A phase II trial of oxaliplatin and trastuzumab in the treatment of HER2-positive metastatic breast cancer

Cancer Investigation

Volumn 28, Issue 8, 2010, Pages 865-871

  Yardley, Denise A ^a,b   Daniel, Davey ^c   Stipanov, Michael ^c   Drosick, D Randolph ^d   Mainwaring, Mark ^b   Peyton, James ^b   Shastry, Mythili ^a   Hainsworth, John D ^a,b  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b PLLC   (United States)

^c Chattanooga Oncology Hematology Associates   (United States)

^d Oncology Hematology Care   (United States)

Author keywords

HER2; Metastatic breast cancer; Oxaliplatin; Phase II; Trastuzumab

Indexed keywords

CARBOPLATIN; CISPLATIN; OXALIPLATIN; TRASTUZUMAB; ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERBB2 PROTEIN, HUMAN; MONOCLONAL ANTIBODY; PLATINUM COMPLEX;

ADULT; AGED; ALOPECIA; ANEMIA; ARTHRALGIA; ARTICLE; BLEEDING; BONE MARROW SUPPRESSION; BREAST METASTASIS; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERSENSITIVITY REACTION; LOADING DRUG DOSE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; ONCOGENE NEU; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SENSORY NEUROPATHY; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING; BREAST NEOPLASMS; DOSE RESPONSE; DRUG ADMINISTRATION; GENETICS; METASTASIS; MIDDLE AGED; PATHOLOGY; PATIENT SELECTION; TOXICITY; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; ORGANOPLATINUM COMPOUNDS; PATIENT SELECTION; RECEPTOR, ERBB-2; TREATMENT OUTCOME; ANTIBODIES, MONOCLONAL, HUMANIZED;

EID: 77956645975     PISSN: 07357907     EISSN: 15324192     Source Type: Journal    
DOI: 10.3109/07357901003631031     Document Type: Article

References (44)

