CA209-9DX: Phase III, randomized, double-blind study of adjuvant nivolumab vs placebo for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after curative resection or ablation

Exposito, M.J. Jimenez; Akce, Mehmet; Álvarez, Jorge Lima; Assenat, Éric; Balart, L.; Baron, Ari David; Decaens, Thomas; Heurgué–Berlot, Alexandra; Martín, Antonio Olveira; Paik, S.W.; Poulart, Valerie; Sehbai, Aasim; Shimada, M.; Takemura, Nobuyuki; Yoon, Jeong-Hwa

doi:10.1093/annonc/mdy432.059

Cited by 12 publications

(4 citation statements)

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“…The STORM phase III clinical trial was performed to assess the efficacy of sorafenib versus placebo in adjuvant treatment after surgical resection or local ablation. This trial failed to demonstrate a significant improvement in RFS or OS in patients treated with sorafenib versus placebo, which could be partially explained by a high discontinuation rate due to adverse events (24% in the sorafenib treatment group) [157]. IMbrave150 phase III clinical trial compared the combination of atezolizumab and bevacizumab (Atezo-Bev), and PD-1L inhibitor and VEGF inhibitor respectively, to sorafenib post HCC resection/ablation in a high-risk-for-recurrence population (tumor greater than five centimeters, vascular invasion or high-grade pathology).…”

Section: Adjuvant Therapiesmentioning

confidence: 90%

Hepatocellular Carcinoma: Surveillance, Diagnosis, Evaluation and Management

Elderkin,

Al Hallak,

Azmi

et al. 2023

Cancers

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Hepatocellular carcinoma (HCC) ranks fourth in cancer-related deaths worldwide. Semiannual surveillance of the disease for patients with cirrhosis or hepatitis B virus allows for early detection with more favorable outcomes. The current underuse of surveillance programs demonstrates the need for intervention at both the patient and provider level. Mail outreach along with navigation provision has proven to increase surveillance follow-up in patients, while provider-targeted electronic medical record reminders and compliance reports have increased provider awareness of HCC surveillance. Imaging is the primary mode of diagnosis in HCC with The Liver Imaging Reporting and Data System (LI-RADS) being a widely accepted comprehensive system that standardizes the reporting and data collection for HCC. The management of HCC is complex and requires multidisciplinary team evaluation of each patient based on their preference, the state of the disease, and the available medical and surgical interventions. Staging systems are useful in determining the appropriate intervention for HCC. Early-stage HCC is best managed by curative treatment modalities, such as liver resection, transplant, or ablation. For intermediate stages of the disease, transarterial local regional therapies can be applied. Advanced stages of the disease are treated with systemic therapies, for which there have been recent advances with new drug combinations. Previously sorafenib was the mainstay systemic treatment, but the recent introduction of atezolizumab plus bevacizumab proves to have a greater impact on overall survival. Although there is a current lack of improved outcomes in Phase III trials, neoadjuvant therapies are a potential avenue for HCC management in the future.

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Section: Adjuvant Therapiesmentioning

confidence: 90%

Hepatocellular Carcinoma: Surveillance, Diagnosis, Evaluation and Management

Elderkin,

Al Hallak,

Azmi

et al. 2023

Cancers

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“…Adjuvant therapy will certainly cause adverse events and increase treatment costs, but it may not significantly reduce the postoperative recurrent rate. Almost all randomized trials that have been published 11 – 13 or are 14 – 16 currently ongoing recruited HCC patients at high risk of recurrence after curative hepatectomy or local ablation. Official guidelines also recommend that HCC patients at high risk of recurrence are eligible to participate in clinical trials and receive adjuvant therapy.…”

Section: Unanswered Questions Of Adjuvant Treatmentmentioning

confidence: 99%

“… 65 Longer follow-up is needed to confirm the efficacy of adjuvant atezolizumab plus bevacizumab. Other randomized trials are currently underway, including CheckMate 9DX, 14 KEYNOTE-937, 15 and EMERALD-2 16 ( Table 1 ). We are looking forward to the reporting of the trial results.…”

Section: Unanswered Questions Of Adjuvant Treatmentmentioning

confidence: 99%

Adjuvant Therapy for Hepatocellular Carcinoma After Curative Treatment: Several Unanswered Questions

Li,

Pan

et al. 2024

J Clin Transl Hepatol

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Most patients with hepatocellular carcinoma (HCC) have a poor prognosis. Hepatectomy and local ablation are the main curative treatments for HCC. Nevertheless, the recurrence rate after hepatectomy or ablation is up to 70%, which seriously affects patient prognosis. Several adjuvant therapies have been explored to reduce postoperative recurrence. However, although a variety of adjuvant therapies have been shown to reduce the recurrence rate and improve overall survival, a standard consensus of national HCC guidelines for adjuvant treatment is lacking. Therefore, there are significant differences in the recommendations for adjuvant therapy for HCC between the Eastern and Western guidelines. A variety of adjuvant treatment methods, such as antiviral therapy, transarterial chemoembolization or traditional Chinese medicine, are recommended by the Chinese HCC guidelines. However, Western guidelines make few recommendations other than antiviral therapy. Adjuvant immune checkpoint inhibitors are recommended only in the recently updated American Association for the Study of Liver Diseases guidelines. This review summarized the existing adjuvant therapy options after curative hepatectomy or ablation and discusses several important dilemmas of adjuvant treatments.

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“…Unfortunately, there are no published randomized trials evaluating this approach and most of the current trials are evaluating the outcomes of patients with advanced disease[68-70,109]. However, the CheckMate 9DX is an ongoing trial evaluating the use of adjuvant Nivolumab in patients with HCC who are at high risk of recurrence after curative resection or ablation[110,111]. The findings of this trial are greatly anticipated.…”

Section: Adjuvant Strategies For Hccmentioning

confidence: 99%

Neoadjuvant and adjuvant treatment strategies for hepatocellular carcinoma

Akateh¹,

Black²,

Conteh³

et al. 2019

WJG

127

103

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Hepatocellular carcinoma (HCC) is the most common liver malignancy worldwide and a major cause of cancer-related mortality for which liver resection is an important curative-intent treatment option. However, many patients present with advanced disease and with underlying chronic liver disease and/or cirrhosis, limiting the proportion of patients who are surgical candidates. In addition, the development of recurrent or de novo cancers following surgical resection is common. These issues have led investigators to evaluate the benefit of neoadjuvant and adjuvant treatment strategies aimed at improving resectability rates and decreasing recurrence rates. While high-level evidence to guide treatment decision making is lacking, recent advances in locoregional and systemic therapies, including antiviral treatment and immunotherapy, raise the prospect of novel approaches that may improve the outcomes of patients with HCC. In this review, we evaluate the evidence for various neoadjuvant and adjuvant therapies and discuss opportunities for future clinical and translational research.

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CA209-9DX: Phase III, randomized, double-blind study of adjuvant nivolumab vs placebo for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after curative resection or ablation

Cited by 12 publications

References 0 publications

Hepatocellular Carcinoma: Surveillance, Diagnosis, Evaluation and Management

Hepatocellular Carcinoma: Surveillance, Diagnosis, Evaluation and Management

Adjuvant Therapy for Hepatocellular Carcinoma After Curative Treatment: Several Unanswered Questions

Neoadjuvant and adjuvant treatment strategies for hepatocellular carcinoma

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