Chemotherapy Regimen Given Prior to Surgery Improves Survival in Patients With Pancreatic Cancer

Treatment with FOLFIRINOX, a combination of several chemotherapy agents, prior to the surgical resection of pancreatic cancer increased survival outcomes when compared to historical data.

A modified treatment regimen of leucovorin calcium (folinic acid), fluorouracil, irinotecan hydrochloride and oxaliplatin — a four-drug chemotherapy combination known as FOLFIRINOX — induced improvements in survival when given to patients with borderline resectable pancreatic cancer before surgery, according to recent study results.

Pancreatic cancer is considered borderline resectable when the cancer has grown into a major blood vessel or nearby tissue or organs. According to information from the University of California, San Francisco, surgery may be an option in this patient population. However, there is a high probability that all of the cancer cells will not be removed during surgery.

These patients, according to lead study author Dr. Matthew H.G. Katz, have not had a standard-of-care option available to them in the past.

“Historically, these tumors have been considered unresectable; over the past decade or so there has been increased enthusiasm for resection but standards for timing of surgery nor preoperative therapy do not really exist,” Katz, who is the chair of the Department of Surgical Oncology at The University of Texas MD Anderson Cancer Center in Houston, said in an interview with CURE®.

As a result, the investigators set out to determine if there may be an optimal pre-surgical treatment approach for this patient population. Additionally, they used historical data as a comparison to gauge the benefit of neoadjuvant FOLFIRINOX alone or combined with hypofractionated radiation therapy. Of note, neoadjuvant treatment is administered to shrink tumors prior to surgery.

The phase 2 trial Katz and colleagues performed comprised 126 patients (49% women; median age, 64 years) with borderline resectable pancreatic cancer. The study participants were then randomized to receive either FOLFIRINOX alone (70 patients) or FOLFIRINOX and hypofractionated radiation therapy (56 patients).

The main goal of the study was to determine what the 18-month overall survival rate was. This was defined as the percentage of patients who remained alive (even with disease progression) at 18 months after randomization to treatment.

The investigators also evaluated how each regimen affected event-free survival (time from treatment randomization to disease progression, surgery with some disease remaining, recurrent disease after surgery or death from any cause). They also aimed to analyze the percentage of patients with microscopic amounts of tumor following surgery, as well as response rates and side effects.

The findings demonstrated that the 18-month overall survival rate among the 65 evaluable patients who received FOLFIRINOX alone prior to resection was 66.7%. This was a significant improvement from the 18-month overall survival rate of 47.3% in the group who received the combination.

Moreover, the median overall survival outcomes were more favorable in the group that received FOLFIRINOX alone (29.8 months versus 17.1 months).

The findings associated with the chemotherapy alone regimen, according to Katz, are quite impressive when compared to that of existing data. Katz noted that there wasn’t much to take from the radiation therapy results other than that treatment didn’t seem to improve survival outcomes.

“Patients with advanced (pancreatic) cancers should be treated with chemotherapy as at least a first step,” Katz concluded. “Some will benefit from surgery to follow. The role for radiation remains unclear, but its routine use is probably inappropriate. It may benefit some patients prior to surgery but not others.”

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