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Second-line treatment of stage III/IV non-small-cell lung cancer (NSCLC) with pemetrexed in routine clinical practice: evaluation of performance status and health-related quality of life.

Schuette W, Tesch H, Büttner H, Krause T, Soldatenkova V, Stoffregen C - BMC Cancer (2012)

Bottom Line: Factors potentially associated with KI benefit response were evaluated using logistic regression models.Patients with baseline KI ≥ 80%, no Grade 3/4 toxicities during the first 2 cycles, or combination regimen as prior first-line therapy were more likely to achieve a KI benefit response.EQ-5D scores improved over time.

View Article: PubMed Central - HTML - PubMed

Affiliation: Hospital Martha-Maria, Halle-Doelau, Department of Internal Medicine II, Halle, Germany.

ABSTRACT

Background: Second-line treatment of advanced non-small-cell lung cancer (NSCLC) improves overall survival. There is a lack of data regarding the impact on patients' overall health condition. This prospective, non-interventional study evaluated performance status (PS) and health-related quality of life (HR-QoL) during second-line pemetrexed treatment in routine clinical practice.

Methods: Stage III/IV NSCLC patients who initiated second-line pemetrexed (standard vitamin and dexamethasone supplementation) were observed for a maximum of 9 treatment cycles. The primary objective was to evaluate the proportion of patients achieving improvement of Karnofsky Index (KI) of ≥ 10% (absolute) or maintaining KI ≥ 80% after the second treatment cycle ("KI benefit response"). HR-QoL was self-rated using the EuroQoL-5D questionnaire (EQ-5D). Factors potentially associated with KI benefit response were evaluated using logistic regression models.

Results: Of 521 eligible patients (73.5% Stage IV, median age 66.3 yrs, 36.1% ≥ 70 yrs, 62.0% with KI ≥ 80%), 471 (90.4%) completed at least 2 treatment cycles. 58.0% (95%CI 53.6%;62.2%) achieved KI benefit response after the second cycle. Patients with baseline KI ≥ 80%, no Grade 3/4 toxicities during the first 2 cycles, or combination regimen as prior first-line therapy were more likely to achieve a KI benefit response. EQ-5D scores improved over time. Grade 3/4 toxicities were reported in 23.8% of patients (mainly fatigue/asthenia 15.9%, neutropenia 8.7%).

Conclusions: In this large prospective, non-interventional study of second-line pemetrexed treatment in patients with advanced NSCLC, including 36% elderly patients ( ≥ 70 years), physician-rated PS and self-rated HR-QoL were maintained or improved in the majority of patients.

Trial registration: Registered on ClinicalTrials.gov (NCT00540241) on October 4, 2007.

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EQ-5D health status profiles: mean ratings for each of the 5 dimensions of the EQ- 5D questionnaire over time. On the EQ-5D questionnaire, the patient rates each of the 5 dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) as associated with "some problems" (= 1), moderate problems (= 2), extreme problems (= 3). EQ- 5D = European Quality Of Life Five Dimensions questionnaire, QoL = Quality Of Life, n = number of patients
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Figure 3: EQ-5D health status profiles: mean ratings for each of the 5 dimensions of the EQ- 5D questionnaire over time. On the EQ-5D questionnaire, the patient rates each of the 5 dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) as associated with "some problems" (= 1), moderate problems (= 2), extreme problems (= 3). EQ- 5D = European Quality Of Life Five Dimensions questionnaire, QoL = Quality Of Life, n = number of patients

Mentions: Approximately half of the patients returned completed EQ-5D questionnaires and therefore were evaluable for HR-QoL. Patients' mean EQ-5D index at baseline was 0.66 (standard deviation [SD] 0.256; N = 231 patients with data available). A small, statistically significant improvement of this score was noted after the second treatment cycle, that is after approximately 6 weeks of treatment (mean increase 0.02, SD 0.214; N = 190 patients; p = 0.003). For those patients remaining on study, the EQ-5D index continued to improve up to treatment cycle 6 (mean increase 0.11, SD 0.228; N = 61 patients; p < 0.001). Figure 3 presents patients' mean EQ-5D ratings for the 5 individual EQ-5D domains at baseline and after the second, fourth and sixth treatment cycle. For the pain/discomfort and anxiety/depression dimensions, improvements had started after the second treatment cycle. Improvements in mobility and usual activities became visible after the fourth cycle only. Patient self-care worsened initially after the second cycle, but then improved up to treatment cycle 6.


