Twenty-seven years of phase III trials for patients with extensive disease small-cell lung cancer: Disappointing results

Isao Oze, Katsuyuki Hotta, Katsuyuki Kiura, Nobuaki Ochi, Nagio Takigawa, Yoshiro Fujiwara, Masahiro Tabata, Mitsune Tanimoto

Research output: Contribution to journalArticle

65 Citations (Scopus)

Abstract

Background: Few studies have formally assessed whether treatment outcomes have improved substantially over the years for patients with extensive disease small-cell lung cancer (ED-SCLC) enrolled in phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials. Methods and Findings: We searched for trials that were reported between January 1981 and August 2008. Phase III randomized controlled trials were eligible if they compared first-line, systemic chemotherapy for ED-SCLC. Data were evaluated by using a linear regression analysis. Results: In total, 52 trials were identified that had been initiated between 1980 and 2006; these studies involved 10,262 patients with 110 chemotherapy arms. The number of randomized patients and the proportion of patients with good performance status (PS) increased over time. Cisplatin-based regimens, especially cisplatin and etoposide (PE) regimen, have increasingly been studied, whereas cyclophosphamide, doxorubicin, and vincristine-based regimens have been less investigated. Multiple regression analysis showed no significant improvement in survival over the years. Additionally, the use of a PE regimen did not affect survival, whereas the proportion of patients with good PS and the trial design of assigning prophylactic cranial irradiation were significantly associated with favorable outcome. Conclusions and Significance: The survival of patients with ED-SCLC enrolled in phase III trials did not improve significantly over the years, suggesting the need for further development of novel targets, newer agents, and comprehensive patient care.

Original languageEnglish
Article numbere7835
JournalPLoS One
Volume4
Issue number11
DOIs
Publication statusPublished - Nov 13 2009

Fingerprint

Small Cell Lung Carcinoma
lung neoplasms
Chemotherapy
Cells
Regression analysis
Cisplatin
Vincristine
Etoposide
cells
cisplatin
Linear regression
Doxorubicin
Cyclophosphamide
drug therapy
Survival
Irradiation
regression analysis
Regression Analysis
Cranial Irradiation
vincristine

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

Twenty-seven years of phase III trials for patients with extensive disease small-cell lung cancer : Disappointing results. / Oze, Isao; Hotta, Katsuyuki; Kiura, Katsuyuki; Ochi, Nobuaki; Takigawa, Nagio; Fujiwara, Yoshiro; Tabata, Masahiro; Tanimoto, Mitsune.

In: PLoS One, Vol. 4, No. 11, e7835, 13.11.2009.

Research output: Contribution to journalArticle

@article{cf4d24136eb94591b191f49b0ac3de55,
title = "Twenty-seven years of phase III trials for patients with extensive disease small-cell lung cancer: Disappointing results",
abstract = "Background: Few studies have formally assessed whether treatment outcomes have improved substantially over the years for patients with extensive disease small-cell lung cancer (ED-SCLC) enrolled in phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials. Methods and Findings: We searched for trials that were reported between January 1981 and August 2008. Phase III randomized controlled trials were eligible if they compared first-line, systemic chemotherapy for ED-SCLC. Data were evaluated by using a linear regression analysis. Results: In total, 52 trials were identified that had been initiated between 1980 and 2006; these studies involved 10,262 patients with 110 chemotherapy arms. The number of randomized patients and the proportion of patients with good performance status (PS) increased over time. Cisplatin-based regimens, especially cisplatin and etoposide (PE) regimen, have increasingly been studied, whereas cyclophosphamide, doxorubicin, and vincristine-based regimens have been less investigated. Multiple regression analysis showed no significant improvement in survival over the years. Additionally, the use of a PE regimen did not affect survival, whereas the proportion of patients with good PS and the trial design of assigning prophylactic cranial irradiation were significantly associated with favorable outcome. Conclusions and Significance: The survival of patients with ED-SCLC enrolled in phase III trials did not improve significantly over the years, suggesting the need for further development of novel targets, newer agents, and comprehensive patient care.",
author = "Isao Oze and Katsuyuki Hotta and Katsuyuki Kiura and Nobuaki Ochi and Nagio Takigawa and Yoshiro Fujiwara and Masahiro Tabata and Mitsune Tanimoto",
year = "2009",
month = "11",
day = "13",
doi = "10.1371/journal.pone.0007835",
language = "English",
volume = "4",
journal = "PLoS One",
issn = "1932-6203",
publisher = "Public Library of Science",
number = "11",

