REVEL Trial of Ramucirumab Plus Docetaxel For Fast Progressing NSC Lung Cancer Demonstrates Promise

MedicalResearch.com Interview with:

Martin Reck, MD, PhD Head of the Department of Thoracic Oncology Head of the Clinical Trial Department Department of Thoracic Oncology at the Lung Clinic Grosshansdorf

Dr. Reck

Martin Reck, MD, PhD
Head of the Department of Thoracic Oncology
Head of the Clinical Trial Department
Department of Thoracic Oncology at the Lung Clinic
Grosshansdorf 


MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is an urgent medical need to improve outcomes in pretreated patients with advanced non-small cell lung cancer (NSCLC), in particular those with fast progressing tumors.

The Phase 3 REVEL study, which included patients with nonsquamous and squamous forms of NSCLC, demonstrated improved overall survival (OS), progression‐free survival (PFS), and objective response rate (ORR) – independent of histology. This analysis confirmed efficacy – with improvement of ORR, PFS and OS – in poor prognosis patients with fast progressing tumors (after 9, 12 or 18 weeks) without additional toxicity or impact on Quality of Life compared to the intent-to-treat (ITT) population results of REVEL.

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Machine Learning Applied To Predicting High-Risk Breast Lesions May Reduce Unnecessary Surgeries

MedicalResearch.com Interview with:

Manisha Bahl, MD, MPH Director, Breast Imaging Fellowship Program, Massachusetts General Hospital Assistant Professor of Radiology, Harvard Medical School

Dr. Bahl

Manisha Bahl, MD, MPH
Director, Breast Imaging Fellowship Program,
Massachusetts General Hospital
Assistant Professor of Radiology,
Harvard Medical School

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Image-guided biopsies that we perform based on suspicious findings on mammography can yield one of three pathology results: cancer, high-risk, or benign. Most high-risk breast lesions are noncancerous, but surgical excision is typically recommended because some high-risk lesions can be upgraded to cancer at surgery. Currently, there are no imaging or other features that reliably allow us to distinguish between high-risk lesions that warrant surgery from those that can be safely followed, which has led to unnecessary surgery of high-risk lesions that are not associated with cancer.

We decided to apply machine learning algorithms to help us with this challenging clinical scenario: to distinguish between high-risk lesions that warrant surgery from those that can be safely followed. Machine learning allows us to incorporate the full spectrum of diverse and complex data that we have available, such as patient risk factors and imaging features, in order to predict which high-risk lesions are likely to be upgraded to cancer and, ultimately, to help our patients make more informed decisions about surgery versus surveillance.

We developed the machine learning model with almost 700 high-risk lesions, then tested it with more than 300 high-risk lesions. Instead of surgical excision of all high-risk lesions, if those categorized with the model to be at low risk for upgrade were surveilled and the remainder were excised, then 97.4% malignancies would have been diagnosed at surgery, and 30.6% of surgeries of benign lesions could have been avoided.

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ACA Medicaid Expansion Linked To Decrease in Uninsured Cancer Patients

MedicalResearch.com Interview with:

Aparna Soni, MA Department of Business Economics and Public Policy Kelley School of Business Indiana University, Bloomington

Aparna Soni

Aparna Soni, MA
Department of Business Economics and Public Policy
Kelley School of Business
Indiana University, Bloomington

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Cancer is the leading cause of death among the non-elderly population in the United States. Unfortunately, uninsured people are less likely to get screened for cancer, and treatment is often unaffordable for those who are uninsured.

One of the key objectives of the Affordable Care Act (ACA) was to improve outcomes for cancer patients. Our objective in this study was therefore to assess changes under the ACA in insurance coverage among patients newly diagnosed with cancer.

Our main finding is that uninsurance among patients with newly diagnosed cancer fell by one-third in 2014.

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ZYTIGA May Benefit Newly Diagnosed High-Risk Metastatic Prostate Cancer

MedicalResearch.com Interview with:

Craig Tendler, M.D. Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Hematology and Supportive Care Janssen Research & Development, LLC.

