Prognostic value of cetuximab-related skin toxicity in metastatic colorectal cancer patients and its correlation with parameters of the epidermal growth factor receptor signal transduction pathway: Results from a randomized trial of the GERMAN AIO CRC Study Group

International Journal of Cancer

Volumn 132, Issue 1, 2013, Pages 236-245

  Stintzing, Sebastian ^a   Kapaun, Christine ^a   Laubender, Rüdiger Paul ^a   Jung, Andreas ^a   Neumann, Jens ^a   Modest, Dominik Paul ^a   Giessen, Clemens ^a   Moosmann, Nicolas ^a,b   Wollenberg, Andreas ^c   Kirchner, Thomas ^a   Heinemann, Volker ^a  

^a UNIVERSITY OF MUNICH   (Germany)

^b KRANKENHAUS BARMHERZIGE BRÜDER   (Germany)

^c LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

Author keywords

acneiform rash; capecitabine; cetuximab; colorectal cancer; first line; skin toxicity

Indexed keywords

CAPECITABINE; CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR; IRINOTECAN; K RAS PROTEIN; OXALIPLATIN;

ACNE; ARTICLE; CANCER GRADING; CANCER PATIENT; CANCER SURVIVAL; CODON; COLORECTAL CANCER; CORRELATION ANALYSIS; DRUG EFFICACY; DRY SKIN; ENZYME ACTIVITY; ERYTHEMA; FEMALE; GENE MUTATION; GENETIC POLYMORPHISM; GERMANY; HUMAN; INTRON; MAJOR CLINICAL STUDY; MALE; METASTASIS; METASTASIS POTENTIAL; MULTICENTER STUDY (TOPIC); MULTIPLE CYCLE TREATMENT; MULTIVARIATE ANALYSIS; ONCOGENE K RAS; OUTCOME ASSESSMENT; PAPULAR RASH; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROGNOSIS; PROTEIN EXPRESSION; PROTEIN FUNCTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RETROSPECTIVE STUDY; SIGNAL TRANSDUCTION; SKIN TOXICITY; TREATMENT OUTCOME;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COHORT STUDIES; COLORECTAL NEOPLASMS; DEOXYCYTIDINE; FEMALE; FLUOROURACIL; HUMANS; MALE; MUTATION; ORGANOPLATINUM COMPOUNDS; POLYMORPHISM, GENETIC; PROGNOSIS; RECEPTOR, EPIDERMAL GROWTH FACTOR; RETROSPECTIVE STUDIES; SIGNAL TRANSDUCTION; SKIN; TREATMENT OUTCOME;

EID: 84868204016     PISSN: 00207136     EISSN: 10970215     Source Type: Journal    
DOI: 10.1002/ijc.27654     Document Type: Article

References (41)

