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Eligibility Of Patients With Advanced Non-small Cell Lung Cancer For Phase III Chemotherapy Trials

J. Vardy, Ryan Dadasovich, P. Beale, M. Boyer, S. Clarke
Published 2008 · Medicine

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BackgroundEvidence that chemotherapy improves survival and quality of life in patients with stage IIIB & IV non small cell lung cancer (NSCLC) is based on large randomized controlled trials. The purpose of this study was to determine eligibility of patients with advanced NSCLC for major chemotherapy trials.MethodsPhysicians treating stage IIIB/IV NSCLC at Sydney Cancer Centre assessed patient eligibility for the E1594, SWOG9509 and TAX326 trials for patients presenting from October 2001 to December 2002. A review of the centre's registry was used to obtain missing data.Results199 patients with advanced NSCLC were registered during the 14-month period. Characteristics of 100 patients were defined prospectively, 85 retrospectively: 77% males, median age 68 (range 32–88), 64% stage IV disease. Only 35% met trial eligibility for E1594 and 28% for SWOG9509 and TAX326. Common reasons for ineligibility were: co-morbidities 75(40%); ECOG Performance Status ≥2 72(39%); symptomatic brain metastasis 15(8%); and previous cancers 21(11%). Many patients were ineligible by more than one criterion.ConclusionThe majority of patients with advanced NSCLC were ineligible for the large chemotherapy trials. The applicability of trial results to advanced lung cancer populations may be limited. Future trials should be conducted in a more representative population.
This paper references
Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies.
C. Gridelli (2007)
Christianity and Democracy: The Global Picture
P. Berger (2004)
Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group.
W. Dewys (1980)
Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials
W. Alberti (1995)
Clinical and cost effectiveness of paclitaxel, docetaxel, gemcitabine, and vinorelbine in non-small cell lung cancer: a systematic review
A. Clegg (2002)
Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer.
J. Schiller (2002)
Clinical predictors of survival in advanced cancer.
P. Glare (2005)
The ELVIS trial: a phase III study of single-agent vinorelbine as first-line treatment in elderly patients with advanced non-small cell lung cancer. Elderly Lung Cancer Vinorelbine Italian Study.
C. Gridelli (2001)
Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life.
M. Cullen (1999)
Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non--small-cell lung cancer: a Southwest Oncology Group trial.
K. Kelly (2001)
Avid (2001)
Prognos - tic effect of weight loss prior to chemotherapy in cancer patients . Eastern Cooperative Oncology Group
DM Parkin (1980)
Cancer burden in the year
DM Parkin (2000)
Cancer burden in the year 2000. The global picture.
D. Parkin (2001)
Corrigendum to “Cancer burden in the year 2000. The global picture” [European Journal of Cancer,37(Suppl. 8) (2001) S4–S66]
D. Parkin (2003)
Prognostic effect of weight loss prior tochemotherapy in cancer patients
W. Dewys (1980)
Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group.
F. Fossella (2003)
Clinical model to predict survival in chemonaive patients with advanced non-small-cell lung cancer treated with third-generation chemotherapy regimens based on eastern cooperative oncology group data.
T. Hoang (2005)

This paper is referenced by
American society of clinical oncology statement: toward individualized care for patients with advanced cancer.
J. Peppercorn (2011)
Pemetrexed in the treatment of advanced lung cancer
B. H. Grønberg (2010)
Ineligibility for the PACIFIC trial in unresectable stage III non-small cell lung cancer patients
K. Hosoya (2019)
The Bottleneck Effect in Lung Cancer Clinical Trials
L. Gonzalez (2013)
The relationship between eligibility criteria and adverse events in randomized controlled trials of hematologic malignancies
A. Statler (2017)
Dutch statistics on lung cancer: sobering experience for a new approach.
M. Zwitter (2012)
Improving the science and politics of quality improvement.
J. Curtis (2011)
Single-agent pegylated liposomal doxorubicin (PLD) in the treatment of metastatic breast cancer: results of an Austrian observational trial
M. Fiegl (2011)
Applicability of the PACIFIC trial results in patients not eligible for the PACIFIC trial: Canadian rapid consensus statement and recommendations.
Dr Andrew G Robinson (2020)
Efficacy and safety of nivolumab in previously treated patients with non-small cell lung cancer: A multicenter retrospective cohort study.
D. Fujimoto (2018)
Real-World Outcomes and Value of First-Line Therapy for Metastatic Non-Small Cell Lung Cancer†
S. Dacosta Byfield (2020)
Are clinical trial eligibility criteria an accurate reflection of a real-world population of advanced non-small-cell lung cancer patients?
K. Al-Baimani (2018)
Generalization and representativeness of phase III immune checkpoint blockade trials in non‐small cell lung cancer
Shin Hye Yoo (2018)
Baseline quality of life is associated with survival among people with advanced lung cancer
Mario J Trejo (2020)
Sensitivity of Edge Detection Methods for Quantifying Cell Migration Assays
Katrina K. Treloar (2013)
Sobering Experience for a New Approach
Matjaž Zwitter (2012)
Facteurs influençant l’inclusion des patients atteints de cancer thoracique dans les essais
S. Lozano (2015)
The eligibility of advanced non-small-cell lung cancer patients for targeted therapy clinical trials.
J. Clarey (2012)
Dose modifications in adjuvant chemotherapy for solid organ malignancies: A systematic review of clinical trials
T. Prasanna (2018)
Evolution of performance status, body mass index, and six-minute walk distance in advanced lung cancer patients undergoing chemotherapy.
L. Machado (2010)
[Which factors influence inclusion of thoracic cancer patients in clinical trials?].
Stéphanie Lozano (2015)
Evolução do status de performance, índice de massa corpórea e distância percorrida no teste de caminhada de seis minutos em pacientes com câncer de pulmão avançado submetidos à quimioterapia
L. Machado (2010)
Variations in Oncologist Recommendations for Chemotherapy for Stage IV Lung Cancer: What Is the Role of Performance Status?
D. Tisnado (2016)
CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations.
E. Felip (2020)
Inflammation-Based Prognostic Indices in Malignant Pleural Mesothelioma
D. Pinato (2012)
Results of platinum-based chemotherapy in unselected performance status (PS) 2 patients with advanced non-small cell lung cancer: a cohort study
S. Jouveshomme (2013)
A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results
T. Kennedy-Martin (2015)
Smoking habits in elderly lung cancer patients: still no changes in epidemiology? A single-center experience
Regina Gironés Sarrió (2010)
Influence of comorbidity on survival, toxicity and health-related quality of life in patients with advanced non-small-cell lung cancer receiving platinum-doublet chemotherapy.
B. H. Grønberg (2010)
Eligibility of Real-World Patients With Stage II and III Colon Cancer for Adjuvant Chemotherapy Trials.
A. Batra (2020)
Clinical Characteristics and Prognosis of Patients With Advanced Non–Small‐cell Lung Cancer Who Are Ineligible for Clinical Trials
H. Kawachi (2018)
Clinical evidence on the undertreatment of older and poor performance patients who have advanced non-small-cell lung cancer: is there a role for targeted therapy in these cohorts?
C. Langer (2011)
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