title: The Safety and Efficacy of Weekly Paclitaxel Administration for Anaplastic Thyroid Cancer Patients: A Nationwide Prospective Study.
abstract: Anaplastic thyroid cancer (ATC) is a rare and extremely aggressive malignancy, with a median survival of less than 6 months due to rapid progression and resistance to multimodal therapies. Effective treatment strategies have not been identified. A prospective clinical study was performed to objectively evaluate outcomes of treatment with paclitaxel.
  
  
  
  An investigator-initiated, multicenter, nonrandomized, open-label, single-arm study to evaluate the feasibility and efficacy of weekly paclitaxel (80 mg/m(2)) administration for patients with pathologically confirmed ATC was conducted in a nationwide organization.
  
  
  
  Feasibility was analyzed in 56 patients. More than one course of treatment was performed in 52 (93%) patients retaining sufficient dose intensity (>84%). No patient had to terminate the treatment because of an adverse event. The median overall survival was 6.7 months [confidence interval 4.4-9.0]. The 6-month survival was 54%. Among the 42 patients with an evaluable lesion, none demonstrated complete remission, 9 (21%) showed partial remission, 22 (52%) achieved stable disease, and 8 (19%) exhibited progressive disease; 3 did not complete the initial treatment course. The objective response rate was 21%, and the clinical benefit rate was 73%. The median time to progression was 1.6 months. Statistically, no additional effect of concomitant radiation was demonstrated in 6 patients receiving combined therapy. Eight patients, in whom a complete post-treatment surgical removal of the tumor was feasible, survived significantly longer (median 7.6 months [CI 8.1-23.0]) than the other 34 patients in whom the tumor could not be completely removed after chemotherapy (5.4 months [CI 3.0-7.8], p = 0.018).
  
  
  
  The study demonstrates objective and accurate information concerning the feasibility and efficacy of a standardized treatment with weekly paclitaxel administration for ATC patients.
  
  
  
  Weekly paclitaxel administration for ATC patients can be of clinical benefit in a neo-adjuvant setting.
authors.affiliation: 1 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .|2 Department of Surgical Oncology, Osaka City University Graduate School of Medicine , Osaka, Japan .
authors.forename: Naoyoshi
authors.initials: N
authors.lastname: Onoda
authors.affiliation: 1 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .|3 Department of Surgery, Ito Hospital , Tokyo, Japan .
authors.forename: Kiminori
authors.initials: K
authors.lastname: Sugino
authors.affiliation: 1 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .|4 Department of Surgery, Kuma Hospital , Kobe, Japan .
authors.forename: Takuya
authors.initials: T
authors.lastname: Higashiyama
authors.affiliation: 1 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .|5 Department of Surgery, Kanaji Thyroid Hospital , Tokyo, Japan .
authors.forename: Makoto
authors.initials: M
authors.lastname: Kammori
authors.affiliation: 6 Division of Head and Neck, Cancer Institute Hospital , Tokyo, Japan .
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Toda
authors.affiliation: 1 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .|7 Department of Surgery II, Shinshu University , Matsumoto, Japan .
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Ito
authors.affiliation: 1 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .|8 Department of Breast and Endocrine Surgery, Kanagawa Cancer Center , Yokohama, Japan .
authors.forename: Akira
authors.initials: A
authors.lastname: Yoshida
authors.affiliation: 9 Department of Surgery, Yokohama City University , Kanagawa, Japan .
authors.forename: Nobuyasu
authors.initials: N
authors.lastname: Suganuma
authors.affiliation: 10 Department of Breast and Endocrine Surgery, Tohoku University , Sendai, Japan .
authors.forename: Noriaki
authors.initials: N
authors.lastname: Nakashima
authors.affiliation: 1 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .|11 Department of Thyroid and Endocrinology, Fukushima Medical University School of Medicine , Fukushima, Japan .
authors.forename: Shinichi
authors.initials: S
authors.lastname: Suzuki
authors.affiliation: 12 Department of Otolaryngology, Tokyo Medical University , Tokyo, Japan .
authors.forename: Kiyoaki
authors.initials: K
authors.lastname: Tsukahara
authors.affiliation: 13 Noguchi Thyroid Clinic and Hospital Foundation , Oita, Japan .
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Noguchi
authors.affiliation: 14 Department of Surgery, Mito Medical Center , Mito, Japan .
authors.forename: Masanori
authors.initials: M
authors.lastname: Koizumi
authors.affiliation: 15 Department of Otorhinolaryngology, Japanese Red Cross Narita Hospital , Chiba, Japan .
authors.forename: Toshimitsu
authors.initials: T
authors.lastname: Nemoto
authors.affiliation: 1 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .|16 Department of Breast and Endocrine Surgery, Tsukuba University , Tsukuba, Japan .
authors.forename: Hisato
authors.initials: H
authors.lastname: Hara
authors.affiliation: 1 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .|4 Department of Surgery, Kuma Hospital , Kobe, Japan .
authors.forename: Akira
authors.initials: A
authors.lastname: Miyauchi
authors.affiliation: 1 Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan , Tokyo, Japan .|6 Division of Head and Neck, Cancer Institute Hospital , Tokyo, Japan .|17 Department of Endocrine Surgery, Nippon Medical School , Tokyo, Japan .
authors.forename: Iwao
authors.initials: I
authors.lastname: Sugitani
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use; D011446:Prospective Studies; D065646:Thyroid Carcinoma, Anaplastic / Q000188:drug therapy* / Q000473:pathology; D013964:Thyroid Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel