Andrew D. Smith

Clinical trials demand extreme rigor. A mistake in trial design, like a bookkeeping error, can lead regulators to reject a potentially valuable drug. Many researchers dislike this intense focus on dotting i’s and crossing t’s. Omid Hamid, MD, enjoys the challenge.

Lynette M. Sholl, MD, discusses why cancer pathologists still want better tissue samples.

Jorge E. Cortes, MD, has been an investigative leader for nearly 30 years in the development of numerous leukemia treatments.

Nearly 15 years have passed since pathologists at Memorial Sloan Kettering Cancer Center conducted gene expression analyses on breast cancer primary tumors and described a potential role for a novel target, which quickly became a major research focus for their colleague Tiffany A. Traina, MD.

Kenneth C. Anderson, MD, discusses key trials in multiple myeloma that have reported promising findings or are poised to shed light on novel treatments.

Jeffrey S. Weber, MD, PhD, looks to earlier use of immunotherapy and novel combinations in melanoma.

Rapid advancements are dramatically changing the lung cancer treatment landscape, creating challenges across the spectrum of care.

Emboldened by strong evidence investigators are growing confident that localized therapy in oligometastatic disease across cancers may soon lead to a new staging system and become standard of care.

In the past 5 years, the FDA has awarded 4 drugs 9 new indications for the treatment of advanced ovarian cancers. Although these approvals represent a welcome expansion of the therapeutic toolkit for this challenging malignancy, the arrival of new options has outpaced efforts to discover the best use for each medication.

Although research findings have established many applications for genetic information in breast cancer, not enough patients are being tested for the risk of germline mutations and new strategies are needed to broaden the clinical application of genomic advancements.

Although there has been significant progress in the field of geriatric oncology, experts say there is still a pressing need to increase clinical trial participation by older patients and to improve the predictive value of assessment tools.

The search for effective alternatives to radical cystectomy (RC) in patients with bladder cancer has lasted more than 3 decades. Progress has been slow, but investigators have proved that a combination of radiation, chemotherapy, and maximal transurethral resection of the bladder tumor works as well as RC in carefully selected patients.

The Tice strain of BCG has emerged as a go-to drug for treating primary and recurrent bladder cancer, but in the United States and some other countries, a constellation of marketplace dynamics has reduced manufacturers of this agent to a sole producer that is unable to keep up with demand. Available supplies are being rationed, and sufficient expansion of supply could be years away.

Now that the FDA has carved out nonmetastatic, castration-resistant prostate cancer as a new disease state, the decision about whether to administer recently approved antiandrogen therapies in this setting hinges on the rate of increase in prostate-specific antigen levels and comorbidities.

Although the first checkpoint inhibitor has just been approved for patients with breast cancer, findings from dozens of ongoing studies may eventually change the paradigm for large subsets of those with the malignancy.

The development of cancer treatments and diagnostic tools using CRISPR/Cas9 and other gene-editing technology is a promising area of research in the United States, although the field is moving into human studies at a relatively slow pace.

Although the need for biomarkers of immunotherapy response has generated much attention, investigators also are pursuing mechanisms for distinguishing which patients will experience adverse effects from these therapies.

A policy change that allows step therapy provisions in Medicare Advantage insurance plans is setting off alarm bells among oncology leaders, who have joined medical associations from across the country in objecting to the revision.

The battle over 340B continues in Congress, with multiple legislative initiatives.

Like clinicians elsewhere, investigators from the University of Colorado, Denver, struggled not only to predict the likelihood that a particular patient would do well with surgery alone but also to convey their estimates in terms that patients would understand.

Tumor-treating field therapy, which uses low-intensity electrical fields to disrupt cancer cell division and promote cell death, has gained a frontline approval in glioblastoma. Several pivotal clinical trials have been launched to determine whether the technology can help patients with other solid tumors.

Benchmarking has historically been difficult in oncology because of barriers to the flow of information and the complexities of care. However, such performance comparisons are now becoming a part of payment models, and practices realize they need comparative data to understand how well they perform.

The National Comprehensive Cancer Network has developed its first set of recommendations to help clinicians manage toxicities in the recognition of the variety of immune-related adverse events that patients receiving checkpoint blockade immunotherapy may experience.

More than a third of the new indications for oncology drugs that became available for patient care during the past 25 years entered clinical practice as a result of the FDA’s accelerated approval program.

The NCCN guideline committee has designated a direct oral anticoagulant as a preferred frontline treatment for most patients with cancer-associated venous thromboembolism.

Although much remains unknown about many mutations and test results rarely clarify the need for any particular response, panel testing has already demonstrated its cost value, which continues to increase every day.

A pair of trials that used checkpoint inhibitors as monotherapy reported lackluster overall response rates in breast cancer.

Sir Murray F. Brennan, MD, made his reputation—and saved many lives—by pioneering the use of rigorous empirical analysis to evaluate alternative strategies and optimize outcomes in surgical oncology.

The gene-editing tool known as CRISPR may eventually enable oncology investigators to create methods for killing tumors directly, but thus far, the focus is on enhancing forms of immunotherapy already in clinical practice.

Most patients who appear to progress after they begin receiving anticancer immunotherapy will never exhibit a response to therapy.