Early versus Late Discontinuation of Maintenance Therapy in Multiple Myeloma
Abstract
:1. Introduction
2. Methods
2.1. Study Design and Patients
2.2. Endpoints
2.3. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Survival Outcomes
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Maintenance < 3 Years (n = 102), 30% | Maintenance ≥ 3 Years (n = 238), 70% | p-Value | |||
---|---|---|---|---|---|
Age at Transplant (Yrs, median range) | 58 | 37–73 | 60 | 37–75 | 0.33 |
Age ≤65 | 83 | 81.4 | 188 | 79.0 | 0.62 |
Age >65 | 19 | 18.6 | 50 | 21.0 | |
Sex | 0.56 | ||||
Male | 57 | 55.9 | 141 | 59.2 | |
Female | 45 | 44.1 | 97 | 40.8 | |
Race | 0.02 | ||||
Black | 6 | 5.9 | 37 | 15.5 | |
White | 96 | 94.1 | 197 | 82.8 | |
Others | 0 | 0.0 | 4 | 1.7 | |
Melphalan use | 0.91 | ||||
140 | 12 | 11.8 | 27 | 11.3 | |
200 | 90 | 88.2 | 211 | 88.7 | |
Pre-Transplant remission status | 0.15 | ||||
CR/VGPR | 55 | 53.9 | 153 | 64.3 | |
PR | 38 | 37.3 | 64 | 26.9 | |
SD/PD | 9 | 8.8 | 21 | 8.8 | |
Post-Transplant remission status | 0.01 | ||||
CR/VGPR | 80 | 78.4 | 206 | 86.6 | |
PR | 14 | 13.7 | 29 | 12.2 | |
SD/PD | 8 | 7.8 | 3 | 1.3 | |
Cytogenetic risk | 0.52 | ||||
Standard risk | 55 | 63.2 | 137 | 67.2 | |
High/Intermediate risk | 32 | 36.8 | 67 | 32.8 | |
ISS staging | 0.07 | ||||
1 | 44 | 53.7 | 78 | 38.6 | |
2 | 23 | 28.0 | 76 | 37.6 | |
3 | 15 | 18.3 | 48 | 23.8 |
Maintenance < 3 Years (n = 102) | Maintenance ≥ 3 Years (n = 238) | |||
---|---|---|---|---|
Maintenance Drugs | n | % | n | % |
Lenalidomide | 90 | 88.2 | 214 | 89.9 |
Bortezomib | 15 | 14.7 | 21 | 8.8 |
Ixazomib | 0 | 0 | 12 | 5.0 |
Lenalidomide + Bortezomib | 0 | 0 | 2 | 0.8 |
Lenalidomide + Cyclophosphamide | 0 | 0 | 2 | 0.8 |
Pomalidomide | 0 | 0 | 3 | 1.3 |
Pomalidomide + Cyclophosphamide | 0 | 0 | 1 | 0.4 |
Thalidomide | 3 | 2.9 | 1 | 0.4 |
Prednisone | 3 | 2.9 | 1 | 0.4 |
Reasons for stopping * | ||||
Patient Preference | 23 | 22.5 | 7 | 2.9 |
Physician Decision | 1 | 1 | 0 | 0 |
Progression | 0 | 0 | 57 | 23.9 |
Recurrent Infection | 1 | 1 | 0 | 0 |
SPM | 4 | 3.9 | 5 | 2.1 |
Adverse events | 51 | 50 | 30 | 12.6 |
Other | 22 | 21.6 | 8 | 3.4 |
Adverse Events | Maintenance < 3 Years | Maintenance ≥ 3 Years |
---|---|---|
Pancytopenia | 8 | 2 |
Neutropenia | 7 | 5 |
Infection | 9 | 2 |
Thrombocytopenia | 1 | 0 |
GI | 8 | 4 |
Neurologic deficits | 1 | 0 |
Cardiac | 1 | 4 |
Depression | 1 | 0 |
Fatigue | 10 | 9 |
Neuropathy | 5 | 4 |
Peripheral neuropathy | 2 | 0 |
Renal | 2 | 1 |
Skin | 3 | 0 |
DVT or pulmonary embolism | 0 | 1 |
Maintenance < 3 Years | Maintenance ≥ 3 Years | |||||
---|---|---|---|---|---|---|
Rate | 95% CI | Rate | 95% CI | |||
Overall survival (OS) | ||||||
Year 1 | 100% | 100% | ||||
Year 3 | 94% | 87% | 97% | 100% | ||
Year 5 | 79% | 69% | 86% | 96% | 92% | 98% |
Year 10 | 45% | 26% | 62% | 71% | 52% | 84% |
Median, 95% CI | 9.8 | 8.2 | NR | NR | NR | NR |
Progression free survival (PFS) | ||||||
Year 1 | 100% | 99% | 97% | 100% | ||
Year 3 | 81% | 72% | 87% | 98% | 95% | 99% |
Year 5 | 50% | 39% | 60% | 80% | 74% | 85% |
Year 10 | 13% | 5% | 25% | 51% | 38% | 63% |
Median, 95% CI | 5.1 | 4.4 | 7.4 | NR | 8.5 | NR |
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Nunnelee, J.; Cottini, F.; Zhao, Q.; Faisal, M.S.; Elder, P.; Rosko, A.; Bumma, N.; Khan, A.; Umyarova, E.; Devarakonda, S.; et al. Early versus Late Discontinuation of Maintenance Therapy in Multiple Myeloma. J. Clin. Med. 2022, 11, 5794. https://doi.org/10.3390/jcm11195794
Nunnelee J, Cottini F, Zhao Q, Faisal MS, Elder P, Rosko A, Bumma N, Khan A, Umyarova E, Devarakonda S, et al. Early versus Late Discontinuation of Maintenance Therapy in Multiple Myeloma. Journal of Clinical Medicine. 2022; 11(19):5794. https://doi.org/10.3390/jcm11195794
Chicago/Turabian StyleNunnelee, Jordan, Francesca Cottini, Qiuhong Zhao, Muhammad Salman Faisal, Patrick Elder, Ashley Rosko, Naresh Bumma, Abdullah Khan, Elvira Umyarova, Srinivas Devarakonda, and et al. 2022. "Early versus Late Discontinuation of Maintenance Therapy in Multiple Myeloma" Journal of Clinical Medicine 11, no. 19: 5794. https://doi.org/10.3390/jcm11195794