Lapatinib-associated toxicity and practical management recommendations

Oncologist

Volumn 12, Issue 7, 2007, Pages 756-765

  Moy, Beverly ^a   Goss, Paul E ^a  

^a MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

Author keywords

Breast cancer; Dual tyrosine kinase inhibitor; EGFR; ErbB 1; ErbB 2; HER 2; Lapatinib; Toxicity

Indexed keywords

ANTHRACYCLINE DERIVATIVE; BENZOYL PEROXIDE; CAPECITABINE; CETUXIMAB; CISPLATIN; CLINDAMYCIN; CLINDAMYCIN PHOSPHATE; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERLOTINIB; FLUOROURACIL; FOLINIC ACID; GEFITINIB; IRINOTECAN; LAPATINIB; LETROZOLE; LOPERAMIDE; MINOCYCLINE; OXALIPLATIN; PACLITAXEL; PLACEBO; PROTEIN TYROSINE KINASE; RETINOIC ACID; RIFABUTIN; RIFAMYCIN; RIFAPENTINE; TAXANE DERIVATIVE; TETRACYCLINE; TRASTUZUMAB; UNINDEXED DRUG;

ABDOMINAL CRAMP; ADJUVANT THERAPY; ADULT RESPIRATORY DISTRESS SYNDROME; ADVANCED CANCER; AREA UNDER THE CURVE; BILE DUCT CANCER; BLOOD BRAIN BARRIER; BRAIN METASTASIS; BREAST CANCER; CANCER REGRESSION; CANCER RELAPSE; CARDIOTOXICITY; CENTRAL NERVOUS SYSTEM METASTASIS; CEREBROVASCULAR ACCIDENT; CLINICAL PRACTICE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; DIARRHEA; DIET THERAPY; DOSAGE SCHEDULE COMPARISON; DRUG ACTIVITY; DRUG BINDING; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG FATALITY; DRUG HALF LIFE; DRUG INHIBITION; DRUG PENETRATION; DRUG POTENTIATION; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; GALLBLADDER CANCER; GASTROESOPHAGEAL REFLUX; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPOXIA; LIVER CANCER; LUNG EMBOLISM; LUNG NON SMALL CELL CANCER; METASTASIS; MONOTHERAPY; NAUSEA; PATIENT CARE; PRIORITY JOURNAL; PUSTULE; RANDOMIZED CONTROLLED TRIAL; RASH; REHYDRATION; RESPIRATORY DISTRESS; REVIEW; TREATMENT RESPONSE; VOMITING;

ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; FEMALE; HUMANS; NEOPLASM RECURRENCE, LOCAL; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RECEPTOR PROTEIN-TYROSINE KINASES; RECEPTOR, ERBB-2;

EID: 34548222618     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.12-7-756     Document Type: Review

References (58)

