The Safety and Efficacy of Weekly Paclitaxel Administration for Anaplastic Thyroid Cancer Patients: A Nationwide Prospective Study

Naoyoshi Onoda, Kiminori Sugino, Takuya Higashiyama, Makoto Kammori, Kazuhisa Toda, Ken Ichi Ito, Akira Yoshida, Nobuyasu Suganuma, Noriaki Nakashima, Shinichi Suzuki, Kiyoaki Tsukahara, Hitoshi Noguchi, Masanori Koizumi, Toshimitsu Nemoto, Hisato Hara, Akira Miyauchi, Iwao Sugitani

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20 Citations (Scopus)

Abstract

Background: 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. Methods: An investigator-initiated, multicenter, nonrandomized, open-label, single-arm study to evaluate the feasibility and efficacy of weekly paclitaxel (80 mg/m2) administration for patients with pathologically confirmed ATC was conducted in a nationwide organization. Results: 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). Summary: The study demonstrates objective and accurate information concerning the feasibility and efficacy of a standardized treatment with weekly paclitaxel administration for ATC patients. Conclusions: Weekly paclitaxel administration for ATC patients can be of clinical benefit in a neo-adjuvant setting.

Original languageEnglish
Pages (from-to)1293-1299
Number of pages7
JournalThyroid
Volume26
Issue number9
DOIs
Publication statusPublished - 2016 Sep

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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    Onoda, N., Sugino, K., Higashiyama, T., Kammori, M., Toda, K., Ito, K. I., Yoshida, A., Suganuma, N., Nakashima, N., Suzuki, S., Tsukahara, K., Noguchi, H., Koizumi, M., Nemoto, T., Hara, H., Miyauchi, A., & Sugitani, I. (2016). The Safety and Efficacy of Weekly Paclitaxel Administration for Anaplastic Thyroid Cancer Patients: A Nationwide Prospective Study. Thyroid, 26(9), 1293-1299. https://doi.org/10.1089/thy.2016.0072