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According to the results of a combined analysis of previously published studies, chemotherapy with a combination of Gemzar® (gemcitabine) and a platinum compound may produce the best outcomes among patients with advanced biliary tract cancer. 

Biliary tract cancer includes cancers of the gallbladder and bile ducts (cholangiocarcinoma). These cancers are relatively rare, and tend to be diagnosed at an advanced stage.

Liver CancerConnect 490

Although Gemzar-cisplatin is a standard initial treatment for advanced disease, NGS testing should be performed to identify potential cancer driving mutations that could be treated with newer precision cancer medicines. 

Patients diagnosed with advanced biliary tract cancer often have poor survival, and the optimal approach to treatment remains uncertain. Patients may be treated with chemotherapy, enrolled in a clinical trial, or given best supportive care (management of symptoms).

In an attempt to identify the most effective chemotherapy regimen for advanced biliary tract cancer, researchers in Germany conducted a combined analysis of 104 previously published studies. Most of these studies were small, Phase II clinical trials. All together, these studies enrolled 2,810 patients.

  • Overall, 23% of patients experienced a partial or complete disappearance of detectable cancer following treatment with chemotherapy.
  • The highest response rates to chemotherapy occurred among patients treated with a combination of Gemzar and a platinum compound. Platinum chemotherapy drugs include Platinol® (cisplatin), Eloxatin® (oxaliplatin), and Paraplatin® (carboplatin).

According to the results of a Phase III clinical trial, treatment of locally advanced or metastatic biliary tract cancer with a combination of Gemzar® (gemcitabine) and cisplatin results in better survival and a lower risk of cancer progression than treatment with Gemzar alone.

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To evaluate a combination of chemotherapy drugs for the treatment of biliary tract cancer, researchers conducted a Phase III clinical trial among 410 patients with inoperable, advanced biliary tract cancer. Study participants were assigned to receive chemotherapy with Gemzar alone or Gemzar plus cisplatin.

  • Overall survival was 11.7 months among patients treated with Gemzar plus cisplatin compared with 8.1 months among patients treated with Gemzar alone.
  • Survival without cancer progression was 8.0 months among patients treated with Gemzar plus cisplatin compared with 5.0 months among patients treated with Gemzar alone.
  • Neutropenia (low white blood cell count) occurred more often in patients treated with Gemzar plus cisplatin than in patients treated with Gemzar alone.

These results suggest that the combination of Gemzar and cisplatin results in better survival than Gemzar alone in patients with advanced biliary tract cancer.4

Liposomal Irinotecan Improves Outcomes for Patients with Biliary Tract Cancer

According to data from the phase 2 NIFTY trial presented during the 2021 ASCO Annual Meeting liposomal irinotecan (Onivyde) in combination with 5-fluorouracil/leucovorin (5-FU/LV) delayed cancer progression and prolonged survival for patients with metastatic biliary tract cancer whose disease had progressed following first-line line gemcitabine/cisplatin. 

Liposomal irinotecan plus 5-FU/LV should be considered as one of the standard treatments for patients with advanced biliary tract cancer whose disease has progressed on gemcitabine/cisplatin.

Liver Cancer Newsletter 490

About Onivyde (liposomal irinotecan)

Irinotecan is a topoisomerase inhibitor that contains SN-38, an active metabolite of irinotecan that binds reversibly to an enzyme, called topoisomerase I. All cells need this enzyme to divide and grow. Irinotecan blocks this enzyme so the cancer cells can't divide. Packing irinotecan in liposomes allows the medication to stay active longer once injected into a patient.

In this study 174 patients were treated with 5-FU/LV with or without Onivyde and directly compared. Liposomal irinotecan plus 5-FU/LV elicited an overall response rate of 14.8% compared with 5.8% with 5-FU/LV alone and at a median follow-up of 11.8 months, the median survival without cancer progression for patients treated with liposomal irinotecan plus 5-FU/LV was 7.1 months compared with 1.4 months for patients treated with 5-FU/LV alone. . The 1-year survival rates were 35.4% and 22.4% respectively. Treatment was fairly well tolerated with neutropenia and fatigue being the most commonly observed side effects.2,3


  1. Eckel F, Schmid RM. Chemotherapy in advanced biliary tract Carcinoma: a pooled analysis of clinical trials. British Journal of Cancer. 2007; 96:896-902.
  2. Yoo C, Kim KP, Kim I, et al. Liposomal irinotecan (nal-IRI) in combination with fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic biliary tract cancer (BTC) after progression on gemcitabine plus cisplatin (GemCis): multicenter comparative randomized phase 2b study (NIFTY). J Clin Oncol. 2021;39(suppl 15):4006. doi:10.1200/JCO.2021.39.15_suppl.4006
  3. Onivyde. Prescribing information. Merrimack Pharmaceuticals Inc. Accessed June 5, 2021.
  4. Valle J, Wasan H, Palmer DH et al. Cisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer. New EnglandJournal of Medicine. 2010; 362:1273-1281.