Abstract
In this phase II study, 23 patients with metastatic breast cancer were treated with a combination of Caelyx (40 mg/m2 on day 1) and vinorelbine (20 mg/m2 on days 1 and 8) every 4 weeks. According to the statistical design, enrollment was closed after the first stage due to the low response rate observed (four partial remissions, 12 stabilizations). Toxicity was acceptable, however, grade 3–4 neutropenia was not negligible. Our study does not support the development of this combination in advanced breast cancer.
References
Hortobagyi GN: Anthracyclines in the treatment of cancer. Drugs 54(suppl. 4): 1-7, 1997
Von Hoff DD, Layard MW, Basa P, Davis Jr HL, Von Hoff AL, Rozencweig M, Muggia FM: Risk factors for doxorubicininduced congestive heart failure. Ann Intern Med 91: 710-717, 1979
Hellman K: Anthracycline cardiac toxicity by dexrazosane: breakthrough of a barrier-sharpens antitumor profile and therapeutic index (Editorial). J Clin Oncol 14: 332-333, 1996
Bonadonna G, Gianni L, Santoro A, Bonfante V, Bidoli P, Casali P, Demicheli R, Valagussa P: Drugs 10 years later: epirubicin. Ann Oncol 4: 359-369, 1993
Gabizon A, Catane R, Uziely B, Kaufman B, Safra T, Coen R, Martin F, Huang A, Barenholz Y: Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethylene-glycol coated liposomes. Cancer Res 54: 987-992, 1994
Uziely B, Jeffers S, Isacson R, Kutsch K, Wei-Tsao D, Yehoshua Z, Libson E, Muggia FM, Gabizon A: Liposomal doxorubicin: antitumor activity and unique toxicities during two complementary phase I study. J Clin Oncol 13: 1777-1785, 1995
Alberts DS, Garcia DJ: Safety aspects of pegylated liposomal doxorubicin in patients with cancer. Drugs 54(suppl. 4): 30-35, 1997
Berry G, Billingham M, Alderman E, Richardson P, Torti F, Lum B, Patek A, Martin FJ: The use of cardiac biopsy to demonstrate reduced cardiotoxicity in AIDS Kaposi's sarcoma patients treated with pegylated liposomal doxorubicin. Ann Oncol 9: 711-716, 1998
Safra T, Muggia F, Jeffers S, Tsao-Wei DD, Groshen S, Lyass O, Henderson R, Berry G, Gabizon A: Pegylated liposomal doxorubicin (Doxil): reduced clinical cardiotoxicity in patients reaching or exceeding cumulative doses 500 mg/m2. Ann Oncol 8: 1029-1033, 2000
Ranson MR, Cheeseman S, White S, Margison J: Caelyx (stealth liposomal doxorubicin) in the treatment of advanced breast cancer. Crit Rev Oncol Hematol 37: 115-120, 2001
Laufman LR, Spiridonidis CH, Jones JJ, Rhodes VA, Wallace K: Phase I trial of doxil plus vinorelbine in patients with advanced malignancies. Proc ASCO (Am Soc Clin Oncol) 17: 246 (abstract 944), 1998
Burstein HJ, Ramirez MJ, Petros WP, Clarke KD, Warmuth MA, Marcom PK, Matulonis UA, Parker LM, Harris LN, Winer EP: Phase I study of Doxil and vinorelbine in metastatic breast cancer. Ann Oncol 10: 1113-1116, 1999
Norris B, Pritchard KI, James K, Myles J, Bennett K, Marlin S, Skillings J, Findlay B, Vandenberg T, Goss B, Latreille J, Rudinskas L, Lofters W, Trudeau M, Osoba D, Rodgers A: Phase III comparative study of vinorelbine combined with doxorubicin versus doxorubicin alone in disseminated metastatic/ recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA8. J Clin Oncol 18: 2385-2394, 2000
Simon R: Optimal two-stage designes for phase II clinical trials. Contr Clin Trials 10: 1-10, 1989
Gianni L, Munzone E, Capri G, Fulfaro F, Tarenzi E, Villani F, Spreafico C, Laffranchi A, Caraceni A, Martini C: Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: high antitumor efficacy and cardiac effects in dose-finding and sequence-finding study. J Clin Oncol 13: 2688-2699, 1995
Slamon DL, 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 overexpress HER2. N Engl J Med 344: 783-792, 2001
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Rimassa, L., Carnaghi, C., Garassino, I. et al. Unexpected Low Efficacy of Stealth Liposomal Doxorubicin (Caelyx) and Vinorelbine in Metastatic Breast Cancer. Breast Cancer Res Treat 77, 185–188 (2003). https://doi.org/10.1023/A:1021300719965
Issue Date:
DOI: https://doi.org/10.1023/A:1021300719965