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Abemaciclib for Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Abemaciclib is the third CDK 4/6 inhibitor to become available for use in women with hormone receptor-positive, HER2-negative advanced breast cancer. In a phase III trial, abemaciclib plus fulvestrant improved progression-free survival compared with fulvestrant alone, and in a nonrandomized phase II study abemaciclib showed single agent activity in patients with progression following chemotherapy. Based upon these results, abemaciclib was approved by the US Food and Drug Administration in combination with fulvestrant for women with progressive disease after prior endocrine therapy and for use as a single agent for women with progressive disease after endocrine therapy and chemotherapy.
Evaluation for Occult Cancer in Unprovoked Venous Thromboembolism
Whether patients with a diagnosis of unprovoked venous embolism (VTE) should be evaluated for occult cancer with an extensive or more limited strategy is controversial. In a meta-analysis of 10 prospective studies (over 2000 patients with unprovoked VTE), the prevalence of cancer at one year was 5 percent. Extensive screening, performed in nearly 60 percent of patients, detected more cancer initially than limited evaluation, but the difference was not significant at one year. The effect on long-term mortality is unknown. Until the benefits of extensive evaluation strategies are proven, we suggest evaluating patients with a single episode of unprovoked VTE using a limited strategy (clinical examination, routine laboratory studies, chest radiography, and age-appropriate screening) for the detection of occult cancer.
Pembrolizumab for Advanced Colorectal Cancer and Other Refractory Solid Tumors With Deficient DNA Mismatch Repair
In a small study comparing pembrolizumab administration in patients with mismatch repair-deficient (dMMR) metastatic colorectal cancer (mCRC) or with MMR proficient (pMMR) mCRC, the objective response rate and disease control rate were 50 and 89 percent, respectively, for patients with dMMR mCRC and 0 and 16 percent for the pMMR group. Largely based upon these data, the US Food and Drug Administration granted accelerated approval to pembrolizumab for the treatment of patients with advanced microsatellite instability-high (MSI-H) or dMMR mCRC that has progressed following conventional chemotherapy. The approval of pembrolizumab also extended to a variety of other advanced solid tumors (including endometrial, other gastrointestinal, breast, prostate, bladder, and thyroid) that were MSI-H or dMMR, had progressed following prior treatment, and for which there were no satisfactory alternative treatment options.
Nivolumab Plus Ipilimumab for Advanced Intermediate/Poor-Risk Renal Cell Carcinoma
Antiangiogenic agents such as sunitinib are currently used as initial treatment for patients with advanced renal cell carcinoma (RCC). A phase III trial evaluated initial treatment with a combination of the checkpoint inhibitors nivolumab and ipilimumab in such patients. In an initial report of this trial, the checkpoint inhibitor combination, compared with sunitinib, increased the objective response rate and progression-free survival in previously untreated intermediate/poor-risk patients, particularly in those whose tumors had high PD-L1 expression. The combination of nivolumab plus ipilimumab is not approved for use in advanced RCC; additional follow-up, including the impact on overall survival, will be required to define the role of this combination.
Plasma EBV DNA Screening in Populations at High Risk for Nasopharyngeal Carcinoma
Epstein-Barr virus (EBV) infection is an important etiologic risk factor for nasopharyngeal carcinoma (NPC) in regions where NPC is endemic. In a large cohort study, screening a healthy high-risk population for EBV DNA had a high sensitivity and specificity for the detection of early-stage NPC and was associated with a favorable progression-free survival (97 percent) at three years for newly diagnosed cases. While EBV-specific serologic screening has had limited specificity for nasopharyngeal carcinoma in other studies, analysis of plasma EBV DNA appears to have superior screening characteristics for screening an at-risk population for NPC in high-risk populations. EBV DNA screening can detect the cancer at an early stage with improved treatment outcomes compared with an unscreened population.
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