Risk of selected gastrointestinal toxicities in breast cancer patients treated with regimens containing lapatinib; A pooled analysis of randomized controlled studies

Expert Review of Anticancer Therapy

Volumn 14, Issue 10, 2014, Pages 1229-1242

  Abdel Rahman, Omar ^a   Fouad, Mona ^a  

^a AIN SHAMS UNIVERSITY   (Egypt)

Author keywords

breast cancer; diarrhea; lapatinib; pooled analysis; vomiting

Indexed keywords

CAPECITABINE; CYCLOPHOSPHAMIDE; DOCETAXEL; EPIRUBICIN; LAPATINIB; LETROZOLE; NERATINIB; PACLITAXEL; PAZOPANIB; PLACEBO; TOPOTECAN; TRASTUZUMAB; ANTINEOPLASTIC AGENT; QUINAZOLINE DERIVATIVE;

ARTICLE; BREAST CANCER; CANCER PATIENT; DATA EXTRACTION; DIARRHEA; GASTROINTESTINAL TOXICITY; HUMAN; INCIDENCE; META ANALYSIS; NAUSEA; PATHOGENESIS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RISK ASSESSMENT; STOMATITIS; SYSTEMATIC REVIEW; VOMITING; BREAST NEOPLASMS; CHEMICALLY INDUCED; DRUG MONITORING; FEMALE; GASTROINTESTINAL DISEASES; PATHOPHYSIOLOGY; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK;

ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; DRUG MONITORING; FEMALE; GASTROINTESTINAL DISEASES; HUMANS; QUINAZOLINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK;

EID: 84907554821     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/14737140.2014.948860     Document Type: Article

References (44)