}

TY - JOUR

T1 - Twenty-seven years of phase III trials for patients with extensive disease small-cell lung cancer

T2 - Disappointing results

AU - Oze, Isao

AU - Hotta, Katsuyuki

AU - Kiura, Katsuyuki

AU - Ochi, Nobuaki

AU - Takigawa, Nagio

AU - Fujiwara, Yoshiro

AU - Tabata, Masahiro

AU - Tanimoto, Mitsune

PY - 2009/11/13

Y1 - 2009/11/13

N2 - Background: Few studies have formally assessed whether treatment outcomes have improved substantially over the years for patients with extensive disease small-cell lung cancer (ED-SCLC) enrolled in phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials. Methods and Findings: We searched for trials that were reported between January 1981 and August 2008. Phase III randomized controlled trials were eligible if they compared first-line, systemic chemotherapy for ED-SCLC. Data were evaluated by using a linear regression analysis. Results: In total, 52 trials were identified that had been initiated between 1980 and 2006; these studies involved 10,262 patients with 110 chemotherapy arms. The number of randomized patients and the proportion of patients with good performance status (PS) increased over time. Cisplatin-based regimens, especially cisplatin and etoposide (PE) regimen, have increasingly been studied, whereas cyclophosphamide, doxorubicin, and vincristine-based regimens have been less investigated. Multiple regression analysis showed no significant improvement in survival over the years. Additionally, the use of a PE regimen did not affect survival, whereas the proportion of patients with good PS and the trial design of assigning prophylactic cranial irradiation were significantly associated with favorable outcome. Conclusions and Significance: The survival of patients with ED-SCLC enrolled in phase III trials did not improve significantly over the years, suggesting the need for further development of novel targets, newer agents, and comprehensive patient care.

AB - Background: Few studies have formally assessed whether treatment outcomes have improved substantially over the years for patients with extensive disease small-cell lung cancer (ED-SCLC) enrolled in phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials. Methods and Findings: We searched for trials that were reported between January 1981 and August 2008. Phase III randomized controlled trials were eligible if they compared first-line, systemic chemotherapy for ED-SCLC. Data were evaluated by using a linear regression analysis. Results: In total, 52 trials were identified that had been initiated between 1980 and 2006; these studies involved 10,262 patients with 110 chemotherapy arms. The number of randomized patients and the proportion of patients with good performance status (PS) increased over time. Cisplatin-based regimens, especially cisplatin and etoposide (PE) regimen, have increasingly been studied, whereas cyclophosphamide, doxorubicin, and vincristine-based regimens have been less investigated. Multiple regression analysis showed no significant improvement in survival over the years. Additionally, the use of a PE regimen did not affect survival, whereas the proportion of patients with good PS and the trial design of assigning prophylactic cranial irradiation were significantly associated with favorable outcome. Conclusions and Significance: The survival of patients with ED-SCLC enrolled in phase III trials did not improve significantly over the years, suggesting the need for further development of novel targets, newer agents, and comprehensive patient care.

UR - http://www.scopus.com/inward/record.url?scp=70649099227&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=70649099227&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0007835

DO - 10.1371/journal.pone.0007835

M3 - Article

C2 - 19915681

AN - SCOPUS:70649099227

VL - 4

JO - PLoS One

JF - PLoS One

SN - 1932-6203

IS - 11

M1 - e7835

ER -