1. Van Cutsem E, Kohne CH, Hitre E, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009; 360: 1408-17.
2. Bokemeyer C, Bondarenko I, Makhson A, et al. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol 2009; 27: 663-71.
3. De Roock W, Jonker DJ, Di Nicolantonio F, et al. Association of KRAS p.G13D mutation with outcome in patients with chemotherapy-refractory metastatic colorectal cancer treated with cetuximab. J Am Med Assoc 2010; 304: 1812-20.
4. Khambata-Ford S, Garrett CR, Meropol NJ, et al. Expression of epiregulin and amphiregulin and K-ras mutation status predict disease control in metastatic colorectal cancer patients treated with cetuximab. J Clin Oncol 2007; 25: 3230-7.
5. Loupakis F, Ruzzo A, Cremolini C, et al. KRAS codon 61, 146 and BRAF mutations predict resistance to cetuximab plus irinotecan in KRAS codon 12 and 13 wild-type metastatic colorectal cancer. Br J Cancer 2009; 101: 715-21.
6. Scartozzi M, Galizia E, Chiorrini S, et al. Arterial hypertension correlates with clinical outcome in colorectal cancer patients treated with first-line bevacizumab. Ann Oncol 2009; 20: 227-30.
7. Gatzemeier U, von Pawel J, Vynnychenko I, et al. First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy: a subgroup analysis of data from the FLEX phase 3 study. Lancet Oncol 2011; 12: 30-7.
8. Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007; 25: 1960-6.
9. Wacker B, Nagrani T, Weinberg J, et al. Correlation between development of rash and efficacy in patients treated with the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib in two large phase III studies. Clin Cancer Res 2007; 13: 3913-21.
10. Potthoff K, Hofheinz R, Hassel JC, et al. Interdisciplinary management of EGFR-inhibitor-induced skin reactions: a German expert opinion. Ann Oncol 2011; 22: 524-35.
11. Moosmann N, von Weikersthal LF, Vehling-Kaiser U, et al. Cetuximab plus capecitabine and irinotecan compared with cetuximab plus capecitabine and oxaliplatin as first-line treatment for patients with metastatic colorectal cancer: AIO KRK-0104a - A randomized trial of the German AIO CRC Study Group. J Clin Oncol 2011; 29: 1050-8.
12. 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: 337-45.
13. Lenz HJ, Van Cutsem E, Khambata-Ford S, et al. Multicenter phase II and translational study of cetuximab in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin, and fluoropyrimidines. J Clin Oncol 2006; 24: 4914-21.
14. Graziano F, Ruzzo A, Loupakis F, et al. Pharmacogenetic profiling for cetuximab plus irinotecan therapy in patients with refractory advanced colorectal cancer. J Clin Oncol 2008; 26: 1427-34.
15. Ocvirk J, Brodowicz T, Wrba F, et al. Cetuximab plus FOLFOX6 or FOLFIRI in metastatic colorectal cancer: CECOG trial. World J Gastroenterol 2010; 16: 3133-43.
16. Tol J, Koopman M, Cats A, et al. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med 2009; 360: 563-72.
17. Cappuzzo F, Finocchiaro G, Rossi E, et al. EGFR FISH assay predicts for response to cetuximab in chemotherapy refractory colorectal cancer patients. Ann Oncol 2008; 19: 717-23.
18. Neumann J, Zeindl-Eberhart E, Kirchner T, et al. Frequency and type of KRAS mutations in routine diagnostic analysis of metastatic colorectal cancer. Pathol Res Pract 2009; 205: 858-62.
19. Selzman CH, Meldrum DR, Cain BS, et al. Interleukin-10 inhibits postinjury tumor necrosis factor-mediated human vascular smooth muscle proliferation. J Surg Res 1998; 80: 352-56.
20. Moosmann N, von Weikersthal LF, Vehling-Kaiser U, et al. Cetuximab plus capecitabine and irinotecan compared with cetuximab plus capecitabine and oxaliplatin as first-line treatment for patients with metastatic colorectal cancer: AIO KRK-0104a-a randomized trial of the German AIO CRC study group. J Clin Oncol 2011; 29: 1050-8.
21. Modest DP, Jung A, Moosmann N, et al. The influence of KRAS- and BRAF-mutations on the efficacy of cetuximab-based 1st-line therapy of metastatic colorectal cancer: an analysis of the AIO KRK-0104-trial. Int J Cancer 2011. doi: 10.1002/ijc.26467. [Epub ahead of print].
