Novel agents in the era of targeted therapy: What have we learned and how has our practice changed?

Annals of Oncology

Volumn 19, Issue SUPPL. 7, 2008, Pages

  Baselga, J ^a  

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

4 [3 CHLORO 4 (2 PYRIDINYLMETHOXY)ANILINO] 3 CYANO 6 (4 DIMETHYLAMINOCROTONAMIDO) 7 ETHOXYQUINOLINE; ANTHRACYCLINE DERIVATIVE; AROMATASE INHIBITOR; BEVACIZUMAB; CAPECITABINE; CETUXIMAB; CISPLATIN; DASATINIB; DEFOROLIMUS; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; EVEROLIMUS; FLUOROURACIL; HEAT SHOCK PROTEIN 90 INHIBITOR; IMATINIB; IMIDAZOQUINOLINE DERIVATIVE; LAPATINIB; LETROZOLE; N (5 CHLORO 1,3 BENZODIOXOL 4 YL) 7 [2 (4 METHYL 1 PIPERAZINYL)ETHOXY] 5 (TETRAHYDRO 2H PYRAN 4 YLOXY) 4 QUINAZOLINAMINE; OCTREOTIDE; PACLITAXEL; PANITUMUMAB; PERTUZUMAB; PLACEBO; RAPAMYCIN DERIVATIVE; TANESPIMYCIN; TAXANE DERIVATIVE; TEMSIROLIMUS; TRASTUZUMAB; UNCLASSIFIED DRUG; UNINDEXED DRUG; ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; HEAT SHOCK PROTEIN 90; MAMMALIAN TARGET OF RAPAMYCIN; ONCOPROTEIN; PHOSPHATIDYLINOSITOL 3 KINASE; PROTEIN KINASE; PROTEIN KINASE INHIBITOR; PROTEIN TYROSINE KINASE;

ACUTE LYMPHOCYTIC LEUKEMIA; ADJUVANT THERAPY; ANTIANGIOGENIC ACTIVITY; ANTINEOPLASTIC ACTIVITY; BRAIN METASTASIS; BREAST CANCER; CANCER THERAPY; CHRONIC MYELOID LEUKEMIA; CLINICAL PRACTICE; CLINICAL TRIAL; COLON CANCER; COLORECTAL CANCER; CONFERENCE PAPER; DISEASE FREE SURVIVAL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG TARGETING; DRUG TOLERABILITY; DRUG WITHDRAWAL; HEAD AND NECK CANCER; HUMAN; LUNG NON SMALL CELL CANCER; MONOTHERAPY; NEUROENDOCRINE TUMOR; OVARY CANCER; OVERALL SURVIVAL; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SOLID TUMOR; UNSPECIFIED SIDE EFFECT; ARTICLE; DRUG ANTAGONISM; DRUG DELIVERY SYSTEM; ENZYMOLOGY; METABOLISM; METHODOLOGY; NEOPLASM; RANDOMIZED CONTROLLED TRIAL;

1-PHOSPHATIDYLINOSITOL 3-KINASE; ANTINEOPLASTIC AGENTS; DRUG DELIVERY SYSTEMS; HSP90 HEAT-SHOCK PROTEINS; HUMANS; NEOPLASMS; ONCOGENE PROTEIN V-AKT; PROTEIN KINASE INHIBITORS; PROTEIN KINASES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTOR, EPIDERMAL GROWTH FACTOR; RECEPTOR, ERBB-2; SRC-FAMILY KINASES;

EID: 53449096849     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdn433     Document Type: Conference Paper

References (88)

