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Cardiac Dysfunction in the Trastuzumab Clinical Trials Experience

From the Memorial Sloan-Kettering Cancer Center, New York, NY; and Genentech Inc, South San Francisco, CA.

Address reprint requests to Andrew Seidman, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; email: seidmana{at}mskcc.org

PURPOSE: This study sought to estimate cardiac dysfunction (CD) risk for patients receiving trastuzumab; to characterize observed CD by severity, treatment, and clinical outcome; to assess effects of baseline clinical risk factors on CD; and to assess effects of cumulative doses of anthracyclines and trastuzumab on CD.

PATIENTS AND METHODS: A retrospective review of records for patients enrolled onto any of seven phase II and III trastuzumab clinical trials was performed. Predefined criteria were used for the diagnosis, and the New York Heart Association functional classification system was used to document CD severity. Product-limit estimates were used to summarize the cumulative anthracycline and trastuzumab doses at the time of CD onset.

RESULTS: Patients treated with trastuzumab were found to be at an increased risk for CD. The incidence was greatest in patients receiving concomitant trastuzumab and anthracycline plus cyclophosphamide (27%). The risk was substantially lower in patients receiving paclitaxel and trastuzumab (13%) or trastuzumab alone (3% to 7%); however, most of these patients had received prior anthracycline therapy. CD was noted in 8% of patients receiving anthracycline plus cyclophosphamide and 1% receiving paclitaxel alone. Most trastuzumab-treated patients developing CD were symptomatic (75%), and most improved with standard treatment for congestive heart failure (79%).

CONCLUSION: Trastuzumab is associated with an increased risk of CD, which is greatest in patients receiving concurrent anthracyclines. In most patients with metastatic breast cancer, the risk of CD can be justified given the improvement in overall survival previously reported with trastuzumab.

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				D. Tripathy, D. J. Slamon, M. Cobleigh, A. Arnold, M. Saleh, J. E. Mortimer, M. Murphy, and S. J. Stewart Safety of Treatment of Metastatic Breast Cancer With Trastuzumab Beyond Disease Progression J. Clin. Oncol., March 15, 2004; 22(6): 1063 - 1070. [Abstract] [Full Text] [PDF]

				K. Lemmens, P. Fransen, S. U. Sys, D. L. Brutsaert, and G. W. De Keulenaer Neuregulin-1 Induces a Negative Inotropic Effect in Cardiac Muscle: Role of Nitric Oxide Synthase Circulation, January 27, 2004; 109(3): 324 - 326. [Abstract] [Full Text] [PDF]

				E. A. Perez and R. Rodeheffer Clinical Cardiac Tolerability of Trastuzumab J. Clin. Oncol., January 15, 2004; 22(2): 322 - 329. [Abstract] [Full Text] [PDF]

				U. Gatzemeier, G. Groth, C. Butts, N. Van Zandwijk, F. Shepherd, A. Ardizzoni, C. Barton, P. Ghahramani, and V. Hirsh Randomized phase II trial of gemcitabine-cisplatin with or without trastuzumab in HER2-positive non-small-cell lung cancer Ann. Onc., January 1, 2004; 15(1): 19 - 27. [Abstract] [Full Text] [PDF]

				A. Jones Combining trastuzumab (Herceptin(R)) with hormonal therapy in breast cancer: what can be expected and why? Ann. Onc., December 1, 2003; 14(12): 1697 - 1704. [Abstract] [Full Text] [PDF]

				G. Bianchi, J. Albanell, W. Eiermann, G. Vitali, D. Borquez, L. Vigano, R. Molina, G. Raab, A. Locatelli, B. Vanhauwere, et al. Pilot Trial of Trastuzumab Starting with or after the Doxorubicin Component of a Doxorubicin plus Paclitaxel Regimen for Women with HER2-Positive Advanced Breast Cancer Clin. Cancer Res., December 1, 2003; 9(16): 5944 - 5951. [Abstract] [Full Text] [PDF]

				M. Cobleigh and D. Frame Is Trastuzumab Every Three Weeks Ready for Prime Time? J. Clin. Oncol., November 1, 2003; 21(21): 3900 - 3901. [Full Text] [PDF]

				B. Leyland-Jones, K. Gelmon, J.-P. Ayoub, A. Arnold, S. Verma, R. Dias, and P. Ghahramani Pharmacokinetics, Safety, and Efficacy of Trastuzumab Administered Every Three Weeks in Combination With Paclitaxel J. Clin. Oncol., November 1, 2003; 21(21): 3965 - 3971. [Abstract] [Full Text] [PDF]

				R. Nahta and F. J. Esteva HER-2-Targeted Therapy: Lessons Learned and Future Directions Clin. Cancer Res., November 1, 2003; 9(14): 5078 - 5084. [Abstract] [Full Text] [PDF]

				E. Rock and A. DeMichele Nutritional Approaches to Late Toxicities of Adjuvant Chemotherapy in Breast Cancer Survivors J. Nutr., November 1, 2003; 133(11): 3785S - 3793. [Abstract] [Full Text] [PDF]

				H. J. Burstein, L. N. Harris, P. K. Marcom, R. Lambert-Falls, K. Havlin, B. Overmoyer, R. J. Friedlander Jr., J. Gargiulo, R. Strenger, C. L. Vogel, et al. Trastuzumab and Vinorelbine as First-Line Therapy for HER2-Overexpressing Metastatic Breast Cancer: Multicenter Phase II Trial With Clinical Outcomes, Analysis of Serum Tumor Markers as Predictive Factors, and Cardiac Surveillance Algorithm J. Clin. Oncol., August 1, 2003; 21(15): 2889 - 2895. [Abstract] [Full Text] [PDF]

				H. Kattlove and R. J. Winn Ongoing Care of Patients After Primary Treatment for Their Cancer CA Cancer J Clin, May 1, 2003; 53(3): 172 - 196. [Abstract] [Full Text] [PDF]

				J. Geneve Re: Demand Grows for Early Access to Promising Cancer Drugs J Natl Cancer Inst, March 19, 2003; 95(6): 492 - 492. [Full Text] [PDF]

				H. J. Burstein, L. N. Harris, R. Gelman, S. C. Lester, R. A. Nunes, C. M. Kaelin, L. M. Parker, L. W. Ellisen, I. Kuter, M. A. Gadd, et al. Preoperative Therapy With Trastuzumab and Paclitaxel Followed by Sequential Adjuvant Doxorubicin/Cyclophosphamide for HER2 Overexpressing Stage II or III Breast Cancer: A Pilot Study J. Clin. Oncol., January 1, 2003; 21(1): 46 - 53. [Abstract] [Full Text] [PDF]

				E. Page, D. Assouline, O. Brun, D. Coeffic, D. Fric, P. Winckel, A. D. Seidman, M. K. Pierri, and C. Hudis Cardiac Dysfunction in Clinical Trials of Trastuzumab J. Clin. Oncol., October 1, 2002; 20(19): 4119 - 4120. [Full Text] [PDF]

				What's so special about {blacktriangledown}trastuzumab? DTB, September 1, 2002; 40(9): 65 - 67. [Abstract] [Full Text] [PDF]

				J. Baselga Why the Epidermal Growth Factor Receptor? The Rationale for Cancer Therapy Oncologist, August 15, 2002; 7(90004): 2 - 8. [Abstract] [Full Text] [PDF]

				J. Speyer Cardiac Dysfunction in the Trastuzumab Clinical Experience J. Clin. Oncol., March 1, 2002; 20(5): 1156 - 1157. [Full Text] [PDF]