Cutaneous Reactions Related to Systemic Immunomodulators and Targeted Therapeutics

Dermatologic Clinics

Volumn 26, Issue 1, 2008, Pages 121-159

  Hammond Thelin, Lisa A ^a  

^a NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; BORTEZOMIB; CANERTINIB; CAPECITABINE; CARBOPLATIN; CETUXIMAB; CISPLATIN; CORTICOSTEROID; DASATINIB; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; ERLOTINIB; GEFITINIB; GEMCITABINE; IMATINIB; IMMUNOMODULATING AGENT; IRINOTECAN; LAPATINIB; LENALIDOMIDE; MATUZUMAB; NIMOTUZUMAB; PACLITAXEL; PELITINIB; SORAFENIB; STEROID; SUNITINIB; THALIDOMIDE; UNINDEXED DRUG; VANDETANIB;

ALOPECIA; CANCER PATIENT; CLINICAL TRIAL; COLORECTAL CANCER; DEPIGMENTATION; DESQUAMATION; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG MEGADOSE; DRUG TARGETING; DRUG WITHDRAWAL; ECCHYMOSIS; HAND FOOT SYNDROME; HISTOPATHOLOGY; HUMAN; HYPERPIGMENTATION; HYPOPIGMENTATION; KIDNEY CARCINOMA; LARYNX CANCER; LUNG NON SMALL CELL CANCER; PARONYCHIA; PRIORITY JOURNAL; PRURITUS; RASH; REVIEW; SKIN BIOPSY; SKIN DISCOLORATION; SKIN FISSURE; SKIN INFLAMMATION; SKIN MANIFESTATION; SKIN TOXICITY; TREATMENT DURATION; VASCULITIC RASH;

ANTINEOPLASTIC AGENTS; HUMANS; IMMUNOLOGIC FACTORS; IMMUNOSUPPRESSIVE AGENTS; NEOPLASMS; PROTEASE INHIBITORS; PROTEIN KINASE INHIBITORS; RECEPTOR, EPIDERMAL GROWTH FACTOR; REFERRAL AND CONSULTATION; SKIN DISEASES; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 36148979326     PISSN: 07338635     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.det.2007.08.010     Document Type: Review

References (196)

1. Perez-Soler R., Delord J.P., Halpern A., et al. HER1/EGFR inhibitor-associated rash: future directions for management and investigation outcomes from the HER1/EGFR inhibitor rash management forum. Oncologist 10 (2005) 345-356
2. Damjanov N., and Meropol N.J. Epidermal growth factor receptor inhibitors for the treatment of colorectal cancer: a promise fulfilled?. Oncology 18 (2004) 479-488
3. Miller K.D., Trigo J.M., Wheeler C., et al. A multicenter phase II trial of ZD6474, a vascular endothelial growth factor receptor-2 and epidermal growth factor receptor tyrosine kinase inhibitor in patients with previously treated metastatic breast cancer. Clin Cancer Res 11 (2005) 3369-3376
4. Holden S.N., Eckhardt S.G., Basser R., et al. Clinical evaluation of ZD6474, an orally active inhibitor of VEGF and EGF receptor signaling, in patients with solid, malignant tumors. Ann Oncol 16 (2005) 1391-1397
5. Yano S., Kondo K., Yamaguchi M., et al. Distribution and function of EGFR in human tissue and the effect of EGFR tyrosine kinase inhibition. Anticancer Res 23 (2003) 3639-3650
6. Stoscheck C.M., Nanney L.B., and King Jr. L.E. Quantitative determination of EGF-R during epidermal wound healing. J Invest Dermatol 99 (1992) 645-649
7. Mascia F., Mariani V., Girolomini G., et al. Blockade of the EGF receptor induces a deranged chemokine expression in keratinocytes leading to enhanced skin inflammation. Am J Pathol 163 (2003) 303-312
8. Herbst R.S., LoRusso P.M., Purdom M., et al. Dermatologic side effects associated with gefitinib therapy: clinical experience and management. Clin Lung Cancer 4 (2003) 366-369
9. Van Doorn R., Kirtschig G., Scheffer E., et al. Follicular and epidermal alterations in patients treated with ZD1839 (Iressa), an inhibitor of the epidermal growth factor receptor. Br J Dermatol 147 (2002) 598
10. Herbst R.S., Giaccone G., Schiller J.H., et al. Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 2. J Clin Oncol 22 (2004) 785-794
11. Fukuoka M., Yano S., Giaccone G., et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small cell lung cancer. J Clin Oncol 21 (2003) 2237-2246
12. Saltz L.B., Meropol N.J., Loewer P.J., et al. Phase II trials of cetuximab in patients with refractory colorectal cancer that express the epidermal growth factor receptor. J Clin Oncol 22 (2004) 1201-1208
13. Soulieres D., Senzer N.N., Vokes E.E., et al. Multicenter phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. J Clin Oncol 22 (2004) 77-85
14. Park J., Park B.B., Kim J.Y., et al. Gefitinib (ZD1839) monotherapy as a salvage regimen for previously treated advanced non-small cell lung cancer. Clin Cancer Res 10 (2004) 4383-4388
