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Treatment-related death in patients with small-cell lung cancer in phase III trials over the last two decades.

Ochi N, Hotta K, Takigawa N, Oze I, Fujiwara Y, Ichihara E, Hisamoto A, Tabata M, Tanimoto M, Kiura K - PLoS ONE (2012)

Bottom Line: Regarding the time trend, while it was not statistically significant, it tended to decrease, with a 0.138% decrease per year and 2.76% decrease per two decades.The most common cause of death was febrile neutropenia without any significant time trend in its incidence over the years examined (p = 0.139).However, deaths due to febrile neutropenia as well as all causes in patients treated with non-platinum chemotherapy increased significantly (p = 0.033).

View Article: PubMed Central - PubMed

Affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.

ABSTRACT

Introduction: Treatment-related death (TRD) remains a serious problem in small-cell lung cancer (SCLC), despite recent improvements in supportive care. However, few studies have formally assessed time trends in the proportion of TRD over the past two decades. The aim of this study was to determine the frequency and pattern of TRD over time.

Methods: We examined phase 3 trials conducted between 1990 and 2010 to address the role of systemic treatment for SCLC. The time trend was assessed using linear regression analysis.

Results: In total, 97 trials including nearly 25,000 enrolled patients were analyzed. The overall TRD proportion was 2.95%. Regarding the time trend, while it was not statistically significant, it tended to decrease, with a 0.138% decrease per year and 2.76% decrease per two decades. The most common cause of death was febrile neutropenia without any significant time trend in its incidence over the years examined (p = 0.139). However, deaths due to febrile neutropenia as well as all causes in patients treated with non-platinum chemotherapy increased significantly (p = 0.033).

Conclusions: The overall TRD rate has been low, but not negligible, in phase III trials for SCLC over the past two decades.

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Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. All analyses were weighted by sample size. A. Median number of randomized patients. B. Proportion of patients with a good PS. C. Proportion of male patients.
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pone-0042798-g002: Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. All analyses were weighted by sample size. A. Median number of randomized patients. B. Proportion of patients with a good PS. C. Proportion of male patients.

Mentions: The median number of randomized patients and proportion of patients with a good PS in each trial increased significantly, with 8.489 patients and 1.075% per year, respectively (regression coefficients = 8.489 and 1.075, corresponding to an 8.489 and 1.075% increase per year; p = 0.003 and 0.009, respectively; Fig. 2A and B). The proportion of male patients, however, showed no particular change over time (Fig. 2C).


Treatment-related death in patients with small-cell lung cancer in phase III trials over the last two decades.

Ochi N, Hotta K, Takigawa N, Oze I, Fujiwara Y, Ichihara E, Hisamoto A, Tabata M, Tanimoto M, Kiura K - PLoS ONE (2012)

Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. All analyses were weighted by sample size. A. Median number of randomized patients. B. Proportion of patients with a good PS. C. Proportion of male patients.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3412813&req=5

pone-0042798-g002: Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. All analyses were weighted by sample size. A. Median number of randomized patients. B. Proportion of patients with a good PS. C. Proportion of male patients.
Mentions: The median number of randomized patients and proportion of patients with a good PS in each trial increased significantly, with 8.489 patients and 1.075% per year, respectively (regression coefficients = 8.489 and 1.075, corresponding to an 8.489 and 1.075% increase per year; p = 0.003 and 0.009, respectively; Fig. 2A and B). The proportion of male patients, however, showed no particular change over time (Fig. 2C).

Bottom Line: Regarding the time trend, while it was not statistically significant, it tended to decrease, with a 0.138% decrease per year and 2.76% decrease per two decades.The most common cause of death was febrile neutropenia without any significant time trend in its incidence over the years examined (p = 0.139).However, deaths due to febrile neutropenia as well as all causes in patients treated with non-platinum chemotherapy increased significantly (p = 0.033).

View Article: PubMed Central - PubMed

Affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.

ABSTRACT

Introduction: Treatment-related death (TRD) remains a serious problem in small-cell lung cancer (SCLC), despite recent improvements in supportive care. However, few studies have formally assessed time trends in the proportion of TRD over the past two decades. The aim of this study was to determine the frequency and pattern of TRD over time.

Methods: We examined phase 3 trials conducted between 1990 and 2010 to address the role of systemic treatment for SCLC. The time trend was assessed using linear regression analysis.

Results: In total, 97 trials including nearly 25,000 enrolled patients were analyzed. The overall TRD proportion was 2.95%. Regarding the time trend, while it was not statistically significant, it tended to decrease, with a 0.138% decrease per year and 2.76% decrease per two decades. The most common cause of death was febrile neutropenia without any significant time trend in its incidence over the years examined (p = 0.139). However, deaths due to febrile neutropenia as well as all causes in patients treated with non-platinum chemotherapy increased significantly (p = 0.033).

Conclusions: The overall TRD rate has been low, but not negligible, in phase III trials for SCLC over the past two decades.

Show MeSH
Related in: MedlinePlus