1. Baselga, J.; Tripathy, D.; Mendelsohn, J.; Baughman, S.; Benz, C.C.; Dantis, L.; Sklarin, N.T.; Seidman, A.D.; Hudis, C.A.; Moore, J.; Rosen, P.P.; Twaddell, T.; Henderson, I.C.; Norton, L. Phase II study of weekly intravenous recombinant humanized antip 185 HER2 monoclonal antibody in patients with HER2/neuoverexpressing metastatic breast cancer. J Clin Oncol 1996, 14 (3), 737-744.
2. Pegram, M.; Hsu, S.; Lewis, G.; Pietras, R.; Beryt, M.; Sliwkowski, M.; Coombs, D.; Baly, D.; Kabbinavar, F.; Slamon, D. Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers. Oncogene 1999, 18 (13), 2241-2251.
3. Pietras, R.J.; Fendly, B.M.; Chazin, V.R.; Pegram, M.D.; Howell, S.B.; Slamon, D.J. Antibody to HER-2/neu receptor blocks DNA repair after cisplatin in human breast and ovarian cancer cells. Oncogene 1994, 9(7), 1829-1838.
4. Pegram, M.D.; Lopez, A.; Konecny, G.; Slamon, D.J. Trastuzumab and chemotherapeutics: drug interactions and synergies. Semin Oncol 2000, 27(6 Suppl. 11), 21-25; discussion 92-100.
5. Pegram,M.D.; Slamon, D.J. Combination therapy with trastuzumab (Herceptin) and cisplatin for chemoresistant metastatic breast cancer: evidence for receptor-enhanced chemosensitivity. Semin Oncol 1999, 26(4 Suppl. 12), 89-95.
6. Konecny, G.; Pegram, M.D.; Beryt, M.; et al. Therapeutic advantage of chemotherapy drugs in combination with Herceptin against human breast cancer cells with HER-2/neu overexpression. Breast Cancer Res Treat 1999, 57, 114a.
7. Martin, M.; Diaz-Rubio, E.; Casado, A.; Santabarbara, P.; Lopez Vega, J.M.; Adrover, E.; Lenaz, L. Carboplatin: an active drug in metastatic breast cancer. J Clin Oncol 1992, 10(3), 433-437.
8. Sledge, G.W., Jr.; Loehrer, P.J., Sr.; Roth, B.J.; Einhorn, L.H. Cisplatin as first-line therapy for metastatic breast cancer. J Clin Oncol 1988, 6(12), 1811-1814.
9. OBrien, M.E.; Talbot, D.C.; Smith, I.E. Carboplatin in the treatment of advanced breast cancer: a phase II study using a pharmacokinetically guided dose schedule. J Clin Oncol 1993, 11(11), 2112-2117.
10. Sledge, G.W., Jr.; Roth, B.J. Cisplatin in the management of breast cancer. Semin Oncol 1989, 16(4 Suppl. 6), 110-115.
11. Yap, H.Y.; Salem, P.; Hortobagyi, G.N.; Bodey, G.P., Sr.; Buzdar, A.U.; Tashima, C.K.; Blumenschein, G.R. Phase II study of cisdichlorodiammineplatinum( II) in advanced breast cancer. Cancer Treat Rep 1978, 62(3), 405-408.
12. Ostrow, S.; Egorin, M.; Aisner, J.; Bachur, N.; Wiernik, P.H. High-dose cis-diamminedichloro-platinum therapy in patients with advanced breast cancer: pharmacokinetics, toxicity, and therapeutic efficacy. Cancer Clin Trials 1980, 3(1), 23-27.
13. Forastiere, A.A.; Hakes, T.B.; Wittes, J.T.; Wittes, R.E. Cisplatin in the treatment of metastatic breast carcinoma: a prospective randomized trial of two dosage schedules. Am J Clin Oncol 1982, 5(3), 243-247.
14. Pegram, M.D.; Lipton, A.; Hayes, D.F.; Weber, B.L.; Baselga, J.M.; Tripathy, D.; Baly, D.; Baughman, S.A.; Twaddell, T.; Glaspy, J.A.; Slamon, D.J. Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185 HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol 1998, 16(8), 2659-2671.
15. Fountzilas, G.; Athanassiadis, A.; Kalogera-Fountzila, A.; Aravantinos, G.; Bafaloukos, D.; Briasoulis, E.; Dombros, N.; Ioannidis, I.; Pavlidis, N.; Kosmidis, P.; Skarlos, D. Paclitaxel by 3-h infusion and carboplatin in anthracycline-resistant advanced breast cancer. a phase II study conducted by the Hellenic Cooperative Oncology Group. Eur J Cancer 1997, 33(11), 1893-1895. (Pubitemid 28129223)
16. Fountzilas, G.; Dimopoulos, A.M.; Papadimitriou, C.; Kalogera-Fountzila, A.; Aravantinos, G.; Bafaloukos, D.; Athanassiades, A.; Nicolaides, C.; Keramopoulos, A.; Pavlidis, N.; Kosmidis, P.; Skarlos, D. First-line chemotherapy with paclitaxel by three-hour infusion and carboplatin in advanced breast cancer (final report): a phase II study conducted by the Hellenic Cooperative Oncology Group. Ann Oncol 1998, 9(9), 1031-1034.
