Three-arm Phase III Trial Comparing Cisplatin Plus 5-FU (CF) Versus Docetaxel, Cisplatin Plus 5-FU (DCF) Versus Radiotherapy with CF (CF-RT) as Preoperative Therapy for Locally Advanced Esophageal Cancer (JCOG1109, NExT Study)

Nakamura, Kenichi; Kato, Ken; Igaki, Hiroyasu; Ito, Yoshiaki; Mizusawa, Junki; Ando, Nobutoshi; Udagawa, Harushi; Tsubosa, Yasuhiro; Daiko, Hiroyuki; Hironaka, Shuichi; Fukuda, Haruhiko; Kitagawa, Yuko

doi:10.1093/jjco/hyt061

Cited by 267 publications

(181 citation statements)

References 9 publications

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“…Therefore, we hypothesize that patients with cT3 require intensive neoadjuvant therapy to supplement or supplant FP in order to improve local management and survival outcomes. To this end, a three-arm phase III trial is in progress to compare the efficacy of FP versus docetaxel, and cisplatin plus 5-fluorouracil versus radiotherapy with FP as neoadjuvant therapy for locally advanced esophageal cancers (JCOG1109) [19]. Notably, cT3 is set as an important stratification factor in JCOG1109.…”

Section: Discussionmentioning

confidence: 99%

Prognostic Factors in Patients Receiving Neoadjuvant 5-Fluorouracil plus Cisplatin for Advanced Esophageal Cancer (JCOG9907)

Yokota

Ando

Igaki³

et al. 2015

Oncology

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Objective: Neoadjuvant chemotherapy with 5-fluorouracil plus cisplatin and subsequent esophagectomy with two- to three-field lymphadenectomy is a standard treatment for patients with clinical stage II/III squamous cell carcinoma (SCC) of the esophagus. This study investigates the prognostic factors for patients who received neoadjuvant chemotherapy. Methods: Of 164 patients assigned to receive neoadjuvant chemotherapy in the JCOG9907 trial, multivariate analyses were performed for 159 and 149 patients to evaluate the preoperative and the combined preoperative and postoperative prognostic factors, respectively. Results: The multivariate analyses using preoperative factors showed that clinical stage T3 [vs. cT1-2; hazard ratio (HR) 3.60, p = 0.0007] and serum albumin (Alb) <4.0 g/dl (vs. ≥4.0 g/dl; HR 2.29, p = 0.0005) were associated with a poor prognosis. Four independent prognostic factors were identified by multivariate analysis of both preoperative and postoperative factors: pathological curability B (pB; R0 with stage IV or pD < pN) or pC [microscopic or macroscopic residual tumor (R1/R2)] [vs. pA (R0); HR 1.93, p = 0.015], pathological stage N1 (vs. pN0; HR 3.86, p = 0.0012), cT3 (vs. cT1-2; HR 2.80, p = 0.0073), and serum Alb <4.0 g/dl (vs. ≥4.0 g/dl; HR 2.03, p = 0.0069). Conclusions: Preoperative cT stage, Alb, and postoperative pathological findings are independent prognostic factors for patients undergoing neoadjuvant chemotherapy for advanced thoracic esophageal SCC. This analysis may aid in stratification according to individual patient risk.

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Section: Discussionmentioning

confidence: 99%

Prognostic Factors in Patients Receiving Neoadjuvant 5-Fluorouracil plus Cisplatin for Advanced Esophageal Cancer (JCOG9907)

Yokota

Ando

Igaki³

et al. 2015

Oncology

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“…The importance of multimodal treatment is recognized in Japan also. Japanese current nation-wide RCT of JCOG1109 is a three-armed comparative study of neoadjuvant treatments (32). However, the radical surgery represented by 3-field lymph node dissection still maintains the popularity, and included in the requirement of surgery in such studies.…”

Section: Significance Of Supraclavicular Node Metastasismentioning

confidence: 99%

Comparison of two major staging systems of esophageal cancer—toward more practical common scale for tumor staging

Udagawa¹,

Ueno²

2018

Ann. Transl. Med.