1. 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.
2. Miller K, Wang M, Gralow J et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007; 357: 2666-2676.
3. Hanahan D, Weinberg R. The hallmarks of cancer. Cell 2000; 100: 57-70.
4. Di Cosimo S, Baselga J. Pharmacodynamic endpoints in primary breast cancer. Ann Oncol 2007; 18 (Suppl 9): Ix21-23.
5. Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat Rev Mol Cell Biol 2001; 2: 127-137.
6. Schlessinger J. Common and distinct elements in cellular signaling via EGF and FGF receptors. Science 2004; 306: 1506-1507.
7. Hudziak RM, Schlessinger J, Ullrich A. Increased expression of the putative growth factor receptor p185HER2 causes transformation and tumorigenesis of NIH 3T3 cells. Proc Natl Acad Sci USA 1987; 84: 7159-7163.
8. Slamon DJ, Godolphin W, Jones LA et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989; 244: 707-712.
9. Yu D, Hung M. Overexpression of ErbB2 in cancer and ErbB2-targeting strategies. Oncogene 2000; 11: 6115-6121.
10. Carter P, Presta L, Gorman CM et al. Humanization of an anti-p185HER2 antibody for human cancer therapy. Proc Natl Acad Sci 1992; 89: 4285-4289.
11. Tokuda Y, Ohnishi Y, Shimamura K et al. In vitro and in vivo anti-tumour effects of a humanised monoclonal antibody against c-erbB-2 product. Br J Cancer 1996; 73: 1362-1365.
12. Baselga J, Norton L, Albanell J, Kim Y-M, Mendelsohn J. Recombinant humanized anti-HER2 antibody (HerceptinTM) enhances the antitumor activity of paclitaxel and doxorubicin against HER2/neu overexpressing human breast cancer xenografts. Cancer Res 1998; 58: 2825-2831.
13. Marty M, Cognetti F, Maraninchi D et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: The M77001 Study Group. J Clin Oncol 2005; 23: 4265-4274.
14. 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.
15. 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.
16. Joensuu H, Kellokumpu-Lehtinen P-L, Bono P et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006; 354: 809-820.
17. Smith I, Procter M, Gelber RD et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: A randomised controlled trial. Lancet 2007; 369: 29-36.
18. 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.
19. Lin N, Dieras V, Paul D. EGF105084, a phase II study of lapatinib for brain metastases in patients (pts) with HER2+ breast cancer following trastuzumab (H) based systemic therapy and cranial radiotherapy (RT). ASCO 2007 Annual Meeting Proceedings. J Clin Oncol 2007; 25 (18 Suppl): (Abstr 1012).
20. Kirsch DG, Hochberg FH. Targeting HER2 in brain metastases from breast cancer. Clin Cancer Res 2003; 9: 5435-5436.
21. Cristofanilli M, Boussen H, Ben Ayed F et al. A phase II combination study of lapatinib (TYKERB) and paclitaxel as neoadjuvant therapy in patients with newly diagnosed inflammatory breast cancer (IBC). Breast Cancer Res Treat 2006; 100 (Suppl 1): S5 (Abstr 1).
22. Wong K, Fracasso P, Bukowski R. HKI-272, an irreversible pan erbB receptor tyrosine kinase inhibitor: Preliminary phase 1 results in patients with solid tumors. J Clin Oncol 2006; 24: 3018.
23. Mom C, Eskens F, Gietema J et al. Phase 1 study with BIBW 2992, an irreversible dual tyrosine kinase inhibitor of epidermal growth factor receptor 1 (EGFR) and 2 (HER2) in a 2 week on 2 week off schedule. ASCO 2006 Annual Meeting Proceedings. J Clin Onool 2006; 24 (18 Suppl): (Abstr 3025).
24. Agus DB, Akita RW, Fox WD et al. Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth. Cancer Cell 2002; 2: 127-137.
25. Franklin MC, Carey KD, Vajdos FF, Leahy DJ, de Vos AM, Sliwkowski MX. Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex. Cancer Cell 2004; 5: 317-328.
