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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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Related in: MedlinePlus

Relative mortality models. Relative mortality functions were estimated for each trial arm separately. While relative mortality rates in the chemotherapy alone arm return close to the underlying population with continued follow-up (slope gradient close to 1), rates appear to remain somewhat higher in the G-CSF treated arm.
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fig2: Relative mortality models. Relative mortality functions were estimated for each trial arm separately. While relative mortality rates in the chemotherapy alone arm return close to the underlying population with continued follow-up (slope gradient close to 1), rates appear to remain somewhat higher in the G-CSF treated arm.

Mentions: One possible explanation for these findings is that because patients who were exposed to G-CSF appeared less likely to experience progression of lymphoma, they were exposed to other competing causes of death for longer than patients who did not receive G-CSF but with the proportional rate of non-lymphoma-related mortality being the same in both groups. To assess this possibility, we constructed relative mortality models for each trial arm separately using England and Wales death rates broken down by sex, age (integer years) and period (annually up until 2005, 2005 figures used for follow-up in 2006) obtained from the Human Mortality Database (Figure 2). This analysis tentatively indicates that after the period of early excess relative mortality associated primarily with lymphoma-related events, the relative mortality rate in the surviving subjects appears somewhat higher in the G-CSF treated subjects than in those who received chemotherapy alone.


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)

Relative mortality models. Relative mortality functions were estimated for each trial arm separately. While relative mortality rates in the chemotherapy alone arm return close to the underlying population with continued follow-up (slope gradient close to 1), rates appear to remain somewhat higher in the G-CSF treated arm.
© Copyright Policy
Related In: Results  -  Collection

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

fig2: Relative mortality models. Relative mortality functions were estimated for each trial arm separately. While relative mortality rates in the chemotherapy alone arm return close to the underlying population with continued follow-up (slope gradient close to 1), rates appear to remain somewhat higher in the G-CSF treated arm.
Mentions: One possible explanation for these findings is that because patients who were exposed to G-CSF appeared less likely to experience progression of lymphoma, they were exposed to other competing causes of death for longer than patients who did not receive G-CSF but with the proportional rate of non-lymphoma-related mortality being the same in both groups. To assess this possibility, we constructed relative mortality models for each trial arm separately using England and Wales death rates broken down by sex, age (integer years) and period (annually up until 2005, 2005 figures used for follow-up in 2006) obtained from the Human Mortality Database (Figure 2). This analysis tentatively indicates that after the period of early excess relative mortality associated primarily with lymphoma-related events, the relative mortality rate in the surviving subjects appears somewhat higher in the G-CSF treated subjects than in those who received chemotherapy alone.

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