Trastuzumab combined with pegylated liposomal doxorubicin in patients with metastatic breast cancer: Phase II study of the Hellenic Cooperative Oncology Group (HeCOG) with Biomarker evaluation

Oncology

Volumn 76, Issue 4, 2009, Pages 275-285

  Christodoulou, Christos ^a,g   Kostopoulos, Ioannis ^b   Kalofonos, Haralabos P ^c   Lianos, Evangelos ^d   Bobos, Mattheos ^b   Briasoulis, Evangelos ^e   Gogas, Helen ^d   Razis, Evangelia ^f   Skarlos, Dimosthenis V ^a   Fountzilas, George ^b  

^a HENRY DUNANT HOSPITAL   (Greece)

^b ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^c UNIVERSITY OF PATRAS   (Greece)

^d UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^e UNIVERSITY HOSPITAL OF IOANNINA   (Greece)

^f HYGEIA HOSPITAL   (Greece)

^g Metropolitan Hospital   (Greece)

Author keywords

Anthracyclines; Breast cancer; FISH; IHC; MTOR; Pegylated liposomal doxorubicin; PTEN; TOP2A; Trastuzumab

Indexed keywords

DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; MAMMALIAN TARGET OF RAPAMYCIN; PARAFFIN; PHOSPHATIDYLINOSITOL 3,4,5 TRISPHOSPHATE 3 PHOSPHATASE; PYRIDOXINE; TRASTUZUMAB;

ADULT; AGED; ALOPECIA; ANEMIA; ARTHRALGIA; ARTICLE; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER LOCALIZATION; CANCER RELAPSE; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED STUDY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GENE; GENE DELETION; GENE MUTATION; HAND FOOT SYNDROME; HEART ARRHYTHMIA; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HUMAN TISSUE; INFECTION; LEUKOPENIA; LIVER TOXICITY; LOADING DRUG DOSE; METASTASIS; METASTATIC BREAST CANCER; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA AND VOMITING; NEUROTOXICITY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN EXPRESSION; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; TOP2A GENE; TREATMENT RESPONSE; ULTRASOUND; UNSPECIFIED SIDE EFFECT;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DOXORUBICIN; HUMANS; MIDDLE AGED; POLYETHYLENE GLYCOLS; PROTEIN KINASES; PTEN PHOSPHOHYDROLASE; RECEPTOR, ERBB-2; VENTRICULAR FUNCTION, LEFT;

EID: 61349090481     PISSN: 00302414     EISSN: None     Source Type: Journal    
DOI: 10.1159/000207504     Document Type: Article

References (37)

1. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L: 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. Marty M, Cognetti F, Maraninchi D, Snyder R, Mauriac L, Tubiana-Hulin M, Chan S, Grimes D, Antón A, Lluch A, Kennedy J, O'Byrne K, Conte P, Green M, Ward C, Mayne K, Extra JM: 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.
3. Fountzilas G, Razis E, Tsavdaridis D, Karina M, Labropoulos S, Christodoulou C, Mavroudis D, Gogas H, Georgoulias V, Skarlos D: Continuation of trastuzumab beyond disease progression is feasible and safe in patients with metastatic breast cancer: a retrospective analysis of 80 cases by the Hellenic Cooperative Oncology Group. Clin Breast Cancer 2003;4:120-125.
4. Gelmon KA, Mackey J, Verma S, Gertler SZ, Bangemann N, Klimo P, Schneeweiss A, Bremer K, Soulières D, Tonkin K, Bell R, Heinrich B, Grenier D, Dias R: Use of trastuzumab beyond disease progression: observation from a retrospective review of case histories. Clin Breast Cancer 2004;5:52-58.
5. Tripathy D, Slamon DJ, Cobleigh M, Arnold A, Saleh M, Mortimer JE, Murphy M, Stewart SJ: Safety of treatment of metastatic breast cancer with trastuzumab beyond disease progression. J Clin Oncol 2004;22:1063-1070.
6. Schaller G, Fuchs I, Gonsch T, Weber J, Kleine-Tebbe A, Klare P, Hindenburg HJ, Lakner V, Hinke A, Bangemann N: Phase II study of capecitabine plus trastuzumab in human epidermal growth factor receptor 2 overexpressing metastatic breast cancer pretreated with anthracyclines or taxanes. J Clin Oncol 2007;25:3246-3250.
7. O'Shaughnessy J, Vukelja SJ, Marsland T, Kimmel G, Ratnam S, Pippen J: Phase II trial of gemcitabine plus trastuzumab in metastatic breast cancer patients previously treated with chemotherapy: preliminary results. Clin Breast Cancer 2002;3(suppl 1):17-20.
8. Burstein HJ, Kuter I, Campos SM, Gelman RS, Tribou L, Parker LM, Manola J, Younger J, Matulonis U, Bunnell CA, Partridge AH, Richardson PG, Clarke K, Shulman LN, Winer EP: Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol 2001;19:2722-2730.
9. Pegram MD, Lipton A, Hayes DF, Weber BL, Baselga JM, Tripathy D, Baly D, Baughman SA, Twaddell T, Glaspy JA, Slamon DJ: Phase II study of receptor-enhanced chemosensitivity using recombinant humanized antip185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol 1998;16:2659-2671.
10. Seidman A, Hudis C, Pierri MK, Shak S, Paton V, Ashby M, Murphy M, Stewart SJ, Keefe D: Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 2002;20:1215-1221.
11. O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C; CAELYX Breast Cancer Study Group: Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004;15:440-449.
12. Konecny G, Pegram MD, Beryt M: Therapeutic advantage of chemotherapy drugs in combination with Herceptin against human breast cancer cells with HER-2/neu overexpression. Breast Cancer Res Treat 1999 (abstract467);57:114-121.
13. Dabbs DJ (ed): Diagnostic Immunohistochemistry, ed 2. Philadelphia, Churchill Livingstone, 2006, pp 37-52. 14 Camp RL, Charette LA, Rimm DL: Validation of tissue microarray technology in breast carcinoma. Lab Invest 2000;80:1943-1949.
14. Skacel M, Skilton B, Pettay JD, Tubbs RR: Tissue microarrays: a powerful tool for highthroughput analysis of clinical specimens: a review of the method with validation data. Appl Immunohistochem Mol Morphol 2002;10:1-6.
15. Blancato J, Singh B, Liu A, Liao DJ, Dickson RB: Correlation of amplification and overexpression of the c-myc oncogene in highgrade breast cancer: FISH, in situ hybridization and immunohistochemical analyses. Br J Cancer 2004;90:1612-1619.
16. Italiano A, Saint-Paul MC, Caroli-Bosc FX, François E, Bourgeon A, Benchimol D, Gugenheim J, Michiels JF: Epidermal growth factor receptor (EGFR) status in primary colorectal tumors correlates with EGFR expression in related metastatic sites: biological and clinical implications. Ann Oncol 2005;16:1503-1507.
17. Tang JM, He QY, Guo RX, Chang XJ: Phosphorylated Akt overexpression and loss of PTEN expression in non-small cell lung cancer confers poor prognosis. Lung Cancer 2006;51:181-191.
18. Peponi E, Drakos E, Reyes G, Leventaki V, Rassidakis GZ, Medeiros LJ: Activation of mammalian target of rapamycin signaling promotes cell cycle progression and protects cells from apoptosis in mantle cell lymphoma. Am J Pathol 2006;169:2171-2180.
19. Perren A, Weng LP, Boag AH, Ziebold U, Thakore K, Dahia PL, Komminoth P, Lees JA, Mulligan LM, Mutter GL, Eng C: Immunohistochemical evidence of loss of PTEN expression in primary ductal adenocarcinomas of the breast. Am J Pathol 1999;155:1253-1260.
