[The efficacy and safety of bortezomib plus thalidomide in treatment of newly diagnosed multiple myeloma].

Abstract

OBJECTIVE:

The aim of this phase II study was to determine the efficacy and safety of combined bortezomib and thalidomide (VT) regime as initial treatment for newly diagnosed multiple myeloma (MM) in China.

METHODS:

Thirty-four patients were enrolled in this study and received VT regime up to 21-day cycles. Bortezomib (1.3 mg/m(2)) was administered intravenously on days 1, 4, 8, and 11, while oral thalidomide (100 mg/day) was given from days 1 to 21. The primary end point was clinical response. The secondary end point was safety.

RESULTS:

Among the 34 patients, 20 were male, 14 were female, with a median age of 59 years, and 15 in international stage system (ISS) III, 18 in ISS II, 1 in ISS I. Among them, 28 completed 2 cycles' treatment and achieved an overall response rate (ORR) of 92.9%; 26 were able to complete the planned 8 cycles of therapy. After 8 cycles, the ORR was 100% (complete response 30.8%, near-complete response 23.1%, partial response 42.3%, minimal response 3.8%). After followed up with a median time of 12 months, the estimated rate without progress of disease was 62%, and the estimated continuous remission rate of 12 months was 62%. The median survival time was not achieved. The most common adverse events were mild to moderate (grades 1, 2). The main toxicities were hematologic (53.3%), gastrointestinal (40.0%), peripheral neuropathy (38.0%), fatigue (36.6%) and fever (32.0%).

CONCLUSIONS:

VT regime provides a very high ORR and complete response rate in the treatment of newly diagnosed MM patients. No patients experienced deep venous thrombosis. In conclusion, bortezomib in combination with thalidomide is a very effective regimen for newly diagnosed MM patients and the toxicities are manageable.

• Authors: Shi-Lun Chen, Lu-Gui Qiu, Bin Jiang, Li Yu, Yu-Ping Zhong, Wen Gao
• Journal: Zhonghua nei ke za zhi (Zhonghua Nei Ke Za Zhi) Vol. 50 Issue 4 Pg. 291-4 (Apr 2011) ISSN: 0578-1426 [Print] China
• PMID: 21600146 (Publication Type: Clinical Trial, Phase II, English Abstract, Journal Article)

Chemical References

• Antineoplastic Agents
• Boronic Acids
• Pyrazines
• Thalidomide
• Bortezomib

Topics

• Antineoplastic Agents (therapeutic use)
• Boronic Acids (therapeutic use)
• Bortezomib
• Female
• Humans
• Male
• Middle Aged
• Multiple Myeloma (diagnosis, drug therapy)
• Pyrazines (therapeutic use)
• Thalidomide (therapeutic use)
• Treatment Outcome