Radiotherapy in the Management of Metastatic Hormone-Sensitive Prostate Cancer: What Is the Standard of Care?
Systemic therapy has historically been the backbone of treatment for patients with metastatic disease. However, recent evidence suggests metastasis-directed therapy in those with oligometastatic disease (≤5 lesions) may improve progression-free and overall survival. Within prostate cancer–specific cohorts, metastasis-directed therapy also appears to delay the time to initiation of androgen deprivation therapy while also generally being associated with a mild toxicity profile and has thus garnered interest as a means to delay systemic therapy. Here we review the evidence surrounding the use of radiation therapy to ...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Treatment of Primary in Metastatic Prostate Cancer: What Is the Standard of Care?
Until recently, men with metastatic prostate cancer were commenced on androgen deprivation therapy at diagnosis, followed by sequential lines of treatment with the development of castration resistance. However, the results of recent clinical trials, which revealed that the addition of radiotherapy to the prostate to a dose of 55 to 60 Gy in 20 fractions over 4 weeks in patients with low-volume metastatic hormone-sensitive prostate cancer, in addition to androgen deprivation therapy and another systemic treatment option, either docetaxel, abiraterone, enzalutamide, or apalutamide, has led to a paradigm change in the managem...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Factors to Guide Treatment Selection for Hormone-Sensitive Metastatic Prostate Cancer
For decades, the mainstay of treatment for metastatic hormone-sensitive prostate cancer has been androgen deprivation therapy. In recent years, 4 systemic therapies—docetaxel, abiraterone, enzalutamide, and apalutamide—have improved overall survival for men with metastatic hormone-sensitive prostate cancer when combined with androgen deprivation therapy, raising the question of which treatment to choose. The role for metastasis-directed therapy with surgery or radiation among these new treatments has also yet to be defined. Thus, several factors have come into play to guide treatment selection, including diseas...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Metastatic Hormone-Sensitive Prostate Cancer: A Review of the Current Treatment Landscape
We describe an overview of the trials that investigated docetaxel (CHAARTED and STAMPEDE-Docetaxel), abiraterone (LATTITUDE and STAMPEDE-Abiraterone), enzalutamide (ARCHES, ENZAMET), apalutamide (TITAN), and radiation to the primary (STAMPEDE-Radiation). Discussion The treatment of mHSPC is a complex topic, and treatment choice should be individualized. Patient preferences, cost, volume of disease, and side effect profiles are important in determining which option is the best for an individual patient. (Source: The Cancer Journal)
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Pathologically Node-Positive Prostate Cancer: Casting for Cure When the Die Is Cast?
The postoperative management of men with lymph node involved prostate cancer (pN+) remains a challenge as there is a general lack of randomized trial data and a range of management strategies. Retrospective studies suggest a variable clinic course for patients with pN+ prostate cancer. Some men progress rapidly to metastatic disease despite further therapies, whereas other men can have a period of prolonged quiescence without adjuvant androgen deprivation therapy (ADT) or radiation therapy (RT). For men who have undergone radical prostatectomy, randomized trial data indicate that the addition of ADT in pN+ disease extends ...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Clinically Lymph Node Positive Prostate Cancer: At the Intersection of Focal and Systemic Disease Control
Clinically node-positive prostate cancer is often found at the time of diagnosis by cross-sectional imaging and remains poorly understood. Advanced imaging modalities such as magnetic resonance imaging nanoparticles or positron emission tomography–based molecular imaging stand to rapidly change the field and hopefully will bring better diagnostic clarity. This will allow for prospective clinical trials using radiographic, clinical, or molecular parameters to establish who may benefit from both localized and systemic treatment intensification and who may avoid overtreatment. Recent advances in metastatic hormone-sensi...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Surrogate Endpoints in Localized Prostate Cancer
Randomized clinical trials assessing novel therapies in men with localized prostate cancer frequently require large patient numbers and more than a decade of follow-up to demonstrate improvements in overall survival. As the landscape of treatment options for prostate cancer is rapidly changing, clinical trials requiring long follow-up threaten to impede treatment improvements and run the risk of results being obsolete by the time that they are reported in publication. To address these issues, there has been tremendous interest in identifying an intermediate clinical endpoint that can be assessed earlier in the disease cour...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Molecular Imaging of Newly Diagnosed Prostate Cancer
