# Efficacy and Safety of a Pegasparaginase-Based Chemotherapy Regimen vs an L-asparaginase-Based Chemotherapy Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-Cell Lymphoma: A Randomized Clinical Trial

Source: https://onco.cc/key-papers/paper-ddgp-vs-smile-nk-t-cell-lymphoma-jama-oncol-2022/  
OnCo record `paper-ddgp-vs-smile-nk-t-cell-lymphoma-jama-oncol-2022` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The final report of the Chinese randomised trial in which a pegaspargase regimen, DDGP, kept advanced NK/T-cell lymphoma controlled for longer than SMILE, with less toxicity to the blood count.

## Summary

An open-label, multicentre randomised trial at 12 hospitals in China from January 2011 to February 2019, in patients aged 14 to 70 with newly diagnosed stage III or IV extranodal natural killer/T-cell lymphoma and performance status 0 to 2. Patients were randomised evenly to DDGP (dexamethasone, cisplatin, gemcitabine and pegaspargase) or SMILE (dexamethasone, methotrexate, ifosfamide, L-asparaginase and etoposide), every 21 days for six cycles. The primary endpoint was progression-free survival.

## Fields

- Kind: Key paper
- Last checked: 2026-11-03
- Also known as: DDGP versus SMILE, final report; Wang 2022
- Tags: lymphoma-evidence-entities
- Journal: JAMA Oncology
- Year: 2022
- DOI: 10.1001/jamaoncol.2022.1968
- Authors: Wang X, Zhang L, Liu X, et al.
- Findings: 87 patients were randomised and 80 treated, 40 in each arm; median age 43, 64 per cent male.; 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).; Median overall survival was not reached against 75.2 months (hazard ratio 0.41, 95 per cent confidence interval 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.; Overall response was 90.0 against 60.0 per cent (p = 0.002).; Grade 3 and 4 leukopenia occurred in 62.5 per cent with DDGP against 85.0 per cent with SMILE, and neutropenia in 65.0 against 85.0 per cent.
- What it means: 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.
- Caveats: 80 treated patients from one national group; the trial has not been repeated.; Open label, and run over eight years.; The registry record lists the study as phase 4, with 80 enrolled and its status unknown.

## Sources

- JAMA Oncology 2022: https://doi.org/10.1001/jamaoncol.2022.1968
- PubMed: https://pubmed.ncbi.nlm.nih.gov/35708709/
- Europe PMC: https://europepmc.org/article/MED/35708709

## Connected records

- cancers: [Extranodal NK/T-cell lymphoma](https://onco.cc/cancers/extranodal-nk-t-cell-lymphoma/), [Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)](https://onco.cc/cancers/peripheral-t-cell-lymphoma/)
- drugs: [Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)](https://onco.cc/drugs/asparaginase/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Dexamethasone](https://onco.cc/drugs/dexamethasone/), [Etoposide](https://onco.cc/drugs/etoposide/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Ifosfamide](https://onco.cc/drugs/ifosfamide/), [Methotrexate](https://onco.cc/drugs/methotrexate/)
- trials: [DDGP versus SMILE](https://onco.cc/trials/ddgp-vs-smile-enktl/), [SMILE](https://onco.cc/trials/smile-enktl/)

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