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 - Publisher Copyright:
© 2018 Elsevier Inc.
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.
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U2 - 10.1016/j.cllc.2018.05.005
DO - 10.1016/j.cllc.2018.05.005
M3 - Article
C2 - 29861395
AN - SCOPUS:85048537586
SN - 1525-7304
VL - 19
SP - e711-e715
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
IS - 5
ER -
