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Evidence-Based Oncology June 2017
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Surabhi Dangi-Garimella, PhD, and Christina Mattina
Conference Coverage: COA
Surabhi Dangi-Garimella, PhD
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Medical World News, June 2017
Surabhi Dangi-Garimella, PhD, and Christina Mattina

Medical World News, June 2017

Surabhi Dangi-Garimella, PhD, and Christina Mattina
An update on the latest developments in clinical and healthcare services research in oncology.
Research Tests Decision Support Technology for Guiding Cancer Screening Choices

Christina Mattina

The results of a new study indicate that a technology-based intervention could help patients make informed decisions about cancer screening. The study, published in Annals of Family Medicine, tracked the outcomes from the implementation of a decision support module at 12 practices serving over 55,000 patients. The module was embedded in the online portals of 11,458 patients who faced an upcoming decision on breast, colorectal, or prostate cancer screening.

An initial assessment within the module gathered important information, such as patients’ concerns with cancer screening, desired levels of decision support, decision-making style, and optimal method of receiving information on the recommended screening options. Using this feedback, the module created a tailored page that provided the patient’s preferred amount of relevant information using words, numbers, pictures, or stories.

Patients could then indicate whether they had made up their minds on their next steps, and if so, whether they wanted their physician to receive a summary of their decision preferences that included discussion points, patient questions, and the preferred balance of decision making between the patient and the provider. Questionnaires collected feedback on the module from the patient and the clinician after the office visit during which the results were discussed.

Of the 11,458 patients invited to use the module, only 903 of the 2355 who started completed it. Around a quarter of module users clicked on at least 1 educational resource, and patients each accessed an average 3.5 resources. Patients most commonly sought information on options for getting screened (70.8%), what screening test works best (49.8%), and potential complications from screening (45.7%).

Patients who forwarded the decision summary to their physicians were more likely discuss the screening at their next visit, and 80.9% said the conversation helped reduce their fears or worries about screening. A majority of patients agreed that the module was easy to complete and understand, and sizable proportions reported that it had improved their knowledge before the office visit (48.1%) and got them more involved in the screening decision (47.7%). Finally, patients who had completed the module were significantly more likely to undergo screening within 3 months than those who had not started or completed it.

According to the researchers, these findings indicate that technology-enabled decision support initiatives are a feasible way to empower patients in decision making and help improve communication between patients and physicians. They noted that invitation response rates and module completion levels were relatively low, but could potentially increase with better workflow integration. This was also a self-selected sample without a control group, so future trials will need to be randomized and controlled to more fully evaluate the role of decision support technologies in cancer screening and other health choices.

The researchers acknowledged that implementing new technologies within practice workflows will not be an easy task, but if “future research confirms the benefits of this approach—more informed patients, better decisions, and wiser use of encounter time—the return on investment could offset the implementation costs and improve care.”

REFERENCE

Krist AH, Woolf SH, Hochheimer C, et al. Harnessing information technology to inform patients facing routine decisions: cancer screening as a test case. Ann Fam Med. 2017;15(3):217-224. doi: 10.1370/afm.2063.

Lowering the Risk of Venous Thromboembolism With Ovarian Cancer Treatment

Surabhi Dangi-Garimella, PhD

Twenty-five percent of patients receiving neoadjuvant chemotherapy treatment for ovarian cancer develop venous thromboembolism (VTE), according to the results of a new study published in the journal Obstetrics & Gynecology.1

Patients with ovarian cancer have historically been associated with developing VTE. Significant risk factors include obesity, older age, advanced disease stage, debulking surgery, and use of anticoagulants. Development of this hematological condition can, in turn, lead to a poor prognosis or a reduced quality of life for patients. Although postoperative efforts have focused on reducing the incidence of thromboembolic events in women with ovarian cancer, the 4-week standard treatment that is currently offered may not be sufficient to reduce the long-term risk.2

With the hypothesis that neoadjuvant chemotherapy increases the incidence of VTE, the authors of the current study conducted a retrospective analysis among 112 patients with ovarian cancer who were being treated with neoadjuvant chemotherapy. Thirteen patients who presented with a symptom of VTE were disregarded prior to analysis. Thirty of the 112 patients at risk (26.8%; 95% CI, 19.3%-35.9%) experienced a VTE. Thirteen patients (11.6%; 95% CI, 6.8%-19.1%) experienced this hematological event during the neoadjuvant chemotherapy treatment, 6 (5.4%; 95% CI, 2.4%-11.5%) developed the condition postoperatively, and 11 (9.9%; 95% CI, 5.5%-17%) developed VTE during adjuvant chemotherapy.

Based on these findings, the authors confirm that neoadjuvant chemotherapy positions patients with ovarian cancer at an extremely high risk of developing VTE. Highlighting the importance of prophylactic treatment in preventing the incidence of VTE, they note that prophylaxis could improve survival in this patient population. This is especially important because of the rapidly growing population of patients with ovarian cancer who are administered neoadjuvant chemotherapy in the United States, they write.