15. Nemunaitis J., Eiseman J., Cunningham C., et al. Phase I clinical and pharmacokinetic evaluation of oral CI-1033 in patients with refractory cancer. Clin Cancer Res 11 (2005) 3846-3853
16. Calvo E., Tolcher A.W., Hammond L.A., et al. Administration of CI-1033, an irreversible pan-erbB tyrosine kinase inhibitor, is feasible on a 7-day on, 7-day off schedule. Clin Cancer Res 10 (2004) 7112-7120
17. Campos S., Hamid O., Seiden M.V., et al. Multicenter, randomized phase II trial of oral CI-1033 for previously treated advanced ovarian cancer. J Clin Oncol 23 (2005) 5597-5604
18. Chan A.T.C., Hsu M.M., Goh B.C., et al. Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma. J Clin Oncol 23 (2005) 3568-3576
19. Burtness B., Goldwasser M.A., Flood W., et al. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic recurrent head and neck cancer: an Eastern Cooperative Oncology Group Study. J Clin Oncol 23 (2005) 8646-8654
20. 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
21. Baselga J., Trigo J.M., Bourhis J., et al. Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. J Clin Oncol 23 (2005) 5568-5577
22. Herbst R.S., Arquette M., Shin D.M., et al. Phase II multicenter study of the epidermal growth factor receptor antibody cetuximab and cisplatin for recurrent and refractory squamous cell carcinoma of the head and neck. J Clin Oncol 23 (2005) 5578-5587
23. Molinari E., De Quatrebarbes J., Andre T., et al. Cetuximab-induced acne. Dermatology 211 (2005) 330-333
24. Erlichman C., Hidalgo M., Boni J.P., et al. Phase I study of EKB-569, an irreversible inhibitor of the epidermal growth factor receptor, in patients with advanced solid tumors. J Clin Oncol 24 (2006) 2252-2260
25. Shepherd F.A., Pereira J.R., Ciuleanu T., et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353 (2005) 123-132
26. Philip P.A., Mahoney M.R., Allmer C., et al. Phase II study of erlotinib (OSI-774) in patients with advanced hepatocellular cancer. J Clin Oncol 23 (2005) 6657-6663
27. Gatzemeier U., Pluzanska A., Szczesna A., et al. Results of a phase II trial of erlotinib (OSI-774) combined with cisplatin and gemcitabine (GC) chemotherapy in advanced non-small cell lung cancer (NSCLC). [abstr#7010]. Proc Am Soc Clin Oncol 23 (2004) 617
28. Herbst R.S., Prager D., Herman R., et al. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small cell lung cancer. J Clin Oncol 23 (2005) 5892-5899
29. Hainsworth J.D., Sosman J.A., Spigel D.R., et al. Treatment of metastatic renal cell carcinoma with combination of bevacizumab and erlotinib. J Clin Oncol 23 (2005) 7889-7896
30. Matheis P., Socinski M.A., Burkhart C., et al. Treatment of gefitinib-associated folliculitis. J Am Acad Dermatol 55 (2006) 710-713
31. West H.L., Franklin W.A., McCoy J., et al. Gefitinib therapy in advanced brochioalveolar carcinoma: Southwest Oncology Group Study S0126. J Clin Oncol 24 (2006) 1807-1813
32. Baselga J., Rischin D., Ranson M., et al. Phase I safety, pharmacokinetic, and pharmacodynamic trial of ZD1839, a selective oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with five selected solid tumor types. J Clin Oncol 20 (2002) 4292-4302
33. Giaccone G., Herbst R.S., Manegold C., et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 1. J Clin Oncol 22 (2004) 777-784
34. Rich J.N., Reardon D.A., and Peery T. Phase II trial of gefitinib in recurrent glioblastoma. J Clin Oncol 22 (2004) 133-142
35. Rothenberg M.L., LaFleur B., Levy D.E., et al. Randomized phase II trials of the clinical and biological effects of two dose levels of gefitinib in patients with recurrent colorectal adenocarcinomas. J Clin Oncol 23 (2005) 9265-9274
36. Burris H.A., Hurwitz H.I., Dees E.C., et al. Phase I safety, pharmacokinetics, and clinical activity study of lapatinib (GW572016), a reversible dual inhibitor of epidermal growth factor receptor tyrosine kinases, in heavily pretreated patients with metastatic carcinomas. J Clin Oncol 23 (2005) 5305-5313
37. Vanhoefer U., Tewes M., Rojo F., et al. Phase I study of the humanized antiepidermal growth factor receptor monoclonal antibody EMD72000 in patients with advanced solid tumors that express the epidermal growth factor receptor. J Clin Oncol 22 (2004) 175-184
