A Phase II Study of Weekly Vinorelbine and Trastuzumab in Patients with HER2-Positive Metastatic Breast Cancer

Bayo-Calero, Juan; Mayordomo, J. I.; Sánchez‐Rovira, Pedro; Perez-Carrion, R.; Illaramendi, J.; Garcia-Bueno, Jose Maria; González-Flores, Encarnación; Crespo, Carmen; Ramos-Vázquez, Manuel; García‐Palomo, Andrés; Ruíz‐Borrego, Manuel; Haba, Juan de la; Gómez-Bernal, Amalia; Yubero-Esteban, Alfonso

doi:10.3816/cbc.2008.n.030

Cited by 21 publications

(6 citation statements)

References 18 publications

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“…Trastuzumab given either alone or in combination with chemotherapy in the first-, second-, or third-line treatment for advanced HER2-positive breast cancer have shown similar magnitude of benefit regardless of HR status. 20-23 …”

Section: Discussionmentioning

confidence: 99%

Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study

Vaz-Luís

Seah

Olson

et al. 2013

Clinical Breast Cancer

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The relationship between clinicopathological features and long-term benefit to trastuzumab-based therapy was evaluated in 164 HER2-positive metastatic breast cancer patients. Treatment duration was associated with hormone receptor status and use of adjuvant trastuzumab; however, with low predictive value. With growing availability of targeted treatments for HER2-positive disease, a major clinical priority is identifying molecular predictors of benefit of anti-HER2 therapies. Background The magnitude of benefit of trastuzumab for the treatment of advanced HER2-positive breast cancer varies widely. In this retrospective study, we investigated the clinicopathological features associated with prolonged first-line trastuzumab-based treatment duration. Patients and Methods A total of 164 patients diagnosed with advanced HER2-positive breast cancer and treated with first-line trastuzumab-based therapy from 1999 to 2009 were identified. Duration of treatment was classified according to tertiles. Different logistic regression models including age, disease-free interval, number of metastatic sites, visceral disease, hormone receptor, and adjuvant trastuzumab were fitted to investigate associations with benefit of prolonged trastuzumab-based therapies. The predictive value of each model was assessed using C-statistics. Results At a median follow-up of 5.8 years (range, 0.7-22.1 years), patients in the short-, intermediate-, and long-term treatment duration groups were given first-line trastuzumab-based therapy for < 7.2 months, 7.2 to 14 months, and > 14 months, respectively. In the multivariate analysis, patients with long-term clinical benefit had a higher likelihood of having hormone receptor-positive tumors (odds ratio [OR]positive vs. negative = 2.39 [95% confidence interval (CI), 1.08-5.31]; P = .032); and a lower likelihood of having received adjuvant trastuzumab (ORadjuvant trastuzumab vs. no adjuvant trastuzumab = 0.30 [95% CI, 0.10-0.96]; P = .043]. C-statistics varied between 0.634 and 0.699. Conclusion Long-term benefit of trastuzumab-based therapy is associated with hormone receptor positivity and the absence of previous adjuvant trastuzumab. Nevertheless, clinicopathological features had a low predictive value for prolonged treatment duration. The validation of the current findings and the identification of molecular features associated the magnitude of trastuzumab benefit should be encouraged.

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Section: Discussionmentioning

confidence: 99%

Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study

Vaz-Luís

Seah

Olson

et al. 2013

Clinical Breast Cancer

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“…This combination showed good results; however, with a little more toxicity, time to treatment failure, time to progression, rate and duration’s response, and overall survival [ 202 , 203 ]. Furthermore, combination of trastuzumab with other cytotoxic agents such as anthracycline, carboplatin, taxanes, vinorelbine, and gemcitabine were effective when used as first- or second-line treatment especially in HER2-positive MBC patients [ 204 – 206 ].…”

Section: Treatments Of Metastatic Breast Cancermentioning

confidence: 99%

Metastatic and triple-negative breast cancer: challenges and treatment options

Al-Mahmood

Sapiezynski

Garbuzenko

et al. 2018

Drug Deliv. and Transl. Res.

