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2023 | OriginalPaper | Buchkapitel

5. Hämatologische Neoplasien und solide Tumore

verfasst von : Prof. Dr. med. Wolf-Dieter Ludwig, Prof. Dr. med. Arnold Ganser, Prof. Dr. med. Georg Maschmeyer

Erschienen in: Arzneiverordnungs-Report 2023

Verlag: Springer Berlin Heidelberg

Zusammenfassung

Auf einen Blick

Verordnungsprofil Das höchste Verordnungsvolumen unter den Onkologika haben erstmals in 2022 die monoklonalen Antikörper (30 %), gefolgt von den Hormonantagonisten zur Behandlung des Mammakarzinoms und des Prostatakarzinoms, auf die 25 % der definierten Tagesdosen (DDD) entfallen (Tab. 5.1). An dritter Stelle stehen die klassischen Zytostatika (22 %) mit der führenden Gruppe der Antimetabolite, was vor allem auf den häufigen Verordnungen von 5-Fluorouracil beruht. Als nächste Gruppen folgen Proteinkinaseinhibitoren, deren Verordnungsvolumen erneut leicht um 8,3 % gegenüber 2021 zugenommen hat. Führende Gruppe der monoklonalen Antikörper sind erneut Antikörper gegen PD-1-Rezeptoren und PD-L1-Liganden, die für ein stetig wachsendes Spektrum von onkologischen Indikationen zugelassen sind, gefolgt von HER2-Antikörpern zur Behandlung des HER2-positiven Mammakarzinoms. Die inzwischen verfügbaren 4 Biosimilars zu Trastuzumab übertreffen wie auch bereits in 2021 deutlich das Verordnungsvolumen des Originalpräparats (Herceptin). Führende Vertreter der Proteinkinaseinhibitoren hinsichtlich ihres Verordnungsvolumens sind die CDK-Inhibitoren für die Behandlung des hormonrezeptorpositiven, fortgeschrittenen Mammakarzinoms (4,2 Mio. DDD), gefolgt gleichauf (jeweils 3,5 Mio. DDD) von den BCR-ABL-Tyrosinkinaseinhibitoren zur Behandlung der chronischen myeloischen Leukämie sowie die Rezeptor-Tyrosinkinaseinhibitoren zur Behandlung u. a. des nicht-kleinzelligen Lungenkarzinoms, des Nierenzellkarzinoms, von gynäkologischen Tumoren (Mamma- bzw. Ovarialkarzinom) und Weichteilsarkomen, aber auch von nicht malignen Erkrankungen (z. B. idiopathische Lungenfibrose, interstitielle Lungenerkrankung). Einen Anstieg der Verordnungen zeigen auch die Bruton-Tyrosinkinaseinhibitoren, insbesondere Acalabrutinib zur Behandlung der chronischen lymphatischen Leukämie bzw. niedrig-maligner Lymphome (z. B. M. Waldenström), der Januskinaseinhibitor Ruxolitinib, die BRAF-/MEK-/, ALK- sowie die PARP-Inhibitoren sowie der BCL-2 Inhibitor Venclyxto. Weitere Proteinkinaseinhibitoren werden eingesetzt vor allem zur Behandlung der primären Myelofibrose (MF) und der nach Polycythämia Vera bzw. Essenzieller Thrombozythämie auftretenden MF.
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Zurück zum Zitat Ferris RL, Blumenschein G Jr, Fayette J (2018) Nivolumab vs investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression. Oral Oncol 81:45–51PubMedPubMedCentralCrossRef Ferris RL, Blumenschein G Jr, Fayette J (2018) Nivolumab vs investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression. Oral Oncol 81:45–51PubMedPubMedCentralCrossRef
Zurück zum Zitat Finn RS, Martin M, Rugo HS et al (2016) Palbociclib and letrozole in advanced breast cancer. N Engl J Med 375:1925–1936PubMedCrossRef Finn RS, Martin M, Rugo HS et al (2016) Palbociclib and letrozole in advanced breast cancer. N Engl J Med 375:1925–1936PubMedCrossRef
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Zurück zum Zitat Franzen N, Romagnoli G, Ziegler A et al (2022) Improving the affordability of anticancer medicines demand evidence-based solutions. Cancer Discov 12:299–302PubMedCrossRef Franzen N, Romagnoli G, Ziegler A et al (2022) Improving the affordability of anticancer medicines demand evidence-based solutions. Cancer Discov 12:299–302PubMedCrossRef
Zurück zum Zitat Gainor JF, Curigliano G, Kim DW et al (2021) Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol 22:959–969PubMedCrossRef Gainor JF, Curigliano G, Kim DW et al (2021) Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol 22:959–969PubMedCrossRef
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Zurück zum Zitat Gisslinger H, Klade C, Georgiev P et al (2020) Ropeginterferon alfa 2-b versus standard therapy for plycythemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study. Lancet Haematol 7:e196–e208PubMedCrossRef Gisslinger H, Klade C, Georgiev P et al (2020) Ropeginterferon alfa 2-b versus standard therapy for plycythemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study. Lancet Haematol 7:e196–e208PubMedCrossRef
