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• Researchers present findings from late-breaking phase 2 study
• Two patients experienced complete response from the new combination
• Team exploring further clinical study in a narrower group of patients

News — ORLANDO, Fla. — A recent research effort led by , Assistant Professor of Oncology at Roswell Park Comprehensive Cancer Center, demonstrated that a new chemotherapy combination — trifluridine/tipiracil (FTD/TPI) and oxaliplatin — is well tolerated and has activity among patients with esophageal cancer.

While this particular combination, when given before standard chemoradiation, did not improve outcomes in all patients, Dr. Mukherjee and his team are currently performing additional analyses to identify subgroups who may benefit from induction chemotherapy with trifluridine/tipiracil and oxaliplatin. Findings from this late-breaking phase 2 clinical study will be presented during the American Association for Cancer Research (AACR) annual meeting, which continues through April 19 in Orlando, Florida.

“Achieving pathologic complete response (pCR) is associated with improved overall survival. Therefore, several studies have used induction chemotherapy before chemoradiation to improve pCR rates but saw mixed results,” notes Dr. Mukherjee, a gastrointestinal medical oncologist and the study’s first author. “We used a novel combination of FTD/TPI and oxaliplatin as induction chemotherapy before the standard chemoradiation in localized esophageal and gastroesophageal junction adenocarcinoma (EGAC) with the primary objective to increase the pCR rate.”

The researchers enrolled 22 patients in this open-label, multicenter phase 2 trial between January 2020 and October 2022. The primary objective was to evaluate pathologic complete response. Secondary objectives included two-year disease-free survival, two-year overall survival and toxicities.

Eligible adult patients were younger than 76 years old and had potentially resectable esophageal and gastroesophageal junction adenocarcinoma as well as adequate organ function and an ECOG performance status of 0-1.

Participants were administered three cycles of induction chemotherapy with trifluridine/tipiracil and oxaliplatin. They then underwent concurrent chemoradiation with weekly carboplatin and paclitaxel for 6 weeks followed by surgery.

After a median follow up of 15.8 months, two-year overall survival and progression-free survival were 43% and 41%, respectively. In terms of toxicity, grade 3 or higher treatment-related adverse events were observed in nine (40.9%) patients, with the most common being neutropenia (13.6%) and lymphopenia (9.1%). Overall, the most common treatment-related adverse events were nausea (59.1%) and fatigue (59.1%), both of which were grade 1-2 events.

Two patients had pathologic complete responses, and an additional four had near pathologic complete responses. While the study was closed early based on those findings, additional research may be conducted in a smaller subgroup of patients.

“We report here that the novel combination of trifluridine/tipiracil and oxaliplatin is well-tolerated and has activity in esophageal cancer, but that this combination does not improve outcomes in all patients with esophageal cancer,” Dr. Mukherjee says, noting that the team is performing a correlative analysis seeking to identify whether a subgroup of patients may benefit from induction chemotherapy with this regimen.

“Now that we have seen the safety and activity of this combination regimen in esophageal cancer,” he says, “further studies may explore this combination in a more advanced setting, and in combination with immune checkpoint inhibitors, which are now widely used in the treatment of esophageal cancer.”

Presentation details:

Presenting author: Sarbajit Mukherjee, MD, MS, Assistant Professor, Roswell Park Comprehensive Cancer Center

Time/date: Monday, April 17, 2023: 1:30-5 p.m. EDT

Session: PO.CT02.01 - Phase II Clinical Trials 1

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This release is also available on the Roswell Park website: 

Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at or contact us at 1-800-ROSWELL (1-800-767-9355) or [email protected].