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1.
Lung Cancer. 2018 Sep;123:7-13. doi: 10.1016/j.lungcan.2018.06.008. Epub 2018 Jun 18.

Factors associated with gene aberration test status and treatment decision in patients with unresectable Stage IIIB/IV nonsquamous non-small cell lung cancer: A multicenter survey in China (CTONG 1506).

Author information

1
Department of Respiratory Medicine, Jingling Hospital, Nanjing University School of Medicine, No. 305 East Zhongshan Road, Xuanwu District, Nanjing, Jiangsu 210002, People's Republic of China. Electronic address: yong_song6310@yahoo.com.
2
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, No. 106 Zhongshan 2nd Road, Guangzhou, Guangdong 510080, People's Republic of China. Electronic address: gzzhouqing@126.com.
3
Department of Respiration and Lung Cancer Comprehensive Treatment Center, Zhongshan Hospital, No. 180 Fenglin Road, Xuhui District, Shanghai 200032, People's Republic of China. Electronic address: xinhaier@sina.com.
4
Department of Internal Medicine, The Tumor Hospital affiliated to Harbin Medical University, No. 51 Haping Road, Nangang District, Harbin, Heilongjiang 150081, People's Republic of China. Electronic address: chengongyan@163.com.
5
Department of Medical Oncology, General Hospital of Tianjin Medical University, No. 24 Anshan Road, Heping District, Tianjin 300052, People's Republic of China. Electronic address: zhongdsh@hotmail.com.
6
Department of Oncology, The Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, Shandong 266003, People's Republic of China. Electronic address: yuzhuang2002@163.com.
7
Department of Medical Oncology, Sichuan Cancer Hospital, No. 55, Section 4, South Renmin Road, Chengdu, Sichuan 610041, People's Republic of China. Electronic address: yuping862@126.com.
8
Department of Medical Oncology, Zhejiang Cancer Hospital, No. 1 East Banshan Road, Gongshu District, Hangzhou, Zhejiang 310022, People's Republic of China. Electronic address: cool_cp@163.com.
9
Thoracic Medicine Department, Hunan Cancer Hospital, No. 283 Tongzipo Road, Yuelu District, Changsha, Hunan 410006, People's Republic of China. Electronic address: cjh_1000@163.com.
10
Department of Medical Oncology, Chinese PLA General Hospital, No. 28 Fuxing Road, Haidian District, Beijing 100039, People's Republic of China. Electronic address: huyi0401@aliyun.com.
11
Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region, No. 6 Taoyuan Road, Nanning, Guangxi 168600, People's Republic of China. Electronic address: fengguosheng88988@163.com.
12
Department of Respiration Medicine, Shanxi Cancer Hospital, No. 3 Zhigongxin Street, Taiyuan, Shanxi 030013, People's Republic of China. Electronic address: songxia76@hotmail.com.
13
Lilly Suzhou Pharmaceutical Co., Ltd., Tower 1 HKRI, Taikoo Hui, No. 288 Shi Men Yi Road, Shanghai 200041, People's Republic of China. Electronic address: shi_qiang@lilly.com.
14
Lilly Suzhou Pharmaceutical Co., Ltd., Tower 1 HKRI, Taikoo Hui, No. 288 Shi Men Yi Road, Shanghai 200041, People's Republic of China. Electronic address: yang_lu_lu@lilly.com.
15
Lilly Suzhou Pharmaceutical Co., Ltd., Tower 1 HKRI, Taikoo Hui, No. 288 Shi Men Yi Road, Shanghai 200041, People's Republic of China. Electronic address: yao_luan_di_susan@lilly.com.
16
Lilly Suzhou Pharmaceutical Co., Ltd., Tower 1 HKRI, Taikoo Hui, No. 288 Shi Men Yi Road, Shanghai 200041, People's Republic of China. Electronic address: zhan_lu_jing@lilly.com.
17
Shanghai Centennial Scientific Co., Ltd., Room 702A, B Block, Fenglin International Center, No. 388 Fenglin Road, Shanghai 200030, People's Republic of China. Electronic address: yangfan@centennialmed.com.
18
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, No. 106 Zhongshan 2nd Road, Guangzhou, Guangdong 510080, People's Republic of China. Electronic address: syylwu@live.cn.