Dr. Tendler

Craig Tendler, M.D.
Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Hematology and Supportive Care
Janssen Research & Development, LLC. 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Janssen announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of ZYTIGA in combination with prednisone and androgen deprivation therapy (ADT) to include treatment of patients with high-risk metastatic hormone naïve prostate cancer (HNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC).

This submission is based on the pivotal Phase 3 LATITUDE trial results presented earlier this year at the plenary session of the American Society of Clinical Oncology (ASCO) Annual Meeting, which found that in patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHNPC), abiraterone acetate with prednisone in combination with androgen deprivation therapy (ADT) demonstrated a significant improvement in median overall survival (OS) and in radiographic progression-free survival (rPFS). Additional data, which were presented at the 2017 European Society for Medical Oncology (ESMO) Annual Conference, demonstrated clinically meaningful and statistically significant improvements in patient reported outcomes (PRO) in patients with high-risk mHNPC who received ZYTIGA in combination with prednisone and ADT compared to placebo plus ADT alone.
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Transplant Network Undercaptures Post-Transplant Skin Cancers

MedicalResearch.com Interview with:

Thuzar M.Shin MD, PhD Assistant Professor of Dermatology Hospital of the University of Pennsylvania

Dr. Shin

Thuzar M.Shin MD, PhD
Assistant Professor of Dermatology
Hospital of the University of Pennsylvania

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The Organ Procurement Transplant Network (OPTN) collects data on cancers that develop after organ transplantation. Previous studies have shown incomplete reporting to the OPTN for many cancers (including melanoma). Skin cancer is the most common malignancy in solid organ transplant recipients and the most common post-transplant skin cancer, cutaneous squamous cell carcinoma (cSCC), is not captured in standard cancer registries. We hypothesized that cSCC and melanoma are underreported to the OPTN. When compared to detailed medical record review obtained from the Transplant Skin Cancer Network database (JAMA Dermatol. 2017 Mar 1;153(3):296-303), we found that the sensitivity of reporting to the OPTN was only 41% for cSCC and 22% for melanoma. The specificity (99% for cSCC and 100% for melanoma) and negative predictive values (93% for cSCC and 99% for melanoma) were high. As a result, the OPTN database is unable to robustly and reliably distinguish between organ transplant recipients with and without these two skin malignancies.

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40% of Cancers Associated With Overweight and Obesity

MedicalResearch.com Interview with:
Dr. C. Brooke Steele D.O.

Division of Cancer Prevention and Control
Centers fo Disease Control and Prevention 

MedicalResearch.com: What is the background for this study?

Response: This report contains new information about cancer risk and people being overweight and obese. Research shows that being overweight or having obesity is associated with at least 13 types of cancer (adenocarcinoma of the esophagus; cancers of the breast [in postmenopausal women], colon and rectum, endometrium, gallbladder, gastric cardia, kidney, liver, ovaries, pancreas, and thyroid; meningioma; and multiple myeloma). We also know that the number of people who weigh more than recommended has increased over the past few decades. Therefore, we looked at the numbers of new cases of cancers associated with overweight and having obesity in the United States, as well as how the rates have changed over a 10-year period. Because screening for colorectal cancer can reduce colorectal cancer incidence through detection and removal of precancerous polyps before they become cancerous, we analyzed trends with and without colorectal cancer.

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Surgical Delays For Melanoma Patients Are Common

MedicalResearch.com Interview with:
Adewole Adamson, MD, MPP
Department of Dermatology
UNC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Surgery is the primary intervention for the treatment of melanoma. Little is known about how delays for surgery, defined as the time between diagnosis and surgical treatment, among melanoma patient differ by insurance type. After adjustment of patient-level, provider-level, and tumor-level factors we found that Medicaid patients experience a 36% increased risk of delays in surgery for melanoma. These delays were 19% less likely in patients diagnosed and 18% less likely in patients surgically treated by dermatologists. Non-white patients also had a 38% increased risk of delays.

