ONCOLOGY Vol 34 Issue 10

Barriers to Clinical Trial Enrollment in Patients With Pancreatic Adenocarcinoma Eligible for Early-Phase Clinical Trials

October 14, 2020

Original Research

ABSTRACT BACKGROUND: Early-phase clinical trials are critical to the advancement of cancer care, especially in patients with pancreatic ductal adenocarcinoma, given its aggressive nature and limited available therapeutic options. METHODS: A retrospective chart review of all patients with refractory or metastatic pancreatic ductal adenocarcinoma, referred to the Sarah Cannon Research Institute at HealthONE between 2014 and 2019, were reviewed. Patients who completed genomic profiling and qualified for a phase 1 trial (primarily 1a but some 1b) were identified to assess barriers to trial enrollment. RESULTS: Of 74 identified patients, 54 patients (73%) qualified for at least 1 clinical trial based on eligibility criteria and alterations detected via molecular profiling. Up to 40 industry-sponsored clinical trials were available during this time for consideration. Of the 54, 28 patients (52%) enrolled in a clinical trial, while 26 (48%) did not enroll. The most frequently cited barriers to enrollment were concerns regarding time commitment (12%), prolonged wait time for enrollment (12%), and fear of adverse events (8%). Seven of the 26 patients (27%) were lost to follow-up or had no stated reason for declining enrollment; others did not go on trial due to death/transition to hospice (n=5; 19%) or progression of disease/declining functional status (n=4; 15%). There were few statistically significant differences between patients who chose to go on trial and those who declined. CONCLUSIONS: An understanding of why eligible patients elect not to participate in early-phase clinical trials provides insight into the patient experience and can help identify misperceptions and areas for improvement in education and the clinical trial enrollment process.

The Expanding Role of Immunotherapy

October 14, 2020

Interview

ONCOLOGY® recently spoke with Mario Sznol, MD, professor of medicine (medical oncology) at Yale School of Medicine and Yale Cancer Center, about the rapidly expanding use of immunotherapies, the future of immuno-oncology, and the management of immune-related toxicities.

Disorders of Sex Development and Malignant Germ Cell Tumors

October 14, 2020

Clinical Quandaries

Key points: Patients with disorders of sex development (DSDs) are at an increased risk of malignant germ cell tumors (GCTs). In adulthood, the partial form of androgen insensitivity syndrome confers the greatest risk of developing malignant GCTs. Gonadoblastoma is the most common gonadal GCT arising in patients with DSDs. Despite being a benign neoplasm, it can undergo malignant transformation in up to 60% of patients with a DSD. Oncologic treatment in patients with disorders of sex development and malignant GCTs does not differ from the standard treatment for testicular GCTs. Treatment of patients with DSDs requires a multidisciplinary team, including a psychiatric, genetic, and reproductive assessment as well as the involvement of an ethics committee. An early diagnosis of DSDs is crucial to avoid the development of potentially serious complications in adulthood.

Strategies to Optimize Axillary Surgery in Patients With Breast Cancer Receiving Neoadjuvant Endocrine Therapy

October 14, 2020

Review Article

ABSTRACT Current guidelines for axillary surgery following systemic therapy do not differentiate between neoadjuvant endocrine therapy (NET) and neoadjuvant chemotherapy (NAC). Without specific guidelines, many assume that axillary surgery after NET should mirror that after NAC; however, NET has traditionally been used for patients with biologically favorable disease, so alternative axillary surgery strategies may be appropriate. Unfortunately, clinical trials that have examined NET have not rigorously studied axillary management or outcomes. The limited observational data available reveal that axillary lymph node dissection (ALND) is less frequently performed for positive nodes following NET than NAC; ALND rates after NET are more like those of upfront surgery patients. Although outcomes of omitting ALND after NET in patients who remain node positive are unknown, hypothesis-generating work from the National Cancer Database suggests that most patients selected for NET have limited nodal burden, and the prognostic significance of residual nodal disease after NET may not carry the same implications as residual disease after NAC. As such, there is opportunity to define axillary surgery strategies after NET that differ from those used after NAC.

Considerations for the Management of Oncology Patients During the COVID-19 Pandemic

October 14, 2020

Review Article

ABSTRACT Worldwide incidence and mortality due to the coronavirus disease 2019 (COVID-19) pandemic is greatest in the United States, with the initial epicenter in New York. In Nassau County, New York, where we practice, our institution has had more than 2500 cases and has discharged from the hospital more than 1000 patients. As many academic and private institutions have swiftly shifted their clinical and research priorities to address the pandemic, data are emerging regarding both the impact of malignancy on COVID-19 outcomes as well as the challenges faced in assuring that cancer care remains unimpeded. Of concern, recent studies of cancer patients primarily in China and Italy have suggested that advanced malignancy is associated with increased susceptibility to severe COVID-19 infection. At present, more than 500 clinical trials are underway investigating the pathogenesis and treatment of COVID-19, including expanded use of oncology drugs, such as small molecular inhibitors of cytokine pathways. Here, we begin by reviewing the latest understanding of COVID-19 pathophysiology and then focus our attention on the impact of this virus on hematologic and oncologic practice. Finally, we highlight ongoing investigational treatment approaches that are so relevant to the care of oncology patients during this extraordinary pandemic.