Durable responses and reversible toxicity of high-dose interleukin-2 treatment of melanoma and renal cancer in a Community Hospital Biotherapy Program

Journal for ImmunoTherapy of Cancer

Volumn 2, Issue 1, 2014, Pages

  Payne, Roxanne ^a   Glenn, Lyn ^a   Hoen, Helena ^a   Richards, Beverley ^a   Smith, John W ^b   Lufkin, Robert ^b   Crocenzi, Todd S ^a   Urba, Walter J ^a   Curti, Brendan D ^a  

^a PROVIDENCE PORTLAND MEDICAL CENTER   (United States)

^b Compass Oncology ^*  (United States)

Author keywords

Interleukin 2; Melanoma; Renal cancer

Indexed keywords

INTERLEUKIN 2; IPILIMUMAB; PHENYLEPHRINE; VEMURAFENIB;

ADULT; AGED; ARTICLE; CANCER GROWTH; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; FEMALE; HUMAN; INCIDENCE; KIDNEY METASTASIS; MAJOR CLINICAL STUDY; MALE; MELANOMA; METABOLIC ACIDOSIS; OVERALL SURVIVAL; PRIORITY JOURNAL; RETROSPECTIVE STUDY;

EID: 84977118146     PISSN: None     EISSN: 20511426     Source Type: Journal    
DOI: 10.1186/2051-1426-2-13     Document Type: Article

References (33)

