Efficacy of cisplatin-gemcitabine-durvalumab in patients with advanced biliary tract cancer experiencing early vs late disease relapse after surgery: a large real-life worldwide population

Prinzi, F. L.; Salani, F.; Rimini, M.; Rizzato, M. D.; Antonuzzo, L.; Camera, S.; Satake, T.; Vandeputte, H.; Vivaldi, C.; Pressiani, T.; Lucchetti, J.; Kim, J. W.; Abidoye, O.; Rapposelli, I. G.; Tamberi, S.; Finkelmeier, F.; Giordano, G.; Pircher, C.; Chon, H. J.; Braconi, C.; Pastorino, A.; Castet, F.; Tamburini, E.; Yoo, C.; Parisi, A.; Diana, A.; Scartozzi, M.; Prager, G. W.; Avallone, A.; Schirripa, M.; Kim, I. H.; Perkhofer, L.; Oneda, E.; Verrico, M.; Adeva, J.; Chan, S. L.; Spinelli, G. P.; Personeni, N.; Garajova, I.; Rodriquenz, M. G.; Leo, S.; Alvim, C. M.; Roque, R.; Fornaro, L.; De Rosa, A.; Lavacchi, D.; Rossari, F.; Ikeda, M.; Dekervel, J.; Niger, M.; Balsano, R.; Tonini, G.; Kang, M.; Bekaii-Saab, T.; Viola, M. G.; Silvestro, L.; Esposito, L.; Boccaccino, A.; Himmelsbach, V.; Landriscina, M.; Djaballah, S. A.; Zanuso, V.; Masi, G.; Lonardi, S.; Rimassa, L.; Casadei-Gardini, A.

doi:10.1093/oncolo/oyae256

Background: In the TOPAZ-1, patients with biliary tract cancers (BTC) and recurrence within 6 months after surgery were excluded, even if this event is frequently observed in clinical practice. Our study aimed to assess if the efficacy of cisplatin-gemcitabine-durvalumab (CGD) in this population is comparable to that reported in the phase 3 trial. Methods: The study cohort included patients with BTC who underwent surgery on the primary tumor, experienced disease recurrence occurring ≤6 months or >6 months after surgery or after the end of adjuvant therapy and started CGD. The primary objectives were overall survival (OS) and progression free survival (PFS). Results: A total of 178 patients were enrolled. No significant differences were observed between early and late relapse groups in OS (23.4 months vs not reached; HR 1.26; 95% CI, 0.67-2.37; P = .45) and PFS [7.0 months vs 9.8 months; HR 1.3(95% CI, 0.9-2.1) P = .13]. Overall response rate and disease control rate (P = .33 and P = .62) were comparable between the 2 groups, as the overall safety profile. In addition, we compared survival outcomes between the selected population and a historical cohort of patients with BTC treated with cisplatin-gemcitabine (CG) and found that despite the absence of statistical significance, CGD showed an outcome trend compared with CG regardless of the time of recurrence after surgery or adjuvant chemotherapy [(CG ≤ 6 vs CGD ≤ 6 months: HR 0.59, 95%CI, 0.35-1.01, P = .05; HR 0.70; 95%CI, 0.46-1.06, P = .09, OS and PFS, respectively) and (CG > 6 vs. CGD > 6 months: HR 0.50; 95%CI, 0.29-0.88, P = 0.0165; HR 0.54; 95%CI, 0.35-0.84, P = .0068, OS and PFS, respectively)]. Conclusion: Our analysis suggests that CGD retains its efficacy independently of the timing of relapse after surgery or completion of adjuvant treatment in patients with advanced BTC.

Efficacy of cisplatin-gemcitabine-durvalumab in patients with advanced biliary tract cancer experiencing early vs late disease relapse after surgery: a large real-life worldwide population / Prinzi, F. L.; Salani, F.; Rimini, M.; Rizzato, M. D.; Antonuzzo, L.; Camera, S.; Satake, T.; Vandeputte, H.; Vivaldi, C.; Pressiani, T.; Lucchetti, J.; Kim, J. W.; Abidoye, O.; Rapposelli, I. G.; Tamberi, S.; Finkelmeier, F.; Giordano, G.; Pircher, C.; Chon, H. J.; Braconi, C.; Pastorino, A.; Castet, F.; Tamburini, E.; Yoo, C.; Parisi, A.; Diana, A.; Scartozzi, M.; Prager, G. W.; Avallone, A.; Schirripa, M.; Kim, I. H.; Perkhofer, L.; Oneda, E.; Verrico, M.; Adeva, J.; Chan, S. L.; Spinelli, G. P.; Personeni, N.; Garajova, I.; Rodriquenz, M. G.; Leo, S.; Alvim, C. M.; Roque, R.; Fornaro, L.; De Rosa, A.; Lavacchi, D.; Rossari, F.; Ikeda, M.; Dekervel, J.; Niger, M.; Balsano, R.; Tonini, G.; Kang, M.; Bekaii-Saab, T.; Viola, M. G.; Silvestro, L.; Esposito, L.; Boccaccino, A.; Himmelsbach, V.; Landriscina, M.; Djaballah, S. A.; Zanuso, V.; Masi, G.; Lonardi, S.; Rimassa, L.; Casadei-Gardini, A.. - In: THE ONCOLOGIST. - ISSN 1083-7159. - 30:3(2025). [10.1093/oncolo/oyae256]