Research Papers:

Neoadjuvant chemotherapy in breast cancer: a dose-dense schedule in real life and putative role of PIK3CA mutations

Valentina Cocciolone _, Katia Cannita, Alessandra Tessitore, Valentina Mastroiaco, Lucia Rinaldi, Stefania Paradisi, Azzurra Irelli, Paola Lanfiuti Baldi, Tina Sidoni, Enrico Ricevuto, Antonella Dal Mas, Giuseppe Calvisi, Gino Coletti, Antonietta Ciccozzi, Laura Pizzorno, Valter Resta, Alberto Bafile, Edoardo Alesse and Corrado Ficorella

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Oncotarget. 2018; 9:27380-27396. https://doi.org/10.18632/oncotarget.25270

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Valentina Cocciolone1,2,*, Katia Cannita2,*, Alessandra Tessitore1, Valentina Mastroiaco1, Lucia Rinaldi2, Stefania Paradisi2, Azzurra Irelli2, Paola Lanfiuti Baldi2, Tina Sidoni2, Enrico Ricevuto1,3, Antonella Dal Mas4, Giuseppe Calvisi4, Gino Coletti4, Antonietta Ciccozzi5, Laura Pizzorno6, Valter Resta6, Alberto Bafile6, Edoardo Alesse1 and Corrado Ficorella1,2

1Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, L’Aquila, Italy

2Medical Oncology Department, S. Salvatore Hospital, University of L’Aquila, L’Aquila, Italy

3Oncology Network ASL1 Abruzzo, UOSD Oncology Territorial Care, S. Salvatore Hospital, University of L’Aquila, L’Aquila, Italy

4Pathology Department, S. Salvatore Hospital, L’Aquila, L’Aquila, Italy

5Radiology Department, S. Salvatore Hospital, L’Aquila, L’Aquila, Italy

6Breast Unit, S. Salvatore Hospital, L’Aquila, L’Aquila, Italy

*These authors have contributed equally to this work

Correspondence to:

Valentina Cocciolone, email: [email protected]

Keywords: neaodjuvant; dose-dense; PIK3CA; real life

Received: July 27, 2017     Accepted: April 06, 2018     Published: June 08, 2018


Background: Dose-dense chemotherapy is one of the treatments of choice for neoadjuvant therapy in breast cancer (BC). Activating mutations in PIK3CA gene predict worse response to neoadjuvant chemotherapy for HER2-positive patients, while their role is less clearly defined for HER2-negative tumors.

Methods: We conducted a phase I/II study of neoadjuvant, sequential, dose-dense anthracycline/taxane chemotherapy, plus trastuzumab in HER2-positive patients and investigated the correlation of pre-treatment PIK3CA mutation status with pathologic complete response (pCR) and long-term outcome in a real-life setting.

Results: we established a dose-dense docetaxel recommended dose of 60 mg/m2 and 65 mg/m2, with or without trastuzumab, respectively, according to HER2-status, following dose-dense epirubicin-cyclophosphamide (90/600 mg/m2), every 2 weeks. The overall pCR rate was 21.4%; median disease-free survival (DFS) was 52 months and median overall survival (OS) was not yet reached. PIK3CA mutation status was not significantly associated with the pCR rate: 18% for both mutated and wild-type patients. The pCR rate was: 25% in the mutated and 24% in the wild-type (p 0.560) cohort of the HER2-positive subgroup; 33% both in the mutant and wild-type cohort of the triple-negative subgroup; no pCR neither in the mutant nor in the wild-type cohort of the HR-positive/HER2-negative subgroup. Among the HER2-positive population, a trend toward worse DFS was observed in case of mutation, as opposed to the triple negative population.

Conclusions: This study proposes an effective and safe neoadjuvant dose-dense anthracycline/taxane schedule and suggests that PIK3CA mutation analysis can be usefully performed in real-life clinical practice.

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