Second‐line treatment of hepatocellular carcinoma after sorafenib: Characterizing treatments used over the past 10 years and real‐world eligibility for cabozantinib, regorafenib, and ramucirumab
Abstract Background The CELESTIAL, RESORCE, and REACH‐2 trials showed survival benefit of cabozantinib, regorafenib, and ramucirumab, respectively, in hepatocellular carcinoma (HCC) patients treated with sorafenib who had good performance status (ECOG 0‐1) and liver function (Child‐Pugh‐A). This stu...
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| Format: | Article |
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Wiley
2020-07-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.3116 |
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| author | Andrea S. Fung Vincent C. Tam Daniel E. Meyers Hao‐Wen Sim Jennifer J. Knox Valeriya Zaborska Janine Davies Yoo‐Joung Ko Eugene Batuyong Haider Samawi Winson Y. Cheung Richard Lee‐Ying |
| author_facet | Andrea S. Fung Vincent C. Tam Daniel E. Meyers Hao‐Wen Sim Jennifer J. Knox Valeriya Zaborska Janine Davies Yoo‐Joung Ko Eugene Batuyong Haider Samawi Winson Y. Cheung Richard Lee‐Ying |
| author_sort | Andrea S. Fung |
| collection | DOAJ |
| description | Abstract Background The CELESTIAL, RESORCE, and REACH‐2 trials showed survival benefit of cabozantinib, regorafenib, and ramucirumab, respectively, in hepatocellular carcinoma (HCC) patients treated with sorafenib who had good performance status (ECOG 0‐1) and liver function (Child‐Pugh‐A). This study characterizes subsequent treatments received by HCC patients after sorafenib, and determines the proportion of patients eligible for novel therapies if strict eligibility criteria (SEC) were utilized compared to more liberal modified eligibility criteria (MEC, including ECOG 2, Child‐Pugh‐B7). Methods HCC patients who received sorafenib between 2008 and 2017 were included from the Canadian HCC CHORD Database. Patients were classified as eligible or ineligible based on available CELESTIAL, RESORCE, and REACH‐2 trial SEC or MEC. Median overall survival (mOS) was assessed using the Kaplan‐Meier method. Results A total of 730 patients were identified; and 172 (23.6%) received subsequent treatment. Patients who received subsequent treatment had longer mOS than those who did not (12.1 vs 3.3 months; P < .001). Using SEC, only 13.1% of patients would be eligible for cabozantinib, regorafenib, or ramucirumab. Expanding eligibility to include patients who meet MEC increased the proportion of eligible patients to 31.7%. Higher ineligibility for regorafenib and ramucirumab was driven by trial‐specific criteria, including sorafenib intolerance (28%) for RESORCE and AFP <400 (58.9%) for REACH‐2. Conclusions A small proportion of real‐world HCC patients would be eligible for cabozantinib, regorafenib, or ramucirumab if SEC in clinical trials were followed, while more than double would be eligible if MEC were applied. Patients who received subsequent treatment had improved mOS, regardless of whether they met SEC or MEC. |
| format | Article |
| id | doaj-art-f4695cfcaa624e019d0cbdbba425df4f |
| institution | OA Journals |
| issn | 2045-7634 |
| language | English |
| publishDate | 2020-07-01 |
| publisher | Wiley |
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| series | Cancer Medicine |
| spelling | doaj-art-f4695cfcaa624e019d0cbdbba425df4f2025-08-20T01:58:43ZengWileyCancer Medicine2045-76342020-07-019134640464710.1002/cam4.3116Second‐line treatment of hepatocellular carcinoma after sorafenib: Characterizing treatments used over the past 10 years and real‐world eligibility for cabozantinib, regorafenib, and ramucirumabAndrea S. Fung0Vincent C. Tam1Daniel E. Meyers2Hao‐Wen Sim3Jennifer J. Knox4Valeriya Zaborska5Janine Davies6Yoo‐Joung Ko7Eugene Batuyong8Haider Samawi9Winson Y. Cheung10Richard Lee‐Ying11Tom Baker Cancer Centre Calgary AB CanadaTom Baker Cancer Centre Calgary AB CanadaTom Baker Cancer Centre Calgary AB CanadaNHMRC Clinical Trials Centre University of Sydney Camperdown NSW AustraliaPrincess Margaret Cancer Centre Toronto ON CanadaBC Cancer Agency Vancouver Centre Vancouver BC CanadaBC Cancer Agency