Difference between revisions of "Cutaneous T-cell lymphoma"
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===Regimen {{#subobject:67ef8a|Variant=1}}=== | ===Regimen {{#subobject:67ef8a|Variant=1}}=== | ||
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|[http://jco.ascopubs.org/content/19/9/2456.long Duvic et al. 2001a] | |[http://jco.ascopubs.org/content/19/9/2456.long Duvic et al. 2001a] | ||
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===Regimen {{#subobject:34eb6|Variant=1}}=== | ===Regimen {{#subobject:34eb6|Variant=1}}=== | ||
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5089160/ Kim et al. 2015] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5089160/ Kim et al. 2015] | ||
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===Regimen {{#subobject:4e103c|Variant=1}}=== | ===Regimen {{#subobject:4e103c|Variant=1}}=== | ||
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|[http://jco.ascopubs.org/content/19/2/376.long Olsen et al. 2001 (L4389-10)] | |[http://jco.ascopubs.org/content/19/2/376.long Olsen et al. 2001 (L4389-10)] | ||
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===Regimen {{#subobject:dfe411|Variant=1}}=== | ===Regimen {{#subobject:dfe411|Variant=1}}=== | ||
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|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31266-7/fulltext Prince et al. 2017 (ALCANZA)] | |[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31266-7/fulltext Prince et al. 2017 (ALCANZA)] |
Revision as of 03:23, 19 August 2018
16 regimens on this page
19 variants on this page
|
Guidelines
NCCN
Relapsed or refractory
Alemtuzumab monotherapy
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Regimen
Study | Evidence | Efficacy |
---|---|---|
Lundin et al. 2003 | Phase II | ORR: 55% |
Chemotherapy
- Alemtuzumab (Campath) as follows:
- 3 mg IV once on day 1, then
- Increased to 10 mg IV once as soon as infusion-related reactions tolerated, then
- Increased to 30 mg IV once as soon as infusion-related reactions tolerated, then
- 30 mg IV 3 days per week
Up to 12 weeks of therapy
References
- Lundin J, Hagberg H, Repp R, Cavallin-Ståhl E, Fredén S, Juliusson G, Rosenblad E, Tjønnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. Epub 2003 Jan 23. link to original article contains protocol PubMed
Belinostat monotherapy
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Regimen
Study | Evidence | Efficacy |
---|---|---|
Foss et al. 2014 | Phase II | ORR: 14% |
Chemotherapy
- Belinostat (Beleodaq) 1000 mg/m2 IV over 30 minutes once per day on days 1 to 5
21-day cycles
References
- Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. link to original article contains protocol PubMed
Bendamustine monotherapy
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Regimen
Study | Evidence | Efficacy |
---|---|---|
Demaj et al. 2013 (BENTLY) | Phase II | ORR: 50% |
Chemotherapy
Note: these infusion instructions are for the Treanda formulation, which was discontinued on 3/31/2016.
- Bendamustine 120 mg/m2 IV over 30 to 60 minutes once per day on days 1 & 2
21-day cycle for 6 cycles
References
- BENTLY: Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. link to original article contains verified protocol PubMed
Bexarotene monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Duvic et al. 2001a | Phase II | ORR: 55% | |
Duvic et al. 2001b | Phase II/III | Bexarotene 6.5 mg/m2/d | Superior ORR |
Prince et al. 2017 (ALCANZA) | Phase III (C) | Brentuximab vedotin | Inferior OGRR at 4 months |
This dose is considered the optimal starting dose by Duvic et al. 2001a and the target dose in ALCANZA.
Chemotherapy
- Bexarotene (Targretin) 300 mg/m2 PO once per day
48-week course in ALCANZA; duration not specified in Duvic et al. 2001a but presumptively until progression or intolerance
References
- Duvic M, Hymes K, Heald P, Breneman D, Martin AG, Myskowski P, Crowley C, Yocum RC; Bexarotene Worldwide Study Group. Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results. J Clin Oncol. 2001 May 1;19(9):2456-71. link to original article contains verified protocol PubMed
- Duvic M, Martin AG, Kim Y, Olsen E, Wood GS, Crowley CA, Yocum RC; Worldwide Bexarotene Study Group. Phase 2 and 3 clinical trial of oral bexarotene (Targretin capsules) for the treatment of refractory or persistent early-stage cutaneous T-cell lymphoma. Arch Dermatol. 2001 May;137(5):581-93. link to original article contains verified protocol PubMed
- ALCANZA: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. link to original article contains verified protocol PubMed
Bexarotene & Pralatrexate
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Regimen
Study | Evidence | Efficacy |
---|---|---|
Duvic et al. 2017 | Phase I/II | ORR: 60% |
This dose is the MTD. Note that the abstract contains a typo for bexarotene dosing; the authors have been contacted.
