Outcomes in patients receiving palliative chemotherapy for advanced biliary tract cancer

Thol, F; Gairing, Simon Johannes; Czauderna, Carolin; Thomaidis, Thomas; Gamstätter, Thomas; Huber, Yvonne; Vollmar, Johanna; Lorenz, J.; Michel, Maurice Stephan; Bartsch, Fabian; Müller, Lukáš; Kloeckner, Roman; Galle, Peter R.; Wörns, Marcus‐Alexander; Marquardt, Jens U.; Moehler, Markus; Weinmann, Arndt; Foerster, Friedrich

doi:10.1016/j.jhepr.2021.100417

Cited by 8 publications

(4 citation statements)

References 58 publications

(132 reference statements)

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“…After progression to first-line gemcitabine-based chemotherapy, nearly half of the patients are offered second-line chemotherapy. In a retrospective German study, nearly one-third of patients received FOLFOX/CAPOX (capecitabine-oxaliplatin) and less than a tenth was offered FOLFIRI or FOLFIRINOX ( 40 ). Studies that assessed the FOLFIRI regimen in this setting are summarized in Table 4 .…”

Section: Discussionmentioning

confidence: 99%

FOLFIRI-bevacizumab as a second-line treatment for advanced biliary tract cancer after gemcitabine-based chemotherapy

Roussot,

Vincent,

Palmier

et al. 2023

Front. Oncol.

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BackgroundAdvanced biliary tract cancer (BTC) has a poor prognosis. Gemcitabine with platinum chemotherapy was the standard first-line chemotherapeutic regimen until the recent addition of anti-PD-1/PD-L1 antibodies. After disease progression, the only second-line chemotherapy that has demonstrated a survival benefit versus supportive care is FOLFOX (folinic acid, fluorouracil, and oxaliplatin), with a modest benefit. This study aimed to assess the efficacy and safety of second-line FOLFIRI (folinic acid, fluorouracil, and irinotecan) combined with bevacizumab for advanced BTC.MethodsThis single-center retrospective study enrolled patients with metastatic BTC (intrahepatic cholangiocarcinoma [ICC], extrahepatic cholangiocarcinoma [ECC], or gallbladder carcinoma) that progressed after first-line gemcitabine-based chemotherapy. FOLFIRI-bevacizumab was administered intravenously every 2 weeks [folinic acid 200 mg/m², fluorouracil 400 mg/m² (bolus), fluorouracil 2400 mg/m² (46-h continuous intravenous infusion), irinotecan 180 mg/m², and bevacizumab 5 mg/kg] until unacceptable toxicity, patient refusal, or disease progression.ResultsOverall, 28 patients received the FOLFIRI-bevacizumab regimen after gemcitabine-based chemotherapy. The median overall survival (OS) was 9.0 months (95% CI 6.4–16.5). The OS rate was 39.3% (95% CI 24.8–62.3) and 10.7% (95% CI 3.7–32.1) at 12- and 24-months respectively. The median progression-free survival (PFS) was 5.2 months (95% CI 3.1–10.2) with FOLFIRI-bevacizumab. The PFS rates at 12 months and 24 months were 17.9% (95% CI 8.19–39.5] and 10.7% (95% CI 3.7–31.2), respectively. The overall response rate (ORR) to FOLFIRI-bevacizumab was 23.1%, with a disease control rate (DCR) of 69.3%. Grade 3-4 adverse events (sAE) were reported in 20 patients (71.4%) treated with FOLFIRI-bevacizumab.ConclusionFOLFIRI-bevacizumab as a second-line treatment for advanced BTC after gemcitabine-based chemotherapy showed efficacy and safety with a promising tumor response rate in this retrospective single-center study.

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Section: Discussionmentioning

confidence: 99%

FOLFIRI-bevacizumab as a second-line treatment for advanced biliary tract cancer after gemcitabine-based chemotherapy

Roussot,

Vincent,

Palmier

et al. 2023

Front. Oncol.

