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Pembrolizumab for advanced hepatocellular carcinoma (February 2023)
Pembrolizumab has regulatory approval in the United States for patients with advanced hepatocellular carcinoma (HCC) refractory to tyrosine kinase inhibitors such as sorafenib and lenvatinib, but has not previously demonstrated an overall survival (OS) benefit. In a placebo-controlled phase III trial (KEYNOTE-394) of over 400 patients with advanced, treatment-refractory HCC from Asia, pembrolizumab improved OS (median 15 versus 13 months).1 For patients with advanced HCC and no more than Child's Class Pugh A disease who have progressed on sorafenib or lenvatinib, we continue to consider pembrolizumab to be an acceptable option.
Limited role for glucocorticoids in cancer-related fatigue (February 2023)
Patients with advanced cancer often experience fatigue related both to their disease and its treatments. In a meta-analysis including three randomized controlled trials in 165 patients with advanced cancer and fatigue, one week of dexamethasone resulted in a small improvement in cancer-related fatigue versus placebo, but this difference did not reach statistical significance.2 Given limited supporting evidence and known adverse events with glucocorticoids, we reserve their use in the treatment of cancer-related fatigue for patients who are in the terminal phase of advanced cancer.
Fam-trastuzumab deruxtecan in breast cancer brain metastases (January 2023)
Treatment for patients with breast cancer brain metastases (BMs) typically includes a local approach (ie, surgery or radiation), and few data exist regarding systemic therapy alone. In a study including 13 patients with advanced HER2-positive breast cancer and either asymptomatic untreated BMs or progressive BMs after local therapy, the antibody-drug conjugate fam-trastuzumab deruxtecan was associated with an intracranial response rate of 46 percent.3 Data on durability of response were not yet mature for this subgroup. Although limited, these data add to accumulating evidence supporting fam-trastuzumab deruxtecan in patients whose BMs have progressed despite prior local therapy; however, the number of patients with newly diagnosed BMs treated with fam-trastuzumab deruxtecan in lieu of radiotherapy is very small, and further data are required before this strategy is employed in routine clinical practice.
Tumor-infiltrating lymphocytes in advanced melanoma (January 2023)
For patients with metastatic melanoma who progress on immune checkpoint inhibitors, effective treatment options are limited, and there is interest in developing novel therapies. In a randomized trial in almost 200 patients with advanced unresectable or metastatic cutaneous melanoma (a majority of whom had progressed on a programmed cell death-1 [PD-1] inhibitor), personalized adoptive cell therapy with tumor-infiltrating lymphocytes (TILs) improved progression-free survival over single-agent ipilimumab (median 7.2 versus 3.1 months).4 While these data are promising, the use of TILs remains investigational, and we await regulatory approval prior to incorporating this approach into routine clinical practice.
Atezolizumab for advanced alveolar soft part sarcoma (January 2023)
For patients with metastatic alveolar soft part sarcoma (ASPS), treatment options are limited and there is interest in investigating novel therapies. In a phase II trial (Study ML39345) in almost 50 adult and pediatric patients with unresectable or metastatic ASPS, atezolizumab demonstrated an objective response rate of 24 percent and was well tolerated.5 For patients with unresectable or metastatic ASPS who have limited but progressive extracranial disease burden, we suggest single-agent immunotherapy rather than surveillance, and we consider atezolizumab to be one appropriate treatment option.
1. Qin S, Chen Z, Fang W, et al. Pembrolizumab Versus Placebo as Second-Line Therapy in Patients From Asia With Advanced Hepatocellular Carcinoma: A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2022.
2. Sandford A, Haywood A, Rickett K, et al. Corticosteroids for the management of cancer-related fatigue in adults with advanced cancer. Cochrane Database Syst Rev. 2023;1(1):CD013782. Epub 2023 Jan 23.
3. Perez-Garcia JM, Vaz Batista M, Cortez P, et al. Trastuzumab deruxtecan in patients with central nervous system involvement from HER2-positive breast cancer: The DEBBRAH trial. Neuro Oncol. 2023;25(1):157.
4. Rohaan MW, Borch TH, van den Berg JH, et al. Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma. N Engl J Med. 2022;387(23):2113.
5. Atezolizumab: United States Food and Drug Administration Prescribing Label https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s047lbl.pdf (Accessed on December 14, 2022).
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