Prävention, Diagnostik, Therapie und Nachsorge des Lungenkarzinoms

1 Einleitung

1.1 Vorbemerkungen

Das Lungenkarzinom ist mit jährlich über 40 000 Sterbefällen in der Bundesrepublik Deutschland die vierthäufigste Todesursache und die häufigste Krebstodesursache [1]. Trotz der Fortschritte in der Diagnostik und Therapie liegt die 5-Jahres-Überlebensrate der Patienten mit Lungenkarzinom in europäischen und nordamerikanischen Ländern nur in einem Bereich von 5,5 – 15,7 % [2] [3]. Ziel der vorliegenden Leitlinie ist die Verbesserung der Prognose und der Lebensqualität von Patienten mit Lungenkarzinomen durch Optimierung des Einsatzes der derzeitigen diagnostischen und therapeutischen Möglichkeiten in einem interdisziplinären Ansatz. Außerdem soll durch die Empfehlung präventiver Maßnahmen die Häufigkeit des Lungenkarzinoms reduziert werden.

Leitlinien sind systematisch entwickelte Darstellungen und Empfehlungen mit dem Zweck, Ärzte bei der Entscheidung über angemessene Maßnahmen der Krankenversorgung (Prävention, Diagnostik, Therapie und Nachsorge) unter spezifischen medizinischen Umständen zu unterstützen [4]. Sie beruhen auf aktuellen wissenschaftlichen Erkenntnissen und in der Praxis bewährten Verfahren und sorgen für mehr Sicherheit in der Medizin, sollen aber auch ökonomische Aspekte berücksichtigen. Die vorliegende Entwicklungsstufe 3 (S3) der Leitlinien nach der Klassifikation der AWMF ist durch die Kombination von formaler Evidenz-Recherche, formaler Konsensfindung, Logik (Algorithmen) sowie Entscheidungs- und Outcome-Analyse gekennzeichnet [5]. Die alleinige Evidenz-Basierung einer Leitlinie kann problematisch sein, da die Ergebnisse der zugrunde gelegten randomisierten kontrollierten Studien an selektionierten Patientengruppen gewonnen wurden und daher nur mit Einschränkungen im Hinblick auf die Gesamtgruppe der Patienten verallgemeinert werden können. Insbesondere die häufigen Begleitkrankheiten des Lungenkarzinoms zwingen zu einer besonderen Beachtung der individuellen Behandlungssituation. Daher wurde bei der Erstellung der vorliegenden Leitlinie besonderer Wert auf eine breite interdisziplinäre Konsensfindung unter Beteiligung von 15 deutschen und österreichischen wissenschaftlichen medizinischen Fachgesellschaften und 3 Berufsverbänden sowie weiterer Expertengruppen gelegt, um auch die Besonderheiten unterschiedlicher Therapiesituationen angemessen zu berücksichtigen. Dennoch entbindet die vorliegende Leitlinie ebenso wie andere Leitlinien die behandelnden Ärzte nicht von der Verantwortung, die individuellen Behandlungssituationen der Patienten zu berücksichtigen und gegebenenfalls in enger Abstimmung mit dem Wunsch des Patienten von den Empfehlungen der Leitlinie abzuweichen.

1.2 Methodik der Leitlinienerstellung

In den von dem Steuerkomitee thematisch definierten Arbeitsgruppen wurde eine systematische Literaturrecherche mit Extraktion von Kernaussagen und einer Evidenzbewertung durchgeführt. Die systematische Literaturrecherche umfasste den Zeitraum bis zum 30. 06. 2006. Der nachfolgende Zeitraum bis zur Veröffentlichung der Leitlinie wurde hinsichtlich relevanter Publikationen von den Arbeitsgruppen beobachtet. Relevante Literatur aus diesem Zeitraum wurde dann in der Leitlinie berücksichtigt, wenn es sich um Studien mit hoher Evidenzstärke (Evidenzgrad 1 – 2) oder Leitlinien handelte und sich neue Aspekte ergaben. Die Bewertung der Evidenzgrade erfolgte nach den Kriterien des Oxford Centre for Evidence-based Medicine (CEBM, 2001 [6]). Die aus den Evidenzgraden abgeleiteten Empfehlungsgrade A – D des CEBM wurden in modifizierter Form übernommen, wobei von der vom CEBM vorgegebenen Beziehung zwischen Evidenz- und Empfehlungsgraden bei Berücksichtigung ethischer Aspekte, der Patienten-Präferenzen, der klinischen Relevanz, des integrierten Outcome, klinisch bedeutsamer Abweichung von der Studiensituation, der Konsistenz und Effektstärke der Studie, der Nutzen, Risiken und Nebenwirkungen und der Anwendbarkeit in begründeten Fällen im Rahmen des formalen Konsensprozesses abgewichen werden konnte (AWMF). [Tab. 1] zeigt die Beziehung zwischen Evidenz- und Empfehlungsgraden für interventionelle (therapeutische) und diagnostische Studien. Studiendesign, Ergebnisse und Evidenzbewertung relevanter Studien sind den Evidenztabellen zu den Leitlinienkapiteln im Anhang, der über das Internet ( www.thieme-connect.de/ejournals/html/10.1055/s-0029-1243837) abrufbar ist, zu entnehmen. Das Literaturverzeichnis der Leitlinie findet sich ebenfalls im Anhang, der über das Internet abrufbar ist ( www.thieme-connect.de/ejournals/html/10.1055/s-0029-1243837).

