Susanna Ulahannan, MD, assistant professor, Section of Hematology/Oncology, associate director, Oklahoma TSET Phase I Program, Stephenson Cancer Center, The University of Oklahoma, discusses the phase II PRODIGE 35/PANOPTIMOX trial in pancreatic cancer.

In the phase II trial, patients with metastatic disease were randomized to 3 treatment arms in the maintenance setting. They compared continuous FOLFIRINOX in arm A with 8 cycles of FOLFIRINOX and then 5-fluorouracil leucovorin (LV5FU2) as maintenance in arm B, explains Ulahannan. When patients progressed, they went back and gave them FOLFIRINOX again.

Arm C was a gemcitabine-based therapy alternating with FOLFIRI. The randomization showed that alternating gemcitabine with FOLFIRI was inferior. The results showed that arm B was comparable to arm A. Median overall survival (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. OS rates at 18 months were 18.5%, 28%, and 13.9%, respectively, demonstrating a P value >.05 favoring the use of FOLFIRINOX and LV5FU2 as maintenance therapy.

This is a phase II trial, so it needs phase III data to confirm the results, states Ulahannan. Nonetheless, physicians now have some randomized data to support the use of this maintenance approach in patients who otherwise experience a lot of toxicity.

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Dr. Ulahannan on the PRODIGE 35 Trial in Pancreatic Cancer

Susanna Ulahannan, MD, assistant professor, Section of Hematology/Oncology, associate director, Oklahoma TSET Phase I Program, Stephenson Cancer Center, The University of Oklahoma, discusses immunotherapy in hepatocellular carcinoma (HCC).

In the field of HCC, physicians have sorafenib (Nexavar) in the first-line setting, and nivolumab (Opdivo) and regorafenib (Stivarga) in the second-line setting. Physicians also have the data with cabozantinib (Cabometyx) and lenvatinib (Lenvima) as well as with ramucirumab (Cyramza). All these agents are being reviewed for FDA approval.

However, HCC is very different from other cancers, explains Ulahannan. Physicians have to look at the cancer as well as liver function and liver disease. With immunotherapy, physicians can better treat these patients, as it can work even if a patient has poor liver function, explains Ulahannan.

Patients who have hepatitis B or C are also eligible for immunotherapy. At the 2018 ASCO Annual Meeting, very early data on a small number of patients were presented with a PD-L1 inhibitor in combination with bevacizumab (Avastin). These were encouraging data, with about a 60% response rate, says Ulahannan.

Dr. Ulahannan on Immunotherapy in Hepatocellular Carcinoma

Susanna Ulahannan, MD, assistant professor, Section of Hematology/Oncology, associate director, Oklahoma TSET Phase I Program, Stephenson Cancer Center, The University of Oklahoma, discusses the VALENTINO trial in advanced colorectal cancer (CRC).

There is a lot of existing data for bevacizumab (Avastin) in combination with 5-fluorouracil (5-FU) in the maintenance setting. This regimen is often used by physicians to help enhance a patient’s quality of life, says Ulahannan. However, there are limited data to support the use of anti-EGFR agents in the maintenance setting.

The phase II VALENTINO study was a noninferior trial looking at panitumumab (Vectibix) as maintenance therapy versus panitumumab and 5-FU. The study met its endpoint. Physicians can now use this regimen as an effective maintenance treatment for patients with 

The study is unlikely to change the standard of care in the maintenance setting as 5-FU is already the basis of maintenance approaches whether combined with a targeted therapy such as VEGFR-targeted agent like bevacizumab (Avastin) or an EGFR-targeting therapy like panitumumab or cetuximab (Erbitux).

Dr. Ulahannan on the VALENTINO Trial in Advanced CRC

Susanna Ulahannan, MD, assistant professor, Section of Hematology/Oncology, associate director, Oklahoma TSET Phase I Program, Stephenson Cancer Center, The University of Oklahoma, discusses the PRODIGE trial in pancreatic cancer.

The phase III GI PRODIGE 24/CCTG PA.6 trial was presented at the 2018 ASCO Annual Meeting and examined the use of adjuvant mFOLFIRINOX versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma. The trial was conducted in France and Canada.

The importance of a study like this cannot be understated, as the overall survival (OS) in pancreatic cancer, even resectable pancreatic cancer, is poor, says Ulahannan. OS has typically hovered around 24 months to 28 months with the previous standard of care of gemcitabine and capecitabine.

The modified FOLFIRINOX regimen had an OS of 54.5 months, says Ulahannan, representing a 36% reduction in the risk of death (HR, 0.64; 95% CI, 0.48-0.86; 

 = .003). The median disease-free survival was 8.8 months longer with mFOLFIRINOX than with gemcitabine.

Susanna Ulahannan, MD

Articles

Dr. Ulahannan on the PRODIGE 35 Trial in Pancreatic Cancer

Dr. Ulahannan on Immunotherapy in Hepatocellular Carcinoma

Dr. Ulahannan on the VALENTINO Trial in Advanced CRC

Dr. Ulahannan on the PRODIGE Trial in Pancreatic Cancer