UDON therapy offers a new hope for patients with esophageal cancer.

UDON Therapy: A Promising Regimen for Esophageal Cancer

Lena Voss in Health & Wellness December 2025 • 4 min read.

"New research highlights the effectiveness and tolerability of UDON therapy in treating recurrent or metastatic esophageal cancer, offering hope for improved outcomes."

Esophageal cancer remains a significant global health challenge, ranking as the sixth leading cause of cancer-related deaths worldwide. While surgery, radiation, and chemotherapy form the cornerstones of treatment, outcomes for patients with advanced or recurrent disease remain poor. This underscores the urgent need for innovative and effective therapeutic strategies.

In Japan, a combination of cisplatin and 5-fluorouracil (5-FU) has been a standard of care for advanced esophageal cancer. However, this regimen can be too harsh for some, leading researchers to explore alternative combinations that balance efficacy with tolerability.

Now, a recent phase II trial investigates a novel combination therapy known as UDON (5-fluorouracil, docetaxel, and nedaplatin) for recurrent or metastatic esophageal cancer. The results shed light on its potential as a well-tolerated and effective treatment option, particularly for those who may not be suitable candidates for more aggressive regimens.

UDON: A Novel Approach to Esophageal Cancer Treatment

UDON therapy offers a new hope for patients with esophageal cancer.

The phase II trial, the focus of this analysis, evaluated the efficacy and safety of the UDON regimen in 23 patients with untreated recurrent or metastatic esophageal cancer. Patients received intravenous nedaplatin, docetaxel, and 5-fluorouracil over a 4-week cycle. The primary endpoint was response rate, with secondary endpoints including overall survival (OS), progression-free survival (PFS), dysphagia score, and adverse events.

The trial demonstrated promising results. Of the 22 evaluable patients:

16 experienced a partial response.
4 had stable disease.

This yielded an objective response rate of 72.7% and a disease control rate of 90.9%. The median overall survival was 11.2 months, and the median progression-free survival was 6.0 months. Notably, in patients with a primary lesion, 64.7% experienced improvement in dysphagia, a common and debilitating symptom of esophageal cancer.

While the UDON regimen demonstrated encouraging antitumor activity, it's important to consider its safety profile. The most frequent grade 3 or 4 adverse events were neutropenia (87.0%) and leukopenia (39.1%). Febrile neutropenia, a serious complication, was observed in two patients (8.7%). However, these adverse events were generally manageable with supportive care and dose adjustments.

UDON: A Step Forward in Esophageal Cancer Therapy?

This phase II study suggests that the UDON regimen is a promising first-line treatment option for Japanese patients with advanced or recurrent esophageal squamous cell carcinoma. Its high response rate, disease control rate, and manageable toxicity profile make it an attractive alternative to more aggressive regimens.

The study authors note that the high response rate and rapid tumor shrinkage associated with UDON warrant further investigation in the neoadjuvant setting (treatment before surgery).

While these findings are encouraging, further research is needed to confirm these results in larger, more diverse patient populations and to directly compare UDON to existing standard-of-care regimens. However, the UDON regimen represents a potentially valuable addition to the esophageal cancer treatment landscape, offering hope for improved outcomes and quality of life for patients facing this challenging disease.

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This article is based on research published under:

DOI-LINK: 10.1634/theoncologist.2018-0653, Alternate LINK

Title: Phase Ii Trial Of 5-Fluorouracil, Docetaxel, And Nedaplatin (Udon) Combination Therapy For Recurrent Or Metastatic Esophageal Cancer

Subject: Cancer Research

Journal: The Oncologist

Publisher: Oxford University Press (OUP)

Authors: Hiroto Ueda, Hisato Kawakami, Yoshikane Nonagase, Naoki Takegawa, Tatsuya Okuno, Takayuki Takahama, Masayuki Takeda, Yasutaka Chiba, Takao Tamura, Kazuhiko Nakagawa

Published: 2018-10-25

Everything You Need To Know

What exactly is the UDON therapy?

The UDON therapy involves a combination of three drugs: 5-Fluorouracil, Docetaxel, and Nedaplatin. This specific combination was evaluated in a phase II trial for treating recurrent or metastatic esophageal cancer. This means the cancer had either returned after initial treatment or spread to other parts of the body. The goal was to assess how well the UDON regimen worked in shrinking tumors and improving patient outcomes like survival and quality of life, specifically for those who might not be suitable for more aggressive treatments.

Why is the UDON regimen important for those with esophageal cancer?

Esophageal cancer is a serious disease with poor outcomes, especially in advanced stages. Globally, it is a leading cause of cancer-related deaths. Standard treatments like surgery, radiation, and chemotherapy are often not enough for those with advanced or recurrent disease. The development of the UDON regimen is significant because it offers a potentially new, effective, and well-tolerated treatment option for these patients, addressing an urgent need for better therapies.

What did the researchers measure in the trial of the UDON therapy?

The phase II trial assessed several key outcomes. The primary goal was to determine the objective response rate, which measures how many patients experienced a reduction in their tumors. Secondary endpoints included overall survival (OS), which is the length of time patients lived after starting treatment; progression-free survival (PFS), the time until the cancer started growing again; dysphagia score, indicating the severity of swallowing difficulties; and adverse events, to assess the treatment's safety profile. These measures provided a comprehensive understanding of the efficacy and safety of the UDON regimen.

What were the main findings of the UDON therapy trial?

The trial results showed promising outcomes. The UDON regimen achieved an objective response rate of 72.7% and a disease control rate of 90.9%. The median overall survival was 11.2 months and the median progression-free survival was 6.0 months. Also, there was improvement in dysphagia (difficulty swallowing) for a significant portion of patients with primary lesions. These results suggest that UDON is effective in shrinking tumors, controlling disease progression, and improving the quality of life for patients with advanced esophageal cancer.

What are the possible side effects of UDON?

Like all cancer treatments, the UDON regimen can cause side effects. The most common severe side effects were neutropenia (low white blood cell count) and leukopenia. Febrile neutropenia, a serious condition, was observed in a few patients. While these adverse events were present, they were generally manageable with supportive care and dose adjustments. The fact that these side effects were manageable is an important consideration, as it indicates that the benefits of the UDON regimen may outweigh the risks for many patients, particularly when compared to more aggressive treatments that may have more severe side effects.