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Patterns of mortality after prolonged follow-up of a randomised controlled trial using granulocyte colony-stimulating factor to maintain chemotherapy dose intensity in non-Hodgkin's lymphoma.

Clamp AR, Ryder WD, Bhattacharya S, Pettengell R, Radford JA - Br. J. Cancer (2008)

Bottom Line: No significant differences were found in PFS or OS.However, 10-year FFP was better in the G-CSF arm (68 vs 47%, P=0.037).Eleven deaths from causes unrelated to NHL or its treatment occurred in the G-CSF arm compared to five in controls.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Oncology, Cancer Research UK, University of Manchester, Christie Hospital, Wilmslow Rd., Manchester M20 4BX, UK. Andrew.clamp@christie.nhs.uk

ABSTRACT
The effect of utilising granulocyte colony-stimulating factor (G-CSF) to maintain chemotherapy dose intensity in non-Hodgkin's lymphoma (NHL) on long-term mortality patterns has not been formally evaluated. We analysed prolonged follow-up data from the first randomised controlled trial investigating this approach. Data on 10-year overall survival (OS), progression-free survival (PFS), freedom from progression (FFP) and incidence of second malignancies were collected for 80 patients with aggressive subtypes of NHL, who had been randomised to receive either VAPEC-B chemotherapy or VAPEC-B+G-CSF. Median follow-up was 15.7 years for surviving patients. No significant differences were found in PFS or OS. However, 10-year FFP was better in the G-CSF arm (68 vs 47%, P=0.037). Eleven deaths from causes unrelated to NHL or its treatment occurred in the G-CSF arm compared to five in controls. More deaths occurred from second malignancies (4 vs 2) and cardiovascular causes (5 vs 0) in the G-CSF arm. Although this pharmacovigilance study has insufficient statistical power to draw conclusions and is limited by the lack of data on smoking history and other cardiovascular risk factors, these unique long-term outcome data generate hypotheses that warrant further investigation.

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Survival end points. Survival curves comparing chemotherapy-alone arm (solid line) and chemotherapy+G-CSF arm (dashed line). Kaplan–Meier plots for (A) overall survival (B) freedom from progression. Cumulative incidence curves for (C) NHL-specific death (D) non-NHL deaths (E) death from causes other than progressive NHL and acute treatment-related infections (F) Deaths from second malignancy.
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fig1: Survival end points. Survival curves comparing chemotherapy-alone arm (solid line) and chemotherapy+G-CSF arm (dashed line). Kaplan–Meier plots for (A) overall survival (B) freedom from progression. Cumulative incidence curves for (C) NHL-specific death (D) non-NHL deaths (E) death from causes other than progressive NHL and acute treatment-related infections (F) Deaths from second malignancy.

Mentions: The Kaplan–Meier survival curves for OS and FFP are illustrated in Figure 1A and 1B respectively. Although OS and PFS (data not shown) were virtually identical in both arms, FFP was significantly higher in the interventional arm receiving G-CSF and consequently 12% higher dose intensity of chemotherapy (10-year FFP 68 and 47% for G-CSF and control arms respectively) suggesting an imbalance in the causes of death between the two arms. It was therefore decided to examine this in more detail and these results are summarised in Table 2.


Patterns of mortality after prolonged follow-up of a randomised controlled trial using granulocyte colony-stimulating factor to maintain chemotherapy dose intensity in non-Hodgkin's lymphoma.

Clamp AR, Ryder WD, Bhattacharya S, Pettengell R, Radford JA - Br. J. Cancer (2008)

Survival end points. Survival curves comparing chemotherapy-alone arm (solid line) and chemotherapy+G-CSF arm (dashed line). Kaplan–Meier plots for (A) overall survival (B) freedom from progression. Cumulative incidence curves for (C) NHL-specific death (D) non-NHL deaths (E) death from causes other than progressive NHL and acute treatment-related infections (F) Deaths from second malignancy.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2480980&req=5

fig1: Survival end points. Survival curves comparing chemotherapy-alone arm (solid line) and chemotherapy+G-CSF arm (dashed line). Kaplan–Meier plots for (A) overall survival (B) freedom from progression. Cumulative incidence curves for (C) NHL-specific death (D) non-NHL deaths (E) death from causes other than progressive NHL and acute treatment-related infections (F) Deaths from second malignancy.
Mentions: The Kaplan–Meier survival curves for OS and FFP are illustrated in Figure 1A and 1B respectively. Although OS and PFS (data not shown) were virtually identical in both arms, FFP was significantly higher in the interventional arm receiving G-CSF and consequently 12% higher dose intensity of chemotherapy (10-year FFP 68 and 47% for G-CSF and control arms respectively) suggesting an imbalance in the causes of death between the two arms. It was therefore decided to examine this in more detail and these results are summarised in Table 2.

Bottom Line: No significant differences were found in PFS or OS.However, 10-year FFP was better in the G-CSF arm (68 vs 47%, P=0.037).Eleven deaths from causes unrelated to NHL or its treatment occurred in the G-CSF arm compared to five in controls.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Oncology, Cancer Research UK, University of Manchester, Christie Hospital, Wilmslow Rd., Manchester M20 4BX, UK. Andrew.clamp@christie.nhs.uk

ABSTRACT
The effect of utilising granulocyte colony-stimulating factor (G-CSF) to maintain chemotherapy dose intensity in non-Hodgkin's lymphoma (NHL) on long-term mortality patterns has not been formally evaluated. We analysed prolonged follow-up data from the first randomised controlled trial investigating this approach. Data on 10-year overall survival (OS), progression-free survival (PFS), freedom from progression (FFP) and incidence of second malignancies were collected for 80 patients with aggressive subtypes of NHL, who had been randomised to receive either VAPEC-B chemotherapy or VAPEC-B+G-CSF. Median follow-up was 15.7 years for surviving patients. No significant differences were found in PFS or OS. However, 10-year FFP was better in the G-CSF arm (68 vs 47%, P=0.037). Eleven deaths from causes unrelated to NHL or its treatment occurred in the G-CSF arm compared to five in controls. More deaths occurred from second malignancies (4 vs 2) and cardiovascular causes (5 vs 0) in the G-CSF arm. Although this pharmacovigilance study has insufficient statistical power to draw conclusions and is limited by the lack of data on smoking history and other cardiovascular risk factors, these unique long-term outcome data generate hypotheses that warrant further investigation.

Show MeSH
Related in: MedlinePlus