17. Perez, E.A.; Hillman, D.W.; Stella, P.J.; Krook, J.E.; Hartmann, L.C.; Fitch, T.R.; Hatfield, A.K.; Mailliard, J.A.; Nair, S.; Kardinal, C.G.; Ingle, J.N. A phase II study of paclitaxel plus carboplatin as firstline chemotherapy for women with metastatic breast carcinoma. Cancer 2000, 88(1), 124-131.
18. Loesch, D.; Robert, N.; Asmar, L.; Gregurich, M.A.; ORourke, M.; Dakhil, S.; Cox, E. Phase II multicenter trial of a weekly paclitaxel and carboplatin regimen in patients with advanced breast cancer. J Clin Oncol 2002, 20(18), 3857-3864.
19. Iaffaioli, R.V.; Tortoriello, A.; Facchini, G.; Santangelo, M.; De Sena, G.; Gesue, G.; Bucci, L.; Scaramellino, G.; Anastasio, E.; Finizio, A.; et al. A phase II study of carboplatin and vinorelbine as secondline treatment for advanced breast cancer. Br J Cancer 1995,72(5), 1256-1258.
20. Wasserheit, C.; Frazein, A.; Oratz, R.; Sorich, J.; Downey, A.; Hochster, H.; Chachoua, A.; Wernz, J.; Zeleniuch-Jacquotte, A.; Blum, R.; Speyer, J. Phase II trial of paclitaxel and cisplatin in women with advanced breast cancer: an active regimen with limiting neurotoxicity. J Clin Oncol 1996, 14(7), 1993-1999.
21. Ray-Coquard, I.; Paraiso, D.; Guastalla, J.P.; Leduc, B.; Guichard, F.; Martin, C.; Chauvenet, L.; Haddad-Guichard, Z.; Lepille, D.; Orfeuvre, H.; Gautier, H.; Castera, D.; Pujade-Lauraine, E. Intensified dose of cyclophosphamide with G-CSF support versus standard dose combined with platinum in first-line treatment of advanced ovarian cancer a randomised study from the GINECO group. Br J Cancer 2007, 97(9), 1200-1205.
22. Slamon, D.; Eiermann, W.; Robert, N.; Pienkowski, T.; Martin, M.; Pawlicki, M.; Chan, A.; Smylie, M.; Liu, M.; Falkson, C.; Pinter, T.; Fornander, T.; Shiftan, T.; Valero, V.; Mackey, J.; Tabah-Fisch, I.; Buyse, M.; Lindsay, M.; Riva, A.; Bee, V.; Pegram, M.; Press, M.; Crown, J. BCIRG 006: 2nd interim analysis phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC->T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC->TH) with docetaxel, carboplatin and trastuzumab (TCH) in Her2neu positive early breast cancer patients. Breast Cancer Res Treat 2006, 100(Suppl. 1), A52.
23. Robert, N.; Leyland-Jones, B.; Asmar, L.; Belt, R.; Ilegbodu, D.; Loesch, D.; Raju, R.; Valentine, E.; Sayre, R.; Cobleigh, M.; Albain, K.; McCullough, C.; Fuchs, L.; Slamon, D. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2006, 24(18), 2786-2792.
24. Burris, H., 3rd; Yardley, D.; Jones, S.; Houston, G.; Broome, C.; Thompson, D.; Greco, F.A.; White, M.; Hainsworth, J. Phase II trial of trastuzumab followed by weekly paclitaxel/carboplatin as firstline treatment for patients with metastatic breast cancer. J Clin Oncol 2004, 22(9), 1621-1629.
25. Pegram, M.D.; Konecny, G.E.; OCallaghan, C.; Beryt, M.; Pietras, R.; Slamon, D.J. Rational combinations of trastuzumab with chemotherapeutic drugs used in the treatment of breast cancer. J Natl Cancer Inst 2004, 96(10), 739-749.
26. Culy, C.R.; Clemett, D.; Wiseman, L.R. Oxaliplatin. A review of its pharmacological properties and clinical efficacy in metastatic colorectal cancer and its potential in other malignancies. Drugs 2000, 60(4), 895-924.
27. Raymond, E.; Chaney, S.G.; Taamma, A.; Cvitkovic, E. Oxaliplatin: a review of preclinical and clinical studies. Ann Oncol 1998, 9(10), 1053-1071.
28. Raymond, E.; Faivre, S.; Woynarowski, J.M.; Chaney, S.G. Oxaliplatin: mechanism of action and antineoplastic activity. Semin Oncol 1998, 25(2 Suppl. 5), 4-12.
29. Schmidt, W.; Chaney, S.G. Role of carrier ligand in platinum resistance of human carcinoma cell lines. Cancer Res 1993, 53(4), 799-805.
