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

References

• Medina PJ, Goodin S. Lapatinib: a dual inhibitor of human epidermal growth factor receptor tyrosine kinases. Clin Ther 2008;30(8):1426-47
   PubMed Web of Science ®Google Scholar
• Untch M, Lück HJ. Lapatinib - member of a new generation of ErbB-Targeting drugs. Breast Care (Basel) 2010;5(s1):8-12
   Google Scholar
• Abdel-Rahman O. Systemic therapy for hepatocellular carcinoma [HCC]: from bench to bedside. J Egypt Natl Canc Inst 2013;25(4):165-71
   PubMedGoogle Scholar
• 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]
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• 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
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• National cancer institute, common toxicity criteria. Available from: http://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf
   Google Scholar
• Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327(7414):557-60
   PubMed Web of Science ®Google Scholar
• DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986;7(3):177-88
   PubMedGoogle Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMedGoogle Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Tykerb [lapatinib] FDA prescribing information. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s007lbl.pdf [Last accessed 11/6/2014]
   Google Scholar
• 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
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• 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
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar