'Encouraging' Results in Trial of FOLFIRINOX for Advanced Gastroesophageal Cancer

By Anne Harding

June 04, 2020

NEW YORK (Reuters Health) - A four-drug combination is associated with improved overall and progression-free survival (PFS) in patients with advanced gastroesophageal adenocarcinoma, a phase-2 trial shows.

Patients given leucovorin, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) as first-line treatment, along with trastuzumab if they had HER2-positive disease, had overall response rates (ORR) of 61% and 85%, respectively, Dr. A. Craig Lockhart of the Leonard M. Miller School of Medicine at the University of Miami and colleagues report in JAMA Oncology.

"The response rates and the survival numbers were excellent and better than any other regimen that is commonly used," Dr. Lockhart told Reuters Health by phone.

Response rates for current treatments for advanced gastroesophageal cancer range from 35%-45%, he and his colleagues note in their report, with overall survival (OS) of nine to 10 months. Typically, Dr. Lockhart explained, these patients will receive 5-FU and a platinum agent as first-line treatment.

Because FOLFIRINOX has shown good results with other gastrointestinal malignancies, the authors tested the regimen in 67 patients, 26 of whom (39%) had HER-2 positive disease. All of the study participants received FOLFIRINOX, while the HER-2 positive patients were also given trastuzumab. All patients in the study had an Eastern Cooperative Oncology Group performance score of 2 or higher.

Patients were followed for a median 17.4 months. ER-negative patients had a median PFS of 8.4 months, with a median OS of 15.5 months. PFS and OS were 13.8 months and 19.6 months, respectively, for the ER-positive patients.

Dose modifications or delays in treatment occurred with 56 patients (84%). Toxic effects included neutropenia, diarrhea, peripheral sensory neuropathy and nausea.

While the results should be interpreted cautiously because they are from a single center and the trial was not randomized, they are "very encouraging," Dr. Lockhart said.

He said he and his colleagues are in discussions with two major cancer clinical trial groups to plan a larger, randomized trial of FOLFIRINOX in advanced gastroesophageal carcinoma, and a trial in the perioperative setting.

The study did not have commercial funding.

SOURCE: https://bit.ly/2U64EiZ JAMA Oncology, online May 29, 2020.