30. Rixe, O.; Ortuzar, W.; Alvarez, M.; Parker, R.; Reed, E.; Paull, K.; Fojo, T. Oxaliplatin, tetraplatin, cisplatin, and carboplatin: spectrum of activity in drug-resistant cell lines and in the cell lines of the National Cancer Institutes Anticancer Drug Screen panel. Biochem Pharmacol 1996, 52(12), 1855-1865.
31. Mackay, H.J.; Cameron, D.; Rahilly, M.; Mackean, M.J.; Paul, J.; Kaye, S.B.; Brown, R. Reduced MLH1 expression in breast tumors after primary chemotherapy predicts disease-free survival. J Clin Oncol 2000, 18(1), 87-93.
32. Extra, J.M.; Espie, M.; Calvo, F.; Ferme, C.; Mignot, L.; Marty, M. Phase I study of oxaliplatin in patients with advanced cancer. Cancer Chemother Pharmacol 1990, 25(4), 299-303.
33. Garufi, C.; Nistico, C.; Brienza, S.; Vaccaro, A.; DOttavio, A.; Zappala, A.R.; Aschelter, A.M.; Terzoli, E. Single-agent oxaliplatin in pretreated advanced breast cancer patients: a phase II study. Ann Oncol 2001, 12(2), 179-182.
34. Zelek, L.; Cottu, P.; Tubiana-Hulin, M.; Vannetzel, J.M.; Chollet, P.; Misset, J.L.; Chouaki, N.; Marty, M.; Gamelin, E.; Culine, S.; Dieras, V.; Mackenzie, S.; Spielmann, M. Phase II study of oxaliplatin and fluorouracil in taxane-and anthracycline-pretreated breast cancer patients. J Clin Oncol 2002, 20(10), 2551-2558. (Pubitemid 34525743)
35. Leonardi, V.; Savio, G.; Laudani, A.; Blasi, L.; Agostara, B. New approaches to breast cancer: oxaliplatin combined with 5-fluorouracil and folinic acid in pretreated advanced breast cancer patients: preliminary reports. Ann N Y Acad Sci 2002, 963, 91-97.
36. Pectasides, D.; Pectasides, M.; Farmakis, D.; Bountouroglou, N.; Nikolaou, M.; Koumpou, M.; Mylonakis, N.; Kosmas, C. Oxaliplatin plus high-dose leucovorin and 5-fluorouracil in pretreated advanced breast cancer: a phase II study. Ann Oncol 2003, 14(4), 537-542. (Pubitemid 41295079)
37. Airoldi, M.; Cattel, L.; Passera, R.; Pedani, F.; Delprino, L.; Micari, C. Gemcitabine and oxaliplatin in patients with metastatic breast cancer resistant to or pretreated with both anthracyclines and taxanes: clinical and pharmacokinetic data. Am J Clin Oncol 2006, 29(5), 490-494.
38. Eisenhauer, E.A.; Therasse, P.; Bogaerts, J.; Schwartz, L.H.; Sargent, D.; Ford, R.; Dancey, J.; Arbuck, S.; Gwyther, S.; Mooney, M.; Rubinstein, L.; Shankar, L.; Dodd, L.; Kaplan, R.; Lacombe, D.; Verweij, J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45(2), 228-247.
39. Slamon, D.J.; 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(11), 783-792.
40. Kaplan, E.; Meier, P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958, 53, 457-481.
41. Bayo-Calero, J.L.; Mayordomo, J.I.; Sanchez-Rovira, P.; Perez-Carrion, R.; Illaramendi, J.J.; Garcia-Bueno, J.M.; Gonzalez-Flores, E.; Crespo, C.; Ramos-Vazquez, M.; Garcia-Palomo, A.; Ruiz-Borrego, M.; de la Haba, J.; Gomez-Bernal, A.; Yubero-Esteban, A. A phase II study of weekly vinorelbine and trastuzumab in patients with HER2-positive metastatic breast cancer. Clin Breast Cancer 2008, 8(3), 264-268. (Pubitemid 351962148)
42. OShaughnessy, J.A.; Vukelja, S.; Marsland, T.; Kimmel, G.; Ratnam, S.; Pippen, J.E. Phase II study of trastuzumab plus gemcitabine in chemotherapy-pretreated patients with metastatic breast cancer. Clin Breast Cancer 2004, 5(2), 142-147.
43. Yardley, D.A.; Burris, H.A., 3rd; Hanson, S.; Greco, F.A.; Spigel, D.R.; Barton, J.; Hainsworth, J.D. Weekly gemcitabine and trastuzumab in the treatment of patients with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer 2009, 9(3), 178-183.
44. OShaughnessy, J.; Osborne, C.; Pippen, J.; Yoffe, M.; Patt, D.; Monaghan, G.; Rocha, C.; Ossovskaya, V.; Sherman, B.; Bradley, C. Efficacy of BSI-201, a poly (ADP-ribose) polymerase-1 (PARP1) inhibitor, in combination with gemcitabine/carboplatin (G/C) in patients with metastatic triple-negative breast cancer (TNBC): results of a randomized phase II trial. J Clin Oncol 2009, 27(18S), Abstract #3.