Combination versus mono-therapy as salvage treatment for advanced biliary tract cancer: A comprehensive meta-analysis of published data

Jin, Ying; Chen, Jinfei

doi:10.1016/j.critrevonc.2019.01.001

Cited by 30 publications

(35 citation statements)

References 44 publications

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“…For patients with locally advanced or metastatic disease, the standard-of-care first-line systemic treatment is chemotherapy with gemcitabine plus cisplatin (8). There is no established standard of care following first-line chemotherapy failure, and second-line chemotherapy shows limited efficacy in patients with advanced biliary tract cancer (9)(10)(11).…”

Section: Introductionmentioning

confidence: 99%

Clinicogenomic Analysis of FGFR2-Rearranged Cholangiocarcinoma Identifies Correlates of Response and Mechanisms of Resistance to Pemigatinib

et al. 2021

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I.M. Silverman has employment with and owns stocks from Incyte Corporation. A. Hollebecque is a paid consultant for Debiopharm and Incyte Corporation. L. Friboulet received research funding from Debiopharm. S. Owens has employment with and owns stocks from Incyte Corporation. R.C. Newton had employment with Incyte Corporation at the time of this work and owns stock from Incyte Corporation. H. Zhen has employment with and owns stocks from Incyte Corporation. L. Féliz has employment with and owns stocks from Incyte Corporation. C. Zecchetto declares no potential conflicts of interest. D. Melisi received research funding from Celgene, Evotec, Incyte Corporation, and Shire; and had a consulting role at Baxter, Eli Lilly, Evotec, iOnctura, and Shire, which was unrelated to the present work. T.C. Burn has employment with and owns stocks from Incyte Corporation. Research.

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Section: Introductionmentioning

confidence: 99%

Clinicogenomic Analysis of FGFR2-Rearranged Cholangiocarcinoma Identifies Correlates of Response and Mechanisms of Resistance to Pemigatinib

et al. 2021

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“…In Asian countries, three single‐arm phase II trials with S‐1 monotherapy after progression on L1 chemotherapy suggested that this compound was safe and moderately efficacious in L2 17‐19 . Retrospective cohorts and meta‐analyses reported conflicting results about the efficacy of FP doublets vs monotherapy 3,5‐9,12 . Single‐agent FP are expected to be less toxic and our results suggest that they may be as effective as doublets in L2, thereby representing a potentially interesting option in this setting where health related quality of life is a central issue.…”

Section: Discussionmentioning

confidence: 85%

“…3,[5][6][7][8][9]12 Single-agent FP are expected to be less toxic and our results suggest that they may be as effective as doublets in L2, thereby representing a potentially interesting option in this setting where health related quality of life is a central issue. In particular, in the subset of patients with ECOG PS 0-1, median OS with FP monotherapy reached 8.4 and 7.3 months in the French and Italian cohorts, respectively, which compared favorably with the OS of patients treated with FOLFOX in the ABC-06 study.…”

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confidence: 83%

“…However, the survival benefit was limited (<1 month) and no prospective data with FP single‐agent are available for comparison. Monotherapy may be noninferior to combination chemotherapy in this setting 12 …”

Section: Introductionmentioning

confidence: 99%

“…Monotherapy may be noninferior to combination chemotherapy in this setting. 12 In our study, we aimed to assess the OS according to chemotherapy regimen and ECOG PS (strongest prognostic factor in L2) in patients treated with (a) FP monotherapy vs combination, and (b) irinotecanbased vs platinum-based doublets, in two large independent cohorts. Methods.…”

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confidence: 99%

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Fluropyrimidine single agent or doublet chemotherapy as second line treatment in advanced biliary tract cancer

