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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 in relation to FN (febrile neutropenia).All analyses were weighted by sample size. A. Cisplatin-containing regimen. B. Carboplatin-containing regimen. C. Non-platinum-regimen. D. CAV (cyclophosphamide, doxorubicin and vincristine)-based regimen.
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pone-0042798-g005: Time trend in the incidence of TRDs in relation to FN (febrile neutropenia).All analyses were weighted by sample size. A. Cisplatin-containing regimen. B. Carboplatin-containing regimen. C. Non-platinum-regimen. D. CAV (cyclophosphamide, doxorubicin and vincristine)-based regimen.

Mentions: Because FN was the most common cause of fatal toxicity during chemotherapy, we focused specifically on the incidence and pattern of FN-related deaths. Overall, there was no significant time trend in TRD, with a regression coefficient of 0.035 and p-value of 0.259 (Fig. 4B). Through the entire period, the proportion of FN-related deaths was similar across the four regimens (cisplatin-based 0.649%, carboplatin-based 0.652%, non-platinum 0.645%, and CAV-based regimens 0.704%). However, the pattern of the time trend was different among the regimens (Fig. 5A D). Non-platinum regimens were associated with a significant increase in death over the years, with a 0.155% increase per year (regression coefficient = 0.155; p = 0.037; Fig. 5C), while no yearly change in the proportion was observed for the other treatment regimens (cisplatin-, carboplatin- and CAV-based regimens; p = 0.337 [Fig. 5A], 0.857 [Fig. 5B], and 0.123 [Fig. 5D], 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 in relation to FN (febrile neutropenia).All analyses were weighted by sample size. A. Cisplatin-containing regimen. B. Carboplatin-containing regimen. C. Non-platinum-regimen. D. CAV (cyclophosphamide, doxorubicin and vincristine)-based regimen.
© Copyright Policy
Related In: Results  -  Collection

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

pone-0042798-g005: Time trend in the incidence of TRDs in relation to FN (febrile neutropenia).All analyses were weighted by sample size. A. Cisplatin-containing regimen. B. Carboplatin-containing regimen. C. Non-platinum-regimen. D. CAV (cyclophosphamide, doxorubicin and vincristine)-based regimen.
Mentions: Because FN was the most common cause of fatal toxicity during chemotherapy, we focused specifically on the incidence and pattern of FN-related deaths. Overall, there was no significant time trend in TRD, with a regression coefficient of 0.035 and p-value of 0.259 (Fig. 4B). Through the entire period, the proportion of FN-related deaths was similar across the four regimens (cisplatin-based 0.649%, carboplatin-based 0.652%, non-platinum 0.645%, and CAV-based regimens 0.704%). However, the pattern of the time trend was different among the regimens (Fig. 5A D). Non-platinum regimens were associated with a significant increase in death over the years, with a 0.155% increase per year (regression coefficient = 0.155; p = 0.037; Fig. 5C), while no yearly change in the proportion was observed for the other treatment regimens (cisplatin-, carboplatin- and CAV-based regimens; p = 0.337 [Fig. 5A], 0.857 [Fig. 5B], and 0.123 [Fig. 5D], 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