Erlotinib 150 mg daily plus chemotherapy in advanced pancreatic cancer

• Verfasst von: Böck, Stefan [VerfasserIn]
• Verfasst von: Vehling-Kaiser, Ursula [VerfasserIn]
• Verfasst von: Waldschmidt, Dirk [VerfasserIn]
• Verfasst von: Kettner, Erika [VerfasserIn]
• Verfasst von: Märten, Angela [VerfasserIn]
• Verfasst von: Winkelmann, Cornelia [VerfasserIn]
• Verfasst von: Klein, Stefan [VerfasserIn]
• Verfasst von: Kojouharoff, Georgi [VerfasserIn]
• Verfasst von: Gauler, Thomas [VerfasserIn]
• Verfasst von: Fischer von Weikersthal, Ludwig [VerfasserIn]
• Verfasst von: Clemens, Michael R. [VerfasserIn]
• Verfasst von: Geißler, Michael [VerfasserIn]
• Verfasst von: Greten, Tim F. [VerfasserIn]
• Verfasst von: Hegewisch-Becker, Susanna [VerfasserIn]
• Verfasst von: Neugebauer, Sascha [VerfasserIn]
• Verfasst von: Heinemann, Volker [VerfasserIn]
• Titel: Erlotinib 150 mg daily plus chemotherapy in advanced pancreatic cancer
• Titelzusatz: an interim safety analysis of a multicenter, randomized, cross-over phase III trial of the "Arbeitsgemeinschaft Internistische Onkologie"
• Verf.angabe: 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
• Jahr: 2010
• Umfang: 7 S.
• Fussnoten: Gesehen am 26.01.2023
• Titel Quelle: Enthalten in: Anti-cancer drugs
• Ort Quelle: Hagerstown, Md. : Lippincott Williams & Wilkins, 1990
• Jahr Quelle: 2010
• Band/Heft Quelle: 21(2010), 1, Seite 94-100
• ISSN Quelle: 1473-5741
• DOI: doi:10.1097/CAD.0b013e32833123ed
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1832495221

Abstract

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.