Phase I-II study of the farnesyl transferase inhibitor tipifarnib plus sequential weekly paclitaxel and doxorubicin-cyclophosphamide in HER2/neu-negative inflammatory carcinoma and non-inflammatory estrogen receptor-positive breast carcinoma

Breast Cancer Research and Treatment

Volumn 141, Issue 3, 2013, Pages 429-435

  Andreopoulou, Eleni ^a   Vigoda, Ivette S ^a   Valero, Vicente ^b   Hershman, Dawn L ^c   Raptis, George ^d   Vahdat, Linda T ^e   Han, Hyo S ^f   Wright, John J ^g   Pellegrino, Christine M ^a   Cristofanilli, Massimo ^h   Alvarez, Ricardo H ^b   Fehn, Karen ^a   Fineberg, Susan ^a   Sparano, Joseph A ^a  

^a ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF TEXAS   (United States)

^c Department of Neurology and the Taub Institute for Research on Alzheimer's Disease and the Aging Brain   (United States)

^d North Shore LIJ Cancer Institute   (United States)

^e WEILL CORNELL MEDICAL COLLEGE   (United States)

^f H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^g NATIONAL CANCER INSTITUTE   (United States)

^h THOMAS JEFFERSON UNIVERSITY   (United States)

Author keywords

Breast cancer; Farnesyl transferase inhibitor; Inflammatory breast cancer; Neoadjuvant chemotherapy; Ras; Tipifarnib

Indexed keywords

CYCLOPHOSPHAMIDE; DEXAMETHASONE; DIPHENHYDRAMINE; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GRANULOCYTE COLONY STIMULATING FACTOR; PACLITAXEL; PROTEIN FARNESYLTRANSFERASE INHIBITOR; RANITIDINE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; TIPIFARNIB;

ADULT; AGED; ANEMIA; ARTICLE; BLOOD TOXICITY; BREAST CANCER; CANCER LOCALIZATION; CANCER PATIENT; CANCER STAGING; DIARRHEA; DRUG DOSE ESCALATION; DRUG FATALITY; DYSPEPSIA; ESTROGEN RECEPTOR POSITIVE BREAST CANCER; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; HUMAN TISSUE; HYPERGLYCEMIA; HYPOGLYCEMIA; INFECTION; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NAIL; NAUSEA; NEUROPATHY; NEUTROPENIA; PAIN; PATIENT SELECTION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SENSORY NEUROPATHY; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DOXORUBICIN; FARNESYL-DIPHOSPHATE FARNESYLTRANSFERASE; FEMALE; HUMANS; INFLAMMATORY BREAST NEOPLASMS; MIDDLE AGED; NEOPLASMS, HORMONE-DEPENDENT; PACLITAXEL; QUINOLONES; RECEPTOR, ERBB-2; RECEPTORS, ESTROGEN; TREATMENT OUTCOME;

EID: 84887052280     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-013-2704-x     Document Type: Article

References (41)

