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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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Main Authors: Hofheinz, Ralf-Dieter (Author) , Horisberger, Karoline (Author) , Woernle, Christoph (Author) , Wenz, Frederik (Author) , Kraus-Tiefenbacher, Uta (Author) , Kähler, Georg (Author) , Dinter, Dietmar (Author) , Grobholz, Rainer (Author) , Heeger, Steffen (Author) , Post, Stefan (Author) , Hochhaus, Andreas (Author) , Willeke, Frank (Author)
Format: Article (Journal)
Language:English
Published: 18 September 2006
In: International journal of radiation oncology, biology, physics
Year: 2006, Volume: 66, Issue: 5, Pages: 1384-1390
ISSN:1879-355X
DOI:10.1016/j.ijrobp.2006.07.005
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ijrobp.2006.07.005
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Author Notes: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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Summary: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.
Item Description:Gesehen am 25.02.2022
Physical Description:Online Resource
ISSN:1879-355X
DOI:10.1016/j.ijrobp.2006.07.005

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