Gefitinib: An adverse effects profile

Expert Opinion on Drug Safety

Volumn 5, Issue 3, 2006, Pages 469-479

  Cersosimo, Robert J ^a  

^a NORTHEASTERN UNIVERSITY   (United States)

Author keywords

Adverse effect; Gefitinib; Toxicity

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTIBIOTIC AGENT; ANTIDIARRHEAL AGENT; ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; ASPARTATE AMINOTRANSFERASE; BENZOYL PEROXIDE; BETAMETHASONE; BRONCHODILATING AGENT; CISPLATIN; CLINDAMYCIN; CORTICOSTEROID; CYANOACRYLATE; ERLOTINIB; ERYTHROMYCIN; GEFITINIB; GEMCITABINE; ITRACONAZOLE; KETOCONAZOLE; LANOLIN ALCOHOL; LOPERAMIDE; MINOCYCLINE; PHENYTOIN; RETINOIC ACID; RIFAMPICIN; TETRACYCLINE; UNINDEXED DRUG; VALPROIC ACID; WARFARIN; XIPAMIDE;

ABDOMINAL PAIN; ACNE; ADVANCED CANCER; ALOPECIA; ANEMIA; ANOREXIA; ASTHENIA; BLEPHARITIS; BLURRED VISION; BONE MARROW SUPPRESSION; BONE PAIN; CLINICAL TRIAL; CONJUNCTIVITIS; CORNEA EROSION; COUGHING; DEHYDRATION; DIARRHEA; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG ERUPTION; DRUG FATALITY; DRUG FEVER; DRUG METABOLISM; DRUG POTENTIATION; DRUG WITHDRAWAL; DRY EYE; DRY SKIN; DYSPNEA; EPISTAXIS; EXFOLIATIVE DERMATITIS; EYE DISEASE; EYE PAIN; EYE TOXICITY; FATIGUE; HEMATURIA; HEMIANOPIA; HEMORRHAGIC CYSTITIS; HEPATITIS; HUMAN; HYPERPIGMENTATION; HYPOALBUMINEMIA; HYPOTENSION; INCIDENCE; INTERSTITIAL LUNG DISEASE; INTERSTITIAL PNEUMONIA; JAPAN; KERATOPATHY; LIVER DYSFUNCTION; LUNG DISEASE; LUNG FIBROSIS; LUNG NON SMALL CELL CANCER; LUNG TOXICITY; METASTASIS; MONOTHERAPY; MUSCLE WEAKNESS; NAIL DISEASE; NAUSEA AND VOMITING; NEPHROTIC SYNDROME; NEUROTOXICITY; NEUTROPENIA; PARONYCHIA; PHOTOPHOBIA; PROMYELOCYTIC LEUKEMIA; PRURITUS; RESPIRATORY DISTRESS; REVIEW; SEBORRHEA; SEBORRHEIC DERMATITIS; SKIN ABSCESS; SKIN EXFOLIATION; SKIN FISSURE; SKIN TOXICITY; SOMNOLENCE; STOMATITIS; THROMBOCYTOPENIA; TREATMENT FAILURE; XEROSIS;

AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; DIARRHEA; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; EXANTHEMA; FEMALE; HUMANS; LUNG DISEASES, INTERSTITIAL; LUNG NEOPLASMS; MALE; MIDDLE AGED; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 33646552401     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.5.3.469     Document Type: Review

References (78)