1. Rochlitz CF, Scott GK, Dodson JM et al (1989) Incidence of activating ras oncogene mutations associated with primary and metastatic human breast cancer. Cancer Res 49:357-360
2. Thor A, Ohuchi N, Hand PH et al (1986) ras gene alterations and enhanced levels of ras p21 expression in a spectrum of benign and malignant human mammary tissues. Lab Invest 55:603-615
3. Smith CA, Pollice AA, Gu LP et al (2000) Correlations among p53, Her-2/neu, and ras overexpression and aneuploidy by multiparameter flow cytometry in human breast cancer: evidence for a common phenotypic evolutionary pattern in infiltrating ductal carcinomas. Clin Cancer Res 6:112-126
4. Bunone G, Briand PA, Miksicek RJ et al (1996) Activation of the unliganded estrogen receptor by EGF involves the MAP kinase pathway and direct phosphorylation. EMBO J 15:2174-2183
5. Kato S, Masuhiro Y, Watanabe M et al (2000) Molecular mechanism of a cross-talk between oestrogen and growth factor signalling pathways. Genes Cells 5:593-601
6. Theillet C, Lidereau R, Escot C et al (1986) Loss of a c-H-ras-1 allele and aggressive human primary breast carcinomas. Cancer Res 46:4776-4781
7. Kleer CG, van Golen KL, Zhang Y et al (2002) Characterization of RhoC expression in benign and malignant breast disease: a potential new marker for small breast carcinomas with metastatic ability. Am J Pathol 160:579-584
8. van Golen KL, Bao L, DiVito MM et al (2002) Reversion of RhoC GTPase-induced inflammatory breast cancer phenotype by treatment with a farnesyl transferase inhibitor. Mol Cancer Ther 1:575-583
9. Zhu K, Hamilton AD, Sebti SM (2003) Farnesyltransferase inhibitors as anticancer agents: current status. Curr Opin Investig Drugs 4:1428-1435
10. Crespo NC, Ohkanda J, Yen TJ et al (2001) The farnesyltransferase inhibitor, FTI-2153, blocks bipolar spindle formation and chromosome alignment and causes prometaphase accumulation during mitosis of human lung cancer cells. J Biol Chem 276:16161-16167
11. Crespo NC, Delarue F, Ohkanda J et al (2002) The farnesyltransferase inhibitor, FTI-2153, inhibits bipolar spindle formation during mitosis independently of transformation and Ras and p53 mutation status. Cell Death Differ 9:702-709
12. Ashar HR, James L, Gray K et al (2001) The farnesyl transferase inhibitor SCH 66336 induces a G(2) → M or G(1) pause in sensitive human tumor cell lines. Exp Cell Res 262:17-27
13. Sepp-Lorenzino L, Rosen N (1998) A farnesyl-protein transferase inhibitor induces p21 expression and G1 block in p53 wild type tumor cells. J Biol Chem 273:20243-20251
14. Le Gouill S, Pellat-Deceunynck C, Harousseau JL et al (2002) Farnesyl transferase inhibitor R115777 induces apoptosis of human myeloma cells. Leukemia 16:1664-1667
15. Han JY, Oh SH, Morgillo F et al (2005) Hypoxia-inducible factor 1alpha and antiangiogenic activity of farnesyltransferase inhibitor SCH66336 in human aerodigestive tract cancer. J Natl Cancer Inst 97:1272-1286
16. Kelland LR, Smith V, Valenti M et al (2001) Preclinical antitumor activity and pharmacodynamic studies with the farnesyl protein transferase inhibitor R115777 in human breast cancer. Clin Cancer Res 7:3544-3550
17. Sun J, Ohkanda J, Coppola D et al (2003) Geranylgeranyltransferase I inhibitor GGTI-2154 induces breast carcinoma apoptosis and tumor regression in H-Ras transgenic mice. Cancer Res 63:8922-8929
18. Kohl NE, Omer CA, Conner MW et al (1995) Inhibition of farnesyltransferase induces regression of mammary and salivary carcinomas in ras transgenic mice. Nat Med 1:792-797
19. Marcus AI, Zhou J, O'Brate A et al (2005) The synergistic combination of the farnesyl transferase inhibitor lonafarnib and paclitaxel enhances tubulin acetylation and requires a functional tubulin deacetylase. Cancer Res 65:3883-3893
20. Loprevite M, Favoni RE, De Cupis A et al (2004) In vitro study of farnesyltransferase inhibitor SCH 66336, in combination with chemotherapy and radiation, in non-small cell lung cancer cell lines. Oncol Rep 11:407-414
21. Wang EJ, Johnson WW (2003) The farnesyl protein transferase inhibitor lonafarnib (SCH66336) is an inhibitor of multidrug resistance proteins 1 and 2. Chemotherapy 49:303-308
22. Jin W, Wu L, Liang K et al (2003) Roles of the PI-3K and MEK pathways in Ras-mediated chemoresistance in breast cancer cells. Br J Cancer 89:185-191
23. Weinstein-Oppenheimer CR, Henriquez-Roldan CF, Davis JM et al (2001) Role of the Raf signal transduction cascade in the in vitro resistance to the anticancer drug doxorubicin. Clin Cancer Res 7:2898-2907
24. Rasouli-Nia A, Liu D, Perdue S et al (1998) High Raf-1 kinase activity protects human tumor cells against paclitaxel-induced cytotoxicity. Clin Cancer Res 4:1111-1116
25. Cornwell MM, Smith DE (1993) A signal transduction pathway for activation of the mdr1 promoter involves the proto-oncogene c-raf kinase. J Biol Chem 268:15347-15350
26. Johnston SR, Hickish T, Ellis P et al (2003) Phase II study of the efficacy and tolerability of two dosing regimens of the farnesyl transferase inhibitor, R115777, in advanced breast cancer. J Clin Oncol 21:2492-2499
27. Sparano JA, Moulder S, Kazi A et al (2006) Targeted inhibition of farnesyltransferase in locally advanced breast cancer: a phase I and II trial of tipifarnib plus dose-dense doxorubicin and cyclophosphamide. J Clin Oncol 24:3013-3018
28. Sparano JA, Moulder S, Kazi A et al (2009) Phase II trial of tipifarnib plus neoadjuvant doxorubicin-cyclophosphamide in patients with clinical stage IIB-IIIC breast cancer. Clin Cancer Res 15:2942-2948
29. Bear HD, Anderson S, Brown A et al (2003) The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 21:4165-4174
30. Green MC, Buzdar AU, Smith T et al (2005) Weekly paclitaxel improves pathologic complete remission in operable breast cancer when compared with paclitaxel once every 3 weeks. J Clin Oncol 23:5983-5992
31. Sparano JA, Wang M, Martino S et al (2008) Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med 358:1663-1671
32. Therasse P, Arbuck SG, Eisenhauer EA et al (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216
33. Symmans WF, Peintinger F, Hatzis C et al (2007) Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy. J Clin Oncol 25:4414-4422
34. Guarneri V, Broglio K, Kau SW et al (2006) Prognostic value of pathologic complete response after primary chemotherapy in relation to hormone receptor status and other factors. J Clin Oncol 24:1037-1044
35. Kuerer HM, Newman LA, Smith TL et al (1999) Clinical course of breast cancer patients with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant chemotherapy. J Clin Oncol 17:460-469
36. Prowell TM, Pazdur R (2012) Pathological complete response and accelerated drug approval in early breast cancer. N Engl J Med 366:2438-2441
37. Prowell TM, Pazdur R (2012) Pathological complete response and accelerated drug approval in early breast cancer. N Engl J Med 366:2438-2441
38. Barker AD, Sigman CC, Kelloff GJ et al (2009) I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharmacol Ther 86:97-100
39. Cortazar P, Zhang L, Untch M et al (2012) Meta-Analysis results from the collaborative trials in neoadjuvant breast cancer (CTNeoBC). Breast Cancer Res Treat 72:S1-11, 2012
40. Esserman LJ, Berry DA, Cheang MC et al (2012) Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657). Breast Cancer Res Treat 132:1049-1062
41. Houssami N, Macaskill P, von Minckwitz G et al (2012) Meta-analysis of the association of breast cancer subtype and pathologic complete response to neoadjuvant chemotherapy. Eur J Cancer 48:3342-3354