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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| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2010
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| In: |
Anti-cancer drugs
Year: 2010, Volume: 21, Issue: 1, Pages: 94-100 |
| ISSN: | 1473-5741 |
| DOI: | 10.1097/CAD.0b013e32833123ed |
| Online Access: | 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 
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| Author Notes: | 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 |
| Summary: | 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. |
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| Item Description: | Gesehen am 26.01.2023 |
| Physical Description: | Online Resource |
| ISSN: | 1473-5741 |
| DOI: | 10.1097/CAD.0b013e32833123ed |