Erlotinib plus Gemcitabin als Therapie bei Patienten mit metastasiertem Pankreaskarzinom: Ergebnisse einer nicht-interventionellen Studie

Zusammenfasung

Von allen Krebserkrankungen hat das metastasierte Pankreaskarzinom die schlechteste Prognose. Mit nab-Paclitaxel/Gemcitabin, FOLFIRINOX und Gemcitabin/Erlotinib gibt es mehrere Therapieoptionen, die das Gesamtüberleben der Patienten verbessern. Insbesondere Patienten, die unter der Therapie mit Erlotinib einen Hautausschlag (Rash) entwickeln, können von der Gemcitabin-Erlotinib-Kombinationstherapie profitieren. Diese nichtinterventionelle Studie (NIS ML21284) untersuchte die Wirksamkeit und Verträglichkeit der Gemcitabin-Erlotinib-Kombinationstherapie in der Behandlungsroutine des metastasierten Pankreaskarzinoms, insbesondere hinsichtlich Rash.

Zwischen 2007 und 2010 wurden die Behandlungsdaten von 433 Patienten aus 98 Zentren dokumentiert. Die erhobenen Parameter wurden deskriptiv ausgewertet.

Nach einer Gemcitabin-Erlotinib-Behandlung war das mediane Gesamtüberleben der Patienten mit Rash-Grad ≥ 1 mit 9,90 (95 %-Konfidenzintervall [KI]: 8,19–11,05) signifikant erhöht gegenüber 6,48 Monaten (95 %-KI: 5,66–7,40) bei Patienten, die keinen Rash entwickelten (p = 0,0010). Dies gilt ebenso für das mediane progressionsfreie Überleben (Patienten mit Rash-Grad ≥ 1 5,43; 95 %-KI: 4,90–6,12 vs. Patienten ohne Rash 3,98 Monate; 95 %-KI: 3,52–5,03, p = 0,0131). Die Gesamtansprechrate lag bei den mit Erlotinib und Gemcitabin behandelten Patienten mit Rash-Grad ≥ 1 um 5,9 % höher als bei Patienten ohne Rash (31,7 % vs. 25,8 %).

Zusammenfassend unterstreichen die Ergebnisse aus der täglichen Behandlungspraxis des metastasierten Pankreaskarzinoms die Bedeutung der Kombinationstherapie Gemcitabin und Erlotinib für die Patientensubgruppe, die unter der Behandlung Rash entwickelt.

Abstract

Metastatic pancreatic cancer has the worst prognosis of all cancers. With nab-Paclitaxel/gemcitabine, FOLFIRINOX, and gemcitabine/erlotinib, several treatment options are available which improve the patient’s overall survival. Especially for patients who develop rash under erlotinib treatment can benefit from gemcitabine/erlotinib combination therapy. This non-interventional study (NIS ML21284) investigated the effectiveness and tolerability of gemcitabine/erlotinib therapy in the treatment routine of metastatic pancreatic cancer, in particular, in the context of the occurrence of a rash.

Between 2007 and 2010, the treatment data of 433 patients in 98 centres were documented. All parameters recorded were assessed descriptively.

Treatment with gemcitabine/erlotinib resulted in both a significant increased median overall survival of the patient subgroup with rash grade ≥ 1 (9.90; 95 % confidence interval [CI], 8.19 to 11.05 vs. 6.48 months; 95 % CI, 5.66 to 7.40, p = 0.0010) and median progression-free survival (5.43, 95 % CI, 4.90 to 6.12 vs. 3.98 months, 95 % CI, 3.52 to 5.03, p = 0.0131). The overall response rate of patients treated with gemcitabine/erlotinib, who had developed rash grade ≥ 1, was 5.9 % higher compared to patients without rash (31.7 % vs. 25.8 %).

In conclusion, these results from the daily treatment routine of metastatic pancreatic cancer underline the importance of combined gemcitabine/erlotinib therapy for a subgroup of patients who develop a rash in the course of erlotinib treatment.

Schlüsselwörter

Pankreaskarzinom - Nichtinterventionelle Studie (NIS) - Erlotinib - Hautausschlag (Rash) - Kombinationstherapie

Key words

Pancreatic cancer - non interventional trial - erlotinib - skin reaction - rash - systemic therapy

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