Abstract

OBJECTIVES:

This study investigated factors associated with (i) the likelihood of receiving a gene aberration test and (ii) the choice of treatment between chemotherapy and targeted therapy in patients with non-small cell lung cancer (NSCLC) in China.

MATERIALS AND METHODS:

This cross-sectional study analyzed data previously extracted from the medical charts of patients with unresectable Stage IIIB/IV nonsquamous NSCLC discharged from one of 12 tertiary hospitals in China between August 2015 and March 2016. Logistic regressions were applied to investigate factors associated with receiving a gene aberration test and the treatment decision.

RESULTS:

Data from 932 patients were analyzed. Patients were less likely to have a gene aberration test if they had a histologic subtype other than adenocarcinoma or a hospital waiting time for test results of >5 days. Patients were more likely to receive tyrosine kinase inhibitor (TKI) treatment than chemotherapy if they had a positive result for epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase gene aberration testing. EGFR positive patients were more likely to receive TKI treatment than chemotherapy if they did not have insurance for TKI or pemetrexed treatment, and more likely to receive chemotherapy than TKI treatment if they had a waiting time for test results of >5 days. EGFR wild-type/unknown patients receiving chemotherapy were more likely to receive pemetrexed if they attended a hospital in a developed area or had insurance for pemetrexed.

CONCLUSION:

In this real-world setting in China, the choice of first-line treatment for advanced NSCLC was appropriately guided by gene aberration testing for most patients. However, gene aberration testing and the treatment decision were influenced by practical factors such as hospital location, the waiting time for test results, and insurance coverage, which should be addressed to ensure optimal patient care.

KEYWORDS:

Chemotherapy; First-line anticancer treatment; Gene aberration test; Nonsquamous non-small cell lung cancer; Real-world research; Tyrosine kinase inhibitor

2.
BMC Cancer. 2017 Jul 3;17(1):462. doi: 10.1186/s12885-017-3451-x.

A multicenter survey of first-line treatment patterns and gene aberration test status of patients with unresectable Stage IIIB/IV nonsquamous non-small cell lung cancer in China (CTONG 1506).

Author information

1
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou, 510080, Guangdong, China.
2
Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu, China.
3
Zhongshan Hospital, Shanghai, China.
4
The Tumor Hospital affiliated to Harbin Medical University, Harbin, Heilongjiang, China.
5
General Hospital of Tianjin Medical University, Heping, Tianjin, China.
6
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.
7
Sichuan Cancer Hospital, Chengdu, Sichuan, China.
8
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China.
9
Hunan Cancer Hospital, Changsha, Hunan, China.
10
Chinese PLA General Hospital, Beijing, China.
11
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China.
12
Shanxi Cancer Hospital, Taiyuan, Shanxi, China.
13
Lilly Suzhou Pharmaceutical Co., Ltd, Shanghai, China.
14
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou, 510080, Guangdong, China. syylwu@live.cn.

Abstract

BACKGROUND:

In recent years, systemic chemotherapy and molecular targeted therapy have become standard first-line treatments for locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). The objective of this survey was to investigate first-line anticancer treatment patterns and gene aberration test status of patients with advanced nonsquamous NSCLC in China.

METHODS:

Patients included in this study had unresectable Stage IIIB/IV nonsquamous NSCLC and were admitted during August 2015 to March 2016 into one of 12 tertiary hospitals throughout China for first-line anticancer treatment. Patient data (demographics, NSCLC histologic type, Eastern Cooperative Oncology Group [ECOG] Performance Status [PS], gene aberration test and results [if performed], and first-line anticancer treatment regimen) were extracted from medical charts and entered into Medical Record Abstraction Forms (MERAFs), which were collated for analysis.

