Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers: National, Comparative, Observational Study ( <scp>TOG</scp> / <scp>GI</scp> ‐ <scp>SAFRADJU</scp> ‐2501)

The recommended adjuvant chemotherapy (adj-ChT) regimen for resected biliary tract cancers (BTC) is capecitabine (Cape); yet, the recommendation is based on limited evidence. Although varied adj-ChTs have been employed in practice, robust real-world data is scarce. We conducted a national, multicenter, hospital-based registry study to evaluate adj-ChTs in resected BTCs. Patients who received adj-ChT (± radiotherapy) between 2010 and 2024 were included. Recurrence-free (RFS) and overall survival (OS) were analyzed by adjusted Cox-regression and propensity score-based inverse-probability-of-treatment-weighting (IPTW), addressing selection bias. Among 617 patients from 44 centers, 513 were eligible. The most frequent adj-ChTs were Cape (35.5% [n = 182]), gemcitabine-cisplatin (Gem-Cis; 22.4% [n = 115]), gemcitabine-capecitabine (Gem-Cape; 20.1% [n = 103]), and gemcitabine (Gem; 10.7% [n = 55]). Median RFS and OS with Cape were 19.7 (95% Confidence Interval [95% CI]: 14.2-41.1) and 41.9 months (95% CI: 25.9-69.2). In adjusted/controlled comparisons with Cape, no differences in RFS or OS were observed with Gem-Cis (RFS: Hazard Ratio [HR] 1.13 [95% CI: 0.77-1.66]; OS: HR: 1.03 [95% CI: 0.66-1.61]), Gem-Cape (RFS: HR 0.97 [95% CI: 0.68-1.38]; OS: HR: 0.81 [95% CI: 0.52-1.24]), or Gem (RFS: HR 1.00 [95% CI: 0.63-1.59]; OS: HR: 0.93 [95% CI: 0.55-1.57]). Similarly, IPTW analyses showed no difference in RFS and OS. Radiotherapy appeared to be associated with improved survival. Performance status, T-stage, lymph-node positivity, and R1-resection were independently associated with RFS and OS. In conclusion, this real-world study did not identify a regimen superior to Cape. Given the modest benefit of adj-ChTs, novel approaches, including neoadjuvant and targeted/immunotherapy strategies, are needed.

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Journal
International Journal of Cancer
Published
2026-06-29
DOI
https://doi.org/10.1002/ijc.70623
Primary Topic
Cholangiocarcinoma and Gallbladder Cancer Studies
Type
article
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article

Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers: National, Comparative, Observational Study ( TOG / GI ‐ SAFRADJU ‐2501)

Öznur Bal, Mehmet Kayaalp, Ilgın Koç Kuş, Mesut Yılmaz et al.
International Journal of Cancer
Cholangiocarcinoma and Gallbladder Cancer Studies
article

Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers: National, Comparative, Observational Study ( TOG / GI ‐ SAFRADJU ‐2501)

Öznur Bal, Mehmet Kayaalp, Ilgın Koç Kuş, Mesut Yılmaz, Lamia Şeker Can, Fatma Keskin Uzundere, Haydar Çağatay Yüksel, Orhun Akdoğan, Elif Sertesen, Mustafa Ersoy, Erman Akkuş, Hacı Arak, Havva Yeşil Çınkır, Teoman Şakalar, Tuğba Akın Telli, Mehmet Mutlu Çatlı, Fatma Paksoy Türköz, Doğan Bayram, Mehmet Cem Fidan, Murat Araz, Lorenza Rimassa, Ertuğrul Bayram, Selahattin Çelik, Yakup Düzköprü, Atila Yıldırım, İlkay Tuğba Ünek, Şeymanur Ala Enli, Elif Şahin, İsmail Oğuz Kara, Ali̇ Kalem, Emel Ayvaz Guneyin, Sibel Oyucu Orhan, Mahmut Kara, Görkem Turhan, Pınar Peker, Hatime Arzu Yaşar, Mehmet Yılmaz, Esmanur Kaplan Tüzün, Maral Martin Mıldanoğlu, Müzeyyen Aslı Ergözoğlu, Mehmet Sinan Akarca, Haydar Temizyurek, Erdem Kolemen, Bilgeşah Kılıçtaş, Nilüfer Avcı, Berkay Yeşilyurt, Emine Bihter Cetin, Ramazan Cosar, Feyza Arslan Tan, Zehra Sadak Öcal, Mustafa Gürbüz, Müslih Ürün, Yusuf İlhan, Onur Yazdan Balçık, Arif Hakan Önder, Ahmet Bilici, Ali Alkan, Bahadır Köylü, Burak Paçacı, Şuayib Yalçın, Fatih Köse
article en

