A prospective multicenter phase II study of FOLFIRINOX as a first-line treatment for patients with advanced and recurrent biliary tract cancer

Takahara, Naminatsu; Nakai, Yousuke; Isayama, Hiroyuki; Sasaki, Takashi; Morine, Yuji; Watanabe, Kazuo; Ueno, Makoto; Ioka, Tatsuya; Kanai, Masashi; Kondo, Shunsuke; Okano, Naohiro; Koike, Kazuhiko

doi:10.1007/s10637-022-01322-7

Cited by 2 publications

(1 citation statement)

References 37 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Takahara et al reported on 35 patients with advanced BTC treated prospectively with full-dose FOLFIRINOX. With a median follow-up of 13.9 months [ 18 ], the objective response rate was 31.4%, and the disease control rate was 74.3%. The median PFS and OS were 7.4 (80% CI, 5.5-7.5) and 14.7 (80% CI, 11.8-15.7) months, respectively.…”

Section: Discussionmentioning

confidence: 99%

Phase II Trial of FOLFIRINOX in Advanced Biliary Tract Cancer

Bazarbashi,

Aseafan,

Elshenawy

et al. 2024

Cureus

View full text Add to dashboard Cite

Introduction: Biliary tract cancers (BTCs), characterized by poor prognosis and limited treatment options, are increasingly prevalent malignancies with a five-year survival rate of less than 20% for advanced-stage disease. The standard first-line chemotherapy combining gemcitabine and cisplatin offers modest survival benefits, necessitating the exploration of more effective therapies. This study reports the results of a single-arm, open-label, phase 2 trial assessing the efficacy and safety of fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFIRINOX) as a first-line treatment for metastatic or locally advanced unresectable BTC. Methods: Patients aged ≥18 with measurable disease and adequate organ function were enrolled, receiving biweekly FOLFIRINOX for up to 12 cycles with follow-up imaging every four cycles. The primary endpoint was the overall response rate (ORR), with progression-free survival (PFS), overall survival (OS), and safety as secondary endpoints. Results: Thirteen patients were enrolled from December 2016 to September 2021 before early termination due to slow accrual and the emergence of immunotherapy. The ORR was 54%, with a disease control rate of 77%. Median PFS and OS were 6.8 and 19.25 months, respectively. Grade 3/4 toxicities were predominantly hematologic, with neutropenia being the most common severe adverse event. Conclusion: The trial suggests that FOLFIRINOX is a potentially effective first-line therapy for unresectable or metastatic BTC with a manageable safety profile. However, the early termination of the study and the introduction of immunotherapy warrant further research to confirm these findings.

show abstract

Section: Discussionmentioning

confidence: 99%

Phase II Trial of FOLFIRINOX in Advanced Biliary Tract Cancer

Bazarbashi,

Aseafan,

Elshenawy

et al. 2024

Cureus

View full text Add to dashboard Cite

show abstract

Skeletal muscle status and survival among patients with advanced biliary tract cancer

Takaoka,

Hamada,

Takahara

et al. 2024

Int J Clin Oncol

View full text Add to dashboard Cite

Background Studies have demonstrated a prognostic role of sarcopenia (i.e., loss of skeletal muscle volume and functionality) in patients with various cancer types. In patients with biliary tract cancer, the quantity and quality of skeletal muscles and their serial changes have not been fully investigated in relation to survival outcomes. Methods We identified 386 patients with unresectable or recurrent biliary tract cancer and calculated skeletal muscle index (SMI) and skeletal muscle density (SMD) to estimate muscular quantity and quality, respectively, based on computed tomography images. Using the Cox regression model with adjustment for potential confounders, we calculated hazard ratios (HRs) and 95% confidence intervals (CIs) for progression-free survival (PFS) and overall survival (OS) according to skeletal muscle status and its serial change. Results Compared to patients without sarcopenia, patients with sarcopenia were associated with shorter PFS (multivariable HR, 1.60; 95% CI, 1.15–2.22; P = 0.005), but not with OS (P = 0.027) at the adjusted α level of 0.013. SMD at baseline was associated with OS (multivariable HR comparing the extreme quartiles, 1.52; 95% CI, 1.07–2.14; Ptrend = 0.012), but not with PFS (Ptrend = 0.13). A reduction in SMI rather than that in SMD was associated with OS. Progressive disease was a risk factor for reductions in SMI and SMD. Conclusions Skeletal muscle quantity and quality and their serial changes were associated with survival outcomes in patients with advanced biliary tract cancer. Our data highlight the importance of designing nutritional and physical interventions for improvements in skeletal muscle status.

show abstract

A prospective multicenter phase II study of FOLFIRINOX as a first-line treatment for patients with advanced and recurrent biliary tract cancer

Cited by 2 publications

References 37 publications

Phase II Trial of FOLFIRINOX in Advanced Biliary Tract Cancer

Phase II Trial of FOLFIRINOX in Advanced Biliary Tract Cancer

Skeletal muscle status and survival among patients with advanced biliary tract cancer

Contact Info

Product

Resources

About