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Erlotinib 150 mg daily plus chemotherapy in advanced pancreatic cancer: an interim safety analysis of a multicenter, randomized, cross-over phase III trial of the "Arbeitsgemeinschaft Internistische Onkologie"

To date, only limited toxicity data are available for the combination of erlotinib with either capecitabine or gemcitabine as front-line therapy for advanced pancreatic cancer. Within a randomized phase III trial, 281 treatment-naive patients were randomly assigned between capecitabine (2000 mg/m2/d...

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Hauptverfasser: Böck, Stefan (VerfasserIn) , Vehling-Kaiser, Ursula (VerfasserIn) , Waldschmidt, Dirk (VerfasserIn) , Kettner, Erika (VerfasserIn) , Märten, Angela (VerfasserIn) , Winkelmann, Cornelia (VerfasserIn) , Klein, Stefan (VerfasserIn) , Kojouharoff, Georgi (VerfasserIn) , Gauler, Thomas (VerfasserIn) , Fischer von Weikersthal, Ludwig (VerfasserIn) , Clemens, Michael R. (VerfasserIn) , Geißler, Michael (VerfasserIn) , Greten, Tim F. (VerfasserIn) , Hegewisch-Becker, Susanna (VerfasserIn) , Neugebauer, Sascha (VerfasserIn) , Heinemann, Volker (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 2010
In: Anti-cancer drugs
Year: 2010, Jahrgang: 21, Heft: 1, Pages: 94-100
ISSN:1473-5741
DOI:10.1097/CAD.0b013e32833123ed
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1097/CAD.0b013e32833123ed
Verlag, lizenzpflichtig, Volltext: https://journals.lww.com/anti-cancerdrugs/Fulltext/2010/01000/Erlotinib_150_mg_daily_plus_chemotherapy_in.10.aspx
Volltext
Verfasserangaben:Stefan Boeck, Ursula Vehling-Kaiser, Dirk Waldschmidt, Erika Kettner, Angela Märten, Cornelia Winkelmann, Stefan Klein, Georgi Kojouharoff, Thomas Gauler, Ludwig Fischer von Weikersthal, Michael R. Clemens, Michael Geissler, Tim F. Greten, Susanna Hegewisch-Becker, Sascha Neugebauer and Volker Heinemann
Beschreibung
Zusammenfassung:To date, only limited toxicity data are available for the combination of erlotinib with either capecitabine or gemcitabine as front-line therapy for advanced pancreatic cancer. Within a randomized phase III trial, 281 treatment-naive patients were randomly assigned between capecitabine (2000 mg/m2/day, for 14 days, once every 3 weeks) plus erlotinib (150 mg/day, arm A) and gemcitabine (1000 mg/m2 as a 30-min infusion) plus erlotinib (150 mg/day, arm B). In case of treatment failure, patients were crossed over to a second-line treatment with the comparator cytostatic drug without erlotinib. The primary study endpoint was the time to treatment failure of second-line therapy (TTF2). This interim analysis of toxicity contains safety data from the first 127 randomized patients. During first-line therapy, patients received a median number of three treatment cycles (range 0-13) in both the arms. Regarding chemotherapy, a treatment delay was observed in 12% of the cycles in arm A and in 22% of the cycles in arm B. Dose reductions of the cytostatic drug were performed in 18 and 27% of treatment cycles, respectively. Erlotinib dose reductions were performed in 6 and 11% of all cycles. Grade 3/4 hematological toxicity was <10% in both the arms; major grade 3/4 toxicities in arms A and B were diarrhea (9 vs. 7%), skin rash (4 vs. 12%), and hand-foot syndrome (7 vs. 0%). No treatment-related death was observed. In conclusion, this interim safety analysis suggests that treatment with erlotinib 150 mg/day is feasible in combination with capecitabine or gemcitabine.
Beschreibung:Gesehen am 26.01.2023
Beschreibung:Online Resource
ISSN:1473-5741
DOI:10.1097/CAD.0b013e32833123ed

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