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Phase I trial of cetuximab in combination with capecitabine, weekly irinotecan, and radiotherapy as neoadjuvant therapy for rectal cancer

Purpose: To establish the feasibility and efficacy of chemotherapy with capecitabine, weekly irinotecan, cetuximab, and pelvic radiotherapy for patients with locally advanced rectal cancer. Methods and materials: Twenty patients with rectal cancer (clinical Stage uT3-T4 or N+) received a standard do...

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Hauptverfasser: Hofheinz, Ralf-Dieter (VerfasserIn) , Horisberger, Karoline (VerfasserIn) , Woernle, Christoph (VerfasserIn) , Wenz, Frederik (VerfasserIn) , Kraus-Tiefenbacher, Uta (VerfasserIn) , Kähler, Georg (VerfasserIn) , Dinter, Dietmar (VerfasserIn) , Grobholz, Rainer (VerfasserIn) , Heeger, Steffen (VerfasserIn) , Post, Stefan (VerfasserIn) , Hochhaus, Andreas (VerfasserIn) , Willeke, Frank (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 18 September 2006
In: International journal of radiation oncology, biology, physics
Year: 2006, Jahrgang: 66, Heft: 5, Pages: 1384-1390
ISSN:1879-355X
DOI:10.1016/j.ijrobp.2006.07.005
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ijrobp.2006.07.005
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Verfasserangaben:Ralf-Dieter Hofheinz, Karoline Horisberger, Christoph Woernle, Frederik Wenz, Uta Kraus-Tiefenbacher, Georg Kähler, Dietmar Dinter, Rainer Grobholz, Steffen Heeger, Stefan Post, Andreas Hochhaus, and Frank Willeke
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Zusammenfassung:Purpose: To establish the feasibility and efficacy of chemotherapy with capecitabine, weekly irinotecan, cetuximab, and pelvic radiotherapy for patients with locally advanced rectal cancer. Methods and materials: Twenty patients with rectal cancer (clinical Stage uT3-T4 or N+) received a standard dosing regimen of cetuximab (400 mg/m(2) on Day 1 and 250 mg/m(2) on Days 8, 15, 22, and 29) and escalating doses of irinotecan and capecitabine according to phase I methods: dose level I, irinotecan 40 mg/m(2) on Days 1, 8, 15, 22, and 29 and capecitabine 800 mg/m(2) on Days 1-38; dose level II, irinotecan 40 mg/m(2) and capecitabine 1000 mg/m(2); and dose level III, irinotecan 50 mg/m(2) and capecitabine 1000 mg/m(2). Radiotherapy was given to a dose of 50.4 Gy (45 Gy plus 5.4 Gy). Resection was scheduled 4-5 weeks after termination of chemoradiotherapy. Results: On dose level I, no dose-limiting toxicities occurred; however, Grade 3 diarrhea affected 1 of 6 patients on dose level II. Of 5 patients treated at dose level III, 2 exhibited dose-limiting toxicity (diarrhea in 2 and nausea/vomiting in 1). Therefore, dose level II was determined as the recommended dose for future studies. A total of 10 patients were treated on dose level II and received a mean relative dose intensity of 100% of cetuximab, 94% of irinotecan, and 95% of capecitabine. All patients underwent surgery. Five patients had a pathologically complete remission and six had microfoci of residual tumor only. Conclusion: Preoperative chemoradiotherapy with cetuximab, capecitabine, and weekly irinotecan is feasible and well tolerated. The preliminary efficacy is very promising. Larger phase II trials are ongoing. (c) 2006 Elsevier Inc.
Beschreibung:Gesehen am 25.02.2022
Beschreibung:Online Resource
ISSN:1879-355X
DOI:10.1016/j.ijrobp.2006.07.005

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