Prevention and Managed Care Updates

Scalp Cooling System for Chemotherapy-Induced Alopecia Approved for Multiple Solid Tumors

The FDA has greenlighted an expanded indication for Paxman’s cooling cap system in the United States. The medical device company, based in the United Kingdom, announced that the Paxman Scalp Cooling System is now indicated to reduce the likelihood of chemotherapy-induced alopecia in patients with solid tumors, such as ovarian, breast, colorectal, bowel, and prostate cancer.¹

The system was approved in August 2017 to reduce and prevent hair loss associated with chemotherapy treatment in women with breast cancer.² Made from lightweight silicone, the cooling cap is soft and flexible, molding to different head shapes and sizes. Liquid coolant passes through the cap, removing heat from the patient’s scalp to ensure it remains at a constant temperature, minimizing hair loss.

According to Paxman, the expanded indication will substantially increase the number of new patients per year who can benefit from the system, from an estimated 250,000 patients with breast cancer to over 1 million with breast cancer or other solid tumors.

“Scalp cooling has been a real game changer for so many of our patients with breast cancer, minimizing the risk of one of the most dreaded [adverse] effects of chemotherapy,” Steven Jay Isakoff, MD, PhD, a medical oncologist at Massachusetts General Hospital in Boston, said in a statement.¹ “Thanks to the recent expanded FDA indication for the Paxman Scalp Cooling System, so many more patients with solid tumors in the US can now consider this option as a safe and effective way to keep their hair during chemotherapy.”

Since the system’s original clearance, 225 have been installed, and another 65 await delivery and installation.

Highlighting the importance of the affordability of scalp cooling, Richard Paxman, chief executive officer of Paxman, told The American Journal of Managed Care^® in an email: “We are working hard with health plans and payers to ensure that in the future, this will be covered. However, at present, the majority of patients are paying out of pocket.

“We are seeing positive feedback from a number of commercial payers,” he added.

Currently, the cap kit costs patients $500; cycles 1 through 4 are $200 each; cycles 5 and 6, $150 each; and cycles 7 through 12, $100 each. However, the pricing per patient is capped at $2200.

No payer coverage exists for the system yet, but the nonprofit HairToStay helps subsidize the cost for eligible patients: The system is discounted by 25%, and HairToStay covers 60% of the remaining cost.

“HairToStay has had the privilege of subsidizing a growing number of Paxman scalp cooling users for nearly a year now,” said Bethany Hornthal, founder of HairToStay, in a statement. “This expanded clearance will increase this wonderful option for patients, and we expect to see a significant increase in demand for scalp cooling and subsidies.”¹

References

1. Paxman announces FDA clearance for an expanded indication of its scalp cooling system in the US [press release]. West Yorkshire, UK: Paxman; June 11, 2018. paxmanscalpcooling.com/about-paxman/news/2018- 06-11-paxman-announces-fda-clearance-for-an-expanded-indication-of-its-scalp-cooling-system-in-the-us. Accessed June 18, 2018.
2. Dangi-Garimella S. Paxman Scalp Cooling System is FDA approved for chemotherapy-associated alopecia. The American Journal of Managed Care® website. ajmc.com/newsroom/paxman-scalp-cooling-system-is-fda-ap- proved-for-chemotherapy-associated-alopecia. Published August 20, 2017. Accessed June 18, 2018.

NCI-Designated Cancer Centers Endorse Goal of Eliminating HPV-Related Cancers

Recognizing a rise in the rate of cancers caused by the human papillomavirus (HPV ) as a significant public health problem, the nation’s top cancer centers have endorsed the goal of eliminating HPV-related cancers.¹

The joint statement from the 70 National Cancer Institute (NCI)—designated cancer centers underscores the importance of increased HPV vaccination and evidence-based screening, with the goal of eliminating cancers caused by the virus. Completion of the recommended 3 doses of the cancer-preventing HPV vaccine remains low across the nation. According to the CDC, 49.5% of girls and 37.5% of boys ages 13 to 17 completed the series in 2016.²

“All 70 cancer centers, representing the nation’s leaders in cancer care and research, perceive low vaccination rates as a public health threat and call upon physicians, patients, and young adults to take advantage of this opportunity to prevent several types of cancer in men and women,” according to a statement from MD Anderson Cancer Center in Houston, Texas.³

In particular, people living with HIV are at an increased risk of developing cancers caused by HPV due to a weakened immune system and a decreased ability to fight viral infections. Because of the higher risk of cervical cancer— often caused by HPV—among women with HIV, it is recommended they be screened regularly for the disease.⁴ The CDC also recommends HPV vaccination for both women and men with HIV infection up to age 26.

