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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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Related in: MedlinePlus

PRISMA flow diagram showing the progress of trials through the review.
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pone-0042798-g001: PRISMA flow diagram showing the progress of trials through the review.

Mentions: Figure 1 shows a flow chart for this study. In total, we identified 97 trials as a result of computer-based and manual searches (File S1). In total, 24,152 patients were randomized and allocated to 208 treatment arms. Table 1 shows the characteristics of all eligible trials. The median proportion of randomized patients with a good PS (0 or 1) and that of male patients in all trials was 80.0 and 71.0%, respectively. Most trials had two chemotherapy arms (86.6%). The number of trials designed to assign TRT in addition to chemotherapy was 53 (54.6%).


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)

PRISMA flow diagram showing the progress of trials through the review.
© Copyright Policy
Related In: Results  -  Collection

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

pone-0042798-g001: PRISMA flow diagram showing the progress of trials through the review.
Mentions: Figure 1 shows a flow chart for this study. In total, we identified 97 trials as a result of computer-based and manual searches (File S1). In total, 24,152 patients were randomized and allocated to 208 treatment arms. Table 1 shows the characteristics of all eligible trials. The median proportion of randomized patients with a good PS (0 or 1) and that of male patients in all trials was 80.0 and 71.0%, respectively. Most trials had two chemotherapy arms (86.6%). The number of trials designed to assign TRT in addition to chemotherapy was 53 (54.6%).

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