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Evidence-Based Oncology October 2017
Formulary Considerations: The Past, Present, and Future
Molly Billstein Leber, PharmD, BCPS, FASHP
Pharmacy's Changing Role as Cancer Care Transitions From Infused to Oral Therapies
Stacey McCullough, PharmD, and Ricky Newton, CPA
Pharmacy Team Engagement in Navigating the Revenue Cycle for High-Cost Medications in Patients With Cancer
Brandon R. Shank, PharmD, MPH, BCOP; Phuoc Anh (Anne) Nguyen, PharmD, MS, BCPS; and Emily C. Pherson, PharmD, BCPS
In Conversation With a Pharmacist: Management of CAR T-Cell Treatment
Surabhi Dangi-Garimella, PhD
PBMs: Their Role, the Problems, and How Practices Can Work With Them
Ray Bailey, RPh, and Ricky Newton, CPA
Positive Quality Interventions: An Innovative Platform for Oncology Practice Collaboration
Joshua Nubla, PharmD; Neal Dave, PharmD; and Michael Reff, RPh, MBA
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Medical World News®, October 2017
AJMC Staff

Medical World News®, October 2017

AJMC Staff
An update on the latest developments in the world of oncology care: product approvals, clinical developments, health policy changes, and more.
Mammography Device Approved by FDA Gives Patients Control Over Pressure Levels

Christina Mattina

The FDA has approved the first 2D digital mammography system that lets patients adjust the level of compression applied to their breast during the imaging procedure.

Mammograms are a key tool in detecting breast cancer, but some women report discomfort with the procedure, which requires the breast to be compressed in order to capture a 2D x-ray image. The new device could potentially expand uptake of mammograms by empowering patients and making the experience more comfortable.

According to the FDA announcement, the Senographe Pristina with Self-Compression, manufactured by GE Healthcare, was approved through the premarket 510(k) pathway.1 GE had to demonstrate that the new device is clinically equivalent to the Senographe Pristina, an approved digital mammography device that allows the technician operating the device full control over compression.

The self-compression device differs from the original machine by including a wireless remote control held by the patient that can adjust the compression force. After the technologist positions the patient’s breast, the patient is asked to use the remote control to gradually increase the level of compression to a point she finds tolerable. The technician then checks whether the compression is sufficient to achieve a clear image and can adjust it if necessary.

Trials conducted as part of the premarket approval process confirmed that allowing patients to control compression with the remote control did not diminish image quality compared with the device now in use. The average time of the mammogram did not increase either. The finding that the new device was at least as safe and effective as the approved device contributed to the FDA’s decision to grant premarket clearance to GE.

“Regular mammograms are an important tool in detecting breast cancer. However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in the announcement. “This device allows patients some control over the amount of compression for their exam.”

This sense of control, along with reduced pain and discomfort, could have significant implications for changing women’s perceptions of mammography and their willingness to undergo screening. A 2013 review published in The Breast showed that between 25% and 46% of women who did not return for subsequent mammograms cited pain during the initial mammogram as the reason.

References:

1. FDA clears mammography device with option for patient-assisted compression [press release]. Silver Spring, MD: FDA; September 1, 2017. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574562.htm. Accessed September 5, 2017.

2 Whelehan P, Evans A, Wells M, Macgillivray S. The effect of mammography pain on repeat participation in breast cancer screening: a systematic review. Breast. 2013;22(4):389-394. doi: 10.1016/j.breast.2013.03.003. 

FDA Emphasizes Risks of Pembrolizumab in Multiple Myeloma After Reviewing Halted Trials

Christina Mattina

Less than two months afterit ordered a stop to 3 trials of pembrolizumab (Keytruda) in multiple myeloma due to safety concerns, the FDA has released a more detailed analysis of what went wrong in the trials.

Merck, which developed pembrolizumab, announced in July that the FDA had placed 2 phase 3 studies on full hold and a phase 1 study on partial hold, citing a pattern of patient deaths.1 The FDA’s safety alert, issued recently to healthcare providers, oncology researchers, and the public, analyzes data from the 2 phase 3 trials that were halted completely.2

KEYNOTE-183 had been studying pembrolizumab in combination with pomalidomide and low-dose dexamethasone in patients with relapsed/ refractory multiple myeloma. KEYNOTE-185 was assessing pembrolizumab in combination with lenalidomide and low-dose dexamethasone in those with newly diagnosed and treatment-naïve multiple myeloma.

KEYNOTE-183 documented 29 deaths in the investigational arm receiving pembrolizumab and 21 deaths in the control arm. The FDA determined that the relative risk of death was 61% higher for participants in the pembrolizum- ab arm. This increased hazard was not accompanied by improved outcomes, as the objective response rate was 34% in the investigational arm and 40% in the control group. Patients receiving pembrolizumab were also more likely to experience a higher rate of grade 3 to 5 toxicities than their counterparts in the control arm (83% vs 65%, respectively), as well as serious adverse events (63% vs 46%). The most common causes of death unrelated to cancer progression in the pembrolizumab arm included several heart-related conditions, neutropenic sepsis, and multiple organ dysfunction.

