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Use of transarterial chemoembolization (TACE) plus external beam radiotherapy may improve outcomes in patients with hepatocellular carcinoma (HCC) showing macroscopic vascular invasion, according to results of a recent randomized study.
The TACE plus radiotherapy approach was well tolerated and improved progression-free survival compared with sorafenib treatment, investigators wrote. The report was published in JAMA Oncology.
“The results of this study represent a significant advance in addressing an urgent unmet need in treating patients with advanced HCC,” noted Sang Min Yoon, MD, PhD, of the department of radiation oncology, University of Ulsan College of Medicine, Seoul, Republic of Korea, and coauthors.
Patients with HCC that shows macroscopic vascular invasion are a particularly poor prognosis subset, according to Dr. Yoon and coauthors.
“Sorafenib is the sole treatment option for these patients, with unsatisfactory response and survival benefit,” they wrote.
Building on observational studies suggesting TACE plus external beam therapy may be a promising approach, Dr. Yoon and colleagues initiated a randomized, open-label clinical trial including 90 patients with liver-confined HCC and macroscopic vascular invasion.
Patients were randomized to sorafenib either 400 mg twice daily or TACE every 6 weeks plus radiotherapy starting within 3 weeks of the first TACE, according to the study description.
The primary endpoint, 12-week progression-free survival, was 86.7% for patients receiving TACE plus radiotherapy, versus 34.3% for patients receiving sorafenib (P less than .001).
The TACE plus radiotherapy group also had a significantly longer overall survival (55.0 vs. 43.0 weeks; P = .04), as well as a significantly higher radiologic response rate and significantly longer median time to progression, the authors reported.
Five patients (11.1%) in the TACE plus radiotherapy group were able to undergo curative surgical resection due to downstaging.
The risk of TACE-induced liver failure is a concern based on results of previous studies in patients with HCC and macroscopic vascular invasion, but in this study, there were no discontinuations due to adverse events in the TACE-radiation group, the authors noted.
“Our study may not be large enough to accurately establish the incidence of adverse events,” they wrote. “However, considering the dismal prognosis, the superior efficacy of TACE plus RT vs. sorafenib may justify its use for these patients.”
Dr. Yoon reported no disclosures related to the study. One coauthor reported research funding and advisory board membership with Bayer Healthcare and Gilead Sciences.
SOURCE: Yoon SM et al. 2018 Mar 15 JAMA Oncol. doi: 10.1001/jamaoncol.2017.5847.
Despite some limitations, the research by Yoon and colleagues provides “much-needed prospective data” suggesting that multimodality therapy may improve the dismal prognosis of patients with hepatocellular carcinoma (HCC) with portal venous invasion, according to authors of an editorial on the study.
“Existing treatments demonstrate poor efficacy for HCC with portal venous invasion, with subgroup analyses in early major prospective trials showing modest, if any, benefits of therapy beyond the natural history of the disease,” wrote editorial authors Khashayar Farsad, MD, PhD, Charlotte E. Costentin, MD, and Andrew X. Zhu, MD, PhD.
The data from Yoon et al. not only support a role for locoregional therapy in this challenging patient subgroup, but also suggest external beam radiotherapy is an “asset in the locoregional therapy toolbox,” they wrote.
In the study, use of transarterial chemoembolization (TACE) plus external beam radiotherapy improved the primary endpoint of 12-week progression-free survival versus sorafenib (86.7% versus 34.3%, respectively; P less than .001), among other improved outcomes, they noted.
That is “impressive” but certain caveats must be considered if extrapolating the data from this small study to clinical practice, they added. For example, most of the patients had liver disease related to hepatitis B virus; compared with patients with liver disease related to hepatitis C virus, that subset of patients may have worse outcomes on sorafenib, the authors wrote.
The TACE protocol used in the study included cisplatin, which is not universally used because of availability or practice patterns, they added. Moreover, a median of four treatments were delivered, while many centers use repeat TACE only when needed (e.g., due to residual disease).
Limitations aside, the study results provide prospective evidence that more effective treatment strategies for HCC with portal venous invasion may be established, according to the authors.
“For those of us managing these patients daily in our clinics and procedure suites, it is encouraging to know there is hope ahead,” they said. “Work in this realm is just beginning, highlighting the need for additional prospective studies to validate and optimize these findings in other patient populations.”
Dr. Farsad is with the Charles T. Dotter Department of Interventional Radiology, Oregon Health & Science University, Portland. Dr. Costentin and Dr. Zhu are with Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston. These comments are derived from their editorial (JAMA Oncol. 2018 Mar 15. doi: 10.1001/jamaoncol.2018.0007). The authors reported no conflict of interest disclosures related to their editorial.
Despite some limitations, the research by Yoon and colleagues provides “much-needed prospective data” suggesting that multimodality therapy may improve the dismal prognosis of patients with hepatocellular carcinoma (HCC) with portal venous invasion, according to authors of an editorial on the study.