1. Medina PJ, Goodin S. Lapatinib: A dual inhibitor of human epidermal growth factor receptor tyrosine kinases. Clin Ther 2008; 30(8):1426-47
2. Untch M, Lück HJ. Lapatinib - member of a new generation of ErbB-Targeting drugs. Breast Care (Basel) 2010;5(s1):8-12
3. Abdel-Rahman O. Systemic therapy for hepatocellular carcinoma [HCC]: From bench to bedside. J Egypt Natl Canc Inst 2013;25(4):165-71
4. Abdel-Rahman O, Fouad M. Risk of cardiovascular toxicities in patients with solid tumors treated with Sunitinib, axitinib, cediranib or regorafenib; an updated systematic review and comparative meta analysis. Crit Rev Oncol Hematol 2014. [Epub ahead of print]
5. Konecny GE, Pegram MD, Venkatesan N, et al. Activity of the dual kinase inhibitor lapatinib [GW572016] against HER-2-overexpressing and trastuzumab-Treated breast cancer cells. Cancer Res 2006;66(3):1630-9
6. Johnson BE, Kabbinavar F, Fehrenbacher L, et al. ATLAS: Randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 2013;31(31):3926-34
7. Abdel-Rahman O, Fouad M. Does the use of lapatinib increase the risk of fatigue and hepatic toxicities in patients with solid tumors?. ; a critical literature review and Meta-Analysis. Expert Opin Drug Saf 2014; 13(8):999-1008
8. Bowen JM, Mayo BJ, Plews E, et al. Development of a rat model of oral small molecule receptor tyrosine kinase inhibitor-induced diarrhea. Cancer Biol Ther 2012;13(13):1269-75
9. Zaks TZ, Akkari A, Briley L, et al. Role of pharmacogenetic studies in early clinical development: Phase I studies with lapatinib. J Clin Oncol 2006;24:3029
10. Briley LP, Chiano M, King K, et al. Pharmacogenetic investigation of lapatinib-Associated diarrhea in metastatic breast cancer clinical trials. J Clin Oncol 2011;29(15; abstr 552
11. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-Analyses: The PRISMA statement. J Clin Epidemiol 2009;62(10):1006-12
12. National cancer institute, common toxicity criteria. Available from: Http://ctep.cancer. gov/protocoldevelopment/ electronic-applications/docs/ctcaev3.pdf
13. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-Analyses. BMJ 2003;327(7414):557-60
14. DerSimonian R, Laird N. Meta-Analysis in clinical trials. Control Clin Trials 1986;7(3): 177-88
15. Robidoux A, Tang G, Rastogi P, et al. Lapatinib as a component of neoadjuvant therapy for HER2-positive operable breast cancer (NSABP protocol B-41): An open-label, randomised phase 3 trial. Lancet Oncol 2013;14(12):1183-92
16. Guarneri V, Generali DG, Frassoldati A, et al. Double-blind, placebo-controlled, multicenter, randomized, Phase IIB neoadjuvant study of letrozole-lapatinib in postmenopausal hormone receptor-positive, human epidermal growth factor receptor 2- negative, operable breast cancer. J Clin Oncol 2014;32(10):1050-7
17. Alba E, Albanell J, de la Haba J, et al. Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: Results from the GEICAM/2006-14 trial. Br J Cancer 2014;110:1139-47
18. Guarneri V, Frassoldati A, Bottini A, et al. Preoperative chemotherapy plus trastuzumab, lapatinib, or both in human epidermal growth factor receptor 2-positive operable breast cancer: Results of the randomized phase II CHER-LOB Study. J Clin Oncol 2012;30(16):1989-95
19. Untch M, Loibl S, Bischoff J, et al. Lapatinib versus trastuzumab in combination with neoadjuvant anthracycline-Taxane-based chemotherapy (GeparQuinto, GBG 44): A randomised phase 3 trial. Lancet Oncol 2012;13(2): 135-44
20. DeCensi A, Puntoni M, Pruneri G, et al. Lapatinib activity in premalignant lesions and HER-2-positive cancer of the breast in a randomized, placebo-controlled presurgical trial. Cancer Prev Res 2011;4(8):1181-9
21. Baselga J, Bradbury I, Eidtmann H, et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): A randomised, open-label, multicentre, phase 3 trial. Lancet 2012; 379(9816):633-40
22. Goss PE, Smith IE, O'Shaughnessy J, et al. Adjuvant lapatinib for women with early-stage HER2-positive breast cancer: A randomised, controlled, phase 3 trial. Lancet Oncol 2013;14(1):88-96
23. Johnston SR, Gómez H, Stemmer SM, et al. A randomized and open-label trial evaluating the addition of pazopanib to lapatinib as first-line therapy in patients with HER2-positive advanced breast cancer. Breast Cancer Res Treat 2013;137(3): 755-66
24. Cristofanilli M, Johnston SR, Manikhas A, et al. A randomized phase II study of lapatinib + pazopanib versus lapatinib in patients with HER2+ inflammatory breast cancer. Breast Cancer Res Treat 2013; 137(2):471-82
25. Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367(19):1783-91
26. Blackwell KL, Burstein HJ, Storniolo AM, et al. Randomized study of Lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer. J Clin Oncol 2010;28(7):1124-30
27. Lin NU, Eierman W, Greil R, et al. Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases. J Neurooncol 2011; 105(3):613-20
28. Schwartzberg LS, Franco SX, Florance A, et al. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor- positive metastatic breast cancer. Oncologist 2010;15(2):122-9
29. Johnston S, Pippen J, Pivot X, et al. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol 2009; 27(33):5538-46
30. Di Leo A, Gomez HL, Aziz Z, et al. Phase III, doubleblind, randomized study comparing lapatinib plus paclitaxel with placebo pluspaclitaxel as first-line treatment for metastatic breast cancer. J Clin Oncol 2008;26(34):554452
31. Geyer CE, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355(26):2733-43
32. Martin M, Bonneterre J, Geyer CE Jr, et al. A phase two randomised trial of neratinib monotherapy versus lapatinib plus capecitabine combination therapy in patients with HER2+ advanced breast cancer. Eur J Cancer 2013;49(18):3763-72
33. Guan Z, Xu B, DeSilvio ML, et al. Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2- overexpressing metastatic breast cancer. J Clin Oncol 2013;31(16):1947-53
34. Hicks DG, Whitney-Miller CL. The evolving role of HER2 evaluation for diagnosis and clinical decision making for breast and gastric adenocarcinoma. Biotech Histochem 2013;88(3-4):121-31
35. Cui H, Cheng Y, Piao SZ, et al. Correlation between HER-2/neu[erbB-2] expression level and therapeutic effect of combination treatment with HERCEPTIN and Chemotherapeutic agents in gastric cancer cell lines. Cancer Cell Int 2014; 14(1):10; Epub ahead of print
36. Crown JP, Burris HA 3rd, Boyle F, et al. Pooled analysis of diarrhea events in patients with cancer treated with lapatinib. Breast Cancer Res Treat 2008;112(2):317-25
37. Tykerb [lapatinib] FDA prescribing information. Available from: Www. accessdata.fda.gov/drugsatfda-docs/label/ 2010/022059s007lbl.pdf [Last accessed 11/ 6/2014]
38. Gamucci T, Moscetti L, Mentuccia L, et al. Optimal tolerability and high efficacy of a modified schedule of lapatinib-capecitabine in advanced breast cancer patients. J Cancer Res Clin Oncol 2014;140(2):221-6
39. Gajria D, Gonzalez J, Feigin K, et al. A Phase II trial of a novel capecitabine dosing schedule in combination with lapatinib for the treatment of patients with HER2-positive metastatic breast cancer. Breast Cancer Res Treat 2012;131(1): 111-16
40. Traina T, Theodoulou M, Feigin K, et al. Safety of a novel capecitabine dosing schedule when combined with lapatinib in patients with HER2-positive metastatic breast cancer refractory to trastuzumab. J Clin Oncol Meeting Abstracts 2009; 27(15S):113
41. Crown J, Kennedy MJ, Tresca P, et al. Optimally tolerated dose of lapatinib in combination with docetaxel plus trastuzumab in first-line treatment of HER2-positive metastatic breast cancer. Ann Oncol 2013;24(8):2005-11
42. Johnson BE, Kabbinavar F, Fehrenbacher L, et al. ATLAS: Randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 2013;31(31):3926-34
43. Li H, Fu W, Gao X, et al. Risk of severe diarrhea with dual anti-HER2 therapies: A meta-Analysis. Tumor Biol 2014;35(5): 4077-85
44. Dang C, Lin N, Moy B, et al. Dose-dense doxorubicin and cyclophosphamide followed by weekly paclitaxel with trastuzumab and lapatinib in HER2/neu-overexpressed/ amplified breast cancer is not feasible because of excessive diarrhea. J Clin Oncol 2010;28(18):2982-8