1. Siegel R, Naishadham D, Jemal A. Cancer statistics. CA Cancer J Clin 2013, 63:11-30. 10.3322/caac.21166, 23335087.
2. Hodi FS, O'Day SJ, McDermott DF, Weber J, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbé C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010, 363:711-723. 10.1056/NEJMoa1003466, 3549297, 20525992.
3. Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011, 364:2517-2526. 10.1056/NEJMoa1104621, 21639810.
4. Schadendorf D, Hodi FS, Roberts C, Weber JS, Margolin K, Hamid O, Chen TT, Berman DM, Wolchok JD. Pooled analysis of long-term survival data from phase II and phase III trials of ipilimumab in metastatic or locally advanced, unresectable melanoma. European Cancer Congress 2013, LBA24.
5. Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, Segal NH, Ariyan CE, Gordon RA, Reed K, Burke MM, Caldwell A, Kronenberg SA, Agunwamba BU, Zhang X, Lowy I, Inzunza HD, Feely W, Horak CE, Hong Q, Korman AJ, Wigginton JM, Gupta A, Sznol M. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 2013, 369:122-133. 10.1056/NEJMoa1302369, 23724867.
6. Flaherty KT, Puzanov I, Kim KB, Ribas A, McArthur GA, Sosman JA, O'Dwyer PJ, Lee RJ, Grippo JF, Nolop K, Chapman PB. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med 2010, 363:809-819. 10.1056/NEJMoa1002011, 3724529, 20818844.
7. Sosman JA, Kim KB, Schuchter L, Gonzalez R, Pavlick AC, Weber JS, McArthur GA, Hutson TE, Moschos SJ, Flaherty KT, Hersey P, Kefford R, Lawrence D, Puzanov I, Lewis KD, Amaravadi RK, Chmielowski B, Lawrence HJ, Shyr Y, Ye F, Li J, Nolop KB, Lee RJ, Joe AK, Ribas A. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. N Engl J Med 2012, 366:707-714. 10.1056/NEJMoa1112302, 3724515, 22356324.
8. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007, 356:115-124. 10.1056/NEJMoa065044, 17215529.
9. Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grunwald V, Thompson JA, Figlin RA, Hollaender N, Kay A, Ravaud A, . RECORD-1 Study Group Phase 3 trial of everolimus for metastatic renal cell carcinoma : final results and analysis of prognostic factors. Cancer 2010, 116:4256-4265. 10.1002/cncr.25219, 20549832, RECORD-1 Study Group.
10. Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarbá JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010, 28:1061-1068. 10.1200/JCO.2009.23.9764, 20100962.
11. Rini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Archer L, Atkins JN, Picus J, Czaykowski P, Dutcher J, Small EJ. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol 2010, 28:2137-2143. 10.1200/JCO.2009.26.5561, 2860433, 20368558.
12. Motzer RJ, Escudier B, Tomczak P, Hutson TE, Michaelson MD, Negrier S, Oudard S, Gore ME, Tarazi J, Hariharan S, Chen C, Rosbrook B, Kim S, Rini BI. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial. Lancet Oncol 2013, 14:552-562. 10.1016/S1470-2045(13)70093-7, 23598172.
13. Rosenberg SA. Interleukin-2 and the development of immunotherapy for the treatment of patients with cancer. Cancer J Sci Am 2000, 6(Suppl 1):S2-S7.
14. Margolin KA, Rayner AA, Hawkins MJ, Atkins MB, Dutcher JP, Fisher RI, Weiss GR, Doroshow JH, Jaffe HS, Roper M. Interleukin-2 and lymphokine-activated killer cell therapy of solid tumors: analysis of toxicity and management guidelines. J Clin Oncol 1989, 7:486-498.
15. Ochoa JB, Curti B, Peitzman AB, Simmons RL, Billiar TR, Hoffman R, Rault R, Longo DL, Urba WJ, Ochoa AC. Increased circulating nitrogen oxides after human tumor immunotherapy: correlation with toxic hemodynamic changes. J Natl Cancer Inst 1992, 84:864-867. 10.1093/jnci/84.11.864, 1375656.
16. Kaufman HL, Kirkwood JM, Hodi FS, Agarwala S, Amatruda T, Bines SD, Clark JI, Curti B, Ernstoff MS, Gajewski T, Gonzalez R, Hyde LJ, Lawson D, Lotze M, Lutzky J, Margolin K, McDermott DF, Morton D, Pavlick A, Richards JM, Sharfman W, Sondak VK, Sosman J, Steel S, Tarhini A, Thompson JA, Titze J, Urba W, White R, Atkins MB. The Society for Immunotherapy of Cancer consensus statement on tumour immunotherapy for the treatment of cutaneous melanoma. Nat Rev Clin Oncol 2013, 10:588-598. 10.1038/nrclinonc.2013.153, 23982524.
17. Curti BD, Urba WJ. Integrating new therapies in the treatment of advanced melanoma. Curr Treat Options Oncol 2012, 13:327-339. 10.1007/s11864-012-0201-9, 22743761.