Positron emission tomography (PET) is a valuable imaging in evaluating many malignancies. There are various molecular imaging tracers that are currently being utilized with prostate cancer (PC). Several PET agents imaging different molecular processes in PC have reached the clinic. While all of these agents have demonstrated an advantage over conventional imaging, there are considerable differences in the performance of each in staging newly diagnosed PC. In this article, we review the current updates available of different PET tracers, with a strong focus on the emerging role of prostate-specific membrane antigen PET in t...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Original Article Source Type: research

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer
Stereotactic ablative radiotherapy (SABR) is a relatively novel form of high precision radiotherapy. For low- and intermediate risk patients, ultrahypofractionation (UHF - more than 5 Gy per day) has been compared to conventionally fractionated or moderately hypofractionated radiotherapy in two large randomized studies. A third smaller randomized study examined the question of the optimal frequency of treatments. The results of these studies will be reviewed. SABR for high risk prostate cancer has been shown to be feasible and is well tolerated with careful planning and setup techniques. However, there is currently insuffi...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Comparing Radiotherapy to Prostatectomy for High-Risk Prostate Cancer: A Narrative Review of Mortality and Quality-of-Life Outcomes
We present here an outline of efforts to date to understand the implications of treatment on functional outcomes and quality-of-life endpoints. (Source: The Cancer Journal)
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Next Generation of Androgen Deprivation Therapy Combined With Radiotherapy for N0 M0 Prostate Cancer
Androgen deprivation therapy in combination with definitive radiation therapy is a standard of care for both intermediate-/high-risk localized prostate, locally advanced prostate cancer. Newer hormonal therapies have shown promising results in patients with castration-resistant disease and are now being investigated in early stages, in combination with radiation therapy. In this section, we review the body of evidence elucidating the mechanism of synergy and immune modulation effect of androgen deprivation therapy and radiation therapy, summarize the pivotal studies supporting its use in the nonmetastatic setting, and pres...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Genomic Strategies to Personalize Use of Androgen Deprivation Therapy With Radiotherapy
The use of combination RT and androgen deprivation therapy in many prostate cancer curative-intent treatment scenarios is supported by level 1 evidence. However, in our current clinical paradigm, we have no ability to determine a priori which patients truly benefit from combination therapy and therefore apply the combination RT and androgen deprivation therapy intensification strategy to all patients, which results in overtreatment or undertreatment of the majority of our patients. Genomics has the ability to more deeply and objectively characterize the disease, in turn refining our prognostication capabilities and enablin...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Neoadjuvant Approaches Prior To Radical Prostatectomy
Patients with high-risk localized prostate cancer benefit from multimodality therapy of curative intent. Androgen-deprivation therapy (ADT) combined with radiation improves survival in this population. However, prior clinical trials of neoadjuvant ADT and surgery failed to consistently demonstrate a survival advantage. The development of novel, more potent hormonal agents presents an opportunity to revisit the potential for neoadjuvant therapy to improve long-term outcomes for patients with localized prostate cancer. We review recent advances in neoadjuvant approaches for prostate cancer and emerging clinical trials data s...
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Introduction by the Guest Editor: The Rapidly Evolving Treatment Landscape of Prostate Cancer—The Convergence of Treatment Paradigms of Localized and Metastatic Diseases
No abstract available (Source: The Cancer Journal)
Source: The Cancer Journal - January 1, 2020 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Targeted Therapies in Chronic Lymphocytic Leukemia: Is 2 (or 3) Better Than 1?
Small molecule inhibitors, including B-cell receptor antagonists and B-cell lymphoma - 2 inhibitors, have revolutionized the treatment of chronic lymphocytic leukemia (CLL). These agents have improved outcomes for patients of all prognostic backgrounds, thus securing their role in the frontline setting. Impressive activity has been demonstrated both with monotherapy and in combination with other targeted therapeutics. The most important remaining question is whether to administer small molecule inhibitors in a sequential fashion or in combination with each other and/or anti-CD20–directed therapy. Together, a number o...
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Real-World Evidence for Chronic Lymphocytic Leukemia in the Era of Targeted Therapies
The landscape of chronic lymphocytic leukemia has transformed in the era of small molecule inhibitor targeted therapies. While randomized controlled trials remain the criterion standard in evaluating new therapies, they are often unable to keep pace with the clinical questions that arise during the use of novel agents. Real-world evidence is generated through analysis of data such as electronic medical records, payer claims, and patient registry databases and can provide invaluable information to supplement randomized controlled trials, such as outcomes in patient populations excluded from clinical trials, rates of discont...