1. Nahta R, Hortobagyi GN, Esteva FJ. Growth factor receptors in breast cancer: Potential for therapeutic intervention. The Oncologist 2003;8:5-17.
2. Moy B, Goss PE. Lapatinib: Current status and future directions in breast cancer. The Oncologist 2006;11:1047-1057.
3. Atalay G, Cardoso F, Awada A et al. Novel therapeutic strategies targeting the epidermal growth factor receptor (EGFR) family and its downstream effectors in breast cancer. Ann Oncol 2003;14:1346-1363.
4. Chu I, Blackwell K, Chen S et al. The dual ErbB1/ErbB2 inhibitor, lapatinib (GW572016), cooperates with tamoxifen to inhibit both cell proliferation-and estrogen-dependent gene expression in antiestrogen-resistant breast cancer. Cancer Res 2005;65:18-25.
5. Klijn JG, Berns PM, Schmitz PI et al. The clinical significance of epidermal growth factor receptor (EGF-R) in human breast cancer: A review on 5232 patients. Endocr Rev 1992;13:3-17.
6. Walker RA, Dearing SJ. Expression of epidermal growth factor receptor mRNA and protein in primary breast carcinomas. Breast Cancer Res Treat 1999;53:167-176.
7. Biscardi JS, Ishizawar RC, Silva CM et al. Tyrosine kinase signalling in breast cancer: Epidermal growth factor receptor and c-Src interactions in breast cancer. Breast Cancer Res 2000;2:203-210.
8. Tsutsui S, Ohno S, Murakami S et al. Prognostic value of epidermal growth factor receptor (EGFR) and its relationship to the estrogen receptor status in 1029 patients with breast cancer. Breast Cancer Res Treat 2002;71:67-75.
9. Pawlowski V, Revillion F, Hebbar M et al. Prognostic value of the type I growth factor receptors in a large series of human primary breast cancers quantified with a real-time reverse transcription-polymerase chain reaction assay. Clin Cancer Res 2000;6:4217-4225.
10. Slamon DJ, Clark GM, Wong SG et al. Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987;235:177-182.
11. Slamon DJ, Godolphin W, Jones LA et al. Studies of the HER-2/neu protooncogene in human breast and ovarian cancer. Science 1989;244:707-712.
12. Borg A, Tandon AK, Sigurdsson H et al. Her-2/neu amplification predicts poor survival in node-positive breast cancer. Cancer Res 1990;50:4332-4337.
13. Nicholson S, Wright C, Sainsbury JR et al. Epidermal growth factor receptor (EGFR) as a marker for poor prognosis in node-negative breast cancer patients: Neu and tamoxifen failure. J Steroid Biochem Mol Biol 1990;37:811-814.
14. Rini BI. VEGF-targeted therapy in metastatic renal cell carcinoma. The Oncologist 2005;10:191-197.
15. Rusnak DW, Lackey K, Affleck K et al. The effects of the novel, reversible epidermal growth factor receptor/ErbB-2 tyrosine kinase inhibitor, GW572016, on the growth of human normal and tumor-derived cell lines in vitro and in vivo. Mol Cancer Ther 2001;1:85-94.
16. Riese DJ 2nd, Stern DF. Specificity within the EGF family/ErbB receptor family signaling network. Bioessays 1998;20:41-48.
17. Amundadottir LT, Leder P. Signal transduction pathways activated and required for mammary carcinogenesis in response to specific oncogenes. Oncogene 1998;16:737-746.
18. Okano J, Gaslightwala I, Birnbaum MJ et al. Akt/protein kinase B isoforms are differentially regulated by epidermal growth factor stimulation. J Biol Chem 2000;275:30934-30942.
19. Rusnak DW, Affleck K, Cockerill SG et al. The characterization of novel, dual ErbB-2/EGFR, tyrosine kinase inhibitors: Potential therapy for cancer. Cancer Res 2001;61:7196-7203.
20. Burris HA 3rd. Dual kinase inhibition in the treatment of breast cancer: Initial experience with the EGFR/ErbB-2 inhibitor lapatinib. The Oncologist 2004;9(suppl 3):10-15.
21. Safran H, Iannitti D, Miner T et al. GW572016, gemcitabine and GW572016, gemcitabine, oxaliplatin, a two-stage, phase I study for advanced pancreaticobiliary cancer. J Clin Oncol 2006;24(suppl 18):179S.
22. Johnston SRD. Clinical trials of intracellular signal transductions inhibitors for breast cancer - a strategy to overcome endocrine resistance. Endocr Relat Cancer 2005;12(suppl 1):S145-S157.
23. Blackwell KL, Burstein H, Pegram M et al. Determining relevant biomarkers from tissue and serum that may predict response to single agent lapatinib in trastuzumab refractory metastatic breast cancer. J Clin Oncol 2005;23(suppl 16):193S.
24. Blackwell KL, Kaplan EH, Franco SX et al. A phase II, open-label, multicenter study of GW572016 in patients with trastuzumab-refractory metastatic breast cancer. J Clin Oncol 2004;22(suppl 14):Abstract 3006.
25. Kaplan EH, Jones CM, Berger MS. A phase II, open-label, multicenter study of GW572016 in patients with trastuzumab refractory metastatic breast cancer. J Clin Oncol 2003;22:Abstract 981.
26. Burstein H, Storniolo AM, Franco S et al. A phase II, open-label, multicenter study of lapatinib in two cohorts of patients with advanced or metastatic breast cancer who have progressed while receiving trastuzumab-containing regimens. Ann Oncol 2004;15(suppl 3):Abstract 1040.
27. Geyer CE, Forster J, Lindquist D et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355:2733-2743.
28. Lin NU, Carey LA, Liu MC et al. Phase II trial of lapatinib for brain metastases in patients with HER2+ breast cancer. J Clin Oncol 2006;24(suppl 18):3S.