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“…Real-world data regarding treatment options beyond 1L and 2L remain scarce [ 18 ]. The ABC-06 trial showed improved OS with modified leucovorin 5-fluorouracil oxaliplatin (FOLFOX) versus best supportive care in patients previously treated with GC [ 9 ].…”

Section: Discussionmentioning

confidence: 99%

Advanced or metastatic biliary tract cancer in Japan: a study using the Japan Medical Data Center payer claims database

Argoubi

Reese²,

Furegato

et al. 2023

J. Comp. Eff. Res.

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Aim: Biliary tract cancers are aggressive, with poor prognosis. This study describes clinical characteristics, treatment patterns and healthcare resource utilization in patients with metastatic biliary tract cancer in Japan. Materials & methods: This cohort-based study collected data from the Japan Medical Data Center claims database (2014–2018). Results: A total of 325 patients were included; 65.2% were male and the mean age was 59.2 years. A 47.6% had an Elixhauser Comorbidity Index score ≥5. Most frequent regimens were gemcitabine + cisplatin (52.9%) for first-line therapy and tegafur + gimeracil + oteracil for second-line therapy (48.6%) and third-line therapy (27.2%). Approximately 77% of patients had ≥1 hospital admission, with a median length of 57 days. Conclusion: This study provides insights on the characteristics and burden of metastatic biliary tract cancer in Japan, highlighting high disease burden in a younger population.

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“…Other analyses have aimed to review outcomes for patients following three lines of palliative systemic therapy; Thol et al determined a mOS1 of 18.2 months for 25 patients treated at a single German centre [26], versus 26.9 months for this population. A further analysis by Rizzo et al, presented in abstract form, found an mOS3 of 4.4 months and mPFS3 of 2.8 months (versus 6.4 and 3.1 months, respectively, for the present population) among 101 patients treated at three academic centres in Italy, with a similarly high proportion of included patients having the iCCA subtype [27]; this study specified chemotherapy as the 3L treatment, and hence, presumably did not include patients treated with targeted therapies, which may explain the differences in survival between studies.…”

Section: Discussionmentioning

confidence: 99%

“…Platinum-free interval did not influence inclusion in the present study. Previous analyses, including those mentioned above, have not included data regarding the re-challenge of systemic therapy, reporting proportions of each treatment received in each line but not reporting any relationships between lines of treatment [24,26,29].…”

Section: Discussionmentioning

confidence: 99%

Third-Line Palliative Systemic Therapy for Advanced Biliary Tract Cancer: Multicentre Review of Patterns of Care and Outcomes

Gray,

Letissier,

d’Abrigeon

et al. 2023

Cancers

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Phase 3 trials have established standard first-line (1L) and 2L systemic therapy options for patients with advanced biliary cancer (ABC). However, a standard 3L treatment remains undefined. Clinical practice and outcomes for 3L systemic therapy in patients with ABC were therefore evaluated from three academic centres. Included patients were identified using institutional registries; demographics, staging, treatment history, and clinical outcomes were collected. Kaplan–Meier methods were used to assess progression-free survival (PFS) and overall survival (OS). Ninety-seven patients, treated between 2006 and 2022, were included; 61.9% had intrahepatic cholangiocarcinoma. At the time of analysis, there had been 91 deaths. Median PFS from initiating 3L palliative systemic therapy (mPFS3) was 3.1 months (95%CI 2.0–4.1), while mOS3 was 6.4 months (95%CI 5.5–7.3); mOS1 was 26.9 months (95%CI 23.6–30.2). Among patients with a therapy-targeted molecular aberration (10.3%; n = 10; all received in 3L), mOS3 was significantly improved versus all other included patients (12.5 vs. 5.9 months; p = 0.02). No differences in OS1 were demonstrated between anatomical subtypes. Fourth-line systemic therapy was received by 19.6% of patients (n = 19). This international multicentre analysis documents systemic therapy use in this select patient group, and provides a benchmark of outcomes for future trial design.

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Outcomes in patients receiving palliative chemotherapy for advanced biliary tract cancer

Cited by 8 publications

References 58 publications

FOLFIRI-bevacizumab as a second-line treatment for advanced biliary tract cancer after gemcitabine-based chemotherapy

FOLFIRI-bevacizumab as a second-line treatment for advanced biliary tract cancer after gemcitabine-based chemotherapy

Advanced or metastatic biliary tract cancer in Japan: a study using the Japan Medical Data Center payer claims database

Third-Line Palliative Systemic Therapy for Advanced Biliary Tract Cancer: Multicentre Review of Patterns of Care and Outcomes

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