Tab. 1 Beziehung zwischen Evidenz- und Empfehlungsgrad (modifiziert nach Oxford Center for Evidence-based Medicine 2001 und AWMF). Evidenzgrad Evidenz Konsensus Empfehlungsgrad Therapeutische Studien Diagnostische Studien Modifizierende Kriterien für Empfehlungsgrad 1a syst. Review von randomisierten kontrollierten klinischen Studien syst. Review validierende Kohortenstudien – ethische Aspekte– Patienten-Präferenzen– klin. Relevanz, integr. Outcome– klinisch bedeutsame Abweichung von Studiensituation – Studien: Konsistenz, Effektstärke– Nutzen, Risiken, Nebenwirkungen– Anwendbarkeit A starke Empfehlung 1b individ. randomisierte kontrollierte Studie (enges Konfidenzintervall) validierende Kohortenstudie mit guten Referenzstandards 1c Alle-oder-keiner-Prinzip absolute Spezifität zum Einschluss oder absolute Sensitivität zum Ausschluss der Diagnose 2a systematische Review von Kohortenstudien syst. Review von exploratorischen Kohortenstudien B mittelstarke Empfehlung 2b individ. Kohortenstudie, randomisierte kontr. Studie geringerer Qualität exploratorische Kohortenstudie mit guten Referenzstandards 2c Outome-Research-Studie 3a syst. Review Fall-Kontroll-Studien syst. Review von nicht-konsekutiven Studien 3b individ. Fall-Kontroll-Studie nicht-konsekutive Studien 4 Fallserie, Kohortenstudien und Fallkontrollstudien geringerer Qualität Fall-Kontroll-Studie, schlechter oder nicht-unabhängiger Referenzstandard C schwache Empfehlung 5 Expertenmeinung ohne explizite kritische Bewertung, physiolog. Modelle etc. Expertenmeinung ohne explizite kritische Bewertung, physiolog. Modelle etc. D fehlende oder inkonsistente Studien, Empfehlung aufgrund von Expertenmeinung

Die Kernaussagen, Empfehlungen, Empfehlungsgrade, Algorithmen (Flussdiagramme) und Qualitätsindikatoren wurden von den jeweiligen Arbeitsgruppen vorgeschlagen und in formalen Konsensverfahren in Konsensuskonferenzen sowie Delphiprozessen von der Leitliniengruppe konsentiert. Der Leitlinientext wurde von den Arbeitsgruppen formuliert und von einem Redaktionskomitee redaktionell überarbeitet. Abschließend erfolgten eine Konsentierung der Leitlinie im Rahmen eines Delphi-Verfahrens durch die Leitliniengruppe sowie die Verabschiedung durch die beteiligten Fachgesellschaften. Die Leitlinie umfasst eine Langfassung, eine Kurzfassung und eine Patientenfassung. Ziele, Aufgaben und Erstellungsprozess der Leitlinie sind detailliert im Leitlinienbericht (Methodenreport) beschrieben, der über das Internet ( www.thieme-connect.de/ejournals/html/10.1055/s-0029-1243837) abgerufen werden kann.

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2 Kontralaterale supraklavikuläre Lymphknotenmetastasen und zytologisch maligner Pleuraerguss werden von einigen Gruppen auch dem Stadium extensive disease zugerechnet.

3 Definition: Ein Pleuraerguss wird dann als maligne bezeichnet, wenn darin bösartige Zellen oder Gewebe nachgewiesen werden.