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

International Journal of Radiation Oncology Biology Physics

Volumn 66, Issue 5, 2006, Pages 1384-1390

  Hofheinz, Ralf Dieter ^a   Horisberger, Karoline ^b   Woernle, Christoph ^b   Wenz, Frederik ^b   Kraus Tiefenbacher, Uta ^b   Kähler, Georg ^b   Dinter, Dietmar ^c   Grobholz, Rainer ^c   Heeger, Steffen ^d   Post, Stefan ^b   Hochhaus, Andreas ^a   Willeke, Frank ^b  

^a III   (Germany)

^b UNIVERSITY OF HEIDELBERG   (Germany)

^c MEDICAL FACULTY MANNHEIM HEIDELBERG UNIVERSITY   (Germany)

^d MERCK KGAA   (Germany)

Author keywords

Capecitabine; Cetuximab; Irinotecan; Locally advanced rectal cancer; Radiotherapy

Indexed keywords

BIOMEDICAL ENGINEERING; DRUG PRODUCTS; ONCOLOGY; PATIENT TREATMENT; RADIOTHERAPY; SURGERY;

CAPECITABINE; CETUXIMAB; IRINOTECAN; LOCALLY ADVANCED RECTAL CANCER;

CHEMOTHERAPY;

CAPECITABINE; CETUXIMAB; IRINOTECAN;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ACNE; ADJUVANT THERAPY; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURGERY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG ERUPTION; DRUG TOLERABILITY; FATIGUE; FEASIBILITY STUDY; FEBRILE NEUTROPENIA; FEMALE; GAMMA RADIATION; HAND FOOT SYNDROME; HUMAN; HUMAN TISSUE; KIDNEY DISEASE; LEUKOPENIA; MALE; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROCTITIS; RECTUM CANCER; REMISSION; SKIN MANIFESTATION; STOMATITIS; THROMBOCYTOPENIA;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; FEASIBILITY STUDIES; FEMALE; FLUOROURACIL; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOADJUVANT THERAPY; RADIOTHERAPY DOSAGE; RECTAL NEOPLASMS;

EID: 33751169352     PISSN: 03603016     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2006.07.005     Document Type: Article

References (39)

