Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

Summary

Solitary plasmacytoma (SP) is characterized by a localized mass of clonal plasma cells with no or minimal bone marrow plasmacytosis. It can present either as EMP or SBP. Radiotherapy is the first-line treatment with high response rate. However, 65-84% SBP patients and 25-35% EMP patients progress at 10 years. We aimed to investigate whether adjuvant bortezomib based chemotherapy with radiotherapy could prolong event-free survival in treatment-naive SP patients compared to that with radiotherapy alone.

Eligibility

Inclusion Criteria:

* treatment-naïve SP.

Exclusion Criteria:

* Not appropriate for radiotherapy.
* ECOG \> 2.
* Co-morbidity of uncontrolled infection.
* Co-morbidity of other active malignancy.
* Patients in pregnancy or lactation.
* Prior or concurrent pulmonary embolism.
* Patients not able to tolerate thrombosis prophylaxis, bortezomib, lenalidomide or dexamethasone.
* Seropositive for human immunodeficiency virus, seropositive for hepatitis C, or HBV-DNA \> 1000 copies/mL.
* Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment.
* Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events.
* Neutrophil \<1×10E9/L，hemoglobin \< 8g/dL，or platelet \< 75×10E9/L.
* Severely compromised hepatic or renal function: ALT or AST \> 3 × ULN, total bilirubin \> 1.5 × ULN，or eGFR \< 40mL/min.

Conditions2

Interventions3

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