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Anticancer Original Research Paper

Ipilimumab in real-world clinical practice: efficacy and safety data from a multicenter observational study

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References

  • Berwick M, Buller DB, Cust A, Gallagher R, Lee TK, Meyskens F, et al. Melanoma epidemiology and prevention. Cancer Treat Res. 2016;167:17–49.10.1007/978-3-319-22539-5
  • Globocan 2012. Estimated cancer incidence, mortality and prevalence worldwide in 2012. [cited 2016 Feb 15]. Available from: http://globocan.iarc.fr
  • Rossi S, Crocetti E, Capocaccia R, Gatta G, AIRTUM Working Group. Estimates of cancer burden in Italy. Tumori. 2013;99(3):416–24.
  • Gasent Blesa JM, Grande Pulido E, Alberola Candel V, Provencio Pulla M. Melanoma: from darkness to promise. Am J Clin Oncol. 2011;34(2):179–87.
  • AIFA website. Determina 6 Febbraio 2013. [cited 2016 Feb 16]. Available from: http://www.agenziafarmaco.gov.it/it/content/arriva-italia-%E2%80%9Cipilimumab%E2%80%9D-il-nuovo-anticorpo-monoclonale-contro-il-melanoma-non-operabile
  • Hodi FS, O’Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. New Engl J Med. 2010;363(8):711–23.10.1056/NEJMoa1003466
  • Weber J. Ipilimumab: controversies in its development, utility and autoimmune adverse events. Cancer Immunol, Immunotherapy: CII. 2009;58(5):823–30.10.1007/s00262-008-0653-8
  • Di Giacomo AM, Biagioli M, Maio M. The emerging toxicity profiles of anti–CTLA-4 antibodies across clinical indications. Semin Oncol. 2010;37(5):499–507. doi:10.1053/j.seminoncol.2010.09.007.
  • Berrocal A, Arance A, Lopez Martin JA, Soriano V, Muñoz E, Alonso L, et al. Ipilimumab for advanced melanoma: experience from the Spanish expanded access program. Melanoma Res. 2014;24(6):577–83.10.1097/CMR.0000000000000108
  • Ascierto PA, Simeone E, Sileni VC, Pigozzo J, Maio M, Altomonte M, et al. Clinical experience with ipilimumab 3 mg/kg: real-world efficacy and safety data from an expanded access programme cohort. J Translational Med. 2014;12:116.10.1186/1479-5876-12-116
  • Ahmad SS, Qian W, Ellis S, Mason E, Khattak MA, Gupta A, et al. Ipilimumab in the real world: the UK expanded access programme experience in previously treated advanced melanoma patients. Melanoma Res. 2015;25(5):432–42.10.1097/CMR.0000000000000185
  • Krajsová I, Arenberger P, Lakomý R, Kubala E, Březinová I, Poprach A, et al. Long-term survival with ipilimumab: experience from a national expanded access program for patients with melanoma. Anticancer Res. 2015;35(11):6303–10.
  • Eigentler TK, Schlaak M, Hassel JC, Loquai C, Stoffels I, Gutzmer R, et al. Effectiveness and tolerability of ipilimumab: experiences from 198 patients included in a named-patient program in various daily-practice settings and multiple institutions. J Immunotherapy 1997/2014;37(7):374–81, Hagerstown, MD.10.1097/CJI.0000000000000046
  • Delyon J, Mateus C, Lefeuvre D, Lanoy E, Zitvogel L, Chaput N, et al. Experience in daily practice with ipilimumab for the treatment of patients with metastatic melanoma: an early increase in lymphocyte and eosinophil counts is associated with improved survival. Ann Oncol. 2013;24(6):1697–703.10.1093/annonc/mdt027
  • Khoja L, Atenafu EG, Ye Q, Gedye C, Chappell M, Hogg D, et al. Real-world efficacy, toxicity and clinical management of ipilimumab treatment in metastatic melanoma. Oncol Lett. 2016 Feb;11(2):1581–5. Epub 2015 Dec 31.
  • Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS. Practical, legal, and ethical issues in expanded access to investigational drugs. New England J Med. 2015;372(3):279–86.
  • Martens A, Wistuba-Hamprecht K, Geukes Foppen M, Yuan J, Postow MA, Wong P, et al. Baseline peripheral blood biomarkers associated with clinical outcome of advanced melanoma patients treated with ipilimumab. Clin Cancer Res. 2016 Jun 15;22(12):2908–18.10.1158/1078-0432.CCR-15-2412