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The latest 8th edition of TNM Classification of Malignant Tumours by Union for InternationalCancer Control (UICC) and 11th edition of Japanese Classification of Esophageal Cancer by Japan Esophageal Society (JES) are the two major classifications widely accepted as tools for clinical staging of esophageal cancer. Both systems consist of three main categories, i.e., T, N, and M, but large difference exists between the two. JES system has more detailed sub-classification of T1 tumors reflecting meticulous work by Japanese investigators on superficial esophageal cancer. N-category shows the largest difference. UICC defines the N-category according to only the number of the metastatic regional lymph nodes. The definition of regional nodes in UICC system is static and uniform, and supraclavicular nodes are definitely excluded. In JES system, regional nodes are subgrouped into five different patterns according to the main tumor location, and the supraclavicular nodes are always regional nodes for thoracic esophageal cancer. Japanese surgeons have described the evidence that regional nodes should be dynamically defined according to tumor location and supraclavicular nodes should be included in regional nodes. Compared to the simplified N-category, the staging matrix of UICC system is somewhat complicated. The clinical stage and pathological stage of UICC system are not identical and difference exists also between squamous cell carcinoma (SCC) and adenocarcinoma. It has another system of pathological prognostic grouping. We can imagine several reasons for the difference occurred between the two systems. One is the difference of major pathology. Another reason is the difference of basic concept of cancer treatment. The relative "dependence" on radical surgery in Japan has required the detailed definition of each lymph node station and the evaluation of "efficacy index" of each station. The strict and detailed definition of lymph node stations has been regarded as an obstacle to those who are not familiar with it. Some simplification can be done but maintaining dynamic definition of regional lymph nodes linked to tumor location. If UICC system can accept this concept, I think the two systems can be unified to realize more practical and useful staging system as an international common language.

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“…A phase III RCT comparing neoadjuvant chemotherapy with cisplatin and paclitaxel versus surgery alone aims to recruit 528 patients in China with IIa-IIIb esophageal squamous cell carcinoma (NCT02395705) (29). A three arm neoadjuvant trial entitled the NExT study (JCOG1109, NCT00525915), began recruitment in Japan in 2012 and aims to recruit 501 patients with stage Ib-IIIc (excluding T4) squamous cell cancer (30). It compares neoadjuvant docetaxel/cisplatin/5-FU versus cisplatin/5-FU/ concurrent RT versus cisplatin/5-FU.…”

Section: Key Current Questions and Active Trialsmentioning

confidence: 99%

Neoadjuvant treatment of locally advanced esophageal and junctional cancer: the evidence-base, current key questions and clinical trials

Donohoe¹,

Reynolds²

2017

J. Thorac. Dis.

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Recent trials, including CROSS, MAGIC, ACCORD, and OEO2, have established neoadjuvant therapy as standard of care for locally advanced (cT 2-3 N any M 0 ) esophageal and junctional cancer compared with surgery alone. The CROSS trial in particular defines a new benchmark for outcomes from multimodal therapy, with a 5 year survival rate of 47% , a median survival of 47 months, a pathologic complete response rate (pCR) of 29% and an R0 resection rate of 92%. Several key questions remain, in particular whether CROSS-regimen chemoradiotherapy is superior to neoadjuvant chemotherapy alone for esophageal cancer, in particular adenocarcinoma. Second, with respect to neoadjuvant chemoradiation, whether an apparent complete clinical response can justify a "watch and wait" surveillance policy, with salvage surgery reserved for where relapse occurs. Third, whether with modern staging, predicted node negative cT2 tumors merit neoadjuvant therapy as standard. Finally, with the enormous interest in the application of targeted and immune-based therapies, and positive leads from other cancers, whether such approaches can improve outcomes in patients undergoing treatment with curative intent. We review herein a brief overview of the existing evidence-base and current active trials addressing these key questions.

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Three-arm Phase III Trial Comparing Cisplatin Plus 5-FU (CF) Versus Docetaxel, Cisplatin Plus 5-FU (DCF) Versus Radiotherapy with CF (CF-RT) as Preoperative Therapy for Locally Advanced Esophageal Cancer (JCOG1109, NExT Study)

Cited by 267 publications

References 9 publications

Prognostic Factors in Patients Receiving Neoadjuvant 5-Fluorouracil plus Cisplatin for Advanced Esophageal Cancer (JCOG9907)

Prognostic Factors in Patients Receiving Neoadjuvant 5-Fluorouracil plus Cisplatin for Advanced Esophageal Cancer (JCOG9907)

Comparison of two major staging systems of esophageal cancer—toward more practical common scale for tumor staging

Neoadjuvant treatment of locally advanced esophageal and junctional cancer: the evidence-base, current key questions and clinical trials

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