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ASCO Calls for HBV Screen Before New Cancer Treatments

by | Jun 12, 2015 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies

To address the low rates of hepatitis B virus (HBV) screening among cancer patients initiating anti-CD20 therapy or hematopoietic cell transplantation, the American Society of Clinical Oncology (ASCO) is updating a clinical opinion to incorporate a risk-adaptive strategy to better identify patients with HBV infection and reduce the risk of HBV reactivation. The provisional clinical opinion, published online May 11 in the Journal of Clinical Oncology, advises that screening tests for HBV should be performed on patients before starting anti-CD20 monoclonal antibodies and hematopoietic cell transplants. However, patients who have risk factors for HBV infection should also be screened before initiating systemic cancer therapy. The ASCO panel found that since the 2010 release of national recommendations, HBV screening remains “suboptimal” among patients at high risk for HBV infection or HBV reactivation after cytotoxic or immunosuppressive therapy. Additionally, despite the U.S. Food and Drug Administration’s 2013 box warning about the risk of HBV reactivation with monoclonal antibody products, “a small but substantial group” of patients with cancer receiving the therapy remain unscreened for HBV infection. While screening strategies vary by cancer center (with some employing risk-based screening and others adopting universal screening before cancer therapy), the panel concluded that they could […]

To address the low rates of hepatitis B virus (HBV) screening among cancer patients initiating anti-CD20 therapy or hematopoietic cell transplantation, the American Society of Clinical Oncology (ASCO) is updating a clinical opinion to incorporate a risk-adaptive strategy to better identify patients with HBV infection and reduce the risk of HBV reactivation. The provisional clinical opinion, published online May 11 in the Journal of Clinical Oncology, advises that screening tests for HBV should be performed on patients before starting anti-CD20 monoclonal antibodies and hematopoietic cell transplants. However, patients who have risk factors for HBV infection should also be screened before initiating systemic cancer therapy. The ASCO panel found that since the 2010 release of national recommendations, HBV screening remains “suboptimal” among patients at high risk for HBV infection or HBV reactivation after cytotoxic or immunosuppressive therapy. Additionally, despite the U.S. Food and Drug Administration’s 2013 box warning about the risk of HBV reactivation with monoclonal antibody products, “a small but substantial group” of patients with cancer receiving the therapy remain unscreened for HBV infection. While screening strategies vary by cancer center (with some employing risk-based screening and others adopting universal screening before cancer therapy), the panel concluded that they could not definitely recommend one strategy due to a “weak” evidence base. The panel recommends HBV screening should include both the hepatitis B surface antigen (HBsAg) test and hepatitis B core antibody (anti-HBc) test, because HBV reactivation can occur in patients who are HBsAg positive/anti-HBc positive or HBsAg negative/anti-HBc positive. Either a total anti-HBc test or an anti-HBc immunoglobulin G (IgG) test should be used to screen for chronic or resolved HBV infection before cancer therapy, but anti-HBc IgM should not be used as it can only confirm acute infection. Two panel members held “a minority viewpoint” advocating for a screening strategy of universal HBsAg and selective anti-HBc testing. For patients found to be HBsAg-negative/anti-HBc–positive clinicians can monitor HBV DNA and ALT levels and initiate on-demand antivirals. Screening is not supported for patients without HBV risk factors and not planning cancer therapy associated with a high risk of reactivation. However, risk-based strategies are complicated, the group admits, by a lack of validated clinical tools to guide risk-based HBV screening. “The ASCO panel acknowledges that there is wide variability in approaching HBV screening before cancer therapy,” write the authors led by Jessica Hwang, M.D., from University of Texas MD Anderson Cancer Center in Houston. “Until clear and definitive evidence is available to guide patient selection, the consensus of the panel is that a risk-adaptive HBV screening and management strategy incorporating what is known about the risks of HBV infection as well as risks of cancer therapy–associated HBV reactivation is reasonable.”

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