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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

Time trend in the incidence of TRDs (treatment-related deaths).The analysis was weighted by sample size. A. Overall incidence of TRDs. B. Incidence of FN (febrile neutropenia)-related TRDs.
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pone-0042798-g004: Time trend in the incidence of TRDs (treatment-related deaths).The analysis was weighted by sample size. A. Overall incidence of TRDs. B. Incidence of FN (febrile neutropenia)-related TRDs.

Mentions: Next, we assessed the time trends in TRD incidence. It was stable over the last two decades, with no statistically significant difference (regression coefficient = −0.138; p = 0.15). This corresponds to a 0.138% decrease per year; however, it does mean that, theoretically, the TRD incidence decreased by 2.76% per two decades (Fig. 4A). Further, we assessed which clinical factor affected this time trend (Table 2). In most clinical settings, there was no particular difference in the time trend, whereas, interestingly, when limited to patient cohorts treated with a non-platinum regimen, there was a significant increase in TRD incidence (0.146% increase per year; p = 0.033). We observed no significant increase or decrease in TRD incidence with other treatment regimens, including cisplatin-, carboplatin-, and CAV-based regimens (p = 0.270, 0.390, and 0.570, respectively).


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 trend in the incidence of TRDs (treatment-related deaths).The analysis was weighted by sample size. A. Overall incidence of TRDs. B. Incidence of FN (febrile neutropenia)-related TRDs.
© Copyright Policy
Related In: Results  -  Collection

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

pone-0042798-g004: Time trend in the incidence of TRDs (treatment-related deaths).The analysis was weighted by sample size. A. Overall incidence of TRDs. B. Incidence of FN (febrile neutropenia)-related TRDs.
Mentions: Next, we assessed the time trends in TRD incidence. It was stable over the last two decades, with no statistically significant difference (regression coefficient = −0.138; p = 0.15). This corresponds to a 0.138% decrease per year; however, it does mean that, theoretically, the TRD incidence decreased by 2.76% per two decades (Fig. 4A). Further, we assessed which clinical factor affected this time trend (Table 2). In most clinical settings, there was no particular difference in the time trend, whereas, interestingly, when limited to patient cohorts treated with a non-platinum regimen, there was a significant increase in TRD incidence (0.146% increase per year; p = 0.033). We observed no significant increase or decrease in TRD incidence with other treatment regimens, including cisplatin-, carboplatin-, and CAV-based regimens (p = 0.270, 0.390, and 0.570, respectively).

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