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In advanced NK/T-cell lymphoma, a gentler regimen built on pegylated asparaginase kept the disease controlled for longer than SMILE, the regimen it was compared with, and caused fewer dangerously low white cell counts.
SMILE showed that an asparaginase-based regimen works in extranodal NK/T-cell lymphoma, where anthracyclines fail, but it is toxic: in its own phase 2 study grade 4 neutropenia occurred in 92 per cent. This open-label randomised trial at 12 hospitals in China, run from January 2011 to February 2019, compared it with DDGP, which keeps the asparaginase (as pegaspargase) and replaces the methotrexate, ifosfamide and etoposide with cisplatin and gemcitabine.
The final report (Wang and colleagues, JAMA Oncology 2022) randomised 87 patients, of whom 80 were treated, 40 in each arm; median age 43. At a median follow-up of 41.5 months, median progression-free survival was not reached with DDGP against 6.8 months with SMILE (hazard ratio 0.42, 95 per cent confidence interval 0.23 to 0.77, p = 0.004), and median overall survival was not reached against 75.2 months (hazard ratio 0.41, 0.19 to 0.89, p = 0.02). Three-year progression-free survival was 56.6 against 41.8 per cent and five-year overall survival 74.3 against 51.7 per cent. Grade 3 and 4 leukopenia occurred in 62.5 against 85.0 per cent. An interim report of the first 42 patients had appeared in Clinical Cancer Research in 2016.
The authors call the result promising preliminary evidence and say a confirmation trial in a larger population is warranted. It is the randomised trial behind the statement on the entity page that gentler asparaginase regimens such as DDGP are widely used in China.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
87 randomised.
median not reached; 3-year rate 56.6 per cent · median 6.8 months; 3-year rate 41.8 per cent
Sourcemedian not reached; 5-year rate 74.3 per cent · median 75.2 months; 5-year rate 51.7 per cent
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | DDGP | 40 | median not reached; 3-year rate 56.6 per cent | 0.42 (0.23 to 0.77) | 0.004 | link |
| SMILE | 40 | 6.8 months | ||||
| Overall survival | DDGP | 40 | median not reached; 5-year rate 74.3 per cent | 0.41 (0.19 to 0.89) | 0.02 | link |
| SMILE | 40 | 75.2 months | ||||
| Overall response rate | DDGP | 40 | 90% | - | 0.002 | link |
| SMILE | 40 | 60% |
A randomised comparison between two asparaginase regimens in advanced NK/T-cell lymphoma, and the evidence for using a pegaspargase-and-gemcitabine regimen rather than SMILE. In the authors' words, the DDGP regimen showed promising preliminary results and a confirmation trial based on a larger population is warranted.
An interim look whose direction the final report confirmed with smaller differences. The early figures are larger than the final ones, which is the usual pattern of an interim analysis on a small sample.
Shares Extranodal NK/T-cell lymphoma, Ifosfamide, Dexamethasone, Etoposide and the tag lymphoma-evidence-entities.
Shares Extranodal NK/T-cell lymphoma, Objective response rate (ORR), Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma) and the tag lymphoma-evidence-entities.
Shares Objective response rate (ORR), Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma) and the tag lymphoma-evidence-entities.
Shares Objective response rate (ORR), Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma) and the tag lymphoma-evidence-entities.
Shares Etoposide, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma), Cytotoxic chemotherapy and the tag lymphoma-evidence-entities.
Shares Objective response rate (ORR), Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma) and the tag lymphoma-evidence-entities.
Shares Objective response rate (ORR), Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma) and the tag lymphoma-evidence-entities.
Shares Etoposide, Non-Hodgkin lymphoma (all types), Cytotoxic chemotherapy and the tag lymphoma-evidence-entities.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/