國家衛生研究院 NHRI:Item 3990099045/11363
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    题名: Prognostic effect of primary tumor location in the NAPOLI-1 phase 3 study in metastatic pancreatic ductal adenocarcinoma (mPDAC)
    作者: Mercade, TM;Wang-Gillam, A;Chen, L;Blanc, J;Lee, K;Bodoky, G;Dean, A;Siveke, J;Mirakhur, B;Chen, J;de Jong, F
    贡献者: National Institute of Cancer Research
    摘要: Introduction: In NAPOLI-1 (NCT01494506), treatment with liposomal irinotecan þ 5-fluorouracil/leucovorin (nal-IRIþ5-FU/LV) significantly increased median overall survival (mOS) vs. 5-FU/LV (6.1 vs. 4.2 months; unstratified hazard ratio [HR]¼0.67, 95% confidence interval [CI]:0.49–0.92; P¼0.012) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who had progressed following gemcitabinebased therapy. A potential prognostic impact ofprimary tumor location on metastatic pancreatic cancer outcomes has been reported. We investigated the effect ofprimary tumor location on survival following inclusion in the NAPOLI-1 study. Methods: This post-hoc analysis explored outcomes in patients with primary tumor locations ofthe pancreatic head only (H only), body only (B only), tail only (T only), and multiple locations including (H_incl) and excluding (H_excl) the head. Results: Of417 patients, 239 (57%) had a primary tumor location ofH only, 54 (13%) B only, 62 (15%) T only, 17 (4%) H_incl and 30 (7%) H_excl. Karnofsky performance status was lower in patients with a primary tumor location ofT only versus the intentto-treat population. The mOS (HRs: 0.87–1.06) and median progression-free survival (mPFS) (HRs: 0.82–0.98) were similar across primary tumor location subgroups and no clear prognostic signal for OS was detected. The mOS and mPFS in patients with a primary tumor location ofH only were 5.0 and 2.7 months, respectively, versus 5.4 and 2.8 months, respectively, for those with B only (mOS: HR¼1.06, 95%CI:0.75–1.50, P¼0.737; mPFS: HR¼0.98, 95%CI:0.70–1.37, P¼0.925). For patients with T only, mOS and mPFS were 4.3 and 1.7 months respectively (mOSH only vs. T only: HR¼0.89, 95%CI:0.64–1.23, P¼0.469; mPFSH only vs. T onlyHR¼0.89, 95%CI:0.66–1.22, P¼0.471). For patients with H_incl, mOS and mPFS were 5.7 and 2.3 months respectively, while for H_excl patients they were 4.6 and 1.4 months, respectively. For the comparison ofmOS between the H only and B onlyþT onlyþH_excl subgroup (mOS¼4.4, mPFS¼1.7 months), HR¼0.88 (95%CI:0.69– 1.11, P¼0.285) while for mPFSHR¼0.83 (95%CI:0.66–1.05, P¼0.116). For the comparison ofmOS between the H only and B onlyþT onlyþH_exclþH_incl subgroup (mOS¼4.6, mPFS¼1.7 months), HR¼0.91 (95%CI:0.72–1.15, P¼0.421), while for mPFSHR¼0.87 (95%CI:0.70–1.09, P¼0.233). For the comparison ofmOS between the H onlyþH_incl and B onlyþT onlyþH_excl subgroup HR¼0.87 (95%CI:0.69– 1.10, P¼0.240), while for mPFS HR¼0.82 (95%CI:0.65–1.03, P¼0.084). Both mOS and mPFS were higher in patients treated with nal IRIþ5 FU/LV vs. 5 FU/LV across primary tumor location subgroups (mOS: HRs: 0.39–0.88; two groups with n<10 per arm were discounted). Safety, drug related AEs and dose modifications/discontinuations in the PTL subgroups were broadly similar to the overall NAPOLI 1 study arms. Conclusion: In NAPOLI-1, 61% ofpatients had a primary tumor location including the pancreatic head. This analysis did not detect a clear prognostic effect ofprimary tumor location on survival for mPDAC patients progressing after gemcitabine-based treatment. Patients with primary tumors in the head only or including head had similar mOS and mPFS to other patients. A consistent treatment benefit was shown with nalIRIþ5-FU/LV vs. 5-FU/LV regardless ofprimary tumor location.
    日期: 2018-06
    關聯: Annals of Oncology. 2018 Jun;29(Suppl. 5):Meeting Abstract P-150.
    Link to: https://doi.org/10.1093/annonc/mdy151.149
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000439970900190
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85081555446
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