Background/Aims: No single classification system has so far effectively predicted the severity for Acute Pancreatitis (AP). This study compares the effectiveness of classification systems: Original Atlanta (OAC), Revised Atlanta (RAC), Determinant based classification (DBC), PANC 3, Harmless AP Score (HAPS), Japanese Severity Score (JSS), Symptoms Nutrition Necrosis Antibiotics and Pain (SNNAP), and Beside Index of Severity for AP (BISAP) in predicting outcomes in AP. Methods: Scores for BISAP, Panc 3, HAPS, SNNAP, OAC, RAC, and DBC were calculated for 221 adult patients hospitalized for AP. Receiver Operating Characteristic curve analysis and Akaike Information Criteria were used to compare the effectiveness of predicting need for surgery, intensive care unit (ICU) admission, readmission within 30 days, and length of hospital stay. Results: Both the RAC and the DBC strongly predict the length of hospital stay (p < 0.0001 for both) and ICU admission (p < 0.0001 for both). Additionally, both BISAP and PANC 3 showed weak predictive capacity at identifying length of stay and ICU admission. Conclusions: We suggest that BISAP and PANC3 be obtained within the initial 24 h of hospitalization to offer an early prediction of length of stay and ICU admission. Subsequently, RAC and DBC can offer further information later in the course of the disease.
IMPORTANCE Adjuvant drugs are used to reduce the risk of tumor recurrence in patients with cancer who are successfully treated with first-line therapy. The same drugs used in the metastatic or first-line setting are often used in the adjuvant setting, and although the resulting adverse effects may be similar between the 2 settings, tolerability may be different. OBJECTIVETo compare the discontinuation rates of drugs in the adjuvant setting and in the metastatic setting in clinical trials of cancer drugs. DESIGN, SETTING, AND PARTICIPANTSThis cross-sectional study examined clinical trials of cancer drugs with results published in major medical and oncology journals between July 2018 through June 2021. Because adjuvant drugs can be used in a metastatic setting, included trials were conducted in an adjuvant setting. Data were analyzed December 2021.EXPOSURES Drugs used in the adjuvant setting, which were also used in the metastatic setting for the same tumor indication. MAIN OUTCOMES AND MEASURESDiscontinuation rates in the adjuvant and metastatic settings, which were calculated by dividing the total number of study participants who withdrew or discontinued because of adverse events by the number of participants allocated to the drug arm. RESULTSA total of 29 trials with a drug being used in the adjuvant and metastatic setting were found. In the adjuvant setting, the median (IQR) age for study participants was 58.0 (52.0-63.5) years, and the median (IQR) percentage of male participants was 55.5% (0.9%-64.8%). In the metastatic setting, the median (IQR) age for study participants was 61 years, and the median (IQR) percentage of male participants was 55.2% (2.0%-66.0%). Overall, a median (IQR) 21.4% (17.7%-29.4%) of participants discontinued because of adverse events or patient withdrawal in the adjuvant setting compared with a median (IQR) 15.9% (9.7%-21.3%) in the metastatic setting (P = .01). Checkpoint inhibitors (median [IQR] rate of discontinuation, 21.4% [18.6%-31.3%] vs 15.2% [9.9%-19.5%]; P = .01) and targeted drugs (median [IQR] rate of discontinuation, 27.7% vs 14.0%; P < .001) demonstrated a higher rate of discontinuation in the adjuvant setting while cytotoxic drugs (median [IQR] rate of discontinuation, 16.6% [12.2%-23.3%] vs 25.5% [19.8%-28.8%]; P = .07) showed no difference between the 2 settings. The largest differences between adjuvant and metastatic discontinuation rates were for sorafenib (renal cell carcinoma, 43.8% vs 5.5%; difference, 38.2%), imatinib (gastrointestinal stromal tumor, 37.4% vs 6.1%; difference, 31.2%), and erlotinib (non-small cell lung cancer, 37.5% vs 8.4%; difference, 29.0%). CONCLUSIONS AND RELEVANCEIn this cross-sectional study of clinical trials that involved novel cancer drugs, drugs used in the adjuvant setting were associated with significantly higher (continued) Key Points Question How does the percentage of patients who withdraw from adjuvant trials because of adverse events compare with patients who withdraw from metastatic trials for the same drug? Findings In this c...
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