Treatment rationale and study design for the pointbreak study: 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

Jyoti D. Patel; Philip Bonomi; Mark A. Socinski; Ramaswamy Govindan; Shengyan Hong; Coleman Obasaju; Eduardo J. Pennella; Allicia C. Girvan; Susan C. Guba

doi:10.3816/CLC.2009.n.035

Treatment rationale and study design for the pointbreak study: 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

Jyoti D. Patel, Philip Bonomi, Mark A. Socinski, Ramaswamy Govindan, Shengyan Hong, Coleman Obasaju, Eduardo J. Pennella, Allicia C. Girvan, Susan C. Guba

Medicine, Hematology Oncology Division

Research output: Contribution to journal › Article › peer-review

70 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	252-256
Number of pages	5
Journal	Clinical Lung Cancer
Volume	10
Issue number	4
DOIs	https://doi.org/10.3816/CLC.2009.n.035
State	Published - 2009

Funding

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.

Keywords

Antifolate
Biomarkers
Induction therapy
Maintenance therapy

ASJC Scopus subject areas

Oncology
Pulmonary and Respiratory Medicine
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Patel, J. D., Bonomi, P., Socinski, M. A., Govindan, R., Hong, S., Obasaju, C., Pennella, E. J., Girvan, A. C., & Guba, S. C. (2009). Treatment rationale and study design for the pointbreak study: 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. Clinical Lung Cancer, 10(4), 252-256. https://doi.org/10.3816/CLC.2009.n.035

Patel, Jyoti D. ; Bonomi, Philip ; Socinski, Mark A. et al. / Treatment rationale and study design for the pointbreak study : 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. In: Clinical Lung Cancer. 2009 ; Vol. 10, No. 4. pp. 252-256.

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title = "Treatment rationale and study design for the pointbreak study: 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",

abstract = "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.",

keywords = "Antifolate, Biomarkers, Induction therapy, Maintenance therapy",

author = "Patel, {Jyoti D.} and Philip Bonomi and Socinski, {Mark A.} and Ramaswamy Govindan and Shengyan Hong and Coleman Obasaju and Pennella, {Eduardo J.} and Girvan, {Allicia C.} and Guba, {Susan C.}",

note = "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{\textquoteright} 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{\textquoteright}s Bureau for Eli Lilly and Company.",

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volume = "10",

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Patel, JD, Bonomi, P, Socinski, MA, Govindan, R, Hong, S, Obasaju, C, Pennella, EJ, Girvan, AC & Guba, SC 2009, 'Treatment rationale and study design for the pointbreak study: 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', Clinical Lung Cancer, vol. 10, no. 4, pp. 252-256. https://doi.org/10.3816/CLC.2009.n.035

Treatment rationale and study design for the pointbreak study: 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. / Patel, Jyoti D.; Bonomi, Philip; Socinski, Mark A. et al.
In: Clinical Lung Cancer, Vol. 10, No. 4, 2009, p. 252-256.

Research output: Contribution to journal › Article › peer-review

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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.

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KW - Antifolate

KW - Biomarkers

KW - Induction therapy

KW - Maintenance therapy

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Patel JD, Bonomi P, Socinski MA, Govindan R, Hong S, Obasaju C et al. Treatment rationale and study design for the pointbreak study: 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. Clinical Lung Cancer. 2009;10(4):252-256. doi: 10.3816/CLC.2009.n.035