26. Baselga J, Cameron D, Miles D et al. Objective response rate in a phase II multicenter trial of pertuzumab (P), a HER2 dimerization inhibiting monoclonal antibody, in combination with trastuzumab (I) in patients (Pts) with HER2 positive metastatic breast cancer (MBC) which had progressed during trastuzumab therapy. ASCO 2007 Annual Meeting Proceedings. J Clin Oncol 2007; 25 (18 Suppl): (Abstr 1004).
27. Mendelsohn J, Baselga J. Epidermal growth factor receptor targeting in cancer. Semin Oncol 2006; 33: 369-385.
28. Cunningham D, Humblet Y, Siena S et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004; 351: 337-345.
29. Van Cutsem E, Peeters M, Siena S et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007; 25: 1658-1664.
30. Khambata-Ford S, Garrett CR, Meropol NJ et al. Expression of epiregulin and amphiregulin and K-ras mutation status predict disease control in metastatic colorectal cancer patients treated with cetuximab. J Clin Oncol 2007; 25: 3230-3237.
31. Forbes S, Clements J, Dawson E et al. Cosmic 2005. Br J Cancer 2006; 94: 318-322.
32. Benvenuti S, Sartore-Bianchi A, Di Nicolantonio F et al. Oncogenic activation of the RAS/RAF signaling pathway impairs the response of metastatic colorectal cancers to anti-epidermal growth factor receptor antibody therapies. Cancer Res 2007; 67: 2643-2648.
33. Di Fiore F, Blanchard F, Charbonnier F et al. Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by cetuximab plus chemotherapy. Br J Cancer 2007; 96: 1166-1169.
34. Lievre A, Bachet JB, Le Corre D et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 2006; 66: 3992-3995.
35. De Roock W, Piessevaux H, De Schutter J et al. KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Ann Oncol 2007; 19: 508-515.
36. Bowtell DD. Options available -from start to finist - for obtaining expression data by microarray. Nat Genet 1999; 21 (Suppl): 25-32.
37. Pao W, Wang TY, Riely GJ et al. KRAS mutations and primary resistance of lung adenocarcinomas to gefitinib or erlotinib. PLoS Med 2005; 2: E17.
38. Massarelli E, Varella-Garcia M, Tang X et al. KRAS mutation is an important predictor of resistance to therapy with epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. Clin Cancer Res 2007; 13: 2890-2896.
39. Miller VA, Zakowski M, Riely GJ et al. EGFR mutation and copy number, EGFR protein expression and KRAS mutation as predictors of outcome with erlotinib in bronchioloalveolar cell carcinoma (BAC): Results of a prospective phase II trial. ASCO 2006 Annual Meeting Proceedings. J Clin Oncol 2006; 24 (18 Suppl): (Abstr 7003).
40. Eberhard DA, Johnson BE, Amler LC et al. Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol 2005; 23: 5900-5909.
41. Philip PA, Benedetti J, Fenoglio-Preiser C et al. Phase III study of gemcitabine [G] plus cetuximab [C] versus gemcitabine in patients [pts] with locally advanced or metastatic pancreatic adenocarcinoma [PC]: SWOG S0205 study. ASCO 2007 Annual Meeting Proceedings. J Clin Oncol 2007; 25 (18 Suppl): LBA4509.
42. Moore MJ, Goldstein D, Hamm J et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007; 25: 1960-1966.
43. Mellinghoff IK, Wang MY, Vivanco I et al. Molecular determinants of the response of glioblastomas to EGFR kinase inhibitors. N Engl J Med 2005; 353: 2012-2024.
44. Samuels Y, Wang Z, Bardelli A et al. High frequency of mutations of the PIK3CA gene in human cancers. Science 2004; 304: 554.
45. Bachman KE, Argani P, Samuels Y et al. The PIK3CA gene is mutated with high frequency in human breast cancers. Cancer Biol Ther 2004; 3: 772-775.
46. Lee JW, Soung YH, Kim SY et al. PIK3CA gene is frequently mutated in breast carcinomas and hepatocellular carcinomas. Oncogene 2005; 24: 1477-1480.
47. Campbell IG, Russell SE, Choong DY et al. Mutation of the PIK3CA gene in ovarian and breast cancer. Cancer Res 2004; 64: 7678-7681.
