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The Clinical Trials of HDC/ABMT in Women with Breast Cancer

The Clinical Trials of HDC/ABMT in Women with Breast Cancer. Prof Cindy Farquhar MD MPH University of Auckland, NZ. History. The first RCTs commenced at the end of 1990 Progress was slow Two US trials took years to randomize 969 women 1990-1998 ASCO 1999: reports 4/5 RCTs no benefit.

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The Clinical Trials of HDC/ABMT in Women with Breast Cancer

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  1. The Clinical Trials of HDC/ABMT in Women with Breast Cancer Prof Cindy Farquhar MD MPH University of Auckland, NZ

  2. History • The first RCTs commenced at the end of 1990 • Progress was slow • Two US trials took years to randomize 969 women 1990-1998 • ASCO 1999: reports 4/5 RCTs no benefit

  3. The first published RCT • Bezwoda 1995 - South African trial • 3 year survivalwas 18% vs 4 % in control group • Small study (n=90) • Event rate in the HDC/ABMT group similar to US conventional treatment

  4. American Society of Clinical Oncologists 1999 Results of 5 RCTs presented Overall summary: • 4/5 concluded “that treatment with HDC/ABMTis no better than conventional chemotherapy” • Jan 2000 - the only trial (South African) to show a benefit was declared fraudulent by the US auditors (Bezwoda 1999)

  5. Systematic review of HDC/ABMT in women with breast cancer • Aim: To determine the effectiveness and safety of HDC/ABMT in women with metastatic and high risk breast cancer • 2 reviews : • women with metastatic breast cancer • women with high risk breast cancer • Methodology: systematic review

  6. Systematic review • All trials meet the inclusion criteria • Assess the quality of the trials • Trial results extracted for overall survival, event free survival and treatment related mortality • Data was pooled using metanalysis

  7. Excluded studies • Bezwoda 1995, 1999 – declared fraudulent in 2000 • Bergh 2000 – overall dose in conventional group higher than HDC/ABMT group • Peters 1996 - – control group crossed over to HDC/ABMT • Madan 2000 – control group crossed over to HDC/ABMT

  8. Metastatic Breast Cancer: included studies

  9. HDC/ABMT in women with metastatic BC: treatment related mortality Increased by standard chemotherapy Increased by HDC/ABMT

  10. HDC in women with metastatic BC: event free survival 1 year follow up 3 year follow up 5 year follow up Increased by standard chemotherapy Increased by HDC/ABMT

  11. HDC in women with metastatic BC: overall survival 3 year follow up 5 year follow up Increased by standard chemotherapy Increased by HDC/ABMT

  12. High Risk Breast Cancer: included studies

  13. HDC in women with high risk BC: treatment related mortality Increased by standard chemotherapy Increased by HDC/ABMT

  14. HDC in women with high risk BC: event free survival 3 year follow up 5 year follow up Increased by standard chemotherapy Increased by HDC/ABMT

  15. HDC in women with high risk BC: overall survival 3 year follow up 5 year follow up Increased by standard chemotherapy Increased by HDC/ABMT Overall 67% of women survived in HDC group and 71% in the control group

  16. Quality of Life Measures • ACCOG : 84 women on HDC/ABMT and 82 standard dose. no difference b/w groups at 6 or 12 months • CALBG: 106 HDC/ABMT and 104 standard dose. HDC worse at 3 months, but no difference at 12 months • Dutch IG trial: HDC/ABMT lower scores at 3 months but no difference at 6 months. • Also looked at cognitive functioning in Dutch IG: significantly impaired in HDC/ABMT

  17. Conclusions: women with metastatic breast cancer • Treatment related mortality was significantly increased • At one year of follow up there is a increase in event free survival in women with HCD/ABMT • At three and five years of follow up there is no impact on either event free survival or overall survival

  18. Conclusions: women with high risk breast cancer • Treatment related mortality was significantly increased • At three years of follow up there is a reduction in event free survival but no impact on overall survival • At five years of follow up there is no impact seen on either event free survival or overall survival

  19. Acknowledgements • The Commonwealth Fund of New York • Robert Wood Johnson Foundation • RAND • University of Auckland, NZ • The Cochrane Breast Cancer Group

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