國家衛生研究院 NHRI:Item 3990099045/10108
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    題名: Quality-adjusted time without symptoms or toxicity (Q-TWIST) of nanoliposomal irinotecan (nal-IRI;MM-398) plus 5-fluorouracil and leucavorin (5-FU/LV) vs 5-FU/LV alone in patients with metastatic pancreatic adenocarcinoma (mPAC) previously treated with ge
    作者: Pelzer, U;Blanc, JF;Melisi, D;Cubillo, A;Von Hoff, DD;Wang-Gillam, A;Chen, LT;Siveke, JT;Wan, Y;Solem, CT;Botteman, M;Yang, Y;de Jong, F;Hubner, R
    貢獻者: National Institute of Cancer Research
    摘要: Introduction: In the primary analysis of the phase 3 NAPOLI-1 trial, nalIRI+5-FU/LV significantly improved median overall survival (OS; 6.1 vs 4.2 months; hazard ratio [HR]=0.67; P = 0.012) and progression-free survival (PFS; 3.1 vs 1.5 months; HR = 0.56; P = 0.0001) vs 5-FU/LV alone in mPAC patients previously treated with gemcitabine-based therapy. Here we report between-treatment differences in quality-adjusted survival using the Q-TWiST methodology, commonly used in oncology. Methods: The total 12-month survival in NAPOLI-1 intent-to-treat cohort was partitioned into time before disease progression without toxicity grade ≥3 (TWiST), time with adverse event grade ≥3 (TOX), and time of disease progression (REL). Mean Q-TWiST was calculated by multiplying mean time spent in each health state by its respective utility. In the base case, the utility for TWiST (uTWiST), toxicity (uTOX), and post-progression (uREL) were set to 1.0, 0.5, and 0.5, respectively. The relative gain in Q-TWiST in nal-IRI+5-FU/LV over 5-FU/LV was calculated as the difference in Q-TWiST divided by the OS of the 5-FU/LV group. Non-parametric bootstrapped 95% confidence intervals (CIs) were derived around estimates. Threshold analyses varied uTOX and uREL between 0.0 and 1.0. An additional scenario analysis was conducted using the per protocol (PP) population. Results: Compared with patients receiving 5-FU/LV (n = 119), those receiving nal-IRI+5-FU/LV (n = 117) spent significantly more time in TWiST (mean 3.4 vs 2.4 months) and TOX (1.0 vs 0.3 months), but similar time in REL (2.5 vs 2.7 months). After weighing time spent in TWiST, TOX, and REL with their respective base-case utilities, nal-IRI+5-FU/LV resulted in 1.3 months (95% CI: 0.4-2.1; 5.1 vs 3.9) greater Q-TWiST, with relative Q-TWiST gain of 24%. In the threshold analyses varying uTOX and uREL, the Q-TWiST ranged from 0.9 to 1.7 months, and the relative Q-TWiST gain ranged from 17% to 31%. In the PP population, Q-TWiST was also significantly superior in patients recieving nal-IRI+5-FU/LV (Q-TWiST gain = 1.8 months; 95% CI: 0.7-3.0). Conclusion: In NAPOLI-1, nal-IRI+5-FU/LV resulted in statistically significantly and clinically important gains in quality-adjusted survival vs 5-FU/LV alone. This confirms the clinical outcome benefit of nal-IRI+5FU/LV in patients with mPAC.
    日期: 2016-10
    關聯: Oncology Research and Treatment. 2016 Oct;39(Suppl. 3):260.
    Link to: http://dx.doi.org/10.1159/000449050
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=2296-5270&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000385691300648
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