Phase II study of panitumumab, oxaliplatin, 5-fluorouracil, and concurrent radiotherapy as preoperative treatment in high-risk locally advanced rectal cancer patients (starpan/STAR-02 Study)

Annals of Oncology

Volumn 22, Issue 11, 2011, Pages 2424-2430

  Pinto, C ^a   Di Fabio, F ^a   Maiello, E ^b   Pini, S ^a   Latiano, T ^b   Aschele, C ^c   Garufi, C ^d   Bochicchio, A ^e   Rosati, G ^f   Aprile, G ^g   Giaquinta, S ^a   Torri, V ^h   Bardelli, A ⁱ   Gion, M ^j   Martoni, A ^a  

^a UNIVERSITY OF BOLOGNA   (Italy)

^b CASA SOLLIEVO DELLA SOFFERENZA HOSPITAL   (Italy)

^c UNIVERSITY OF GENOA   (Italy)

^d REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^e REFERRAL CANCER CENTER OF BASILICATA   (Italy)

^f SAN CARLO HOSPITAL   (Italy)

^g SANTA MARIA DELLA MISERICORDIA UNIVERSITY HOSPITAL   (Italy)

^h MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

ⁱ UNIVERSITY OF TURIN   (Italy)

^j Regional General Hospital   (Italy)

more..

Author keywords

5 fluorouracil; Chemoradiotherapy; Oxaliplatin; Panitumumab; Radiotherapy; Rectal cancer

Indexed keywords

B RAF KINASE; ENDOTHELIAL LEUKOCYTE ADHESION MOLECULE 1; EPIDERMAL GROWTH FACTOR; FLUOROURACIL; FOLINIC ACID; K RAS PROTEIN; OXALIPLATIN; PANITUMUMAB; PHOSPHATIDYLINOSITOL 3 KINASE; TRANSFORMING GROWTH FACTOR ALPHA; VASCULOTROPIN;

ABDOMINAL PAIN; ACNE; ADJUVANT THERAPY; ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BRAF GENE; CANCER RADIOTHERAPY; CANCER STAGING; CONFIDENCE INTERVAL; CONTINUOUS INFUSION; CYSTITIS; DIARRHEA; DRUG DOSE REDUCTION; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG SAFETY; FEMALE; HAND FOOT SYNDROME; HIGH RISK PATIENT; HUMAN; LEUKOPENIA; LIVER DISEASE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUTATIONAL ANALYSIS; NAIL DISEASE; NAUSEA; NEUTROPENIA; ONCOGENE; ONCOGENE K RAS; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PIK3CA GENE; POSITRON EMISSION TOMOGRAPHY; PREOPERATIVE CARE; PRIORITY JOURNAL; RECTUM ABDOMINOPERINEAL RESECTION; RECTUM CANCER; RECTUM SURGERY; SIDE EFFECT; SKIN MANIFESTATION; SKIN PRURITUS; STOMATITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME; TUMOR LOCALIZATION; VOMITING; WEIGHT REDUCTION;

EID: 80155136973     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdq782     Document Type: Article

References (40)