REFERENCES

1. Greco PS, Bazzi AA, McLean K, et al. Incidence and timing of thromboembolic events in patients with ovarian cancer undergoing neoadjuvant chemotherapy [published online May 5, 2017]. Obstet Gynecol. 2017. doi: 10.1097/ AOG.0000000000001980.

2. Pant A, Liu D, Schink J, Lurain J. Venous thromboembolism in advanced ovarian cancer patients undergoing frontline adjuvant chemotherapy. Int J Gynecol Cancer. 2014;24(6):997-1002. doi: 10.1097/IGC.0000000000000164.

Pembrolizumab Plus Chemotherapy Approved for Metastatic Nonsquamous NSCLC

Surabhi Dangi-Garimella, PhD

Tumor response rate and progression-free survival (PFS) were the benchmarks that helped pembrolizumab (Keytruda) gain accelerated approval as first-line treatment for metastatic nonsquamous non–small cell lung cancer (NSCLC) in combination with pemetrexed (pem) and carboplatin (carbo), irrespective of PD-L1 expression.

Observations in a subpopulation of patients who were part of the KEYNOTE-021 trial led to the new approval. A cohort of 123 treatment-naïve patients with metastatic nonsquamous NSCLC, with no mutations in EGFR or ALK genes, were treated with pembrolizumab plus pem/carbo or pem/carbo alone. Including pembrolizumab in the treatment regimen improved the objective response rate from 29% (95% CI, 18%-41%) to 55% (95% CI, 42%-68%). Further, a majority of patients (93%) who received pembrolizumab had a duration of response that was at least 6 months (range, 1.4+ to 13+ months) compared with 81% of patients who did not (range, 1.4+ to 15.2+ months). Pembrolizumab also improved the median PFS by about 3.1 months.

With respect to adverse events, pembrolizumab treatment resulted in pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Pembrolizumab can also cause severe or life-threatening infusion-related reactions.

“This approval marks an important milestone in the treatment of lung cancer. Now, pembrolizumab in combination with pemetrexed and carboplatin can be prescribed in the first-line setting for patients with metastatic nonsquamous non–small cell lung cancer, irrespective of PD-L1 expression,” said Corey Langer, MD, director of thoracic oncology and professor of medicine at the Hospital of the University of Pennsylvania.1 Langer emphasized that physicians should consider individual patient characteristics, such as biomarker status, histology, and other clinical factors, to carve out an appropriate treatment plan.

The approval of pembrolizumab as first-line therapy, alone or in combination with chemotherapy agents, has opened up the horizon’s for Merck, the company that developed the molecule. More than 200,000 individuals are diagnosed annually with NSCLC in the United States.2 The drug spend will be an issue, however: the combination of pembrolizumab and chemotherapy will cost more than $250,000 annually.

REFERENCES

1. FDA approves Merck’s Keytruda (pembrolizumab) as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression [press release]. Kenilworth, NJ; Merck: May 10, 2017. http://www.mrk.newsroom.com/news-release/prescription-medicine- news/fda-approves-mercks-keytruda-pembrolizumab-first-line-combin. Accessed May 11, 2017.

2. What’s new in non-small cell lung cancer research? American Cancer Society website. https://www.cancer.org/cancer/ non-small-cell-lung-cancer/about/new-research.html. Updated May 16, 2016. Accessed May 11, 2017.

USPSTF: Do Not Screen for Thyroid Cancer in Asymptomatic Individuals

Surabhi Dangi-Garimella, PhD

The US Preventive Services Task Force (USPSTF) has provided a D recommendation (discourages the use of service) for thyroid cancer screening in asymptomatic individuals.

Thyroid cancer incidence has increased nearly 3 times over a 40-year period: 15.3 cases per 100,000 persons in 2013 compared with 4.9 cases per 100,000 in 1975. However, mortality rates have not seen much of a spike, increasing by just 0.7 deaths per 100,000 persons each year. It’s also important to note that the 5-year survival for the disease ranges from 99.9% for localized disease to 55.3% for individuals who have metastases.

The USPSTF revisited neck palpation or ultrasound as a screening technique used in asymptomatic individuals to evaluate its impact on health outcomes. The recommendations, however, do not apply to individuals with hoarseness, pain, difficulty swallowing, or other throat symptoms or persons who have lumps, swelling, asymmetry of the neck, or other reasons for a neck examination. They also do not apply to persons at increased risk of thyroid cancer because of a history of exposure to ionizing radiation, particularly persons with a diet low in iodine, an inherited genetic syndrome associated with thyroid cancer, or a first-degree relative with a history of thyroid cancer.

The USPSTF committee found no direct evidence that compared screened versus unscreened populations or immediate surgery versus surveillance or observation that showed an impact on health outcomes, such as mortality, quality of life, or harms. “The USPSTF found inadequate direct evidence on the harms of screening, but determined that the magnitude of the overall harms of screening and treatment can be bounded as at least moderate, given adequate evidence of harms of treatment and indirect evidence that overdiagnosis and overtreatment are likely to be substantial with population-based screening,” the authors noted.

 
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