Background: A multimodality approach to locally advanced gallbladder cancer (LA-GBC) may improve their dismal survival. We did a pilot study to evaluate safety and efficacy of neoadjuvant chemoradiotherapy (NACRT) in LA-GBC.
Methods: Patients with cytologically proven, resectable LA-GBC (stage III=12, IVA=4), no metastasis at laparoscopy, were allocated to sequential (n=8) and concurrent (n=8) NACRT. Sequential group received gemcitabine 900 mg/m2 and oxaliplatin
80 mg/m2 on days 1, 8, 22 and 29. Concurrent group received gemcitabine 300 mg/m2 and oxaliplatin 50 mg/m2 weekly for 4 weeks. Radiotherapy (35 Gy/15 fractions/3 weeks) was given to both groups. Patients were reassessed by CT scan before surgery. In sequential group, radiological complete response (rCR), partial response (rPR) and progressive disease (rPD) were seen in 1, 2 and 4 patients, respectively. One patient died before response assessment.
Results: In concurrent group, rCR, rPR and stable disease were seen in 1, 6 and 1 patients, respectively. The overall response rates was better in concurrent arm (8/8 versus 3/7; p=0.025). Grade III toxicity occurred in 1 patient (concurrent). Eight patients (sequential 2,concurrent 6) underwent resection (R0 in all). Pathological complete response (pCR) was seen in 1 (sequential) while 7 patients (sequential 1,concurrent 6) showed partial response. At a minimum follow-up of 5 years for surviving patients, the median overall survival was 8.6 months and 28.8 months in sequential and concurrent groups respectively.
Conclusion: Although both sequential and concurrent NACRT were safe and effective in LA-GBC, response rates, resectability and long term survival were somewhat better in the Concurrent group. A larger study would be required to confirm these results in LA-GBC.