HealthDay News — For patients with biliary tract cancer (BTC), no significant improvement is observed in overall survival with the addition of albumin-bound paclitaxel to gemcitabine and cisplatin (GAP) versus gemcitabine/cisplatin (GC), according to a study presented at the American Society of Clinical Oncology annual Gastrointestinal Cancers Symposium, held from Jan. 19 to 21 in San Francisco.
Rachna T. Shroff, M.D., from the University of Arizona in Tucson, and colleagues conducted a randomized phase III trial comparing GAP to GC among newly diagnosed advanced BTC patients. A total of 441 patients (73 percent with metastases) were randomly assigned in a 2:1 ratio to either GAP or GC and were treated until progression.
The researchers found that the median overall survival was 14 and 12.7 months for GAP and GC, respectively (hazard ratio, 0.93; 95 percent confidence interval, 0.74 to 1.19; P = 0.58); the overall response rate (confirmed and nonconfirmed) was 34 and 25 percent, respectively (P = 0.11), and median progression-free survival was 8.2 and 6.4 months, respectively (hazard ratio, 0.92; 95 percent confidence interval, 0.72 to 1.16; P = 0.47). In exploratory subset analyses, overall survival was improved with GAP versus GC in patients with locally advanced disease (median, 19.2 versus 13.7 months; hazard ratio, 0.67; 95 percent confidence interval, 0.42 to 1.06; P = 0.09) and in patients with gallbladder adenocarcinoma (median, 17.0 versus 9.3 months; hazard ratio, 0.74; 95 percent confidence interval, 0.41 to 1.35; P = 0.33).
“While the addition of nab-paclitaxel did not improve survival, the triplet may merit further investigation in locally advanced biliary cancers as a potential neoadjuvant approach,” Shroff said in a statement.
The study was partially funded by Celgene, a subsidiary of Bristol Myer Squibb, the manufacturer of nab-paclitaxel.