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Expert Details Latest Data Across GI Cancers

Caroline Seymour
Published: Monday, Aug 06, 2018

Susanna Ulahannan, MD

Susanna Ulahannan, MD

Among the gastrointestinal (GI) cancer findings presented at the 2018 ASCO Annual Meeting, the phase III PRODIGE 24/CCTG PA.6 trial results were the most significant, said Susanna Ulahannan, MD.

In PRODIGE 24, adjuvant therapy with a modified FOLFIRINOX regimen (mFOLFIRINOX) drastically improved survival compared with gemcitabine for patients with resected pancreatic cancer. mFOLFIRINOX induced a 36% reduction in the risk of death versus standard gemcitabine (HR, 0.64; 95% CI, 0.48-0.86; P = .003).1 The median overall survival (OS) was approximately 20 months longer with the 4-drug regimen at 54.4 months versus gemcitabine at 35.0 months. Additionally, the median disease-free survival was 8.8 months longer with mFOLFIRINOX than with gemcitabine.

Also impactful were the results of the phase II PRODIGE 35/PANOPTIMOX trial, in which patients with metastatic pancreatic cancer were randomized to 3 treatment arms: arm A, FOLFIRINOX every 2 weeks for a maximum of 12 cycles; arm B, FOLFIRINOX during 4 months for 8 cycles, followed by LV5FU2 as maintenance therapy until progression; and arm C, alternating FOLFIRI.3 with gemcitabine every 2 months.

The results showed that arm B was comparable with arm A. Median OS in Arms A, B, and C were 10.1 months (95% CI, 8.5-12.2), 11.0 months (95% CI, 8.7-13.1), and 7.3 months (95% CI, 5.7-9.5), respectively. 2

“These 2 trials were very exciting,” said Ulahannan. “Seeing an OS of more than 50 months is very encouraging. We have to remember that it is a selected population and it is a toxic regimen. With all those caveats, I feel that it's very encouraging.”

Additionally, Ulahannan said that although the phase III PRODIGE 7 trial demonstrated that heated chemotherapy during resection showed no benefit in patients with advanced colorectal cancer (CRC), physicians are working to reassess which patients are most likely to benefit from therapy.3

Ulahannan also noted that incremental advances in liver cancer were seen with cabozantinib (Cabometyx), lenvatinib (Lenvima), and ramucirumab (Cyramza). Another avenue may be immunotherapy in liver cancer, she said, despite a patient’s poor liver function.

In an interview during the 2018 OncLive® State of the Science Summit,™ A Summer of Progress: Updates from ASCO 2018, Ulahannan, assistant professor, Section of Hematology/Oncology, associate director, Oklahoma TSET Phase I Program, Stephenson Cancer Center, The University of Oklahoma, highlighted these trials from the 2018 ASCO Annual Meeting across GI malignancies and future therapeutic approaches across the landscape.

OncLive: Can you discuss the importance of the PRODIGE 24 trial?

Ulahannan: The PRODIGE 24 trial in pancreatic cancer…was done in France and Canada and has changed the standard of care. The OS in pancreatic cancer, even in resectable cancer, is poor. What we have seen in trials prior in the adjuvant setting was an OS of 24 months. [We saw an OS of] 28 months in the last standard of care with gemcitabine and capecitabine.

The mFOLFIRINOX regimen that was presented at the 2018 ASCO Annual Meeting had an OS of 54.5 months, which is remarkable. We haven't seen any data like these before. From a GI perspective, that was the most exciting data from that meeting.

Can you elaborate on the other PRODIGE trials that were presented?

There was also a PRODIGE study in the maintenance setting in pancreatic cancer. The initial PRODIGE study looking at FOLFIRINOX in metastatic pancreatic cancer was the first one that showed an OS of more than 11 months in the metastatic setting. That is the standard of care now. However, that's a toxic regimen. The investigators went back to see if there was something we could do to make it more tolerable for our patients.

In the maintenance setting, they did a randomized phase II trial comparing continuous FOLFIRINOX with 8 cycles of FOLFIRINOX and then 5-fluorouracil (5-FU) leucovorin as maintenance. When patients progressed, they went back and gave them FOLFIRINOX again.


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