In alignment with the Healthy People 2020 Initiative, the statement called for:

• Vaccination of more than 80% of males and females ages 13 to 15 by 2020
• Screening of 93% of age-eligible females for cervical cancer by 2020
• Prompt follow-up and proper treatment of females who screen positive for high-grade cervical precancerous lesions^1,3

It is also encouraged that men and women up to age 26 complete the recommended vaccine series; healthcare providers make clear and strong recommendations for HPV vaccination and cervical screening; and healthcare community members educate parents, guardians, community members, and colleagues about the goal of eliminating HPV-related cancers.

The statement estimates that higher rates of vaccination and evidence-based cancer screening can prevent 12,000 cervical cancers and nearly 40,000 other HPV-related cancers. “Increased HPV vaccination rates combined with appropriate cervical cancer screening measures could soon eliminate cervical cancer, with other HPV-related cancers in males and females to follow,” reads the statement.

In addition to the 70 cancer centers, the American Cancer Society, American Association for Cancer Research, American Society for Clinical Oncology, Prevent Cancer Foundation, American Society for Preventive Oncology, and Association of American Cancer Institutes endorsed the statement.

This is the third national call to action from the NCI-designated cancer centers, with the first statement published in 2016.

References

1. St. Jude partners with NCI cancer centers with goal of eliminating HPV-related cancers [press release]. Memphis, TN: St. Jude Children’s Research Hospital; June 7, 2018. eurekalert.org/pub_releases/2018-06/sjcr-sjp060718. php. Access June 18, 2018.
2. Walker TY, Elam-Evans LD, Singleton JA, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years - United States, 2016. MMWR Morb Mortal Wkly Rep. 2017;66:874-882. doi: 10.15585/mmwr.mm6633a2.
3. MD Anderson and nation’s top cancer centers endorse goal of eliminating HPV-related cancers [press release]. Houston, TX: The University of Texas MD Anderson Cancer Center; June 7, 2018. mdanderson. org/newsroom/2018/06/md-anderson-and-nations-top-cancer-centers-endorse-goal-of-eliminating- hpv-related-cancers.html. Accessed June 18, 2018.
4. HIV infection and cancer risk. NCI website. cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/ hiv-fact-sheet. Updated September 14, 2017. Accessed June 18, 2018.

Cancer Increases Risk of Developing Type 2 Diabetes, Study Finds

Having cancer boosts a person’s chances of later developing type 2 diabetes (T2D), even when risk factors that existed before cancer are taken into account, according to a recent study in JAMA Oncology.

Authors of the study, which examined health records of 494,189 people in South Korea for an average of 7 years, said the findings should alert primary care physicians to routinely screen cancer survivors for T2D. The authors speculate that some cancer-fighting drugs increase the risk of developing T2D, including corticosteroids, which are used in many regimens but raise the risk of hyperglycemia. Some chemotherapy agents also elevate blood glucose, they said.

Investigators used data from the National Health Insurance Service—National Sample Cohort, a 2.2% representative sample of the population. Under the country’s single-payer healthcare system, Koreans receive a free health screening every 1 to 2 years, when cardiovascular and diabetes risks are assessed.

By tracking diagnostic codes for patients who had been treated for cancer, investigators found a link between having the disease and being at increased risk of T2D, even after controlling for preexisting conditions. During the study period, 15,130 participants developed cancer. Those who did were more likely to be women, drink alcohol every day, have a higher body mass index, and have additional comorbidities. Of this group, the number of incident cases of diabetes seen at follow-up was 834, compared with 25,776 who developed diabetes but not cancer. The overall sex- and age-adjusted hazard ratio (HR) for diabetes associated with cancer was 1.36 (95% CI, 1.26-1.45).

Cancer survivors were most at risk of developing T2D within the first 2 years after diagnosis, but their risk level remained elevated throughout the follow-up period. Risk levels varied by cancer type:

• Patients with pancreatic cancer had 5 times the risk of developing T2D (HR, 5.15; 95% CI, 3.32-7.99).
• Those with kidney cancer had twice the risk (HR, 2.06; 95% CI, 1.34-3.16),
• and those with liver cancer had close to twice the risk (HR, 1.95; 95% CI, 1.50-2.54).