1. NO AUTHORS LISTED: Iressa. package insert. Wilmington, DE AstraZeneca, Inc., May 2003.
2. THATCHER N, CHANG A, PARIKH P et al.: Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet (2005) 366:1527-1537.
3. NO AUTHORS LISTED: Iressa package insert. Wilmington, DE AstraZeneca, Inc., June 2005.
4. ZAMPINO MG, LPRIZZO K, MASSACESI C et al.: First-line gefitinib combined with simplified FOLFOX-6 in patients with epidermal growth factor receptor-positive advanced colorectal cancer. Proc. Amer. Soc. Clin. Oncol. (2005) 24(Suppl. 16S):285S.
5. GOVINDAN R, KRATZKE RA, HERNDON JE 2nd et al.: Gefitinib in patients with malignant mesothelioma: a Phase II study by the Cancer and Leukemia Group B. Clin. Cancer Res. (2005) 11:2300-2304.
6. RICH JN, REARDONDA, PEERY T et al.: Phase II trial of gefitinib in recurrent glioblastoma. J. Clin. Oncol. (2004) 22:133-142.
7. CIARDIELLO F, TROIANI T, CAPUTO F et al.: Phase II trial of gefitinib combined with docetaxel as first-line therapy in patients with metastatic breast cancer. Proc. Amer. Soc. Clin. Oncol. (2005) 24(Suppl. 16S):211S.
8. VIENS P, LHOMME C, EXTRA JM et al.: A Phase II trial to evaluate efficacy and safety of gefitinib (ZD1839) inpatients with loco-regionally advanced or metastatic squatnous-ceff carcinoma of the cervix. Proc. Amer. Sec. Clin. Oncol. (2003) 22:456.
9. CANIL CM, MOORE MJ, WINQUIST E et al.: Randomized Phase II study of two doses of gefitinib in hormone-refi-actory prostate cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group. J. Clin. Oncol. (2005) 23:455-460.
10. DAWSON NA, GUO C, ZAK R et al.: A Phase II trial of gefitinib (Iressa, ZD1839) in stage IV and recurrent renal cell carcinoma. Clin. Cancer Res. (2004) 10:7812-7819.
11. HOPFNER M, SUTTER AP, HUETHER A et al.: Targeting the epidermal growth factor receptor by gefitinib for treatment of hepatocellular carcinoma. J. Hepatol. (2004) 41:1008-1016.
12. COHEN EE, ROSEN F, STADLER WM et al.: Phase II trial of ZD1839 in recurrent or metastatic squamous cell carcinoma of the head and neck. J. Clin. Oncol. (2003) 21:1980-1987.
13. DOI T, KOIZUMI W, SIENA S et al.: Efficacy, tolerability and pharmacokinetics of gefitinib (ZD1839) in pre-treated patients with metastatic gastric cancer. Proc. Amer. Soc. Clin. Oncol. (2003) 22:258.
14. CERSOSIMO RJ: Gefitinib, a new antineoplastic agent for advanced non-small cell lung cancer. Amer. J. Health-Sys. Pharm. (2004) 61:889-898.
15. SWAISLAND H, LAIGHT A, STAFFORD L et al.: Pharmacokinerics and tolerability of die orally active selective epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in healthy volunteers. Clin. Pharmacokinet. (2001) 40:297-306.
16. HERBST RS, MADDOX A-M, ROTHENBERG ML 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. (2002) 20:3815-3825.
17. BASELGA J, RISCHIN D, RANSON M et al.: Phase I study, pharmacokinetic, and pharmcodynarnic trial of ZD1839, a selective oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with five selected solid tumor types. J. Clin. Oncol. (2002) 20:4292-4302.
18. 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. (2003) 21:2237-2246.
19. KRIS MG, NATALE RB, HERBST RS et al.: Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer. JAMA (2003) 290:2149-2158.
20. NO AUTHORS LISTED: Iressa Product Monograph, AstraZeneca Canada, Inc., Mississauga, Ontario, May 2005.
21. FORSYTHE B, FAULKNER K.: Overview of the tolerability of gefidnib (IRESSA) monotherapy. Clinical experience in non-small cell lung cancer. Drug Saf. (2004) 27:14:1081-1092.