“Existing treatments demonstrate poor efficacy for HCC with portal venous invasion, with subgroup analyses in early major prospective trials showing modest, if any, benefits of therapy beyond the natural history of the disease,” wrote editorial authors Khashayar Farsad, MD, PhD, Charlotte E. Costentin, MD, and Andrew X. Zhu, MD, PhD.
The data from Yoon et al. not only support a role for locoregional therapy in this challenging patient subgroup, but also suggest external beam radiotherapy is an “asset in the locoregional therapy toolbox,” they wrote.
In the study, use of transarterial chemoembolization (TACE) plus external beam radiotherapy improved the primary endpoint of 12-week progression-free survival versus sorafenib (86.7% versus 34.3%, respectively; P less than .001), among other improved outcomes, they noted.
That is “impressive” but certain caveats must be considered if extrapolating the data from this small study to clinical practice, they added. For example, most of the patients had liver disease related to hepatitis B virus; compared with patients with liver disease related to hepatitis C virus, that subset of patients may have worse outcomes on sorafenib, the authors wrote.
The TACE protocol used in the study included cisplatin, which is not universally used because of availability or practice patterns, they added. Moreover, a median of four treatments were delivered, while many centers use repeat TACE only when needed (e.g., due to residual disease).
Limitations aside, the study results provide prospective evidence that more effective treatment strategies for HCC with portal venous invasion may be established, according to the authors.
“For those of us managing these patients daily in our clinics and procedure suites, it is encouraging to know there is hope ahead,” they said. “Work in this realm is just beginning, highlighting the need for additional prospective studies to validate and optimize these findings in other patient populations.”
Dr. Farsad is with the Charles T. Dotter Department of Interventional Radiology, Oregon Health & Science University, Portland. Dr. Costentin and Dr. Zhu are with Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston. These comments are derived from their editorial (JAMA Oncol. 2018 Mar 15. doi: 10.1001/jamaoncol.2018.0007). The authors reported no conflict of interest disclosures related to their editorial.
Despite some limitations, the research by Yoon and colleagues provides “much-needed prospective data” suggesting that multimodality therapy may improve the dismal prognosis of patients with hepatocellular carcinoma (HCC) with portal venous invasion, according to authors of an editorial on the study.
“Existing treatments demonstrate poor efficacy for HCC with portal venous invasion, with subgroup analyses in early major prospective trials showing modest, if any, benefits of therapy beyond the natural history of the disease,” wrote editorial authors Khashayar Farsad, MD, PhD, Charlotte E. Costentin, MD, and Andrew X. Zhu, MD, PhD.
The data from Yoon et al. not only support a role for locoregional therapy in this challenging patient subgroup, but also suggest external beam radiotherapy is an “asset in the locoregional therapy toolbox,” they wrote.
In the study, use of transarterial chemoembolization (TACE) plus external beam radiotherapy improved the primary endpoint of 12-week progression-free survival versus sorafenib (86.7% versus 34.3%, respectively; P less than .001), among other improved outcomes, they noted.
That is “impressive” but certain caveats must be considered if extrapolating the data from this small study to clinical practice, they added. For example, most of the patients had liver disease related to hepatitis B virus; compared with patients with liver disease related to hepatitis C virus, that subset of patients may have worse outcomes on sorafenib, the authors wrote.
The TACE protocol used in the study included cisplatin, which is not universally used because of availability or practice patterns, they added. Moreover, a median of four treatments were delivered, while many centers use repeat TACE only when needed (e.g., due to residual disease).
Limitations aside, the study results provide prospective evidence that more effective treatment strategies for HCC with portal venous invasion may be established, according to the authors.
“For those of us managing these patients daily in our clinics and procedure suites, it is encouraging to know there is hope ahead,” they said. “Work in this realm is just beginning, highlighting the need for additional prospective studies to validate and optimize these findings in other patient populations.”
Dr. Farsad is with the Charles T. Dotter Department of Interventional Radiology, Oregon Health & Science University, Portland. Dr. Costentin and Dr. Zhu are with Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston. These comments are derived from their editorial (JAMA Oncol. 2018 Mar 15. doi: 10.1001/jamaoncol.2018.0007). The authors reported no conflict of interest disclosures related to their editorial.
Use of transarterial chemoembolization (TACE) plus external beam radiotherapy may improve outcomes in patients with hepatocellular carcinoma (HCC) showing macroscopic vascular invasion, according to results of a recent randomized study.
The TACE plus radiotherapy approach was well tolerated and improved progression-free survival compared with sorafenib treatment, investigators wrote. The report was published in JAMA Oncology.
“The results of this study represent a significant advance in addressing an urgent unmet need in treating patients with advanced HCC,” noted Sang Min Yoon, MD, PhD, of the department of radiation oncology, University of Ulsan College of Medicine, Seoul, Republic of Korea, and coauthors.
Patients with HCC that shows macroscopic vascular invasion are a particularly poor prognosis subset, according to Dr. Yoon and coauthors.
