SWOG Researchers Go Digital At #ASCO20

Due to the coronavirus pandemic, ASCO officials cancelled the annual Chicago meeting, the world’s largest cancer research conference, and switched to an online format. About 2,215 abstracts will be presented over three days, and more than 3,400 abstracts were accepted for online publication. SWOG investigators will report on trials involving cancer treatment, prevention, and care strategies, as well as results of the first trial run through the NCI’s National Clinical Trials Network (NCTN) to focus on financial toxicity – the severe financial and emotional toll exacted on patients by the costs of their cancer care.

Davendra Sohal, MD, MPH, an associate professor at the University of Cincinnati, will deliver an oral presentation on the primary findings from S1505, a randomized SWOG trial that compares two common chemotherapy regimens for early-stage pancreatic cancer, and tests chemotherapy prior to pancreatic cancer surgery.

In S1505, one group of pre-surgery patients received modified FOLFIRINOX, or mFOLFIRINOX, a combination of three chemotherapy drugs – fluorouracil, irinotecan, and oxaliplatin. The other group received a combination of gemcitabine and nab-paclitaxel. Sohal and his team found that chemotherapy treatment prior to surgery results in good outcomes – regardless of the drugs patients receive. Of the patients who received mFOLFIRINOX, 73 percent underwent surgery for their pancreatic cancer, while 70 percent of patients who received gemcitabine and nab-paclitaxel underwent surgery. Two years after treatment, 43 percent and 47 percent of all eligible patients who started treatment were alive in the mFOLFIRINOX and gemcitabine and nab-paclitaxel arms, respectively.

“We didn’t find that one regimen was better than the other,” Sohal said. “We did demonstrate that treating pancreatic cancer patients with chemotherapy before surgery can be done safely, and we established a benchmark with this approach, which can help us build future trials that can test other pancreatic cancer drugs and further refine pre-surgery chemotherapy treatment.”

Here are other SWOG highlights of the ASCO20 Virtual Scientific Program: 

• Results from S1211 will be orally presented by Saad Usmani, MD, a hematologist with Atrium Health and co-vice chair of SWOG’s myeloma committee. Usmani’s phase II SWOG study is the first randomized trial comparing treatments for high-risk multiple myeloma, a difficult-to-treat version of this blood cancer for which there is no standard of care. Usmani and his team compared the effects of eight cycles of chemotherapy with lenalidomide, bortezomib, and dexamethasone induction with or without the addition of elotuzumab. Results were negative; The addition of elotuzumab didn’t offer a significant benefit. However, patients on both arms of the trial appear to have better progression-free survival, and lived much longer, than high-risk multiple myeloma patients typically do. This finding casts a positive light on combination treatment for this disease, and sets a tangible benchmark for the next SWOG phase III trial.
   
• Results from S1416 will be orally presented by Priyanka Sharma, MD, vice chair of SWOG’s breast cancer research committee and professor of medicine at the University of Kansas Cancer Center. Eve Rodler, MD, of the University of California Davis Comprehensive Cancer Center, serves as co-leader of S1416. More than half of all cases of triple negative breast cancer (TNBC) demonstrate DNA repair deficiency, which can be due to an inherited, or germline mutation, in the BRCA gene, or due to other causes leading to tumors that appear “BRCA-like.” In other words, they behave like tumors caused by a BRCA mutation but don’t have an inherited gene abnormality. In germline BRCA mutation associated breast cancers, this DNA repair deficiency is successfully treated with PARP inhibitors, and Sharma and Rodler wanted to see if these drugs could also be effective for BRCA-like cancers. In S1416, patients were treated either with standard cisplatin chemotherapy and a placebo, or cisplatin plus veliparib, an investigational PARP inhibitor. Patients with germline BRCA normal but BRCA-like TNBC who got the investigational drug in addition to cisplatin had significantly improved progression-free survival and showed a trend towards improved overall survival. NCI funded the study with AbbVie Inc. providing veliparib to support the study through a Cooperative Research and Development Agreement with NCI.
   
• Results from S1417CD will be presented in a poster discussion session by Veena Shankaran, MD, MS, co-director of the Hutchinson Institute for Cancer Outcomes at Fred Hutchinson Cancer Research Center. Shankaran’s SWOG trial, S1417CD, is the first prospective, multicenter study of financial toxicity. The primary goal was to determine how often patients with metastatic colorectal cancer experience financial hardship over the course of their treatment. Patients filled out questionnaires assessing assets, debt, spending, stress level, and quality of life when they enrolled in the trial, then subsequently three, six, nine and 12 months into their treatment. Dr. Shankaran and her team also pulled patients’ credit reports at the trial’s start and finish. Results are arresting. Three out of four patients experienced major financial hardship, defined as taking on credit card debt, taking out a loan, having a 20 percent or greater drop in income, or selling or refinancing a home. What’s more, most patients enrolled in the trial were not considered financially vulnerable. Shankaran said the findings underscore the need for clinical and policy solutions, such as early financial navigation for patients and the elimination of cost sharing between patients and their insurance companies.
   
• Results from one cohort of S1609 will be presented in a poster session by Sylvia Adams, MD, a SWOG and ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) investigator and professor of medicine at the Perlmutter Cancer Center at New York University Langone Health. Adams wanted to test immunotherapy drugs to treat metaplastic breast cancer, a concept she came up with through ECOG-ACRIN, which is also part of the NCTN. At the suggestion of the NCI, she found a home for her idea in DART, short for Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors, a unique SWOG trial testing the immunotherapy combination of ipilimumab plus nivolumab in a variety of rare cancers. Metaplastic breast cancer is a rare form of TNBC that’s actually a hybrid, including cells from the breast and tissue such as muscle or bone. These unique features make this cancer very difficult to treat, and most patients die within nine months of developing metastatic disease. In this sub-set of DART, 17 eligible patients with metaplastic breast cancer received the immunotherapy combination. Three had positive, lasting responses; their tumors shrank significantly and all three remain alive and progression-free 23 to 27 months after treatment. While one patient died on the study, and some experienced side effects such as fatigue, Adams said results are promising, leading her team to study trial tissue samples to determine if there is a biological reason behind the positive responses. S1609 is funded by NCI and Bristol-Myers Squibb Company provided the nivolumab to support the study through a Cooperative Research and Development Agreement with NCI.

 “I’m particularly impressed with this year’s ASCO presentations,” said SWOG Chair Charles D. Blanke, MD. “They spotlight some of our most ground-breaking clinical trials in recent years, and are a testament to the creativity, ambition, and tenacity of SWOG researchers.”