Chemotherapy
- Bexarotene (Targretin) 150 mg/m2 PO once per day
- Pralatrexate (Folotyn) 15 mg/m2 IV once per day on days 1, 8, 15
28-day cycles
References
- Duvic M, Kim YH, Zinzani PL, Horwitz SM. Results from a phase I/II open-label, dose-finding study of pralatrexate and oral bexarotene in patients with relapsed/refractory cutaneous T-cell lymphoma. Clin Cancer Res. 2017 Jul;23(14):3552-6. Epub 2017 Feb 6. link to original article contains verified protocol link to PMC article PubMed
Brentuximab vedotin monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Kim et al. 2015 | Phase II | OGRR: 70% (90% CI, 53-83) | |
Duvic et al. 2015 | Phase II | ORR: 73% (95% CI, 60-86) | |
Prince et al. 2017 (ALCANZA) | Phase III (E) | Investigator's choice: Bexarotene Methotrexate |
Superior OGRR at 4 months |
Chemotherapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV over 30 minutes once on day 1
21-day cycle for up to 16 cycles
References
- Kim YH, Tavallaee M, Sundram U, Salva KA, Wood GS, Li S, Rozati S, Nagpal S, Krathen M, Reddy S, Hoppe RT, Nguyen-Lin A, Weng WK, Armstrong R, Pulitzer M, Advani RH, Horwitz SM. Phase II investigator-initiated study of brentuximab vedotin in mycosis fungoides and Sézary syndrome with variable CD30 expression level: A multi-institution collaborative project. J Clin Oncol. 2015 Nov 10;33(32):3750-8. Epub 2015 Jul 20. link to original article contains verified protocol link to PMC article PubMed
- Duvic M, Tetzlaff MT, Gangar P, Clos AL, Sui D, Talpur R. Results of a phase II trial of brentuximab vedotin for CD30+ cutaneous T-cell lymphoma and lymphomatoid papulosis. J Clin Oncol. 2015 Nov 10;33(32):3759-65. Epub 2015 Aug 10. link to original article contains verified protocol link to PMC article PubMed
- ALCANZA: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. link to original article contains verified protocol PubMed
Denileukin diftitox monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Olsen et al. 2001 (L4389-10) | Phase III (E) | Alternate dosing (9 mcg/kg) | Seems not superior |
Prince et al. 2010 (L4389-11) | Phase III (E) | Alternate dosing (9 mcg/kg) | Superior ORR |
Placebo | Superior PFS |
Dose is that which was recommended in L4389-11 based on superior response.
Chemotherapy
- Denileukin diftitox (Ontak) 18 mcg/kg IV over 15 to 60 minutes once per day on days 1 to 5
Supportive medications
- "Premedication with Acetaminophen (Tylenol) (650 mg in Olsen et al. 2001) and an antihistamine was required 30 to 60 minutes before each infusion" and could be used after infusions as needed.
- Olsen et al. 2001 used Promethazine (Phenergan) 25 mg or Prochlorperazine (Compazine) 10 mg (route/schedule not specified) as needed for nausea.
- Corticosteroid use was not allowed.
21-day cycles for up to 8 cycles
Up to 3 additional cycles allowed in L4389-10 for patients who had ongoing response.
References
- L4389-10: Olsen E, Duvic M, Frankel A, Kim Y, Martin A, Vonderheid E, Jegasothy B, Wood G, Gordon M, Heald P, Oseroff A, Pinter-Brown L, Bowen G, Kuzel T, Fivenson D, Foss F, Glode M, Molina A, Knobler E, Stewart S, Cooper K, Stevens S, Craig F, Reuben J, Bacha P, Nichols J. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J Clin Oncol. 2001 Jan 15;19(2):376-88. link to original article contains verified protocol PubMed
- L4389-11: Prince HM, Duvic M, Martin A, Sterry W, Assaf C, Sun Y, Straus D, Acosta M, Negro-Vilar A. Phase III placebo-controlled trial of denileukin diftitox for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2010 Apr 10;28(11):1870-7. Epub 2010 Mar 8. link to original article contains verified protocol PubMed
- Meta-analysis: Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. Epub 2013 Jun 14. link to original article PubMed
Lenalidomide monotherapy
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Regimen
Study | Evidence | Efficacy |
---|---|---|
Querfeld et al. 2013 | Phase II | ORR: 28% |
Chemotherapy
- Lenalidomide (Revlimid) 10 mg PO once per day on days 1 to 21
- Dose increased by 5 mg per day with each cycle to a maximum of 25 mg PO once per day, as tolerated
28-day cycle for up to 2 years or until disease progression
References
- Querfeld C, Rosen ST, Guitart J, Duvic M, Kim YH, Dusza SW, Kuzel TM. Results of an open-label multicenter phase II trial of lenalidomide monotherapy in refractory mycosis fungoides and Sezary syndrome. Blood. 2014 Feb 20;123(8):1159-66. Epub 2013 Dec 11. link to original article contains verified protocol PubMed
Methotrexate monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Prince et al. 2017 (ALCANZA) | Phase III (C) | Brentuximab vedotin | Inferior OGRR at 4 months |
Chemotherapy
- Methotrexate (MTX) 5 to 50 mg PO once per week
48-week course
References
- Retrospective: Zackheim HS, Kashani-Sabet M, McMillan A. Low-dose methotrexate to treat mycosis fungoides: a retrospective study in 69 patients. J Am Acad Dermatol. 2003 Nov;49(5):873-8. link to original article PubMed
- ALCANZA: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. link to original article contains verified protocol PubMed
Mogamulizumab monotherapy
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Variant #1, 8-week course
Study | Evidence |
---|---|
Ogura et al. 2014 (KW-0761-001) | Phase II |
Chemotherapy
- Mogamulizumab (Poteligeo) 1 mg/kg IV once per week
8-week course
Variant #2, indefinite
Study | Evidence |
---|---|
Duvic et al. 2015 (KW-0761-001) | Phase I/II |
Chemotherapy
- Mogamulizumab (Poteligeo) as follows:
- Weeks 1 to 6: 1 mg/kg IV once per week in weeks 1 to 4
- Week 7 onwards: 1 mg/kg IV once every other week
Continued indefinitely
References
- KW-0761-004: Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. Epub 2014 Mar 10. link to original article contains protocol PubMed
- KW-0761-001: Duvic M, Pinter-Brown LC, Foss FM, Sokol L, Jorgensen JL, Challagundla P, Dwyer KM, Zhang X, Kurman MR, Ballerini R, Liu L, Kim YH. Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma. Blood. 2015 Mar 19;125(12):1883-9. Epub 2015 Jan 20. link to original article contains protocol PubMed
Pralatrexate monotherapy
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Regimen
Study | Evidence | Efficacy |
---|---|---|
Horwitz et al. 2012 | Phase II | RR: 45% |
Dose is that identified as recommended based on de-escalation strategy.