The KEYNOTE-185 trial appeared to pose even more risk to participants. There were 19 deaths in the investigational arm and 9 in the control group, indicating a risk of death that was over 2-fold for the patients receiving pembrolizumab. Higher incidences of grade 3 to 5 toxicities (72% vs 50%) and serious adverse events (54% vs 39%) were observed in the pembrolizumab arm than in the control arm.

Noncancer causes of death in the investigational arm of KEYNOTE-185 included the cardiac events seen in KEYNOTE-183, intestinal ischemia, suicide, and sudden death. The objective response rate in the pembrolizumab arm was 64%, compared with 62% seen in the control arm.

Both the data analysis and a press statement3 from the FDA emphasized that these safety risks only apply to multiple myeloma, which is not an approved indication of pembrolizumab, and that patients taking the drug for approved indications—which include melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, and others—should continue to do so.

“Today’s alert underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in the announcement. 

References:

1. Mattina C. FDA halts some pembrolizumab trials for multiple myeloma, citing patient deaths. The American Journal of Managed Care® website. ajmc.com/newsroom/fda-halts-some-pembrolizumab-trials-for-multiple-myeloma-cit-ing-patient-deaths. Published July 7, 2017. Accessed September 1, 2017.

2. FDA alerts healthcare professionals and oncology clinical investigators about two clinical trials on hold evaluating Keytruda (pembrolizumab) in patients with multiple myeloma [press release]. Silver Spring, MD: FDA; August 31, 2017. www.fda.gov/Drugs/DrugSafety/ucm574305.htm. Accessed September 1, 2017.

3. Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma [press release]. Silver Spring, MD: FDA; August 31, 2017. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574341.htm. Accessed September 1, 2017. 

Race, Socioeconomic Status Linked to Rehospitalizations Among Patients With Advanced Cancer

AJMC staff

A new study in the Journal of Clinical Oncology identifies an increased role for physicians in boosting human papillomavirus (HPV) vaccination rates among childhood cancer survivors to reduce their risk of a second cancer.1

The study surveyed 982 childhood cancer survivors (the majority of whom were leukemia/lymphoma survivors), aged 9 to 26 years, who had completed treatment between 1 and 5 years prior to the survey. The survey touched on:

  • Whether they had received an HPV vaccine
  • Whether their provider had recommended the vaccine
  • Their attitude toward vaccination
The results drawn on the HPV vaccination rates were compared with the vaccine initiation rates in the general population. More than a 1.5-fold difference was noted between the 2 populations: a 24% vaccination rate among the childhood cancer survivors compared with 40% in the general-population peers. Males, overall, were more likely to get vaccinated.

The biggest difference, the study noted, was among teens 13 to 17 years of age: 22% for cancer survivors compared with 42% for their general population peers. However, the numbers were on par in the older population (18 to 26 years old): 25% for survivors and 24% for their general population peers.

With nearly 7 million adolescents and young children infected with HPV annually, the virus has a significant bearing on the incidence of cervical cancers and many oral, anal, vaginal, vulvar, and penile cancers. Childhood cancer survivors are particularly susceptible to HPV infection due to their already weakened immune system post cancer treatment. This has led organizations, like the American Society of Clinical Oncology, to recommend that girls and boys should be vaccinated against HPV to reduce the incidence of cancer.

The current study identified lack of physician recommendation as being the biggest barrier to vaccination: 72% did not get a recommendation and only 5% of those surveyed ended up getting vaccinated. The most important finding was, of the 28% who received a recommendation from their physicians, more than half got vaccinated.

“This study shows that an effective, affordable, and widely available tool for cancer prevention is being underutilized by survivors of childhood cancer,” said study author James Klosky, PhD, ABPP, an associate member at St. Jude Children’s Research Hospital in Memphis, Tennessee, in a statement. “As clinicians, we need to initiate more conversations about HPV vaccination, especially with childhood cancer survivors, because they stand to benefit even more than their peers.”

Next, Klosky said, researchers must develop interventions that ensure clear communication between a patient’s survivorship and primary healthcare teams, so that appropriate measures are in place for care continuity.

References:

Klosky JL, Hudson MM, Chen Y, et al. Human papillomavirus vaccination rates in young cancer survivors [published online August 24, 2017]. J Clin Oncol. 2017. doi: 10.1200/JCO.2017.74.1843. 

Financial Concerns Influence Care-Seeking Behavior of Childhood Cancer Survivors

Surabhi Dangi-Garimella, PhD

High out-of-pocket (OOP) medical costs in survivors of childhood cancer can influence their treatment choices and care-related behavior and ultimately affect their health outcomes. This was the conclusion of a study that evaluated the prevalence of financial burden in this patient population.1

 
Copyright AJMC 2006-2017 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
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