22. REILING RB, NATALE R, WADE J et al.: Efficacy and safety of gefitinib in chemo-naive patients with non-small cell lung cancer (NSCLC) in an expanded access program (EAP). Proc. Amer. Soc. Clin. Oncol. (2005) 24(Suppl. 16S):643S.
23. COHEN MH, WILLIAMS GA, SRIDHARA R, CHEN G, PAZDUR R: FDA drug approval summary: gefitinib (ZD1839) (Iressa) tablets. Oncologist (2003) 8:303-306.
24. MU X-L, LI L-Y, ZHANG X-T, WANG S-I, WANG M-Z: Evaluation of safety and efficacy of gefitinib (Iressa, ZD1839) as monotherapy in a series of Chinese patients with advanced non-small cell lung cancer: experience from a compassionate-use programme. BMC Cancer (2004) 4:51-58.
25. RUCKDESCHEL JC, SIMON G, ANTONIA S et al.: ZD1839 (Iressa) as a single agent for the treatment of metastatic non-small cell lung cancer. Proc. Amer. Soc. Clin. Oncol. (2002) 21:318a.
26. LIEM AK, CHENG H, QUAN E et al.: Expanded access single institution clinical program experience with ZD1839 (Iressa) for patients with advanced non-small cell lung cancer (NSCLC). Proc. Amer. Soc. Clin. Oncol. (2002) 21:222b.
27. JANNE PA, OSTLER PA, LUCCA J et al.: ZD1839 (Ircssa) shows antitumor activity in patients with recurrent non-small cell lung cancer created on a compassionate-use protocol. Proc. Amer. Soc. Clin. Oncol. (2002) 21:319a.
28. NAKAGAWA K, TAMURA T, NEGORO S et al.: Phase I pharmacokinetic trial of the selective oral epidermal growth factor receptor tyrosinc kinase inhibitor gefi tinib (Iressa, ZD1839) in Japanese patients with solid malignant tumors. Ann. Oncol. (2003) 14:922-930.
29. RANSON M, HAMMOND L, FERRY D et al.: ZD1839, a selective oral epidermal growth factor remptor-tyrosme kinase inhibitor, is well-tolerated and active in patients with solid, malignant tumors: results of a Phase I trial. J. Clin. Oncol. (2002) 20:2240-2250.
30. MAINWARING MG, HAINSWORTH JD, GIAN VG et et al.: Gefitinib (ZD1839) in the treatment of patients with advanced refitactory non-small cell lung cancer (NSCLC) 250 patients treated at the Sarah Cannon Cancer Center. Proc. Amer. Soc. Clin. Oncol. (2003) 22:690.
31. GELIBTER A, PINO MS, CERIBELI A et al.: Results from compassionate use of ZD1839 in pre-treated non small cell lung cancer (NSCLC) our experience. Proc. Am. Soc. Clin. Oncol. (2003) 22:232.
32. ARGIRIS A, MITTAL N: Gefitinib as first-line, compassionate use therapy in patients with advanced non-small cell lung cancer. Lung Cancer (2004) 43:317-322.
33. CERESOLI GL, CAPPUZZO F, GREGORC V, BARTOLINI A, CRINO L, VILLA E: Gefitinib in patients with brain metastases from non-small cell lung cancer: a prospective trial. Ann. Oncol. (2004) 15:1042-1047.
34. LOPEZ-MARTIN AA, CONSTELA M, ALGARRA SM et al.: ZD1839 in advanced non-small cell lung cancer (NSCLC) patients progressed to chemotherapy (CT). Proc. Am Soc. Clin. Oncol. (2003) 22:670.
35. BRACONI C, SALVAGNI S, SCARTOZZI M et al.: ZD1839 for compassionate use in pretreated patients (pts) with advance non-small cell lung cancer (ANSCLC). Proc, Amer. Soc. Clin. Oncol. (2003) 22:683.
36. SANTORO A, CAVINA R, LATTERI F et al.: Activity of a specific inhibitor, gefitinib (Iressa, ZD1839), of epidermal growth factor receptor in refractory non-small cell lung cancer. Ann. Oncol. (2004) 15:33-37.
37. RAZIS E, SKARLOS D, BRIASOULIS E: Treatment of non-small cell lung cancer with gefitinib (Iressa, Z131839) the Greek experience with a compassionate use program. Anti-Cancer Drugs (2005) 16:191-198.
38. GRIDELLI C, ROSSI A, MAIONE P et al.: Gefitinib as salvage therapy in pretreated patients with advanced non-small cell lung cancer. Data from a compassionate use prograrn. Anti-Cancer Res. (2004) 24:1873-1877.