Elevated risk was also seen among patients with some of the most common forms of cancer, such as lung (HR, 1.74; 95% CI, 1.34-2.24) and breast (HR, 1.60, 95% CI, 1.27-2.01).

Those with blood cancers had a significantly elevated risk (HR, 1.61; 95% CI, 1.07-2.43). Elevated risk was also seen among those who had gallbladder, thyroid, or stomach cancer.

Besides facing the risk of T2D posed by some of the cancer treatments, patients often lose weight and muscle, the authors noted, and many experience a loss of appetite, a condition called cancer cachexia that is associated with increased insulin resistance. Being hospitalized can trigger bouts of stress hyperglycemia.

“Clinical studies in cancer traditionally focus on cancer progression, cancer-related mortality, and treatment-related complications but often neglect long-term consequences of cancer and its treatment,” the authors wrote. “Increased survival due to advances in cancer diagnosis and treatment, however, is driving the emphasis toward chronic disease and long-term outcomes.”

Reference

Vigorous Exercise May Reduce Mortality in Adult Survivors of Childhood Cancer

Hwangbo Y, Kang D, Kang M, et al. Incidence of diabetes after cancer development: a Korean National Cohort Study [published online June 7, 2018]. JAMA Oncol. doi: 10.1001/jamaoncol.2018.1684.It is well understood that, in the general population, regular exercise is associated with a longer life. But less is known about whether exercise similarly benefits adult survivors of childhood cancer, who may already have an a shortened life expectancymeas because of late effects of treatment, including subsequent malignant neoplasms and cardiovascular disease (CVD). A study published in JAMA Oncology sought to evaluate whether vigorous exercise can change mortality in this population.

The retrospective cohort study of adult survivors who participated in the Childhood Cancer Survivorship Study (CCSS) followed 15,450 patients who received diagnoses and were treated at 27 locations in the United States and Canada between January 1970 and December 1999.

At baseline and follow-up, enrollees were asked to report how many days in the prior week they had engaged in vigorous exercise (sufficient to result in heavy breathing, sweating, or increased heart rate). The investigators converted self-reported exercise into an average of metabolic equivalent tasks (METs) in hours per week. MET-hours per week were then categorized into 4 groups: 0, 3 to 6, 9 to 12, and 15 to 21.

The investigators found that vigorous exercise exposure greater than 0 MET- hours per week was associated with a significant reduction in the incidence of all-cause, relapse-related, and health-related mortality. At year 15, the group with 0 MET-hours per week had an incidence of all-cause mortality of 11% (95% CI, 10.6%-12.8%). By comparison, the other groups had the following incidence of all-cause mortality:

• 3 to 6 MET-hours per week: 8.6% (95% CI, 7.4%-9.7%)
• 9 to 12 MET-hours per week: 7.4% (95% CI, 6.2%-8.6%)
• 12 to 21 MET-hours per week: 8.0% (95% CI, 6.5%-9.5%)

Compared with the no-exercise group, the adjusted risk ratio (RR) was 0.81 (95% CI, 0.68-0.97) for the group with 3 to 6 MET-hours; 0.82 (95% CI, 0.68-1.00), 9 to 12 MET-hours; and 0.79 (95% CI, 0.62-1.00), 15 to 21 MET-hours. Exercise exposure of 15 to 18 MET-hours per week, which could be divided into sessions of 60 minutes per day, 5 days per week, appeared to be optimal.

Additionally, survivors who increased their exercise over time continued to reduce their risk of mortality; increased exercise exposure over 8 years was associated with an adjusted 40% reduction in the rate of all-cause mortality, compared with maintaining a low level of exercise (RR, 0.60; 95% CI, 0.44-0.82).

The authors say that their findings significantly extend the current evidence base and provide epidemiological evidence to support endorsing exercise for cancer survivors, though they warn that, because observational studies are susceptible to reverse-causation bias, the results must be interpreted with caution. At a minimum, they suggest, the study supports counseling all cancer survivors, as appropriate, to increase participation in vigorous exercise at least once a week, which may be a realistic and achievable goal for a significant proportion of survivors.

Reference

Scott JM, Li N, Liu Q, et al. Association of exercise with mortality in adult survivors of childhood cancer [published online June 3, 2018.] JAMA Oncol. doi: 10.1001/jamaoncol.2018.2254.

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