38. Rowinsky E.K., Schwartz G.H., Gollob J.A., et al. Safety, pharmacokinetics, and activity of ABX-EGF, a fully human anti-epidermal growth factor receptor monoclonal antibody in patients with metastatic renal cell cancer. J Clin Oncol 22 (2004) 3003-3015
39. Perez-Soler R. Can rash associated with HER1/EGFR inhibition be used as a marker of treatment outcome?. Oncology 17 Suppl 12 (2003) 23-28
40. Kimyai-Asadi A., and Jih M.H. Follicular toxic effects of chimeric anti-epidermal growth factor receptor antibody cetuximab used to treat human solid tumors. Arch Dermatol 138 (2002) 129-131
41. Hidalgo M., Siu L.L., Nemunaitis J., et al. Phase I and pharmacologic study of OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced solid malignancies. J Clin Oncol 19 (2001) 3267-3279
42. Ranson M., Hammond L., Ferry D., et al. ZD1839, a selective oral epidermal growth factor receptor-tyrosine kinase inhibitor is well tolerated and active in patients with solid, malignant tumors: results of a phase I trial. J Clin Oncol 20 (2002) 2240-2250
43. Herbst R., Maddox A.M., Rothenberg M.L., et al. Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small-cell lung cancer and other solid tumors: results of a phase I trial. J Clin Oncol 20 (2002) 3815-3825
44. Schoffski P., Lutz M.P., Folprecht G., et al. Cetuximab (C225) plus irinotecan (CPT-11) plus infusional 5-FU-folinic acid (FA) is safe and active in metastatic colorectal cancer (MCRC), that expresses epidermal growth factor receptor (EGFR). Proc Am Soc Clin Oncol 21 (2002) 1599
45. Jacot W., Bessis D., and Jorda E. Acneiform eruption induced by epidermal growth factor receptor inhibitors in patients with solid tumors. Br J Dermatol 151 (2004) 238
46. Sundermeyer M.L., Lessin S.R., and Meropol N.J. Targeted therapies in colorectal cancer: complications and management. Current Colorectal Cancer Reports 2 (2006) 125-133
47. Micantonio T., Fargnoli M.C., Ricevuto E., et al. Efficacy of treatment with tetracyclines to prevent acneiform eruption secondary to cetuximab therapy. Arch Dermatol 141 (2005) 1173-1174
48. Malik S.N., Siu L., Rowinsky E.K., et al. Pharmacodynamic evaluation of the epidermal growth factor receptor inhibitor OSI-774 in human epidermis of cancer patients. Clin Cancer Res 9 (2003) 2478-2486
49. Fernandez-Galar M., Espana A., and Lopez-Picazo J.M. Acneiform lesions secondary to ZD1839, an inhibitor of the epidermal growth factor receptor. Clin Exp Dermatol 29 (2004) 138
50. Hannoud S., Rixe O., Bloch J., et al. [Skin signs associated with epidermal growth factor inhibitors]. Ann Dermatol Venereol 133 (2006) 239-242 [in French]
51. Fox L.P. Pathology and management of dermatologic toxicities associated with anti-EGFR therapy. Oncology 20 (2006) 26-34
52. Hammond L.A., Figueroa J., Schwartzberg L., et al. Feasibility and pharmacokinetic (PK) trial of ZD1839 (IRESSA), an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in patients with advanced colorectal cancer. [a(#544)]. Proc Am Soc Clin Oncol 20 (2001) 137
53. Busam K.J., Capodieci P., Motzer R., et al. Cutaneous side-effects in cancer patients treated with the antiepidermal growth factor receptor antibody C225. Br J Dermatol 144 (2001) 1169-1176
54. Mitra S.S., and Simcock R. Erlotinib induced skin rash spares skin in previous radiotherapy field. J Clin Orthod 24 16 (2006) e28-e29
55. 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
56. Clark G.M., Perez-Soler R., Siu L., et al. Rash severity is predictive of increased survival with erlotinib HCl. [abstr#786]. Proc Am Soc Clin Oncol 22 (2003) 196
57. Saltz L., Kies M., Abbruzzese J.L., et al. The presence and intensity of the cetuximab-induced acne-like rash predicts increased survival in studies across multiple malignancies. [abstr#817]. Proc Am Soc Clin Oncol 22 (2003) 204
58. Kris M.G., Natale R.B., Herbst R.S., et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small-cell lung cancer: a randomized trial. JAMA 290 (2003) 2149-2158
59. Cohen E.E.W., Rosen F., Stadler W.M., et al. Phase II trial of ZD1839 in recurrent or metastatic squamous cell carcinoma of the head and neck. J Clin Oncol 21 (2003) 1980-1987
60. Ramos TC, Figueredo J, Catala M, et al. Treatment of high-grade glioma patients with the humanized anti-epidermal growth factor receptor (EGFR) antibody h-R3. Cancer Biol Ther 2006;5(4):375-79.
