Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: a randomised trial
N = 161
- Population
- Patients aged 16 to 60 years with relapsed Hodgkin's disease; 161 randomised.
- Design
- Randomised trial: all patients received two cycles of Dexa-BEAM (dexamethasone, carmustine, etoposide, cytarabine, melphalan); only those with chemosensitive disease (complete or partial remission after two courses) proceeded to two further courses of Dexa-BEAM or to high-dose BEAM with transplantation of haemopoietic stem cells (BEAM-HSCT). Primary endpoint: freedom from treatment failure for patients with chemosensitive disease. Analysis was per protocol. 17 patients were excluded after randomisation (ten given Dexa-BEAM and seven given BEAM-HSCT). Recruited February 1993 to September 1997 from 56 institutions; the scientific committee stopped the study for low accrual after 117 chemosensitive patients (150 planned). Dexa-BEAM and BEAM-HSCT arm sizes are the chemosensitive patients (56 and 61).
- Primary endpoint
- FFTF
- Arms
- Dexa-BEAM (control, n = 56): Two further courses of Dexa-BEAM after two initial courses
- BEAM-HSCT (experimental, n = 61): High-dose BEAM with transplantation of haemopoietic stem cells after two initial courses of Dexa-BEAM
- People
- Schmitz N, German Hodgkin's Lymphoma Study Group; Lymphoma Working Party of the European Group for Blood and Marrow Transplantation
Δ 36-month FFTF+21 pointsΔ 36-month OS+6 points
Show the numbers
| Endpoint | Analysis | BEAM-HSCT | Dexa-BEAM | Effect |
|---|---|---|---|---|
| FFTFPatients with chemosensitive disease after two courses of Dexa-BEAM; per-protocol analysis | primarymedian follow-up 39 monthsSchmitz 2002 | 55% at 3 y | 34% at 3 y | P=0.019Difference (Dexa-BEAM minus BEAM-HSCT) -21% (95% CI -39.87 to -2.13); median follow-up 39 months (range 3-78 in the full text; the abstract labels it IQR). The paper states the 3-year FFTF figures were estimated from the curves, so exact numbers cannot be given. The analysis population was 117 chemosensitive patients (56 Dexa-BEAM, 61 BEAM-HSCT). |
| OSPatients with chemosensitive disease after two courses of Dexa-BEAM (117); per protocol | primarySchmitz 2002 | 71% at 3 y | 65% at 3 y | P=0.331Difference (Dexa-BEAM minus BEAM-HSCT) -6% (95% CI -23.88 to 11.88), not significant; the comparison stratified for type of relapse gave P=0.405. The paper states these 3-year figures were estimated from the curves. Overall survival was a secondary endpoint. |
| Endpoint | Analysis | BEAM-HSCT | Dexa-BEAM | Effect |
|---|---|---|---|---|
| FFTFPatients with chemosensitive disease after two courses of Dexa-BEAM; per-protocol analysis | primarymedian follow-up 39 monthsSchmitz 2002 | 55% at 3 y | 34% at 3 y | P=0.019Difference (Dexa-BEAM minus BEAM-HSCT) -21% (95% CI -39.87 to -2.13); median follow-up 39 months (range 3-78 in the full text; the abstract labels it IQR). The paper states the 3-year FFTF figures were estimated from the curves, so exact numbers cannot be given. The analysis population was 117 chemosensitive patients (56 Dexa-BEAM, 61 BEAM-HSCT). |
| OSPatients with chemosensitive disease after two courses of Dexa-BEAM (117); per protocol | primarySchmitz 2002 | 71% at 3 y | 65% at 3 y | P=0.331Difference (Dexa-BEAM minus BEAM-HSCT) -6% (95% CI -23.88 to 11.88), not significant; the comparison stratified for type of relapse gave P=0.405. The paper states these 3-year figures were estimated from the curves. Overall survival was a secondary endpoint. |
Appears in
Sources
Schmitz N, Pfistner B, Sextro M, Sieber M, Carella AM, Haenel M, et al. Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: a randomised trial. Lancet. 2002;359(9323):2065-71.