  • Tarhini A. Immune-mediated adverse events associated with ipilimumab ctla-4 blockade therapy: the underlying mechanisms and clinical management. Scientifica (Cairo). 2013;2013:857519.
  • Horvat TZ, Adel NG, Dang TO, Momtaz P, Postow MA, Callahan MK, et al. Immune-related adverse events, need for systemic immunosuppression, and effects on survival and time to treatment failure in patients with melanoma treated with ipilimumab at memorial sloan kettering cancer center. J Clin Oncol. 2015 Oct 1;33(28):3193–8.10.1200/JCO.2015.60.8448
  • Spigel DR. The value of observational cohort studies for cancer drugs. Biotechnol Healthc. 2010;7(2):18–24.
  • Stein A, Petersen V, Schulze M, Seraphin J, Hoeffkes HG, Valdix AR, et al. Bevacizumab plus chemotherapy as first-line treatment for patients with metastatic colorectal cancer: results from a large German community-based observational cohort study. Acta Oncol. 2015 Feb;54(2):171–8.10.3109/0284186X.2014.961649
  • Hurwitz HI, Bekaii-Saab TS, Bendell JC, Cohn AL, Kozloff M, Roach N, et al. Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: final results from the Avastin(®) Registry – Investigation of Effectiveness and Safety (ARIES) observational cohort study. Clin Oncol (R Coll Radiol). 2014 Jun;26(6):323–32.
  • Vici P, Pizzuti L, Natoli C, Moscetti L, Mentuccia L, Vaccaro A, et al. Outcomes of HER2-positive early breast cancer patients in the pre-trastuzumab and trastuzumab eras: a real-world multicenter observational analysis. The RETROHER study. Breast Cancer Res Treat. 2014 Oct;147(3):599–607.10.1007/s10549-014-3133-1
  • Gori S, Inno A, Fiorio E, Foglietta J, Ferro A, Gulisano M, et al. The promher study: an observational italian study on adjuvant therapy for HER2-positive, pT1a-b pN0 breast cancer. PLoS OnE. 2015 Sep 4;10(9):e0136731.10.1371/journal.pone.0136731
  • Robert C, Ribas A, Wolchok JD, Hodi FS, Hamid O, Kefford R, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet. 2014 Sep 20;384(9948):1109–17.10.1016/S0140-6736(14)60958-2
  • Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, et al. Combined Nivolumab and Ipilimumab or Monotherapy in untreated melanoma. N Engl J Med. 2015 Jul 2;373(1):23–34.10.1056/NEJMoa1504030
  • Ribas A, Hamid O, Daud A, Hodi FS, Wolchok JD, Kefford R, et al. Association of pembrolizumab with tumor response and survival among patients with advanced melanoma. JAMA. 2016 Apr 19;315(15):1600–9.10.1001/jama.2016.4059
  • Zaretsky JM, Garcia-Diaz A, Shin DS, Escuin-Ordinas H, Hugo W, Hu-Lieskovan S, et al. Mutations associated with acquired resistance to PD-1 blockade in melanoma. N Engl J Med. 2016 Sep 1;375(9):819–29. Epub 2016 Jul 13.
  • Ascierto PA, Simeone E, Sileni VC, Del Vecchio M, Marchetti P, Cappellini GC, et al. Sequential treatment with ipilimumab and BRAF inhibitors in patients with metastatic melanoma: data from the Italian cohort of the ipilimumab expanded access program. Cancer Invest. 2014 May;32(4):144–9.10.3109/07357907.2014.885984
  • Weber JS, Gibney G, Sullivan RJ, Sosman JA, Slingluff CL Jr, Lawrence DP, et al. Sequential administration of nivolumab and ipilimumab with a planned switch in patients with advanced melanoma (CheckMate 064): an open-label, randomised, phase 2 trial. Lancet Oncol. 2016 Jul;17(7):943–55.10.1016/S1470-2045(16)30126-7
  • Theurich S, Rothschild SI, Hoffmann M, Fabri M, Sommer A, Garcia-Marquez M, et al. Local tumor treatment in combination with systemic ipilimumab immunotherapy prolongs overall survival in patients with advanced malignant melanoma. Cancer Immunol Res. 2016 Sep 2;4(9):744–54.

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