TY - JOUR
T1 - A Randomized Phase III Study Comparing Carboplatin With Nab-Paclitaxel Versus Docetaxel for Elderly Patients With Squamous-Cell Lung Cancer
T2 - Study Protocol
AU - Kogure, Yoshihito
AU - Saka, Hideo
AU - Takiguchi, Yuichi
AU - Atagi, Shinji
AU - Kurata, Takayasu
AU - Ebi, Noriyuki
AU - Inoue, Akira
AU - Kubota, Kaoru
AU - Takenoyama, Mitsuhiro
AU - Seto, Takashi
AU - Kada, Akiko
AU - Yamanaka, Takeharu
AU - Ando, Masahiko
AU - Yamamoto, Nobuyuki
AU - Gemma, Akihiko
AU - Ichinose, Yukito
N1 - Funding Information:
We thank the patients, their families, and all of the investigators who are participating in this study. This study is supported by the National Cancer Center Research and Development Fund (26-A-22). This study is being conducted by the National Hospital Organization Nagoya Medical Center under a funding contract with Taiho Pharmaceutical Co Ltd, Tokyo, Japan.
Funding Information:
Dr Kogure has received personal payments from AstraZeneca outside the scope of this study. Dr Saka has received a grant and personal payments from Taiho Pharmaceutical relative to this study, as well as grants from Kyowa Hakko Kirin, Boehringer Ingelheim Japan, Novartis Pharma, Daiichi Sankyo, Merck Serono, Esai, Bristol-Meyers Squibb, Ono Pharmaceutical, Chugai Pharmaceutical, Eli Lilly Japan, Beyer Pharmaceuticals, MSD, Olympus, Sanofi, Quintiles Transnational Japan, the West Japan Oncology Group, and AstraZeneca, and personal payments from Chugai Pharmaceutical, Kyorin Pharmaceutical, Nagoya University, Boehringer Ingelheim Japan, Eli Lilly Japan, Astellas Pharma, Nobelpharma, Olympus Medical Systems, Boston Scientific, Covidien Japan, the Japanese Society of Respiratory Endoscopy, Ono Pharmaceutical, The Chunichi Shimbun, Becton, Dickinson and Company, and AstraZeneca outside the scope of this study. Dr Takiguchi has received personal payments from Bristol Meyers Squibb (Japan) and Ono Pharmaceutical Co (Japan), and grants from Ono Pharmaceutical Co (Japan), and Bristol Meyers Squibb (Japan) relative to this study, personal payments from Eli Lilly (Japan), AstraZeneca (Japan), MSD, Chugai Pharmaceutical, Taiho Pharmaceutical, Merck Serono, Eizai, Pfizer (Japan), Boehringer Ingelheim (Japan), and Kyowa-Hakko Kirin, and grants from Eli Lilly (Japan), Chugai Pharmaceutical, Eizai, Pfizer (Japan), Boehringer Ingelheim (Japan), Kyowa-Hakko Kirin, and Daiichi-Sankyo Pharmaceutical, and other from Eli Lilly (Japan) and Chugai Pharmaceutical, outside the scope of this study. Dr Atagi has received grants and personal payments from Taiho Pharmaceutical relative to this study; grants from Pfizer, Chugai Pharmaceutical, AstraZeneca, MSD, Ono Pharmaceutical, Yakult Pharmaceutical Industry, Eli Lilly, and Boehringer Ingelheim, and personal fees from Chugai Pharmaceutical, AstraZeneca, Eli Lilly, Boehringer Ingelheim, Bristol-Myers Squibb, and Ono Pharmaceutical, outside the scope of this study. Dr Kurata has received grants and personal payments from AstraZeneca and Eli Lilly, grants from MSD and Chugai, and personal payments from Ono and Bristol Myers Squibb outside the scope of this study. Dr Inoue has received personal payments from Taiho outside the scope of this study. Dr Kubota has received grants and personal payments from Boehringer Ingelheim, personal payments from Chugai-Pharma, Taiho Pharmaceuticals, Eli Lilly Japan, MSD, and Novartis Pharma, outside the scope of this study. Dr Takenoyama has received grants and personal payments from Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan, Kyowa Hakko Kirin, and Ono Pharmaceutical, grants from Nippon Boehringer Ingelheim and Novartis Pharma, and personal payments from AstraZeneca and Taiho Pharmaceutical, outside the scope of this study. Dr Seto has received personal payments from Bristol-Myers Squibb, Fuji Pharma, Hisamitsu Pharmaceutical, Kissei Pharmaceutical, Kyowa Hakko Kirin, Mochida Pharmaceutical, Nippon Kayaku, Ono Pharmaceutical, Roche Diagnostics, Roche Singapore, Sanofi, Showa Yakuhin Kako, Sumitomo Dainippon Pharma, Taiho Pharmaceutical, and Takeda Pharmaceutical, grants from Astellas Pharma, Bayer Yakuhin, Merck Serono, Novartis Pharma and Verastem, and grants and personal payments from AstraZeneca, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly Japan, MSD, Nippon Boehringer Ingelheim, Pfizer Japan, and Yakult Honsha, outside the scope of this study. Dr Kada has received payments from Takeda, outside the scope of this study. Dr Ando has received a grant from Kyowa Hakko Kirin Co, Ltd, outside the scope of this study. Dr Yamamoto has received personal payments from Taiho Pharmaceutical Co, Ltd, relative to this study. Dr Gemma has received personal payments from Taiho outside the scope of this study. Dr Ichinose has received a grant from Takeda Bio Development Center and personal payments from Chugai Pharmaceutical, Kyowa Hakko Kirin, Taiho Pharmaceutical Co, and Taisho Toyama Pharmaceutical, outside the scope of this study. Drs Ebi and Yamanaka have stated that they have no conflicts of interest.