39. PARK J, PARK BB, KIM JY et al.: Gefitinib (ZD 1839) monotherapy as a salvage regimen for previously treated advanced non-small cell lung cancer. Clin. Cancer Res. (2004) 10:4383-4388.
40. CAPPUZZO F, BARTPLINI S, CERESOLI GL et al.: Efficacy and tolerability of gefitinib in pretreated elderly patients with advanced non-small cell lung cancer (NSCLC). Br. J. Cancer (2004) 90:82-86.
41. 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. Vener. (2004) 84:23-26.
42. FERNANDEZ-GALAR M, ESPANA A. LOPEZ-PICAZO, JM: Acneiform lesions secondary to ZD1839, an inhibitor of the epidermal growth factor receptor. Clin. Exp. Dermatol. (2004) 29:138-140.
43. PURDOM M: Management of acneiform rashes related to gefitinib therapy. Clin. J. Oncol. Nurs. (2004) 8:316-317.
44. PASCUAL JC, BANULS J, BELINCHON I, BLANES M, MASSUTI B: Trichomegaly following treatment with gefitinib (ZD1839). Br. J. Dermatol. (2004) 151:1111-1112.
45. WARTHAN MM, JUMPER CAA, SMITH JL: Acneiform eruption induced by iressa (gefitinib) tablets used to treat non-small cell lung cancer. J. Drug Dermatol. (2004) 3:569-570.
46. SHAH NT, KRIS MG, PAO W et al.: Practical management of patients with non-small cell lung cancer treated with gefitinib. J. Clin. Oncol. (2005) 23(1):165-174.
47. MOHAMED MK, RAMALINGAM S, LIN Y, GOODING W, BELANI CP: Skin rash and good performance status predict improved survival with gefitinib in patients with advanced non-small cell lung cancer. Ann. Oncol. (2005) 16:780-785.
48. CHIU CH, TSAI CM, CHEN YM, CHIANG SC, LIOU JL, PERNAG RP: Gefitinib, is active in patients with brain metastascs from non-small cell lung cancer and response is related to skin toxicity. Lung Cancer (2005) 47:129-138.
49. PEREZ-SOLER R, SALTZ L: Cutaneous adverse effects with HER 1/ EGFR-targeted agents: is there a silver lining? J. Clin. Oncol. (2005) 23:5235-5246.
50. NAKANO J, NAKAMURA M: Paronychia induced by gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor. J. Dermatol. (2003) 30:261-262.
51. CHANG G-C, YANG T-Y, CHEN K-C, YIN M-C, WANG R-C, LIN Y-C: Complications of therapy in cancer patients. Case 1. Paronychia and skin hyperpigmentation induced by gefitinib in advanced non-small cell lung cancer. J. Clin. Oncol. (2004) 22:4646-4648.
52. DAINICHI T, TANAKA M, TSURUTA N, FURUE M, NODA K: Development of multiple paronychia and periungual granulation in patients treated with gefitinib, an inhibitor of epidermal growth factor receptor. Dermatology (2003) 207:324-325.
53. TROJAN A, JACKY E, FOLLATH F, DUMMER R: Necrolytic migratory erythema (Glucagonorna)-like skin lesions induced by EGF-receptor inhibition. Swiss Med. Wkly (2003) 133:22-23.
54. ZORZOU M-P, STRATIGOS A, EFSTATHIOU E, BAMIAS A: Exacerbation of psoriasis after treatment with an EGFR tyrosine kinase inhibitor. Acta Dermatol. (2004) 84:308-309.
55. VAN DOORN R, KIRTSCHIG G, SCHEFFER E, STOOF TJ, GIACCONE G: Follicular and epidermal alterations in patients with ZD1839 (Iressa), an inhibitor of the epidermal growth factor receptor. Br. J. Dermatol. (2002) 147:598-601.
56. KUROKAWA I, ENDO K, HIRABAYASHI M: Purpuric drug eruption possibly due to gefitinib (Iressa). Int. J. Dermatol. (2005) 44:167-168.
57. TULLO AB, ESMAELI B, MURRAY PI et al.: Ocular findings in patients with solid rumours treated with the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib ('Iressa', ZD1839) in Phase I and II clinical trials. Eye (2005) 19:729-738.
58. NAKAGAWA M, TERAMUKAI S, TADA H et al.: Hypoalbwninemia as a risk factor of interstitial lung disease (ILD) during gefitinib treatment in patients with non-small cell lung cancer (NSCLC) a JMTO study. Proc. Am. Soc. Clin. Oncol. (2005) 24(Suppl. 16S):667S.
