Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study

Area of Science:

• Oncology
• Gastroenterology
• Clinical Trials

Background:

• Unresectable gallbladder cancer (GBC) presents a significant therapeutic challenge.
• Current treatment options for advanced GBC are limited, necessitating the exploration of novel chemotherapy regimens.
• Evaluating new treatment protocols is crucial for improving patient outcomes in GBC.

Purpose of the Study:

• To assess the efficacy of modified gemcitabine and oxaliplatin (mGEMOX) chemotherapy.
• To compare mGEMOX against best supportive care (BSC) and fluorouracil/folinic acid (FUFA) in unresectable GBC.
• To determine the impact of mGEMOX on overall survival (OS) and progression-free survival (PFS).

Main Methods:

• A single-center randomized controlled trial was conducted.
• Eighty-one patients with unresectable GBC were assigned to three arms: BSC, FUFA, or mGEMOX.
• Chemotherapy regimens included weekly FUFA and a 3-week cycle of mGEMOX for up to six cycles.

Main Results:

• The mGEMOX arm showed significantly higher objective response rates (30.8%) compared to FUFA (14.3%) and BSC (0%) (P < .001).
• Median OS was significantly improved in the mGEMOX arm (9.5 months) versus FUFA (4.6 months) and BSC (4.5 months) (P = .039).
• Median PFS was also significantly prolonged with mGEMOX (8.5 months) compared to FUFA (3.5 months) and BSC (2.8 months) (P < .001).

Conclusions:

• Modified gemcitabine and oxaliplatin (mGEMOX) chemotherapy is effective in improving OS and PFS for unresectable GBC.
• mGEMOX demonstrates superior efficacy compared to BSC and FUFA in this patient population.
• While toxicities were comparable, mGEMOX showed a higher incidence of transaminitis and myelosuppression, requiring careful monitoring.