20. Bhargava R, Lal P, Chen B: HER-2/neu and topoisomerase IIa gene amplification and protein expression in invasive breast carcinomas: chromogenic in situ hybridization and immunohistochemical analyses. Am J Clin Pathol 2005;123:889-895.
21. Corzo C, Corominas JM, Tusquets I, Salido M, Bellet M, Fabregat X, Serrano S, Solé F: The MYC oncogene in breast cancer progression: from benign epithelium to invasive carcinoma. Cancer Genet Cytogenet 2006;165:151-156.
22. Al-Kuraya K, Schraml P, Torhorst J, Tapia C, Zaharieva B, Novotny H, Spichtin H, Maurer R, Mirlacher M, Këchli O, Zuber M, Dieterich H, Mross F, Wilber K, Simon R, Sauter G: Prognostic relevance of gene amplifications and coamplifications in breast cancer. Cancer Res 2004;64:8534-8540.
23. Knoop AS, Knudsen H, Balslev E, Rasmussen BB, Overgaard J, Nielsen KV, Schonau A, Gunnarsdóttir K, Olsen KE, Mouridsen H, Ejlertsen B;Danish Breast Cancer Cooperative Group: Retrospective analysis of topoisomerase IIa amplifications and deletions as predictive markers in primary breast cancer patients randomly assigned to cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, epirubicin, and fluorouracil: Danish Breast Cancer Cooperative Group. J Clin Oncol 2005;23:7483-7490.
24. Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, Mc-Shane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, van de Vijver M, Wheeler TM, Hayes DF; American Society of Clinical Oncology; College of American Pathologists: American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol 2007;25:118-145.
25. Razis E, Briasoulis E, Vrettou E, Skarlos DV, Papamichael D, Kostopoulos I, Samantas E, Xanthakis I, Bobos M, Galanidi E, Bai M, Gikonti I, Koukouma E, Kafiri G, Papakostas P, Kalogeras MT, Kosmidis P, Fountzilas G: Potential value of PTEN in predicting cetuximab response in colorectal cancer. An exploratory study. BMC Cancer 2008;13;8:234.
26. Corzo C, Tusquets I, Salido M, Corominas JM, Bellet M, Suarez M, Baró T, Fabregat X, Serrano S, Solé F: Characterization of HER1 (cerbB1) status in locally advanced breast cancer using fluorescence in situ hybridization and immunohistochemistry. Tumour Biol 2005;26:25-30.
27. Watters AD, Going JJ, Cooke TG, Bartlett JMS: Chromosome 17 aneusomy is associated with poor prognostic factors in invasive breast carcinoma. Breast Cancer Res Treat 2003;77:109-114.
28. Watters AD, Going JJ, Cooke TG, Bartlett JMS: Chromosome 17 aneusomy is associated with poor prognostic factors in invasive breast carcinoma. Breast Cancer Res Treat 2003;77:109-114.
29. Korshunov A, Sycheva R, Golanov A: The prognostic relevance of molecular alterations in glioblastomas for patients age < 50 years. Cancer 2005;104:825-832.
30. Perez EA, Suman VJ, Davidson NE, Martino S, Kaufman PA, Lingle WL, Flynn PJ, Ingle JN, Visscher D, Jenkins RB: HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 intergroup adjuvant trial. J Clin Oncol 2006;24:3032-3038.
31. Chia S, Clemons M, Martin LA, Rodgers A, Gelmon K, Pond GR, Panasci L: Pegylated liposomal doxorubicin and trastuzumab in HER-2 overexpressing metastatic breast cancer: a multicenter phase II trial. J Clin Oncol 2006;24:2773-2778.
32. Wolff AC, Wang M, Sparano JA, et al: Cardiac safety and clinical activity of pegylated liposomal doxorubicin (D) and docetaxel (T) with and without trastuzumab (H) as 1st line chemotherapy in HER2-positive and HER2-negative metastatic breast cancer (MBC): Eastern Cooperative Oncology Group (ECOG) trial E3198 (abstract 3040). Breast Cancer Res Treat 2004;88(suppl 1):S125.
33. Andreopoulou E, Gaiotti D, Kim E, et al: Feasibility and cardiac safety of pegylated liposomal doxorubicin plus trastuzumab in heavily pretreated patients with recurrent HER2-overexpressing metastatic breast cancer. Clin Breast Cancer 2007;7:690-696.
34. Stickeler E, Watermann DO, Woll J, et al: Cardiac safety of pegylated liposomal doxorubicin (PLD) in combination with trastuzumab (T) in patients with metastatic breast cancer (MBC): results from a multicenter phase II study. ASCO Meeting Proceedings Part I. J Clin Oncol 2007;25(18S):1106.
35. Mellinghoff IK, Cloughesy TF, Mischel PS: PTEN-mediated resistance to epidermal growth factor receptor kinase inhibitors. Clin Cancer Res 2007;13:378-381.
36. Widakowich C, Dinh P, de Azambuja E, Awada A, Piccart-Gebhart M: HER-2 positive breast cancer: what else beyond trastuzumab-based therapy? Anticancer Agents Med Chem 2008;8:488-496.
37. Järvinen TA, Tanner M, Rantanen V, Bärlund M, Borg A, Grénman S, Isola J: Amplification and deletion of topoisomerase II alpha associate with ErbB-2 amplification and affect sensitivity to topoisomerase II inhibito doxorubicin in breast cancer. Am J Pathol 2000;156:839-847.