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Editor’s Note: FDA Response to Comments by Dr. Steven E. Vogl

In 2011, the U.S. Food and Drug Administration (FDA) convened an advisory committee that recognized metastasis-free survival as a clinically relevant endpoint for nonmetastatic prostate cancer due to shorter trial readout times and acknowledgment that a substantial delay in the transition to a...

solid tumors
prostate cancer

Should We Treat Rising PSA in Men With Castrate Androgen Levels?

In rapid succession, the SPARTAN study results were presented at the 2018 Genitourinary Cancers Symposium, the data were published in The New England Journal of Medicine,1 and the drug apalutamide -(Erleada) was approved by the U.S. Food and Drug Administration (FDA) for men with previously...

solid tumors
lung cancer
issues in oncology

Enormous Cost of Failure to Screen Heavy Smokers for Lung Nodules

In 2011 the American College of Radiology Imaging Network (ACRIN) group published its publicly funded study of three annual screening chest computed tomography (CT) scans among heavy smokers aged 55 to 74.1 The results remain the first and only screening study for any cancer demonstrating a...

solid tumors
breast cancer

Extended Duration of Aromatase Inhibitors Need Not Be Very Long

At the 2017 San Antonio Breast Cancer Symposium (SABCS), Michael Gnant, MD, FACS, of the Medical University of Vienna presented the 9-year median follow-up of a trial looking at the length of extended aromatase inhibitor therapy. At least four other recently presented or published trials have...

colorectal cancer

Duration of Adjuvant Oxaliplatin-Based Therapy for Stage III Colon Cancer

“At Microphone 1” is an occasional column written by Steven E. Vogl, MD, of the Bronx, New York. When he is not in his clinic, he can generally be found at major oncology meetings and often at the microphone, where he stands ready with critical questions for presenters of new data. The opinions...

solid tumors
breast cancer

Neratinib Is Approved: Should We Reject It Anyway?

The U.S. Food and Drug Administration (FDA) approved 1 year of extended adjuvant neratinib (Nerlynx) after chemotherapy and a year of trastuzumab (Herceptin) for HER2-positive breast cancer this summer on the basis of the ExteNET trial. Many were surprised at the approval, since the evidence of...

breast cancer

Model Emphasizes Long-Term Risks of Ovarian Ablation Plus Aromatase Inhibitor

“At Microphone 1” is an occasional column written by Steven E. Vogl, MD, of Bronx, New York. When he’s not in his clinic, Dr. Vogl can generally be found at major oncology meetings and often at the microphone, where he stands ready with critical questions for presenters of new data. Here Dr. Vogl...

solid tumors
breast cancer

Adjuvant Pertuzumab in HER2-Positive Breast Cancer: Value Yet to Be Demonstrated

The ASCO Post issue of June 25, 2017, did an excellent job of summarizing the results and controversy generated by the initial results of the APHINITY trial, reported at the 2017 ASCO Annual Meeting and published simultaneously online in The New England Journal of Medicine.1 With a median follow-up ...

issues in oncology

Duration Studies in Oncology Have Often Been Poorly Designed and Analyzed

The ASCO Post is pleased to introduce “At Microphone 1,” an occasional column written by Steven E. Vogl, MD, of Bronx, New York. When he’s not in his clinic, Dr. Vogl can generally be found at major oncology meetings, and often at the microphone where he stands ready with important questions for...

breast cancer
genomics/genetics

Genomic Landscape of Metastatic Breast Cancer Differs From That of Primary Breast Cancer

Researchers working on whole-exome and transciptome sequencing of endocrine-resistant estrogen receptor–positive metastatic breast cancer have shown that the mutational landscape differs from that of estrogen receptor–positive primary breast cancer, and these differences have the potential to...

breast cancer

Patients With Incomplete Response to Neoadjuvant Chemotherapy Benefit From Capecitabine

Treatment with capecitabine increased disease-free and overall survival in breast cancer patients with residual disease after neoadjuvant chemotherapy, according to a study reported by researchers from Japan and Korea at the 2015 San Antonio Breast Cancer Symposium.1 “It has been unclear whether...

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