Abstract

The recommended adjuvant chemotherapy (adj-ChT) regimen for resected biliary tract cancers (BTC) is capecitabine (Cape); yet, the recommendation is based on limited evidence. Although varied adj-ChTs have been employed in practice, robust real-world data is scarce. We conducted a national, multicenter, hospital-based registry study to evaluate adj-ChTs in resected BTCs. Patients who received adj-ChT (± radiotherapy) between 2010 and 2024 were included. Recurrence-free (RFS) and overall survival (OS) were analyzed by adjusted Cox-regression and propensity score-based inverse-probability-of-treatment-weighting (IPTW), addressing selection bias. Among 617 patients from 44 centers, 513 were eligible. The most frequent adj-ChTs were Cape (35.5% [n = 182]), gemcitabine-cisplatin (Gem-Cis; 22.4% [n = 115]), gemcitabine-capecitabine (Gem-Cape; 20.1% [n = 103]), and gemcitabine (Gem; 10.7% [n = 55]). Median RFS and OS with Cape were 19.7 (95% Confidence Interval [95% CI]: 14.2-41.1) and 41.9 months (95% CI: 25.9-69.2). In adjusted/controlled comparisons with Cape, no differences in RFS or OS were observed with Gem-Cis (RFS: Hazard Ratio [HR] 1.13 [95% CI: 0.77-1.66]; OS: HR: 1.03 [95% CI: 0.66-1.61]), Gem-Cape (RFS: HR 0.97 [95% CI: 0.68-1.38]; OS: HR: 0.81 [95% CI: 0.52-1.24]), or Gem (RFS: HR 1.00 [95% CI: 0.63-1.59]; OS: HR: 0.93 [95% CI: 0.55-1.57]). Similarly, IPTW analyses showed no difference in RFS and OS. Radiotherapy appeared to be associated with improved survival. Performance status, T-stage, lymph-node positivity, and R1-resection were independently associated with RFS and OS. In conclusion, this real-world study did not identify a regimen superior to Cape. Given the modest benefit of adj-ChTs, novel approaches, including neoadjuvant and targeted/immunotherapy strategies, are needed.

International Journal of Cancer
Sakarya University (TR), Van Yüzüncü Yıl Üniversitesi (TR), Aksaray University (TR), Dicle University (TR), Bahçeşehir University (TR), Izmir University (TR), Humanitas University (IT), Koç University (TR), Ankara University (TR), Karadeniz Technical University (TR), Istanbul Bilim University (TR), Manisa Celal Bayar University (TR), Başkent University (TR), Bursa Technical University (TR), Dokuz Eylül University (TR), Inonu University (TR), Turkish Armed Forces (TR), Kütahya Dumlupınar Üniversitesi (TR), Bezmiâlem Vakıf Üniversitesi (TR), Istanbul Medipol University (TR), Fenerbahçe University (TR), Ege University (TR), Gülhane Askerî Tıp Akademisi (TR), Memorial Ankara Hospital (TR), Necmettin Erbakan University (TR), Antalya Eğitim ve Araştırma Hastanesi (TR), Istanbul University-Cerrahpaşa (TR), Medical Park Gaziantep Hospital (TR), Alanya University (TR), Sağlık Bilimleri Üniversitesi (TR), Turgut Özal Tıp Merkezi (TR), Department of Public Health (MM), IRCCS Humanitas Research Hospital (IT), Antalya IVF (TR), Kahramanmaraş Sütçü İmam University (TR), Pamukkale University (TR), Eskişehir Osmangazi University (TR), Kocaeli Üniversitesi (TR), Afyon Kocatepe University (TR), Cukurova University (TR), Gaziantep University (TR), Atatürk University (TR), Hacettepe University (TR), Istanbul University (TR), Marmara University (TR), Muğla University (TR), Gazi University (TR)
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Cholangiocarcinoma and Gallbladder Cancer Studies
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