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Erlotinib plus gemcitabine versus gemcitabine for pancreatic cancer: real-world analysis of Korean national database.

Shin S, Park CM, Kwon H, Lee KH - BMC Cancer (2016)

Bottom Line: There was also no significant difference in the respective one-year survival rates (27.0 % vs. 27.3 %; p = 0.5988).Multivariate analysis using age, gender, and comorbidities as covariates did not reveal any significant differences in survival.Based on this relative effectiveness, the incremental cost per life year gained over GEM was estimated at USD 70,843.64 for GEM-E.

View Article: PubMed Central - PubMed

Affiliation: National Evidence-based healthcare Collaborating Agency, Seoul, Korea.

ABSTRACT

Background: A randomized clinical trial has found that the addition of erlotinib to gemcitabine (GEM-E) for pancreatic cancer led to a modest increase in survival. The aim of this national population-based retrospective study was to compare the effectiveness of GEM-E to GEM alone for pancreatic cancer patients in real clinical practice.

Methods: Patients with pancreatic cancer (ICD-10: C25) with prescription claims of gemcitabine or erlotinib between Jan 1, 2007 and Dec 31, 2012 were retrospectively identified from the Korean Health Insurance claims database. To be included in the study population, patients were required to have had a histological or cytological diagnosis within one year before chemotherapy. Patients treated with prior radiotherapy, surgery, or chemotherapy were excluded to reduce heterogeneity. Overall survival from the initiation of therapy and the medical costs of GEM-E and GEM were compared.

Results: A total of 4,267 patients were included in the analysis. Overall survival was not significantly longer in patients treated with GEM-E (median 6.77 months for GEM-E vs. 6.68 months for GEM, p = 0.0977). There was also no significant difference in the respective one-year survival rates (27.0 % vs. 27.3 %; p = 0.5988). Multivariate analysis using age, gender, and comorbidities as covariates did not reveal any significant differences in survival. Based on this relative effectiveness, the incremental cost per life year gained over GEM was estimated at USD 70,843.64 for GEM-E.

Conclusions: GEM-E for pancreatic cancer is not more effective than GEM in a real-world setting, and it does not provide reasonable cost-effectiveness over GEM.

No MeSH data available.


Related in: MedlinePlus

Kaplan-Meier curves for overall survival. Abbreviation: GEM, Gemcitabine; GEM-E, Gemcitabine + Erlotinib
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Fig2: Kaplan-Meier curves for overall survival. Abbreviation: GEM, Gemcitabine; GEM-E, Gemcitabine + Erlotinib

Mentions: The survival curves for each treatment, derived from the Kaplan-Meier estimates, are shown in Fig. 2. The median overall survival of the patients receiving GEM-E was not significantly longer (6.77 months for GEM-E vs. 6.68 months for GEM, p = 0.0977) (Table 2). The actual difference in median survival was 3 days (mean 20 days). The 1-year survival rates of patients receiving GEM-E and GEM were 27.0 and 27.3 %, respectively (p = 0.5988). Multivariate analysis using age, sex, and comorbidities as covariates did not reveal any significant differences in survival (hazard ratio 0.966, p = 0.3353, Additional file 1: Table S1). For sensitivity analysis, the follow-up period was extended for five years; however, the median overall survival time was similar to the survival seen in the base analysis (data not shown).Fig. 2


Erlotinib plus gemcitabine versus gemcitabine for pancreatic cancer: real-world analysis of Korean national database.

Shin S, Park CM, Kwon H, Lee KH - BMC Cancer (2016)

Kaplan-Meier curves for overall survival. Abbreviation: GEM, Gemcitabine; GEM-E, Gemcitabine + Erlotinib
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4940912&req=5

Fig2: Kaplan-Meier curves for overall survival. Abbreviation: GEM, Gemcitabine; GEM-E, Gemcitabine + Erlotinib
Mentions: The survival curves for each treatment, derived from the Kaplan-Meier estimates, are shown in Fig. 2. The median overall survival of the patients receiving GEM-E was not significantly longer (6.77 months for GEM-E vs. 6.68 months for GEM, p = 0.0977) (Table 2). The actual difference in median survival was 3 days (mean 20 days). The 1-year survival rates of patients receiving GEM-E and GEM were 27.0 and 27.3 %, respectively (p = 0.5988). Multivariate analysis using age, sex, and comorbidities as covariates did not reveal any significant differences in survival (hazard ratio 0.966, p = 0.3353, Additional file 1: Table S1). For sensitivity analysis, the follow-up period was extended for five years; however, the median overall survival time was similar to the survival seen in the base analysis (data not shown).Fig. 2

Bottom Line: There was also no significant difference in the respective one-year survival rates (27.0 % vs. 27.3 %; p = 0.5988).Multivariate analysis using age, gender, and comorbidities as covariates did not reveal any significant differences in survival.Based on this relative effectiveness, the incremental cost per life year gained over GEM was estimated at USD 70,843.64 for GEM-E.

View Article: PubMed Central - PubMed

Affiliation: National Evidence-based healthcare Collaborating Agency, Seoul, Korea.

ABSTRACT

Background: A randomized clinical trial has found that the addition of erlotinib to gemcitabine (GEM-E) for pancreatic cancer led to a modest increase in survival. The aim of this national population-based retrospective study was to compare the effectiveness of GEM-E to GEM alone for pancreatic cancer patients in real clinical practice.

Methods: Patients with pancreatic cancer (ICD-10: C25) with prescription claims of gemcitabine or erlotinib between Jan 1, 2007 and Dec 31, 2012 were retrospectively identified from the Korean Health Insurance claims database. To be included in the study population, patients were required to have had a histological or cytological diagnosis within one year before chemotherapy. Patients treated with prior radiotherapy, surgery, or chemotherapy were excluded to reduce heterogeneity. Overall survival from the initiation of therapy and the medical costs of GEM-E and GEM were compared.

Results: A total of 4,267 patients were included in the analysis. Overall survival was not significantly longer in patients treated with GEM-E (median 6.77 months for GEM-E vs. 6.68 months for GEM, p = 0.0977). There was also no significant difference in the respective one-year survival rates (27.0 % vs. 27.3 %; p = 0.5988). Multivariate analysis using age, gender, and comorbidities as covariates did not reveal any significant differences in survival. Based on this relative effectiveness, the incremental cost per life year gained over GEM was estimated at USD 70,843.64 for GEM-E.

Conclusions: GEM-E for pancreatic cancer is not more effective than GEM in a real-world setting, and it does not provide reasonable cost-effectiveness over GEM.

No MeSH data available.


Related in: MedlinePlus