HD9
Standard and increased-dose BEACOPP chemotherapy compared with COPP-ABVD for advanced Hodgkin's disease
N = 1,201
- Population
- Newly diagnosed Hodgkin's disease in unfavorable stage IIB or IIIA, or stage IIIB or IV, aged 15 to 65 years; 1201 eligible patients randomised, 1195 evaluable.
- Design
- Multicentre randomised trial of the German Hodgkin's Lymphoma Study Group, 1993 to 1998: eight cycles of COPP-ABVD, BEACOPP (baseline dose) or increased-dose BEACOPP, each followed by local radiotherapy when indicated. Enrolment in the COPP-ABVD group was stopped in 1996 owing to inferior results (authors' report). The trial acronym HD9 comes from the title of the 10-year follow-up report.
- Arms
- COPP-ABVD (control, n = 260): Eight cycles of COPP (cyclophosphamide, vincristine, procarbazine, prednisone) alternating with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
- BEACOPP (baseline dose) (experimental, n = 469): Eight cycles of BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone)
- Increased-dose BEACOPP (experimental, n = 466): Eight cycles of increased-dose (escalated) BEACOPP
- People
- Diehl V, German Hodgkin's Lymphoma Study Group
Δ 60-month FFTF+7 pointsΔ 60-month OS+5 pointsΔ 120-month FFTF+6 pointsΔ 120-month OS+5 points
Show the numbers
| Endpoint | Analysis | BEACOPP (baseline dose) / Increased-dose BEACOPP | COPP-ABVD | Effect |
|---|---|---|---|---|
| FFTFEvaluable patients (1195 of 1201 randomised) | primaryDiehl 2003 | 76% at 5 y | 69% at 5 y | P=0.04 (COPP-ABVD vs BEACOPP); <0.001 (increased-dose BEACOPP vs COPP-ABVD and vs BEACOPP)Five-year rates. Median follow-up was 72, 54 and 51 months in the COPP-ABVD, BEACOPP and increased-dose BEACOPP groups, respectively. Early progression was significantly less frequent with increased-dose BEACOPP than with COPP-ABVD or standard BEACOPP (authors' report). |
| OSEvaluable patients (1195 of 1201 randomised) | primaryDiehl 2003 | 88% at 5 y | 83% at 5 y | P=0.16 (COPP-ABVD vs BEACOPP); 0.06 (BEACOPP vs increased-dose BEACOPP); 0.002 (COPP-ABVD vs increased-dose BEACOPP)Five-year rates, same follow-up as the freedom-from-treatment-failure result. |
| FFTFPatients of the HD9 trial at 10-year follow-up (arms A, B, C: COPP/ABVD, BEACOPP baseline, BEACOPP escalated); the analysis population is not labelled in the abstract | long term-updatemedian follow-up 111 monthsEngert 2009 | 70% at 10 y | 64% at 10 y | P<.001Ten-year rates; P is as given for the three-group comparison. Escalated BEACOPP was significantly better than baseline BEACOPP for FFTF (P < .0001). |
| OSPatients of the HD9 trial at 10-year follow-up (arms A, B, C: COPP/ABVD, BEACOPP baseline, BEACOPP escalated); the analysis population is not labelled in the abstract | long term-updatemedian follow-up 111 monthsEngert 2009 | 80% at 10 y | 75% at 10 y | P<.001Ten-year rates. Escalated BEACOPP was significantly better than baseline BEACOPP for overall survival (P = .0053). A total of 74 second malignancies (6.2%) were documented; acute myeloid leukemia occurred in 0.4%, 1.5% and 3.0% of the COPP/ABVD, baseline BEACOPP and escalated BEACOPP groups, non-Hodgkin lymphoma in 2.7%, 1.7% and 1.0%, and solid tumors in 2.7%, 3.4% and 1.9%; overall second-malignancy rates were 5.7%, 6.6% and 6.0%. The 2009 abstract describes 1,196 patients in the trial, one more than the 1,195 evaluable in the 2003 analysis. |
| Endpoint | Analysis | BEACOPP (baseline dose) / Increased-dose BEACOPP | COPP-ABVD | Effect |
|---|---|---|---|---|
| FFTFEvaluable patients (1195 of 1201 randomised) | primaryDiehl 2003 | 76% at 5 y | 69% at 5 y | P=0.04 (COPP-ABVD vs BEACOPP); <0.001 (increased-dose BEACOPP vs COPP-ABVD and vs BEACOPP)Five-year rates. Median follow-up was 72, 54 and 51 months in the COPP-ABVD, BEACOPP and increased-dose BEACOPP groups, respectively. Early progression was significantly less frequent with increased-dose BEACOPP than with COPP-ABVD or standard BEACOPP (authors' report). |
| OSEvaluable patients (1195 of 1201 randomised) | primaryDiehl 2003 | 88% at 5 y | 83% at 5 y | P=0.16 (COPP-ABVD vs BEACOPP); 0.06 (BEACOPP vs increased-dose BEACOPP); 0.002 (COPP-ABVD vs increased-dose BEACOPP)Five-year rates, same follow-up as the freedom-from-treatment-failure result. |
| FFTFPatients of the HD9 trial at 10-year follow-up (arms A, B, C: COPP/ABVD, BEACOPP baseline, BEACOPP escalated); the analysis population is not labelled in the abstract | long term-updatemedian follow-up 111 monthsEngert 2009 | 70% at 10 y | 64% at 10 y | P<.001Ten-year rates; P is as given for the three-group comparison. Escalated BEACOPP was significantly better than baseline BEACOPP for FFTF (P < .0001). |
| OSPatients of the HD9 trial at 10-year follow-up (arms A, B, C: COPP/ABVD, BEACOPP baseline, BEACOPP escalated); the analysis population is not labelled in the abstract | long term-updatemedian follow-up 111 monthsEngert 2009 | 80% at 10 y | 75% at 10 y | P<.001Ten-year rates. Escalated BEACOPP was significantly better than baseline BEACOPP for overall survival (P = .0053). A total of 74 second malignancies (6.2%) were documented; acute myeloid leukemia occurred in 0.4%, 1.5% and 3.0% of the COPP/ABVD, baseline BEACOPP and escalated BEACOPP groups, non-Hodgkin lymphoma in 2.7%, 1.7% and 1.0%, and solid tumors in 2.7%, 3.4% and 1.9%; overall second-malignancy rates were 5.7%, 6.6% and 6.0%. The 2009 abstract describes 1,196 patients in the trial, one more than the 1,195 evaluable in the 2003 analysis. |
Appears in
Sources
Diehl V, Franklin J, Pfreundschuh M, Lathan B, Paulus U, Hasenclever D, et al. Standard and increased-dose BEACOPP chemotherapy compared with COPP-ABVD for advanced Hodgkin's disease. N Engl J Med. 2003;348(24):2386-95.
Engert A, Diehl V, Franklin J, Lohri A, Dörken B, Ludwig WD, et al. Escalated-dose BEACOPP in the treatment of patients with advanced-stage Hodgkin's lymphoma: 10 years of follow-up of the GHSG HD9 study. J Clin Oncol. 2009;27(27):4548-54.