Pub Date : 2023-12-05DOI: 10.1097/01.cot.0000997504.83797.89
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Pub Date : 2023-11-20DOI: 10.1097/01.cot.0000996408.72744.97
Susan Jenks
Pancreatic Cancer: Pancreatic CancerInvestigators in a large-scale global initiative to improve pancreatic cancer survival will soon begin testing two blood-based biomarkers for their ability to distinguish between normal cells and early-stage disease in high-risk individuals. Validating these molecular markers is expected to take 3-5 years. Their identification arises from the collaborative research efforts of the Pancreatic Cancer Early Detection (PRECEDE) Consortium, now underway at 51 medical centers around the world. The consortium's goal is to improve patients' 5-year relative survival from a dismal 11 percent for all stages of disease today to 50 percent in the coming decade. Some 5,226 participants have been enrolled in the study so far with a goal of 10,000 participants, enabling researchers to address questions about risk factors, the level of that risk, and early-detection strategies to prevent or delay cancer development. Although PRECEDE is a 10-year observational study, “We're already starting to get some results,” said Diane Simeone, MD, the study's principal investigator and Director of the Pancreatic Cancer Center at NYU Langone Health. The newly identified biomarkers will be assessed for how well they perform in the largest of the study's six cohorts—individuals whose family histories, germ-line DNA mutations, or cystic tumors put them at increased risk for these complex cancers. One of the blood-based biomarkers measures specific proteins found on the surface of exosomes—sac-like structures inside cells—which house a grab bag of genetic debris, including DNA, RNA, and metabolites. Another product measures methylated DNA, which regulates gene expression. While PRECEDE is not the only research group actively assessing candidate biomarkers for early pancreatic cancers, the consortium's broad scope and collaborative data-sharing—a prerequisite for joining—could help move the needle closer to early detection sooner, according to Simeone. In addition to the 51 medical centers now in the consortium, at least 25 others from the U.K., India, Japan, and Hungary recently expressed an interest in joining. The American Cancer Society estimates that 64,050 men and women in the U.S. will be diagnosed with pancreatic cancer in 2023, while 50,500 are expected to die of the disease. Less than 10-15 percent of these cancers are detected early when they are resectable and amenable to surgery, but even then, experts say most exceed the size that carries the best hope for long-term survival. Moreover, “in half of patients, we still can't pinpoint why they got this cancer,” Simeone said. Hurdles to early detection lie, in part, to the pancreas' location deep within the abdomen and also to vague symptoms similar to other illnesses. Also, no effective screening test yet exists, nor is one recommended for the general population as yet because of high costs and the likelihood of overdiagnosis. However, ironically perhaps, early Stage I disease, which car
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Pub Date : 2023-11-20DOI: 10.1097/01.cot.0000996384.79881.ca
Dibash Kumar Das
Genomics, Lung Cancer: Genomics, Lung CancerIn a recent development in the treatment of epidermal growth factor receptor (EGFR)-mutated metastatic non-small cell lung cancer (NSCLC), researchers reported positive results from a Phase Ib clinical trial evaluating the safety and tolerability of the combination of osimertinib and ipilimumab. The research was presented at the ESMO 2023 Congress, held in Madrid, Spain (Abstract 1335P). Osimertinib, an oral EGFR tyrosine kinase inhibitor (TKI), has proven to be a valuable option for the first-line treatment of EGFRm mNSCLC. However, combining osimertinib with PD-1/PD-L1 inhibitors has been hindered by excessive toxicity concerns. This led researchers to explore alternative combinations with immune checkpoint inhibitors, such as the CTLA-4 inhibitor ipilimumab. The decision to explore this combination stemmed from a prior Phase I trial that evaluated the use of the EGFR TKI erlotinib with ipilimumab in EGFRm mNSCLC. While the trial was terminated due to gastrointestinal dose-limiting toxicities (DLTs), it did reveal an unprecedented improvement in survival with a median overall survival of 42.3 months. Based on this observation, the researchers designed a clinical trial to investigate the combination of osimertinib with ipilimumab in EGFRm mNSCLC with a focus on the dose-escalation phase. This single-center, Phase IB trial enrolled patients who had been on a stable dose of first-line osimertinib (40 or 80 mg/day) for at least 28 days without disease progression. The trial commenced with Cohort 1 (C1), where patients received osimertinib daily along with ipilimumab at 3mg/kg every 3 weeks. A safety run was conducted with six patients, and the dose was planned to be expanded if fewer than or equal to one out of six patients experienced DLTs. However, if two or more out of six patients encountered DLTs, the study would de-escalate to Cohort 2 (C2), where patients received osimertinib daily with ipilimumab at 1mg/kg every 3 weeks. C2 would be expanded if fewer than or equal to one out of six patients experienced DLTs, and the study would be closed if two or more out of six patients experienced DLTs. The primary objective of the study was to determine the tolerability (per NCI CTCAE v5) of the osimertinib and ipilimumab combination, with key secondary endpoints including objective response rate, progression-free survival (PFS), and overall survival. Between September 2020 and March 2022, a total of 10 patients were enrolled, with four in C1 and six in C2. The majority of patients were never-smokers (80%), female (80%), and White (100%) with an ECOG performance status of 1. During the trial, three DLTs were observed, including one Grade 3 thromboembolic event and two Grade 2 cases of diarrhea, all of which occurred in C1. Common all-grade treatment-related adverse events (TRAEs) included diarrhea (60% of patients), fatigue, nail changes, and rash (40% of patients each). Grade 3-4 TRAEs were rare, with only on
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