Pilot Studies for Personalized Cancer Medicine: Focusing on the Patient for Treatment Selection

Mattos-Arruda, Leticia De; Rodón, Jordi

doi:10.1634/theoncologist.2013-0135

Cited by 22 publications

(14 citation statements)

References 51 publications

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“…In fact, neoadjuvant trials to test specific agents based on biomarker signature of HER2-positive breast cancers have already been initiated 113, 114 . For example, the I-SPY 2 trial 114 is a neoadjuvant dynamic adaptive-design phase II trial that is enrolling patients with high-risk breast cancer.…”

Section: Discussionmentioning

confidence: 99%

Translating neoadjuvant therapy into survival benefits: one size does not fit all

et al. 2016

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Neoadjuvant therapy has been established as an effective therapeutic approach for patients with locally advanced breast cancer. Similar outcomes between neoadjuvant and adjuvant chemotherapy have been demonstrated in several trials. Nevertheless, neoadjuvant therapy has some advantages over adjuvant therapy, including tumour downstaging, in vivo assessment of therapeutic efficacy, reduced treatment durations, and the need to enrol fewer patients for clinical trials to reach their preplanned objectives. The number of neoadjuvant trials in patients with breast cancer has increased substantially in the past 5 years, particularly in the context of HER2-positive disease. Substantial improvements in the pathological complete response rate to anti-HER2 therapy, a proposed surrogate end point for long-term clinical benefit, have been observed with neoadjuvant dual-agent HER2 blockade. Thus, it was hypothesized that this approach would provide additional survival benefits over standard-of-care therapy with the anti-HER2 antibody trastuzumab in the adjuvant setting. Emerging data, however, are calling this notion into question. We discuss potential reasons why results of neoadjuvant trials of targeted therapies have not been mirrored in the adjuvant setting, and other than inherent differences in clinical-trial designs and statistical power, we consider how the biology of the disease, patient characteristics, and drug administration and schedule might influence the results.

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Section: Discussionmentioning

confidence: 99%

Translating neoadjuvant therapy into survival benefits: one size does not fit all

et al. 2016

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“…The implicit search for clinical benefit may also be more pronounced among patients who know their tumors have particular molecular characteristics that may make them targets for particular kinds of agents. 73 Another recent development is in the use of preclinical predictive pharmacokinetic models that are more sophisticated, providing the ability to predict an active drug level before Phase I start. Also, new clinical trial designs, such as ''accelerated dose escalation'' to spare patients from potential ''under dosing.''…”

Section: Evolution Of Phase I Trials and Palliative Carementioning

confidence: 99%

Phase I Cancer Trials and Palliative Care: Antagonism, Irrelevance, or Synergy?

Cassel

Fabbro

Arkenau

et al. 2016

Journal of Pain and Symptom Management

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This article synthesizes the presentations and conclusions of an international symposium on Phase 1 oncology trials, palliative care, and ethics held in 2014. The purpose of the symposium was to discuss the intersection of three independent trends that unfolded in the past decade. First, large-scale reviews of hundreds of Phase I trials have indicated there is a relatively low risk of serious harm and some prospect of clinical benefit that can be meaningful to patients. Second, changes in the design and analysis of Phase I trials, the introduction of "targeted" investigational agents that are generally less toxic, and an increase in Phase I trials that combine two or more agents in a novel way have changed the conduct of these trials and decreased fears and apprehensions about participation. Third, the field of palliative care in cancer has expanded greatly, offering symptom management to late-stage cancer patients, and demonstrated that it is not mutually exclusive with disease-targeted therapies or clinical research. Opportunities for collaboration and further research at the intersection of Phase 1 oncology trials and palliative care are highlighted.

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“…The current models of 'Precision Medicine' tailor medical treatments to the genomic complexity of each patient's tumour (De Mattos-Arruda and Rodon, 2013). The analysis of genomic alterations in tumour tissue biopsies aims to select and match patients for specific targeted therapies.…”

Section: Mattosmentioning

confidence: 99%

Cell‐free circulating tumour DNA as a liquid biopsy in breast cancer

2015

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Recent developments in massively parallel sequencing and digital genomic techniques support the clinical validity of cell-free circulating tumour DNA (ctDNA) as a 'liquid biopsy' in human cancer. In breast cancer, ctDNA detected in plasma can be used to non-invasively scan tumour genomes and quantify tumour burden. The applications for ctDNA in plasma include identifying actionable genomic alterations, monitoring treatment responses, unravelling therapeutic resistance, and potentially detecting disease progression before clinical and radiological confirmation. ctDNA may be used to characterise tumour heterogeneity and metastasis-specific mutations providing information to adapt the therapeutic management of patients. In this article, we review the current status of ctDNA as a 'liquid biopsy' in breast cancer.

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Pilot Studies for Personalized Cancer Medicine: Focusing on the Patient for Treatment Selection

Cited by 22 publications

References 51 publications

Translating neoadjuvant therapy into survival benefits: one size does not fit all

Translating neoadjuvant therapy into survival benefits: one size does not fit all

Phase I Cancer Trials and Palliative Care: Antagonism, Irrelevance, or Synergy?

Cell‐free circulating tumour DNA as a liquid biopsy in breast cancer

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