61. Allan D. Nimotuzumab: evidence of clinical benefit without rash. Oncologist 10 9 (2005) 760-761
62. Crombet T., Torres L., Neninger E., et al. Pharmacological valuation of humanized anti-epidermal growth factor receptor, monoclonal antibody h-R3, in patients with advanced epithelial-derived cancer. J Immunother 26 (2003) 139-148
63. Crombet T., Osorio M., Cruz T., et al. Use of the humanized anti-epidermal growth factor receptor monoclonal antibody h-R3 in combination with radiotherapy in the treatment of locally advanced head and neck cancer patients. J Clin Oncol 22 9 (2004) 1646-1654
64. Mita C.A., Schwartz G., Mita M.M., et al. A pilot, pharmacokinetic (PK), and pharmacodynamic (PD) study to determine the feasibility of intrapatient dose escalation to tolerable rash and the activity of maximal doses of erlotinib (E) in previously treated patients with advanced non-small cell lung cancer (NSCLC). [abstract#3045]. Proc Am Soc Clin Oncol 23 16S (2005) 203S
65. Segaert S., and Van Cutsem E. Clinical signs, pathophysiology and management of skin toxicity during therapy with epidermal growth factor receptor inhibitors. Ann Oncol 16 (2005) 1425-1433
66. Pao W., Miller V., Zakowski M., et al. EGF receptor gene mutations are common in lung cancers from "never smokers" and are associated with sensitivity of tumors to gefitinib (Iressa) and erlotinib (Tarceva). Proc Natl Acad Sci U S A 101 (2004) 13306-13311
67. Bunn P.A., and Franklin W. Epidermal growth factor receptor expression, signal pathway, and inhibitors in non-small cell lung cancer. Semin Oncol 29 Suppl 14 (2002) 38-44
68. Albanell J., Rojo F., Averbuch S., et al. Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition. J Clin Oncol 20 (2002) 110-124
69. Tscharner G.G., Buhler S., Borner M., et al. Grover's disease induced by cetuximab. Dermatology 213 1 (2006) 37-39
70. Trojan A., Jacky E., Follath F., et al. Necrolytic migratory erythema (Glucagonoma)-like skin lesions induced by EGF-receptor inhibition. Swiss Med Wkly 133 (2003) 22
71. Sagara R., Kitami A., Nakada T., et al. Adverse reactions to gefitinib (Iressa): revealing sycosis- and pyoderma gangrenosum-like lesions. Int J Dermatol (2006) [published online]
72. Kurokawa I., Endo K., and Hirabayashi M. Purpuric drug eruption possibly due to gefitinib. Int J Dermatol 44 (2005) 167-168
73. Lenz H.J. Anti-EGFR mechanism of action: antitumor effect and underlying cause of adverse events. Oncology 20 (2006) 5-13
74. Messersmith W.A., Laheru D.A., Senzer N.N., et al. Phase I trial of irinotecan, infusional 5-fluorouracil, and leucovorin (FOLFIRI) with erlotinib (OSI-774): early termination due to increased toxicities. Clin Cancer Res 10 (2004) 6522-6527
75. National Cancer Institute. Common terminology criteria for adverse events, version 3.0. Bethesda (MD): National Cancer Institute; 2003.
76. Cortesi E., Cerato D.P., D'Auria G., et al. Management of cutaneous adverse effects during treatment with ZD1839 in advanced non-small cell lung cancer (NSCLC): surprising efficacy of early local treatment. [a7100]. Proc Am Soc Clin Oncol 23 (2004) 638
77. Alexandrescu D.T., Vaillant J.G., and Dasanu C.A. Effect of treatment with a colloidal oatmeal lotion on the acneform eruption induced by epidermal growth factor receptor and multiple tyrosine-kinase inhibitors. Clin Exp Dermatol (2006) [Epub]
78. Townsley C.A., Major P., Siu L.L., et al. Phase II study of erlotinib (OSI-774) in patients with metastatic colorectal cancer. Br J Cancer 94 (2006) 1136-1143
79. Rhee J., Oishi K., Garey J., et al. Management of rash and other toxicities in patients with epidermal growth factor receptor-targeted agents. Clin Colorectal Cancer 5 Suppl 2 (2005) S101-S106
80. Garey J.S., Oishi K.J., Burke B., et al. Treatment of skin rash in a phase II study of cisplatin, docetaxel, and erlotinib in patients with advanced head and neck cancer: a prospective algorithmic approach. [a8231]. Proc Am Soc Clin Oncol 23 (2006) 786S
81. Garland L.L., Hidalgo M., Mendelson D.S., et al. A phase I and pharmacokinetic study of oral CI-1033 in combination with docetaxel in patients with advanced solid tumors. Clin Cancer Res 12 (2006) 4274-4282
82. Gutzmer R., Werfel T., Mao R., et al. Successful treatment with oral isotretinoin of acneiform skin lesions associated with cetuximab. Br J Dermatol 153 (2005) 849
83. Segaert S., Tabernero J., Chosidow O., et al. The management of skin reactions in cancer patients receiving epidermal growth factor receptor targeted therapies. J Dtsch Dermatol Ges 3 (2005) 599
84. Perez-Soler R., Chachaoua A., Hammond L., et al. Determinants of tumor response and survival with erlotinib. J Clin Oncol 22 (2004) 3238-3247
85. Bouche O., Brixi-Benmansour H., Bertin A., et al. Trichilomegaly of the eyelashes following treatment with cetuximab. Ann Oncol 16 (2005) 1171-1172