Chemotherapy
- Pralatrexate (Folotyn) 15 mg/m2 IV push once per day on days 1, 8, 15
Supportive medications
- Cyanocobalamin (Vitamin B12) 1 mg IM once every 8 to 10 weeks, within 10 weeks of treatment initiation
- Folic acid (Folate) 1 mg PO once per day, starting at least 10 days prior to treatment initiation
28-day cycles
References
- Horwitz SM, Kim YH, Foss F, Zain JM, Myskowski PL, Lechowicz MJ, Fisher DC, Shustov AR, Bartlett NL, Delioukina ML, Koutsoukos T, Saunders ME, O'Connor OA, Duvic M. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood. 2012 May 3;119(18):4115-22. Epub 2012 Mar 6. link to original article contains verified protocol PubMed
Romidepsin monotherapy
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Regimen
Study | Evidence | Efficacy |
---|---|---|
Piekarz et al. 2009 | Phase II | ORR: 34% (95% CI, 23-46) |
Whittaker et al. 2010 (GPI-04-0001) | Phase II | ORR: 34% (95% CI, 25-45) |
Chemotherapy
- 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
- Piekarz RL, Frye R, Turner M, Wright JJ, Allen SL, Kirschbaum MH, Zain J, Prince HM, Leonard JP, Geskin LJ, Reeder C, Joske D, Figg WD, Gardner ER, Steinberg SM, Jaffe ES, Stetler-Stevenson M, Lade S, Fojo AT, Bates SE. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2009 Nov 10;27(32):5410-7. Epub 2009 Oct 13. link to original article contains verified protocol link to PMC article PubMed
- GPI-04-0001: Whittaker SJ, Demierre MF, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T, Becker JC, Samtsov A, McCulloch W, Kim YH. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol. 2010 Oct 10;28(29):4485-91. Epub 2010 Aug 9. link to original article contains verified protocol PubMed
Vorinostat monotherapy
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Regimen
FDA-recommended dose |
Study | Evidence | Efficacy |
---|---|---|
Duvic et al. 2006 | Phase IIa | ORR: 24% |
Olsen et al. 2007 | Phase IIb | ORR: 30% |
Note: Duvic et al. 2006 evaluated several different doses, but this is the one that "had the most favorable safety profile".
Chemotherapy
- Vorinostat (Zolinza) 400 mg PO once per day
Continued indefinitely
References
- Duvic M, Talpur R, Ni X, Zhang C, Hazarika P, Kelly C, Chiao JH, Reilly JF, Ricker JL, Richon VM, Frankel SR. Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL). Blood. 2007 Jan 1;109(1):31-9. Epub 2006 Sep 7. Erratum in: Blood. 2007 Jun 15;109(12):5086. link to original article link to PMC article contains protocol PubMed
- Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. link to original article contains verified protocol PubMed
- Update: Duvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, Geskin LJ. Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma. Clin Lymphoma Myeloma. 2009 Dec;9(6):412-6. link to SD article PubMed
Relapsed or refractory, subsequent lines of treatment
Denileukin diftitox monotherapy
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Regimen
Study | Evidence |
---|---|
Duvic et al. 2012 | Non-randomized |
Chemotherapy
- Denileukin diftitox (Ontak) 18 mcg/kg IV once per day on days 1 to 5
21-day cycle for up to 8 cycles
References
- Duvic M, Martin AG, Olsen EA, Fivenson DP, Prince HM. Efficacy and safety of denileukin diftitox retreatment in patients with relapsed cutaneous T-cell lymphoma. Leuk Lymphoma. 2013 Mar;54(3):514-9. Epub 2012 Sep 3. link to original article contains protocol PubMed