1. Kapiteijn E., Marijnen C., Nagtegaal I., et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 345 (2001) 638-646
2. Sauer R., Becker H., Hohenberger W., et al. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 351 (2004) 1731-1740
3. Bosset J.F., Calais G., Mineur L., et al. Preoperative radiation (Preop RT) in rectal cancer: Effect and timing of additional chemotherapy (CT). 5-Year results of the EORTC 22921 trial. [Abstract]. Proc Am Soc Clin Oncol 23 (2005) 3505
4. Gerard J.P., Bonnetain F., Conroy T., et al. Preoperative (preop) radiotherapy (RT) +/- 5-FU/folinic acid (FA) in T3-4 rectal cancers: Results of the FFCD 9203 trial. [Abstract]. Proc Am Soc Clin Oncol 23 (2005) 3504
5. Tepper J.E., O'Connell M., Niedzwiecki D., et al. Adjuvant therapy in rectal cancer: Analysis of stage, sex, and local control-Final report of Intergroup 0114. J Clin Oncol 20 (2002) 1744-1750
6. O'Connell M.J., Martenson J.A., Weiand H.S., et al. Improving adjuvant therapy by combining protracted infusion fluorouracil with radiation therapy after curative surgery. N Engl J Med 331 (1994) 502-507
7. Queisser W., Hartung G., Kopp-Schneider A., et al., Colon and Rectum Carcinoma, Mannheim Study Group. Adjuvant radio-chemotherapy with 5-fluorouracil and folinic acid in stage II and III rectal cancer: 12 vs. 6 months of therapy. Onkologie 23 (2000) 334-339
8. Mohiuddin M., Winter K., Mitchell E., et al. Randomized phase II study of neoadjuvant combined-modality chemoradiation for distal rectal cancer: Radiation Therapy Oncology Group Trial 0012. J Clin Oncol 24 (2006) 650-655
9. Mehta V.K., Cho C., Ford J.M., et al. Phase II trial of preoperative 3D conformal radiotherapy, protracted venous infusion 5-fluorouracil, and weekly CPT-11, followed by surgery for ultrasound-staged T3 rectal cancer. Int J Radiat Oncol Biol Phys 55 (2003) 132-137
10. Levine E.L., Gollins S., Susnerwala S., et al. Irinotecan, 5-FU and radiotherapy in locally advanced inoperable rectal cancer. [Abstract]. Proc Am Soc Clin Oncol 22 (2004) 3612
11. Klautke G., Kirchner R., Hopt U., et al. Continuous infusion of 5-FU and weekly irinotecan with concurrent radiotherapy as neoadjuvant treatment for locally advanced or recurrent rectal cancer. Br J Cancer 92 (2005) 1215-1220
12. Klautke G., Kuchenmeister U., Foitzik T., et al. Concurrent chemoradiation with capecitabine and weekly irinotecan as preoperative treatment for rectal cancer: Results from a phase I/II study. Br J Cancer 94 (2006) 976-981
13. Gollins S., Myint S., Levine E., et al. Phase I study of capecitabine plus weekly irinotecan (CAPIRI) plus radiotherapy as preoperative downstaging treatment for locally advanced rectal cancer (LARC). [Abstract]. Proc Am Soc Clin Oncol 23 (2005) 3565
14. Hofheinz R.D., von Gerstenberg-Helldorf B., Wenz F., et al. Phase I trial of capecitabine and weekly irinotecan in combination with radiotherapy for neoadjuvant therapy of rectal cancer. J Clin Oncol 23 (2005) 1350-1357
15. Willeke F., Tiefenbacher U., Hochhaus A., et al. Phase II trial of capecitabine and irinotecan in combination with concurrent radiotherapy for neoadjuvant treatment of locally advanced rectal cancer. [Abstract]. Proc Am Soc Clin Oncol 23 (2005) 3589
16. Mitchell E.P. Irinotecan in preoperative combined-modality therapy for locally advanced rectal cancer. Oncology (Huntingt) 14 Suppl. 14 (2000) 56-59
17. Rich T.A., and Kirichenko A.V. Camptothecin schedule and timing of administration with irradiation. Oncology (Huntingt) 15 Suppl. 5 (2001) 37-41
18. Saltz L.B., Cox J.V., Blanke C., et al., Irinotecan Study Group. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 343 (2000) 905-914
19. Köhne C.H., van Cutsem E., Wils J., et al. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J Clin Oncol 23 (2005) 4856-4865
20. Hurwitz H., Fehrenbacher L., Novotny W., et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350 (2004) 2335-2342
21. Rödel C., Martus P., Papadoupolos T., et al. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol 23 (2005) 8688-8696
22. Roh M.S., Colangelo L., Wieand S., et al. Response to preoperative multimodality therapy predicts survival in patients with carcinoma of the rectum. [Abstract]. Proc Am Soc Clin Oncol 22 (2004) 3505
23. Cunningham D., Humblet Y., Siena S., et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351 (2004) 337-345
24. Folprecht G., Lutz M.P., Schöffski P., et al. Cetuximab and irinotecan/5-fluorouracil/folinic acid is a safe combination for the first-line treatment of patients with epidermal growth factor receptor expressing metastatic colorectal cancer. Ann Oncol 17 (2006) 450-460
25. Krause M., Ostermann G., Petersen C., et al. Decreased repopulation as well as increased reoxygenation contribute to the improvement in local control after targeting of EGFR by C225 during fractionated irradiation. Radiother Oncol 76 (2005) 162-167
26. Huang S.M., Bock J.M., and Harari P.M. Epidermal growth factor receptor blockade with C225 modulates proliferation, apoptosis, and radiosensitivity in squamous cell carcinomas of the head and neck. Cancer Res 59 (1999) 1935-1940
27. Bonner J.A., Harari P.M., Giralt J., et al. Radiotherapy plus cetuximab for squamous cell carcinoma of the head and neck. N Engl J Med 354 (2006) 567-578
28. Giralt J., de las Heras M., Cerezo L., et al. The expression of epidermal growth factor receptor results in a worse prognosis for patients with rectal cancer treated with preoperative radiotherapy: A multicenter, retrospective analysis. Radiother Oncol 74 (2005) 101-108
29. Compton C.C., and Cancer Committee. Updated protocol for the examination of specimens from patients with carcinomas of the colon and rectum, excluding carcinoid tumors, lymphomas, sarcomas, and tumors of the vermiform appendix: A basis for checklists. Arch Pathol Lab Med 124 (2000) 1016-1025
30. Andre C., Boni C., Mounedij-Boudiaf L., et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 350 (2004) 2343-2351
31. Wolmark N., Wieand H.S., Kuebler J.P., et al. A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon: Results of NSABP Protocol C-07. [Abstract]. Proc Am Soc Clin Oncol 23 (2005) 3500
32. van Cutsem E., Labianca R., Hossfeld D., et al. Randomized phase III trial comparing infused irinotecan/5-fluorouracil (5-FU)/folinic acid (IF) versus 5-FU/FA (F) in stage III colon cancer patients (pts) (PETACC 3). [Abstract]. Proc Am Soc Clin Oncol 23 (2005) 8
33. Dworak O., Keilholz L., and Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis 12 (1997) 19-23
34. Losi L., Luppi G., Gavioli M., et al. Prognostic value of Dworak grade of regression (GR) in patients with rectal carcinoma treated with preoperative radiochemotherapy. Int J Colorectal Dis (2005) [Epub ahead of print]
35. Biondo S., Navarro M., Marti-Rague J., et al. Response to neoadjuvant therapy for rectal cancer: Influence on long-term results. Colorectal Dis 7 (2005) 472-479
36. Díaz-González J., Calvo F.A., Cortés J., et al. Prognostic factors for disease-free survival in patients with T3-4 or N+ rectal cancer treated with preoperative chemoradiation therapy, surgery, and intraoperative irradiation. Int J Radiat Oncol Biol Phys 64 (2006) 1122-1128
37. Hartley A., Ho K.F., McConkey C., et al. Pathological complete response following pre-operative chemoradiotherapy in rectal cancer: Analysis of phase II/III trials. Br J Radiol 78 (2005) 934-938
38. Prewett M.C., Hooper A.T., Bassi R., et al. Enhanced antitumor activity of anti-epidermal growth factor receptor monoclonal antibody IMC-C225 in combination with irinotecan (CPT-11) against human colorectal tumor xenografts. Clin Cancer Res 8 (2002) 994-1003
39. Chung K.J., Shia J., Kemeny N.E., et al. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol 23 (2005) 803-810