Neuzillet¹,

Casadei-Gardini

Brieau

et al. 2020

Intl Journal of Cancer

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Fluoropyrimidine (FP) plus platinum chemotherapy has been recently established as a second-line (L2) preferred option in advanced biliary tract cancer (aBTC) (ABC-06 phase III trial). However, the overall survival (OS) benefit was limited and comparison with FP monotherapy was not available. Our aim was to assess the OS of patients treated with a FP monotherapy compared to a doublet with irinotecan or platinum in L2. We performed a retrospective analysis of two large multicenter prospective cohorts: a French cohort (28 centers) and an Italian cohort (9 centers). All consecutive patients with aBTC receiving FP-based L2 after gemcitabine plus cisplatin/ gemcitabine plus oxaliplatin L1 between 2003 and 2016 were included. A subgroup analysis according to performance status (PS) and an exploratory analysis according to platinum sensitivity in L1 were planned. In the French cohort (n = 351), no significant OS difference was observed between the FP monotherapy and doublet groups (median OS: 5.6 vs 6.8 months, P = .65). Stratification on Eastern Cooperative Oncology Group (ECOG) PS showed similar results in PS 0-1 and 2. Median OS was not different between FP monotherapy, platinum-and irinotecan-based doublets (5.6 vs 7.1 vs 6.7 months, P = .68). Similar findings were observed in the Italian cohort (n = 174) and in the sensitivity analysis in pooled cohorts (n = 525). No L2 regimen seemed superior over others in the platinum resistant/refractory or sensitive subgroups. Our results suggest that FP monotherapy is as active as FP doublets in aBTC in L2, regardless of the patient PS and country, and could be a therapeutic option in this setting.

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Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation

et al. 2021

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Isocitrate dehydrogenase 1 (IDH1) variations occur in up to approximately 20% of patients with intrahepatic cholangiocarcinoma. In the ClarIDHy trial, progression-free survival as determined by central review was significantly improved with ivosidenib vs placebo.OBJECTIVE To report the final overall survival (OS) results from the ClarIDHy trial, which aimed to demonstrate the efficacy of ivosidenib (AG-120)-a first-in-class, oral, small-molecule inhibitor of mutant IDH1-vs placebo for patients with unresectable or metastatic cholangiocarcinoma with IDH1 mutation. DESIGN, SETTING, AND PARTICIPANTS This multicenter, randomized, double-blind, placebo-controlled, clinical phase 3 trial was conducted from February 20, 2017, to May 31, 2020, at 49 hospitals across 6 countries among patients aged 18 years or older with cholangiocarcinoma with IDH1 mutation whose disease progressed with prior therapy.INTERVENTIONS Patients were randomized 2:1 to receive ivosidenib, 500 mg, once daily or matched placebo. Crossover from placebo to ivosidenib was permitted if patients had disease progression as determined by radiographic findings. MAIN OUTCOMES AND MEASURESThe primary end point was progression-free survival as determined by blinded independent radiology center (reported previously). Overall survival was a key secondary end point. The primary analysis of OS followed the intent-to-treat principle. Other secondary end points included objective response rate, safety and tolerability, and quality of life.RESULTS Overall, 187 patients (median age, 62 years [range, 33-83 years]) were randomly assigned to receive ivosidenib (n = 126; 82 women [65%]; median age, 61 years [range, 33-80 years]) or placebo (n = 61; 37 women [61%]; median age, 63 years [range, 40-83 years]); 43 patients crossed over from placebo to ivosidenib. The primary end point of progression-free survival was reported elsewhere. Median OS was 10.3 months (95% CI, 7.8-12.4 months) with ivosidenib vs 7.5 months (95% CI, 4.8-11.1 months) with placebo (hazard ratio, 0.79 [95% CI, 0.56-1.12]; 1-sided P = .09). When adjusted for crossover, median OS with placebo was 5.1 months (95% CI, 3.8-7.6 months; hazard ratio, 0.49 [95% CI, 0.34-0.70]; 1-sided P < .001). The most common grade 3 or higher treatment-emergent adverse event (Ն5%) reported in both groups was ascites (11 patients [9%] receiving ivosidenib and 4 patients [7%] receiving placebo). Serious treatment-emergent adverse events considered ivosidenib related were reported in 3 patients (2%). There were no treatment-related deaths. Patients receiving ivosidenib reported no apparent decline in quality of life compared with placebo.CONCLUSIONS AND RELEVANCE This randomized clinical trial found that ivosidenib was well tolerated and resulted in a favorable OS benefit vs placebo, despite a high rate of crossover. These data, coupled with supportive quality of life data and a tolerable safety profile, demonstrate the clinical benefit of ivosidenib for patients with advanced cholangiocarcinoma with IDH1 mutation.

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Combination versus mono-therapy as salvage treatment for advanced biliary tract cancer: A comprehensive meta-analysis of published data

Cited by 30 publications

References 44 publications

Clinicogenomic Analysis of FGFR2-Rearranged Cholangiocarcinoma Identifies Correlates of Response and Mechanisms of Resistance to Pemigatinib

Clinicogenomic Analysis of FGFR2-Rearranged Cholangiocarcinoma Identifies Correlates of Response and Mechanisms of Resistance to Pemigatinib

Fluropyrimidine single agent or doublet chemotherapy as second line treatment in advanced biliary tract cancer

Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation

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