Motoo Nomura1, Ken Kato2, Nobutoshi Ando3, Atsushi Ohtsu4, Kei Muro5, Hiroyasu Igaki6, Tetsuya Abe7, Hiroya Takeuchi8, Hiroyuki Daiko9, Masahiro Gotoh10, Kozo Kataoka11, Masashi Wakabayashi12, Yuko Kitagawa8. 1. Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto. 2. Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo. 3. International Goodwill Hospital, Yokohama. 4. Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Kashiwa. 5. Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya. 6. Esophageal Surgery Division, National Cancer Center Hospital, Tokyo. 7. Department of Gastrointestinal Surgery, Aichi Cancer Center Hospital, Nagoya. 8. Department of Surgery, Keio University School of Medicine, Tokyo. 9. Esophageal Surgery Division, National Cancer Center Hospital East, Kashiwa. 10. Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki. 11. Japan Clinical Oncology Group Operations Office, National Cancer Center, Tokyo. 12. Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo, Japan.
Abstract
BACKGROUND: Neoadjuvant chemotherapy followed by surgery (NAC-S) represents the standard treatment for patients with Stage II/III esophageal squamous cell carcinoma (ESCC) in Japan. Chemoradiotherapy (CRT) is performed in patients who refuse or have contraindications to surgery. However, randomized clinical trials that compare NAC-S with CRT have not been conducted. The aim of this study was to explore subgroups of patients undergoing CRT to identify those with survival outcomes potentially equivalent to NAC-S. METHODS: Pooled data from two clinical trials in patients with Stage II/III ESCC, the JCOG9907 trial and the JCOG9906 trial were used. JCOG9907 demonstrated that NAC-S resulted in superior overall survival (OS) compared with surgery followed by adjuvant chemotherapy. JCOG9906 was a single-arm trial that explored the efficacy and safety of CRT. The eligibility criteria in the two trials were almost identical. Subgroup analyses of clinical data (serum albumin, cT, cN, cstage and tumor location) were conducted with Cox proportional hazards regression models for patients assigned to receive NAC-S in JCOG9907 and patients in JCOG9906. RESULTS: The analysis comprised 163 patients from JCOG9907 in NAC-S arm (NAC-S group) and 73 patients from JCOG9906 who received CRT (CRT group). Baseline characteristics were similar between the two groups. OS was better in the NAC-S group than the CRT group (adjusted hazard ratio 1.72; 95% confidence interval 1.19-2.50). All subgroups in the NAC-S group had longer OS compared with those in the CRT group. CONCLUSIONS: OS was superior after NAC-S rather than CRT. None of the CRT subgroups had similar OS to the NAC-S groups.
BACKGROUND: Neoadjuvant chemotherapy followed by surgery (NAC-S) represents the standard treatment for patients with Stage II/III esophageal squamous cell carcinoma (ESCC) in Japan. Chemoradiotherapy (CRT) is performed in patients who refuse or have contraindications to surgery. However, randomized clinical trials that compare NAC-S with CRT have not been conducted. The aim of this study was to explore subgroups of patients undergoing CRT to identify those with survival outcomes potentially equivalent to NAC-S. METHODS: Pooled data from two clinical trials in patients with Stage II/III ESCC, the JCOG9907 trial and the JCOG9906 trial were used. JCOG9907 demonstrated that NAC-S resulted in superior overall survival (OS) compared with surgery followed by adjuvant chemotherapy. JCOG9906 was a single-arm trial that explored the efficacy and safety of CRT. The eligibility criteria in the two trials were almost identical. Subgroup analyses of clinical data (serum albumin, cT, cN, cstage and tumor location) were conducted with Cox proportional hazards regression models for patients assigned to receive NAC-S in JCOG9907 and patients in JCOG9906. RESULTS: The analysis comprised 163 patients from JCOG9907 in NAC-S arm (NAC-S group) and 73 patients from JCOG9906 who received CRT (CRT group). Baseline characteristics were similar between the two groups. OS was better in the NAC-S group than the CRT group (adjusted hazard ratio 1.72; 95% confidence interval 1.19-2.50). All subgroups in the NAC-S group had longer OS compared with those in the CRT group. CONCLUSIONS: OS was superior after NAC-S rather than CRT. None of the CRT subgroups had similar OS to the NAC-S groups.
Authors: Arianna Barbetta; Meier Hsu; Kay See Tan; Dessislava Stefanova; Koby Herman; Prasad S Adusumilli; Manjit S Bains; Matthew J Bott; James M Isbell; Yelena Y Janjigian; Geoffrey Y Ku; Bernard J Park; Abraham J Wu; David R Jones; Daniela Molena Journal: J Thorac Cardiovasc Surg Date: 2018-02-15 Impact factor: 5.209