Romidepsin-CHOEP followed by high-dose chemotherapy and stem-cell transplantation in untreated Peripheral T-Cell Lymphoma: results of the PTCL13 phase Ib/II study

被引：22

作者：

Chiappella, Annalisa ^{[1
]}

Dodero, Anna ^{[1
]}

Evangelista, Andrea ^{[2
]}

Re, Alessandro ^{[3
]}

Orsucci, Lorella ^{[4
]}

Usai, Sara Veronica ^{[5
]}

Castellino, Claudia ^{[6
]}

Stefoni, Vittorio ^{[7
]}

Pinto, Antonio ^{[8
]}

Zanni, Manuela ^{[9
]}

Ciancia, Rosanna ^{[10
]}

Ghiggi, Chiara ^{[11
]}

Rossi, Francesca Gaia ^{[12
]}

Arcari, Annalisa ^{[13
]}

Ilariucci, Fiorella ^{[14
]}

Zilioli, Vittorio Ruggero ^{[15
]}

Flenghi, Leonardo ^{[16
]}

Celli, Melania ^{[17
]}

Volpetti, Stefano ^{[18
]}

Benedetti, Fabio ^{[19
]}

Ballerini, Filippo ^{[20
]}

Musuraca, Gerardo ^{[21
]}

Bruna, Riccardo ^{[22
]}

Patti, Caterina ^{[23
]}

Leonardi, Francesco ^{[24
]}

Arcaini, Luca ^{[25
,26
]}

Magagnoli, Massimo ^{[27
]}

Cavallo, Federica ^{[28
]}

Bermema, Anisa ^{[1
]}

Tucci, Alessandra ^{[3
]}

Boccomini, Carola ^{[4
]}

Ciccone, Giovannino ^{[2
]}

Carniti, Cristiana ^{[29
]}

Pileri, Stefano Aldo ^{[30
]}

Corradini, Paolo ^{[1
]}

机构：

[1] Fdn IRCCS Ist Nazl Tumori, Div Hematol & Stem Cell Transplantat, Milan, Italy

[2] Azienda Osped & Univ Citta Salute & Sci & CPO Pie, Unit Clin Epidemiol, Turin, Italy

[3] ASST Spedali Civili Brescia, Hematol Div, Brescia, Italy

[4] Azienda Osped & Univ Citta Salute & Sci, Div Hematol, Turin, Italy

[5] Osped Oncol Armando Businco, Hematol Unit, Cagliari, Italy

[6] Azienda Osped S Croce & Carle, Div Hematol, Cuneo, Italy

[7] Univ Bologna, Inst Hematol Seragnoli, Bologna, Italy

[8] IRCCS, Fdn G Pascale, Ist Nazl Tumori, Hematol Oncol & Stem Cell Transplantat Unit, Naples, Italy

[9] Azienda Osped Santi Antonio & Biagio & Cesare Arr, Div Hematol, Alessandria, Italy

[10] Ctr Riferimento Oncol Aviano CRO IRCCS, Hematol, Aviano, Italy

[11] IRCCS Osped Policlin San Martino, Unit Hematol & Cellular therapies, Genoa, Italy

[12] Fdn IRCCS Ca Granda, Div Hematol, OM Policlin, Milan, Italy

[13] Osped Guglielmo Saliceto, Hematol Unit, Piacenza, Italy

[14] IRCCS Reggio Emilia, Hematol, Azienda USL, Reggio Emilia, Italy

[15] ASST Grande Osped Metropolitano Niguarda, Div Hematol, Milan, Italy

[16] Azienda Osped Perugia, Hematol, Perugia, Italy

[17] Osped Infermi, Hematol, Rimini, Italy

[18] ASUFC, Presidio Osped Univ Santa Maria della Misericordi, Clin Hematol, Udine, Italy

[19] Azienda Osped Univ Verona, Hematol & Stem Cell Transplantat, Verona, Italy

[20] IRCCS Osped Policlin San Martino, Hematol, Genoa, Italy

[21] IRCCS Ist Romagnolo Studio Tumori IRST Dino Amado, Hematol unit, Meldola, Italy

[22] Osped Maggiore La Carita, Div Hematol, Novara, Italy

[23] Azienda Villa Sofia Cervello, Div Onco Hematol, Palermo, Italy

[24] Azienda Osped Univ Parma, Hematol & CTMO, Parma, Italy

[25] Univ Pavia, Fdn IRCCS Policlin San Matteo, Dept Mol Med, Pavia, Italy

[26] Fdn IRCCS Policlin San Matteo, Div Hematol, Pavia, Italy

[27] IRCCS Humanitas Res Hosp, Humanitas Canc Ctr, Dept Oncol & Hematol, Rozzano, Italy

[28] Univ Torino, Dept Mol Biotechnol & Hlth Sci, Div Hematol, Azienda Osped & Univ Citta Salute & Sci, Turin, Italy

[29] Fdn IRCCS Ist Nazl Tumori, Div Hematol & Stem Cell Transplantat, Lab Hematol, Milan, Italy

[30] European Inst Oncol IRCCS, Div Haematopathol, Milan, Italy

来源：

LEUKEMIA | 2023年 / 37卷 / 02期

关键词：

LONG-TERM REMISSIONS; ALLOGENEIC TRANSPLANTATION; IMPACT;

D O I：

10.1038/s41375-022-01780-1

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The standard treatment for young patients with untreated PTCLs is based on anthracycline containing-regimens followed by high-dose-chemotherapy and stem-cell-transplantation (HDT + SCT), but only 40% of them can be cured. Romidepsin, a histone-deacetylase inhibitor, showed promising activity in relapsed PTCLs; in first line, Romidepsin was added with CHOP. We designed a study combining romidepsin and CHOEP as induction before HDT + auto-SCT in untreated PTCLs (PTCL-NOS, AITL/THF, ALK-ALCL), aged 18-65 years. A phase Ib/II trial was conducted to define the maximum tolerated dose (MTD) of Ro-CHOEP, and to assess efficacy and safety of 6 Ro-CHOEP as induction before HDT. The study hypothesis was to achieve a 18-month PFS of 70%. Twenty-one patients were enrolled into phase Ib; 7 dose-limiting toxicities were observed, that led to define the MTD at 14 mg/ms. Eighty-six patients were included in the phase II. At a median follow-up of 28 months, the 18-month PFS was 46.2% (95%CI:35.0-56.7), and the 18-month overall survival was 73.1% (95%CI:61.6-81.7). The overall response after induction was 71%, with 62% CRs. No unexpected toxicities were reported. The primary endpoint was not met; therefore, the enrollment was stopped at a planned interim analysis. The addition of romidepsin to CHOEP did not improve the PFS of untreated PTCL patients.

引用

页码：433 / 440

页数：8

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