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Circulating Tumor Cells Linked To Poor Prognosis in Early Stage Lung Cancers

MedicalResearch.com Interview with:

Dr. Sunitha Nagrath, PhD Associate Professor, Chemical Engineering University of Michigan

Dr. Nagrath

Dr. Sunitha Nagrath, PhD
Associate Professor, Chemical Engineering
University of Michigan 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Lung cancer is leading cause of cancer-related mortality, and detecting it in earlier stages is crucial to improving outcomes for patients. The motivation for this study lies in understanding the phenotypic and genetic make-up of lung cancer during its early stages, using a blood sample (blood biopsy). We have done this by employing a microfluidic device to capture cancer cells circulating in the blood that is obtained from the peripheral veins and the pulmonary vein (a vein next to the tumor itself) from patients with early stage lung cancers. The idea behind using blood from the pulmonary vein was to obtain a richer yield of these circulating tumor cells, which are rare in the blood.

Through this study, we found that the pulmonary vein does yield a much higher quantity of circulating tumor cells, and also often harbors these cells in large clusters. We further went on to study the significance of these clusters, and found that these clusters indicated aggressive traits such as resistance to treatment, and could also potentially suggest poorer patient outcomes at long term.

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Lymph Node Staging of Potentially Curable Lung Cancer Needs Improvement

MedicalResearch.com Interview with:

Raymond U. Osarogiagbon, MBBS, FACP Translational Lung Cancer Research Multidisciplinary Thoracic Oncology Program Baptist Centers for Cancer Care Memphis, TN

Dr. Osarogiagbon

Raymond U. Osarogiagbon, MBBS, FACP
Translational Lung Cancer Research
Multidisciplinary Thoracic Oncology Program
Baptist Centers for Cancer Care
Memphis, TN 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Most long-term survivors of lung cancer are among the patients who were fortunate enough to be identified early enough to undergo curative-intent surgery. In the US, 60,000 individuals undergo curative-intent surgery for lung cancer every year. This number is likely to increase over the next few years as lung cancer screening becomes more widely adopted. Unfortunately, fewer than 50% of patients who undergo curative-intent surgery actually survive up to 5 years.

We show that the quality of surgery, especially the quality of pathologic nodal staging is a powerful driver of survival differences between groups of patients. In general, pathologic nodal staging (important as it is stratifying patients into risk groups so those at high risk can be offered additional treatments to increase the chances of cure while those at truly low risk can be left alone without exposure to cost and side-effects of additional treatments) is very poorly done. We show how the percentage of patients whose pathologic staging met sequentially more stringently-define thoroughness of staging metrics falls off sharply, while the survival sequentially increases.

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Radiation Therapy Plus Checkpoint Inhibitors Did Not Increase Adverse Events in Metastatic Lung Cancer

MedicalResearch.com Interview with:

Florence K Keane MD Resident, Radiation Oncology Harvard Radiation Oncology Program Boston, Massachusetts

Dr. Keane

Florence K Keane MD
Resident, Radiation Oncology
Harvard Radiation Oncology Program
Boston, Massachusetts

MedicalResearch.com: What is the background for this study?

Response: Checkpoint inhibitors (CPIs) have recently transformed the management of patients with metastatic lung cancer, demonstrating significant improvements in overall and progression-free survival in both the first-line setting in patients with increased expression of PD-L1 (≥50%) and in patients with previously treated NSCLC who have progressed on chemotherapy. CPIs are also moving into the treatment of patients with localized lung cancer, with the recently published PACIFIC trial demonstrating a significant improvement in progression-free survival in patients with inoperable stage III NSCLC treated with adjuvant durvalumab after definitive chemoradiotherapy.

However, CPIs are associated with unique toxicities as compared to cytotoxic chemotherapy, including pulmonary, endocrine, neurologic, gastrointestinal, and dermatologic adverse events, which may be fatal in some cases. The risk of autoimmune pneumonitis with checkpoint inhibitors is estimated to be on the order of 5%. Many patients with lung cancer will require radiotherapy for palliation of symptoms. Thoracic radiotherapy (TRT) is also a risk factor for pneumonitis, with a dose- and volume-dependent impact on risk. However, it is unknown whether treatment with CPIs and TRT is associated with increased risk of toxicity.

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