RESULTS:

Overall, 1041 MERAFs were collected and data from 932 MERAFs were included for analysis. Patients with unresectable Stage IIIB/IV nonsquamous NSCLC had a median age of 59 years, 56.4% were male, 58.2% were never smokers, 95.0% had adenocarcinoma, and 92.9% had an ECOG PS ≤1. A total of 665 (71.4%) patients had gene aberration tests; 46.5% (309/665) had epidermal growth factor receptor (EGFR) gene mutations, 11.5% (48/416) had anaplastic lymphoma kinase (ALK) gene fusions, and 0.8% (1/128) had a c-ros oncogene 1 gene fusion. The most common first-line treatment regimen for unresectable Stage IIIB/IV nonsquamous NSCLC was chemotherapy (72.5%, 676/932), followed by tyrosine kinase inhibitors (TKIs; 26.1%, 243/932), and TKIs plus chemotherapy (1.4%, 13/932). Most chemotherapy regimens were platinum-doublet regimens (93.5%, 631/676) and pemetrexed was the most common nonplatinum chemotherapy-backbone agent (70.2%, 443/631) in platinum-doublet regimens. Most EGFR mutation-positive patients (66.3%, 205/309) were treated with EGFR-TKIs.

CONCLUSIONS:

Findings from our survey of 12 tertiary hospitals throughout China showed an increased rate of gene aberration testing, compared with those rates reported in previous surveys, for patients with advanced nonsquamous NSCLC. In addition, pemetrexed/platinum-doublet chemotherapy was the predominant first-line chemotherapy regimen for this population. Most patients were treated based on their gene aberration test status and results.

KEYWORDS:

Chemotherapy; China; Epidermal growth factor receptor; First-line anticancer treatment; Non-small cell lung cancer; Tyrosine kinase inhibitor

PMID:
28673332
PMCID:
PMC5496179
DOI:
10.1186/s12885-017-3451-x
[Indexed for MEDLINE]
Free PMC Article
Icon for BioMed Central Icon for PubMed Central
3.
Clin Lung Cancer. 2017 Mar;18(2):e143-e149. doi: 10.1016/j.cllc.2016.10.010. Epub 2016 Oct 26.

Pretreatment Red Blood Cell Total Folate Concentration Is Associated With Response to Pemetrexed in Stage IV Nonsquamous Non-Small-cell Lung Cancer.

Author information

1
Abramson Cancer Center, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA. Electronic address: stephen.bagley@uphs.upenn.edu.
2
Penn Institute for Biomedical Informatics, University of Pennsylvania, Philadelphia, PA.
3
Center of Excellence in Environmental Toxicology and Center for Cancer Pharmacology, Department of Systems Pharmacology and Translational Therapeutics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
4
Abramson Cancer Center, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
5
Division of Pulmonary, Allergy, and Critical Care Medicine, Thoracic Oncology Group, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.

Abstract

INTRODUCTION:

Pemetrexed inhibits folate-dependent enzymes involved in pyrimidine and purine synthesis. Previous studies of genetic variation in these enzymes as predictors of pemetrexed efficacy have yielded inconsistent results. We investigated whether red blood cell (RBC) total folate, a phenotypic rather than genotypic, marker of cellular folate status was associated with the response to pemetrexed-based chemotherapy in advanced nonsquamous non-small-cell lung cancer (NSCLC).

MATERIALS AND METHODS:

We conducted a prospective cohort study of patients with stage IV nonsquamous NSCLC receiving first-line chemotherapy containing pemetrexed. The pretreatment RBC total folate level was quantified using liquid chromatography mass spectrometry. We then compared the objective response rate (ORR) between patients with RBC total folate concentrations greater than and less than an optimal cutoff value determined from the receiver operating characteristic curve. A logistic regression model was used to adjust for age, sex, and the use of bevacizumab.

