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Breast cancer is the uncontrolled, abnormal growth of malignant breast tissue affecting predominantly women. Metastatic breast cancer (mBC) is an advanced stage of the disease when the disease has spread beyond the original organ. Hormone receptor status and human epidermal growth factor 2 (HER2) status are two predictive factors that are taken into consideration when estimating the prognosis of patients with breast cancer.

Health Technology Assessment - NIHR Journals Library.

Version: December 2011

Breast cancer is the uncontrolled, abnormal growth of malignant breast tissue affecting predominantly women. Metastatic breast cancer (mBC) is an advanced stage of the disease when the disease has spread beyond the original organ.

NIHR Health Technology Assessment programme: Executive Summaries - NIHR Journals Library.

Version: 2011

Bibliographic details: Shen JJ, Hu SL, Shen G, Xu TJ, Chen Y, Wu L, Xu WP.  Lapatinib plus adjuvant chemotherapy for metastatic and HER-2 positive advanced breast cancer patients: a meta-analysis. Chinese Journal of Cancer Prevention and Treatment 2010; 17(24): 2038-2041

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2010

Patients with HER2-positive breast cancer are living still longer and increasingly experiencing brain metastases. Current HER2-targeted therapies have limited potential to cross the blood-brain-barrier. We performed a systematic review to investigate data on HER2-targeting therapies in the treatment of brain metastases in breast cancer. We searched PUBMED for all human studies published 1998-2012 using the following search terms: breast neoplasm/cancer, human epidermal growth factor receptor 2/HER2, ErbB2, trastuzumab, lapatinib, brain/cerebral neoplasm/metastases and blood-brain barrier. We identified few and mostly small clinical studies. Study designs were very heterogeneous making comparisons on endpoints difficult. Overall survival for patients treated with trastuzumab varied from 8 to 25 months and 5.5 to 11 months for patients receiving lapatinib. The majority of studies were retrospective thus possibly biasing data. Only three studies were identified comparing trastuzumab to lapatinib. Conclusively, no solid data exist on how to treat patients with HER2-positive disease and brain metastases. Although continuous HER2-blockade is recommended by international consensus guidelines, it is still not evident which HER2-targeting agent should be preferred when brain metastases occur. The choice of chemotherapy to accompany the blockade is not obvious and we do not know if dual is better than single blockade. Further clinical trials are urgently needed.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

The efficacy of treatments involving lapatinib for patients with metastatic breast cancers was evaluated in a Bayesian metaanalysis of published data from randomized controlled clinical trials. Four randomized controlled trials including 2,708 patients met the inclusion criteria. Among these patients, 568 were positive for the human epidermal growth factor receptor 2(HER2). The clinical benefit rate(CBR)for HER2-positive patients was the primary outcome of the analysis, and the overall survival(l OS) and the number needed to treat(NNT)were the secondary outcomes of the reported meta-analysis. The Bayesian metaanalysis was conducted according to the Markov-chain Monte-Carlo technique in WinBUGS. The CBR for HER2-positive patients was significantly improved(odds ratio[OR]: 2.281, 95% confidence interval[CI]: 1.490-3.628), whereas no statistically significant improvement was seen in the overall patient CBR(OR: 1.559, 95% CI: 0.768-3.238). The OS hazard ratio (HR)and NNT for the CBR were also estimated for HER2-positive patients. The difference in the OS HR was not statistically significant(HR: 0.789, 95% CI: 0.556-1.086)for HER2-positive patients. The improvement in the NNT for the CBR was statistically significant(NNT 5.164, 95% CI: 3.803-8.723)for HER2-positive patients.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

BACKGROUND: This paper reports a systematic review and meta-analysis of all randomized controlled trials comparing the efficacy of lapatinib plus chemotherapy or endocrine therapy (CET) versus CET alone in human epidermal growth factor receptor 2-overexpressing (HER-2+) locally advanced or metastatic breast cancer.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

BACKGROUND: Third-generation aromatase inhibitors (letrozole, anastrozole) have shown superior efficacy in early and advanced breast cancer compared with tamoxifen. For HR+, HER2+ MBC, combination of an AI with an anti-HER2 agent (lapatinib or trastuzumab) has shown clinical benefit.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

OBJECTIVE: A systematic review and meta-analysis of fatigue and hepatic adverse events associated with lapatinib use in solid tumor patients were performed.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

The review concluded that addition of lapatinib to conventional treatment might offer superior survival benefit to patients with advanced metastatic human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer. The review was somewhat limited by its searches and reporting, but the authors' suitably cautious conclusion appears likely to be reliable.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2010

