Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program
N = 166
- Population
- Relapsed low-grade or follicular lymphoma; 166 patients entered (the abstract's intent-to-treat group).
- Design
- Multi-institutional trial of the chimeric anti-CD20 antibody IDEC-C2B8 (rituximab) in 31 centres; one treatment group, with no comparison arm described in the abstract. Patients received an outpatient course of 375 mg/m2 intravenously weekly for four doses.
- Arms
- IDEC-C2B8 (rituximab) (experimental, n = 166): Rituximab 375 mg/m2 intravenously weekly for four doses
- People
- McLaughlin P
Show the numbers
| Endpoint | Analysis | IDEC-C2B8 (rituximab) | Control | Effect |
|---|---|---|---|---|
| ORRIntent-to-treat group (166 entered) | primaryMcLaughlin 1998 | 48% | — | The abstract gives the response rate as 48% of the intent-to-treat group, without a confidence interval or a split into complete and partial responses. |
| TTPResponders | primarymedian follow-up 11.8 monthsMcLaughlin 1998 | median 13 months | — | Projected median time to progression among responders, at a median follow-up of 11.8 months. |
| Endpoint | Analysis | IDEC-C2B8 (rituximab) | Control | Effect |
|---|---|---|---|---|
| ORRIntent-to-treat group (166 entered) | primaryMcLaughlin 1998 | 48% | — | The abstract gives the response rate as 48% of the intent-to-treat group, without a confidence interval or a split into complete and partial responses. |
| TTPResponders | primarymedian follow-up 11.8 monthsMcLaughlin 1998 | median 13 months | — | Projected median time to progression among responders, at a median follow-up of 11.8 months. |
- IDEC-C2B8 (rituximab) (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | IDEC-C2B8 (rituximab) |
|---|---|
| 0 | 100.0% |
| 8 | 65.3% |
| 16 | 42.6% |
| 24 | 27.8% |
| 33 | 17.2% |