59. SHIH Y-N, CHIU C-H, TSAI C-M, PERNG R-P: Interstitial pneumonia during gefitinib treatment of non-small cell lung cancer. J. Clin. Med. Assoc. (2005) 68:183-186.
60. INOMATA S-I, TAKAHASHI H, NAGATA M et al.: Acute lung injury as an adverse event of gefitinib. Anti-Cancer Drugs (2004) 15:461-467.
61. TAKANO T, OHE Y, KUSUMOTO M: Risk factors for interstitial lung disease and predictive factors for tumor response in patients with advanced non-small cell lung cancer treated with gefitinib. Lung Cancer (2004) 45:93-104.
62. HOTTA K, HARITA S, BESSHO A et al.: Interstitial lung disease (ILD) during gefitinib treatment in Japanese patients with non-small cell lung cancer (NSCLC) Okayama Lung Cancer Study Group. Proc. Am. Soc. Clin. Oncol. (2004) 23(Suppl. 14S):632S.
63. SETO T, YAMAMOTO N Interstitial lung disease (ILD) induced by gefitinib in patients with advanced non-small cell lung cancer (NSCLC) Results of a West Japan Thoracic Oncology Group (WJTOG) epidemiological survey. Proc. Am. Soc. Clin. Oncol. (2004) 23(Suppl. 14S):632S.
64. INOUE A, SAIJO Y, MAEMONDA M et al.: Severe acute interstitial pneumonia and gefitinib. Lancet (2003) 361:137-139.
65. KONISHI J, YAMAZAKI K, KINOSHITA I et al.: Analysis of the response and toxicity to gefitinib of non-small cell lung cancer. Anti-Cancer Res. (2005) 25:435-441.
66. AOE K, HIRAKI A, MURAKAMI T et al.: Sudden onset of interstitial lung disease induced by gefitinib in a lung cancer patient with multiple drug allergy. Anti-Cancer Res. (2005) 25:415-418.
67. NAGARIA NC COGSWELL J, CHOE JK, KASIMIS B: Side effects and good effects from new chemotherapeutic agents. Case 1. Gefitinib-induced interstitial fibrosis. J. Clin. Oncol. (2005) 23:2423-424.
68. OHYANAGI F, ANDO Y, NAGASHIMA F, NARABAYASHI M, SASAKI Y: Acute gefitinib-induced pneumonitis. Int. J. Clin. Oncol. (2004) 9:406-409.
69. RABINOWITS G, HERCHENHORN D, RABINOWITS M, WEATGE D, TORRES W: Fatal pulmonary toxicity in a patient treated with gefitinib for non-small cell lung cancer after previous hemolytic-uremic syndrome due to gemcitabine. Anti-Cancer Drugs (2003) 14:665-668.
70. IEKI R, SAITOH E, SHIBUYA M: Acute lung injury as a possible adverse drug reaction related to gefitinib. Eur. Respir. J. (2003) 22:179-181.
71. OKAMOTO I, FUJII K, MATSUMOTO M et al.: Diffuse alveolar damage after ZD1839 therapy in a patient with non-small cell lung cancer. Lung Cancer (2003) 40:339-342.
72. SUMPTER K, HARPER-WYNNE C, O'BRIEN M, CONGLETON J: Severe acute interstitial pneumonia and gefitinib. Lung Cancer (2004) 43:367-368.
73. CAMUS P, KUDOH S, EBINA M: Interstitial lung disease associated with drug therapy. Br. J. Cancer (2004) 91 (Suppl. 2):S18-S23.
74. KUMASAKA, R, NAKAMURA N, SHIRATO K et al.: Side effects of therapy: case 1. Nephrotic syndrome associated with gefitinib therapy. J. Clin. Oncol. (2004) 22:2504-2505.
75. UCHIDA A, MATSUO K, TANIMOTO M: APL during gefitinib treatment for non-small cell lung cancer. N. Engl. J. Med. (2005) 352:843.
76. FUJISAKA Y, YAMAMOTO N, NOKIHARA H et al.: Induction of cytochrome P450 (CYP3A4) by gefitinib in non small cell lung cancer (NSCLC) patients. Proc. Am. Soc. Clin. Oncol. (2005) 24(Suppl. 16S):198S.
77. YOSHIMURA M, IMAMURA F, UENO K, YAMAMOTO S: Severe myelotoxicity in a combination of gefitinib and vinorelbine. Lung Cancer (2004) 45:121-123.
78. SHEPHERD FA, PEREIRA JR, CIULEANU T et al.: Erlotinib, in previously treated non-small cell lung cancer. N. Engl. J. Med. (2005) 353:123-132.