86. Boucher K.W., Davidson K., Mirakhur B., et al. Paronychia induced cetuximab, an antiepidermal growth factor receptor antibody. J Am Acad Dermatol 45 (2002) 632-633
87. Dueland S., Sauer T., Lund-Johansen F., et al. Epidermal growth factor receptor inhibition induces trichomegaly. Acta Oncol 42 (2003) 345-346
88. Razis E., Karina M., Karanastassi S., et al. Three case reports of hand-foot syndrome with gefitinib. Cancer Invest 24 (2006) 514-516
89. Lee M.W., Seo C.W., Kim S.W., et al. Cutaneous side effects in non-small cell lung cancer patients treated with Iressa (ZD1839), an inhibitor of epidermal growth factor. Acta Derm Venereol 83 (2004) 116508
90. Monti M., Mancini L.L., Ferrari B., et al. Complications of therapy and a diagnostic dilemma case. Case 2. Cutaneous toxicity induced by cetuximab. J Clin Oncol 21 (2003) 4651-4653
91. Chang G.C., Yang T.Y., Chen K.C., et al. Complications of therapy in cancer patients. J Clin Oncol 22 (2004) 4646-4648
92. Suh K.Y., Kindler H.L., Medenica M., et al. Doxycycline for the treatment of paronychia induced by the epidermal growth factor receptor inhibitor cetuximab. Br J Dermatol 154 (2006) 191-192
93. Rothenberg M., and Hochster H. Treatment of colorectal cancer. Expert Insights 3 (2005) 1-4
94. Golub L.M., Lee H.M., Ryan M.E., et al. Tetracyclines inhibit connective tissue breakdown by multiple non-antimicrobial mechanisms. Adv Dent Res 12 (1998) 12-26
95. Shah N.T., Kris M.G., Pao W., et al. Practical management of patients with non-small-cell lung cancer treated with gefitinib. J Clin Oncol 23 (2005) 165-174
96. Pascual J.C., Belinchon I., Sivera F., et al. Severe cutaneous toxicity following treatment with gefitinib (ZD1839). Br J Dermatol 153 (2005) 1222
97. Robert C., Soria J.C., Spatz A., et al. Cutaneous side-effects of kinase inhibitors and blocking antibodies. Lancet 6 (2005) 491-500
98. Montagut C., Grau J.J., Grimalt R., et al. Abnormal hair growth in a patient with head and neck cancer treated with the anti-epidermal growth factor receptor monoclonal antibody cetuximab. J Clin Oncol 23 (2005) 5273-5275
99. Moss J.E., and Burtness B. Cetuximab-associated acneiform eruption. N Engl J Med 353 (2005) e17
100. Stadler W.M. New targets, therapies, and toxicities: lessons to be learned. J Clin Oncol 24 (2006) 4-5
101. Normolle D., and Lawrence T. Designing dose-escalation trials with late-onset toxicities using the time-to event continual reassessment method. J Clin Oncol 24 (2006) 4426-4433
102. Perea S., Oppenheimer D., Amador M., et al. Genotypic bases of EGFR inhibitors pharmacological actions. [abstract#3005]. Proc Am Soc Clin Oncol 23 (2004) 196
103. Liu W.W., Innocenti F., Chen P., et al. Inter-ethnic differences in the allelic distribution of human epidermal growth factor receptor intron 1 polymorphism. Clin Cancer Res 9 (2003) 1009-1012
104. Zhou Q., Kibat C., Cheung Y.B., et al. Pharmacogenetics of the epidermal growth factor receptor (EGFR) gene in Chinese, Malay, and Indian populations. [abstract#3019]. Proc Am Soc Clin Oncol 23 (2004) 199
105. Mendel D.B., Laird A.D., Xin X., et al. In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptor inhibitors: determination of a pharmacokinetic/pharmacodynamic relationship. Clin Cancer Res 9 (2003) 327-337
106. Faivre S., Delbado C., Vera K., et al. Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitargeted tyrosine kinase inhibitor, in patients with cancer. J Clin Oncol 24 (2006) 25-35
107. O'Farrell A.M., Foran J.M., Fiedler W., et al. An innovative phase I clinical study demonstrates inhibition of FLT3 phosphorylation by SU11248 in acute myeloid leukemia patients. Clin Cancer Res 9 (2003) 5465-5476
108. Fiedler W., Serve H., Dohner H., et al. A phase I study of SU11248 in the treatment of patients with refractory or resistant acute myeloid leukemia (AML) or not amenable to conventional therapy for the disease. Blood 105 (2005) 986-993
109. Demetri G.D., van Oosterom A.T., Garrett C.R., et al. The efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumor after failure of imatinib: a randomized controlled trial. Lancet 368 (2006) 1329-1338
110. Motzer R.J., Rini B.I., Bukowski R.M., et al. Sunitinib in patients with metastatic renal cell carcinoma. JAMA 295 (2006) 2516-2524
111. Wood L. Managing the side effects of sorafenib and sunitinib. Community Oncology 3 (2006) 558-562
112. Robert C., Spatz, Faivre S., et al. Tyrosine kinase inhibition: grey hair. Lancet 361 (2003) 1056
113. Moss K.G., Toner G.C., Cherrington J.M., et al. Hair depigmentation is a biological readout for pharmacological inhibition of kit in mice and humans. J Pharmacol Exp Ther 307 (2003) 476-480
114. Wilhelm S.M., Carter C., Tang L.Y., et al. Bay439006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinase involved in tumor progression and angiogenesis. Cancer Res 64 (2004) 7099-7109