48. Levine DA, Bogomolniy F, Yee CJ et al. Frequent mutation of the PIK3CA gene in ovarian and breast cancers. Clin Cancer Res 2005; 11: 2875-2878.
49. Philp AJ, Campbell IG, Leet C et al. The phosphatidylinositol 3′-kinase p85alpha gene is an oncogene in human ovarian and colon tumors. Cancer Res 2001; 61: 7426-7429.
50. Cantley LC, Neel BG. New insights into tumor suppression: PTEN suppresses tumor formation by restraining the phosphoinositide 3-kinase/ AKT pathway. Proc Natl Acad Sci 1999; 96: 4240-4245.
51. Cantley LC. The phosphoinositide 3-kinase pathway. Science 2002; 296: 1655-1657.
52. Sarbassov DD, Guertin DA, Ali SM, Sabatini DM. Phosphorylation and regulation of Akt/PKB by the rictor-mTOR complex. Science 2005; 307: 1098-1101.
53. Inoki K, Li Y, Zhu T, Wu J, Guan KL. TSC2 is phosphorylated and inhibited by Akt and suppresses mTOR signalling. Nat Cell Biol 2002; 4: 648-657.
54. Hennessy BT, Smith DL, Ram PT, Lu Y, Mills GB. Exploiting the PI3K/AKT pathway for cancer drug discovery. Nat Rev Drug Discov 2005; 4: 988-1004.
55. Engelman JA, Luo J, Cantley LC. The evolution of phosphatidylinositol 3-kinases as regulators of growth and metabolism. Nat Rev Genet 2006; 7: 606-619.
56. Liaw D, Marsh DJ, Li J et al. Germline mutations of the PTEN gene in Cowden disease, an inherited breast and thyroid cancer syndrome. Nat Genet 1997; 16: 64-67.
57. Samuels Y, Diaz LA Jr., Schmidt-Kittler O et al. Mutant PIK3CA promotes cell growth and invasion of human cancer cells. Cancer Cell 2005; 7: 561-573.
58. Bader AG, Kang S, Vogt PK. Cancer-specific mutations in PIK3CA are oncogenic in vivo. Proc Natl Acad Sci USA 2006; 103: 1475-1479.
59. Nagata Y, Lan KH, Zhou X et al. PTEN activation contributes to tumor inhibition by trastuzumab, and loss of PTEN predicts trastuzumab resistance in patients. Cancer Cell 2004; 6: 117-127.
60. Raymond E, Alexandre J, Faivre S et al. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. J Clin Oncol 2004; 22: 2336-2347.
61. Braunstein S, Karpisheva K, Pola C et al. A hypoxia-controlled cap-dependent to cap-independent translation switch in breast cancer. Mol Cell 2007; 28: 501-512.
62. O'Reilly KE, Rojo F. She Q-B et al. mTOR Inhibition induces upstream receptor tyrosine kinase signaling and activates Akt. Cancer Res 2006; 66: 1500-1508.
63. Di Cosimo S, Scaltriti M, Val D et al. The PI3-K/AKT/mTOR pathway as a target for breast cancer therapy. ASCO 2007 Annual Meeting Proceedings 2007; 25 (18 Suppl): (Abstr 3511).
64. Yao J, Phan A, Chang D et al. Phase II study of RAD001 (everolimus) and depot octreotide (Sandostatin LAR) in patients with advanced low grade neuroendocrine carcinoma (LGNET), ASCO 2006 Annual Meeting Proceedings. J Clin Oncol 2006; 24 (18 Suppl): (Abstr 4042).
65. Carpenter JT, Roche H, Campone M et al. Randomized 3-arm, phase 2 study of temsirolimus (CCI-779) in combination with letrozole in postmenopausal women with locally advanced or metastatic breast cancer. Proc Am Soc Clin Oncol 2005; 23: (Abstr 564).
66. Tabemero J, Rojo F, Burris H et al. A phase I study with tumor molecular pharmacodynamic (MPD) evaluation of dose and schedule of the oral mTOR-inhibitor everolimus (RAD001) in patients (pts) with advanced solid tumors. Proc Am Soc Clin Oncol 2005; 23: (Abstr 3007).
67. Baselga J, Semiglazov V, van Dam P et al. Phase II double-blind randomized trial of daily oral RAD001 (everolimus) plus letrozole (LET) or placebo (P) plus LET as neoadjuvant therapy for ER+ breast cancer, San Antonio Breast Cancer Symposium 2007: (Abstr 2066).
68. Dowsett M, Smith IE, Ebbs SR et al. Prognostic value of Ki67 expression after short-term presurgical endocrine therapy for primary breast cancer. J Natl Cancer Inst 2007; 99: 167-170.