The authors concluded that lapatinib plus aromatase inhibitor and trastuzumab plus aromatase inhibitor appeared to be clinically more effective than aromatase inhibitor monotherapy. It was not possible to compare lapatinib plus aromatase inhibitor with trastuzumab plus aromatase inhibitor. Given the clinical heterogeneous populations, their conclusion reflects the evidence presented and is likely to be reliable.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2011

The authors concluded that a clear improvement in pathological complete response was shown by addition of both trastuzumab and lapatinib to neoadjuvant chemotherapy in human epidermal receptor 2-positive breast cancer; trastuzumab demonstrated a better toxicity profile and superiority to lapatinib in this setting. These conclusions reflect available evidence for tumour response and toxicity, and are likely reliable.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

The review found combination lapatinib and capecitabine was more effective than capecitabine for reducing risk of cancer progression in women with metastasized or advanced breast cancer with overexpression of HER-2 receptors after first-line treatment with other drugs. These conclusions reflected the limited evidence, but should be treated with caution due to review shortcomings in processes, insufficient studies and potential bias.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2009

This review found that clinical benefits from treatment with lapatinib were limited to women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Lack of information about included populations, interventions and trial quality means that the reliability of the authors' conclusions is unclear and the results of the review should be interpreted with a substantial degree of caution.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2010

Tumours characterised by the presence of the HER2 protein are found in about one in five women with metastatic breast cancer. These tend to be more aggressive and the prognosis and choice of treatment are affected. Trastuzumab (Herceptin®) is a targeted biological drug (a monoclonal antibody) that attaches to the HER2 protein, blocking the growth of malignant cells.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: June 12, 2014

Oral cancers (cancer of the mouth and cancer of the throat) are the sixth most common cancer worldwide, accounting for an estimated 4% of all cancers. There is a higher frequency of these cancers in men. Smoking, alcohol consumption and betel quid chewing are the main risk factors. Cancer of the throat is associated with infection from the human papilloma virus (HPV), which can be transmitted through sexual contact. Low socioeconomic status (a measure of a person's income, education and occupation in relation to other people's) is associated with a higher frequency of oral cancers and poorer survival rates. Survival following a diagnosis of mouth or throat cancer remains poor, with around 50% of people still alive at five years (five‐year survival rate).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: December 1, 2015

A single non-inferiority randomised controlled trial (RCT) provides evidence for the effectiveness of INTRABEAM in comparison to whole-breast external beam radiotherapy. The difference in local recurrence between INTRABEAM and WB-EBRT in the RCT did not exceed a 2.5% non-inferiority margin, providing INTRABEAM was given at the same time as breast-conserving surgery. An independent economic model found that INTRABEAM was associated with lower total costs but also fewer quality adjusted life years gained than whole-breast external beam radiotherapy (WB-EBRT) in the base-case cost-effectiveness analysis.

Health Technology Assessment - NIHR Journals Library.

Version: August 2015

The aim of the present report is to assess the added benefit of trastuzumab emtansine in patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior treatment for locally advanced or metastatic disease, or developed disease recurrence during or within 6 months of completing adjuvant therapy.

Institute for Quality and Efficiency in Health Care (IQWiG).

Version: March 28, 2014

Expert-reviewed information summary about the treatment of ductal carcinoma in situ, lobular carcinoma in situ, and invasive breast cancer.

PDQ Cancer Information Summaries [Internet] - National Cancer Institute (US).

Version: April 6, 2018

There is no single universal definition of the upper aerodigestive tract; for the purposes of this guideline, it encompasses the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinuses. The vast majority of cancers at these sites are squamous cell carcinomas (National Head and Neck Cancer Audit, 2014). Some other cancers with less common histological diagnoses, such as mucosal melanomas of the upper aerodigestive tract, are also covered by this guideline.

NICE Guideline - National Collaborating Centre for Cancer (UK).

Version: February 2016

Breast cancer is the most common cancer for women in England and Wales, with about 37,000 new cases diagnosed and 11,000 deaths recorded in England and Wales each year. In men breast cancer is rare, with about 270 cases diagnosed, and 70 deaths in England and Wales each year. Of these new cases in women and men, around 10% are diagnosed in the advanced stages, when the tumour has spread significantly within the breast or to other organs of the body. In addition, there is a significant number of women who have been previously treated with curative intent who subsequently develop either a local recurrence or metastases. Over recent years there have been important developments in the investigation and management of these patients including new chemotherapy, and biological and hormonal agents. There is some evidence of practice variation across the country and of patchy availability of certain treatments and procedures. A clinical guideline will help to address these issues and offer guidance on best practice.

NICE Clinical Guidelines - National Collaborating Centre for Cancer (UK).

Version: February 2009

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