Modified FOLFIRINOX Versus CISGEM Chemotherapy for Patients With Advanced Biliary Tract Cancer (PRODIGE 38 AMEBICA): A Randomized Phase II Study

2021 ◽  
Author(s):  
Jean marc Phelip ◽  
Jérôme Desrame ◽  
Julien Edeline ◽  
Emilie Barbier ◽  
Eric Terrebonne ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Phase Ii ◽  
Biliary Tract Cancer ◽  
Tract Cancer ◽  
Intention To Treat ◽  
Triplet Chemotherapy ◽  
End Point ◽  
Randomized Phase Ii ◽  
Treat Population ◽  
Doublet Chemotherapy

PURPOSE Whether triplet chemotherapy is superior to doublet chemotherapy in advanced biliary tract cancer (BTC) is unknown. METHODS In this open-label, randomized phase II-III study, patients with locally advanced or metastatic BTC and an Eastern Cooperative Oncology Group performance status of 0 or 1 were randomly assigned (1:1) to receive oxaliplatin, irinotecan, and infusional fluorouracil (mFOLFIRINOX), or cisplatin and gemcitabine (CISGEM) for a maximum of 6 months. We report the results of the phase II part, where the primary end point was the 6-month progression-free survival (PFS) rate among the patients who received at least one dose of treatment (modified intention-to-treat population) according to Response Evaluation Criteria in Solid Tumors version 1.1 (statistical assumptions: 6-month PFS rate ≥ 59%, 73% expected). RESULTS A total of 191 patients (modified intention-to-treat population, 185: mFOLFIRINOX, 92; CISGEM, 93) were randomly assigned in 43 French centers. After a median follow-up of 21 months, the 6-month PFS rate was 44.6% (90% CI, 35.7 to 53.7) in the mFOLFIRINOX arm and 47.3% (90% CI, 38.4 to 56.3) in the CISGEM arm. Median PFS was 6.2 months (95% CI, 5.5 to 7.8) in the mFOLFIRINOX arm and 7.4 months (95% CI, 5.6 to 8.7) in the CISGEM arm. Median overall survival was 11.7 months (95% CI, 9.5 to 14.2) in the mFOLFIRINOX arm and 13.8 months (95% CI, 10.9 to 16.1) in the CISGEM arm. Adverse events ≥ grade 3 occurred in 72.8% of patients in the mFOLFIRINOX arm and 72.0% of patients in the CISGEM arm (toxic deaths: mFOLFIRINOX arm, two; CISGEM arm, one). CONCLUSION mFOLFIRINOX triplet chemotherapy did not meet the primary study end point. CISGEM doublet chemotherapy remains the first-line standard in advanced BTC.

scholarly journals Varlitinib plus capecitabine in second-line advanced biliary tract cancer: a randomized, phase II study (TreeTopp)

ESMO Open ◽  
2022 ◽  
Vol 7 (1) ◽  
pp. 100314
Author(s):  
M.M. Javle ◽  
D.-Y. Oh ◽  
M. Ikeda ◽  
W.-P. Yong ◽  
K. Hsu ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Phase Ii ◽  
Biliary Tract Cancer ◽  
Phase Ii Study ◽  
Second Line ◽  
Tract Cancer ◽  
Randomized Phase Ii

Photodynamic therapy with temoporfin in combination with gemcitabine/capecitabine in biliary tract cancer: Feasibility and safety in a randomized phase II trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14637-e14637
Author(s):  
Truls Hauge ◽  
Trond Warloe ◽  
Petra Weber Hauge ◽  
Isabel Franco-Lie ◽  
Anders Drolsum ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Biliary Tract ◽  
Phase Ii ◽  
Biliary Tract Cancer ◽  
Phase Ii Trial ◽  
Light Exposure ◽  
Treatment Modalities ◽  
Tract Cancer ◽  
Randomized Phase Ii

e14637 Background: Patients whocannot be offered curative surgical treatment for biliary tract cancer (BTC) have a poor prognosis. Photodynamic therapy (PDT) has been shown to improve survival and quality of life in patients with unresectable BTC. A combination of treatment modalities might improve survival further, but such data are still lacking. Therefore we have performed the first randomized trial on the combination of temoporfin/PDT and chemotherapy. Here we report data on the feasibility and safety. Methods: Randomized phase II trial, planned to include 20 patients with time to progression as primary endpoint, feasibility and toxicity as secondary endpoints. Inclusion criteria were unresectable BTC confirmed by histology or cytology, need for biliary stent, bilirubin level < 50 mmol/L and no previous cancer disease. The treatment arms were: A: Stent, temoporfin / PDT followed by gemcitabin / capecitabin (GemCap). B: Stent, GemCap. Only one initial PDT treatment was given. Results: Twenty patients with locally advanced and metastatic disease were included, 10 patients in each arm. Two patients in arm B did not receive any treatment (thrombocytopenia, study withdrawal) and two patients in arm A did not receive chemotherapy (ECOG>2, infection). PDT was feasible in all 10 patients without any acute procedure-related complication. During the first 30 days, two cases of cholangitis in arm A and three in arm B were observed. Cutaneous erythema (grade 1-2) was observed after PDT in two patients. Conclusions: PDT using temoporfin in combination with chemotherapy in BTC was feasible. Restrictions to light exposure were well tolerated. PDT in combination with chemotherapy did not increase the complication rate during the first 30 days follow-up. Three months follow-up data will be available at the time for presentation. Larger prospective trials are warranted to assess the efficacy of this treatment combination.

