Clinical Activity of Trastuzumab and Vinorelbine in Women With HER2-Overexpressing Metastatic Breast Cancer

PURPOSE: To determine the response rate and toxicity profile of trastuzumab administered concurrently with weekly vinorelbine in women with HER2-overexpressing advanced breast cancer. PATIENTS AND METHODS: Forty women with HER2-positive (+3 by immunohistochemistry, n = 30; +2 or positive, n = 10) breast cancer were enrolled onto a study of trastuzumab (4 mg/kg × 1, 2 mg/kg weekly thereafter) and vinorelbine (25 mg/m2 weekly, with dose adjusted each week for neutrophil count). Eighty-two percent of women had received prior chemotherapy as part of adjuvant (30%), metastatic (25%), or both (28%) treatment, including substantial portions of patients who had previously received either anthracyclines (20%), taxanes (15%), or both types (38%) of chemotherapy. RESULTS: Responses were observed in 30 of 40 patients (overall response rate, 75%, conditional corrected 95% confidence interval, 57% to 89%). The response rate was 84% in patients treated with trastuzumab and vinorelbine as first-line therapy for metastatic disease, and 80% among HER2 +3 positive patients. High response rates were also seen in women treated with second- or third-line therapy, and among patients previously treated with anthracyclines and/or taxanes. Combination therapy was feasible; patients received concurrent trastuzumab and vinorelbine in 93% of treatment weeks. Neutropenia was the only grade 4 toxicity. No patients had symptomatic heart failure. Grade 2 cardiac toxicity was observed in three patients. Prior cumulative doxorubicin dose in excess of 240 mg/m2 and borderline pre-existing cardiac function were associated with grade 2 cardiac toxicity. CONCLUSION: Trastuzumab in combination with vinorelbine is highly active in women with HER2-overexpressing advanced breast cancer and is well tolerated.

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Abstract OT1-1-02: A single-arm phase IIIb study of pertuzumab and trastuzumab with a taxane as first-line therapy for patients with HER2-positive advanced breast cancer (PERUSE)

10.1158/0008-5472.sabcs12-ot1-1-02 ◽

2012 ◽

Cited By ~ 4

Author(s):

T Bachelot ◽

E Ciruelos ◽

T Peretz-Yablonski ◽

A Schneeweiss ◽

F Puglisi ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Advanced Breast ◽

First Line ◽

Her2 Positive ◽

First Line Therapy ◽

Line Therapy ◽

Phase Iiib

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A randomized and open-label trial evaluating the addition of pazopanib to lapatinib as first-line therapy in patients with HER2-positive advanced breast cancer

Breast Cancer Research and Treatment ◽

10.1007/s10549-012-2399-4 ◽

2013 ◽

Vol 137 (3) ◽

pp. 755-766 ◽

Cited By ~ 33

Author(s):

Stephen R. D. Johnston ◽

Henry Gómez ◽

Salomon M. Stemmer ◽

Maria Richie ◽

Michael Durante ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Advanced Breast ◽

First Line ◽

Her2 Positive ◽

Open Label ◽

First Line Therapy ◽

Line Therapy ◽

Open Label Trial

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Docetaxel and capecitabine as first-line chemotherapy in patients with advanced breast cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.10734 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 10734-10734

Author(s):

C. Gennatas ◽

V. Michalaki ◽

J. Psychogios ◽

S. Gennatas ◽

A. Kondi-Paphiti ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Median Duration ◽

Metastatic Breast ◽

Advanced Breast ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Duration Of Response ◽

