Skip to main content
Erschienen in: Clinical and Translational Oncology 10/2016

22.01.2016 | Research Article

Clinical use of ipilimumab for metastatic melanoma in Spain: towards a more consistent approach

verfasst von: S. Martín-Algarra, L. de la Cruz-Merino, V. Soriano, J. L. Manzano, E. Espinosa

Erschienen in: Clinical and Translational Oncology | Ausgabe 10/2016

Einloggen, um Zugang zu erhalten

Abstract

Introduction

Ipilimumab has been approved in patients with advanced melanoma by different regulatory bodies worldwide, but its use in clinical practice is not fully consistent among oncologists. We have surveyed a representative sample of Spanish medical oncologists on issues related to the use of ipilimumab.

Materials and methods

The survey was based on the Delphi method, where experts respond anonymously to two rounds of a questionnaire. Questionnaire consisted of 42 statements divided among the following eight categories: Pathology and Diagnosis; Patterns of Response; Parameters affecting Treatment Selection; Patient Profile; Sequencing of Treatment; Definition of Long-Term Survivors; Quality of Life; Concept of Immuno-oncology. The experts were asked to rate each statement on a scale of 1–9, where 1 meant “completely disagree” and 9 meant “completely agree”.

Results

Thirty-three oncologists responded to both rounds of the survey (62.3 % of total surveyed). On issues related to pathology and diagnosis, patterns of response, and immuno-oncology, the specialists reached a high level of consensus. There was also a high level of agreement, albeit without consensus on assessment of BRAF mutations before deciding on treatment with ipilimumab. However, there was a lower level of agreement on sequencing treatment with BRAF inhibitors and ipilimumab, on predictive factors, on the use of corticosteroids, and on patient quality of life.

