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Mixed Data Regarding Denosumab as Adjuvant Breast Cancer Treatment

Data are evolving regarding the use of the anti-RANK-ligand denosumab as an adjuvant breast cancer treatment. In preliminary results of one randomized trial of 3400 postmenopausal women receiving adjuvant aromatase inhibitors (AI), denosumab improved disease-free survival (DFS). However, in a separate trial of 4500 patients with early breast cancer, over half of whom were on adjuvant AI treatment, denosumab did not improve DFS in the overall population or in subgroups categorized by either tumor receptor or patient menopause status. We continue to use denosumab for bone health indications only, rather than breast cancer outcomes, pending further data.


Early Experience With Checkpoint Inhibitors in Recurrent Glioblastoma

Although multiple trials are testing various forms of immunotherapy in patients with glioblastoma, published data remain limited. In a phase I trial investigating the safety of monotherapy or combination therapy with two checkpoint inhibitors, nivolumab (a programmed death 1 [PD-1] inhibitor) with and without ipilimumab (an anti-cytotoxic T-lymphocyte antigen 4 [CTLA4] antibody), in 40 patients with recurrent glioblastoma, nivolumab monotherapy was better tolerated than combination therapy, and a partial response was seen in three patients (one treated with monotherapy, two with combination therapy). An additional eight patients had stable disease for >=12 weeks (two treated with nivolumab monotherapy). PD-1 ligand expression did not correlate with clinical response. Further studies are needed to help select patients most likely to respond to checkpoint inhibitor immunotherapy.


Initial Sorafenib Versus Nonsurgical Liver-Directed Therapies for Liver-Limited Hepatocellular Cancer

Two new studies have addressed the relative benefit of initial systemic therapy versus nonsurgical liver-directed therapy in patients with liver-limited hepatocellular cancer (HCC) that is not amenable to resection, transplantation, or local ablation:


* A randomized trial involving 360 Asian patients with newly diagnosed unresectable HCC without portal vein thrombus or extrahepatic metastases (89 percent Child-Pugh A cirrhosis) compared sorafenib with radioembolization using 90-Y microspheres; radioembolization provided a higher disease control rate with fewer adverse events.


* In a trial comparing transhepatic arterial chemoembolization (TACE) plus radiotherapy (RT) versus sorafenib in 90 patients with liver-confined HCC invading no more than the first or second branch of the portal vein, and Child-Pugh A cirrhosis, TACE/RT improved progression-free survival, radiographic response rates, and overall survival.



Given the more favorable side effect profile, locoregional forms of therapy such as TACE and radioembolization may be preferable to systemic therapy for initial treatment of unresectable liver-limited HCC in patients who are suitable candidates for such procedures.


Treatment of Metastatic Castration-Sensitive Prostate Cancer

Multiple clinical trials have delineated the benefits and toxicities of combining androgen deprivation therapy (ADT) with either docetaxel or abiraterone compared with ADT alone for the initial treatment of men with metastatic castration-sensitive prostate cancer (CSPC). Based upon these trials, the American Society of Clinical Oncology (ASCO) has published guidelines for the treatment of metastatic CSPC. Both ADT plus docetaxel and ADT plus abiraterone are preferred options compared with ADT alone for patients with high-volume CSPC and/or high risk for more rapid disease progression or death. There are no direct data comparing ADT plus docetaxel versus ADT plus abiraterone, and the choice of treatment should include a discussion with the patient about potential toxicities, duration of treatment, and costs.


Pembrolizumab for Recurrent or Metastatic PD-L1 Positive Cervical Cancer

For women with recurrent or metastatic cervical cancer, chemotherapy has been standard treatment, initially in combination regimens and, upon progression, as single agent treatment. However, in preliminary results of a phase II study, among 81 previously treated patients with advanced cervical cancer with programmed death-ligand 1 (PD-L1) expression of 1 percent or more, the objective response rate to the immune checkpoint inhibitor pembrolizumab was 13 percent at a median follow-up of 10.3 months, and the median duration of response had not been reached. For women who have experienced progression on prior chemotherapy for metastatic cervical cancer and desire further treatment, we now assess PD-L1 expression and offer pembrolizumab as an option if PD-L1 is expressed.


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