SAN FRANCISCO – Eleven noteworthy studies exploring new approaches in the treatment and management of gastrointestinal cancers will be presented at the 2023 ASCO Gastrointestinal Cancers Symposium, taking place January 19-21, 2023, at the Moscone West Building in San Francisco, California.  

Experts in gastrointestinal cancers are available to comment on the studies below and ASCO’s Media Team can assist you in arranging interviews with study authors and/or outside experts.  

Thursday Presentations
The embargo on the following abstracts lifts at 10:00 AM (ET) on Thursday, January 19, 2023:

Abstract LBA294: INTEGRATE IIa: A randomised, double-blind, phase III study of regorafenib versus placebo in refractory advanced gastro-oesophageal cancer (AGOC)—A study led by the Australasian Gastro-intestinal Trials Group (AGITG).
View the full abstract (Abstract presentation part of session beginning at 11:15 AM (PT) on Thursday, January 19)

Abstract LBA292: Zolbetuximab plus mFOLFOX6 as 1L treatment for patients with HER2-/claudin-18.2+ locally advanced unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Primary phase III results from SPOTLIGHT
View the full abstract (Abstract presentation part of session beginning at 1:30 PM (PT) on Thursday, January 19)
"Zolbetuximab combined with first-line chemotherapy (mFOLFOX6) led to significantly longer progression-free survival and overall survival in patients with claudin 18.2 (CLDN18.2)-positive/HER2-, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Zolbetuximab plus chemotherapy is a new potential standard treatment for these patients," said lead study author Kohei Shitara, MD.

Friday Presentations
The embargo on the following abstracts will lift at 5:00 PM (ET) on Tuesday, January 17, 2023:

Abstract 494: Nanvuranlat, an L-type amino acid transporter (LAT1) inhibitor for patients with pretreated advanced refractory biliary tract cancer (BTC): Primary endpoint results of a randomized, double-blind, placebo-controlled phase 2 study.
View the full abstract (Abstract presentation part of session beginning at 7:00 AM (PT) on Friday, January 20)
“Nanvuranlat, a LAT1 inhibitor, demonstrated a statistically significant progression-free survival benefit in patients with pretreated advanced refractory biliary tract cancer. Treatments in later lines of chemotherapy for biliary tract cancer are very limited. Nanvuranlat may help improve survival in patients with biliary tract cancer that is refractory to standard treatments,” said lead study author Junji Furuse, MD, PhD.

“Lat1 is a transporter of L-type amino acid, and its expression is associated with poor prognosis. This phase II trial demonstrates that Nanvuranlat, a promising LAT1 inhibitor, improved progression-free survival compared to best supportive care in patients with refractory biliary tract cancer and may offer a new treatment option.  However, these findings will likely need to be assessed in a more diverse patient population which will allow validation of efficacy and treatment-related toxicities.”—Cathy Eng, MD, FACP, FASCO, ASCO Expert in gastrointestinal cancers

Abstract 550: Outcomes by antibiotic use in participants with advanced biliary tract cancer treated with durvalumab or placebo plus gemcitabine and cisplatin in the phase 3 TOPAZ-1 study.
View the full abstract (Abstract presentation part of poster session beginning at 12:00 PM (PT) on Friday, January 20)
“Use of antibiotics during treatment with immune checkpoint inhibitors has been correlated with poorer outcomes. Our results support that advanced biliary tract cancer patients’ risk of death and the risk that their cancer would grow, spread, or get worse was not meaningfully different between patients who used antibiotics and those who did not use antibiotics at the same time as they were receiving durvalumab-based treatment. People with advanced biliary tract cancer can safely be treated with antibiotics, while still benefiting from treatment with durvalumab plus chemotherapy,” said lead study author Aiwu Ruth He, MD, PhD.

Abstract 489: NRG/RTOG 1112: Randomized phase III study of sorafenib vs. stereotactic body radiation therapy (SBRT) followed by sorafenib in hepatocellular carcinoma (HCC).
View the full abstract (Abstract presentation part of session beginning at 1:30 PM (PT) on Friday, January 20)
“Our findings show that personalized stereotactic body radiation therapy was associated with improved outcomes, with no concerning increase in adverse events and a strong suggestion for improved quality of life, compared to sorafenib alone. External beam radiation therapy is an effective therapy in the treatment of hepatocellular carcinoma that should benefit many patients from around the world in the future, especially patients with macrovascular invasion, who previously had limited treatment options. Stereotactic body radiation therapy should be included as a standard treatment option for these patients, especially those who are planned to be treated with tyrosine kinase inhibitors or those who are not candidates for, or who have progression or intolerance to systemic therapies,” said lead study author Laura A. Dawson, MD, FASTRO, FRCPC.

The embargo on the following abstracts will lift at 10:00 AM (ET) on Friday, January 20, 2023:

Abstract LBA492: Canadian Cancer Trials Group HE.1: A phase III study of palliative radiotherapy for symptomatic hepatocellular carcinoma and liver metastases.
View the full abstract (Abstract presentation part of session beginning at 7:00 A.M. PST on Friday, January 20)
“For patients who have hepatic pain due to locally advanced primary or metastatic liver cancer, low dose radiation therapy should be considered as a standard palliative intervention to improve pain. This intervention is a simple treatment option that is widely available globally, that should improve the lives of patients from around the world with hepatic cancer pain,” said lead study author Laura A. Dawson, MD, FASTRO, FRCPC.