Vancouver Centre Vancouver BC CanadaSunnybrook Health Sciences Centre – Odette Cancer Centre Toronto ON CanadaTom Baker Cancer Centre Calgary AB CanadaSt. Michael's Hospital Toronto ON CanadaTom Baker Cancer Centre Calgary AB CanadaTom Baker Cancer Centre Calgary AB CanadaAbstract Background The CELESTIAL, RESORCE, and REACH‐2 trials showed survival benefit of cabozantinib, regorafenib, and ramucirumab, respectively, in hepatocellular carcinoma (HCC) patients treated with sorafenib who had good performance status (ECOG 0‐1) and liver function (Child‐Pugh‐A). This study characterizes subsequent treatments received by HCC patients after sorafenib, and determines the proportion of patients eligible for novel therapies if strict eligibility criteria (SEC) were utilized compared to more liberal modified eligibility criteria (MEC, including ECOG 2, Child‐Pugh‐B7). Methods HCC patients who received sorafenib between 2008 and 2017 were included from the Canadian HCC CHORD Database. Patients were classified as eligible or ineligible based on available CELESTIAL, RESORCE, and REACH‐2 trial SEC or MEC. Median overall survival (mOS) was assessed using the Kaplan‐Meier method. Results A total of 730 patients were identified; and 172 (23.6%) received subsequent treatment. Patients who received subsequent treatment had longer mOS than those who did not (12.1 vs 3.3 months; P < .001). Using SEC, only 13.1% of patients would be eligible for cabozantinib, regorafenib, or ramucirumab. Expanding eligibility to include patients who meet MEC increased the proportion of eligible patients to 31.7%. Higher ineligibility for regorafenib and ramucirumab was driven by trial‐specific criteria, including sorafenib intolerance (28%) for RESORCE and AFP <400 (58.9%) for REACH‐2. Conclusions A small proportion of real‐world HCC patients would be eligible for cabozantinib, regorafenib, or ramucirumab if SEC in clinical trials were followed, while more than double would be eligible if MEC were applied. Patients who received subsequent treatment had improved mOS, regardless of whether they met SEC or MEC.https://doi.org/10.1002/cam4.3116cabozantinibhepatocellular carcinomaramucirumabregorafenibtrial eligibility |
| spellingShingle | Andrea S. Fung Vincent C. Tam Daniel E. Meyers Hao‐Wen Sim Jennifer J. Knox Valeriya Zaborska Janine Davies Yoo‐Joung Ko Eugene Batuyong Haider Samawi Winson Y. Cheung Richard Lee‐Ying Second‐line treatment of hepatocellular carcinoma after sorafenib: Characterizing treatments used over the past 10 years and real‐world eligibility for cabozantinib, regorafenib, and ramucirumab Cancer Medicine cabozantinib hepatocellular carcinoma ramucirumab regorafenib trial eligibility |
| title | Second‐line treatment of hepatocellular carcinoma after sorafenib: Characterizing treatments used over the past 10 years and real‐world eligibility for cabozantinib, regorafenib, and ramucirumab |
| title_full | Second‐line treatment of hepatocellular carcinoma after sorafenib: Characterizing treatments used over the past 10 years and real‐world eligibility for cabozantinib, regorafenib, and ramucirumab |
| title_fullStr | Second‐line treatment of hepatocellular carcinoma after sorafenib: Characterizing treatments used over the past 10 years and real‐world eligibility for cabozantinib, regorafenib, and ramucirumab |
| title_full_unstemmed | Second‐line treatment of hepatocellular carcinoma after sorafenib: Characterizing treatments used over the past 10 years and real‐world eligibility for cabozantinib, regorafenib, and ramucirumab |
| title_short | Second‐line treatment of hepatocellular carcinoma after sorafenib: Characterizing treatments used over the past 10 years and real‐world eligibility for cabozantinib, regorafenib, and ramucirumab |
| title_sort | second line treatment of hepatocellular carcinoma after sorafenib characterizing treatments used over the past 10 years and real world eligibility for cabozantinib regorafenib and ramucirumab |
| topic | cabozantinib hepatocellular carcinoma ramucirumab regorafenib trial eligibility |
| url | https://doi.org/10.1002/cam4.3116 |
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