Zurück zum Zitat Goldman JW, Dvorkin M, Chen Y et al (2021) Durvalumab, with or without tremelimumab, plus platinum-etoposide vs platinum-etoposide alone in first-line treatment of extensive-stage SCLC (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol 22:51–65PubMedCrossRef Goldman JW, Dvorkin M, Chen Y et al (2021) Durvalumab, with or without tremelimumab, plus platinum-etoposide vs platinum-etoposide alone in first-line treatment of extensive-stage SCLC (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol 22:51–65PubMedCrossRef
Zurück zum Zitat Goldschmidt H, Ashcroft J, Szabo Z et al (2019) Navigating the treatment landscape in multiple myeloma: which combinations to use and when? Ann Hematol 98:1–18PubMedCrossRef Goldschmidt H, Ashcroft J, Szabo Z et al (2019) Navigating the treatment landscape in multiple myeloma: which combinations to use and when? Ann Hematol 98:1–18PubMedCrossRef
Zurück zum Zitat Goss GD, Cobo M, Lu S et al (2021) Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung: Final analysis of the randomised phase 3 LUX-Lung 8 trial. EClinicalMedicine 37:100940PubMedPubMedCentralCrossRef Goss GD, Cobo M, Lu S et al (2021) Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung: Final analysis of the randomised phase 3 LUX-Lung 8 trial. EClinicalMedicine 37:100940PubMedPubMedCentralCrossRef
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Zurück zum Zitat Griesinger F, Curigliano G, Thomas M (2022) Safety and efficacy of pralsetinib in RET fusion-positive non-small-cell lung cancer including as first-line therapy: update from the ARROW trial. Ann Oncol 33:1168–1178PubMedCrossRef Griesinger F, Curigliano G, Thomas M (2022) Safety and efficacy of pralsetinib in RET fusion-positive non-small-cell lung cancer including as first-line therapy: update from the ARROW trial. Ann Oncol 33:1168–1178PubMedCrossRef
Zurück zum Zitat Grosicki S, Simonova M, Spicka I et al (2020) Once-per-week selinexor, bortezomib, and dexamethasone vs twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet 396:1563–1573PubMedCrossRef Grosicki S, Simonova M, Spicka I et al (2020) Once-per-week selinexor, bortezomib, and dexamethasone vs twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet 396:1563–1573PubMedCrossRef
Zurück zum Zitat Guglielmelli P, Vannucchi AM (2020) Current management strategies for polycythemia vera and essential thrombocythemia. Blood Rev 42:100714PubMedCrossRef Guglielmelli P, Vannucchi AM (2020) Current management strategies for polycythemia vera and essential thrombocythemia. Blood Rev 42:100714PubMedCrossRef
Zurück zum Zitat Guigay J, Aupérin A, Fayette J et al (2021) Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol 22:463–475PubMedCrossRef Guigay J, Aupérin A, Fayette J et al (2021) Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol 22:463–475PubMedCrossRef
Zurück zum Zitat Hall ME, Huelster HL, Luckenbaugh AN et al (2020) Metastatic hormone-sensitive prostate cancer: current perspective on the evolving therapeutic landscape. Onco Targets Ther 13:3571–3581PubMedPubMedCentralCrossRef Hall ME, Huelster HL, Luckenbaugh AN et al (2020) Metastatic hormone-sensitive prostate cancer: current perspective on the evolving therapeutic landscape. Onco Targets Ther 13:3571–3581PubMedPubMedCentralCrossRef
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Zurück zum Zitat Harrison CN, Campbell PJ, Buck G et al (2005) Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. N Engl J Med 353:33–45PubMedCrossRef Harrison CN, Campbell PJ, Buck G et al (2005) Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. N Engl J Med 353:33–45PubMedCrossRef
Zurück zum Zitat Hauschild A, Grob JJ, Demidov LV et al (2012) Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet 380:358–365PubMedCrossRef Hauschild A, Grob JJ, Demidov LV et al (2012) Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet 380:358–365PubMedCrossRef
Zurück zum Zitat Heuser M, Ofran Y, Boissel N et al (2020) Acute myeloid leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 31:697–712PubMedCrossRef Heuser M, Ofran Y, Boissel N et al (2020) Acute myeloid leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 31:697–712PubMedCrossRef
