NK malignancies consist of two different clinical entities, extranodal NK/T cell lymphoma and
aggressive NK leukaemia. Queen Mary Hospital (QMH) had started to use PIGLETS chemotherapy
for treatment of NK malignancies since 2013, with promising results. The study in QMH had
ended because of successful recruitment in the planned number of subjects.
When PIGLETS was used in extranodal NK/T cell lymphoma, patients with stage I/II lymphoma
have an overall response rate of nearly 90%, while patients with stage III/IV disease have an
overall response rate of around 60%. The figures are comparable to the SMILE chemotherapy
previously used. However, PIGLETS regimen carries much lower risk of nephrotoxicity when
compared with SMILE. It has since become a standard protocol in management of NK malignancies
in our institution.
PIGLETS chemotherapy carries two major problems:
1. the name PIGLETS may appear offensive to some religious populations. (e.g. Muslim)
2. significant nausea/vomiting was seen in previous studies, and these could at least be
partially alleviated with substance P antagonist aprepitant
Thus the investigators decided to start a study, renaming the original PIGLETS regimen into
SIMPLE chemotherapy, adding aprepitant as antiemetics and to recruit more patients for
evaluation of clinical efficacy. The results of SIMPLE chemotherapy will be compared to SMILE
in a non-inferiority trial setting.