Phase I/II Study of Docetaxel/Cisplatin/Fluorouracil Combination Chemotherapy Against Metastatic Esophageal Squamous Cell Carcinoma

Takahashi, Hiroaki; Arimura, Yoshiaki; Yamashita, Kentaro; Okahara, Satoshi; Tanuma, Tokuma; Kodaira, Junichi; Hokari, Kaku; Tsukagoshi, Hiroyuki; Shinomura, Yasuhisa; Hosokawa, Masao

doi:10.1097/jto.0b013e3181c1ffd5

Cited by 56 publications

(64 citation statements)

References 29 publications

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“…The combination DCF has been used to treat unresectable and recurrent SCC of the esophagus and is well tolerated with high response rates (33,34). Recently, preoperative chemotherapy using DCF was reported to have increased survival rate benefits for patients with resectable and advanced esophageal cancer (35).…”

Section: Univariate Analysismentioning

confidence: 99%

Prognoses of advanced esophago‑gastric junction cancer may be modified by thoracotomy and splenectomy

et al. 2017

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Abstract. Globally, the incidence of esophago-gastric junction (EGJ) cancer is rapidly increasing. However, the proposed strategies for the treatment of these types of cancer are so diverse that there is no established consensus on the optimal treatment. The aim of the present study was to identify independent prognostic factors to delineate the optimal strategies for the treatment of EGJ cancer. The medical records of 150 patients with EGJ cancer who underwent curative surgery at the Kitasato University were retrospectively reviewed. The median follow-up period was 48 months. The patients with tumors that were classified as post-treatment primary tumor stage 3 [(y)pT3] or higher had a 5-year disease-specific survival (DSS) rate of 53%, whereas those with tumors that were classified as (y)pT0-2 had a 5-year DSS rate of 90%. Therefore, prognostic analysis was restricted to those tumors that were designated (y)pT3 or higher. A multivariate Cox's proportional hazards model identified the following independent prognostic factors that negatively influenced the DSS: i) Presence of tumors classified as post-treatment regional lymph node stage 1-3 [(y)pN1-3] [hazard ratio (HR), 3.62; 95% confidence interval (CI), 1.39-12.36]; ii) not undergoing treatment with splenectomy (HR, 2.40; 95% CI, 1.15-5.15); and iii) undergoing treatment with thoracotomy (HR, 2.07; 95% CI, 1.02-4.23). In patients with (y)pN0 tumors, the DSS rate was significantly improved for those who underwent splenectomy than for those who did not (P=0.024). In patients with (y)pN1-3 tumors, the DSS rate was significantly worse for those who underwent thoracotomy compared with those who did not (P=0.004). Splenectomy and thoracotomy may critically affect prognosis in locally advanced EGJ cancer that are classified as (y)pN0 and (y)pN1-3, respectively. Surgical treatments require optimization in order to improve prognoses in advanced EGJ cancer.

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Section: Univariate Analysismentioning

confidence: 99%

Prognoses of advanced esophago‑gastric junction cancer may be modified by thoracotomy and splenectomy

et al. 2017

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“…Our study showed that the RDP2 of docetaxel was 30 mg/m , Days 1-5; every 4 weeks) had promising efficacy with a response rate of 62% and a median OS of 11.1 months. As for safety, Grade 3-4 neutropenia was observed in 25.5% and febrile neutropenia in 0%, which was remarkably better than that for the original DCF regimen (13)(14)(15)(16). Therefore, 2-weekly DCF regimen has been considered as the most promising treatment for metastatic or recurrent esophageal cancer in JEOG.…”

Section: Introductionmentioning

confidence: 99%

“…Recently, some groups have reported that the addition of docetaxel to CF (DCF) was effective for patients with gastric cancer and head and neck cancer (11,12). Taking these results into account, several studies evaluating the efficacy and safety of DCF regimen for metastatic or recurrent esophageal cancer have been reported (13)(14)(15)(16). In these reports, the dose and schedule of DCF were as follows: docetaxel (50-70 mg/m 2 , Day 1), cisplatin (60-70 mg/m 2 , Day 1) and fluorouracil (600-800 mg/m 2 , Days 1-5) every 3-4 weeks.…”

Section: Introductionmentioning

confidence: 99%

“…Thus, further improvement of the DCF regimen is considered to be needed to lessen the toxicity while maintaining the antimetastatic activity. Divided doses of docetaxel combined with CF have been investigated in several studies and showed a safer toxicity profile especially for hematologic toxicities or febrile neutropenia (17)(18)(19), compared with the original DCF regimen (13)(14)(15)(16). We, JEOG, have developed a 2-weekly DCF regimen in which docetaxel is administered twice every 4 weeks (Days 1 and 15).…”