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Zurück zum Zitat Kinsey EN, Zhang T, Armstrong AJ (2020) Metastatic hormone-sensitive prostate cancer. A review of the current treatment landscape. Cancer J 26:64–75PubMedCrossRef Kinsey EN, Zhang T, Armstrong AJ (2020) Metastatic hormone-sensitive prostate cancer. A review of the current treatment landscape. Cancer J 26:64–75PubMedCrossRef
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Zurück zum Zitat Kröger NM, Deeg JH, Olavarria E et al (2015) Indication and management of allogeneic stem cell transplantation in primary myelofibrosis: a consensus process by an EBMT/ELN international working group. Leukemia 29:2126–2133PubMedCrossRef Kröger NM, Deeg JH, Olavarria E et al (2015) Indication and management of allogeneic stem cell transplantation in primary myelofibrosis: a consensus process by an EBMT/ELN international working group. Leukemia 29:2126–2133PubMedCrossRef
Zurück zum Zitat Kumar SK, Jacobus SJ, Cohen AD et al (2020) Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial. Lancet Oncol 21:1317–1330PubMedPubMedCentralCrossRef Kumar SK, Jacobus SJ, Cohen AD et al (2020) Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial. Lancet Oncol 21:1317–1330PubMedPubMedCentralCrossRef
Zurück zum Zitat Kudo M, Finn RS, Qin S et al (2018) Lenvatinib vs sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet 391:1163–1173PubMedCrossRef Kudo M, Finn RS, Qin S et al (2018) Lenvatinib vs sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet 391:1163–1173PubMedCrossRef
Zurück zum Zitat Lambert J, Pautas C, Terré C et al (2019) Gemtuzumab ozogamicin for de novo acute myeloid leukemia: final efficacy and safety updates from the open-label, phase III ALFA-0701 trial. Haematologica 104:113–119PubMedPubMedCentralCrossRef Lambert J, Pautas C, Terré C et al (2019) Gemtuzumab ozogamicin for de novo acute myeloid leukemia: final efficacy and safety updates from the open-label, phase III ALFA-0701 trial. Haematologica 104:113–119PubMedPubMedCentralCrossRef
Zurück zum Zitat Lancet JE, Uy GL, Cortes JE et al (2018) CPX-351 (cytarabine and daunorubicin) liposome for injection versus conventional cytarabine plus daunorubicin in older patients with newly diagnosed secondary Acute Myeloid Leukemia. J Clin Oncol 36:2684–2692PubMedPubMedCentralCrossRef Lancet JE, Uy GL, Cortes JE et al (2018) CPX-351 (cytarabine and daunorubicin) liposome for injection versus conventional cytarabine plus daunorubicin in older patients with newly diagnosed secondary Acute Myeloid Leukemia. J Clin Oncol 36:2684–2692PubMedPubMedCentralCrossRef
Zurück zum Zitat Ledermann JA, Harter P, Gourley C et al (2016) Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol 17:1579–1589PubMedCrossRef Ledermann JA, Harter P, Gourley C et al (2016) Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol 17:1579–1589PubMedCrossRef
Zurück zum Zitat Liu SV, Reck M, Mansfield AS et al (2021) Updated overall survival and PD-L1 subgroup analysis of patients with extensive-stage small-cell lung cancer treated with atezolizumab, carboplatin, and etoposide (IMpower133). J Clin Oncol 39:619–630PubMedPubMedCentralCrossRef Liu SV, Reck M, Mansfield AS et al (2021) Updated overall survival and PD-L1 subgroup analysis of patients with extensive-stage small-cell lung cancer treated with atezolizumab, carboplatin, and etoposide (IMpower133). J Clin Oncol 39:619–630PubMedPubMedCentralCrossRef
Zurück zum Zitat Lonial S, Nooka AK, Thulasi P et al (2021) Management of belantamab mafodotin-associated corneal events in patients with relapsed or refractory multiple myeloma (RRMM). Blood Cancer J 11:103PubMedPubMedCentralCrossRef Lonial S, Nooka AK, Thulasi P et al (2021) Management of belantamab mafodotin-associated corneal events in patients with relapsed or refractory multiple myeloma (RRMM). Blood Cancer J 11:103PubMedPubMedCentralCrossRef
Zurück zum Zitat Lyman GH, Moses HL (2016) Biomarker tests for molecularly targeted therapies – the key to unlocking precision medicine. N Engl J Med 375:4–6PubMedCrossRef Lyman GH, Moses HL (2016) Biomarker tests for molecularly targeted therapies – the key to unlocking precision medicine. N Engl J Med 375:4–6PubMedCrossRef
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Zurück zum Zitat Madhusoodanan J (2023) Fast-track troubles: How US drug policy could be harming people with cancer around the world. Nature 620:264–267PubMedCrossRef Madhusoodanan J (2023) Fast-track troubles: How US drug policy could be harming people with cancer around the world. Nature 620:264–267PubMedCrossRef
