When an aggressive lymphoma (such as large B-cell lymphoma) comes back or does not respond to the first treatment, another chemotherapy is usually given to shrink the disease, followed by a transplant of the patient's own stem cells. This study compared two regimens: GDP (based on gemcitabine) and DHAP (an older regimen based on cytarabine). Both regimens worked equally well, a similar number of patients went on to transplant and survival was also similar, but GDP had fewer side effects, patients needed hospital admission less often and they had a better quality of life.
Relapsed or refractory DLBCL in transplant-eligible patients; a less toxic alternative to R-DHAP before autologous transplantation
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Rituximab | 375 mg/m² | IV | Day 1 |
| Cisplatin | 75 mg/m² | IV | Day 1 |
| Gemcitabine | 1000 mg/m² | IV | Days 1 and 8 |
| Dexamethasone | 40 mg daily | Oral or IV | Days 1–4 |
R-GDP doses from the published protocol of the LYSA group; results and design from LY.12.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Cisplatin IV over 60 minutes on day 1, dexamethasone on days 1 to 4 (oral according to the LY.12 secondary analysis table; "IV or oral" according to ClinicalTrials.gov) and gemcitabine IV over 30 minutes on days 1 and 8; from the 2005 amendment, in B-cell malignancies rituximab IV over 3 to 6 hours on day 1; 21-day cycles, given as an outpatient. 2 cycles and a third cycle if the response was insufficient; response was assessed after cycle 2 and responding patients were referred for stem-cell collection and autologous transplantation. Treatment delays, dose modifications and the addition of G-CSF were allowed. Drug doses (mg) are not stated in these sources and the full text of the paper was not openly available to us.
Cisplatin as a 24-hour IV infusion on day 1, dexamethasone as in the GDP group and cytarabine IV over 3 hours every 12 hours for 2 doses on day 2; in B-cell malignancies rituximab IV on day 1; 21-day cycles, usually with a 3-day (2-night) hospital stay. Number of cycles and referral for transplantation as in the GDP group. Drug doses (mg) are not stated in these sources.
Source of the regimen details: ClinicalTrials.gov NCT00078949 and Table 1 of the LY.12 secondary analysis (Oncologist 2023; PMC10485297): drugs, route, days and infusion duration; drug doses are not stated in these sources and the full text of the JCO paper was not openly available to us
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Adults with relapsed or refractory aggressive non-Hodgkin lymphoma after one anthracycline-containing regimen who were candidates for autologous stem-cell transplantation (ASCT): diffuse large B-cell lymphoma (including primary mediastinal B-cell lymphoma and T-cell-rich B-cell lymphoma), indolent lymphoma transformed to DLBCL at relapse, peripheral T-cell lymphoma, anaplastic large-cell lymphoma and Burkitt-like lymphoma; no CNS involvement at relapse. Enrolment from 2003 to 2011 in Canada, Italy, the USA and Australia; median age 55 years, 61% male and 86% ECOG 0 or 1. Patients with B-cell lymphoma also received rituximab.
Co-primary endpoints: response rate after two cycles of treatment and transplantation rate.
Secondary endpoints: event-free survival, overall survival, treatment toxicity and quality of life.
GDP was associated with less toxicity (P < 0.001) and less need for hospital admission (P < 0.001) and better preserved quality of life (P = 0.04). The abstract does not report detailed adverse event figures. In a secondary analysis, the median number of days in hospital during salvage therapy was zero days with GDP versus 11 days with DHAP.
LY.12 showed that GDP (with rituximab in B-cell lymphoma) is non-inferior to DHAP for response, with similar transplantation rates and survival, but with less toxicity and hospitalisation and better quality of life. These results support GDP as a less toxic option for chemotherapy before autologous transplantation in relapsed or refractory aggressive lymphomas.
The study was designed for non-inferiority, not superiority, so GDP has not been shown to be more effective. Different types of aggressive lymphoma were studied together. The abstract does not report doses or toxicity details. The study was conducted before newer second-line treatments (such as CAR-T cell therapy) became widespread.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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