Conclusions

The disparity in many of these topics suggests that oncologists need more information on certain aspects of ipilimumab treatment. We need to define generally accepted algorithms of treatment, especially with regard to issues that were shown to be controversial or unclear.
Literatur
1.
Zurück zum Zitat Garbe C, Peris K, Hauschild A, Saiag P, Middleton M, Spatz A, et al. Diagnosis and treatment of melanoma: European consensus-based interdisciplinary guideline. Eur J Cancer. 2010;46:270–83.CrossRefPubMed Garbe C, Peris K, Hauschild A, Saiag P, Middleton M, Spatz A, et al. Diagnosis and treatment of melanoma: European consensus-based interdisciplinary guideline. Eur J Cancer. 2010;46:270–83.CrossRefPubMed
2.
Zurück zum Zitat Forman D, Bray F, Brewster DH, Gombe Mbalawa C, Kohler B, Piñeros M, Steliarova-Foucher E, Swaminathan R, Ferlay J (eds) (2014) Cancer incidence in five continents, Vol. X. IARC Scientific Publication No. 164. Lyon: International Agency for Research on Cancer. Forman D, Bray F, Brewster DH, Gombe Mbalawa C, Kohler B, Piñeros M, Steliarova-Foucher E, Swaminathan R, Ferlay J (eds) (2014) Cancer incidence in five continents, Vol. X. IARC Scientific Publication No. 164. Lyon: International Agency for Research on Cancer.
3.
Zurück zum Zitat 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;24:577–83.CrossRefPubMedPubMedCentral 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;24:577–83.CrossRefPubMedPubMedCentral
4.
Zurück zum Zitat Hodi FS, O’Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711–23.CrossRefPubMedPubMedCentral Hodi FS, O’Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711–23.CrossRefPubMedPubMedCentral
5.
Zurück zum Zitat Lee SM, Betticher DC, Thatcher N. Melanoma: chemotherapy. Br Med Bull. 1995;51:609–30.PubMed Lee SM, Betticher DC, Thatcher N. Melanoma: chemotherapy. Br Med Bull. 1995;51:609–30.PubMed
6.
Zurück zum Zitat Avril MF, Aamdal S, Grob JJ, Hauschild A, Mohr P, Bonerandi JJ, et al. Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study. J Clin Oncol. 2004;22:1118–25.CrossRefPubMed Avril MF, Aamdal S, Grob JJ, Hauschild A, Mohr P, Bonerandi JJ, et al. Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study. J Clin Oncol. 2004;22:1118–25.CrossRefPubMed
7.
Zurück zum Zitat Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, et al. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999;17:2745–51.PubMed Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, et al. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999;17:2745–51.PubMed
8.
Zurück zum Zitat Middleton MR, Grob JJ, Aaronson N, Fierlbeck G, Tilgen W, Seiter S, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000;18:158–66.PubMed Middleton MR, Grob JJ, Aaronson N, Fierlbeck G, Tilgen W, Seiter S, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000;18:158–66.PubMed
9.
Zurück zum Zitat Atkins MB, Lotze MT, Dutcher JP, Fisher RI, Weiss G, Margolin K, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999;17:2105–16.PubMed Atkins MB, Lotze MT, Dutcher JP, Fisher RI, Weiss G, Margolin K, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999;17:2105–16.PubMed
10.
Zurück zum Zitat Wolchok JD, Weber JS, Hamid O, Lebbé C, Maio M, Schadendorf D, et al. Ipilimumab efficacy and safety in patients with advanced melanoma: a retrospective analysis of HLA subtype from four trials. Cancer Immun. 2010;10:9.PubMedPubMedCentral Wolchok JD, Weber JS, Hamid O, Lebbé C, Maio M, Schadendorf D, et al. Ipilimumab efficacy and safety in patients with advanced melanoma: a retrospective analysis of HLA subtype from four trials. Cancer Immun. 2010;10:9.PubMedPubMedCentral
11.
Zurück zum Zitat 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;32:144–9.CrossRefPubMed 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;32:144–9.CrossRefPubMed
12.
Zurück zum Zitat Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364:2507–16.CrossRefPubMedPubMedCentral Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364:2507–16.CrossRefPubMedPubMedCentral
13.
Zurück zum Zitat Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, et al. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012;380:358–65.CrossRefPubMed Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, et al. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012;380:358–65.CrossRefPubMed
14.
Zurück zum Zitat Flaherty KT, Robert C, Hersey P, Nathan P, Garbe C, Milhem M, et al. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012;367:107–14.CrossRefPubMed Flaherty KT, Robert C, Hersey P, Nathan P, Garbe C, Milhem M, et al. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012;367:107–14.CrossRefPubMed
15.
Zurück zum Zitat Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, et al. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med. 2014;371:1877–88.CrossRefPubMed Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, et al. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med. 2014;371:1877–88.CrossRefPubMed
16.
Zurück zum Zitat Larkin J, Ascierto PA, Dréno B, Atkinson V, Liszkay G, Maio M, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014;371:1867–76.CrossRefPubMed Larkin J, Ascierto PA, Dréno B, Atkinson V, Liszkay G, Maio M, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014;371:1867–76.CrossRefPubMed
17.
Zurück zum Zitat Eggermont A, Robert C, Soria JC, Zitvogel L. Harnessing the immune system to provide long-term survival in patients with melanoma and other solid tumors. Oncoimmunology. 2014;3:e27560.CrossRefPubMedPubMedCentral Eggermont A, Robert C, Soria JC, Zitvogel L. Harnessing the immune system to provide long-term survival in patients with melanoma and other solid tumors. Oncoimmunology. 2014;3:e27560.CrossRefPubMedPubMedCentral
18.
Zurück zum Zitat Luke JJ, Hodi FS. Ipilimumab, vemurafenib, dabrafenib, and trametinib: synergistic competitors in the clinical management of BRAF mutant malignant melanoma. Oncologist. 2013;18:717–25.CrossRefPubMedPubMedCentral Luke JJ, Hodi FS. Ipilimumab, vemurafenib, dabrafenib, and trametinib: synergistic competitors in the clinical management of BRAF mutant malignant melanoma. Oncologist. 2013;18:717–25.CrossRefPubMedPubMedCentral
21.
Zurück zum Zitat Robert C, Thomas L, Bondarenko I, O’Day S, Weber J, Garbe C, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364:2517–26.CrossRefPubMed Robert C, Thomas L, Bondarenko I, O’Day S, Weber J, Garbe C, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364:2517–26.CrossRefPubMed
22.
Zurück zum Zitat Shahabi V, Whitney G, Hamid O, Schmidt H, Chasalow SD, Alaparthy S, et al. Assessment of association between BRAF-V600E mutation status in melanomas and clinical response to ipilimumab. Cancer Immunol Immunother. 2012;61:733–7.CrossRefPubMed Shahabi V, Whitney G, Hamid O, Schmidt H, Chasalow SD, Alaparthy S, et al. Assessment of association between BRAF-V600E mutation status in melanomas and clinical response to ipilimumab. Cancer Immunol Immunother. 2012;61:733–7.CrossRefPubMed
23.
Zurück zum Zitat Linstone HA, Turoff M. Delphi method: techniques and applications. 1975. Linstone HA, Turoff M. Delphi method: techniques and applications. 1975.
24.
Zurück zum Zitat Royle P, Waugh N. Literature searching for clinical and cost-effectiveness studies used in health technology assessment reports carried out for the National Institute for Clinical Excellence appraisal system. Health Technol Assess. 2003; 7: iii, ix–x, 1–51. Royle P, Waugh N. Literature searching for clinical and cost-effectiveness studies used in health technology assessment reports carried out for the National Institute for Clinical Excellence appraisal system. Health Technol Assess. 2003; 7: iii, ix–x, 1–51.
25.
Zurück zum Zitat Martín-Algarra S, Fernández-Figueras MT, López-Martín JA, Santos-Briz A, Arance A, Lozano MD, et al. Guidelines for biomarker testing in metastatic melanoma: a National Consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology. Clin Transl Oncol. 2014;16:362–73.CrossRefPubMed Martín-Algarra S, Fernández-Figueras MT, López-Martín JA, Santos-Briz A, Arance A, Lozano MD, et al. Guidelines for biomarker testing in metastatic melanoma: a National Consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology. Clin Transl Oncol. 2014;16:362–73.CrossRefPubMed
26.
Zurück zum Zitat Weber JS, Amin A, Minor D, Siegel J, Berman D, O’Day SJ. Safety and clinical activity of ipilimumab in melanoma patients with brain metastases: retrospective analysis of data from a phase 2 trial. Melanoma Res. 2011;21:530–4.CrossRefPubMed Weber JS, Amin A, Minor D, Siegel J, Berman D, O’Day SJ. Safety and clinical activity of ipilimumab in melanoma patients with brain metastases: retrospective analysis of data from a phase 2 trial. Melanoma Res. 2011;21:530–4.CrossRefPubMed
27.
Zurück zum Zitat Dummer R, Hauschild A, Guggenheim M, Keilholz U, Pentheroudakis G. Cutaneous melanoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012; 23(Suppl 7): vii86–vii91. Dummer R, Hauschild A, Guggenheim M, Keilholz U, Pentheroudakis G. Cutaneous melanoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012; 23(Suppl 7): vii86–vii91.
28.
Zurück zum Zitat Kaufman HL, Kirkwood JM, Hodi FS, Agarwala S, Amatruda T, Bines SD, et al. The Society for Immunotherapy of Cancer consensus statement on tumour immunotherapy for the treatment of cutaneous melanoma. Nat Rev Clin Oncol. 2013;10:588–98.CrossRefPubMed Kaufman HL, Kirkwood JM, Hodi FS, Agarwala S, Amatruda T, Bines SD, et al. The Society for Immunotherapy of Cancer consensus statement on tumour immunotherapy for the treatment of cutaneous melanoma. Nat Rev Clin Oncol. 2013;10:588–98.CrossRefPubMed
29.
Zurück zum Zitat Ackerman A, Klein O, McDermott DF, Wang W, Ibrahim N, Lawrence DP, et al. Outcomes of patients with metastatic melanoma treated with immunotherapy prior to or after BRAF inhibitors. Cancer. 2014;120:1695–701.CrossRefPubMed Ackerman A, Klein O, McDermott DF, Wang W, Ibrahim N, Lawrence DP, et al. Outcomes of patients with metastatic melanoma treated with immunotherapy prior to or after BRAF inhibitors. Cancer. 2014;120:1695–701.CrossRefPubMed
30.
Zurück zum Zitat Revicki DA, van den Eertwegh AJ, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, et al. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes. 2012;10:66.CrossRefPubMedPubMedCentral Revicki DA, van den Eertwegh AJ, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, et al. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes. 2012;10:66.CrossRefPubMedPubMedCentral
Metadaten
Titel
Clinical use of ipilimumab for metastatic melanoma in Spain: towards a more consistent approach
verfasst von
S. Martín-Algarra
L. de la Cruz-Merino
V. Soriano
J. L. Manzano
E. Espinosa
Publikationsdatum
22.01.2016
Verlag
Springer International Publishing
Erschienen in
Clinical and Translational Oncology / Ausgabe 10/2016
Print ISSN: 1699-048X
Elektronische ISSN: 1699-3055
DOI
https://doi.org/10.1007/s12094-016-1484-2

