A prospective, open-label, multicenter, observational study to evaluate the efficacy and safety of bortezomib-melphalan-prednisone as initial treatment for autologous stem cell transplantation-ineligible patients with multiple myeloma.

Min Kyoung Kim,Byung Soo Kim,Hyo Jung Kim,Deog Yeon Jo,Jae Hoon Lee,Hawk Kim,Joon Ho Moon,Ho Sup Lee,Sung Hwa Bae,Young-Don Joo,Jeong-Ok Lee,Seong Hyun Jeong,Jin Seok Kim,Ki Hwan Kim,Joon Seong Park,Seong Kyu Park,Mark Hong Lee,Hyeon Gyu Yi,Moo-Kon Song,Myung Soo Hyun,Sang Min Lee,Chul Won Choi,Keon Woo Park,Do Yeun Cho ,Hoon Gu Kim ,Je Jung Lee ,Yeung Chul Mun ,Ho Jin Shin ,Sung Soo Yoon ,Kihyun Kım ,Moo Rim Park ,Sung Cil Lim ,Jun Young Lee ,Sang Byung Bae ,Jae Yong Kwak ,Won Sik Lee ,Sung Hyun Kim ,Chang Ki Min ,Young Rok ,Yang Soo Kim ,Jeong‐A Kim ,Soo Jeong Kim ,Seung Hyun Nam ,Su Youn Kim

doi:10.18632/oncotarget.16790

Abstract

Bortezomib-melphalan-prednisone (VMP) showed superior efficacy versus MP as first-line treatment for transplantation-ineligible multiple myeloma (MM). This study investigated the efficacy of VMP for Korean patients with MM.Overall, 177 MM patients received 9 cycles of VMP in this prospective, multicenter, observational study. The primary endpoint was 2-year progression-free survival (PFS).Thirty-nine (22%) patients were aged ≥ 75 years and 83 (47.4%) patients had International Staging System stage III. A median of 5 cycles were delivered. Overall response rate (ORR) was 72.9%, and complete response (CR) rate was 20.3%. With a median follow-up of 11.9 months, median PFS was 17 months. The 2-year PFS and overall survival (OS) rates were 29.2% and 80.0%, respectively. Median OS was not reached. PFS was significantly different depending on performance status (Eastern Cooperative Oncology Group < 2 vs. ≥ 2; p = 0.0002), β2-microglobulin level (< 5.5 vs. ≥ 5.5 mg/L; p = 0.0481), and cumulative dose of bortezomib (< 35.1 vs. ≥ 35.1 mg/m2; p < 0001). The common adverse events (AEs) were in line with the well-known toxicity profiles associated with VMP.In conclusion, VMP is a feasible and effective front-line treatment for transplant-ineligible older patients with MM in Korea. Continuing therapy with prompt adjustment of treatment according to AEs may be important to improve outcomes of elderly patients.

Highlights

Multiple myeloma (MM) is a progressive plasma cell neoplasm characterized by reduced resistance against infection, skeletal injuries, renal failure, and anemia
179 patients were enrolled into this observational study at 38 centers in Korea from May 22, 2011 to May 29, 2014, of whom 177, who received at least 1 dose of the study drug, were included in the analyses
According to the International Staging System (ISS), 22 (12.6%) patients were in stage I, 70 (40.0%) were in stage II, and 83 (47.4%) were in stage III (Table 1)

Summary

Introduction

Multiple myeloma (MM) is a progressive plasma cell neoplasm characterized by reduced resistance against infection, skeletal injuries (bone pain and fracture), renal failure, and anemia. The prognosis is mostly recurrent, with a median survival of approximately 3 to 4 years. Studies have shown that treatment with MP resulted in partial response (PR) or greater responses in approximately half of the treated patients; complete response (CR) was relatively rare and median survival was approximately 3 years [3,4,5,6]. High-dose therapy with hematopoietic stem cell transplantation has become the preferred treatment for patients under the age of 65 years, but older patients and patients with clinically significant comorbidities usually do not tolerate this treatment. With increasing incidence of MM among patients aged ≥ 70 years, it is becoming increasingly important to investigate treatment options in patients who are not eligible for autologous stem cell transplantation [7]. Several recent studies have proved the efficacy and safety of bortezomib in patients with recurrent or refractory MM [8] and the www.impactjournals.com/oncotarget

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