1. Sauer R, Becker H, Hohenberger W et al. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 2004; 351: 1731-1740.
2. Gerard JP, Conroy T, Bonnetain F et al. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol 2006; 24: 4620-4625.
3. Bosset JF, Collette L, Calais G et al. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med 2006; 355: 1114-1123.
4. Gérard JP, Azria D, Gourgou-Bourgade S et al. Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: results of the phase III trial ACCORD 12/0405-Prodige 2. J Clin Oncol 2010; 28: 1638-1644.
5. Aschele C, Pinto C, Cordio S et al. Preoperative ?uorouracil (FU)-based chemoradiation with and without weekly oxaliplatin in locally advanced rectal cancer: pathologic response analysis of the Studio Terapia Adiuvante Retto (STAR)-01 randomized phase III trial. J Clin Oncol 2009; 27: 170S; Proc ASCO, 233A.
6. Giralt J, de las HM, 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 2005; 74: 101-108.
7. Kim J-S, Kim J-M, Li S et al. Epidermal growth factor receptor as a predictor of tumor downstaging in locally advanced rectal cancer patients treated with preoperative chemoradiotherapy. Int J Radiat Oncol Biol Phys 2006; 66: 195-200.
8. Koop R, Rothbauer E, Mueller E et al. Reduced survival of rectal cancer patients with increased tumor epidermal growth factor receptor levels. Dis Colon Rectum 2003; 46: 1391-1399.
9. Rodel C, Martus P, Papadoupolos T et al. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol 2005; 23: 8688-8696.
10. Capirci C, Valentini V, Cionini L et al. Prognostic value of pathological complete response after neoadjuvant therapy in locally advanced rectal cancer: long term analysis on 566 ypCR patients. Int J Radiat Oncol Biol Phys 2008; 72: 99-107.
11. Cunningham D, Humblet Y, Siena S et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004; 351: 337-345.
12. Van Cutsem E, Peeters M, Siena S et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007; 25: 1658-1664.
13. Van Cutsem E, Lang I, Folprecht G et al. Cetuximab plus FOLFIRI in the treatment of metastatic colorectal cancer (mCRC): the in?uence of KRAS and BRAF biomarkers on outcome: updated data from the CRYSTAL trial. J Clin Oncol 2010; 28: 15S; Proc ASCO, 3570A.
14. Siena S, Tabernero J, Cunningham D et al. Randomized phase III study of panitumumab (pmab) with FOLFOX4 compared to FOLFOX4 alone as first-line treatment (tx) for metastatic colorectal cancer (mCRC): PRIME trial. J Clin Oncol 2010; 28: 15S; Proc ASCO, 3566A.
15. Peeters M, Price TJ, Hotko YS et al. Randomized phase III study of panitumumab (pmab) with FOLFIRI versus FOLFIRI alone as second-line treatment (tx) in patients (pts) with metastatic colorectal cancer (mCRC): analysis by tumor epidermal growth factor receptor (EGFR) staining. J Clin Oncol 2010; 28: 15S; Proc ASCO, 3565A.
16. Bonner JA, Maihle NJ, Folven BR et al. The interaction of epidermal growth factor and radiation in human head and neck squamous cell carcinoma cell lines with vastly different radiosensitivities. Int J Radiat Oncol Biol Phys 1994; 29: 243-247.
17. Liang K, Ang KK, Milas L et al. The epidermal growth factor receptor mediates radioresistance. Int J Radiat Oncol Biol Phys 2003; 57: 246-254.
18. Bonner JA, Harari PM, Giralt J et al. Radiotherapy plus cetuximab for squamouscell carcinoma of the head and neck. N Engl J Med 2006; 354: 567-578.
19. Bonner JA, Harari PM, Giralt J et al. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol 2010; 11: 21-28.
20. Baumann M, Krause M, Dikomey E et al. EGFR-targeted anti-cancer drugs in radiotherapy: preclinical evaluation of mechanisms. Radiother Oncol 2007; 83: 238-248.
21. Glynne-Jones R, Mawdsley S, Harrison M. Cetuximab and chemoradiation for rectal cancer-is the water getting muddy? Acta Oncol 2010; 49: 278-286.
22. Greene LP, Balch CM, Fleming ID et al. AJCC Cancer Staging Manual, 6th edition. New York: Springer 2002.
23. Dworak O, Keilholz L, Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis 1997; 12: 19-23.
24. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38: 143-151.
25. A'Hearn RP. Sample size tables for exact phase II clinical trials. Stat Med 2001; 20: 859-866.
26. Martoni A, Di Fabio F, Pinto C et al. Prospective study on the 18F-FDG-PET/CT predictive and prognostic value in patients treated with neoadjuvant chemoradiation therapy and radical surgery for locally advanced rectal cancer. Ann Oncol 2011; 22: 650-656.
27. Bertolini F, Chiara S, Bengala C et al. Neoadjuvant treatment with single-agent cetuximab followed by 5-FU, cetuximab, and pelvic radiotherapy: a phase II study in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys 2009; 73: 466-472.
28. Machiels JP, Sempoux C, Scalliet P et al. Phase I/II study of preoperative cetuximab, capecitabine, and external beam radiotherapy in patients with rectal cancer. Ann Oncol 2007; 18: 738-744.
29. Eisterer WM, De Vries A, Oefner D et al. Neoadjuvant chemoradiation therapy with capecitabine (X) plus cetuximab (C), and external beam radiotherapy (RT) in locally advanced rectal cancer (LARC): ABCSG trial R03. J Clin Oncol 2009; 27: 15S; Proc ASCO, A4109.
30. Velenik V, Ocvirk J, Oblak I et al. A phase II study of cetuximab, capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer. Eur J Surg Oncol 2010; 36: 244-250.
31. Rö del C, Arnold D, Hipp M et al. Phase I-II trial of cetuximab, capecitabine, oxaliplatin, and radiotherapy as preoperative treatment in rectal cancer. Int J Radiat Oncol Biol Phys 2008; 70: 1081-1086.
32. Hong YS, Kim DY, Lee KS et al. Phase II study of preoperative chemoradiation (CRT) with cetuximab, irinotecan and capecitabine in patients with locally advanced resectable rectal cancer. J Clin Oncol 2007; 25: 18S; Proc ASCO, 4045A.
33. Horisberger K, Treschl A, Mai S et al. Cetuximab in combination with capecitabine, irinotecan, and radiotherapy for patients with locally advanced rectal cancer: results of a phase II MARGIT trial. Int J Radiat Oncol Biol Phys 2009; 74: 1487-1493.
34. Debucquoy A, Haustermans K, Daemen A et al. Molecular response to cetuximab and efficacy of preoperative cetuximab-based chemoradiation in rectal cancer. J Clin Oncol 2009; 27: 2751-2757.
35. Aschele C, Friso ML, Pucciarelli S et al. A phase I-II study of weekly oxaliplatin, 5-fluorouracil continuous infusion and preoperative radiotherapy in locally advanced rectal cancer. Ann Oncol 2005; 16: 1140-1146.
36. Luna-Pérez P, Segura J, Alvarado I et al. Specific c-K-ras gene mutations as a tumor-response marker in locally advanced rectal cancer treated with preoperative chemoradiotherapy. Ann Surg Oncol 2000; 7: 727-731.
37. Gaedcke J, Grade M, Jung K et al. KRAS and BRAF mutations in patients with rectal cancer treated with preoperative chemoradiotherapy. Radiother Oncol 2010; 94: 76-81.
38. Bengala C, Bettelli S, Bertolini F et al. Epidermal growth factor receptor gene copy number, K-ras mutation and pathological response to preoperative cetuximab, 5-FU and radiation therapy in locally advanced rectal cancer. Ann Oncol 2009; 20: 469-474.
39. Kim S, Shim E, Yeo H et al. KRAS mutation status and clinical outcome of preoperative chemoradiation (CRT) with or without cetuximab in locally advanced rectal cancer (LARC): a pooled analysis of two phase II trials. J Clin Oncol 2010; 28: 15S; Proc ASCO, 3650A.
40. Willett CG, Duda DG, Di Tomaso E et al. Efficacy, safety, and biomarkers of neoadjuvant bevacizumab, radiation therapy, and fluorouracil in rectal cancer: a multidisciplinary phase II study. J Clin Oncol 2009; 27: 3020-3026.