69. Stauffer F, Garcia-Echeverirria C, Furet P. Biochemical, cellular, and in vivo profiling of a new P13K inhibitor from the imidazoquinoline series. American Association for Cancer Research Annual Meeting 2007 Apr 14-18 2007; Los Angeles, Philadelphia; (Abstr 269).
70. Martin GS, The hunting of the Src. Nat Rev Mol Cell Biol 2001; 2: 467-475.
71. Thomas SM, Brugge JS. Cellular functions regulated by Src family kinases. Annu Rev Cell Dev Biol 1997; 13: 513-609.
72. Bromann PA, Korkaya H, Courtneidge SA. The interplay between Src family kinases and receptor tyrosine kinases. Oncogene 2004; 23: 7957.
73. Blume-Jensen P, Hunter T. Oncogenic kinase signalling. Nature 2001; 411: 355-365.
74. Avizienyte E, Frame MC. Src and FAK signalling controls adhesion fate and the epithelial-to-mesenchymal transition. Curr Opin Cell Biol 2005; 17: 542-547.
75. Muthuswamy SK, Siegel PM, Dankort DL, Webster MA, Muller WJ. Mammary tumors expressing the neu proto-oncogene possess elevated c-Src tyrosine kinase activity. Mol Cell Biol 1994; 14: 735-743.
76. Verbeek B, Vroom T, Adriaansen-Slot S, Ottenhoff-Kalff A, Geertzema G, Rijksen A. c-Src protein expression is increased in human breast cancer. an immunohistochemical and biochemical analysis. J Pathol 1996; 180: 383-388.
77. Huang F, Reeves K, Han X et al. Identification of candidate molecular markers predicting sensitivity in solid tumors to dasatinib: Rationale for patient selection, Cancer Res 2007; 67: 2226-2238.
78. Hennequin LF, Allen J, Breed J et al. N-(5-Chloro-1,3-benzodioxol-4y-l- 7-[2-(4-methylpiperazin-1-yl)ethoxy)-5-(tetrahydro-2H-pyran-4-yloxy) quinazolin-4-amine, a novel, highly selective, orally available, dual-specific c-Src/Abl kinase inhibitor. J Med Chem 2006; 49: 6465-6488.
79. Eastell R, Hannon RA, Gallagher N, Clack G, Macpherson M, Marshall A. The effect of AZD0530, a highly selective, orally available Src/Abl kinase inhibitor, on biomarkers of bone resorption in healthy males. ASCO 2005 Annual Meeting Proceedings. J Clin Oncol 2005; 23 (16 Suppl): (Abstr 3041).
80. Tabernero J, Cervantes A, Hoekman K et al. Phase I study of AZD0530, an oral potent inhibitor of Src kinase: First demonstration of inhibition of Src activity in human cancers. ASCO 2007 Annual Meeting Proceedings. J Clin Oncol 2007; 25 (18 Suppl): (Abstr 3520).
81. Neckers L, Kern A, Tsutsumi S. Hsp90 inhibitors disrupt mitochondrial homeostasis in cancer cells. Chem Biol 2007; 14: 1204-1206.
82. Zhang H, Burrows F. Targeting multiple signal transduction pathways through inhibition of Hsp90. J Mol Med 2004; 82: 488-499.
83. Maloney A, Workman P. HSP90 as a new therapeutic target for cancer therapy: The story unfolds. Expert Opin Biol Ther 2002; 2: 3-24.
84. Basso AD, Solit DB, Munster PN, Rosen N. Ansamycin antibiotics inhibit Akt activation and cyclin D expression in breast cancer cells that overexpress HER2. Oncogene 2002; 21: 1159-1166.
85. Neckers L. Effects of geldanamycin and other naturally occurring small molecule antagonists of heat shock protein 90 on HER2 protein expression. Breast Dis 2000; 11: 49-59.
86. Modi S, Stopeck A, Gordon MS et al. Phase I trial of KOS-953, a heat shock protein 90 inhibitor, and trastuzumab (T). ASCO 2006 Annual Meeting Proceedings. J Clin Oncol 2006; 24 (18 Suppl): (Abstr 501).
87. Miller K, Rosen L, Modi S et al. Phase I trial of alvespimycin (KOS-1022; 17-DMAG) and trastuzumab (T). ASCO 2007 Annual Meeting Proceedings (Post-Meeting Edition). J Clin Oncol 2007; 25 (18 Suppl): (Abstr 1115).
88. Nagrath S, Sequist LV, Maheswaran S et al. Isolation of rare circulating tumour cells in cancer patients by microchip technology. Nature 2007; 450: 1235-1239.