Michel Ducreux, MD, Gustave Roussy Cancer Center, Villejuif, France, discusses results from the randomized phase 3 PRODIGE 29/NEOPAN trial comparing modified FOLFIRINOX (leucovorin calcium, fluorouracil, irinotecan hydrochloride, oxaliplatin) chemotherapy with gemcitabine for patients with metastatic pancreatic cancer.

In this study, the median progression-free survival (PFS) of patients treated with FOLFIRINOX was significantly longer than those treated with gemcitabine. While gemcitabine is currently the standard of care for this patient population, Dr Ducreux explains, in his opinion, the results of this study make an argument for FOLFIRINOX as the standard of care.

These results were first presented at the 2022 European Society of Medical Oncology (ESMO) Congress.

Transcript:

Hello. I am Professor Michel Ducreux. I am a GI oncologist working in Gustave Roussy Cancer Center in Villejuif, France. Here at the 2022 ESMO Congress in Paris, I have presented for the first time, the results of the NEOPAN trial.

The concept of the trial was to include patients with locally advanced pancreatic cancer, truly locally advanced pancreatic cancer, not borderline resectable pancreatic cancer, randomized between 2 arms. Arm A was gemcitabine alone for 6 months, and arm B was for FOLFIRINOX for 6 months. After the end of the 6 months of chemotherapy, the center could choose to either give maintenance with chemotherapy, or to finish with radiotherapy or chemoradiotherapy, or to stop any treatment.

The main end point of the trial was to improve the median PFS. It was an end point that was met. There was a clear improvement in median PFS with a median PFS with FOLFIRINOX that was 9.7 months, that was higher than the median of PFS of the patients treated in gemcitabine arm.

It was a little bit disappointing that, in terms of overall survival, there was absolutely no consequence of this improvement in median PFS given by FOLFIRINOX. The median overall survival in the 2 groups was 15.6 or 15.7 months. This is exactly the median survival that was observed in the LEAP-007 trial with gemcitabine alone. This is something that is interesting, I would say.

If we look at the toxicity that was observed—the protocol that we used was modified FOLFIRINOX without bolus—and what we observed is that the toxicity of this regimen is clearly less. And when you compare the toxicity of FOLFIRINOX and gemcitabine, it's a little bit more toxic, FOLFIRINOX, but not so much. Especially for thrombocytopenia, we observed thrombocytopenia more frequently and more severely with gemcitabine than with FOLFIRINOX. But, obviously, neuropathy was observed more frequently with FOLFIRINOX, and also febrile neutropenia a little bit.

In terms of consequence for the patients, what we observe too is that there were only 3 secondary resections in each arm. That means that even with an intense neoadjuvant treatment, it was quite impossible to perform surgery in these patients, probably because they were severe locally advanced pancreatic carcinoma.

In conclusion, what I can say, is that this trial with 170 patients randomized between gemcitabine and FOLFIRINOX with locally advanced pancreatic cancer met the primary end point, that was an improvement in median PFS, with the cost in terms of toxicities not too high. The median survival was not changed. This means we will have a look now at the quality of lives. That will be important. In my opinion, the conclusion of this trial is that FOLFIRINOX is becoming a standard of care for the treatment of locally advanced pancreatic cancer.

Source:

Ducreux MP, Desgrippes R, Rinaldi Y, et al. PRODIGE 29-UCGI 26(NEOPAN): A phrase III randomised trial comparing chemotherapy with folfirinox or gemcitabine in locally advanced pancreatic carcinoma (LAPC). Presented at ESMO Congress; September 9-13, 2022; Paris, France. Abstract 1296MO.