Perioperative nivolumab monotherapy versus nivolumab plus ipilimumab in resectable hepatocellular carcinoma: a randomised, open-label, phase 2 trial
Hepatocellular carcinoma has high recurrence rates after surgery; however, there are no approved standard-of-care neoadjuvant or adjuvant therapies. Immunotherapy has been shown to improve survival in advanced hepatocellular carcinoma; we therefore aimed to evaluate the safety and tolerability of pe...
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Published in | The lancet. Gastroenterology & hepatology Vol. 7; no. 3; p. 208 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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01.03.2022
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Abstract | Hepatocellular carcinoma has high recurrence rates after surgery; however, there are no approved standard-of-care neoadjuvant or adjuvant therapies. Immunotherapy has been shown to improve survival in advanced hepatocellular carcinoma; we therefore aimed to evaluate the safety and tolerability of perioperative immunotherapy in resectable hepatocellular carcinoma.
In this single-centre, randomised, open-label, phase 2 trial, patients with resectable hepatocellular carcinoma were randomly assigned (1:1) to receive 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery at 6 weeks) followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for 2 years, or 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery) plus one dose of 1 mg/kg of ipilimumab intravenously concurrently with the first preoperative dose of nivolumab, followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for up to 2 years plus 1 mg/kg of ipilimumab intravenously every 6 weeks for up to four cycles. Patients were randomly assigned to the treatment groups by use of block randomisation with a random block size. The primary endpoint was the safety and tolerability of nivolumab with or without ipilimumab. Secondary endpoints were the proportion of patients with an overall response, time to progression, and progression-free survival. This trial is registered with ClinicalTrials.gov (NCT03222076) and is completed.
Between Oct 30, 2017, and Dec 3, 2019, 30 patients were enrolled and 27 were randomly assigned: 13 to nivolumab and 14 to nivolumab plus ipilimumab. Grade 3-4 adverse events were higher with nivolumab plus ipilimumab (six [43%] of 14 patients) than with nivolumab alone (three [23%] of 13). The most common treatment-related adverse events of any grade were increased alanine aminotransferase (three [23%] of 13 patients on nivolumab vs seven [50%] of 14 patients on nivolumab plus ipilimumab) and increased aspartate aminotransferase (three [23%] vs seven [50%]). No patients in either group had their surgery delayed due to grade 3 or worse adverse events. Seven of 27 patients had surgical cancellations, but none was due to treatment-related adverse events. Estimated median progression-free survival was 9·4 months (95% CI 1·47-not estimable [NE]) with nivolumab and 19·53 months (2·33-NE) with nivolumab plus ipilimumab (hazard ratio [HR] 0·99, 95% CI 0·31-2·54); median time to progression was 9·4 months (95% CI 1·47-NE) in the nivolumab group and 19·53 months (2·33-NE) in the nivolumab plus ipilimumab group (HR 0·89, 95% CI 0·31-2·54). In an exploratory analysis, three (23%) of 13 patients had an overall response with nivolumab monotherapy, versus none with nivolumab plus ipilimumab. Three (33%) of nine patients had a major pathological response (ie, ≥70% necrosis in the resected tumour area) with nivolumab monotherapy compared with three (27%) of 11 with nivolumab plus ipilimumab.
Perioperative nivolumab alone and nivolumab plus ipilimumab appears to be safe and feasible in patients with resectable hepatocellular carcinoma. Our findings support further studies of immunotherapy in the perioperative setting in hepatocellular carcinoma.
Bristol Myers Squibb and the US National Institutes of Health. |
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AbstractList | Hepatocellular carcinoma has high recurrence rates after surgery; however, there are no approved standard-of-care neoadjuvant or adjuvant therapies. Immunotherapy has been shown to improve survival in advanced hepatocellular carcinoma; we therefore aimed to evaluate the safety and tolerability of perioperative immunotherapy in resectable hepatocellular carcinoma.
In this single-centre, randomised, open-label, phase 2 trial, patients with resectable hepatocellular carcinoma were randomly assigned (1:1) to receive 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery at 6 weeks) followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for 2 years, or 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery) plus one dose of 1 mg/kg of ipilimumab intravenously concurrently with the first preoperative dose of nivolumab, followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for up to 2 years plus 1 mg/kg of ipilimumab intravenously every 6 weeks for up to four cycles. Patients were randomly assigned to the treatment groups by use of block randomisation with a random block size. The primary endpoint was the safety and tolerability of nivolumab with or without ipilimumab. Secondary endpoints were the proportion of patients with an overall response, time to progression, and progression-free survival. This trial is registered with ClinicalTrials.gov (NCT03222076) and is completed.
Between Oct 30, 2017, and Dec 3, 2019, 30 patients were enrolled and 27 were randomly assigned: 13 to nivolumab and 14 to nivolumab plus ipilimumab. Grade 3-4 adverse events were higher with nivolumab plus ipilimumab (six [43%] of 14 patients) than with nivolumab alone (three [23%] of 13). The most common treatment-related adverse events of any grade were increased alanine aminotransferase (three [23%] of 13 patients on nivolumab vs seven [50%] of 14 patients on nivolumab plus ipilimumab) and increased aspartate aminotransferase (three [23%] vs seven [50%]). No patients in either group had their surgery delayed due to grade 3 or worse adverse events. Seven of 27 patients had surgical cancellations, but none was due to treatment-related adverse events. Estimated median progression-free survival was 9·4 months (95% CI 1·47-not estimable [NE]) with nivolumab and 19·53 months (2·33-NE) with nivolumab plus ipilimumab (hazard ratio [HR] 0·99, 95% CI 0·31-2·54); median time to progression was 9·4 months (95% CI 1·47-NE) in the nivolumab group and 19·53 months (2·33-NE) in the nivolumab plus ipilimumab group (HR 0·89, 95% CI 0·31-2·54). In an exploratory analysis, three (23%) of 13 patients had an overall response with nivolumab monotherapy, versus none with nivolumab plus ipilimumab. Three (33%) of nine patients had a major pathological response (ie, ≥70% necrosis in the resected tumour area) with nivolumab monotherapy compared with three (27%) of 11 with nivolumab plus ipilimumab.