PY - 2018/9
Y1 - 2018/9
N2 - Background: Treatment with carboplatin (CBDCA) with weekly paclitaxel (PTX) has shown survival benefits compared with vinorelbine or gemcitabine in elderly patients with non-small-cell carcinoma (NSCLC). Docetaxel (DOC), however, remains a standard treatment in NSCLC. The 130-nm albumin-bound formulation of PTX (nab-PTX) has shown activity in NSCLC. Treatment with CBDCA with weekly nab-PTX showed significantly higher efficacy than CBDCA with PTX in patients with squamous histology and significantly increased overall survival (OS) in patients aged 70 years and older. Patients and Methods: This randomized, multicenter, phase III trial (UMIN000019843) was designed to compare the efficacy and safety of CBDCA with nab-PTX with DOC in patients aged 70 years and older with advanced squamous NSCLC. Elderly patients who have received no previous chemotherapy for advanced/metastatic squamous NSCLC with Eastern Cooperative Oncology Group performance status of 0 or 1 will be randomized 1:1 to DOC (60 mg/m 2 intravenous [I.V.] on day 1) or CBDCA (area under the blood concentration time curve 6 on day 1) with nab-PTX (100 mg/m 2 I.V. on days 1, 8, and 15) of each 21-day cycle. The primary end point is OS. Recruitment began in December 2015 and planned enrollment is 250 patients. Conclusion: If OS is greater in patients treated with CBDCA with nab-PTX than with DOC, this study will provide a new standard of care for elderly patients with squamous NSCLC.
AB - Background: Treatment with carboplatin (CBDCA) with weekly paclitaxel (PTX) has shown survival benefits compared with vinorelbine or gemcitabine in elderly patients with non-small-cell carcinoma (NSCLC). Docetaxel (DOC), however, remains a standard treatment in NSCLC. The 130-nm albumin-bound formulation of PTX (nab-PTX) has shown activity in NSCLC. Treatment with CBDCA with weekly nab-PTX showed significantly higher efficacy than CBDCA with PTX in patients with squamous histology and significantly increased overall survival (OS) in patients aged 70 years and older. Patients and Methods: This randomized, multicenter, phase III trial (UMIN000019843) was designed to compare the efficacy and safety of CBDCA with nab-PTX with DOC in patients aged 70 years and older with advanced squamous NSCLC. Elderly patients who have received no previous chemotherapy for advanced/metastatic squamous NSCLC with Eastern Cooperative Oncology Group performance status of 0 or 1 will be randomized 1:1 to DOC (60 mg/m 2 intravenous [I.V.] on day 1) or CBDCA (area under the blood concentration time curve 6 on day 1) with nab-PTX (100 mg/m 2 I.V. on days 1, 8, and 15) of each 21-day cycle. The primary end point is OS. Recruitment began in December 2015 and planned enrollment is 250 patients. Conclusion: If OS is greater in patients treated with CBDCA with nab-PTX than with DOC, this study will provide a new standard of care for elderly patients with squamous NSCLC.
KW - Chemotherapy
KW - Combination therapy
KW - NSCLC
KW - Overall survival
KW - Single agent
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UR - http://www.scopus.com/inward/citedby.url?scp=85048537586&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2018.05.005
DO - 10.1016/j.cllc.2018.05.005
M3 - Article
C2 - 29861395
AN - SCOPUS:85048537586
VL - 19
SP - e711-e715
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
SN - 1525-7304
IS - 5
ER -
