TY - JOUR
T1 - Treatment rationale and study design for the pointbreak study
T2 - A randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/bevacizumab versus paclitaxel/carboplatin/ bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer
AU - Patel, Jyoti D.
AU - Bonomi, Philip
AU - Socinski, Mark A.
AU - Govindan, Ramaswamy
AU - Hong, Shengyan
AU - Obasaju, Coleman
AU - Pennella, Eduardo J.
AU - Girvan, Allicia C.
AU - Guba, Susan C.
N1 - Funding Information:
This work was sponsored by Eli Lilly and Company, Indianapolis, IN. Drs. Obasaju, Pennella, Girvan, Guba, and Hong are full-time employees and minor stockholders of Eli Lilly and Company. Dr. Patel has a consultant/advisory relationship with and has received research funding from Eli Lilly and Company. Dr. Govindan reports a consultant/advisory relationship with Eli Lilly and Company; Genentech, Inc.; AstraZeneca, and ImClone Systems Incorporated. Dr. Socinski received research funding from and is on the Speakers’ Bureau for both Eli Lilly and Company and Genentech, Inc.; Dr. Bonomi has a consultant/advisory relationship, has received research funding from, and is on the Speaker’s Bureau for Eli Lilly and Company.
PY - 2009
Y1 - 2009
N2 - We present the treatment rationale and study design of the PointBreak study, a phase III study of pemetrexed/ carboplatin/bevacizumab induction followed by pemetrexed/bevacizumab maintenance (arm A) compared with paclitaxel/carboplatin/bevacizumab induction followed by bevacizumab maintenance (arm B) in patients with advanced nonsquamous non-small-cell lung cancer (NSCLC). Treatment consists of up to 4 cycles of induction therapy followed by maintenance therapy until disease progression or treatment discontinuation in approximately 900 patients (450 per treatment arm). The efficacy objectives of this study are to compare overall survival (OS), response rates, disease control rates, progression-free survival, and time to progressive disease between the 2 treatment arms. In addition, safety, quality of life, pharmacokinetics, and translational research will be investigated for both treatment arms. If the primary objective (OS) is achieved, this study will provide robust results on an alternative treatment option, pemetrexed/carboplatin/bevacizumab followed by maintenance therapy with pemetrexed/bevacizumab, for patients with nonsquamous NSCLC.
AB - We present the treatment rationale and study design of the PointBreak study, a phase III study of pemetrexed/ carboplatin/bevacizumab induction followed by pemetrexed/bevacizumab maintenance (arm A) compared with paclitaxel/carboplatin/bevacizumab induction followed by bevacizumab maintenance (arm B) in patients with advanced nonsquamous non-small-cell lung cancer (NSCLC). Treatment consists of up to 4 cycles of induction therapy followed by maintenance therapy until disease progression or treatment discontinuation in approximately 900 patients (450 per treatment arm). The efficacy objectives of this study are to compare overall survival (OS), response rates, disease control rates, progression-free survival, and time to progressive disease between the 2 treatment arms. In addition, safety, quality of life, pharmacokinetics, and translational research will be investigated for both treatment arms. If the primary objective (OS) is achieved, this study will provide robust results on an alternative treatment option, pemetrexed/carboplatin/bevacizumab followed by maintenance therapy with pemetrexed/bevacizumab, for patients with nonsquamous NSCLC.
KW - Antifolate
KW - Biomarkers
KW - Induction therapy
KW - Maintenance therapy
UR - http://www.scopus.com/inward/record.url?scp=70349452141&partnerID=8YFLogxK
U2 - 10.3816/CLC.2009.n.035
DO - 10.3816/CLC.2009.n.035
M3 - Article
C2 - 19632943
AN - SCOPUS:70349452141
SN - 1525-7304
VL - 10
SP - 252
EP - 256
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
IS - 4
ER -