18. Motzer RJ, Agarwal N, Beard C, Bolger GB, Boston B, Carducci MA, Choueiri TK, Figlin RA, Fishman M, Hancock SL, Hudes GR, Jonasch E, Kessinger A, Kuzel TM, Lange PH, Levine EG, Margolin KA, Michaelson MD, Olencki T, Pili R, Redman BG, Robertson CN, Schwartz LH, Sheinfeld J, Wang J. NCCN clinical practice guidelines in oncology: kidney cancer. J Natl Compr Canc Netw 2009, 7:618-630.
19. Trzeciak S, Dellinger RP, Parrillo JE. Septic Shock. Critical Care Medicine, Principles of Diagnosis and Management in the Adult 2008, 439. Philadelphia: Mosby Elsevier, Parrillo JE, Dellinger RP.
20. Curti BD, Longo DL, Ochoa AC, Conlon KC, Smith JW, Alvord WG, Creekmore SP, Fenton RG, Gause BL, Holmlund J. Treatment of cancer patients with ex vivo anti-CD3-activated killer cells and interleukin-2. J Clin Oncol 1993, 11:652-660.
21. Royal RE, Steinberg SM, Krouse RS, Heywood G, White DE, Hwu P, Marincola FM, Parkinson DR, Schwartzentruber DJ, Topalian SL, Yang JC, Rosenberg SA. Correlates of response to IL-2 therapy in patients treated for metastatic renal cancer and melanoma. Cancer J Sci Am 1996, 2:91-98.
22. Fisher RI, Rosenberg SA, Fyfe G. Long-term survival update for high-dose recombinant interleukin-2 in patients with renal cell carcinoma. Cancer J Sci Am 2000, 6(Suppl 1):S55-S57.
23. Atkins MB, Kunkel L, Sznol M, Rosenberg SA. High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: long-term survival update. Cancer J Sci Am 2000, 6(Suppl 1):S11-S14.
24. McDermott D, Haanen J, Chen TT, Lorigan P, O'Day S, . MDX010-20 Investigators Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20). Ann Oncol 2013, 24:2694-2698. 10.1093/annonc/mdt291, 23942774, MDX010-20 Investigators.
25. Motzer RJ, Hutson TE, Cella D, Reeves J, Hawkins R, Guo J, Nathan P, Staehler M, de Souza P, Merchan JR, Boleti E, Fife K, Jin J, Jones R, Uemura H, De Giorgi U, Harmenberg U, Wang J, Sternberg CN, Deen K, McCann L, Hackshaw MD, Crescenzo R, Pandite LN, Choueiri TK. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med 2013, 369:722-731. 10.1056/NEJMoa1303989, 23964934.
26. White RL, Schwartzentruber DJ, Guleria A, MacFarlane MP, White DE, Tucker E, Rosenberg SA. Cardiopulmonary toxicity of treatment with high dose interleukin-2 in 199 consecutive patients with metastatic melanoma or renal cell carcinoma. Cancer 1994, 74:3212-3222. 10.1002/1097-0142(19941215)74:12<3212::AID-CNCR2820741221>3.0.CO;2-I, 7982185.
27. Cho DC, Puzanov I, Regan MM, Schwartzberg T, Seery V, Lee MY, Liu V, Bhatt R, Koon H, Mier JW, Sosman JA, Atkins MB, McDermott DF. Retrospective analysis of the safety and efficacy of Interleukin-2 after prior VEGF-targeted therapy in patients with advanced renal cell carcinoma. J Immunother 2009, 32:181-185. 10.1097/CJI.0b013e3181952b1d, 19238017.
28. Beale RJ, Hollenberg SM, Vincent JL, Parrillo JE. Vasopressor and inotropic support in septic shock: an evidence-based review. Crit Care Med 2004, 32:S455-S465. 10.1097/01.CCM.0000142909.86238.B1, 15542956.
29. Flancbaum L, Dick M, Dasta J, Sinha R, Choban P. A dose-response study of phenylephrine in critically ill, septic surgical patients. Eur J Clin Pharmacol 1997, 51:461-465. 10.1007/s002280050231, 9112060.
30. Klapper JA, Downey SG, Smith FO, Yang JC, Hughes MS, Kammula US, Sherry RM, Royal RE, Steinberg SM, Rosenberg S. High-dose interleukin-2 for the treatment of metastatic renal cell carcinoma: a retrospective analysis of response and survival in patients treated in the surgery branch at the National Cancer Institute between 1986 and 2006. Cancer 2008, 113:293-301. 10.1002/cncr.23552, 3486432, 18457330.
31. Gitlitz BJ, Hoffman DM, Moldawer N, Belldegrun A, Figlin RA. Treatment of metastatic renal cell carcinoma with high-dose bolus interleukin-2 in a non-intensive care unit: an analysis of 124 consecutively treated patients. Cancer J 2001, 7:112-120.
32. Schwartzentruber DJ. Guidelines for the safe administration of high-dose interleukin-2. J Immunother 2001, 24:287-293. 10.1097/00002371-200107000-00004, 11565830.
33. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45:228-247. 10.1016/j.ejca.2008.10.026, 19097774.