Second-line treatment of stage III/IV non-small-cell lung cancer (NSCLC) with pemetrexed in routine clinical practice: evaluation of performance status and health-related quality of life.

Schuette W, Tesch H, Büttner H, Krause T, Soldatenkova V, Stoffregen C - BMC Cancer (2012)

EQ-5D health status profiles: mean ratings for each of the 5 dimensions of the EQ- 5D questionnaire over time. On the EQ-5D questionnaire, the patient rates each of the 5 dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) as associated with "some problems" (= 1), moderate problems (= 2), extreme problems (= 3). EQ- 5D = European Quality Of Life Five Dimensions questionnaire, QoL = Quality Of Life, n = number of patients
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3293714&req=5

Figure 3: EQ-5D health status profiles: mean ratings for each of the 5 dimensions of the EQ- 5D questionnaire over time. On the EQ-5D questionnaire, the patient rates each of the 5 dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) as associated with "some problems" (= 1), moderate problems (= 2), extreme problems (= 3). EQ- 5D = European Quality Of Life Five Dimensions questionnaire, QoL = Quality Of Life, n = number of patients
Mentions: Approximately half of the patients returned completed EQ-5D questionnaires and therefore were evaluable for HR-QoL. Patients' mean EQ-5D index at baseline was 0.66 (standard deviation [SD] 0.256; N = 231 patients with data available). A small, statistically significant improvement of this score was noted after the second treatment cycle, that is after approximately 6 weeks of treatment (mean increase 0.02, SD 0.214; N = 190 patients; p = 0.003). For those patients remaining on study, the EQ-5D index continued to improve up to treatment cycle 6 (mean increase 0.11, SD 0.228; N = 61 patients; p < 0.001). Figure 3 presents patients' mean EQ-5D ratings for the 5 individual EQ-5D domains at baseline and after the second, fourth and sixth treatment cycle. For the pain/discomfort and anxiety/depression dimensions, improvements had started after the second treatment cycle. Improvements in mobility and usual activities became visible after the fourth cycle only. Patient self-care worsened initially after the second cycle, but then improved up to treatment cycle 6.

Bottom Line: Factors potentially associated with KI benefit response were evaluated using logistic regression models.Patients with baseline KI ≥ 80%, no Grade 3/4 toxicities during the first 2 cycles, or combination regimen as prior first-line therapy were more likely to achieve a KI benefit response.EQ-5D scores improved over time.

View Article: PubMed Central - HTML - PubMed

Affiliation: Hospital Martha-Maria, Halle-Doelau, Department of Internal Medicine II, Halle, Germany.

ABSTRACT

Background: Second-line treatment of advanced non-small-cell lung cancer (NSCLC) improves overall survival. There is a lack of data regarding the impact on patients' overall health condition. This prospective, non-interventional study evaluated performance status (PS) and health-related quality of life (HR-QoL) during second-line pemetrexed treatment in routine clinical practice.

Methods: Stage III/IV NSCLC patients who initiated second-line pemetrexed (standard vitamin and dexamethasone supplementation) were observed for a maximum of 9 treatment cycles. The primary objective was to evaluate the proportion of patients achieving improvement of Karnofsky Index (KI) of ≥ 10% (absolute) or maintaining KI ≥ 80% after the second treatment cycle ("KI benefit response"). HR-QoL was self-rated using the EuroQoL-5D questionnaire (EQ-5D). Factors potentially associated with KI benefit response were evaluated using logistic regression models.

Results: Of 521 eligible patients (73.5% Stage IV, median age 66.3 yrs, 36.1% ≥ 70 yrs, 62.0% with KI ≥ 80%), 471 (90.4%) completed at least 2 treatment cycles. 58.0% (95%CI 53.6%;62.2%) achieved KI benefit response after the second cycle. Patients with baseline KI ≥ 80%, no Grade 3/4 toxicities during the first 2 cycles, or combination regimen as prior first-line therapy were more likely to achieve a KI benefit response. EQ-5D scores improved over time. Grade 3/4 toxicities were reported in 23.8% of patients (mainly fatigue/asthenia 15.9%, neutropenia 8.7%).

Conclusions: In this large prospective, non-interventional study of second-line pemetrexed treatment in patients with advanced NSCLC, including 36% elderly patients ( ≥ 70 years), physician-rated PS and self-rated HR-QoL were maintained or improved in the majority of patients.

Trial registration: Registered on ClinicalTrials.gov (NCT00540241) on October 4, 2007.

Show MeSH
Related in: MedlinePlus