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Increased overall survival independent of RECIST response in metastatic breast cancer patients continuing trastuzumab treatment: evidence from a retrospective study

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Abstract

Recent studies have reported the potential clinical utility for metastatic breast cancer (MBC) patients of continuing trastuzumab beyond progression. Based on those results, here the authors have examined the benefits of trastuzumab-continuation by specifically evaluating RECIST responses upon first line trastuzumab-treatment as a potential predictive marker for therapeutic effect of trastuzumab-continuation beyond metastatic disease progression. The authors carried out a retrospective analysis of 272 HER2 positive MBC patients under trastuzumab treatment at 22 different oncology Italian centers during the years of 2000 and 2001 who progressed under first line trastuzumab-treatment. The primary end point of the study was the survival from the date of first documented progression upon first line trastuzumab treatment of disease. Data analysis involved the use of matching on propensity score to balance variables between treated and untreated subjects and to reduce bias. Of the 272 HER2-positive MBC patients, 154 (56.6%) continued treatment. 79 (51.3%) of those 154 patients showed responses based on RECIST criteria during first-line trastuzumab-treatment. Of the 118 patients that suspended trastuzumab, RECIST responses had been observed in 44 (37.3%). Cox proportional hazards analysis of progressed patients, matched using propensity score, showed that discontinuation of trastuzumab at metastatic disease progression was a risk factor for significantly reduced overall survival in both responder (HR = 2.23; 95% CI = 1.03–4.82) and non-responder groups (HR = 3.53, 95% CI = 1.73–7.21), with no significant differences in the two estimated HRs (P-value of the likelihood-ratio test = 0.690). Continued trastuzumab treatment after disease progression has clinically and statistically significant effects in both RECIST responder and non-responder MBC patients.

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Acknowledgments

This study was supported by AIRC (Associazione Italiana per la Ricerca sul Cancro) and FIRB/MIUR (Ministero Università e Ricerca) and Roche spa.

Author information

Authors and Affiliations

  1. Fondazione IRCCS Istituto Nazionale dei Tumori, via Venezian 1, 20133, Milan, Italy

    Manuela Campiglio, Rosaria Bufalino, Marco Sandri, Elisa Ferri, Serenella M. Pupa, Marianna Sasso, Sylvie Ménard & Elda Tagliabue

  2. Humanitas Centro Catanese di Oncologia, Catania, Italy

    Rosa Anna Aiello

  3. Istituto Nazionale Tumori, Pascale, Napoli, Italy

    Andrea De Matteis

  4. Istituto Tumori Regina Elena, Rome, Italy

    Marcella Mottolese

  5. Università Federico II, Naples, Italy

    Sabino De Placido

  6. Università di Ferrara, Ferrara, Italy

    Patrizia Querzoli

  7. Oncologia Medica 2, Istituto Oncologico Veneto IRCCS, Padova, Italy

    Antonio Jirillo

  8. Azienda Istituti Ospedalieri Cremona, Cremona, Italy

    Alberto Bottini

  9. Ospedali degli Infermi, Azianda USL-Rimini, Rimini, Italy

    Manuela Fantini

  10. Ospedale Mater Salutis, Legnago, Italy

    Andrea Bonetti

  11. Ospedale San Giovanni, Turin, Italy

    Fulvia Pedani

  12. Ospedale San Giovanni-Addolorata, Rome, Italy

    Maria Mauri

  13. Università di Verona, Verona, Italy

    Annamaria Molino

  14. Ospedale Santa Chiara, Trento, Italy

    Antonella Ferro

  15. Dipartimento di Morfologia Umana e Scienze Biomediche “Città Studi”, Università degli Studi di Milano, Milano, Italy

    Andrea Balsari

Authors
  1. Manuela Campiglio
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  2. Rosaria Bufalino
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  3. Marco Sandri
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  4. Elisa Ferri
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  5. Rosa Anna Aiello
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  6. Andrea De Matteis
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  7. Marcella Mottolese
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  8. Sabino De Placido
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  9. Patrizia Querzoli
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  10. Antonio Jirillo
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  11. Alberto Bottini
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  12. Manuela Fantini
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  13. Andrea Bonetti
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  14. Fulvia Pedani
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  15. Maria Mauri
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  16. Annamaria Molino
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  17. Antonella Ferro
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  18. Serenella M. Pupa
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  19. Marianna Sasso
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  20. Sylvie Ménard
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  21. Andrea Balsari
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  22. Elda Tagliabue
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Corresponding author

Correspondence to Sylvie Ménard.

Additional information

A. Balsari and E. Tagliabue contributed equally to this work.

This study was conducted on behalf of the Demetra group. The additional members of the Demetra group are given in Appendix.

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Appendix

Appendix

Eleonora Taibi and Giuseppe Nuciforo: Humanitas Centro Catanese di Oncologia, Catania; Gianfranco Di Feo: Istituto Nazionale Tumori, Pascale, Napoli; Giulio Metro and Federica Cuppone: Istituto Tumori Regina Elena, Roma; Giuseppe Cancello: Università Federico II, Napoli; Maria Lunardi: Università di Ferrara; Annamaria Scola: Oncologia Medica 2, Istituto Oncologico Veneto IRCCS, Padova; Alessandra Bersiga and Simone Bonardi: Azienda Istituti Ospedalieri Cremona; Lorenzo Gianni and Alberto Ravaioli: Ospedali degli Infermi, Azianda USL-Rimini; Marta Zaninelli and Laura Furini: Ospedale Mater Salutis, Legnano; Ester Berardengo: Ospedale San Giovanni, Torino; Leopoldo Costarelli: Ospedale San Giovanni-Addolorata, Roma; Eliana Gilioli: Università di Verona; Michela Frisinghelli: Ospedale Santa Chiara, Trento; Alberto Morabito: Istituto di Statistica Medica e Biometria, Università degli Studi, Milano; Mario Brandi and Giovanni Simone: IRCCS-Ospedale Oncologico, Bari; Giovanna Cavazzini and Alberto Bellomi: Azienda Ospedaliera C. Poma, Mantova; Giorgio Mustacchi and Fabrizio Zanconati: A. S.S. Centro Oncologico, Trieste; Alessandro Bertolini and Salvatore Ambrosi: Ospedale Civile di Sondrio, Sondrio; Angelo Di Leo and Claudino Wederson: Ospedale Misericordia e Dolce, Prato; Anna Sapino and Isabella Castellano: Azienda Ospedaliera Molinette, Torino; Dario Giuffrida and Lorenzo Memeo: Istituto Oncologico del Mediterraneo, Viagrande; Andrea Decensi: E.O. Ospedali Galliera, Genova.

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Campiglio, M., Bufalino, R., Sandri, M. et al. Increased overall survival independent of RECIST response in metastatic breast cancer patients continuing trastuzumab treatment: evidence from a retrospective study. Breast Cancer Res Treat 128, 147–154 (2011). https://doi.org/10.1007/s10549-011-1484-4

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