115. Awada A., Hendlisz A., Gil T., et al. Phase I safety and pharmacokinetics of BAY-439006 administered for 21 days on/7 days off in patients with advanced refractory solid tumours. Br J Cancer 92 (2005) 1855-1861
116. Clark J.W., Eder J.P., Ryan D., et al. The safety and pharmacokinetics of the multi-targeted tyrosine kinase inhibitor (including Raf kinase and VEGF kinase), BAY 43-9006, in patients with advanced, refractory solid tumors. Clin Cancer Res 11 (2005) 5472-5480
117. Moore M.J., Hirte H.W., Siu L., et al. Phase I study to determine the safety and pharmacokinetics of the novel Raf kinase and VEGFR inhibitor BAY43-9006, administered for 28 days on/7 days off in patients with advanced, refractory solid tumors. Ann Oncol 16 (2005) 1688-1694
118. Strumberg D., Richly H., Hilger R.A., et al. Phase I clinical and pharmacokinetic study of the novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY43-9006 in patients with advanced refractory solid tumors. J Clin Oncol 23 (2005) 965-972
119. Siu L., Awada A., Takimoto C.H., et al. Phase I trial of sorafenib and gemcitabine in advanced solid tumors with an expanded cohort in advanced pancreatic cancer. Clin Cancer Res 12 (2006) 144-151
120. Ratain M.J., Eisen T., Stadler W.M., et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 24 (2006) 2505-2512
121. Eisen T., Ahmad T., Flaherty K.T., et al. Sorafenib in advanced melanoma: a phase II randomized discontinuation trial analysis. Br J Cancer 95 (2006) 581-586
122. Escudier B., Szczylik C., Eisen T., et al. Randomized phase III trial of the Raf kinase and VEGFR inhibitor Sorafenib (Bay 43-9006) in patients with advanced renal cell carcinoma (RCC). Proc Am Soc Clin Oncol 23 (2005) 4510a
123. Abou-Alfa G.K., Schwartz L., Ricci S., et al. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol 24 (2006) 4293-4300
124. Richly H., Henning B.F., Kupsch P., et al. Results of a phase I trial of sorafenib (Bay-439006) in combination with doxorubicin in patients with refractory solid tumors. Ann Oncol 17 (2006) 866-873
125. Awada A, Gil T, Vanhamme J, et al. A phase I study of sorafenib in combination with capecitabine in patients with advanced solid tumors [abstr#98]. Proc 18th EORTC-NCI-AACR Symposium Molec Targets Cancer Ther 2006;4:33.
126. Strumberg D., Awada A., Hirte H., et al. Pooled safety analysis of BAY43-9006 (Sorafenib) monotherapy in patients with advanced solid tumors: is rash associated with treatment outcome?. Eur J Cancer 42 (2006) 548-556
127. Robert C., Faivre S., Raymond E., et al. Subungual splinter hemorrhages: a clinical window to inhibition of vascular endothelial growth factor receptors?. Ann Intern Med 143 (2005) 313-314
128. Autier J, Escudier B, Spatz A, et al. A prospective study of the cutaneous side-effects of sorafenib, a novel multikinase inhibitor [abstr#105]. Proc 18th EORTC-NCI-AACR Symposium Molec Targets Cancer Ther 2006;4:35.
129. Duran I, Hotte SJ, Chen EX, et al. Dual inhibition of the MAPK pathway by combination targeted therapy: a phase I trial of Sorafenib (SOR) and erlotinib (ERL) in advanced solid tumors [abstr#550]. Proc 18th EORTC-NCI-AACR Symposium Molec Targets Cancer Ther 2006;4:167.
130. Druker B.J., Talpaz M., Resta D.J., et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med 344 (2001) 1031-1037
131. Druker B.J., Sawyers C.L., Kantarjian H., et al. Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia. N Engl J Med 344 (2001) 1038-1042
132. Brouard M., and Sauart J.H. Cutaneous reactions to STI571. N Engl J Med 345 (2001) 618-619
133. Valeyrie L., Bustuji-Garin S., Revuz J., et al. Adverse cutaneous reactions to imatinib (STI571) in Philadelphia chromosome-positive leukemias: a prospective study of 54 patients. J Am Acad Dermatol 48 (2003) 201-206
134. Van Oosterom A.T., Judson I., Verweij J., et al. Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal cancers: a phase I study. Lancet 358 (2001) 1421-1423
135. Glabbeke M.V., Verweij J., Casali P.G., et al. Predicting toxicities for patients with advanced gastrointestinal stromal tumours treated with imatinib: a study of the European Organization for Research and Treatment of Cancer, the Italian Sarcoma Group, and the Australasian Gastro-Intestinal Trials Group (EORTC-ISG-AGITG). Eur J Cancer (2006) [Epub ahead of print]
136. Brouard M., Prins C., Mach-Pascual S., et al. Acute generalized exanthematous pustulosis associated with STI571 in a patient with chronic myeloid leukemia. Dermatology 203 (2001) 57-59
137. Schwarz M., Kreuzer K.A., Baskaynak G., et al. Imatinib-induced acute generalized exanthematous pustulosis (AGEP) in two patients with chronic myeloid leukemia. Eur J Haemtol 69 (2002) 254-256
138. Clark S.H., Duvic M., and Prietol V.G. Mycosis fungoides-like reactions in a patient treated with Gleevec. J Cutan Pathol 30 (2003) 279-281
