Neoadjuvant therapy in gall bladder cancer improves resectability and survival: a prospective study.

BACKGROUND

Gallbladder carcinoma has dismal prognosis with <20 % resectability at presentation. The role of Neoadjuvant chemotherapy (NACT) remains undefined.

METHODS

This is a prospective single center study of 226 gallbladder carcinoma patients receiving NACT. Gemcitabine-platinum combinations were administered followed by response assessment. Primary endpoints included resectability and survival outcomes.

RESULTS

Of 226 patients, 135 (59.7 %) completed NACT. Intention-to-treat resection rate was 36.2 % (82/226), increasing to 60.7 % (82/135) among treatment completers. R0 resection achieved in 95.1 % (78/82). Grade ≥3 toxicity occurred in 9.7 % with 1.7 % treatment-related mortality. Median overall survival: 27 months (resectable) versus 13 months (unresectable) (p < 0.001). Two-year overall survival: 62.1 % versus 31.4 % respectively. Perioperative mortality: 3.7 %; major morbidity: 13.5 %. Incidental gallbladder cancer showed higher resectability (44.1 % vs 33.7 %) with 2-year overall survival 75 % versus 55.6 %. Multivariate analysis identified resectability (HR 2.714, p = 0.0002), perineural invasion (HR 2.986, p = 0.018), and advanced T-stage (HR 1.940, p = 0.041) as independent prognostic factors.

CONCLUSIONS

NACT enables curative resection in 60.7 % completing treatment with acceptable toxicity, supporting incorporation into treatment algorithms for locally advanced gallbladder cancer.