Weitere Artikel der Ausgabe 10/2016

Clinical and Translational Oncology 10/2016 Zur Ausgabe

Adjuvante Immuntherapie verlängert Leben bei RCC

25.04.2024 Nierenkarzinom Nachrichten

Nun gibt es auch Resultate zum Gesamtüberleben: Eine adjuvante Pembrolizumab-Therapie konnte in einer Phase-3-Studie das Leben von Menschen mit Nierenzellkarzinom deutlich verlängern. Die Sterberate war im Vergleich zu Placebo um 38% geringer.

Alectinib verbessert krankheitsfreies Überleben bei ALK-positivem NSCLC

25.04.2024 NSCLC Nachrichten

Das Risiko für Rezidiv oder Tod von Patienten und Patientinnen mit reseziertem ALK-positivem NSCLC ist unter einer adjuvanten Therapie mit dem Tyrosinkinase-Inhibitor Alectinib signifikant geringer als unter platinbasierter Chemotherapie.

Bei Senioren mit Prostatakarzinom auf Anämie achten!

24.04.2024 DGIM 2024 Nachrichten

Patienten, die zur Behandlung ihres Prostatakarzinoms eine Androgendeprivationstherapie erhalten, entwickeln nicht selten eine Anämie. Wer ältere Patienten internistisch mitbetreut, sollte auf diese Nebenwirkung achten.

ICI-Therapie in der Schwangerschaft wird gut toleriert

Müssen sich Schwangere einer Krebstherapie unterziehen, rufen Immuncheckpointinhibitoren offenbar nicht mehr unerwünschte Wirkungen hervor als andere Mittel gegen Krebs.

Update Onkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.