{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,6,25]],"date-time":"2025-06-25T10:14:43Z","timestamp":1750846483921,"version":"3.40.5"},"reference-count":15,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,4,1]],"date-time":"2019-04-01T00:00:00Z","timestamp":1554076800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Asia-Pac J Clncl Oncology"],"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>We investigated the efficacy, safety and optimal schedule of nanoparticle albumin\u2010bound paclitaxel monotherapy as second\u2010 or third\u2010line treatment for non\u2010small\u2010cell lung cancer patients without <jats:italic>epidermal growth factor receptor<\/jats:italic> mutation and <jats:italic>anaplastic lymphoma kinase<\/jats:italic> rearrangement.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with pretreated advanced non\u2010small\u2010cell lung cancer without <jats:italic>epidermal growth factor receptor<\/jats:italic> mutation and <jats:italic>anaplastic lymphoma kinase<\/jats:italic> rearrangement were included. The patients were administered 100\u00a0mg\/m<jats:sup>2<\/jats:sup> of nanoparticle albumin\u2010bound paclitaxel on days 1, 8, 15 and 22 (level 0) or on days 1, 8 and 15 (level \u20131) every 4\u00a0weeks during phase I of the trial. The primary endpoint was objective response rate. The estimated objective response rate was 15% and the threshold was 5% with an <jats:italic>\u03b1<\/jats:italic> error of 0.05 and <jats:italic>\u03b2<\/jats:italic> error of 0.2 in phase II.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The recommended schedule was determined as level \u20131 in phase I. The characteristics of the 55 patients enrolled in phase II were as follows: median age\u00a0=\u00a066 years, male\/female\u00a0=\u00a040\/15, second\/third line\u00a0=\u00a034\/21 and adenocarcinoma\/squamous cell carcinoma\/large cell carcinoma\/others\u00a0=\u00a034\/17\/2\/2. Objective response rate was 7.3% (95% confidence interval, 2.0\u201317.6%). Median progression\u2010free survival was 3.4 months. Treatment\u2010related grade 3 or 4 toxicities were neutropenia (36.4%), febrile neutropenia (5.5%) and pulmonary infection (3.6%). Three patients had grade 2 pneumonitis and one treatment\u2010related death occurred due to adult respiratory distress syndrome.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study failed to meet predefined primary endpoints for pretreated patients with advanced non\u2010small\u2010cell lung cancer without <jats:italic>epidermal growth factor receptor<\/jats:italic> mutation and <jats:italic>anaplastic lymphoma kinase<\/jats:italic> rearrangement.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ajco.13147","type":"journal-article","created":{"date-parts":[[2019,4,2]],"date-time":"2019-04-02T04:35:03Z","timestamp":1554179703000},"page":"250-256","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A phase I\/II trial of weekly nab\u2010paclitaxel for pretreated non\u2010small\u2010cell lung cancer patients without <i>epidermal growth factor receptor<\/i> mutations and <i>anaplastic lymphoma kinase<\/i> rearrangement"],"prefix":"10.1111","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5314-2489","authenticated-orcid":false,"given":"Daijiro","family":"Harada","sequence":"first","affiliation":[{"name":"Department of Thoracic Oncology National Hospital Organization Shikoku Cancer Center  Matsuyama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiyuki","family":"Kozuki","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Hospital Organization Shikoku Cancer Center  Matsuyama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoyuki","family":"Nogami","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Hospital Organization Shikoku Cancer Center  Matsuyama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akihiro","family":"Bessho","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine 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