139. Hsiao L.T., Chung H.M., Lin J.T., et al. Stevens-Johnson syndrome after treatment with STI571: a case report. Br J Hematol 117 (2002) 620-622
140. Lim D.S., and Muir J. Oral lichenoid reaction to imatinib (STI571, Gleevec). Dermatology 205 (2002) 169-171
141. Brazzelli V., Roveda E., Prestinari F., et al. Vitiligo-like lesions and diffuse lightening of the skin in a pediatric patient treated with imatinib mesylate: a noninvasive colorimetric assessment. Pediatr Dermatol 23 2 (2006) 175-178
142. Hasan S., Dinh K., Lombardo F., et al. Hypopigmentation in an African patient treated with imatinib mesylate: a case report. J Natl Med Assoc 95 (2003) 722-724
143. Tsao A.S., Kantarjian H., Cortes J., et al. Imatinib mesylate causes hypopigmentation in the skin. Cancer 98 (2003) 2483-2487
144. Raanani P., Goldman J.M., and Ben-Bassat I. Depigmentation in a chronic myeloid leukemia patient treated with STI-571. J Clin Oncol 20 (2002) 869-870
145. Grichnik J.M., Burch J.A., Burchette J., et al. The SCF-KIT pathway plays a critical role in the control of normal human melanocyte homeostasis. J Invest Dermatol 111 (1998) 233-238
146. Longley B.J., and Carter E.I. SCF-KIT pathway in human epidermal melanocyte homeostasis. J Invest Dermatol 113 (1999) 139-140
147. Hemesath T.J., Price E.R., Takemoto C., et al. MAP kinase links the transcription factor Micropthalmia to c-Kit signalling in melanocytes. Nature 391 (1998) 298-301
148. Pagroni A., Kligman A.M., Sadiq I., et al. Hypopigmented macules of photodamaged skin and their treatment with topical tretinoin. Acta Derm Venereol 79 (1999) 305-310
149. Etienne G., Cony-Makhoul P., and Mahon F.X. Imatinib mesylate and gray hair. N Engl J Med 347 (2002) 446
150. Fda.gov/ohrms/dockets/AC/06/briefing/2006-4220-B1-01BristolMyersSquibb-b ackground.pdf.
151. Assouline S., Laneuville P., and Gambacorti-Passerini C. Panniculitis during dasatinib therapy for imatinib-resistant chronic myelogenous leukemia. N Engl J Med 354 (2006) 2623-2624
152. Orlowski R.Z. The role of the ubiquitin-proteosome pathway in apoptosis cell death differ. Cell Death Differ 6 (1999) 303-313
153. Grimm L.M., and Osborne B.A. Apoptosis and the proteosome. Prob Cell Differ 23 (1999) 209-228
154. Kane R.C., Bross P.F., Farrell A.T., et al. Velcade: U.S. FDA approval for the treatment of multiple myeloma progressing on prior therapy. Oncologist 8 (2003) 508-513
155. Orlowski R.Z., Stinchcombe T.E., Mitchell B.S., et al. Phase I trial of the proteosome inhibitor PS-341 in patients with refractory hematologic malignancies. J Clin Oncol 20 (2002) 4420-4427
156. Adams J. Proteosome inhibition in cancer: development of PS-341. Semin Oncol 28 (2001) 613-619
157. Papandreou C.N., Daliani D.D., Nix D., et al. Phase I trial of the proteosome inhibitor bortezomib in patients with advanced solid tumors with observations in androgen-independent prostate cancer. J Clin Oncol 22 (2004) 2108-2121
158. Shah M.H., Young D., Kindler H.L., et al. Phase II study of the proteosome inhibitor bortezomib (PS-341) in patients with metastatic neuroendocrine tumors. Clin Cancer Res 10 (2004) 6111-6118
159. Dy G.K., Thomas J.P., Wilding G., et al. A phase I and pharmacologic trial of 2 schedules of the proteasome inhibitor PS-341 (Bortezomib, Velcade), in patients with advanced cancer. Clin Cancer Res 11 (2005) 3410-3416
160. Davis N.B., Taber D.A., Ansari R.H., et al. Phase II trial of PS-341 in patients with renal cell cancer: a University of Chicago phase II consortium study. J Clin Oncol 22 (2004) 115-119
161. Hamilton A.L., Eder J.P., Pavlick A.C., et al. Proteosome inhibition with bortezomib (PS-341): a phase I study with pharmacodynamic endpoints using a day 1 and day 4 schedule in a 14-day cycle. J Clin Oncol 23 (2005) 6107-6116
162. Yang C.H., Gonzalez-Angulo A.M., Reuben J.M., et al. Bortezomib (VELCADE) in metastatic breast cancer: pharmacodynamics, biological effects, and prediction of clinical benefits. Ann Oncol 17 (2006) 813-817
163. Richardson P.G., Barlogie B., Berenson J., et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med 348 (2003) 2609-2617
164. Richardson P.G., Sonneveld P., Schuster M.W., et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med 352 (2005) 2487-2498
165. Blaney S.M., Bernstein M., Neville K., et al. Phase I study of the proteosome inhibitor bortezomib in pediatric patients with refractory solid tumors: a children's group study (ADVL0015). J Clin Oncol 22 (2004) 4804-4809
166. Fisher R.I., Bernstein S.H., Kahl B.S., et al. Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. JClin Oncol 24 (2006) 4867-4874
167. Gerecitano J., Goy A., Wright J., et al. Drug-induced cutaneous vasculitis in patients with non-Hodgkin lymphoma treated with the novel proteasome inhibitor bortezomib: a possible surrogate marker of response?. Br J Hematol 134 (2006) 391-398
