P-0157 - Neoadjuvant therapy in Indian patients with locally advanced gall bladdercancer:

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Hepatobiliary Cancers
Presenter Bhawna Sirohi
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors P. Jagannath
  • Chairman, Department of Surgical Oncology, Lilavati Hospital and Research Centre, Mumbai/IN



Gemcitabine/platinum (Gem-P) is currently the standard of care for patients with advanced biliary tract cancers based on the ABC02 study ((Juan Velle 2010). Patients usually present in locally advanced (LA) stage in India and as surgery remains the only curative option- neoadjuvant (NA) strategy was explored to down size/downstage and improve resectability.


This is retrospective analysis of the prospectively maintained database of 48 patients with LA GB cancer treated between Feb 2009 to Sept 2013. LA GB is defined as GB mass invading liver >2cm without porta hepatis / vascular invasion, GB mass adherent to duodenum and hepatic flexure; N2 nodal disease). Patients received GEM-P (Gemcitabine –cisplatin or oxaliplatin)- cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 on D1 and D8 of 21d cycle, Or Gem-oxaliplatin, patients received gemcitabine 1000mg/m2 D1 as a 100 minute infusion and oxaliplatin 100mg/m2 D2 over 2 hrs every 14 days. Response was assessed after3-4 cycles.


Of the 48 pts (median age 53y, (range 30-71)); 16 were Male, 32 were Female. 38 patients were treated with Gem-P (31 oxaliplatin, 6 cisplatin) based therapy. 10 received chemoradiotherapy (CTRT) with wkly gemcitabine 300mg/m2- of these 6 received chemoradiotherapy alone while 4 received with neoadjuvant chemotherapy. Site of disease was liver in 26 pts, nodal in 19, adjacent organ in 15 & other in 8 pts. Median number of chemotherapy cycles given were 4 (2-12). Response rate to NA therapy was 7 (15%) complete response (CR), 23(48%) partial response (PR), 9 stable disease (SD), 8 (17%) progressive disease (PD) and not assessed in 1 patients (1 died post CTRT). Overall clinical benefit rate (CR + PR + SD) was 82%. Of the 25 patients had adequate response and underwent surgery. 20 (42%) had radical surgery (2 with multivisceral resection), 4 revision cholecystectomy and 1port site excision. All patients had R0 resection except 1 who had R2 resection with involvement of hilum. 20 patients did not undergo surgery due to PD (n = 9), SD (n = 4), died (n = 1), inoperable at surgery (n = 4), 2 patients being in CR did not wish to undergo surgery Lymph nodes (LN) yield was available in 21 patients and the median yield was 6 (range 2-16); 8/21 had positive LN. Overall, 24 pts have relapsed – 16 are from the group who did not have surgery and 8 from group that have undergone radical surgery. The median OS and PFS of whole group were 31 and 8.3 months respectively. The group undergoing R0 resection had maximum benefit.


This is the first report of the use of neoadjuvant chemotherapy in patients with LA GB cancer. Preoperative chemotherapy is feasible with acceptable toxicity and perioperative morbidity. 40% of LA GB could be down staged and offered R0 resection. Such approach improves survival in select locally advanced Ca GB.