RESULTS:

The ORR was 62% (32 of 52 patients). Receiver operating characteristic analysis was used to establish that a RBC total folate cutoff value of 364.6 nM optimally discriminated between pemetrexed responders and nonresponders. Patients with RBC total folate < 364.5 nM had an ORR of 27% compared with 71% for patients with RBC total folate > 364.5 nM (P = .01). This difference persisted after adjusting for age, sex, and the use of bevacizumab (odds ratio, 0.07; 95% confidence interval, 0.01-0.57; P = .01).

CONCLUSION:

A low pretreatment RBC total folate was associated with an inferior response to pemetrexed-based chemotherapy in stage IV nonsquamous NSCLC. Larger, multicenter studies are needed to validate RBC total folate as a predictive marker of pemetrexed response.

KEYWORDS:

Biomarker; Chemotherapy; Folic acid; MTHFR; Polymorphism

PMID:
27863923
PMCID:
PMC5346447
DOI:
10.1016/j.cllc.2016.10.010
[Indexed for MEDLINE]
Free PMC Article
Icon for Elsevier Science Icon for PubMed Central
4.
J Thorac Oncol. 2015 Feb;10(2):353-9. doi: 10.1097/JTO.0000000000000277.

Quality of life analyses from the randomized, open-label, phase III PointBreak 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.

Author information

1
*Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN; †Feinberg School of Medicine, Northwestern University, Chicago, IL; ‡Ocala Oncology, Ocala, FL and US Oncology Research, Inc., Houston, TX; §David Geffen School of Medicine at UCLA/Translational Research in Oncology-US, Los Angeles, CA; ║Northwest Georgia Oncology Centers, Marietta, GA; ¶Washington University School of Medicine, St. Louis, MO; #Tulsa Cancer Institute, Tulsa, OK; **Eli Lilly and Company, Indianapolis, IN; ††University of Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh, PA; and ‡‡Rush University Medical Center, Chicago, IL.

Abstract

INTRODUCTION:

Treatment impact on quality of life (QoL) informs treatment management decisions in advanced nonsquamous non-small-cell lung cancer (NS NSCLC). QoL outcomes from the phase III PointBreak trial are reported.

METHODS:

Chemonaive patients (n = 939) with stage IIIB/IV nonsquamous non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status 0 to 1 were randomized (1:1) to pemetrexed-carboplatin-bevacizumab (pemetrexed arm) or paclitaxel-carboplatin-bevacizumab (paclitaxel arm). Patients without progressive disease received maintenance pemetrexed-bevacizumab (pemetrexed arm) or bevacizumab (paclitaxel arm). QoL was assessed using Functional Assessment of Cancer Therapy (FACT)-General (FACT-G), FACT-Lung (FACT-L), and FACT/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) instruments. Subscale scores, total scores, and trial outcome indices were analyzed using linear mixed-effects models. Post hoc analyses examined the association between baseline FACT scores and overall survival (OS).

RESULTS:

Mean score differences in change from baseline significantly favored the pemetrexed arm for the neurotoxicity subscale score, FACT-Ntx total scores, and FACT-Ntx trial outcome index. They occurred at cycle 2 (p < 0.001) and persisted through induction cycles 2 to 4 and six maintenance cycles. Investigator-assessed, qualitative, drug-related differences in grade 2 (1.6% versus 10.6%) and grade 3 (0.0% versus 4.1%) sensory neuropathy and grade 3/4 fatigue (10.9% versus 5.0%, p = 0.0012) were observed between the pemetrexed and paclitaxel arms. Baseline FACT-G, FACT-L, and FACT-Ntx scores were significant prognostic factors for OS (p < 0.001).