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Chimeric Antigen Receptor T Cells in Chronic Lymphocytic Leukemia: Are We Any Closer to a Cure?
Recent advances in the treatment of chronic lymphocytic leukemia (CLL) have dramatically changed outcomes for patients. Despite these improvements, CLL is still considered incurable. Chimeric antigen receptor–modified T cells have demonstrated the ability to produce long-term remissions in subsets of heavily pretreated patients with B-cell malignancies, including CLL. Unfortunately, the majority of patients with CLL do not attain durable responses. Recent studies have focused on understanding the mechanisms and predictors of response in these patients. In this review, we will discuss the literature for chimeric antig...
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Resistance Mechanisms to Targeted Agents in Chronic Lymphocytic Leukemia
Agents that specifically target pathologic mechanisms of survival have now been approved for the treatment of chronic lymphocytic leukemia in both the treatment-naive and relapsed/refractory settings. These 4 agents include the Bruton tyrosine kinase inhibitor ibrutinib, the B-cell leukemia/lymphoma-2 inhibitor venetoclax, and the phosphatidylinositol-3 kinase inhibitors idelalisib and duvelisib. Although clinical outcomes are improved with all of these inhibitors, acquired resistance does occur and leads to progression of disease. Resistance to targeted therapy can occur through direct mutations of the target or through t...
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Cost-effectiveness of New Targeted Agents in the Treatment of Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) is the most common adult leukemia and is clinically heterogeneous. Integration of oral targeted therapies (OTTs) in the management of CLL has fundamentally altered CLL treatment pathways and improved outcomes for patients with CLL. We review the cost-effectiveness of OTTs in the treatment of CLL. We used MeSH (Medical Subject Heading) terms and keywords to search the National Library of Medicine online MEDLINE database (PubMed) for articles related to cost-effectiveness of OTTs in CLL care. Oral targeted therapies add considerable expense to the treatment of CLL for patients and the hea...
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Relevance of Minimal Residual Disease in the Era of Targeted Agents
The evaluation of minimal residual disease (MRD) in chronic lymphocytic leukemia (CLL) has evolved in parallel with the enormous progresses in the therapeutic armamentarium and the application of cutting-edge diagnostic techniques the CLL community witnessed in the past few years. Minimal residual disease is considered an objective measure of disease status defined by the number of residual leukemic cells detected in a sample of peripheral blood and/or bone marrow as proportion of the total white blood cells and defined undetectable if fewer than 1 CLL cell among 10,000 white blood cells (10−4 or 0.01%) is detected. ...
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

BCL-2 Inhibitors, Present and Future
The members of the B-cell leukemia/lymphoma-2 (BCL-2) family of proteins are key regulators of the intrinsic apoptotic pathway; dysregulation of this pathway leads to pathologic survival of cancer cells. B-cell leukemia/lymphoma-2 had long been viewed as a promising target for the treatment of several hematologic malignancies, specifically chronic lymphocytic leukemia (CLL), yet for many years the development of a drug to successfully target this protein remained elusive. The approval of the BCL-2 inhibitor venetoclax for relapsed/refractory del(17p) CLL in 2016 represented the culmination of decades of molecular and clini...
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Phosphatidylinositol 3 Kinase δ Inhibitors: Present and Future
This article reviews the clinical data on efficacy and toxicity across the class and discusses ongoing efforts to understand and mitigate the likely on-target autoimmune toxicity. (Source: The Cancer Journal)
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Bruton Tyrosine Kinase Inhibitors: Present and Future
Bruton tyrosine kinase (BTK) is a nonreceptor tyrosine kinase that plays a central role in the signal transduction of the B-cell antigen receptor and other cell surface receptors, both in normal and malignant B lymphocytes. B-cell antigen receptor signaling is activated in secondary lymphatic organs and drives the proliferation of malignant B cells, including chronic lymphocytic leukemia (CLL) cells. During the last 10 years, BTK inhibitors (BTKis) are increasingly replacing chemotherapy-based regimen, especially in patients with CLL and mantle cell lymphoma (MCL). Bruton tyrosine kinase inhibitors are particularly active ...
