PARMA
Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma
N = 109
- Population
- Patients with relapsed, chemotherapy-sensitive intermediate- or high-grade non-Hodgkin lymphoma who responded to two courses of salvage chemotherapy.
- Design
- Prospective randomised study. 215 patients with relapsed non-Hodgkin lymphoma were treated between July 1987 and June 1994 and all received two courses of conventional chemotherapy; the 109 who responded were randomly assigned to four further courses of chemotherapy plus radiotherapy (54 patients) or radiotherapy plus intensive chemotherapy and autologous bone marrow transplantation (55 patients). A later report of the same trial (Blay 1998) names the regimens as DHAP for the conventional arm and BEAC followed by autologous bone marrow transplantation, and describes the 215 patients as having intermediate- or high-grade non-Hodgkin lymphoma. Median follow-up 63 months.
- Arms
- Chemotherapy without transplantation (control, n = 54): Four further courses of chemotherapy (DHAP per Blay 1998) plus radiotherapy
- Autologous bone marrow transplantation (experimental, n = 55): Radiotherapy plus intensive chemotherapy (BEAC per Blay 1998) and autologous bone marrow transplantation
- People
- Philip T, senior author Harousseau JL, Parma Group
Δ 60-month EFS+34 pointsΔ 60-month OS+21 pointsΔ Response rate+40 points
Show the numbers
| Endpoint | Analysis | Autologous bone marrow transplantation | Chemotherapy without transplantation | Effect |
|---|---|---|---|---|
| EFSRandomised patients with chemotherapy-sensitive relapse (109); the abstract does not state the analysis population | primarymedian follow-up 63 monthsPhilip 1995 | 46% at 5 y | 12% at 5 y | P=0.001Five-year event-free survival rates. There were three deaths from toxic effects in the transplantation group and none in the chemotherapy group. |
| OSRandomised patients with chemotherapy-sensitive relapse (109); the abstract does not state the analysis population | primarymedian follow-up 63 monthsPhilip 1995 | 53% at 5 y | 32% at 5 y | P=0.038 |
| Response rateRandomised patients (109)Response rate after the randomised treatment, as reported; the abstract gives no further definition. | primaryPhilip 1995 | 84% | 44% | — |
| Endpoint | Analysis | Autologous bone marrow transplantation | Chemotherapy without transplantation | Effect |
|---|---|---|---|---|
| EFSRandomised patients with chemotherapy-sensitive relapse (109); the abstract does not state the analysis population | primarymedian follow-up 63 monthsPhilip 1995 | 46% at 5 y | 12% at 5 y | P=0.001Five-year event-free survival rates. There were three deaths from toxic effects in the transplantation group and none in the chemotherapy group. |
| OSRandomised patients with chemotherapy-sensitive relapse (109); the abstract does not state the analysis population | primarymedian follow-up 63 monthsPhilip 1995 | 53% at 5 y | 32% at 5 y | P=0.038 |
| Response rateRandomised patients (109)Response rate after the randomised treatment, as reported; the abstract gives no further definition. | primaryPhilip 1995 | 84% | 44% | — |