CONCLUSIONS:

Randomized patients reported similar changes in QoL, except for less change from baseline in neurotoxicity on the pemetrexed arm; investigators reported greater neurotoxicity on the paclitaxel arm and greater fatigue on the pemetrexed arm. Higher baseline FACT scores were favorable prognostic factors for OS.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00762034.

PMID:
25611228
DOI:
10.1097/JTO.0000000000000277
[Indexed for MEDLINE]
Free full text
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5.
Clin Lung Cancer. 2015 May;16(3):200-8. doi: 10.1016/j.cllc.2014.11.004. Epub 2014 Nov 18.

Exploratory Subset Analysis of African Americans From the PointBreak Study: Pemetrexed-Carboplatin-Bevacizumab Followed by Maintenance Pemetrexed-Bevacizumab Versus Paclitaxel-Carboplatin-Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB/IV Nonsquamous Non-Small-Cell Lung Cancer.

Author information

1
US Oncology Research, Ocala, FL. Electronic address: craig.reynolds@usoncology.com.
2
Northwestern University Feinberg School of Medicine, Chicago, IL.
3
University of California, Los Angeles, David Geffen School of Medicine, Translational Research in Oncology-United States, Los Angeles, CA.
4
Tulsa Cancer Institute, Tulsa, OK.
5
Rush University Medical Center, Chicago, IL.
6
Washington University School of Medicine, St Louis, MO.
7
Eli Lilly and Company, Indianapolis, IN.
8
Sarah Cannon Research Institute, Nashville, TN and Tennessee Oncology, PLLC, Nashville, TN.
9
Northwest Georgia Oncology Centers, PC, Marietta, GA.
10
Division of Hematology/Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, PA.

Abstract

INTRODUCTION:

African Americans have a greater incidence of lung cancer than whites and have been underrepresented in clinical trials. In the PointBreak trial (pemetrexed-carboplatin-bevacizumab and maintenance pemetrexed-bevacizumab [PemCBev] vs. paclitaxel-carboplatin-bevacizumab and maintenance bevacizumab [PacCBev]), 10% of the patients were African American. PointBreak had negative findings; PemCBev did not demonstrate superior overall survival (OS).

MATERIALS AND METHODS:

PointBreak subgroup efficacy and safety data were retrospectively analyzed: African Americans versus whites for PemCBev; PemCBev versus PacCBev in African Americans; and academic versus community settings for African Americans. Hazard ratios (HRs) and P values were derived from a multivariate Cox proportional hazards model after adjusting for covariates.

RESULTS:

Of 939 intent-to-treat (ITT) patients, 94 were African American and 805 were white. African-American enrollment was uniform across the study sites (median, 1 African American per site). In the PemCBev arm, OS (HR, 1.125; P = .525), progression-free survival (PFS) (HR, 1.229; P = .251), response (P = .607), and toxicity profiles were similar in African Americans versus whites. For African Americans, OS (HR, 1.375; P = .209), PFS (HR, 0.902; P = .670), response (P = 1.000), and toxicity profiles were similar in the PemCBev versus PacCBev arm. For African Americans, no significant differences were seen in OS (HR, 0.661; P = .191) or PFS (HR, 0.969; P = .915) in academic versus community practice settings.

CONCLUSION:

In the PemCBev arm, this exploratory analysis showed no significant differences between African Americans and whites for the efficacy outcomes or toxicity profiles. Consistent with the ITT population negative trial result, for African Americans, the median OS was not superior for either arm. For African Americans, PFS and OS were similar in the academic and community settings. Additional outcomes data for African Americans should be collected in lung cancer studies.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00762034.

KEYWORDS:

Alimta; Avastin; Minority groups

PMID:
25516338
DOI:
10.1016/j.cllc.2014.11.004
[Indexed for MEDLINE]
Icon for Elsevier Science
6.
J Clin Oncol. 2013 Dec 1;31(34):4349-57. doi: 10.1200/JCO.2012.47.9626. Epub 2013 Oct 21.

PointBreak: a randomized phase III study of pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer.

