Tolerance of gemcitabine–oxaliplatin (GEMOX) in advanced and metastatic gallbladder cancer: A real-world, single-center retrospective study from north India.

Abstract

e16224 Background: Gallbladder cancer (GBC) is highly prevalent in North India and commonly presents at an advanced or metastatic stage. GEMOX is frequently used as first-line chemotherapy; however, real-world data on treatment tolerance in this high-burden setting are limited. This retrospective study evaluated the toxicity profile and treatment feasibility of GEMOX in patients with advanced and metastatic GBC treated in routine clinical practice. Methods: This retrospective, single-center study included adults with unresectable or metastatic gallbladder adenocarcinoma treated with GEMOX between January 2020 and June 2025, either in the first line or in later lines. GEMOX was administered every 14 days (gemcitabine 1000 mg/m², oxaliplatin 100 mg/m²). Treatment tolerance was the primary endpoint and was assessed by the incidence and severity of adverse events graded per CTCAE v5.0, as well as dose reductions and treatment discontinuation due to toxicity. Data were extracted from institutional electronic health records and analyzed descriptively. Results: Of 379 patients with gallbladder cancer screened, 219 received GEMOX in the first or second line; 38 were excluded due to incomplete data, leaving 181 patients for analysis. Median age was 52 years, 71.3% were female, and ECOG performance status was 0–1 in 52.5%, 2 in 42.0%. At presentation, abdominal pain and jaundice were noted in 87.3% and 43.7% of patients, respectively, and 26.5% required biliary drainage (PTBD 17.1%, biliary stenting 9.3%). Most patients had metastatic disease (90.1%), with the liver as the most common metastatic site (69%). Median baseline CA 19-9 was 150 U/mL (range, 0.19–46,600). The median number of chemotherapy cycles delivered was 5 (range, 1–19). Anemia and peripheral sensory neuropathy (PSN) were the most common toxicities (any grade: 89.5% and 64.6%), with grade ≥3 events in 35.4%, mainly PSN (16.0%) and anemia (15.5%) (Table 1). Dose reductions occurred in 28.7% and treatment discontinuation due to toxicity in 17.1%, most often from cumulative neuropathy. Median progression-free survival was 4.2 months (95% CI, 3.85–4.55). Conclusions: Gemcitabine–oxaliplatin showed a manageable real-world toxicity profile in advanced gallbladder cancer, with treatment-limiting effects driven mainly by cumulative neuropathy and anemia. These data support the feasibility of GEMOX in routine practice in a high-burden setting. Treatment-related toxicities and tolerance with gemox (n = 181). Toxicity / Tolerance Parameter n (%) Any-grade anemia 162 (89.5) Any-grade PSN 117 (64.6) Any-grade nausea/vomiting 134 (74.0) Grade ≥3 toxicity (overall) 64 (35.4)   Grade 3 PSN 29 (16.0)   Grade 3 anemia 28 (15.5)   Grade 3 nausea/vomiting 13 (7.2) Dose reductions required 52 (28.7) Treatment discontinuation due to toxicity 31 (17.1)