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Targeted Therapy in Chronic Lymphocytic Leukemia
Despite a prevailing view that advances in cancer therapy will come through selective targeting of enzymes encoded by mutated oncogenes responsible for the neoplastic phenotype, recent advances in the treatment of patients with chronic lymphocytic leukemia (CLL) have instead exploited knowledge of its biology. Indeed, CLL cells depend on interactions with cells and soluble factors present in the tumor microenvironment for proliferation and survival. B-cell receptor signaling and chemokine-receptor signaling play prominent roles. Elucidation of these signaling pathways has defined physiologic targets for drugs, such as ibru...
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

The Shifting Paradigm in Chronic Lymphocytic Leukemia: Is Chemotherapy Still Relevant?
Chemoimmunotherapy (CIT) was the standard treatment for patients with chronic lymphocytic leukemia for the last 2 decades. Recently, with the introduction of targeted therapies, the role of CIT has declined significantly. In the first-line setting, the role of CIT is limited to young fit patients with mutated immunoglobulin heavy chain variable region and without del(17p)/TP53 mutation. There is a limited role for CIT in relapsed chronic lymphocytic leukemia. (Source: The Cancer Journal)
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Introduction by the Guest Editor: Staying Ahead of the Rapidly Evolving World of Chronic Lymphocytic Leukemia
No abstract available (Source: The Cancer Journal)
Source: The Cancer Journal - November 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Evaluation of Traditional Chinese Medicine Herbs in Oncology Clinical Trials
Despite wide empirical use and demand for traditional Chinese medicine (TCM) herbs worldwide, high-quality clinical trials of TCM herbs in oncology are limited. We developed recommendations for rigorous clinical trials to evaluate their safety and efficacy for oncology patients. To accomplish this goal, the TCM & Cancer Research Committee of the Chinese Pharmaceutical Association convened a working group of oncologists, TCM experts, clinical researchers, biostatisticians, and industry/government representatives to develop principles and approaches for TCM cancer drug clinical trials. They identified 2 categories of her...
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Practical Application of “About Herbs” Website: Herbs and Dietary Supplement Use in Oncology Settings
The Integrative Medicine Service at Memorial Sloan Kettering Cancer Center developed and maintains About Herbs (www.aboutherbs.com), which provides summaries of research data including purported uses, adverse effects, and herb-drug interactions for about 284 dietary supplements. Using Google Analytics, we found the website registered more than 26,317,000 hits since November 2002. The 10 most searched-for herbs/supplements of 2018 are chaga mushroom, turmeric, ashwagandha, reishi mushroom, graviola, Active Hexose-Correlated Compound, boswellia, dandelion, green tea, and Coriolus versicolor. Here we discuss their safety, her...
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Integrative Therapies for Cancer-Related Fatigue
Cancer-related fatigue (CRF) is a common symptom for which cancer patients often use integrative and integrative therapies; however, evidence supporting these therapies is limited. The aim of this review is to provide evidence-based recommendations for integrative interventions during and after cancer treatment for CRF. These recommendations are based on a systematic literature review from 1990 through 2019. Cognitive behavior therapy plus hypnosis and American ginseng can be considered during active treatment, and acupressure, mindfulness-based cognitive therapy, and qigong/tai chi easy can be considered during posttreatm...
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Integrative Medicine Therapies for Pain Management in Cancer Patients
Pain management for cancer patients should include pharmacologic and nonpharmacologic interventions. Integrative medicine therapies, such as mind-body practice, acupuncture, massage therapy, and music therapy, have been studied for their roles in pain management. Data from randomized controlled trials support the effect of hypnosis, acupuncture, and music therapy in reduction of pain. Mindfulness meditation, yoga, qigong, and massage therapy, although may not reduce pain per se, can relieve anxiety and mood changes, which are commonly associated with pain. In clinical practice, one should also consider burdens and risks to...
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Integrative Approaches for Sleep Health in Cancer Survivors
Sleep disturbance and insomnia are prevalent problems for the more than 15 million cancer survivors in the United States. If not addressed, poor-quality sleep can negatively impact physical and psychological recovery from cancer diagnosis and treatment. Cancer survivors are increasingly turning to integrative therapies to improve sleep and optimize their health. The purpose of this article is to review the evidence for the use of nonpharmacological integrative therapies to improve sleep health in cancer patients. Therapies are grouped into the following categories: cognitive-behavioral, meditative (e.g., mindfulness-based ...
