Primäre medikamentöse Thromboembolieprophylaxe bei ambulanten Patienten mit fortgeschrittenem Pankreaskarzinom unter Chemotherapie?

Zusammenfassung

Hintergrund und Fragestellung: Obwohl das deutlich erhöhte Risiko von Tumorpatienten für venöse Thromboembolien allgemein bekannt ist, ist die Indikationsstellung zur primärprophylaktischen Antikoagulation bei ambulanten Malignompatienten auch in den verfügbaren Leitlinien unzureichend geregelt. Dies gilt selbst für Hochrisikopatienten wie Patienten mit fortgeschrittenem Pankreaskarzinom, die sich einer ambulanten Chemotherapie unterziehen.

Patienten und Methodik: Daten von 312 Patienten der prospektiv randomisierten CONKO-004-Studie wurden für diese Analyse herangezogen. Die Patienten wurden nach vordefinierten Parametern ausgewertet, um eine Risikostratifizierung hinsichtlich einer venösen Thromboembolie (VTE) zu ermöglichen. Zudem wurden die Patienten nach dem „Khorana-Scoring-Modell“ (KSM) analysiert, um dessen Aussagekraft und klinische Bedeutung an diesem Patientenkollektiv zu überprüfen.

Ergebnisse: Die globale Analyse hatte eine „number needed to treat“ (NNT) von 12 medikamentös primärprophylaktisch zu behandelnden Patienten erbracht, um eine VTE zu verhindern. Eine modifizierte Risikostratifizierung analog dem KSM senkte die NNT auf 9, dies erscheint jedoch klinisch nicht relevant. Einzelne Parameter, insbesondere der Allgemeinzustand der Patienten (Karnofsky-Performance-Status), ließen sich einem erhöhten VTE-Risiko zuordnen; dies kann dem Kliniker helfen, individualisierte Entscheidungen zu treffen.

Folgerung: Die Daten der CONKO-004-Studie sprechen – auch nach der vorliegenden Risikostratifizierung – dafür, dass ambulante Patienten mit inoperablem Pankreaskarzinom für die ersten 3 Monate der Erstlinien-Chemotherapie eine prophylaktische Antikoagulation mit NMH erhalten sollten.

Abstract

Background and objective: The indication for medical venous thrombosis prophylaxis in ambulatory cancer patients is still under discussion. To provide more data on this topic we conducted an analysis in ambulatory patients with advanced pancreatic adenocarcinoma, reflecting a patient cohort at high risk of symptomatic venous thromboembolism (sVTE).

Patients and methods: Data from 312 consecutively recruited patients of the CONKO-004 trial were analysed according to predefined parameters and additionally with respect to established scores. To focus on patients with highest risk of sVTE unvaried and multivariate analyses were conducted.

Results: The global analyses had educed a number needed to treat (NNT) by medical thrombosis prophylaxis of 12 patients to prevent one sVTE. The modified score model did not provide further clinical benefit. However, the regression model can identify single parameters with a trend to higher risk of sVTE or higher risk of severe bleeding. Most of the parameters do not have enough power to be significant, but they can support clinical decisions.

Conclusion: These data suggest that medical thrombosis prophylaxis should be performed in patients with advanced pancreatic cancer at least for the initial 3 months of first line chemotherapy.

Schlüsselwörter

Pankreaskarzinom - Thrombose - Heparin - Primärprophylaxe

Keywords

pancreatic cancer - thrombosis - heparin - primary prevention

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