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    Clinical role of tumour markers in advanced biliary cancers (ABC) treated with second-line active-symptom-control (ASC) alone or ASC with oxaliplatin/5-FU chemotherapy (ASC plus mFOLFOX) in the randomised phase III, multi-centre, open-label ABC-06 trial

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    Authors
    Lamarca, Angela
    Palmer, D.
    Wasan, H.
    Ross, P.
    Ma, Y. T.
    Arora, A.
    Falk, S.
    Gillmore, R.
    Wadsley, J.
    Patel, K.
    Anthoney, A.
    Maraveyas, A.
    Waters, J.
    Hoobs, C.
    Macdonald, T.
    Ryder, D.
    Ramage, J.
    Davies, L.
    Bridgewater, J.
    Valle, Juan W
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    Affiliation
    The Christie National Health Service Foundation Trust, Manchester,
    Issue Date
    2022
    
    Metadata
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    Abstract
    Background: The ABC-06 clinical trial stablished ASC+mFOLFOX as the standard of care treatment after Cisplatin and Gemcitabine (CisGem) for ABC. Methods: Within the ABC-06 study, patients (pts) diagnosed with ABC (chol- angiocarcinoma, gallbladder or ampullary cancer) with progression after CisGem were randomised (1:1) to ASC+mFOLFOX or ASC. Tumour markers (CA19.9, CEA and CA125), were scheduled at baseline (BSL) and at every follow-up visit. This post-hoc analysis explored if changes (stable/reducing vs increasing) of Ca19.9 at week 4 from initiation of ASC+mFOLFOX was associated with radiological progression-free survival (PFS). Secondary end-points included impact of raised BSL Ca19.9 (defined as x1.5 ULN) and chemotherapy-induced changes on overall survival (OS). CEA and CA125 were also analysed. Results: Out 162 pts randomised, BSL Ca19.9 data was available for 135 pts. Paired BSL and week-4 Ca19.9 data was available for 37 pts in the ASC+mFOLFOX arm: Ca19.9 was stable/reducing in 17 (45.9%) and increasing in 20 pts (54.1%). Stable/ reducing Ca19.9 showed a numerically longer median radiological PFS (4.3 months (m) vs 3.3m) but differences did not reach statistical significance (HR 1.08 (95% CI 0.55-2.14); p¼0.81). When restricted to patients with raised BSL Ca19.9 (23 pts), impact on PFS was more marked (5.7m vs 3.2m), but remained non-significant (HR 1.68 (95% CI 0.70-4.01); p¼0.23). Stable/reducing Ca19.9 at week 4 did not impact significantly on OS (p¼0.56 (regardless of BSL Ca19.9 level; 37 pts); p¼0.84 (if raised BSL Ca19.9; 23 pts)). Raised BSL Ca19.9 was associated both with shorter unadjusted clinical median PFS (3.2m vs 5.0m; HR 1.53 (95% CI 1.05-2.23); p¼0.027) and un- adjusted OS (4.4m vs 6.4m; HR 1.97 (95% CI 1.33-2.93); p When Cox Regression model (120 pts) for OS exploring the prognostic roles of raised BSL Ca19.9, CEA and CA125 was adjusted for pre-defined stratification factors (platinum sensitivity, albumin, and stage) and randomised trial arm, each raised tumour marker had an independent impact (HR 1.56 (95% CI 1.03 to 2.35); p¼0.03 / HR 1.60 (95% CI 1,06 to 2.43) p¼0.026 / HR 1.70 (95% CI 1.13 to 2.56); p¼0.011 for Ca19.9, CEA and CA125, respectively). Unadjusted median OS was 8.9m if all tumour markers at BSL were non- raised, and 7.0m, 4.0m, 3.2m in the event of having 1, 2 or 3 raised BSL tumour markers. Conclusions: For ABC patients treated with second-line ASC+mFOLFOX, utility of Ca19.9 measured at week-4 after chemotherapy initiation is limited; raised BSL Ca19.9, CEA and CA125 have independent prognostic roles and future studies may need to consider these (individually or pooled) as stratification factors.
    Citation
    Lamarca A, Palmer D, Wasan H, Ross P, Ma YT, Arora A, et al. Clinical role of tumour markers in advanced biliary cancers (ABC) treated with second-line active-symptom-control (ASC) alone or ASC with oxaliplatin/5-FU chemotherapy (ASC plus mFOLFOX) in the randomised phase III, multi-centre, open-label ABC-06 trial. Annals of Oncology. 2022 Jun;33:S280-S. PubMed PMID: WOS:000823826500101.
    Journal
    Annals of Oncology
    URI
    http://hdl.handle.net/10541/625589
    Type
    Meetings and Proceedings
    Language
    en
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    All Christie Publications

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