168. Agterof M.J., and Biesma D.H. Bortezomib-induced skin lesions. N Engl J Med 352 (2005) 2534
169. Min C.K., Lee S., Kim Y.J., et al. Cutaneous leucoclastic vasculitis (LV) following bortezomib therapy in a myeloma patient; association with pro-inflammatory cytokines. Eur J Haematol 76 (2006) 265-268
170. Singhal S., Mehta J., Desikan R., et al. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med 341 (1999) 1565-1571
171. Bartlett J.B., Dredge K., and Dalgfleish A.G. The evolution of thalidomide and its IMID derivatives as anticancer agents. Nat Rev Cancer 4 (2004) 314-322
172. Moschella S.L. Is there a role for tumor necrosis factor-alpha inhibitors especially thalidomide in dermatology?. Skinmed 4 (2005) 19-32
173. Hall V.C., El-Azhary R.A., Bouwhuis S., et al. Dermatologic side effects in patients with multiple myeloma. J Am Acad Dermatol 48 (2003) 548-552
174. Le Nouail P., Viseaux V., Chaby G., et al. [Drug reaction with eosinophilia and systemic symptoms (DRESS) following imatinib therapy]. Ann Dermatol Venereol 133 (2006) 686-688 [in French]
175. Rajkumar S.V., Gerz M.A., and Witzig T.E. Life-threatening toxic epidermal necrolysis with thalidomide therapy for myeloma. N Engl J Med 343 (2000) 972-973
176. Bielsa I., Teixido J., Rivera M., et al. Erythroderma due to thalidomide: report of 2 cases. Dermatology 189 (1994) 179-181
177. Salafia A., and Kharkar R.D. Thalidomide and exfoliative dermatitis. Int J Lepr Other Mycobact Dis 56 (1988) 625
178. Horowitz S.B., and Stirling A.L. Thalidomide-induced toxic epidermal necrolysis. Pharmacotherapy 19 (1999) 1177-1180
179. Sharma R.A., Steward W.P., Daines C.A., et al. Toxicity profile of the immunomodulatory thalidomide analogue, lenalidomide: phase I clinical trial of three dosing schedules in patients with solid malignancies. Eur J Cancer 42 (2006) 2318-2325
180. Deng A., Harvey V., Sina B., et al. Interstitial granulomatous dermatitis associated with the use of tumor necrosis factor alpha inhibitors. Arch Dermatol 142 2 (2006) 198-202
181. Chu P., Connolly K., and LeBoit P.E. The histopathological spectrum of palisaded neutrophilic and granulomatous dermatitis in a patient with collagen vascular disease. Arch Dermatol 130 (1994) 1278-1283
182. Ghobrial I.M., and Rajkumar S.V. Management of thalidomide toxicity. J Support Oncol 1 (2003) 194-205
183. Singhal S., and Mehta J. Peer viewpoint: management of thalidomide toxicity. J Support Oncol 1 (2003) 194-205
184. Skotnicki J.S., Leone C.L., and Smith A.L. Design, synthesis, and biological evaluation of C-42 hydroxyesters of rapamycin: the identification of CCI-779. Clin Cancer Res 7 (2001) 3749S-3750S
185. Gibbons J.J., Discafanic C., and Peterson R. The effect of CCI-779, a novel macrolide antitumor agent, on growth of tumor cells in vitro in nude mouse xenografts in vivo. [a1000]. Proc Am Assoc Cancer Res 40 (1999) 301
186. Chan S., Scheulen M.E., Johnston S., et al. Phase II study of temsirolimus (CCI-779), a novel inhibitor of mTOR, in heavily pretreated patients with locally advanced or metastatic breast cancer. J Clin Oncol 23 (2005) 5314-5322
187. Witzig T.E., Geyer S.M., Ghobrial I., et al. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 23 (2005) 5347-5356
188. Atkins M.B., Hidalgo M., Stadler W.M., et al. Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. J Clin Oncol 22 (2004) 909-918
189. Galanis E., Buckner J.C., Maurer M.J., et al. Phase II trial of temsirolimus (CCI-779) in recurrent glioblastoma multiforme: a north central treatment group study. J Clin Oncol 23 (2005) 5294-5304
190. Raymond E., Alexandre J., Faivre S., et al. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. J Clin Oncol 22 (2004) 2336-2347
191. Kunzle N., Venetz J.P., Pascual M., et al. Sirolimus-induced acneiform eruption. Dermatology 211 (2005) 366-369
192. Avastin package insert. South San Francisco, CA: Genentech Inc.
193. Gordon M.S., Margolin K., Talpaz M., et al. Phase I safety and pharmacokinetic study of recombinant human anti-vascular endothelial growth factor in patients with advanced cancer. J Clin Oncol 19 (2001) 843-850
194. Chen H.X., Gore-Langton R.E., and Cheson B.D. Clinical trials: referral resource: current clinical trials of the anti-VEGF monoclonal antibody bevacizumab. Oncology 15 (2001) 1019-1026
195. Pegram M.D., and Reese D.M. Combined biological therapy of breast cancer using monoclonal antibodies directed against HER2/neu protein and vascular endothelial growth factor. Semin Oncol 29 Suppl 11 (2002) 29-37
196. Gotlib V., Khaled S., Lapko I., et al. Skin rash secondary to bevacizumab in a patient with advanced colorectal cancer and relation to response. [case reports]. Anti-Cancer Drugs 17 (2006) 1227-1229