated GCSF use, 43% anemia, 45% thrombocytopenia (without report of G 3-4 bleeding or bruising despite ASA use), and 8% diarrhea. Conclusions: The phase II portion of the study in an ITT population noted a modest 48% CR rate and a high discontinuation rate due to AEs or SAEs. The utility of post initial therapy strategy (len maintenance vs ASCT) continue to be monitored for PFS and OS in this limited cohort. Improving frontline outcomes for pts with PTCL remains an unmet need. Keywords: peripheral T-cell lymphomas (PTCL). Disclosures: Lunning, M: Consultant Advisory Role: AbbVie, Bayer, Celgene, DAVA, Gilead Sciences, Inc Janssen, Juno Therapeutics, Kite, Novartis, OncLive, Portola, Seattle Genetics, Spectrum, TG Therapeutics, VANIUM, Verastem; Research Funding: Celgene, Curis, Janssen Scientific Affairs, LLC Juno Therapeutics, MiRagen, TG Therapeutics. Horwitz, S: Consultant Advisory Role: Millennium/Takeda; Trillium; Mundipharma; Kyowa-Hakka-Kirin; Portola; Aileron Therapeutics; Innate Pharma; Corvus; Spectrum; Seattle Genetics; Verastem; ADC Therapeutics; Research Funding: Millennium/Takeda, Kyowa Hakka Kiron; Aleron; Spectrum; Seattle Genetics; Verastem. Advani, R: Consultant Advisory Role: Janssen Pharmaceutical; Cell Medica; Bayer Healthcare Pharmaceutic; Merck; Forty Seven, Inc; Millenium; Roche/Genentech; Pharmacyclics; Celgene; Regeneron Pharmaceuticals, Inc; Kura; Infinity; Autolus; Kyowa; Takeda; Bristol Myers Squibb; Agensys; Gilead/Kite; Seattle Genetics; AstraZeneca; Research Funding: Forty Seven; Genentech; Seattle Genetics. Vose, J: Honoraria: Epizyme; Roche; Novartis; Legend; Abbvie; Research Funding: Novartis; Celgene; Incyte; Bristol Myers Squibb; Seattle Genetics; Acerta Pharma; Kite Pharma; Merck. Mehta-Shah, N: Consultant Advisory Role: Kyowa Hakka Kirin; Research Funding: Verastem; Celgene; Astra Zeneca; Roche/Genentech; Bristol Myers Squibb. Moskowitz, A: Consultant Advisory Role: Bristol Myers-Squibb; Seattle Genetics; Honoraria: Takeda; Seattle Genetics; Research Funding: Bristol Myers-Squibb; Incyte Seattle Genetics; ADC Therapeutics; Merck. Ansell, S: Research Funding: Regeneron; Trillium; Bristol-Myers Squibb; Celldex; LAM Therapeutics; Takeda; Seattle Genetics; Merck & Co; Pfizer; Affimed." @default.
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• W2951683868 title "PHASE I/II STUDY OF CHOEP PLUS LENALIDOMIDE AS INITIAL THERAPY FOR PATIENTS WITH STAGE II-IV PERIPHERAL T-CELL LYMPHOMA: PHASE II RESULTS" @default.
• W2951683868 doi "https://doi.org/10.1002/hon.91_2630" @default.
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