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. 2018 Dec 7;2(1):e104.
doi: 10.1002/hsr2.104. eCollection 2019 Jan.

Bortezomib retreatment for relapsed and refractory multiple myeloma in real-world clinical practice

Cyrille Hulin  1 , Javier de la Rubia  2 , Meletios A Dimopoulos  3 , Evangelos Terpos  3 , Eirini Katodritou  4 , Vania Hungria  5 , Hadewijch De Samblanx  6 , Anne-Marie Stoppa  7 , Jesper Aagesen  8 , Deniz Sargin  9 , Anastasia Sioni  3 , Andrew Belch  10 , Joris Diels  11 , Robert A Olie  12 , Don Robinson Jr  13 , Anna Potamianou  14 , Helgi van de Velde  15 , Michel Delforge  16
Affiliations

Bortezomib retreatment for relapsed and refractory multiple myeloma in real-world clinical practice

Cyrille Hulin et al. Health Sci Rep. .

Abstract

Aims: Studies have shown that bortezomib retreatment is effective in relapsed/refractory multiple myeloma (MM). The observational, prospective electronic VELCADE® OBservational Study (eVOBS) study assessed bortezomib-based therapies for patients with MM in everyday practice. Here, we report on those patients receiving retreatment with bortezomib.

Methods: Consenting adults scheduled to receive bortezomib for MM were enrolled at 162 sites across Europe, Canada, Brazil, Russia, and Turkey between 2006 and 2010. Retrospective data on prior therapies and prospective observational data after bortezomib initiation were captured electronically at baseline, after every bortezomib cycle, and every 12 weeks after discontinuation or progression. Investigator-assessed responses and adverse events (AEs) were evaluated.

Results: Ninety-six of 873 patients enrolled to eVOBS received bortezomib as first retreatment for progressive disease during the prospective observation period. Median age was 62 years, 53% were male, and median number of prior therapies at retreatment was 4. Overall, 41% of patients initiated bortezomib retreatment in combination with dexamethasone, 16% in combination with lenalidomide, and 21% received monotherapy. Rate of partial response or better (≥PR) was 75% at initial bortezomib therapy, including 44% complete response (CR)/near CR (nCR); at retreatment, ≥PR rate was 46%, including 15% CR/nCR. Median progression-free survival was 11.4 months (95% confidence interval [CI]: 9.1-12.7) from start of initial bortezomib treatment and 6.4 months (95% CI: 4.4-7.2) from start of retreatment. Median overall survival from start of retreatment was 17.6 months (95% CI: 14.4-23.5). Of the 96 patients retreated with bortezomib, 77% reported an AE. Peripheral neuropathy during bortezomib retreatment occurred in 49% of patients, including 10% grade 3/4.

Conclusion: These data suggest that retreatment with bortezomib is a feasible option for patients with relapsed/refractory MM.

Keywords: multiple myeloma; real world; refractory; relapsed; retreatment.

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Figures

Figure 1
Figure 1
Kaplan‐Meier analysis of time to ≥PR from the start of bortezomib retreatment, stratified by number of prior lines of therapy. PR, partial response
Figure 2
Figure 2
Kaplan‐Meier analysis of (A) progression‐free survival and (B) overall survival after bortezomib retreatment, stratified by best response to retreatment. CR, complete response; MR, minimal response; nCR, near complete response; OS, overall survival; PD, progressive disease; PFS, progression‐free survival; PR, partial response
Figure 3
Figure 3
Kaplan‐Meier analysis of (A) progression‐free survival and (B) overall survival from the start of bortezomib retreatment, stratified by treatment‐free interval between initial bortezomib treatment and subsequent line of therapy. OS, overall survival; PD, progressive disease; PFS, progression‐free survival; TFI, treatment‐free interval
Figure 4
Figure 4
Kaplan‐Meier analysis of overall survival from the start of retreatment, stratified by number of prior lines of therapy
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