title: Phase I study of nab-paclitaxel plus carboplatin and concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer.
abstract: BACKGROUND
  The aim of our study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus carboplatin in combination with thoracic radiotherapy for patients with locally advanced stage III non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Weekly nab-paclitaxel plus carboplatin was administered intravenously for 6 weeks. Doses of each drug were planned as follows: level 1, 40/2; level 2, 60/2; level 3, 80/2 (nab-paclitaxel [mg/m2]/carboplatin [area under the plasma concentration time curve mg/ml/min]). Concurrent thoracic radiotherapy was administered in 2-Gy fractions 5 times weekly, to a total dose of 60 Gy.
  
  
  RESULTS
  Fourteen patients were enrolled in the present study. Eleven (78%) patients received full cycles (6 cycles) of chemotherapy, and 12 (86%) patients received 60 Gy of thoracic radiotherapy. At level 1, none of 3 patients experienced a dose-limiting toxicity (DLT). At level 2, 2 of 7 patients developed grade 3 diarrhea, grade 3 hyponatremia, grade 3 fatigue, and grade 3 esophagitis. Therefore, 4 patients were started at dose level 3 and none developed a DLT. No pulmonary toxicities, such as interstitial pneumonitis and treatment-related deaths, were observed at either level. Therefore, level 3 was considered the MTD and level 3 was defined as the RD. An objective response was observed in 71.4% of all patients.
  
  
  CONCLUSIONS
  This regimen is feasible and well tolerated for the treatment of patients with unresectable locally advanced NSCLC.
authors.affiliation: Department of Oncology Clinical Development, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan. kkaira1970@yahoo.co.jp.|Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan. kkaira1970@yahoo.co.jp.
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Kaira
authors.affiliation: Department of Respiratory Medicine, Shibukawa Medical Center, Shibukawa, Gunma, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Tomizawa
authors.affiliation: Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Maebashi, Gunma, Japan.
authors.forename: Hisao
authors.initials: H
authors.lastname: Imai
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.|Department of Respiratory Medicine, Shibukawa Medical Center, Shibukawa, Gunma, Japan.
authors.forename: Reiko
authors.initials: R
authors.lastname: Sakurai
authors.affiliation: Department of Radiology, Shibukawa Medical Center, Shibukawa, Gunma, Japan.
authors.forename: Masana
authors.initials: M
authors.lastname: Matsuura
authors.affiliation: Department of Respiratory Medicine, Shibukawa Medical Center, Shibukawa, Gunma, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Yoshii
authors.affiliation: Department of Respiratory Medicine, Shibukawa Medical Center, Shibukawa, Gunma, Japan.
authors.forename: Mai
authors.initials: M
authors.lastname: Ochiai
authors.affiliation: Department of Respiratory Medicine, Shibukawa Medical Center, Shibukawa, Gunma, Japan.
authors.forename: Mie
authors.initials: M
authors.lastname: Kotake
authors.affiliation: Department of Radiation Oncology, Gunma Prefectural Cancer Center, Maebashi, Gunma, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ebara
authors.affiliation: Department of Radiation Oncology, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
authors.forename: Jun-Ichi
authors.initials: JI
authors.lastname: Saitoh
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.|Oncology Center, Gunma University Hospital, Maebashi, Gunma, Japan.
authors.forename: Noriaki
authors.initials: N
authors.lastname: Sunaga
authors.affiliation: Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Maebashi, Gunma, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Minato
authors.affiliation: Department of Respiratory Medicine, Shibukawa Medical Center, Shibukawa, Gunma, Japan.
authors.forename: Ryusei
authors.initials: R
authors.lastname: Saito
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Hisada
mesh_terms: D000368:Aged; D000418:Albumins / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D013909:Thorax / Q000187:drug effects*
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D016190:Carboplatin; D017239:Paclitaxel
keywords: Carboplatin; Non-small cell lung cancer; Phase I study; Radiation; nab-PTX