PerFECT – Pertuzumab in First Line Treatment of HER2-positive metastatic breast Cancer patients: A cohort study of patients treated either with docetaxel and Trastuzumab or docetaxel, trastuzumab and pertuzumab

Background: Most patients with HER2-positive metastatic breast cancer (MBC) receive first-line treatment with anti-HER2 agents and have already received anti-HER2 therapy as adjuvant or neoadjuvant therapy in the local setting of their disease presentation. Despite that, they constitute only a minority among clinical trials, and their response to reintroduction to anti-HER2 treatments is inconclusive based upon conflicting studies. We aimed to examine if previous exposure influences the clinical outcome of patients treated with anti-HER2 treatments compared to patients who were naïve to anti-HER2 agents. Methods: We conducted a retrospective observational study of HER2-positive MBC patients who were treated with trastuzumab and pertuzumab from 2014 to 2018. We collected and analyzed data including patients’ demographic characteristic as well as extracted data of previous treatment regimens and the efficiency of the anti-HER2 therapy measured by response rate (RR), time to tumor progression (TTP), and overall survival (OS). Results: Eighty patients met the inclusion criteria, 26 (32.5%) of them were previously exposed to anti-HER2 treatments and 54 (67.5%) were not previously exposed to anti-HER2 therapy. No significant differences were detected in RR after 3 months of treatment (p = 0.684). TTP was significantly better among patients with no previous exposure in comparison with patients with previous exposure to anti-HER2 therapy (21 vs. 14 months, p = 0.044) and we noted a trend in better OS (p = 0.056). Conclusion: Our analysis suggests that previous exposure to anti-HER2 agents might influence the clinical outcome of first-line treatment in metastatic HER2 patients. These findings justify further exploration of the benefit of reintroduction of anti-HER2 treatment enabling the optimal treatment for patients with previous anti-HER2 therapy exposure.

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Combination of trastuzumab, oxaliplatin, and docetaxel as first-line treatment in HER2-positive metastatic breast cancer patients: First-step results of a phase II trial (HOT trial)

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.1132 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 1132-1132

Author(s):

D. Amoroso ◽

S. Donati ◽

C. Valsuani ◽

C. Puccetti ◽

M. Rondini ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Metastatic Breast ◽

Bone Marrow Toxicity ◽

Line Treatment ◽

Breast Cancer Patients ◽

First Line ◽

Her2 Positive ◽

Her 2 ◽

First Line Treatment

1132 Background: The addiction of trastuzumab to standard chemotherapy has improved the outcome of HER-2-positive metastatic breast cancer (MBC) pts. Oxaliplatin and docetaxxel are among the most active agents in MBC pts pretreated with anthracyclines. In vitro studies showed synergistic effect of the combination. We investigated the feasibility and the safety of the 3-drug combination given as first line chemotherapy (CT) in HER-2-positive MBC. Methods: HER-2-positive MBC pts were prospectively enrolled to receive a first-line treatment consisting of trastuzumab 8 mg/kg loading dose iv (followed by 6 mg/kg) on day 1, docetaxel 75 mg/sqm iv on day 1, and oxaliplatin 70 mg/sqm on day 2 every 21 days. All pts received peg-filgrastim 6 mg on day 3 to prevent bone marrow toxicity. Pts received up to 9 cycles of CT. Primary end points were overall response rate (ORR) (according to RECIST criteria), clinical benefit (CB), and tolerability. Cardiac function was evaluated by echocardiography at baseline, each 3 courses and at the end of treatment. Results: To date, 13 pts have been enrolled (median age 59 yrs [range 34–70]; ECOG PS 0) representing the first-step accrual according to Minimax design. Ten pts had previously received anthracyclines as adjuvant treatment and 11 pts presented with visceral metastasis. All pts received at least 6 cycles of treatment with 7 pts continuing up to 9 cycles. Response and toxicity data are available for all pts. Two pts experienced CR, 7 pts PR, and 4 pts showed SD (lasting more than 6 months in 3 cases) with an ORR of 70% and a CB of 100%. No pts progressed during treatment. No grade 4 toxicity was observed. Most common grade 3 toxicities were diarrhea (18%), nausea/vomiting (22%), mucositis (11%). In particular, 2 episodes of febrile neutropenia were reported and no grade 4 haematologycal toxicity was observed. No significative reduction of LVEF were reported. Conclusions: The combination of trastuzumab, oxaliplatin, and docetaxel (HOT combination) showed promising activity and was well tolerated as first-line treatment in pts with HER-2-positive MBC. Peg-filgrastim profilaxis improved safety profile. No significant financial relationships to disclose.

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