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In a randomized trial involving patients with non–small-cell lung cancer with mutant EGFR (T790M) in whom a tyrosine kinase inhibitor had failed, osimertinib was associated with significantly longer progression-free survival than platinum therapy plus pemetrexed. Among patients with advanced non–small-cell lung cancer with a mutant epidermal growth factor receptor (EGFR), EGFR tyrosine kinase inhibitors (TKIs) are the standard first-line therapy. 1 – 4 Despite high tumor response rates with first-line EGFR-TKIs, disease progresses in a majority of patients after 9 to 13 months of treatment. 5 – 12 At the time of progression, approximately 60% of patients (regardless of race or ethnic background) are found to have a p.Thr790Met point mutation (T790M) in the gene encoding EGFR. 13 – 16 The presence of the T790M variant reduces binding of first-generation or second-generation EGFR-TKIs to the ATP-binding pocket of EGFR, thereby reducing . . .

This trial compared the efficacy of antiplatelet therapy with prasugrel or clopidogrel in patients with non–ST-segment elevation MI or unstable angina. Although prasugrel provides more intense platelet inhibition, clinical outcomes were similar with the two drugs. Clinical-practice guidelines for patients with acute coronary syndromes consisting of unstable angina or myocardial infarction without ST-segment elevation recommend a strategy of early invasive management (angiography within 48 to 72 hours with provisional revascularization) for patients at moderate to high risk. 1 , 2 However, analyses from clinical trials and national registries have shown that many such patients are treated medically without revascularization and that such patients have poorer long-term cardiovascular outcomes than those who undergo revascularization. 3 – 6 Even though patients with acute coronary syndromes who receive only medical therapy have an increased-risk profile, they have been underrepresented in large-scale, contemporary, randomized . . .

The OlympiAD Phase III study (NCT02000622) established the clinical benefits of olaparib tablet monotherapy (300 mg twice daily) over chemotherapy treatment of physician’s choice (TPC) in patients with a germline BRCA1/2 mutation (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who had received ≤2 chemotherapy lines in the metastatic setting. Here, we report pre-specified analyses of data from Asian (China, Japan, Korea and Taiwan) patients in the study. All patients were randomized 2:1 to olaparib tablets (300 mg twice daily) or single-agent chemotherapy TPC (21-day cycles of either capecitabine, eribulin or vinorelbine). The primary endpoint was progression-free survival assessed by blinded independent central review. The prevalence of gBRCAm in the OlympiAD Asian subgroup screened for study recruitment was 13.5%. Patient demographics and disease characteristics of the Asian subgroup (87/302 patients) were generally well balanced between treatment arms. Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29–0.97]), which was consistent with findings in the global OlympiAD study population. Findings on secondary efficacy and safety/tolerability outcome measures in Asian patients were also similar to those observed in the global OlympiAD study population. The OlympiAD study was not powered to detect race-related differences between treatment groups; however, the consistency of our findings with the global OlympiAD study population suggests that previously reported findings are generalizable to Asian patients.

Up to 30% of patients with metastatic castration-resistant prostate cancer have deleterious mutations in genes involved in homologous recombination repair of DNA damage. The use of the PARP inhibitor olaparib in such patients was associated with longer progression-free survival and a longer time to pain progression than control therapy.

Among patients who had mutations in BRCA1 or BRCA2 and were at high risk for disease progression, those who were assigned to a year of olaparib adjuvant therapy had 3-year invasive disease–free survival of 86%, as compared with 77% among those who were assigned to placebo. Few patients stopped olaparib owing to side effects.

When used as maintenance therapy, the PARP inhibitor olaparib provided a significant progression-free survival benefit in women with ovarian cancer who had a response to primary chemotherapy, particularly in those whose tumors were deficient in homologous recombination (e.g., BRCA -mutated tumors). Hematologic toxic effects were observed.

Among women with previously untreated hormone-receptor–positive advanced breast cancer, the addition of the cyclin-dependent kinase inhibitor palbociclib to letrozole therapy resulted in longer progression-free survival than that with letrozole alone. Hormone-receptor–positive breast cancer represents the largest therapeutic subtype of the disease, accounting for 60 to 65% of all malignant neoplasms of the breast. For more than 50 years, the treatment of hormone-receptor–positive disease has been focused on targeting the estrogen-receptor signaling pathway. 1 However, both new and acquired resistance to hormonal blockade occurs in a large subset of these cancers, and new approaches are needed. 2 The cyclin-dependent kinases (CDKs) are a large family of serine–threonine kinases that play an important role in regulating cell-cycle progression. The interaction of cyclin D with CDK4 and CDK6 facilitates the hyperphosphorylation of the retinoblastoma (Rb) . . .

In a multicenter trial in 566 patients with critical illness who had delirium, the use of haloperidol or ziprasidone, as compared with placebo, had no significant effect on the duration of delirium or coma. Side effects and extrapyramidal disorders occurred at similar rates in all groups.

Approximately 7% of pancreatic cancers occur in patients with a germline mutation in BRCA1 or BRCA2 , an alteration that compromises DNA repair. In a randomized trial in patients with metastatic pancreatic cancer that had responded to platinum-based chemotherapy, progression-free survival was nearly twice as long with olaparib than with placebo (7.4 months vs. 3.8 months).

The addition of palbociclib to fulvestrant prolonged overall survival among women with hormone receptor–positive, HER2-negative advanced breast cancer who had sensitivity to previous hormonal therapy. In the entire trial group, survival differences were not significant.