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Integrative Approaches to Stress Management
This narrative review provides an overview of the scope of psychosocial distress and stress in cancer patients and survivors and the potential negative consequences of untreated symptoms. Evidence-based interventions to treat these symptoms are reviewed, beginning with a summary of published clinical practice guidelines, followed by more detailed reviews of the specific integrative interventions with the largest empirical support: cognitive-behavioral stress management, yoga, mindfulness-based interventions, and massage. We also comment on use of natural health products because of their popularity. Finally, we conclude wit...
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Helping Patients Eat Better During and Beyond Cancer Treatment: Continued Nutrition Management Throughout Care to Address Diet, Malnutrition, and Obesity in Cancer
This article presents an overview of recommendations and guidelines for nutrition and weight management and provides recent examples of behavioral theory-based targeted lifestyle interventions designed to increase adherence to recommendation by cancer patients and survivors. (Source: The Cancer Journal)
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions
Physical activity provides numerous health benefits for cancer survivors. This review provides a summary of the evidence supporting the efficacy of physical activity to improve patient-reported and physiological outcomes during and after cancer therapy, discusses observational studies that have reported associations of physical activity with cancer outcomes and prognosis, summarizes ongoing phase III randomized trials of physical activity with clinical disease endpoints in cancer survivors, describes randomized trials of physical activity that have examined biomarkers hypothesized to relate to cancer outcomes and prognosis...
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Patient-Reported Outcomes in Integrative Oncology: Bridging Clinical Care With Research
There is growing interest in the value of routine collection and monitoring of patient-reported outcomes as part of high-quality, patient-centered, oncology care. Integrative oncology, with its focus on providing symptom and lifestyle support for patients throughout the cancer care continuum, serves a diverse patient population with a complex, changing symptom burden. Monitoring of patient-reported outcomes can contribute significantly to the successful comprehensive evaluation and management of patients receiving integrative oncology care. Data collected as part of an integrative oncology evaluation can also support real-...
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Managing Patient Expectations: Integrative, Not Alternative
Expectations and beliefs about complementary and integrative medicine are the main predictors of its use in cancer patients. These expectations are rarely informed by consultation with a health care provider but are, rather, a result of family endorsement and information from nonmedical sources. As a rising number of cancer patients pursue integrative medicine, it is of increasing importance that health care providers understand their patients' expectations and motivations. These can range from symptom management to unrealistic hopes for cure. Complementary and integrative medicine can be used to complement criterion-stand...
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Introduction
No abstract available (Source: The Cancer Journal)
Source: The Cancer Journal - September 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Errors in Genetic Testing: The Fourth Case Series
Discussion As genetic testing continues to become more common and complex, it is clear that we must ensure that appropriate testing is ordered and that results are interpreted and used correctly. Access to certified genetic counselors continues to be an issue for some because of workforce limitations. Potential solutions involve action on multiple fronts: new genetic counseling delivery models, expanding the genetic counseling workforce, improving genetics and genomics education of nongenetics health care professionals, addressing health care policy barriers, and more. Genetic counselors have also positioned themselves i...
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Original Articles Source Type: research

Future Approaches to Precision Oncology–Based Clinical Trials
The last 2 decades have seen a rapid advance of the precision oncology paradigm—from its early singular successes to becoming the prevailing model of cancer therapy. As the treatment of cancer moves away from traditional chemotherapy, so too will oncology clinical trials have to move away from the traditional model of phase I to phase III progression of drug development. Achieving this goal of individualized care will involve a concerted effort by the entire cancer care community to fundamentally change the design and implementation of oncology clinical trials. We envision that the next 2 decades will be a period of ...
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Defining, Identifying, and Understanding “Exceptional Responders” in Oncology Using the Tools of Precision Medicine
Widely available molecular profiling technology, including next-generation sequencing has changed the landscape of drug development in cancer. An increasing number of clinical trials in early drug development require patient selection based on molecular alterations. Concurrently, efforts to identify molecular alterations in tumors that exhibited exceptional response after systemic treatment with standard or investigational agents have been published or are in progress. These discoveries may ultimately serve as predictive markers or “actionable mutations” for future therapies. To test the feasibility of collecti...
