Presentation and Outcomes with First-Line Chemotherapy in Advanced Cholangiocarcinomas—A Relatively Rare Component of Biliary Tract Cancers in India

Abstract

Background Biliary tract cancers (BTCs) are a rare group of cancers with limited data with respect to advanced unresectable cholangiocarcinoma (CCA). Materials and Methods The study is a retrospective study of patients with advanced unresectable/metastatic CCA, who received first-line palliative chemotherapy (CT1) from January 2014 to March 2019 at the Tata Memorial Hospital, Mumbai. Baseline clinical characteristics, chemotherapeutic regimens, and toxicities were evaluated. Results One hundred and forty patients satisfied criteria for evaluation. Median age of the entire cohort was 57 years (range: 32–80). There were 87 patients (62.1%) with intrahepatic CCA, 35 patients (25%) with perihilar CCA, and 14 patients (10%) with distal CCA. One hundred and twelve patients (80%) had metastatic disease at presentation. Commonest CT1 regimens were gemcitabine–cisplatin (GC) in 89 patients (63.5%) and gemcitabine–oxaliplatin (GO) in 34 patients (24.3%). Sixty-three patients (45%) received second-line chemotherapy. With a median follow-up of 27 months, median progression-free survival for the entire cohort was 7.56 months (95% confidence interval [CI]: 6.23–8.88), and median OS was 12.16 months (95% CI: 10.08–14.24). Common chemotherapy-related grade 3/4 side effects included vomiting in 25 patients (17.9%), diarrhea in 23 patients (16.4%), and thrombocytopenia in 22 patients (15.7%). Conclusion The current study in advanced CCAs is the largest of its nature from India. The common regimens used as first line were GC and GO. Tolerance and overall survival appear similar to previously published data.

Treatment Outcomes in Advanced Biliary Tract Cancers: Single Institution Retrospective Analysis

“…15 16 This could be due to differences in the tumor biology at these two sites. The CCA cohort of ours had a median OS of 9 months, which was inferior to that reported by Bhargava et al 23 (12 months), ABC-02 trial (11.7 months), and BT22 trial (11.2 months).…”

Phase Ib study of anlotinib combined with TQB2450 in pretreated advanced biliary tract cancer and biomarker analysis

“… 1 Advanced BTCs are often refractory to chemotherapy, and the response rate for first‐line chemotherapy combining gemcitabine and cisplatin is only about 25%–30%, with a median overall survival (OS) of 11–13 months. 2 , 3 The efficacy of second‐line chemotherapy for BTCs remains dismal. The ABC‐06 study showed that combination therapy of leucovorin, fluorouracil, and oxaliplatin (FOLFOX) only achieved an objective response rate (ORR) of 5% and an OS of 6.2 months, 4 and the NIFTY study reported that liposomal irinotecan in combination with 5‐fluorouracil/leucovorin achieved a median OS of 8.6 months.…”

“…Late diagnosis, a high relapse rate after surgery, and refractoriness to treatments contribute to poor prognosis in patients with BTCs, with a 5 year survival rate below 20% 1. Advanced BTCs are often refractory to chemotherapy, and the response rate for first‐line chemotherapy combining gemcitabine and cisplatin is only about 25%–30%, with a median overall survival (OS) of 11–13 months 2,3. The efficacy of second‐line chemotherapy for BTCs remains dismal.…”

Prolonged survival with first-line chemotherapy in advanced extrahepatic cholangiocarcinoma

“…A meta-analysis done by Valle et al further supported this treatment strategy 12. In a recent large retrospective study on cholangiocarcinomas to evaluate outcomes with first-line chemotherapy by Bhargava et al , the median PFS was 7.56 months and overall survival (OS) was 12.16 months with GemCis regimen being used in 63.5% of patients 13. These findings are very similar to those seen in the seminal ABC-02 (median PFS—8 months; median OS—11.7 months) and BT22 (median PFS—5.8 months; median OS—11.2 months) Studies.…”