22. Tveit K, Guren T, Glimelius B, et al. Randomized phase III study of 5-fluorouracil/folinate/oxaliplatin given continuously or intermittently with or without cetuximab, as first-line treatment of metastatic colorectal cancer: The NORDIC VII Study (NCT00145314). Ann Oncol 2010; 21: viii1-viii12, 2010;ESMO 2010 Abstract: LBA20.
23. Maughan TS, Adams RA, Smith CG, et al. Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial. Lancet 2011; 377: 2103-14.
24. Tejpar S, Bokemeyer C, Celik I, et al. Influence of KRAS G13D mutations on outcome in patients with metastatic colorectal cancer (mCRC) treated with first-line chemotherapy with or without cetuximab. 2011 ASCO Annual Meeting. J Clin Oncol 2011; 29 (suppl; abstr 3511).
25. Karapetis CS, Khambata-Ford S, Jonker DJ, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008; 359: 1757-65.
26. Pessino A, Artale S, Sciallero S, et al. First-line single-agent cetuximab in patients with advanced colorectal cancer. Ann Oncol 2008; 19: 711-6.
27. Saltz LB, Meropol NJ, Loehrer PJ, Sr., et al. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol 2004; 22: 1201-8.
28. Van Cutsem E, Rougier P, Kohne C, et al. A meta-analysis of the CRYSTAL and OPUS studies combining cetuximab with chemotherapy (CT) as 1st-line treatment for patients (pts) with metastatic colorectal cancer (mCRC): results according to KRAS and BRAF mutation status. EJC Suppl 2009; 7: 345-45.
29. Douillard JY, Siena S, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol 2010; 28: 4697-705.
30. Price TJ, Peeters M, Douillard J, et al. Safety summary of panitumumab (pmab) in combination with chemotherapy (ctx) from four clinical trials in patients (pts) with metastatic colorectal cancer (mCRC). J Clin Oncol 2009; 27 (suppl; abstr e15005).
31. Lievre A, Bachet JB, Boige V, et al. KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab. J Clin Oncol 2008; 26: 374-9.
32. Di Fiore F, Blanchard F, Charbonnier F, et al. Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by Cetuximab plus chemotherapy. Br J Cancer 2007; 96: 1166-9.
33. Tosolini M, Kirilovsky A, Mlecnik B, et al. Clinical impact of different classes of infiltrating T cytotoxic and helper cells (Th1, th2, treg, th17) in patients with colorectal cancer. Cancer Res 2011; 71: 1263-71.
34. Mlecnik B, Tosolini M, Kirilovsky A, et al. Histopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction. J Clin Oncol 2011; 29: 610-8.
35. Zitvogel L, Kepp O, Kroemer G,. Immune parameters affecting the efficacy of chemotherapeutic regimens. Nat Rev Clin Oncol 2011; 8: 151-60.
36. Park JH, Han SW, Oh DY, et al. Analysis of KRAS, BRAF, PTEN, IGF1R, EGFR intron 1 CA status in both primary tumors and paired metastases in determining benefit from cetuximab therapy in colon cancer. Cancer Chemother Pharmacol 2011; 68: 1045-55.
37. Klinghammer K, Knodler M, Schmittel A, et al. Association of epidermal growth factor receptor polymorphism, skin toxicity, and outcome in patients with squamous cell carcinoma of the head and neck receiving cetuximab-docetaxel treatment. Clin Cancer Res 2010; 16: 304-10.
38. Dahan L, Norguet E, Etienne-Grimaldi MC, et al. Pharmacogenetic profiling and cetuximab outcome in patients with advanced colorectal cancer. Biomed Chromatogr Cancer 2011; 11: 496.
39. Miligi L, Costantini AS, Benvenuti A, et al. Occupational exposure to solvents and the risk of lymphomas. Epidemiology 2006; 17: 552-61.
40. Boeck S, Jung A, Laubender RP, et al. Molecular markers of the EGFR pathway in erlotinib-treated patients with advanced pancreatic cancer (APC): translational analyses of a randomized, cross-over AIO phase III trial-2011 ASCO Annual Meeting. J Clin Oncol 2011; 29 (suppl; abstr 4047).
41. Parmar S, Schumann C, Rudiger S, et al. Pharmacogenetic predictors for EGFR-inhibitor-associated skin toxicity. Pharmacogenomics J 2011. doi: 10.1038/tpj.2011.51. [Epub ahead of print].