Saturday Presentations
The embargo on the following abstracts will lift at 5:00 PM (ET) on Tuesday, January 17, 2023:

Abstract 132: Preoperative chemotherapy prior to primary tumor resection for asymptomatic synchronous unresectable colorectal liver-limited metastases: A multicenter randomized controlled trial.
View the full abstract (Abstract presentation part of poster session beginning at 6:30 AM (PT) on Saturday, January 21)

Abstract 100: Phase III FIRE-4 study (AIO KRK-0114): Evaluation of first-line treatment efficacy of FOLFIRI/cetuximab in patients with RAS-WT mCRC receiving the first cycle of treatment with chemotherapy only.
View the full abstract (Abstract presentation part of poster session beginning at 6:30 AM (PT) on Saturday, January 21)
“According to the National Comprehensive Cancer Network guidelines, RAS wild-type left-sided metastatic colorectal cancer patients should start with anti-EGFR (cetuximab or panitumumab) plus doublet chemotherapy (FOLFOX or FOLFIRI) as first-line treatment. This has shown to improve survival times in multiple phase-3 studies when compared to bevacizumab plus doublet chemotherapy. In some cases, results of RAS mutational analysis may still be pending at the time of initiating systemic treatment. Within the phase III FIRE-4 study, one cycle of FOLFIRI without the admission of any antibody was allowed per protocol. When compared to patients treated with cetuximab from the first cycle neither tumor response rates nor survival times were negatively impacted. Therefore, it may be feasible to start with doublet chemotherapy without any monoclonal antibody adding anti-EGFR antibodies or bevacizumab according to the RAS testing result in later cycles,” said lead study author Sebastian Stintzing, MD.

“The FIRE-4 trial demonstrates that one cycle of standard chemotherapy prior to randomization for a clinical trial does not negatively compromise the primary endpoint of progression-free survival. The flexibility of this clinical trial design should be considered for any clinical trial that incorporates the standard of care. This approach will help reduce patient and provider concerns pending RAS status and improve patient enrollment to clinical trials.”—Cathy Eng, MD, FACP, FASCO, ASCO Expert in gastrointestinal cancers

Abstract 10: Organ preservation and total neoadjuvant therapy for rectal cancer: Investigating long-course chemoradiation versus short-course radiation therapy.
View the full abstract (Abstract presentation part of session beginning at 7:00 AM (PT) on Saturday, January 21)

“This retrospective analysis suggests a reduced chance of organ (sphincter) preservation with short course radiation therapy. These findings will need to be validated and a prospective phase III trial is currently being conducted in Europe.”—Cathy Eng, MD, FACP, FASCO, ASCO Expert in gastrointestinal cancers

Abstract 4: Trifluridine/tipiracil plus bevacizumab for third-line treatment of refractory metastatic colorectal cancer: The phase 3 randomized SUNLIGHT study.
View the full abstract (Abstract presentation part of session beginning at 11:00 AM (PT) on Saturday, January 21)
“In the SUNLIGHT study, median overall survival improved by 3.3 months with trifluridine/tipiracil plus bevacizumab. The survival benefit was observed across all subgroups, irrespective of age, sex, location of primary disease, number of metastatic sites, and RAS mutation status. This is one of the first studies to show improved efficacy over an existing active treatment in patients with refractory metastatic colorectal cancer. In addition, the magnitude of the benefit observed was greater than that seen in other trials, and in a population that included patients with poor prognostic factors, such as RAS mutations,” said lead study author Josep Tabernero, MD, PhD.

“This randomized phase III trial in European patients after receiving 1-2 lines of prior chemotherapy validates earlier phase II Danish data demonstrating improved overall survival of  trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone.” —Cathy Eng, MD, FACP, FASCO, ASCO Expert in gastrointestinal cancers

Abstract 5: Kinetics of postoperative circulating cell-free DNA and impact on minimal residual disease detection rates in patients with resected stage I-III colorectal cancer.
View the full abstract (Abstract presentation part of session beginning at 11:00 AM (PT) on Saturday, January 21)
“In our analysis, ctDNA can be reliably evaluated starting in week three (day 15+) after surgery, regardless of underlying cfDNA concentration. Positive ctDNA is highly associated with poor recurrence-free survival. For patients seeking to including ctDNA in their medical decision-making, these results suggest that earlier testing of ctDNA is possible. Earlier testing may improve feasibility of ctDNA testing by minimizing time to receipt of results,” said lead study author Stacey A. Cohen, MD.

View the disclosures for Dr. Eng: https://coi.asco.org/share/U5V-NT84/Cathy%20Eng

View the disclosures for Dr. Kunz: https://coi.asco.org/share/TLS-NHXP/Pamela%20Kunz

ATTRIBUTION TO THE 2023 GASTROINTESTINAL CANCERS SYMPOSIUM IS REQUESTED IN ALL NEWS COVERAGE.

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