Methods
All patients with relapsed ALCL included in the study were initially
treated in our hospital in 2016–2018. Histology confirmation was
required for the diagnosis of relapsed ALCL in all patients. Detailed
data on the first- and second-line treatments and the outcomes of these
patients were collected from their medical files.
A cycle of therapy was defined as a 4-week interval during which
vinorelbine was given as a weekly intravenous injection of 25
mg/m2 for 3 consecutive weeks (days 1, 8, and 15)
followed by a 1-week rest. Steroids were combined with vinorelbine
during the first 4 to 6 weeks of the treatment. At least 2 cycles of
weekly vinorelbine regimen were administered unless there were signs of
disease progression. After 2 cycles, a formal assessment by computed
tomography (CT) or magnetic resonance imaging (MRI) scans was performed.
Fluorodeoxyglucose positron emission tomography scan is recommended but
not mandatory. The treatment after 2 cycles of single-drug vinorelbine
therapy was at the discretion of the physician. Any further single-drug
vinorelbine therapy was only to be administered if CR was achieved after
the initial two cycles.
Complete remission was defined as disappearance of all evidence of
disease. Unconfirmed complete response was defined as a residual lymph
node mass >1.5 cm on CT scans, or MRI evaluations that
regressed by >75% in the sum of the products of the
greatest perpendicular diameters (SPD) of the lesions, or any residual
lesions in organs that decreased by >75% with a negative
PET scan. Progressive disease was defined as an increase of
>25% in SPD or the development of a new lesion.
Toxicity was graded according to the Common Terminology Criteria for
Adverse Events, version 3.0. Hematological and hepatic toxicity rates
were estimated. Dose reductions of vinorelbine were not permitted in
this protocol. Vinorelbine was withheld at either the second or third
dose (days 8 or 15, respectively) of each vinorelbine cycle for an
absolute neutrophil count less than 500/mm3 or
platelets <50,000/mm3. If a dose was
withheld, it was not repeated.