29. Stein SH, Gomez HL, Chavez MA et al. Interim results of a phase II randomized study of lapatinib (GW572016) as first-line treatment for patients with FISH-amplified advanced or metastatic breast cancer. Eur J Cancer Suppl 2005;3):78.
30. Gomez HL, Chavez MA, Doval DC et al. A phase II, randomized trial using the small molecule tyrosine kinase inhibitor lapatinib as a first-line treatment in patients with FISH positive advanced or metastatic breast cancer. J Clin Oncol 2005;23(suppl 16):203S.
31. Paoletti P, Lokay K. Tykerb at ASCO 2006. Available at http://www.gsk. com (advanced search: lapatinib). Accessed June 25, 2007.
32. Trudeau M, Johnston S, Kaufman et al. Lapatinib (Tycerb) monotherapy in patients with recurrent inflammatory breast cancer (IBC): Clinical activity and biologic predictors of response. Ann Oncol 2006;17(suppl 9):ix69.
33. Cristofanilli M, Boussen H, Baselga J. A phase II combination study of lapatinib and paclitaxel as a neoadjuvant therapy in patients with newly diagnosed inflammatory breast cancer. Breast Cancer Res 2006;100(suppl 1):S5.
34. Piccart-Gebhart MJ, Perez, EA, Baselga et al. ALTTO (adjuvant lapatinib and/or trastuzumab treatment optimisation) study (BIG 2- 06/N063D/EGF106708): A phase III study for HER-2-overexpressing early breast cancer. The Breast 2006;100(suppl 1):S5.
35. Moy B, Maltzman JD, Goss PE. Phase II study of lapatinib after completion of adjuvant therapy in trastuzumab-naive women with ErbB2-overexpressing breast cancer. The Breast 2007;16(suppl 1):S47.
36. Moy B, Goss PE. TEACH: Tykerb evaluation after chemotherapy. Clin Breast Cancer 2007;7:489-492.
37. Weitzen R, Zach L, Kaufman B et al. High incidence of brain metastasis (BM) in patients on trastuzumab (H) for advanced breast cancer. Proc Am Soc Clin Oncol 2002;21:Abstract 1936.
38. 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;23:165-174.
39. Busam KJ, Capodieci P, Motzer R et al. Cutaneous side-effects in cancer patients treated with the antiepidermal growth factor receptor antibody C225. Br J Dermatol 2001;144:1169-1176.
40. Kris M, 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: A randomized trial. JAMA 2003;290:2149-2158.
41. Perez-Soler R, Saltz L. Cutaneous adverse effects with HER1/EGFR-targeted agents: Is there a silver lining? J Clin Oncol 2005;23:5235-5246.
42. Ramanathan RK, Belani CP, Singh DA. Phase II study of lapatinib, a dual inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase 1 and 2 (Her2/Neu) in patients (pts) with advanced biliary tree cancer (BTC) or hepatocellular cancer (HCC). A California Consortium (CCC-P) Trial. J Clin Oncol 2006;24(suppl 18):S181.
43. Schwartz G, Chu QS, Hammond LA et al. Phase I clinical, biology, and pharmacokinetic study of the combination of GW572016 and capecitabine in patients with advanced solid tumors. J Clin Oncol 2004;22(suppl 14):212s.
44. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-792.
45. Guarneri V, Lenihan DJ, Valero V et al. Long-term cardiac tolerability of trastuzumab in metastatic breast cancer: The M.D. Anderson Cancer Center experience. J Clin Oncol 2006;24:4107-4115.
46. Ewer MS, Vooletich MT, Durand J-B et al. Reversibility of trastuzumab-related cardiotoxicity: New insights based on clinical course and response to medical treatment. J Clin Oncol 2005;23:7820-7826.
47. Romond EH, Perez EA, Bryant J et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005;353:1673-1684.
48. Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353:1659-1672.
49. Suter TM, Procter M, Van Veldhuisen DJ et al. Cardiac side effects in the Herceptin adjuvant (HERA) trial. The Breast 2007;16(suppl 1):S44.
50. Perez EA, Byrne JA, Isaac W et al. Cardiac safety experience in 3127 patients treated with lapatinib. Ann Oncol 2006;17(suppl 9):ix70.
51. Ross HJ, Blumenschein A, Dowlati J et al. Preliminary safety results of a phase II trial comparing two schedules of lapatinib (GW572016) as first line therapy for advanced or metastatic non-small cell lung cancer. J Clin Oncol 2005;23(suppl 16):S645.
52. Wilkinson GR. Drug metabolism and variability among patients in drug response. N Engl J Med 2005;352:2211-2221.
53. Midgley R, Flaherty K, Haller D et al. Phase I study of GW572016 (lapatinib), a dual kinase inhibitor, in combination with irinotecan (IR), 5-fluorouracil (FU) and leucovorin (LV). J Clin Oncol 2005;23(suppl 16).
54. Mathijssen RHJ, van Alphen RJ, Verweij J et al. Clinical pharmacokinetics and metabolism of irinotecan (CPT-11). Clin Cancer Res 2001;7:2182-2194.
55. Chu Q, Goldstein L, Murray N et al. A phase I, open-label study of the safety, tolerability, and pharmacokinetics of lapatinib (GW572016) in combination with letrozole in cancer patients. J Clin Oncol 2005;23(suppl 16):S192.
56. Alexandrescu DT, Vaillant JG, Dasanu CA. 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 2007;32:71-74.
57. Roche, Inc. Xeloda® [product information]. Nutley, NJ: Roche, Inc., February 2005.
58. Ewer MS, Perez EA, Baselga J et al. Cardiac safety guidelines for the adjuvant use of trastuzumab (Herceptin) in HER2-positive early breast cancer. The Breast 2007;16(suppl 1):S63.