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Zurück zum Zitat Miles D, Gligorov J, André F et al (2021) Primary results from IMpassion131, a double-blind, placebo-controlled randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metatstatic triple-negative breast cancer. Ann Oncol 32:9945–1004CrossRef Miles D, Gligorov J, André F et al (2021) Primary results from IMpassion131, a double-blind, placebo-controlled randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metatstatic triple-negative breast cancer. Ann Oncol 32:9945–1004CrossRef
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Zurück zum Zitat Plimack ER, Powles T, Stus V et al (2023) Pembrolizumab plus axitinib versus sunitinib as first-line treatment of advanced renal cell carcinoma: 43-month follow-up of the phase 3 KEYNOTE-426 study. Eur Urol 84:449–454PubMedCrossRef Plimack ER, Powles T, Stus V et al (2023) Pembrolizumab plus axitinib versus sunitinib as first-line treatment of advanced renal cell carcinoma: 43-month follow-up of the phase 3 KEYNOTE-426 study. Eur Urol 84:449–454PubMedCrossRef
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Zurück zum Zitat Réa D, Mauro MJ, Boquimpani C et al (2021) A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs. Blood 138:2031–2041PubMedPubMedCentralCrossRef Réa D, Mauro MJ, Boquimpani C et al (2021) A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs. Blood 138:2031–2041PubMedPubMedCentralCrossRef
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Zurück zum Zitat Richardson PG, Kumar SK, Masszi T et al (2021) Final overall survival analysis of the TOURMALINE-MM1 phase III trial of ixazomib, lenalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma. J Clin Oncol 39:2430–2442PubMedCrossRef Richardson PG, Kumar SK, Masszi T et al (2021) Final overall survival analysis of the TOURMALINE-MM1 phase III trial of ixazomib, lenalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma. J Clin Oncol 39:2430–2442PubMedCrossRef
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Zurück zum Zitat Vogler S, Panteli D, Busse R (2021) Biologika und Biosimilars in Deutschland und im europäischen Vergleich – Marktsteuerungsmechanismen und Preisvergleich. In: Ludwig WD, Mühlbauer B, Seifert R (Hrsg) Arzneiverordnungs-Report 2021. Springer, Berlin Vogler S, Panteli D, Busse R (2021) Biologika und Biosimilars in Deutschland und im europäischen Vergleich – Marktsteuerungsmechanismen und Preisvergleich. In: Ludwig WD, Mühlbauer B, Seifert R (Hrsg) Arzneiverordnungs-Report 2021. Springer, Berlin
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Zurück zum Zitat Vokinger KN (2022) Beschleunigte Zulassungen und therapeutischer Nutzen von Arzneimitteln in den USA und Europa. In: Ludwig WD, Mühlbauer B, Seifert R (Hrsg) Arzneiverordnungs-Report 2022. Springer, Berlin Vokinger KN (2022) Beschleunigte Zulassungen und therapeutischer Nutzen von Arzneimitteln in den USA und Europa. In: Ludwig WD, Mühlbauer B, Seifert R (Hrsg) Arzneiverordnungs-Report 2022. Springer, Berlin
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Zurück zum Zitat Wolf J, Seto T, Han JY et al (2020) Capmatinib in MET exon 14-mutated or MET-amplified non-small-cell lung cancer. N Engl J Med 383:944–957PubMedCrossRef Wolf J, Seto T, Han JY et al (2020) Capmatinib in MET exon 14-mutated or MET-amplified non-small-cell lung cancer. N Engl J Med 383:944–957PubMedCrossRef
Zurück zum Zitat Yang JC, Wu YL, Schuler M et al (2015) Afatinib vs cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol 16:141–151PubMedCrossRef Yang JC, Wu YL, Schuler M et al (2015) Afatinib vs cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol 16:141–151PubMedCrossRef
Zurück zum Zitat Franzen N, Retel V, Schats W, van Harten WH (2020) Evidence underlying policy proposals for sustainable anticancer drug prices. JAMA Oncol 6:906–916CrossRef Franzen N, Retel V, Schats W, van Harten WH (2020) Evidence underlying policy proposals for sustainable anticancer drug prices. JAMA Oncol 6:906–916CrossRef
Metadaten
Titel
Hämatologische Neoplasien und solide Tumore
verfasst von
Prof. Dr. med. Wolf-Dieter Ludwig
Prof. Dr. med. Arnold Ganser
Prof. Dr. med. Georg Maschmeyer
Copyright-Jahr
2023
Verlag
Springer Berlin Heidelberg
DOI
https://doi.org/10.1007/978-3-662-68371-2_5

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