Trastuzumab-related cardiotoxicity in early breast cancer: A cohort study

Martina Bonifazi, Matteo Franchi, Marta Rossi, Lorenzo Moja, Alberto Zambelli, Antonella Zambon, Giovanni Corrao, Carlo La Vecchia, Carlo Zocchetti, Eva Negri

Research output: Contribution to journalArticlepeer-review


Background. Concerns have been raised about the cardiac safety profile of trastuzumab for the adjuvant treatment of early stage breast cancer in clinical practice. We assessed tras- tuzumab-related cardiotoxicity and its predictors in a large co-hort of Italian women. Methods. Through a record linkage between four regional health care databases, we identified the rate of severe car-diac adverse events among women treated with trastu-zumab for early breast cancer in Lombardy. The cumulative risk of cardiotoxicity was estimated using the Kaplan-Meier method, and independent predictors were assessed using the Cox model. Results. Of 2,046 trastuzumab users, 53 (2.6%) experienced at least one hospitalization for a cardiac event, and there were two cardiac deaths. The cumulative risk of cardiotoxicity in- creased up to 2 years after starting treatment, reaching a pla-teau at 2.8%. The risk was low (0.2%) among young women, whereas the incidence was approximately 10% in women aged >70 years, irrespective of cardiovascular risk factors. Age and history of cardiac disease were strong predictors of cardiotoxicity, with a hazard ratio of 11.3 (95% confidence in-terval [CI]: 3.5-36.6) for women aged >70 years as compared with those

Original languageEnglish
Pages (from-to)795-801
Number of pages7
JournalThe oncologist
Issue number7
Publication statusPublished - 2013


  • Adjuvant chemotherapy
  • Cardiotoxicity
  • Early breast cancer
  • Survival
  • Trastuzumab

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)


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