Chikatoshi Katada1, Mitsuhiro Sugawara2, Hiroki Hara3, Hirofumi Fujii4, Takako Eguchi Nakajima5,6, Takayuki Ando7, Takashi Kojima8, Akinori Watanabe1, Yasutoshi Sakamoto9, Hideki Ishikawa10, Ayumu Hosokawa7,11, Yasuo Hamamoto12, Manabu Muto13, Makoto Tahara14, Wasaburo Koizumi1. 1. Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan. 2. Department of Pharmacy, Kitasato University Hospital, Sagamihara. 3. Department of Gastroenterology, Saitama Cancer Center, Saitama. 4. Division of Clinical Oncology, Jichi Medical University, Shimotsuke. 5. Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki. 6. Kyoto Innovation Center for Next Generation Clinical Trials and iPS Cell Therapy, Kyoto University Hospital, Kyoto. 7. Third Department of Internal Medicine, University of Toyama, Toyama. 8. Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa. 9. Kitasato Clinical Research Center, Kitasato University School of Medicine, Sagamihara. 10. Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto. 11. Department of Clinical Oncology, University of Miyazaki Hospital, Miyazaki. 12. Keio Cancer Center, Keio University School of Medicine, Tokyo. 13. Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto. 14. Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa.
Abstract
BACKGROUND: An exploratory study was designed to evaluate the efficacy of granulocyte colony stimulating factor support for chemotherapy consisting of docetaxel, cisplatin and 5-fluorouracil chemotherapy in patients with oesophageal cancer. METHODS: The inclusion criteria were as follows: (1) oesophageal squamous cell carcinoma, (2) a schedule to receive three courses of induction chemotherapy (docetaxel 75 mg/m2 day 1, cisplatin 75 mg/m2 day 1, 5-fluorouracil 750 mg/m2 days 1-5, every 3 weeks), (3) stage IB-III, (4) 20-75 years old, (5) 0-1 performance status, (6) preserved organ functions and (7) written informed consent. The endpoints were to evaluate the efficacy of granulocyte colony stimulating factor support including secondary prophylactic usage for docetaxel, cisplatin and 5-fluorouracil chemotherapy. Patients who previously had 'febrile neutropenia', or 'Grade 3 or 4 infection accompanied by grade 3 or 4 neutropenia' prophylactically received granulocyte colony stimulating factor support from day 7. RESULTS: A total of 91 patients were included in the analysis. Granulocyte colony stimulating factor support was given to 81.3%. The incidence of grade 4 neutropenia and febrile neutropenia were 81.3 and 32.9%, respectively. The dose of anticancer agents was reduced in 48.4%. There were no treatment-related deaths. The relative dose intensity of docetaxel, cisplatin and 5-fluorouracil were 92.7 ± 9.8%, 86.0 ± 15.6% and 91.8 ± 10.0%, respectively. In the secondary prophylactic granulocyte colony stimulating factor support group, the neutrophil count significantly increased between day 7 and day 13 as compared with the non-prophylactic granulocyte colony stimulating factor support group (P < 0.05 for each day). CONCLUSIONS: Granulocyte colony stimulating factor support including secondary prophylactic usage may be feasible for maintaining the intensity of docetaxel, cisplatin and 5-fluorouracil chemotherapy in patients with oesophageal cancer.
BACKGROUND: An exploratory study was designed to evaluate the efficacy of granulocyte colony stimulating factor support for chemotherapy consisting of docetaxel, cisplatin and 5-fluorouracil chemotherapy in patients with oesophageal cancer. METHODS: The inclusion criteria were as follows: (1) oesophageal squamous cell carcinoma, (2) a schedule to receive three courses of induction chemotherapy (docetaxel 75 mg/m2 day 1, cisplatin 75 mg/m2 day 1, 5-fluorouracil 750 mg/m2 days 1-5, every 3 weeks), (3) stage IB-III, (4) 20-75 years old, (5) 0-1 performance status, (6) preserved organ functions and (7) written informed consent. The endpoints were to evaluate the efficacy of granulocyte colony stimulating factor support including secondary prophylactic usage for docetaxel, cisplatin and 5-fluorouracil chemotherapy. Patients who previously had 'febrile neutropenia', or 'Grade 3 or 4 infection accompanied by grade 3 or 4 neutropenia' prophylactically received granulocyte colony stimulating factor support from day 7. RESULTS: A total of 91 patients were included in the analysis. Granulocyte colony stimulating factor support was given to 81.3%. The incidence of grade 4 neutropenia and febrile neutropenia were 81.3 and 32.9%, respectively. The dose of anticancer agents was reduced in 48.4%. There were no treatment-related deaths. The relative dose intensity of docetaxel, cisplatin and 5-fluorouracil were 92.7 ± 9.8%, 86.0 ± 15.6% and 91.8 ± 10.0%, respectively. In the secondary prophylactic granulocyte colony stimulating factor support group, the neutrophil count significantly increased between day 7 and day 13 as compared with the non-prophylactic granulocyte colony stimulating factor support group (P < 0.05 for each day). CONCLUSIONS:Granulocyte colony stimulating factor support including secondary prophylactic usage may be feasible for maintaining the intensity of docetaxel, cisplatin and 5-fluorouracil chemotherapy in patients with oesophageal cancer.