scholarly journals Treatment of Patients with Advanced Biliary Tract Cancer with Either Oxaliplatin, Gemcitabine, and Capecitabine or Cisplatin and Gemcitabine—A Randomized Phase II Trial

Cancers ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 1975
Author(s):  
Alice Markussen ◽  
Lars Henrik Jensen ◽  
Laura Vittrup Diness ◽  
Finn Ole Larsen
Keyword(s):  
Biliary Tract ◽  
Phase Ii ◽  
Biliary Tract Cancer ◽  
Median Overall Survival ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Tumor Control ◽  
Free Survival ◽  
Tract Cancer ◽  
Randomized Phase Ii

This study is an investigator-initiated randomized phase II trial focusing on the treatment of advanced biliary tract cancer with either oxaliplatin 50 mg/m2 and gemcitabine 1000 mg/m2 on day 1 in a two-week cycle with capecitabine 650 mg/m2 twice-daily continuously or cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 on day 1 and day 8 in a three-week cycle. One-hundred patients were included. Forty-seven patients received oxaliplatin, gemcitabine, and capecitabine with a median progression-free survival (mPFS) of 5.7 months (95% CI 3.0–7.8) and a median overall survival (mOS) of 8.7 months (95% CI 6.5–11.2). Forty-nine patients received cisplatin and gemcitabine with a mPFS of 7.3 months (95% CI 6.0–8.7) and a mOS of 12.0 months (95% CI 8.3–16.7). This trial confirms a mOS of 12 months with cisplatin and gemcitabine, as found in earlier trials. With a superior tumor control rate of 79% vs. 60% (p = 0.045), a difference in the mPFS of 1.6 months (HR = 0.721, p = 0.1), and a difference in the mOS of 3.3 months (HR = 0.731, p = 0.1), cisplatin and gemcitabine should still be considered the standard first-line treatment for advanced biliary tract cancer.

Fixed dose rate (FDR) gemcitabine (G) and capecitabine (C) in patients with metastatic biliary tract cancer (BTC): Final results of phase II trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15510-e15510
Author(s):  
D. Santini ◽  
B. Vincenzi ◽  
E. Vasile ◽  
V. Catalano ◽  
V. Virzì ◽  
...  
Keyword(s):  
Dose Rate ◽  
Biliary Tract ◽  
Phase Ii ◽  
Biliary Tract Cancer ◽  
Phase Ii Trial ◽  
Fixed Dose ◽  
Tract Cancer ◽  
Intention To Treat ◽  
Fixed Dose Rate ◽  
Ecog Ps

e15510 Background: The combination of fixed dose rate (FDR) gemcitabine (C) and capecitabine (G) has been demonstrated to be well tolerated in patients with advanced cancers. To determine the activity and safety of this combination in metastatic metastatic biliary tract cancer patients, a phase II trial was conducted. Methods: Patients with unresectable BTC who had pathologically confirmed adenocarcinoma, no prior chemotherapy, ECOG PS < 2 and measurable disease were enrolled. Treatment consisted of FDR G at 800 mg/m(2) infused in 80 minutes on days 1 and 8 every 21 days with C administered orally bid in equal doses (650 mg/m2 bid) for 14 days (28 doses). Results: Between Feb 2005 and Sept 2008, 30 pts were enrolled. Median age was 67 (45–86) with 14 males. 30 pts were evaluable for response and toxicity. A total of 219 cycles were administered (median, 8; range, 2–16). One patient achieved CR and 8 pts achieved PR giving an overall response rate of 30.0% in intention-to-treat population (95% CI, 19.2–42.6%). And 11 pts (36.6%) had stable disease. The median time to progression of all patients was 7.4 months (mo) (95% CI, 3.2–19.5). The median overall survival was 15.3 mo (95% CI, 4.6–27.9). Grade 3/4 neutropenia and thrombocytopenia were noted in 13.3% and 6.6% of the pts, respectively. Grade 2/3 non-hematologic toxicities were asthenia (50.0 % of pts), diarrhea (16.6%), stomatitis (23.3%) and hand-foot syndrome (6.6%). There was no treatment-related death. Gemcitabine was skipped at least once/reduced in 20%/15% of the patients, respectively. Capecitabine was skipped at least once/reduced in 20%/25% of the patients, respectively. Conclusions: The combination of FDR gemcitabine and capecitabine in this three week cycle is safe and seems to have advantages in activity over other regimens in advanced biliary cancer. No significant financial relationships to disclose.

Sign in / Sign up

Export Citation Format

Share Document