Ecog Ps

10734 Background: Capecitabine (C) and Docetaxel (D) have demonstrated synergy in both preclinical and clinical studies in metastatic breast cancer (MBC). The aim of the study was to evaluate the activity and tolerability of the combination of CD as a first -line therapy for patients with advanced breast cancer. Methods: Thirty- five patients have been enrolled in the study. Median age was 54 years (range 35–73). ECOG PS was of 0–2 (PS 0: 6 patients, PS 1: 5 patients, PS 2: 14 patients), All patients were Her-2 neu negative. Patients received Docetaxel 75 mg/m2 on day 1, with routine pre and post-medication with steroids, and Capecitabine 950 mg/m2 p.o. bid on days 1–14, every 3 weeks until disease progression or unacceptable toxicity. Results: A total of 233 cycles were given with a median of 7 (2–12). Of the 35 evaluable patients, 17 patients (48%) achieved partial response (PR) and 6 patients (17%) attained stable disease (SD). The median duration of response was 12 weeks and the median duration of SD was 20 weeks. The median time to progression (TTP) was 28 weeks. The median overall survival was 90 weeks. All patients were evaluable for toxicity. Toxicity was mainly hematological with G3 or 4 neutropenia in 7 patients (20%). Febrile neutropenia was not encountered. There was not significant GI toxicity. Conclusions: Combination chemotherapy with Capecitabine and Docetaxel shows promising efficacy as first- line therapy in advanced breast cancer with an acceptable toxicity profile. No significant financial relationships to disclose.

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Randomized phase II study of weekly versus every-3-week ixabepilone plus bevacizumab (ixa/bev) versus paclitaxel plus bev (pac/bev) as first-line therapy for metastatic breast cancer (MBC)

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.1029 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 1029-1029

Author(s):

H. S. Rugo ◽

M. Campone ◽

D. Amadori ◽

A. Wardley ◽

E. Villa ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Objective Response ◽

Locally Advanced ◽

Human Tumor ◽

Metastatic Breast ◽

Advanced Breast ◽

First Line ◽

First Line Therapy ◽

Line Therapy

1029 Background: Pac/bev is superior to pac alone as first-line therapy for MBC. Ixa/bev has greater preclinical activity than pac/bev in human tumor models. The primary objective of this trial was to evaluate objective response rates (ORR) of ixa/bev given weekly or every 3 weeks relative to pac/bev as 1st line therapy for women with advanced breast cancer. Methods: Women with measurable disease and no prior chemotherapy for advanced breast cancer (locally advanced or MBC) were randomized in a 3:3:2 ratio to Arm A (ixa 16 mg/m2 IV on days 1, 8 & 15 q28 days/ bev 10 mg/kg IV q 2 wks), Arm B (ixa 40 mg/m2 IV q3 wks / bev 15 mg/kg IV q 3 wks) or Arm C (pac 90 mg/m2 IV, schedule/bev as in Arm A). Treatment was continued until disease progression or unacceptable toxicity. Results: Key efficacy and safety results from a pre-planned analysis of all randomized subjects after at least 24 weeks of follow-up are presented. Baseline characteristics were balanced between arms except for liver metastasis. Conclusions: The combination of ixa/bev weekly or q 3 wks demonstrated encouraging clinical activity and safety comparable to 1st line pac/bev in E2100. Final PFS will be provided when data is mature. These results support ongoing clinical trials of ixa given weekly or q 3wk in 1st line MBC, and in combination with bev. [Table: see text] [Table: see text]

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Lapatinib and capecitabine as third-line therapy in young woman with advanced breast cancer

ABOUTOPEN ◽

10.19156/abtpn.2018.0037 ◽

2018 ◽

Vol 4 (1) ◽

pp. 35-38

Author(s):

Michela Donadio

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Young Woman ◽

Clinical Status ◽

Advanced Breast ◽

Her2 Positive ◽

First Line Therapy ◽

Line Therapy ◽

Third Line Therapy ◽

Third Line

We report the case of a young woman with HER2-positive advanced breast cancer, arising during pregnancy, with visceral involvement at onset, treated with third line therapy with the combination lapatinib and capecitabine resulting in a nearly complete long-term tumor response . The patient had previously been treated with first line therapy with double block, pertuzumab and trastuzumab and, after disease progression, with T-DM1 resulting in a short-term stability of clinical status (Oncology).

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