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Rocca A, Cortesi P, Cortesi L, et al. Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer. Ther Adv Med Oncol. 2021;13:1758835920985632doi: 10.1177/1758835920985632.
Rocca, A., Cortesi, P., Cortesi, L., Gianni, L., Matteucci, F., Fantini, L., Maestri, A., Giunchi, D. C., Cavanna, L., Ciani, R., Falcini, F., Bagni, A., Meldoli, E., Dall'Agata, M., Volpi, R., Andreis, D., Nanni, O., Curcio, A., Lucchi, L., Amadori, D., & Fedeli, A. (2021). Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer. Therapeutic advances in medical oncology, 131758835920985632. https://doi.org/10.1177/1758835920985632
Rocca, Andrea, et al. "Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer." Therapeutic advances in medical oncology vol. 13 (2021): 1758835920985632. doi: https://doi.org/10.1177/1758835920985632
Rocca A, Cortesi P, Cortesi L, Gianni L, Matteucci F, Fantini L, Maestri A, Giunchi DC, Cavanna L, Ciani R, Falcini F, Bagni A, Meldoli E, Dall'Agata M, Volpi R, Andreis D, Nanni O, Curcio A, Lucchi L, Amadori D, Fedeli A. Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer. Ther Adv Med Oncol. 2021 Feb 09;13:1758835920985632. doi: 10.1177/1758835920985632. eCollection 2021. PMID: 33613693; PMCID: PMC7876584.
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Ther Adv Med Oncol. 2021 Feb 09;13:1758835920985632. doi: 10.1177/1758835920985632. eCollection 2021.

Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer.

Therapeutic advances in medical oncology

Andrea Rocca, Pietro Cortesi, Laura Cortesi, Lorenzo Gianni, Federica Matteucci, Lorenzo Fantini, Antonio Maestri, Donata Casadei Giunchi, Luigi Cavanna, Rosa Ciani, Fabio Falcini, Antonella Bagni, Elena Meldoli, Monia Dall'Agata, Roberta Volpi, Daniele Andreis, Oriana Nanni, Annalisa Curcio, Leonardo Lucchi, Dino Amadori, Anna Fedeli

Affiliations

  1. Department of Clinical and Experimental Oncology and Hematology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via Maroncelli 40, Meldola 47014, Italy.
  2. Department of Clinical and Experimental Oncology and Hematology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
  3. Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy.
  4. Department of Medical Oncology, Infermi Hospital, Rimini, Italy.
  5. Nuclear Medicine Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
  6. Department of Medical Oncology, Santa Maria della Scaletta Hospital, Imola, Italy.
  7. Department of Onco-Hematology, Guglielmo da Saliceto Hospital, Piacenza, Italy.
  8. Cancer Prevention Unit, Azienda Usl della Romagna, Forlì, Italy.
  9. Cancer Prevention Unit, Azienda Usl della Romagna, Forlì, Italy Romagna Cancer Registry, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
  10. Breast Diagnostic Unit, Maurizio Bufalini Hospital, Cesena, Italy.
  11. Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
  12. Breast Surgery Unit, Morgagni-Pierantoni Hospital, Forlì, Italy.
  13. Breast Surgery Unit, Maurizio Bufalini Hospital, Forlì, Italy.

PMID: 33613693 PMCID: PMC7876584 DOI: 10.1177/1758835920985632

Abstract

BACKGROUND: The aim of this study was to improve activity over single human epidermal growth factor receptor 2 (HER2)-blockade sequential neaodjuvant regimens for HER2-positive breast cancer, by exploiting the concomitant administration of trastuzumab, taxane and anthracycline, while restraining cardiac toxicity with use of liposomal doxorubicin, and by adding metformin, based on preliminary evidence of antitumor activity.

PATIENTS AND METHODS: This multi-center, single-arm, two-stage phase II trial, assessed the safety and the activity of a new treatment regimen for HER2-positive, early or locally advanced breast cancer. Patients received six 21-day cycles of non-pegylated liposomal doxorubicin, 50 mg/m

RESULTS: Among 47 evaluable patients, there were 18 pCR [38.3%, 95% confidence interval (CI) 24.5-53.6%]. A negative estrogen-receptor status, high Ki67, and histological grade 3 were related with pCR, although only grade reached statistical significance. FLT-PET maximum standardized uptake value after one cycle was inversely related to pCR in the breast (odds ratio 0.29, 95% CI 0.06-1.30,

CONCLUSIONS: The concomitant administration of trastuzumab, liposomal doxorubicin, docetaxel, and metformin is safe and shows good activity, but does not appear to improve activity over conventional sequential regimens.

© The Author(s), 2021.

Keywords: HER2+ breast cancer; metformin; neoadjuvant therapy; non-pegylated liposomal doxorubicin; primary systemic therapy; trastuzumab

Conflict of interest statement

Conflict of interest statement: Andrea Rocca: personal fees for advisory boards from Pfizer, Novartis and Lilly and congress, travel, and accommodation fees from Roche. Laura Cortesi: honoraria from A

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