Trial reportCancer communications (London, England)2023
Positron emission tomography-adapted therapy in low-risk diffuse large B-cell lymphoma: results of a randomized, phase III, non-inferiority trial.
Trial report in Cancer communications (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed, 9 citations in OpenAlex.
- Response-guided first-line therapy and treatment of relapse in aggressive lymphoma: 10-year follow-up of the PETAL trial.Blood neoplasia · 2024Trial
- Positron emission tomography-adapted therapy in low-risk diffuse large B-cell lymphoma: results of a randomized, phase III, non-inferiority trial.Cancer communications (London, England) · 2023Trial
- Emerging treatment strategies for newly diagnosed diffuse large B-cell lymphoma.International journal of clinical oncology · 2026Review
- Association between metabolic syndrome components and the risk of malignant neoplasms of the brain: a nationwide cohort study.Frontiers in oncology · 2026Article
- ITK overexpression enhances T cell cytotoxicity against DLBCL through the TCR-CaScientific reports · 2025Article
- Different Role of PET-CT Evaluation in Newly Diagnosed Follicular Lymphoma Upon Rituximab-Based Chemotherapy and Chemo-Free Immunotherapy.Hematological oncology · 2025Article
- Unusual symptoms reveal a rare splenic lymphoma: a case report of PS-DLBCL with neck and shoulder pain as the initial presentation.Frontiers in oncology · 2025Article
- Comparison of Cox regression and generalized Cox regression models to machine learning in predicting survival of children with diffuse large B-cell lymphoma.Translational cancer research · 2024Article
- [Chinese expert consensus on the diagnosis and management of elderly patients with diffuse large B-cell lymphoma (2024)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2024Article
Corrections and comments
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Authors and funding
14 authors at 1 institution in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe current standard of care for non-bulky diffuse large B-cell lymphoma (DLBCL) patients with an International Prognostic Index (IPI) of 0 is four cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) but whether the same efficacy can be achieved with reduced chemotherapy regimen of four cycles for non-bulky DLBCL patients with an IPI of 1 remains unclear. This study compared four cycles versus six cycles of chemotherapy in non-bulky low-risk DLBCL patients with negative interim positron emission tomography with computed tomography (PET-CT, Deauville 1-3), irrespective of age and other IPI risk factors (IPI 0-1).
methodsThis was an open-label, randomized, phase III, non-inferiority trial. Patients aged 14-75 years with newly diagnosed low-risk DLBCL, according to IPI, achieving PET-CT confirmed complete response (CR) after four cycles of R-CHOP were randomized (1:1) between four cycles of rituximab (4R-CHOP+4R arm) or two cycles of R-CHOP plus two cycles of rituximab (6R-CHOP+2R arm). The primary endpoint was 2-year progression-free survival (PFS), conducted in the intention-to-treat population. Safety was assessed in patients with at least one cycle of assigned treatment. The non-inferiority margin was -8%.
resultsA total of 287 patients were included in the intention-to-treat analysis, the median follow-up was 47.3 months, and the 2-year PFS rate was 95% (95% confidence interval [CI], 92% to 99%) and 94% (95% CI, 91% to 98%) for the 4R-CHOP+4R and 6R-CHOP+2R arm. The absolute difference in 2-year PFS between the two arms was 1% (95% CI, -5% to 7%), supporting the non-inferiority of 4R-CHOP+4R. Grade 3-4 neutropenia was lower in the last four cycles of rituximab alone in the 4R-CHOP+4R arm (16.7% versus 76.9%), with decreased risk of febrile neutropenia (0.0% versus 8.4%) and infection (2.1% versus 14.0%).
conclusionsFor newly diagnosed low-risk DLBCL patients, interim PET-CT after four cycles of R-CHOP was effective in identifying patients with Deauville 1-3 who would have a good response and Deauville 4-5 patients who might have high-risk biological features or develop resistance. Reducing the standard six cycles to four cycles of chemotherapy had comparable clinical efficacy and fewer adverse events in low-risk, non-bulky DLBCL with interim PET-CT confirmed CR.
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