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Background <p>Durvalumab plus gemcitabine–cisplatin (GCD) has become a standard first-line therapy for advanced biliary tract cancer (BTC) following the TOPAZ-1 trial. However, whether the survival benefit observed in trial-eligible patients can be generalized to broader real-world populations remains uncertain. We evaluated the impact of TOPAZ-1 eligibility on the effectiveness of GCD in routine clinical practice.</p> Methods <p>In this multicenter retrospective cohort study, 610 patients with unresectable or recurrent BTC treated with first-line GCD (<i>n</i> = 268) or gemcitabine–cisplatin (GC) (<i>n</i> = 342) at 19 Japanese institutions were analyzed. Patients were classified according to TOPAZ-1 eligibility criteria. Overall survival (OS) was compared between treatment groups in the entire cohort and stratified by eligibility status. Multivariable Cox models were constructed separately for eligible and ineligible patients.</p> Results <p>Among 610 patients, 324 (53.1%) met TOPAZ-1 eligibility criteria. In the overall cohort, GCD was associated with longer OS than GC (median, 13.7 vs 11.3&#xa0;months; <i>p</i> = 0.009). Among eligible patients, GCD significantly improved OS compared with GC (18.0 vs 13.1&#xa0;months; <i>p</i> = 0.004), whereas no significant difference was observed among ineligible patients (10.8 vs 10.0&#xa0;months; <i>p</i> = 0.675). However, the interaction between treatment and TOPAZ-1 eligibility was not statistically significant (<i>p</i> for interaction = 0.162).</p> Conclusions <p>In this real-world cohort, the survival benefit of GCD appeared to be primarily observed in patients meeting TOPAZ-1 eligibility criteria. Trial-based eligibility may influence the magnitude of benefit from immunochemotherapy in advanced BTC, underscoring the importance of patient selection in routine practice.</p>

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Impact of TOPAZ-1 eligibility on the survival benefit of durvalumab plus gemcitabine–cisplatin in advanced biliary tract cancer: a multicenter real-world study

  • 期刊论文

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  • 发表日期：

    2026年4月12日

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  • Hisashi Kosaka,
  • Rie Sugimoto,
  • Masahiko Kinoshita,
  • Satoshi Yasuda,
  • Satoru Kakizaki,
  • Jun Sakata,
  • Kiyonori Yamai,
  • Takeshi Hatanaka,
  • Yusuke Yamamoto,
  • Toshifumi Sato,
  • Toru Ishikawa,
  • Takanori Morikawa,
  • Jun Hanaoka,
  • Haruki Mori,
  • Hidenori Toyoda,
  • Tsuyoshi Sanuki,
  • Misaki Yokoi,
  • Hiroyuki Shibata,
  • Koji Fukuda,
  • Kazuhito Kawata,
  • Koji Amaya,
  • Takashi Ito,
  • Masaaki Hidaka,
  • Atsushi Naganuma,
  • Keishi Sugimachi,
  • Masaki Kaibori

摘要

Background

Durvalumab plus gemcitabine–cisplatin (GCD) has become a standard first-line therapy for advanced biliary tract cancer (BTC) following the TOPAZ-1 trial. However, whether the survival benefit observed in trial-eligible patients can be generalized to broader real-world populations remains uncertain. We evaluated the impact of TOPAZ-1 eligibility on the effectiveness of GCD in routine clinical practice.

Methods

In this multicenter retrospective cohort study, 610 patients with unresectable or recurrent BTC treated with first-line GCD (n = 268) or gemcitabine–cisplatin (GC) (n = 342) at 19 Japanese institutions were analyzed. Patients were classified according to TOPAZ-1 eligibility criteria. Overall survival (OS) was compared between treatment groups in the entire cohort and stratified by eligibility status. Multivariable Cox models were constructed separately for eligible and ineligible patients.

Results

Among 610 patients, 324 (53.1%) met TOPAZ-1 eligibility criteria. In the overall cohort, GCD was associated with longer OS than GC (median, 13.7 vs 11.3 months; p = 0.009). Among eligible patients, GCD significantly improved OS compared with GC (18.0 vs 13.1 months; p = 0.004), whereas no significant difference was observed among ineligible patients (10.8 vs 10.0 months; p = 0.675). However, the interaction between treatment and TOPAZ-1 eligibility was not statistically significant (p for interaction = 0.162).

Conclusions

In this real-world cohort, the survival benefit of GCD appeared to be primarily observed in patients meeting TOPAZ-1 eligibility criteria. Trial-based eligibility may influence the magnitude of benefit from immunochemotherapy in advanced BTC, underscoring the importance of patient selection in routine practice.