411

258

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The major current conventional types of metastatic breast cancer (MBC) treatments include surgery, radiation, hormonal therapy, chemotherapy, or immunotherapy. Introducing biological drugs, targeted treatment and gene therapy can potentially reduce the mortality and improve the quality of life in patients with MBC. However, combination of several types of treatment is usually recommended. Triple negative breast cancer (TNBC) accounts for 10–20% of all cases of breast carcinoma and is characterized by the low expression of progesterone receptor (PR), estrogen receptor (ER), and human epidermal growth factor receptor 2 (HER2). Consequently, convenient treatments used for MBC that target these receptors are not effective for TNBC which therefore requires special treatment approaches. This review discusses the occurrence of MBC, the prognosis and predictive biomarkers of MBC, and focuses on the novel advanced tactics for treatment of MBC and TNBC. Nanotechnology-based combinatorial approach for the suppression of EGFR by siRNA and gifitinib is described.

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“…Taken together, the published clinical trails on first-line combination therapy with trastuzumab plus vinorelbine in HER2-overexpressing MBC report objective responses in 60-78% of patients, with a median duration of response of 7-12 months, a TTP of 7-17 months, and a median OS > 20 months, with mild and manageable toxicity 10,11,[19][20][21][22] . In pretreated HER2-overexpressing MBC, the combination also achieved a RR ranging from 20% to more than 60%, with a median duration of response of about 6 months and a median TTP of 4-8 months [23][24][25] . In our study, RR, TTP and OS are in agreement with those of previous reports, with value of 78%, 9 and 29 months, respectively.…”

Section: Discussionmentioning

confidence: 96%

Trastuzumab and Vinorelbine as Highly Effective and Safe Therapy for HER-2-Overexpressing Metastatic Breast Cancer. A Single Institution Experience

Lauro

Murrone

Bidoli

et al. 2008

Tumori

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Aims and Background Trastuzumab-based therapy has improved survival of women with human epidermal growth factor receptor 2 (HER2)-overexpressing metastatic breast cancer. Study Design From September 2002 to July 2006, 45 women with metastatic breast cancer HER2 3+, or 2+ and positive for HER2 gene amplification, were enrolled in the study and received a combination therapy with vinorelbine, 25 mg/m2 weeks 1 and 2, plus trastuzumab, 4 mg/kg loading dose and then 2 mg/kg weekly, in a three weeks cycle. Eligibility criteria included measurable disease and a baseline ejection fraction ≥50%. Forty-two percent of the patients were not pretreated, whereas 58% had received a previous chemotherapy regimen for metastatic disease, including anthracy-clines and/or taxanes (47%), and trastuzumab plus taxol (11%). Results We observed 14 (31%) complete responses and 21 (47%) partial responses, with an overall response rate of 78%. Stable disease >6 months was assessed for 5 (11%) patients with a clinical benefit of 89%. Five (11%) patients progressed. With a median follow-up of 11 months, median time to progression was 9 months and median duration of response was 7.6 months for complete remissions and 4 months for partial remissions. Median survival was 29 months. Conclusions In spite of a smaller dose intensity of vinorelbine than previously reported, the regimen evaluated was notably effective in terms of response rate, time to progression and survival, with very mild toxicity.

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A Phase II Study of Weekly Vinorelbine and Trastuzumab in Patients with HER2-Positive Metastatic Breast Cancer

Cited by 21 publications

References 18 publications

Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study

Clinicopathological Features Among Patients With Advanced Human Epidermal Growth Factor–2-Positive Breast Cancer With Prolonged Clinical Benefit to First-Line Trastuzumab-Based Therapy: A Retrospective Cohort Study

Metastatic and triple-negative breast cancer: challenges and treatment options

Trastuzumab and Vinorelbine as Highly Effective and Safe Therapy for HER-2-Overexpressing Metastatic Breast Cancer. A Single Institution Experience

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