{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T10:04:57Z","timestamp":1781777097693,"version":"3.54.5"},"reference-count":16,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2001,2,15]]},"abstract":"<jats:p> 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. <\/jats:p><jats:p> PATIENTS AND METHODS: Two hundred ten patients with locally advanced, recurrent, or metastatic disease were randomly placed in either Arm A, paclitaxel 200 mg\/m<jats:sup>2<\/jats:sup> (24-hour infusion) + cisplatin 75mg\/m<jats:sup>2<\/jats:sup> + granulocyte colony-stimulating factor, or Arm B, paclitaxel 135 mg\/m<jats:sup>2<\/jats:sup> (24-hour infusion) + cisplatin 75 mg\/m<jats:sup>2<\/jats:sup>. 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. <\/jats:p><jats:p> 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 granulocytopenia, 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. <\/jats:p><jats:p> 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. <\/jats:p>","DOI":"10.1200\/jco.2001.19.4.1088","type":"journal-article","created":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T06:36:16Z","timestamp":1487918176000},"page":"1088-1095","source":"Crossref","is-referenced-by-count":128,"title":["Phase III Comparison of High-Dose Paclitaxel + Cisplatin + Granulocyte Colony-Stimulating Factor Versus Low-Dose Paclitaxel + Cisplatin in Advanced Head and Neck Cancer: Eastern Cooperative Oncology Group Study E1393"],"prefix":"10.1200","volume":"19","author":[{"given":"Arlene A.","family":"Forastiere","sequence":"first","affiliation":[{"name":"From the Johns Hopkins Oncology Center, Baltimore, MD; Dana-Farber Cancer Institute and Brigham & Women\u2019s Hospital, Boston, MA; Vanderbilt University, Nashville, TN; H. Lee Moffitt Cancer Center, Tampa, FL; and Fairview University Medical Center, Minneapolis, MN."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Traci","family":"Leong","sequence":"additional","affiliation":[{"name":"From the Johns Hopkins Oncology Center, Baltimore, MD; Dana-Farber Cancer Institute and Brigham & Women\u2019s Hospital, Boston, MA; Vanderbilt University, Nashville, TN; H. Lee Moffitt Cancer Center, Tampa, FL; and Fairview University Medical Center, Minneapolis, MN."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Rowinsky","sequence":"additional","affiliation":[{"name":"From the Johns Hopkins Oncology Center, Baltimore, MD; Dana-Farber Cancer Institute and Brigham & Women\u2019s Hospital, Boston, MA; Vanderbilt University, Nashville, TN; H. Lee Moffitt Cancer Center, Tampa, FL; and Fairview University Medical Center, Minneapolis, MN."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara A.","family":"Murphy","sequence":"additional","affiliation":[{"name":"From the Johns Hopkins Oncology Center, Baltimore, MD; Dana-Farber Cancer Institute and Brigham & Women\u2019s Hospital, Boston, MA; Vanderbilt University, Nashville, TN; H. Lee Moffitt Cancer Center, Tampa, FL; and Fairview University Medical Center, Minneapolis, MN."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel R.","family":"Vlock","sequence":"additional","affiliation":[{"name":"From the Johns Hopkins Oncology Center, Baltimore, MD; Dana-Farber Cancer Institute and Brigham & Women\u2019s Hospital, Boston, MA; Vanderbilt University, Nashville, TN; H. Lee Moffitt Cancer Center, Tampa, FL; and Fairview University Medical Center, Minneapolis, MN."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald C.","family":"DeConti","sequence":"additional","affiliation":[{"name":"From the Johns Hopkins Oncology Center, Baltimore, MD; Dana-Farber Cancer Institute and Brigham & Women\u2019s Hospital, Boston, MA; Vanderbilt University, Nashville, TN; H. Lee Moffitt Cancer Center, Tampa, FL; and Fairview University Medical Center, Minneapolis, MN."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George L.","family":"Adams","sequence":"additional","affiliation":[{"name":"From the Johns Hopkins Oncology Center, Baltimore, MD; Dana-Farber Cancer Institute and Brigham & Women\u2019s Hospital, Boston, MA; Vanderbilt University, Nashville, TN; H. Lee Moffitt Cancer Center, Tampa, FL; and Fairview University Medical Center, Minneapolis, MN."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"R1-85093","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1992.10.8.1245"},{"key":"R2-85093","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1992.10.2.257"},{"key":"R3-85093","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.annonc.a058906"},{"key":"R4-85093","doi-asserted-by":"publisher","DOI":"10.1016\/0360-3016(92)90642-U"},{"key":"R5-85093","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199106133242402"},{"key":"R7-85093","doi-asserted-by":"publisher","DOI":"10.1097\/00001622-199805000-00007"},{"key":"R8-85093","doi-asserted-by":"crossref","unstructured":"Forastiere  AA,   Trotti  A:   Radiotherapy and concurrent chemotherapy:   A strategy that improves locoregional control and survival in oropharyngeal cancer.   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