Author information

1
Jyoti D. Patel, Northwestern University; Philip Bonomi, Rush University Medical Center, Chicago, IL; Mark A. Socinski, University of Pittsburgh, Pittsburgh, PA; Edward B. Garon, University of California at Los Angeles, Los Angeles, CA; Craig H. Reynolds, US Oncology Research, Ocala, FL; David R. Spigel, Sarah Cannon Research Institute-Tennessee Oncology, Nashville, TN; Mark R. Olsen, Tulsa Cancer Institute, Tulsa, OK; Robert C. Hermann, Northwest Georgia Oncology Centers, Marietta, GA; Robert M. Jotte, Rocky Mountain Cancer Centers, Denver, CO; Thaddeus Beck, Highlands Oncology Group, Fayetteville, AR; Donald A. Richards, US Oncology Research, Tyler, TX; Susan C. Guba, Jingyi Liu, Bente Frimodt-Moller, and William J. John, Eli Lilly, Indianapolis, IN; Coleman K. Obasaju and Eduardo J. Pennella, Lilly USA, Indianapolis, IN; and Ramaswamy Govindan, Washington University School of Medicine, St. Louis, MO.

Abstract

PURPOSE:

PointBreak (A Study of Pemetrexed, Carboplatin and Bevacizumab in Patients With Nonsquamous Non-Small Cell Lung Cancer) compared the efficacy and safety of pemetrexed (Pem) plus carboplatin (C) plus bevacizumab (Bev) followed by pemetrexed plus bevacizumab (PemCBev) with paclitaxel (Pac) plus carboplatin (C) plus bevacizumab (Bev) followed by bevacizumab (PacCBev) in patients with advanced nonsquamous non-small-cell lung cancer (NSCLC).

PATIENTS AND METHODS:

Patients with previously untreated stage IIIB or IV nonsquamous NSCLC and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to receive pemetrexed 500 mg/m(2) or paclitaxel 200 mg/m(2) combined with carboplatin area under the curve 6 and bevacizumab 15 mg/kg every 3 weeks for up to four cycles. Eligible patients received maintenance until disease progression: pemetrexed plus bevacizumab (for the PemCBev group) or bevacizumab (for the PacCBev group). The primary end point of this superiority study was overall survival (OS).

RESULTS:

Patients were randomly assigned to PemCBev (n = 472) or PacCBev (n = 467). For PemCBev versus PacCBev, OS hazard ratio (HR) was 1.00 (median OS, 12.6 v 13.4 months; P = .949); progression-free survival (PFS) HR was 0.83 (median PFS, 6.0 v 5.6 months; P = .012); overall response rate was 34.1% versus 33.0%; and disease control rate was 65.9% versus 69.8%. Significantly more study drug-related grade 3 or 4 anemia (14.5% v 2.7%), thrombocytopenia (23.3% v 5.6%), and fatigue (10.9% v 5.0%) occurred with PemCBev; significantly more grade 3 or 4 neutropenia (40.6% v 25.8%), febrile neutropenia (4.1% v 1.4%), sensory neuropathy (4.1% v 0%), and alopecia (grade 1 or 2; 36.8% v 6.6%) occurred with PacCBev.

CONCLUSION:

OS did not improve with the PemCBev regimen compared with the PacCBev regimen, although PFS was significantly improved with PemCBev. Toxicity profiles differed; both regimens demonstrated tolerability.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00762034.

PMID:
24145346
PMCID:
PMC4881367
DOI:
10.1200/JCO.2012.47.9626
[Indexed for MEDLINE]
Free PMC Article
Icon for Atypon Icon for PubMed Central
7.
Clin Lung Cancer. 2009 Jul;10(4):252-6. 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.

Author information

1
Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA. jd-patel@northwestern.edu.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00762034.

PMID:
19632943
DOI:
10.3816/CLC.2009.n.035
[Indexed for MEDLINE]
Icon for Elsevier Science

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