Perioperative nivolumab alone and nivolumab plus ipilimumab appears to be safe and feasible in patients with resectable hepatocellular carcinoma. Our findings support further studies of immunotherapy in the perioperative setting in hepatocellular carcinoma.
Bristol Myers Squibb and the US National Institutes of Health. |
Author | Xu, Li Yao, James C Qayyum, Aliya Jindal, Sonali Allison, James Patrick Vauthey, Jean-Nicolas Beretta, Laura Kaseb, Ahmed Omar Xiao, Lianchun Chun, Yun Shin Lee, Sunyoung S Carter, Kristen Yavuz, Betul Gok Sun, Jing Jing Basu, Sreyashi Cristini, Vittorio Duan, Fei Yadav, Shalini S Sakamuri, Divya Sharma, Padmanee Nicholas, Courtney Wolff, Robert A Singh Raghav, Kanwal Pratap Cao, Hop Sanderson Tran Sun, Ryan Hasanov, Elshad Rashid, Asif Tzeng, Ching-Wei David Mohamed, Yehia I |
Author_xml | – sequence: 1 givenname: Ahmed Omar surname: Kaseb fullname: Kaseb, Ahmed Omar email: akaseb@mdanderson.org organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: akaseb@mdanderson.org – sequence: 2 givenname: Elshad surname: Hasanov fullname: Hasanov, Elshad organization: Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 3 givenname: Hop Sanderson Tran surname: Cao fullname: Cao, Hop Sanderson Tran organization: Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 4 givenname: Lianchun surname: Xiao fullname: Xiao, Lianchun organization: Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 5 givenname: Jean-Nicolas surname: Vauthey fullname: Vauthey, Jean-Nicolas organization: Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 6 givenname: Sunyoung S surname: Lee fullname: Lee, Sunyoung S organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 7 givenname: Betul Gok surname: Yavuz fullname: Yavuz, Betul Gok organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 8 givenname: Yehia I surname: Mohamed fullname: Mohamed, Yehia I organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 9 givenname: Aliya surname: Qayyum fullname: Qayyum, Aliya organization: Department of Abdominal Imaging, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 10 givenname: Sonali surname: Jindal fullname: Jindal, Sonali organization: Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 11 givenname: Fei surname: Duan fullname: Duan, Fei organization: Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 12 givenname: Sreyashi surname: Basu fullname: Basu, Sreyashi organization: Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 13 givenname: Shalini S surname: Yadav fullname: Yadav, Shalini S organization: Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 14 givenname: Courtney surname: Nicholas fullname: Nicholas, Courtney organization: Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 15 givenname: Jing Jing surname: Sun fullname: Sun, Jing Jing organization: Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 16 givenname: Kanwal Pratap surname: Singh Raghav fullname: Singh Raghav, Kanwal Pratap organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 17 givenname: Asif surname: Rashid fullname: Rashid, Asif organization: Department of Pathology, Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 18 givenname: Kristen surname: Carter fullname: Carter, Kristen organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 19 givenname: Yun Shin surname: Chun fullname: Chun, Yun Shin organization: Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 20 givenname: Ching-Wei David surname: Tzeng fullname: Tzeng, Ching-Wei David organization: Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 21 givenname: Divya surname: Sakamuri fullname: Sakamuri, Divya organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 22 givenname: Li surname: Xu fullname: Xu, Li organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 23 givenname: Ryan surname: Sun fullname: Sun, Ryan organization: Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 24 givenname: Vittorio surname: Cristini fullname: Cristini, Vittorio organization: Mathematics in Medicine Program, Houston Methodist Research Institute, Houston, TX, USA – sequence: 25 givenname: Laura surname: Beretta fullname: Beretta, Laura organization: Department of Molecular and Cellular Oncology, Division of Basic Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 26 givenname: James C surname: Yao fullname: Yao, James C organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 27 givenname: Robert A surname: Wolff fullname: Wolff, Robert A organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 28 givenname: James Patrick surname: Allison fullname: Allison, James Patrick organization: Department of Pathology, Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA – sequence: 29 givenname: Padmanee surname: Sharma fullname: Sharma, Padmanee email: padsharma@mdanderson.org organization: Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: padsharma@mdanderson.org |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35065057$$D View this record in MEDLINE/PubMed |
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SubjectTerms | Aged Alanine Transaminase - blood Antineoplastic Agents, Immunological - administration & dosage Antineoplastic Agents, Immunological - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Aspartate Aminotransferases - blood Carcinoma, Hepatocellular - drug therapy Carcinoma, Hepatocellular - surgery Female Humans Ipilimumab - administration & dosage Ipilimumab - adverse effects Liver Neoplasms - drug therapy Liver Neoplasms - surgery Male Middle Aged Nivolumab - administration & dosage Nivolumab - adverse effects Perioperative Care Progression-Free Survival |
Title | Perioperative nivolumab monotherapy versus nivolumab plus ipilimumab in resectable hepatocellular carcinoma: a randomised, open-label, phase 2 trial |
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