Advances in adjuvant therapy of biliary tract cancer: an overview of current clinical evidence based on phase II and III trials

Belkouz, Ali; Wilmink, Johanna W.; Mohammad, Nadia Haj; Hagendoorn, Jeroen; Vos‐Geelen, Judith de; Dejong, C.H.C.; Homs, Marjolein Y.V.; Koerkamp, Bas Groot; Gulik, Thomas M. Van; Oijen, M.G.H. van; Punt, Cja; Klümpen, Heinz‐Josef

doi:10.1016/j.critrevonc.2020.102975

Cited by 16 publications

(16 citation statements)

References 39 publications

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“…In the current case, the diameter of the tumor was 45 mm after chemotherapy; microvascular invasion was also present; thus, we would expect the current case to have a high risk of recurrence. Although the effectiveness of adjuvant therapy for BTC has been shown, no standard adjuvant chemotherapy regimen has been established for patients with BTC or CoCC [20]. Additionally, although clinical trials (JCOG1202) are currently in progress and no results have been obtained, S-1 is considered to be a promising agent for postoperative adjuvant therapy in patients with BTC [21].…”

Section: Discussionmentioning

confidence: 99%

Locally advanced cholangiolocellular carcinoma successfully treated with curative resection after downsizing chemotherapy: a case report

et al. 2021

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Background Cholangiolocellular carcinoma (CoCC) is an extremely rare disease comprising less than 1% of all primary malignant liver tumors. No effective treatment other than resection has been established. Herein, we report a case of locally advanced CoCC diagnosed as unresectable, which was successfully treated with curative resection after downsizing chemotherapy. Case presentation A 59-year-old Japanese woman with chronic hepatitis B was diagnosed with locally advanced intrahepatic cholangiocellular carcinoma. As it was difficult to perform R0 resection in the local hospital, chemotherapy combined with gemcitabine plus cisplatin was administered every 3 weeks. After a total of 10 courses of chemotherapy over 10 months the tumor was shown to be reduced in size by computed tomography imaging, and she was referred to our department for surgical resection. The effect of chemotherapy was classified as a “partial response” in the response evaluation criteria of solid tumors. After adding one course of chemotherapy, an extended left hepatectomy with resection of the caudate lobe was performed. R0 resection was achieved. Based on the pathological findings, the final diagnosis of CoCC was determined and eight courses of S-1 adjuvant chemotherapy were administered. At 14 months after the operation, the patient was alive without tumor recurrence. Conclusions Downsizing chemotherapy with gemcitabine and cisplatin may be an effective treatment strategy in locally advanced CoCC. Further evidence is required to establish an optimal strategy for the treatment of locally advanced CoCC.

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Section: Discussionmentioning

confidence: 99%

Locally advanced cholangiolocellular carcinoma successfully treated with curative resection after downsizing chemotherapy: a case report

et al. 2021

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“…Similarly, the comparison between the reference doublet in treatment-naive metastatic patients (CisGem) and resected BTC (capecitabine) is under investigation in the ACTICCA-1 trial (NCT02170090) [56]. Notably enough, the ACTICCA-1 was initiated to compare CisGem versus observation alone, but the trial was amended to compare the reference doublet to the newly established standard regimen capecitabine, aiming for superiority of the combination regimen versus the oral monotherapy.…”

Section: Ongoing Trialsmentioning

confidence: 99%

Ivosidenib in IDH-mutant cholangiocarcinoma: where do we stand?

Rizzo

Ricci

Brandi

2021

Expert Review of Precision Medicine and Drug Development

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Introduction: Unfortunately, potentially curative surgical resection is possible in approximately the 25% of biliary tract cancer (BTC) patients at diagnosis, and even following radical surgery, relapse rates remain high. Thus, the role of adjuvant systemic treatment has been widely explored in this setting over the last decades, with the hope of lowering recurrence rates and improving outcomes of BTC patients. Areas covered: In this review, we provide an overview of available evidence regarding adjuvant systemic therapy in resected BTC, critically discussing the pros and cons of recently published clinical trials such as the BILCAP, the BCAT, and the PRODIGE-12/ACCORD-18 phase III studies. Expert opinion: Although the BILCAP trial has established adjuvant capecitabine for 6 months following radical resection as a novel standard of care, the role of adjuvant systemic chemotherapy is the object of debate and controversy in the BTC medical community. Although most of the international guidelines on BTC management have not yet been updated, the recently published ASCO guidelines support the use of capecitabine in this setting. Several phase I to III clinical trials are currently evaluating the role of novel therapeutic approaches in patients with resected BTC, and the results of these studies are highly awaited.

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“…The main reason for the unfavorable outcome is the high incidence of recurrence [ 8 ]. Approximately 37.9–60% of patients occur local recurrence and/or distant metastases within 1 year after resection, with a median overall survival (OS) as low as 16.3 months [ 9 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

DWI-based radiomic signature: potential role for individualized adjuvant chemotherapy in intrahepatic cholangiocarcinoma after partial hepatectomy

et al. 2022

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Objectives To develop a diffusion-weighted imaging (DWI) based radiomic signature for predicting early recurrence (ER) (i.e., recurrence within 1 year after surgery), and to explore the potential value for individualized adjuvant chemotherapy. Methods A total of 124 patients with intrahepatic cholangiocarcinoma (ICC) were randomly divided into the training (n = 87) and the validation set (n = 37). Radiomic signature was built using radiomic features extracted from DWI with random forest. An integrated radiomic nomogram was constructed with multivariate logistic regression analysis to demonstrate the incremental value of the radiomic signature beyond clinicopathological-radiographic factors. A clinicopathological-radiographic (CPR) model was constructed as a reference. Results The radiomic signature showed a comparable discrimination performance for predicting ER to CPR model in the validation set (AUC, 0.753 vs. 0.621, p = 0.274). Integrating the radiomic signature with clinicopathological-radiographic factors further improved prediction performance compared with CPR model, with an AUC of 0.821 (95%CI 0.684–0.959) in the validation set (p = 0.01). The radiomic signature succeeded to stratify patients into distinct survival outcomes according to their risk index of ER, and remained an independent prognostic factor in multivariable analysis (disease-free survival (DFS), p < 0.0001; overall survival (OS), p = 0.029). Furthermore, adjuvant chemotherapy improved prognosis in high-risk patients defined by the radiomic signature (DFS, p = 0.029; OS, p = 0.088) and defined by the nomogram (DFS, p = 0.031; OS, p = 0.023), whereas poor chemotherapy efficacy was detected in low-risk patients. Conclusions The preoperative DWI-based radiomic signature could improve prognostic prediction and help to identify ICC patients who may benefit from postoperative adjuvant chemotherapy.

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Advances in adjuvant therapy of biliary tract cancer: an overview of current clinical evidence based on phase II and III trials

Cited by 16 publications

References 39 publications

Locally advanced cholangiolocellular carcinoma successfully treated with curative resection after downsizing chemotherapy: a case report

Locally advanced cholangiolocellular carcinoma successfully treated with curative resection after downsizing chemotherapy: a case report

Ivosidenib in IDH-mutant cholangiocarcinoma: where do we stand?

DWI-based radiomic signature: potential role for individualized adjuvant chemotherapy in intrahepatic cholangiocarcinoma after partial hepatectomy

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