A Phase II study of weekly vinorelbine and trastuzumab in patients with HER2-positive metastatic breast cancer

Clinical Breast Cancer

Volumn 8, Issue 3, 2008, Pages 264-268

  Bayo Calero, Juan Lucas ^a   Mayordomo, José I ^b   Sánchez Rovira, Pedro ^c   Pérez Carrión, Ramón ^d   Illaramendi, José J ^e   García Bueno, José M ^f   González Flores, Encarnación ^g   Crespo, Carmen ^h   Ramos Vázquez, Manuel ⁱ   García Palomo, Andrés ^j   Ruiz Borrego, Manuel ^k   De La Haba, Juan ^l   Gómez Bernal, Amalia ^m   Yubero Esteban, Alfonso ⁿ  

^a HOSPITAL JUAN RAMÓN JIMÉNEZ   (Spain)

^b HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA   (Spain)

^c Hosp Univ Ciudad de Jaén   (Spain)

^d MD ANDERSON CANCER CENTER   (Spain)

^e Instituto de Investigación Sanitaria de Navarra   (Spain)

^f HOSPITAL GENERAL UNIVERSITARIO DE ALBACETE   (Spain)

^g HOSPITAL UNIVERSITARIO VIRGEN DE LAS NIEVES   (Spain)

^h HOSPITAL RAMÓN Y CAJAL   (Spain)

ⁱ Cent Oncol Reg   (Spain)

^j HOSPITAL DE LEÓN   (Spain)

^k HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^l HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^m HOSPITAL UNIVERSITARIO DE SALAMANCA   (Spain)

ⁿ Hospital General de Teruel Obispo Polanco   (Spain)

more..

Author keywords

Anthracycline; Asthenia; Hematologic toxicity; Hormone receptor status

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; NAVELBINE; TRASTUZUMAB;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER GROWTH; CANCER PATIENT; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; FEBRILE NEUTROPENIA; FEMALE; FEVER; HEART FAILURE; HUMAN; INFECTION; LEUKOPENIA; MAJOR CLINICAL STUDY; METASTASIS; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; PAIN; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; PHLEBITIS; PROGNOSIS; STOMATITIS; TREATMENT RESPONSE; VOMITING;

EID: 46949109559     PISSN: 15268209     EISSN: None     Source Type: Journal    
DOI: 10.3816/CBC.2008.n.030     Document Type: Article

References (24)

1. Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987; 235:177-82.
2. 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; 344:783-92.
3. 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; 23:4265-74.
4. Pegram MD, Lopez A, Konecny G, et al. Trastuzumab and chemo-therapeutics: drug interactions and synergies. Semin Oncol 2000; 27(suppl ll):21-5; discussion 92-100.
5. Bell R. What can we learn from Herceptin trials in metastatic breast cancer? Oncology 2002; 63(suppl 1): 39-46.
6. Domenech GH, Vogel CL. A review of vinorelbine in the treatment of breast cancer. Clin Breast Cancer 2001; 2:113-28.
7. Burstein HJ, Kuter I, Campos SM, et al. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol 2001; 19:2722-30.
8. Burstein HJ, Harris LN, Marcom PK, et al. Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis ofserum tumor markers as predictive factors, and cardiac surveillance algorithm. J Clin Oncol 2003; 21:2889-95.
9. Suzuki Y, Tokuda Y, Saito Y, et al. Combination of trastuzumab and vinorelbine in metastatic breast cancer. Jpn J Clin Oncol 2003; 33:514-7.
10. Jahanzeb M, Mortimer JE, Yunus F, et al. Phase II trial of weekly vinorelbine and trastuzumab as first-line therapy in patients with HER2+ metastatic breast cancer. Oncologist 2002; 7:410-7.
11. Papaldo P, Fabi A, Ferretti G, et al. A phase II study on metastatic breast cancer patients treated with weekly vinorelbine with or without trastuzumab according to HER2 expression: changing the natural history of HER2-positive disease. Ann Oncol 2006; 17:630-6.
12. Chan A, Martin M, Untch M, et al. Vinorelbine plus trastuzumab combination as first-line therapy for HER 2-positive metastatic breast cancer patients: an international phase II trial. Br J Cancer 2006; 95:788-93.
13. Therasse R Arbuck SG, Eisenhauer EA, et al. 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 2000; 92:205-16.
14. National Cancer Institute Cancer Therapy Evaluation Program [Web site]. Common toxicity criteria, version 2.0, and Common Terminology Criteria for Adverse Events v3.0. Available at: http:// ctep.cancer.gov/reporting/ctc.html. Accessed: September 1, 2007.
15. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10:1-10.
16. Baselga J. Herceptin alone or in combination with chemotherapy in the treatment of HER2-positive metastatic breast cancer: pivotal trials. Oncology 2001; 61(suppl 2): 14-21.
17. Suter TM, Cook-Bruns N, Barton C. Cardiotoxicity associated with trastuzumab (Herceptin) therapy in the treatment of metastatic breast cancer. Breast 2004; 13:173-83.
18. Pegram MD, Konecny GE, O'Callaghan C, et al. Rational combinations of trastuzumab with chemotherapeutic drugs used in the treatment of breast cancer. J Natl Cancer Inst 2004; 96:739-49.
19. Esteva FJ, Valero V, Booser D, et al. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2 overexpressing metastatic breast cancer. J Clin Oncol 2002; 20:1800-8.
20. Nabholtz JM, Crown J, Yonemoto L, et al. Results of two open-label multicentre pilot phase II trials with Herceptin in combination with docetaxel and platinum salts (cis- or carboplatin) (TCH) as therapy for advanced breast cancer in women overexpressing HER2. Breast Cancer Res Treat 2000; 64:82 (Abstract 327).
21. Christodoulou C, Fountzilas G, Razi E, et al. Gemcitabine and trastuzumab combination as salvage treatment in patients with HER 2-positive metastatic breast cancer. Proc Am Soc Clin Oncol 2003; 22:42 (Abstract 166).
22. O'Shaughnessy JA, Vukelja S, Marsland T, et al. Phase II study of trastuzumab plus gemcitabine in chemotherapy-pretreated patients with metastatic breast cancer. Clin Breast Cancer 2004; 5:142-7.
23. Schaller G, Bangemann N, Weber J, et al. Efficacy and safety of trastuzumab plus capecitabine in a German multicentre phase II study of pre-treated metastatic breast cancer. J Clin Oncol 2005; 23(16 suppl):57s (Abstract 717).
24. Xu L, Song S, Zhu J, et al. Results of a phase II trial of Herceptin® plus Xeloda® in patients with previously untreated HER2-positive metastatic breast cancer. Breast Cancer Res Treat 2004; 88(suppl 1): S128 (Abstract 3049).