Difference between revisions of "Peripheral T-cell lymphoma - historical"
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m (Text replacement - "style="background-color:#1a9851" |Phase III" to "style="background-color:#1a9851" |Phase 3") |
Warner-admin (talk | contribs) m (Text replacement - "|Phase II" to "|Phase 2") |
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112033/ Piekarz et al. 2011 (NIH 01-C-0049)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112033/ Piekarz et al. 2011 (NIH 01-C-0049)] | ||
|NR | |NR | ||
| − | | style="background-color:#91cf61" |Phase | + | | style="background-color:#91cf61" |Phase 2 |
| style="background-color:#d3d3d3" | | | style="background-color:#d3d3d3" | | ||
| style="background-color:#666666; color:white" |ORR: 38% (95% CI 24-53) | | style="background-color:#666666; color:white" |ORR: 38% (95% CI 24-53) | ||
| Line 30: | Line 30: | ||
|[https://doi.org/10.1200/jco.2011.37.4223 Coiffier et al. 2012 (GPI-06-0002)] | |[https://doi.org/10.1200/jco.2011.37.4223 Coiffier et al. 2012 (GPI-06-0002)] | ||
|NR | |NR | ||
| − | | style="background-color:#91cf61" |Phase | + | | style="background-color:#91cf61" |Phase 2 (RT) |
| style="background-color:#d3d3d3" | | | style="background-color:#d3d3d3" | | ||
| style="background-color:#4d4d4d; color:white" |ORR: Investigator assessment: 29% <br>Central review: 25% | | style="background-color:#4d4d4d; color:white" |ORR: Investigator assessment: 29% <br>Central review: 25% | ||
Revision as of 17:49, 12 February 2022
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main PTCL page for current regimens.
2 regimens on this page
2 variants on this page
|
Relapsed or Refractory
Romidepsin monotherapy
| back to top |
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Piekarz et al. 2011 (NIH 01-C-0049) | NR | Phase 2 | ORR: 38% (95% CI 24-53) | |
| Coiffier et al. 2012 (GPI-06-0002) | NR | Phase 2 (RT) | ORR: Investigator assessment: 29% Central review: 25% | |
| O'Connor et al. 2019 (LUMIERE) | 2012-2014 | Phase 3 (C) | Alisertib | Did not meet primary endpoints of ORR/PFS |
Note: patients in NIH 01-C-0049 had a median of 3 prior treatments (range 1-11); patients in GPI-06-0002 had a median of 2 prior treatments (range 1-8).
Targeted therapy
- Romidepsin (Istodax) 14 mg/m2 IV over 4 hours once per day on days 1, 8, 15
28-day cycle for up to 6 cycles, with optional extension of treatment for patients with stable disease or response
References
- NIH 01-C-0049: Piekarz RL, Frye R, Prince HM, Kirschbaum MH, Zain J, Allen SL, Jaffe ES, Ling A, Turner M, Peer CJ, Figg WD, Steinberg SM, Smith S, Joske D, Lewis I, Hutchins L, Craig M, Fojo AT, Wright JJ, Bates SE. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011 Jun 2;117(22):5827-34. Epub 2011 Feb 25. link to original article contains verified protocol link to PMC article PubMed NCT00007345
- GPI-06-0002: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. Epub 2012 Jan 23. link to original article contains verified protocol PubMed NCT00426764
- Update: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7(1):11. link to original article link to PMC article PubMed
- Update: Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016 Mar 10;9:22. link to original article link to PMC article PubMed
- LUMIERE: Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. link to original article contains protocol PubMed NCT01482962