Phase I trial of 5-FU, docetaxel, and nedaplatin (UDON) combination therapy for recurrent or metastatic esophageal cancer

Ueda, Shinya; Kawakami, Hisato; Nishina, Sachiko; Sakiyama, Tsutomu; Nonagase, Yoshikane; Okabe, Takafumi; Tamura, Takao; Nakagawa, Kazuhiko

doi:10.1007/s00280-015-2799-3

Cited by 4 publications

(4 citation statements)

References 19 publications

(31 reference statements)

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“…In the present study, the efficacy and safety of the UDON regimen was evaluated as first-line treatment for Japanese patients with advanced or recurrent esophageal cancer (all of whom had squamous cell carcinoma). Consistent with the results of a previous phase I study [1], a high antitumor activity of UDON was found, with an overall response rate (RR) of 72.7%, which is likely equivalent to that for 3-or 4-weekly DCF (docetaxel, cisplatin, and 5-FU) [2] and possibly higher than that for weekly [3] or 2-weekly DCF [4]. Spider plot analysis revealed a rapid response in 11 of the 16 patients showing a partial response (PR), with these individuals achieving tumor shrinkage of ≥30% after one cycle of UDON chemotherapy.…”

Section: Discussionsupporting

confidence: 92%

“…The current phase II study included more than a few patients with a low creatinine clearance of <60 mL/minute. However, the toxicity profile of UDON was similar to that seen in our previous phase I trial [1], with the most frequent adverse events being hematologic. The incidence of hematologic toxicities of grade 3 or 4 in the present study was similar to that of DCF regimens [3,4,15,17].…”

Section: Study Completed Investigator's Assessmentsupporting

confidence: 76%

“…We have therefore developed the triplet combination therapy of 5‐FU, biweekly docetaxel, and nedaplatin (UDON). In a phase I study of UDON in patients with recurrent or metastatic esophageal cancer , no dose‐limiting toxicity was observed at any level and the planned dose escalation was completed without reaching the maximum tolerated dose. No toxicity of grade ≥ 4 was observed.…”

mentioning

confidence: 99%

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Phase II Trial of 5-Fluorouracil, Docetaxel, and Nedaplatin (UDON) Combination Therapy for Recurrent or Metastatic Esophageal Cancer

et al. 2018

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Lessons Learned. The 5‐fluorouracil, docetaxel, and nedaplatin (UDON) regimen was well tolerated and showed promising antitumor activity in terms of both objective response rate and survival for patients with advanced or recurrent esophageal squamous cell carcinoma in the first‐line setting. UDON may be an optimal treatment option for patients with advanced esophageal cancer who are unfit for docetaxel, cisplatin, and 5‐fluorouracil regimens. The high response rate as well as the rapid and marked tumor shrinkage associated with UDON suggest that further evaluation of this regimen in the neoadjuvant setting is warranted. Background. A phase II study was performed to evaluate the efficacy and safety of 5‐fluorouracil (5‐FU), docetaxel, and nedaplatin (UDON) combination therapy for untreated recurrent or metastatic esophageal cancer. Methods. Patients received intravenous nedaplatin (90 mg/m 2 ) on day 1, docetaxel (35 mg/m 2 ) on days 1 and 15, and 5‐fluorouracil (800 mg/m 2 ) on days 1–5 of 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. Results. Between March 2015 and July 2017, 23 patients were enrolled. Of 22 evaluable patients, 16 and 4 individuals experienced a partial response and stable disease, respectively, yielding a response rate of 72.7% (95% confidence interval [CI], 49.8%–89.3%) and disease control rate of 90.9% (95% CI, 70.8%–98.9%). Median OS and PFS were 11.2 months (95% CI, 9.1 months to not reached) and 6.0 months (95% CI, 2.5–10.6 months), respectively. Eleven (64.7%) of the 17 patients with a primary lesion showed amelioration of dysphagia after treatment. Frequent adverse events of grade 3 or 4 included neutropenia (87.0%) and leukopenia (39.1%). Febrile neutropenia was observed in two patients (8.7%). Conclusion. This phase II study demonstrated promising antitumor activity and good tolerability of UDON.

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Section: Discussionsupporting

confidence: 92%

Section: Study Completed Investigator's Assessmentsupporting

confidence: 76%

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confidence: 99%

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Phase II Trial of 5-Fluorouracil, Docetaxel, and Nedaplatin (UDON) Combination Therapy for Recurrent or Metastatic Esophageal Cancer

et al. 2018

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“…Nedaplatin is a cisplatin analog that has been developed to decrease the toxicities induced by cisplatin, such as nephrotoxicity and gastrointestinal toxicity (19)(20)(21).…”

Section: Nedaplatinmentioning

confidence: 99%

Future directions in esophageal cancer therapy

Wald

Smaglo

Mok

et al. 2017

Ann. Cardiothorac. Surg.

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Resection techniques for esophageal carcinoma continue to evolve, from endoscopic mucosal resection or endoscopic submucosal dissection for early stage disease to standard and robot-assisted minimally invasive esophagectomy as part of multimodal therapy for locally advanced disease. Though currently limited to assessing conduit perfusion and sentinel lymph nodes, embedded technology in the robotic surgical platform will likely play an expanded role during esophagectomy in the future. The use of targeted therapies, checkpoint inhibitors, engineered immune cell therapy, and cancer vaccines show promise in the treatment of systemic disease. Radiation therapy techniques are becoming increasingly sophisticated and they may play a more active role in stage IV disease in the future.

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Phase I trial of nedaplatin chemotherapy concurrent with radiotherapy for untreated locoregionally advanced nasopharyngeal carcinoma

Liang

Wang

Feng

et al. 2016

Cancer Chemother Pharmacol

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Phase I trial of 5-FU, docetaxel, and nedaplatin (UDON) combination therapy for recurrent or metastatic esophageal cancer

Abstract: The RD of UDON was identified as level 3. The good tolerability and high antitumor efficacy of this regimen warrant further evaluation in this setting.

Cited by 4 publications

References 19 publications

Phase II Trial of 5-Fluorouracil, Docetaxel, and Nedaplatin (UDON) Combination Therapy for Recurrent or Metastatic Esophageal Cancer

Phase II Trial of 5-Fluorouracil, Docetaxel, and Nedaplatin (UDON) Combination Therapy for Recurrent or Metastatic Esophageal Cancer

Future directions in esophageal cancer therapy

Phase I trial of nedaplatin chemotherapy concurrent with radiotherapy for untreated locoregionally advanced nasopharyngeal carcinoma

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