Oral Drug Combo Shows Efficacy for Older AML Patients; Delayed Pegfilgrastim Reduces Breast Cancer Bone Pain
Two separate clinical trials have reported advances in cancer care. An oral drug combination of decitabine-cedazuridine and venetoclax showed efficacy in older patients with acute myeloid leukemia, with a 47% complete response rate in a phase 2b trial. A separate randomized controlled trial found that delaying pegfilgrastim administration to 72 hours post-chemotherapy significantly reduced bone pain in women with stage I–III breast cancer.
Two recent clinical studies have advanced cancer treatment approaches, one demonstrating the efficacy of an oral drug combination for older patients with acute myeloid leukemia and another showing that delaying pegfilgrastim administration reduces bone pain in breast cancer patients.
In the first study, an oral combination of decitabine-cedazuridine and venetoclax was evaluated in a phase 1 to 2 open-label, multicenter nonrandomized trial involving patients with newly diagnosed acute myeloid leukemia (AML) aged 75 years or older who were ineligible for intensive chemotherapy. The trial enrolled 189 patients: 30 in phase 1, 58 in phase 2a, and 101 in phase 2b. Researchers observed no drug-drug interactions between the agents. In phase 2b, 47 percent of patients achieved a complete response, while 63 percent achieved a complete response or complete response with incomplete hematologic recovery. The median overall survival was 15.5 months. Common grade 3 or higher adverse events included anemia (30 percent), neutropenia (26 percent), and febrile neutropenia (25 percent). Mortality rates were 3 percent at 30 days and 10 percent at 60 days. The study, published in the New England Journal of Medicine, was funded by Taiho Oncology.
The second study was a phase 3 randomized controlled trial of 159 patients with stage I–III breast cancer, which found that administering pegfilgrastim 72 hours after chemotherapy significantly reduced bone pain compared with dosing at 24 or 48 hours. In cycle 1, mean area under the curve (AUC) scores for worst bone pain over 5 days were 6.05 in the 72-hour group, versus 12.74 in the 24-hour group and 14.20 in the 48-hour group. The 72-hour group also had lower rates of any-grade and severe bone pain, and markedly reduced use of rescue analgesia (1.9 percent versus 28.3 percent and 22.6 percent in the 24- and 48-hour groups, respectively). Quality of life was maintained in the 72-hour group, while it declined significantly in the other two groups. No cases of febrile neutropenia occurred, and adverse event rates were similar across all groups.