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Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185).

ABSTRACT: BACKGROUND:The optimal surveillance strategy for pancreatic cysts, which occur in up to 20% of the adult population, is ill defined. The risk of malignant degeneration of these cysts is low, however the morbidity and mortality associated with pancreatic cancer are high. Two clinical surveillance guidelines are in regular use. Both the Fukuoka and American Gastroenterological Association (AGA) guidelines rely on radiographic and endoscopic imaging. They differ primarily in their recommended frequencies of interval surveillance imaging. While evidence driven clinical guidelines should promote higher quality care, competing guidelines on the same topic may provide discordant recommendations and potential reduction in the quality and/or value of care. OBJECTIVES:The primary objective is to compare the clinical effectiveness of the two surveillance guidelines to identify patients most likely to benefit from pancreatic resection. Secondary objectives include comparison of resource utilization, patient reported outcomes, incidental findings are other clinical outcomes. METHODS:4606 asymptomatic patients with newly identified pancreatic cysts ?1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance. All participants will be followed prospectively for 5 years. CONCLUSION:Differing guidelines confuse providers, patients and policymakers. This large, prospective, randomized trial will compare the clinical effectiveness and resource allocation requirements of two guidelines addressing a common clinical entity. CLINICALTRIALS. GOV IDENTIFIER:NCT04239573.

SUBMITTER: Weinberg DS

PROVIDER: S-EPMC7686040 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185).

Weinberg David S DS Gatsonis Constantine C Zeh Herbert J HJ Carlos Ruth C RC O'Dwyer Peter J PJ

Contemporary clinical trials 20200910

<h4>Background</h4>The optimal surveillance strategy for pancreatic cysts, which occur in up to 20% of the adult population, is ill defined. The risk of malignant degeneration of these cysts is low, however the morbidity and mortality associated with pancreatic cancer are high. Two clinical surveillance guidelines are in regular use. Both the Fukuoka and American Gastroenterological Association (AGA) guidelines rely on radiographic and endoscopic imaging. They differ primarily in their recommend ...[more]

PMID: 32920242

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Project description:BackgroundEribulin mesylate, a synthetic analog of halichondrin B, is a novel tubulin-binding agent that inhibits cancer cell proliferation at low-nanomolar levels.MethodsIn a multicenter ECOG trial, patients with progressive metastatic CRPC, ECOG 0-2 were treated with eribulin 1.4 mg/m as an IV bolus over 5 minutes on days 1 and 8 of a 21-day cycle. This noncomparative study stratified points to either a chemonaive (CN), prior-taxane (Tax) only, or 2 prior cytotoxic (TCx) chemotherapy arm. The trial was powered to detect a 50% PSA reduction using Consensus Criteria in at least 40% versus 20% (90% power, one-sided α=0.10) for the CN stratum and 25% versus. 10% (power 87%, one-sided α=0.10) for the Tax and TCx strata.ResultsIn total, 119 pts received treatment of which 116 were eligible for the primary response determination in this study. Median age 70 years (range, 45 to 88); median number of treatment cycles 4 (range, 1 to 20+); ECOG 0-1 90%. Confirmed PSA response rates (50% decline from baseline) were 29% (90% [18.2%, 41.2%]; P=0.20), 10% (90% [5.2%, 27.1%]; P=1.00), and 4% ([0.2%, 18.3%]; P=0.59) in the chemonaive stratum, the prior-taxane stratum, and the 2-prior-chemotherapy stratum, respectively. Median progression-free survival was 3.5 months (95% CI, 2.0, 5.9), 2.3 months (95% CI, 2.0, 2.9) and 3.7 months (95% CI, 2.1, 4.2) for the chemonaive stratum, the prior-taxane stratum and the 2-prior-chemotherapy stratum, respectively. Nonhematological toxicities of any grade (mainly grade 1 and 2) were fatigue (74%), neuropathy (40%), alopecia (39%), nausea (35%), and anorexia (34%). Common hematological toxicities were decreased leukocytes (75%), decreased neutrophils (72%), and decreased hemoglobin (66%). The most common grade ≥ 3 toxicities were decreased neutrophils (55%), decreased leukocytes (42%), sensory neuropathy (13%), and fatigue (11%). Overall, there was a 4% rate of febrile neutropenia.ConclusionsIn summary, per the prespecified study endpoints, eribulin did not have adequate activity in chemotherapy naïve or chemotherapy pretreated patients with metastatic CRPC to support further study in this setting.

Dataset Information

Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185).

Publications

Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185).

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