TY - JOUR
T1 - A phase II study of paclitaxel by weekly 1-h infusion for advanced or recurrent esophageal cancer in patients who had previously received platinum-based chemotherapy
AU - Kato, Ken
AU - Tahara, Makoto
AU - Hironaka, Shuichi
AU - Muro, Kei
AU - Takiuchi, Hiroya
AU - Hamamoto, Yasuo
AU - Imamoto, Haruhiko
AU - Amano, Norihito
AU - Seriu, Taku
N1 - Funding Information:
Patients were excluded if they had active infection, uncontrolled comorbidities (e.g. serious cerebrovascular disorders, hypertension, diabetes mellitus, severe infection, or active gastric ulcer), acute inflammatory disease, interstitial pneumonia or pulmonary fibrosis, symptomatic metastases of the central nervous system, neuropathy grade C2 by National Cancer Institute common toxicity criteria (NCI-CTC) version 2.0, or body cavity fluid retention requiring treatment. Financial support was provided by Bristol-Myers K.K. (Shinjuku, Tokyo, Japan). The study was conducted in compliance with the ethical principles of the Declaration of Helsinki, Good Clinical Practice guidelines, and Articles/Notifications of the Ministry of Health, Labour and Welfare in Japan. Written informed consent was obtained from all patients.
Funding Information:
Acknowledgments The Paclitaxel Esophageal Cancer Study Group comprises the following institutions: National Cancer Center Hospital, Tokyo; National Cancer Center Hospital East, Chiba; Shizuoka Cancer Center, Shizuoka; Aichi Cancer Center Central Hospital, Aichi; Osaka Medical College, Osaka; Tochigi Cancer Center, Tochigi; Kinki University School of Medicine, Osaka; The Cancer Institute Hospital of JFCR, Tokyo; Kitasato University East Hospital, Kanagawa; Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka; Saitama Cancer Center, Saitama; and Graduate School of Medicine, Osaka University, Osaka, Japan. This study was supported by a grant from Bristol-Myers K.K.
PY - 2011/6
Y1 - 2011/6
N2 - Purpose: To evaluate the efficacy and safety of weekly paclitaxel (Taxol®) in patients with advanced or recurrent esophageal cancer. Methods: Fifty-three patients with recurrent or advanced esophageal cancer who had previously received platinum-based chemotherapy were treated with paclitaxel 100 mg/m2 once weekly by 1-h infusion on days 1, 8, 15, 22, 29, and 36 of a 49-day cycle. Fifty-two patients were evaluable for efficacy and 53 for safety. Forty-one (77%) patients had recurrent, and 12 (23%) had advanced disease. Most patients (52/53) had squamous cell carcinoma, and one had adenocarcinoma. Results: A median of 2 cycles was delivered (range 1-8). The overall response rate was 44.2% (23/52; 95% confidence interval (CI) 30.5, 58.7%), with 4 patients (7.7%) achieving complete response. The median duration of response was 4.8 months, and median overall survival was 10.4 months. The most common Grade 3 or 4 adverse events were neutropenia (52.8%), leukopenia (45.3%), anorexia (9.4%), and fatigue (9.4%). Adverse events resulted in treatment discontinuation in 34.0% of patients and dose reductions in 43.4%. There were no treatment-related deaths. Conclusions: Weekly paclitaxel demonstrated efficacy and manageable toxicity in patients with advanced or recurrent esophageal cancer and may be a treatment option for this population.
AB - Purpose: To evaluate the efficacy and safety of weekly paclitaxel (Taxol®) in patients with advanced or recurrent esophageal cancer. Methods: Fifty-three patients with recurrent or advanced esophageal cancer who had previously received platinum-based chemotherapy were treated with paclitaxel 100 mg/m2 once weekly by 1-h infusion on days 1, 8, 15, 22, 29, and 36 of a 49-day cycle. Fifty-two patients were evaluable for efficacy and 53 for safety. Forty-one (77%) patients had recurrent, and 12 (23%) had advanced disease. Most patients (52/53) had squamous cell carcinoma, and one had adenocarcinoma. Results: A median of 2 cycles was delivered (range 1-8). The overall response rate was 44.2% (23/52; 95% confidence interval (CI) 30.5, 58.7%), with 4 patients (7.7%) achieving complete response. The median duration of response was 4.8 months, and median overall survival was 10.4 months. The most common Grade 3 or 4 adverse events were neutropenia (52.8%), leukopenia (45.3%), anorexia (9.4%), and fatigue (9.4%). Adverse events resulted in treatment discontinuation in 34.0% of patients and dose reductions in 43.4%. There were no treatment-related deaths. Conclusions: Weekly paclitaxel demonstrated efficacy and manageable toxicity in patients with advanced or recurrent esophageal cancer and may be a treatment option for this population.
KW - Esophageal cancer
KW - Paclitaxel
KW - Phase II study
KW - Weekly infusion
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U2 - 10.1007/s00280-010-1422-x
DO - 10.1007/s00280-010-1422-x
M3 - Article
C2 - 20703479
AN - SCOPUS:79959597158
SN - 0344-5704
VL - 67
SP - 1265
EP - 1272
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
IS - 6
ER -
