TY - JOUR
T1 - Phase III comparison of high-dose paclitaxel + cisplatin + granulocyte colony-stimulating factor versus low-dose paclitaxel + cisplatin in advanced head and neck cancer
T2 - Eastern cooperative oncology group study e1393
AU - Forastiere, A. A.
AU - Leong, T.
AU - Rowinsky, E.
AU - Murphy, B. A.
AU - Vlock, D. R.
AU - DeConti, R. C.
AU - Adams, G. L.
N1 - Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2001/2/15
Y1 - 2001/2/15
N2 - Purpose: To determine dose-response effects and the activity of paclitaxel combined with cisplatin in patients with incurable squamous cell carcinoma of the head and neck. Patients and Methods: Two hundred ten patients with locally advanced, recurrent, or metastatic disease were randomly placed in either Arm A, paclitaxel 200 mg/m2 (24-hour infusion) + cisplatin 75mg/m2 + granulocyte colony-stimulating factor, or Arm B, paclitaxel 135 mg/m2 (24-hour infusion) + cisplatin 75 mg/m2. Cycles were repeated every 3 weeks until progression or a total of 12 cycles for complete responses. Primary outcomes were event-free and overall survival. Results: No significant differences in outcomes were observed between the high- and low-dose paclitaxel regimens. The estimated median survival was 7.3 months (95% confidence interval, 6.0 to 8.6). The 1-year survival rate was 29%, and event-free survival was 4.0 months. The objective response rate (complete response plus partial response) was 35% for the high-dose patients and 36% for the low-dose patients. Myelosuppression was the most frequent toxicity: grade 3 or 4 gronulocytopenia, 70% of patients in Arm A and 78% in Arm B; febrile neutropenia, 27% of patients in Arm A and 39% in Arm B. Grade 5 toxicities occurred in 22 patients (10.5%). Treatment was terminated early in 31% because of excessive toxicity or patient refusal. Conclusion: This phase III multicenter trial showed (1) no advantage for high-dose paclitaxel and (2) excessive hematologic toxicity associated with both regimens. Therefore, neither of the paclitaxel regimens evaluated in this trial can be recommended.
AB - Purpose: To determine dose-response effects and the activity of paclitaxel combined with cisplatin in patients with incurable squamous cell carcinoma of the head and neck. Patients and Methods: Two hundred ten patients with locally advanced, recurrent, or metastatic disease were randomly placed in either Arm A, paclitaxel 200 mg/m2 (24-hour infusion) + cisplatin 75mg/m2 + granulocyte colony-stimulating factor, or Arm B, paclitaxel 135 mg/m2 (24-hour infusion) + cisplatin 75 mg/m2. Cycles were repeated every 3 weeks until progression or a total of 12 cycles for complete responses. Primary outcomes were event-free and overall survival. Results: No significant differences in outcomes were observed between the high- and low-dose paclitaxel regimens. The estimated median survival was 7.3 months (95% confidence interval, 6.0 to 8.6). The 1-year survival rate was 29%, and event-free survival was 4.0 months. The objective response rate (complete response plus partial response) was 35% for the high-dose patients and 36% for the low-dose patients. Myelosuppression was the most frequent toxicity: grade 3 or 4 gronulocytopenia, 70% of patients in Arm A and 78% in Arm B; febrile neutropenia, 27% of patients in Arm A and 39% in Arm B. Grade 5 toxicities occurred in 22 patients (10.5%). Treatment was terminated early in 31% because of excessive toxicity or patient refusal. Conclusion: This phase III multicenter trial showed (1) no advantage for high-dose paclitaxel and (2) excessive hematologic toxicity associated with both regimens. Therefore, neither of the paclitaxel regimens evaluated in this trial can be recommended.
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U2 - 10.1200/JCO.2001.19.4.1088
DO - 10.1200/JCO.2001.19.4.1088
M3 - Article
C2 - 11181673
AN - SCOPUS:0035865304
SN - 0732-183X
VL - 19
SP - 1088
EP - 1095
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 4
ER -