Abstract 281P
Background
Biliary tract cancers (BTC) are rare yet aggressive malignancies. Gemcitabine with either Cisplatin or Oxaliplatin constitutes the current standard therapy for metastatic BTC in LMIC. However, data comparing these regimens directly is scarce. Therefore, we conducted randomized controlled trial comparing the efficacy and safety of these two frontline treatments.
Methods
This open-label, prospective study randomized patients with histology-proven metastatic BTC, aged >18 years, and ECOG PS≤3 into two arms. Arm-A received Gemcitabine 1000 mg/m2 plus Cisplatin 25 mg/m2 on days 1 and 8, while Arm B received Gemcitabine 1000 mg/m2 on days 1 and 8 with Oxaliplatin 100 mg/m2 on day 1 only, every 21 days. Radiological response evaluations were done after 4 cycles of therapy or at any evidence of clinical progression, whichever occurred earlier. Adverse events were documented according to CTCAE 5.0. Data analysis was performed using SPSS Statistics (Version 23.0).
Results
Among 210 screened patients, 52 eligible subjects were recruited from May 2022 to April 2023. The median overall survival (OS) was 7.6 months in the GemCis arm versus 5.7 months in the GemOx arm (HR, 1.21; 95% CI, 0.64 to 2.29; P = 0.566). Median progression-free survival (PFS) was 3.9 months in the GemCis arm versus 3.7 months in the GemOx arm (HR, 0.77; 95% CI, 0.43 to 1.39; P = 0.392). The 6-month PFS rate was 18.5% in the GemCis arm versus 28.1% in the GemOx arm. The 6-month OS rate was 56.9% in the GemCis arm and 51.2% in the GemOx arm (P = 0.39). Treatment completion rate and toxicity profile favored the GemOx arm, with a higher incidence of peripheral neuropathy, fatigue, and grade 1/2 thrombocytopenia. The GemCis arm exhibited more grade 3 and higher hematological toxicity, infection, required more growth factor and blood product support, hospitalization and a poorer completion rate.
Conclusions
In conclusion, our trial found no significant difference in survival outcomes between GemCis and GemOx for metastatic BTC. However, GemOx exhibited a better toxicity profile and treatment completion rate. Further research is needed to confirm these findings in larger studies, especially the integration of immunotherapeutic options.
Clinical trial identification
CTRI/2023/07/054679.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.