Section: Introductionmentioning

confidence: 99%

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A randomized controlled Phase III trial comparing 2-weekly docetaxel combined with cisplatin plus fluorouracil (2-weekly DCF) with cisplatin plus fluorouracil (CF) in patients with metastatic or recurrent esophageal cancer: rationale, design and methods of Japan Clinical Oncology Group study JCOG1314 (MIRACLE study)

Kataoka¹,

Tsushima

Mizusawa³

et al. 2015

Japanese Journal of Clinical Oncology

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Chemotherapy with cisplatin plus fluorouracil is the current standard treatment for metastatic or recurrent esophageal cancer. We have developed a 2-weekly docetaxel combined with CF regimen and conducted a Phase I/II trial for metastatic or recurrent esophageal cancer (JCOG0807). Promising efficacy and safety were shown in JCOG0807, and we have commenced a Phase III trial in September 2014 to confirm the superiority of 2-weekly DCF to CF for patients with metastatic or recurrent esophageal cancer. A total of 240 patients will be accrued from 41 Japanese institutions over a period of 4 years. The primary end point is overall survival. The secondary end points are progression-free survival, response rate and proportion of adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000015107

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“…The recent development of systemic chemotherapy, including the combination of docetaxel, cisplatin and 5-fluorouracil (DCF), has improved long-term outcomes in patients with ESCC (3)(4)(5). Although the DCF regimen was expected to yield a high response rate in ESCC, the approach frequently results in severe adverse events such as acute kidney injury (AKI).…”

Section: Introductionmentioning

confidence: 99%

Plasma ghrelin levels as a predictor of adverse renal events due to cisplatin-based chemotherapy in patients with esophageal cancer

Yanagimoto

Takiguchi

Miyazaki

et al. 2016

Japanese Journal of Clinical Oncology

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Objective: Although combination chemotherapy with docetaxel, cisplatin and 5-fluorouracil demonstrates high response rates in esophageal squamous cell carcinoma, patients treated with docetaxel, cisplatin and 5-fluorouracil frequently experience acute kidney injury. Ghrelin has shown renal protective effects in an experimental acute kidney injury model by reducing tubular apoptosis. In this prospective observational study, we evaluated the association between plasma ghrelin concentrations and docetaxel, cisplatin and 5-fluorouracil-related acute kidney injury. Methods: Forty consecutive patients with esophageal squamous cell carcinoma who received docetaxel, cisplatin and 5-fluorouracil from October 2013 to July 2014 were enrolled in this study. Serum creatinine and urinary α-1 microglobulin, a marker of renal tubular damage, were measured six times during chemotherapy. Results: The increases of creatinine level which is defined in Common Terminology Criteria for Adverse Event were observed less frequently in patients with acyl ghrelin concentrations of ≥9.6 fmol/ml (HAG group) than in those with concentrations <9.6 fmol/ml on Day 2 (LAG group) (P = 0.024). Serum creatinine was significantly lower in the HAG group than in the LAG group (Day 8: 0.79 ± 0.16 vs. 0.97 ± 0.26, P = 0.024; Day 11: 0.85 ± 0.19 vs. 1.08 ± 0.34 mg/dl, P = 0.049). Urinary α-1 microglobulin levels were significantly lower in the HAG group than in the LAG group (Day 4: 2.48 ± 1.83 vs. 3.33 ± 1.41, P = 0.011; Day 8: 4.67 ± 5.50 vs. 5.09 ± 2.54, P = 0.011; Day 11: 11.55 ± 13.78 vs. 16.43 ± 17.84 mg/l, P = 0.020). Conclusions: Plasma acyl ghrelin concentrations on Day 2 of chemotherapy may be a potential predictor of docetaxel, cisplatin and 5-fluorouracil-induced acute kidney injury.

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Phase I/II Study of Docetaxel/Cisplatin/Fluorouracil Combination Chemotherapy Against Metastatic Esophageal Squamous Cell Carcinoma

Abstract: A TPF regimen against metastatic SCCE was well tolerated and achieved a favorable objective response rate and survival benefit compared with other recently reported regimens. Randomized phase III trials of the TPF regimen are warranted and urgently required.

Cited by 56 publications

References 29 publications

Prognoses of advanced esophago‑gastric junction cancer may be modified by thoracotomy and splenectomy

Prognoses of advanced esophago‑gastric junction cancer may be modified by thoracotomy and splenectomy

Plasma ghrelin levels as a predictor of adverse renal events due to cisplatin-based chemotherapy in patients with esophageal cancer

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