1. Phase II study of neoadjuvant chemotherapy and extended surgery for locally advanced gastric cancer
- Author
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Mitsuru Sasako, S Ito, Y. Kawashima, H Oshita, Takeshi Sano, Hiroshi Imamura, Takaki Yoshikawa, Seiichiro Yamamoto, Kazumasa Fujitani, and Norimasa Fukushima
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,Irinotecan ,Gastrectomy ,Stomach Neoplasms ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Humans ,Stomach cancer ,Survival rate ,Aged ,business.industry ,Mortality rate ,Induction chemotherapy ,Cancer ,Middle Aged ,medicine.disease ,Chemotherapy regimen ,Surgery ,Treatment Outcome ,Chemotherapy, Adjuvant ,Lymphatic Metastasis ,Lymph Node Excision ,Lymphadenectomy ,Camptothecin ,Female ,Cisplatin ,business ,Epidemiologic Methods ,medicine.drug - Abstract
Background Locally advanced gastric cancer with extensive lymph node metastasis is usually considered unresectable and so treated by chemotherapy. This trial explored the safety and efficacy of preoperative chemotherapy followed by extended surgery in the management of locally advanced gastric adenocarcinoma. Methods Patients with gastric cancer with extensive lymph node metastasis received two or three 28-day cycles of induction chemotherapy with irinotecan (70 mg/m2 on days 1 and 15) and cisplatin (80 mg/m2 on day 1), and then underwent gastrectomy with curative intent with D2 plus para-aortic lymphadenectomy. Primary endpoints were 3-year overall survival and incidence of treatment-related death. Results The study was terminated because of three treatment-related deaths when 55 patients had been enrolled (mortality rate above 5 per cent). Two deaths were due to myelosuppression and one to postoperative complications. Clinical response and R0 resection rates were 55 and 65 per cent respectively. The pathological response rate was 15 per cent. Median overall survival was 14·6 months and the 3-year survival rate 27 per cent. Conclusion This multimodal treatment of locally advanced gastric cancer provides reasonable 3-year survival compared with historical data, but at a considerable cost in terms of morbidity and mortality.
- Published
- 2009