“Sorafenib is the sole treatment option for these patients, with unsatisfactory response and survival benefit,” they wrote.
Building on observational studies suggesting TACE plus external beam therapy may be a promising approach, Dr. Yoon and colleagues initiated a randomized, open-label clinical trial including 90 patients with liver-confined HCC and macroscopic vascular invasion.
Patients were randomized to sorafenib either 400 mg twice daily or TACE every 6 weeks plus radiotherapy starting within 3 weeks of the first TACE, according to the study description.
The primary endpoint, 12-week progression-free survival, was 86.7% for patients receiving TACE plus radiotherapy, versus 34.3% for patients receiving sorafenib (P less than .001).
The TACE plus radiotherapy group also had a significantly longer overall survival (55.0 vs. 43.0 weeks; P = .04), as well as a significantly higher radiologic response rate and significantly longer median time to progression, the authors reported.
Five patients (11.1%) in the TACE plus radiotherapy group were able to undergo curative surgical resection due to downstaging.
The risk of TACE-induced liver failure is a concern based on results of previous studies in patients with HCC and macroscopic vascular invasion, but in this study, there were no discontinuations due to adverse events in the TACE-radiation group, the authors noted.
“Our study may not be large enough to accurately establish the incidence of adverse events,” they wrote. “However, considering the dismal prognosis, the superior efficacy of TACE plus RT vs. sorafenib may justify its use for these patients.”
Dr. Yoon reported no disclosures related to the study. One coauthor reported research funding and advisory board membership with Bayer Healthcare and Gilead Sciences.
SOURCE: Yoon SM et al. 2018 Mar 15 JAMA Oncol. doi: 10.1001/jamaoncol.2017.5847.
Use of transarterial chemoembolization (TACE) plus external beam radiotherapy may improve outcomes in patients with hepatocellular carcinoma (HCC) showing macroscopic vascular invasion, according to results of a recent randomized study.
The TACE plus radiotherapy approach was well tolerated and improved progression-free survival compared with sorafenib treatment, investigators wrote. The report was published in JAMA Oncology.
“The results of this study represent a significant advance in addressing an urgent unmet need in treating patients with advanced HCC,” noted Sang Min Yoon, MD, PhD, of the department of radiation oncology, University of Ulsan College of Medicine, Seoul, Republic of Korea, and coauthors.
Patients with HCC that shows macroscopic vascular invasion are a particularly poor prognosis subset, according to Dr. Yoon and coauthors.
“Sorafenib is the sole treatment option for these patients, with unsatisfactory response and survival benefit,” they wrote.
Building on observational studies suggesting TACE plus external beam therapy may be a promising approach, Dr. Yoon and colleagues initiated a randomized, open-label clinical trial including 90 patients with liver-confined HCC and macroscopic vascular invasion.
Patients were randomized to sorafenib either 400 mg twice daily or TACE every 6 weeks plus radiotherapy starting within 3 weeks of the first TACE, according to the study description.
The primary endpoint, 12-week progression-free survival, was 86.7% for patients receiving TACE plus radiotherapy, versus 34.3% for patients receiving sorafenib (P less than .001).
The TACE plus radiotherapy group also had a significantly longer overall survival (55.0 vs. 43.0 weeks; P = .04), as well as a significantly higher radiologic response rate and significantly longer median time to progression, the authors reported.
Five patients (11.1%) in the TACE plus radiotherapy group were able to undergo curative surgical resection due to downstaging.
The risk of TACE-induced liver failure is a concern based on results of previous studies in patients with HCC and macroscopic vascular invasion, but in this study, there were no discontinuations due to adverse events in the TACE-radiation group, the authors noted.
“Our study may not be large enough to accurately establish the incidence of adverse events,” they wrote. “However, considering the dismal prognosis, the superior efficacy of TACE plus RT vs. sorafenib may justify its use for these patients.”
Dr. Yoon reported no disclosures related to the study. One coauthor reported research funding and advisory board membership with Bayer Healthcare and Gilead Sciences.
SOURCE: Yoon SM et al. 2018 Mar 15 JAMA Oncol. doi: 10.1001/jamaoncol.2017.5847.
FROM JAMA ONCOLOGY
Key clinical point: Use of transarterial chemoembolization (TACE) plus external beam radiotherapy may improve outcomes in patients with hepatocellular carcinoma (HCC) showing macroscopic vascular invasion.
Major finding: Progression-free survival at 12 weeks was 86.7% for patients receiving TACE plus radiotherapy group, versus 34.3% for patients receiving sorafenib (P less than .001).
Study details: A randomized, open-label clinical trial of 90 patients with liver-confined HCC and macroscopic vascular invasion.
Disclosures: One author reported research funding and advisory board membership with Bayer Healthcare and Gilead Sciences.
Source: Yoon SM et al. JAMA Oncol. 2018 Mar 15. doi: 10.1001/jamaoncol.2017.5847.