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Precision Cancer Trials With Immunomodulatory Agents: Personalizing Histology Agnostic Approaches
We present a review and discussion of the progress in biomarker-defined approaches to drug development in immunology. (Source: The Cancer Journal)
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Basket Trials and the MD Anderson Precision Medicine Clinical Trials Platform
Precision medicine incorporates information regarding tumor biology involved in patients' carcinogenesis and individualized treatment of patients using drugs that inhibit the molecular basis of their disease. Implementation of precision medicine accelerated the drug approval process, translating discoveries in basic science and biotechnology into patient care. Clinical trials with innovative or adaptive design including “basket” and “umbrella” trials explore personalized therapies against in selected tumor types and/or across tumor types. In 2007, we started the Initiative for Molecular Profiling an...
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

National Cancer Institute Basket/Umbrella Clinical Trials: MATCH, LungMAP, and Beyond
This article describes these trials, ALCHEMIST, LungMAP, NCI/NRG ALK Trial, MPACT, NCI-MATCH, and pediatric MATCH, and their contributions to the area of precision medicine. (Source: The Cancer Journal)
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Clinical Applications of Next-Generation Sequencing in Precision Oncology
The ability of next-generation sequencing (NGS) to comprehensively assess the molecular profile of a tumor specimen has transformed the clinical testing landscape in oncology. Accordingly, recent years have seen broad uptake of clinical NGS to inform cancer patient management. However, significant challenges remain. The annotation and clinical interpretation of variants identified by NGS tests often require rigorous review and may vary between laboratories. While a clearer regulatory path has emerged, reimbursement for NGS tests remains a subject of continuing debate. Basket clinical studies such as the National Cancer Ins...
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Biostatistical and Logistical Considerations in the Development of Basket and Umbrella Clinical Trials
Oncology clinical trials are undergoing transformation to evaluate targeted therapies addressing a wider variety of biologically defined cancer subgroups. Multiarm basket and umbrella trials conducted under master protocols have become more prominent mechanisms for the clinical evaluation of promising new biologically driven anticancer therapies that are integral to precision oncology medicine. These new trial designs permit efficient clinical evaluation of multiple therapies in a variety of histologically and biologically defined cancers. These complex trials require extensive planning and attention to many factors, inclu...
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

From the Broad Phase II Trial to Precision Oncology: A Perspective on the Origins of Basket and Umbrella Clinical Trial Designs in Cancer Drug Development
Oncologic phase II trials that evaluate the activity of new therapeutic agents have evolved dramatically over the past 50 years. The standard approach beginning in the late 1960s focused on individual studies that evaluated new anticancer agents against a wide range of both solid and hematopoietic malignancies often in a single “broad phase II trial” that included hundreds of patients; such studies efficiently established the landscape for subsequent development of a specific drug with respect to likely disease focus, toxicity, dose, and schedule. In the 1980s and 1990s, emphasis on histological context drove a...
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Introduction by the Guest Editor: Oncologic Precision Medicine and the Use of Basket and Umbrella Clinical Trials
No abstract available (Source: The Cancer Journal)
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Review Articles Source Type: research

Glycemic Variation and Cancer Occurrence—A New Paradigm
No abstract available (Source: The Cancer Journal)
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Original Articles Source Type: research

Visit-to-Visit Hemoglobin A1c Variability Is Associated With Later Cancer Development in Patients With Diabetes Mellitus
Conclusions These results demonstrated that visit-to-visit HbA1c variability is a potential risk factor for later tumorigenesis. The association may be mediated by oxidative stress or hormone variability. Routine cancer screening may be suggested for diabetic patients with unstable glycemic control. (Source: The Cancer Journal)
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Original Articles Source Type: research

Adverse Events in Genetic Testing: The Fourth Case Series
Discussion As genetic testing continues to become more common and complex, it is clear that we must ensure that appropriate testing is ordered and that results are interpreted and used correctly. Access to certified genetic counselors continues to be an issue for some because of workforce limitations. Potential solutions involve action on multiple fronts: new genetic counseling delivery models, expanding the genetic counseling workforce, improving genetics and genomics education of nongenetics health care professionals, addressing health care policy barriers, and more. Genetic counselors have also positioned themselves i...
Source: The Cancer Journal - July 1, 2019 Category: Cancer & Oncology Tags: Original Articles Source Type: research