A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients

Background There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %. Methods A multicenter prospective phase II trial was conducted t...
Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Pellegrini, Cinzia [verfasserIn] Dodero, Anna Chiappella, Annalisa Monaco, Federico Degl’Innocenti, Debora Salvi, Flavia Vitolo, Umberto Argnani, Lisa Corradini, Paolo Zinzani, Pier Luigi

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2016

Schlagwörter:	Peripheral T-cell lymphoma Relapsed Refractory Gemcitabine Romidepsin

Anmerkung:	© Pellegrini et al. 2016

Übergeordnetes Werk:	Enthalten in: Journal of hematology & oncology - London : Biomed Central, 2008, 9(2016), 1 vom: 12. Apr.
Übergeordnetes Werk:	volume:9 ; year:2016 ; number:1 ; day:12 ; month:04

Links:	Volltext

DOI / URN:	10.1186/s13045-016-0266-1

Katalog-ID:	SPR02961905X

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520			\|a Background There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %. Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. Trial registration The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886.
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700	1		\|a Zinzani, Pier Luigi \|4 aut
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allfields	10.1186/s13045-016-0266-1 doi (DE-627)SPR02961905X (SPR)s13045-016-0266-1-e DE-627 ger DE-627 rakwb eng Pellegrini, Cinzia verfasserin aut A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Pellegrini et al. 2016 Background There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %. Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. Trial registration The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886. Peripheral T-cell lymphoma (dpeaa)DE-He213 Relapsed (dpeaa)DE-He213 Refractory (dpeaa)DE-He213 Gemcitabine (dpeaa)DE-He213 Romidepsin (dpeaa)DE-He213 Dodero, Anna aut Chiappella, Annalisa aut Monaco, Federico aut Degl’Innocenti, Debora aut Salvi, Flavia aut Vitolo, Umberto aut Argnani, Lisa aut Corradini, Paolo aut Zinzani, Pier Luigi aut Enthalten in Journal of hematology & oncology London : Biomed Central, 2008 9(2016), 1 vom: 12. Apr. (DE-627)568914813 (DE-600)2429631-4 1756-8722 nnns volume:9 year:2016 number:1 day:12 month:04 https://dx.doi.org/10.1186/s13045-016-0266-1 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2016 1 12 04
spelling	10.1186/s13045-016-0266-1 doi (DE-627)SPR02961905X (SPR)s13045-016-0266-1-e DE-627 ger DE-627 rakwb eng Pellegrini, Cinzia verfasserin aut A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Pellegrini et al. 2016 Background There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %. Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. Trial registration The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886. Peripheral T-cell lymphoma (dpeaa)DE-He213 Relapsed (dpeaa)DE-He213 Refractory (dpeaa)DE-He213 Gemcitabine (dpeaa)DE-He213 Romidepsin (dpeaa)DE-He213 Dodero, Anna aut Chiappella, Annalisa aut Monaco, Federico aut Degl’Innocenti, Debora aut Salvi, Flavia aut Vitolo, Umberto aut Argnani, Lisa aut Corradini, Paolo aut Zinzani, Pier Luigi aut Enthalten in Journal of hematology & oncology London : Biomed Central, 2008 9(2016), 1 vom: 12. Apr. (DE-627)568914813 (DE-600)2429631-4 1756-8722 nnns volume:9 year:2016 number:1 day:12 month:04 https://dx.doi.org/10.1186/s13045-016-0266-1 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2016 1 12 04
allfields_unstemmed	10.1186/s13045-016-0266-1 doi (DE-627)SPR02961905X (SPR)s13045-016-0266-1-e DE-627 ger DE-627 rakwb eng Pellegrini, Cinzia verfasserin aut A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Pellegrini et al. 2016 Background There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %. Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. Trial registration The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886. Peripheral T-cell lymphoma (dpeaa)DE-He213 Relapsed (dpeaa)DE-He213 Refractory (dpeaa)DE-He213 Gemcitabine (dpeaa)DE-He213 Romidepsin (dpeaa)DE-He213 Dodero, Anna aut Chiappella, Annalisa aut Monaco, Federico aut Degl’Innocenti, Debora aut Salvi, Flavia aut Vitolo, Umberto aut Argnani, Lisa aut Corradini, Paolo aut Zinzani, Pier Luigi aut Enthalten in Journal of hematology & oncology London : Biomed Central, 2008 9(2016), 1 vom: 12. Apr. (DE-627)568914813 (DE-600)2429631-4 1756-8722 nnns volume:9 year:2016 number:1 day:12 month:04 https://dx.doi.org/10.1186/s13045-016-0266-1 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2016 1 12 04
allfieldsGer	10.1186/s13045-016-0266-1 doi (DE-627)SPR02961905X (SPR)s13045-016-0266-1-e DE-627 ger DE-627 rakwb eng Pellegrini, Cinzia verfasserin aut A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Pellegrini et al. 2016 Background There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %. Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. Trial registration The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886. Peripheral T-cell lymphoma (dpeaa)DE-He213 Relapsed (dpeaa)DE-He213 Refractory (dpeaa)DE-He213 Gemcitabine (dpeaa)DE-He213 Romidepsin (dpeaa)DE-He213 Dodero, Anna aut Chiappella, Annalisa aut Monaco, Federico aut Degl’Innocenti, Debora aut Salvi, Flavia aut Vitolo, Umberto aut Argnani, Lisa aut Corradini, Paolo aut Zinzani, Pier Luigi aut Enthalten in Journal of hematology & oncology London : Biomed Central, 2008 9(2016), 1 vom: 12. Apr. (DE-627)568914813 (DE-600)2429631-4 1756-8722 nnns volume:9 year:2016 number:1 day:12 month:04 https://dx.doi.org/10.1186/s13045-016-0266-1 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2016 1 12 04
