PMID- 36241930
OWN - NLM
STAT- MEDLINE
DCOM- 20221129
LR  - 20221129
IS  - 1437-7772 (Electronic)
IS  - 1341-9625 (Linking)
VI  - 27
IP  - 12
DP  - 2022 Dec
TI  - Phase I/II study of nedaplatin and nab-paclitaxel for patients with previously 
      untreated advanced squamous cell lung cancer: Kanto Respiratory Disease Study 
      Group (KRSG) 1302.
PG  - 1841-1848
LID - 10.1007/s10147-022-02241-6 [doi]
AB  - BACKGROUND: Nedaplatin and nab-paclitaxel are each efficacious in the treatment 
      of squamous cell lung cancer. PATIENTS AND METHODS: Eligibility criteria were: no 
      prior chemotherapy, advanced squamous cell lung cancer; performance status 0-1, 
      age > 20 years but < 75 years, and adequate hematologic, hepatic and renal 
      function. Patients received escalating doses of nab-paclitaxel under a fixed dose 
      of nedaplatin (100 mg/m(2), day 1) every 3 weeks in phase I. The initial 
      nab-paclitaxel dose was 100 mg/m(2) on days 1 and 8 (level 1), and the next dose 
      was 100 mg/m(2) on days 1, 8, and 15 (level 2). In phase II, patients received 
      the recommended doses. The primary endpoint was tumor response rate. RESULTS: In 
      phase I, three patients at level 1 experienced no dose-limiting toxicities (DLTs) 
      and two patients at level 2 experienced DLTs. Level 1 was thus determined as the 
      recommended dose. Twenty-three patients were enrolled in phase II. The 3 patients 
      in level 1 and 23 patients in phase II were included together for analyses. Three 
      of these 26 patients were excluded from response analysis due to pneumonia and 
      patient refusal. Response rate was 91.3% (95% confidence interval, 72.0-98.9%). 
      Toxicities observed during all cycles were tolerable. CONCLUSIONS: The 
      recommended dose for this combination was nedaplatin at 100 mg/m(2) on day 1 and 
      nab-paclitaxel at 100 mg/m(2) on days 1 and 8 every 3 weeks. The combination of 
      nedaplatin and nab-paclitaxel appears safe and efficacious in patients with 
      untreated advanced squamous cell lung cancer.
CI  - (c) 2022. The Author(s) under exclusive licence to Japan Society of Clinical 
      Oncology.
FAU - Kasai, Takashi
AU  - Kasai T
AUID- ORCID: 0000-0002-3112-4001
AD  - Division of Thoracic Oncology, Department of Medical Oncology, Tochigi Cancer 
      Center, 4-9-13 Yonan, Utsunomiya, Tochigi, Japan. takasai@tochigi-cc.jp.
FAU - Mori, Kiyoshi
AU  - Mori K
AD  - Division of Thoracic Oncology, Department of Thoracic Diseases, Utsunomiya 
      Memorial Hospital, Tochigi, Japan.
FAU - Sugiyama, Tomohide
AU  - Sugiyama T
AD  - Division of Thoracic Oncology, Department of Medical Oncology, Tochigi Cancer 
      Center, 4-9-13 Yonan, Utsunomiya, Tochigi, Japan.
FAU - Koyama, Nobuyuki
AU  - Koyama N
AD  - Department of Respiratory Medicine, Saitama Medical Center, Saitama Medical 
      University, Saitama, Japan.
FAU - Nakamura, Yoichi
AU  - Nakamura Y
AD  - Division of Thoracic Oncology, Department of Medical Oncology, Tochigi Cancer 
      Center, 4-9-13 Yonan, Utsunomiya, Tochigi, Japan.
FAU - Ohyanagi, Fumiyoshi
AU  - Ohyanagi F
AD  - Department of Respiratory Medicine, Saitama Cancer Center, Saitama, Japan.
FAU - Fukuda, Hiroki
AU  - Fukuda H
AD  - Department of General Thoracic Surgery, Saitama Medical Center, Saitama Medical 
      University, Saitama, Japan.
FAU - Hoshi, Eishin
AU  - Hoshi E
AD  - Department of General Thoracic Surgery, Saitama Cardiovascular and Respiratory 
      Center, Saitama, Japan.
FAU - Kobayashi, Kunihiko
AU  - Kobayashi K
AD  - Department of Respiratory Medicine, Saitama Medical University International 
      Medical Center, Saitama, Japan.
FAU - Nakayama, Mitsuo
AU  - Nakayama M
AD  - Department of General Thoracic Surgery, Saitama Medical Center, Saitama Medical 
      University, Saitama, Japan.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20221014
PL  - Japan
TA  - Int J Clin Oncol
JT  - International journal of clinical oncology
JID - 9616295
RN  - 0 (130-nm albumin-bound paclitaxel)
RN  - 8UQ3W6JXAN (nedaplatin)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Humans
MH  - Young Adult
MH  - Adult
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy
MH  - Paclitaxel/adverse effects
MH  - *Carcinoma, Squamous Cell/drug therapy/pathology
MH  - *Lung Neoplasms/drug therapy/etiology
MH  - Epithelial Cells/pathology
OTO - NOTNLM
OT  - Nab-paclitaxel
OT  - Nedaplatin
OT  - Phase I/II study
OT  - Platinum compound
OT  - Squamous cell lung cancer
EDAT- 2022/10/15 06:00
MHDA- 2022/11/30 06:00
CRDT- 2022/10/14 23:40
PHST- 2022/06/10 00:00 [received]
PHST- 2022/08/17 00:00 [accepted]
PHST- 2022/10/15 06:00 [pubmed]
PHST- 2022/11/30 06:00 [medline]
PHST- 2022/10/14 23:40 [entrez]
AID - 10.1007/s10147-022-02241-6 [pii]
AID - 10.1007/s10147-022-02241-6 [doi]
PST - ppublish
SO  - Int J Clin Oncol. 2022 Dec;27(12):1841-1848. doi: 10.1007/s10147-022-02241-6. 
      Epub 2022 Oct 14.