New paclitaxel formulation offers alternative for advanced gastric cancer

Last Updated: 2017-02-02

By Will Boggs MD

NEW YORK (Reuters Health) - A new, nanoparticle albumin-bound formulation of paclitaxel (nab-paclitaxel) is noninferior to the standard solvent-based paclitaxel as salvage chemotherapy for advanced gastric cancer, researchers from Japan report.

Nab-paclitaxel has been shown to be equivalent to or more effective than solvent-based paclitaxel in several solid tumors and is now widely available for the treatment of breast, pancreatic, and non-small-cell lung cancer.

In an earlier phase 2 study, 27.8% of patients with advanced gastric cancer achieved an overall response to nab-paclitaxel administered every three weeks, the Japanese team notes in The Lancet Gastroenterology and Hepatology, online January 18.

Dr. Kohei Shitara from National Cancer Center Hospital East in Kashiwa and colleagues in the ABSOLUTE trial investigated the efficacy and safety of nab-paclitaxel every three weeks and weekly versus weekly solvent-based paclitaxel in a noninferiority trial of 741 patients with previously treated advanced gastric cancer.

Median overall survival, the primary endpoint, was 10.3 months with nab-paclitaxel every three weeks, 11.1 months with weekly nab-paclitaxel, and 10.9 months with weekly solvent-based paclitaxel.

Weekly nab-paclitaxel was noninferior to solvent-based paclitaxel, but nab-paclitaxel every three weeks was not.

Overall response rates did not differ significantly between nab-paclitaxel every three weeks (25%), weekly nab-paclitaxel (33%), and weekly solvent-based paclitaxel (24%). Median times to treatment failure were also similar (3.3 months, 4.5 months, and 3.7 months, respectively).

Quality-of-life scores were lower in the group that received nab-paclitaxel every three weeks than in the other groups throughout the trial.

Virtually all patients in all three treatment groups experienced at least one adverse drug reaction. But adverse reactions leading to treatment discontinuation were more common with nab-paclitaxel every three weeks (17%) than in the weekly nab-paclitaxel (7%) or weekly solvent-based paclitaxel (5%) group.

"Given the shorter infusion time, which can reduce infusion reactions, use of weekly nab-paclitaxel for previously treated advanced gastric cancer may be an option," the researchers conclude.

Dr. Florian Lordick from University Cancer Center Leipzig in Germany, who wrote a linked editorial, told Reuters Health by email, "Patients, nowadays, have second-line treatment options that lead to progression-free and overall survival times which have not been seen previously. This means longer survival and longer disease and symptom control are possible, nowadays, in the situation of advanced and metastatic gastric cancer."

"Nab-paclitaxel given on a weekly basis is a valid option, especially in patients who do not tolerate the solvents of classical paclitaxel (Cremophor or ethanol)," he said.

Dr. Lordick's editorial notes that "a health economic analysis of these treatments is essential to determine what incremental costs are associated with the use of nab-paclitaxel and whether nab-paclitaxel is cost-effective in view of the shorter infusion times, lower need for prophylactic medication, and fewer hypersensitivity reactions."

Taiho Pharmaceutical funded the study and had various relationships with all 20 of the authors of the report.

Dr. Shitara did not respond to a request for comments.

SOURCE: http://bit.ly/2ktovIo and http://bit.ly/2jGySDY

Lancet Gastroenterol Hepatol 2017.