allfieldsSound	10.1186/s13045-016-0266-1 doi (DE-627)SPR02961905X (SPR)s13045-016-0266-1-e DE-627 ger DE-627 rakwb eng Pellegrini, Cinzia verfasserin aut A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Pellegrini et al. 2016 Background There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %. Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. Trial registration The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886. Peripheral T-cell lymphoma (dpeaa)DE-He213 Relapsed (dpeaa)DE-He213 Refractory (dpeaa)DE-He213 Gemcitabine (dpeaa)DE-He213 Romidepsin (dpeaa)DE-He213 Dodero, Anna aut Chiappella, Annalisa aut Monaco, Federico aut Degl’Innocenti, Debora aut Salvi, Flavia aut Vitolo, Umberto aut Argnani, Lisa aut Corradini, Paolo aut Zinzani, Pier Luigi aut Enthalten in Journal of hematology & oncology London : Biomed Central, 2008 9(2016), 1 vom: 12. Apr. (DE-627)568914813 (DE-600)2429631-4 1756-8722 nnns volume:9 year:2016 number:1 day:12 month:04 https://dx.doi.org/10.1186/s13045-016-0266-1 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2016 1 12 04
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source	Enthalten in Journal of hematology & oncology 9(2016), 1 vom: 12. Apr. volume:9 year:2016 number:1 day:12 month:04
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topic_facet	Peripheral T-cell lymphoma Relapsed Refractory Gemcitabine Romidepsin
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authorswithroles_txt_mv	Pellegrini, Cinzia @@aut@@ Dodero, Anna @@aut@@ Chiappella, Annalisa @@aut@@ Monaco, Federico @@aut@@ Degl’Innocenti, Debora @@aut@@ Salvi, Flavia @@aut@@ Vitolo, Umberto @@aut@@ Argnani, Lisa @@aut@@ Corradini, Paolo @@aut@@ Zinzani, Pier Luigi @@aut@@
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Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. 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author	Pellegrini, Cinzia
spellingShingle	Pellegrini, Cinzia misc Peripheral T-cell lymphoma misc Relapsed misc Refractory misc Gemcitabine misc Romidepsin A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients
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topic_title	A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients Peripheral T-cell lymphoma (dpeaa)DE-He213 Relapsed (dpeaa)DE-He213 Refractory (dpeaa)DE-He213 Gemcitabine (dpeaa)DE-He213 Romidepsin (dpeaa)DE-He213
topic	misc Peripheral T-cell lymphoma misc Relapsed misc Refractory misc Gemcitabine misc Romidepsin
topic_unstemmed	misc Peripheral T-cell lymphoma misc Relapsed misc Refractory misc Gemcitabine misc Romidepsin
topic_browse	misc Peripheral T-cell lymphoma misc Relapsed misc Refractory misc Gemcitabine misc Romidepsin
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title	A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients
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title_full	A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients
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author_browse	Pellegrini, Cinzia Dodero, Anna Chiappella, Annalisa Monaco, Federico Degl’Innocenti, Debora Salvi, Flavia Vitolo, Umberto Argnani, Lisa Corradini, Paolo Zinzani, Pier Luigi
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title_sort	phase ii study on the role of gemcitabine plus romidepsin (gemro regimen) in the treatment of relapsed/refractory peripheral t-cell lymphoma patients
title_auth	A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients
abstract	Background There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %. Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. Trial registration The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886. © Pellegrini et al. 2016
abstractGer	Background There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %. Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. Trial registration The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886. © Pellegrini et al. 2016
abstract_unstemmed	Background There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %. Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. Trial registration The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886. © Pellegrini et al. 2016
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title_short	A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients
url	https://dx.doi.org/10.1186/s13045-016-0266-1
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Methods A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen. Results The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption. Conclusions GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes. 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A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients

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