Shuji Ozaki1, Hiroshi Handa2, Hiromi Koiso3, Takayuki Saitoh4, Kazutaka Sunami5, Tadao Ishida6, Kenshi Suzuki6, Tomoko Narita7, Shinsuke Iida7, Yuichi Nakamura8, Kazuhito Suzuki9, Noriko Nishimura10, Hirokazu Murakami11, Kazuyuki Shimizu12. 1. Department of Hematology, Tokushima Prefectural Central Hospital, 1-10-3 Kuramoto, Tokushima, 770-8539, Japan. ozaki@tph.gr.jp. 2. Department of Hematology, Gunma University Graduate School of Medicine, Gunma, Japan. 3. Infection Control and Prevention Center, Gunma University Hospital, Gunma, Japan. 4. Department of Laboratory Sciences, Gunma University Graduate School of Health Sciences, Gunma, Japan. 5. Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan. 6. Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan. 7. Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. 8. Department of Hematology, Saitama Medical University Hospital, Saitama, Japan. 9. Department of Clinical Oncology/Hematology, The Jikei University Kashiwa Hospital, Kashiwa, Japan. 10. Division of Hematology Oncology, Cancer Institute Hospital of the Japanese Society for Cancer Research, Tokyo, Japan. 11. Faculty of Medical Technology and Clinical Engineering, Gunma University of Health and Welfare, Gunma, Japan. 12. Department of Hematology/Oncology, Higashi Nagoya National Hospital, Nagoya, Japan.
Abstract
BACKGROUND: Maintenance ± consolidation or continuous therapy is considered a standard of care for both transplant-eligible and -ineligible patients with multiple myeloma (MM). However, long-term benefits of such therapy have not yet been clarified in the context of clinical practice. PURPOSE: To clarify the efficacy of maintenance/continuous approach, we retrospectively analyzed the cohort data of newly diagnosed MM patients by propensity-score matching based on age, gender, revised International Staging System (R-ISS) stage, and implementation of transplantation to reduce the bias due to confounding variables. FINDINGS: Among 720 patients, 161 were identified for each of the maintenance and no maintenance groups. Maintenance/continuous therapy employed immunomodulatory drugs (n = 83), proteasome inhibitors (n = 48), combination of both (n = 29), or dexamethasone alone (n = 1). Progression-free survival (PFS) was significantly prolonged in the maintenance group compared with the no maintenance group (median 37.7 and 21.9 months, p = 0.0002, respectively). Prolongation of PFS was observed in both transplanted and non-transplanted patients (p = 0.017 and p = 0.0008, respectively), with standard risk (p < 0.00001), R-ISS stage I (p = 0.037) and stage II (p = 0.00094), and those without obtaining complete response (p = 0.0018). There was no significant benefit in overall survival (OS), but it tended to be better in the maintenance group in non-transplanted patients. Regarding the treatment pattern, the substitution or addition of drugs different from the induction therapy and the combination with immunomodulatory drugs and proteasome inhibitors appeared to be more beneficial for PFS but not OS. CONCLUSION: These results support the benefit of current maintenance/continuous approach in routine clinical practice in the management of MM.
BACKGROUND: Maintenance ± consolidation or continuous therapy is considered a standard of care for both transplant-eligible and -ineligible patients with multiple myeloma (MM). However, long-term benefits of such therapy have not yet been clarified in the context of clinical practice. PURPOSE: To clarify the efficacy of maintenance/continuous approach, we retrospectively analyzed the cohort data of newly diagnosed MM patients by propensity-score matching based on age, gender, revised International Staging System (R-ISS) stage, and implementation of transplantation to reduce the bias due to confounding variables. FINDINGS: Among 720 patients, 161 were identified for each of the maintenance and no maintenance groups. Maintenance/continuous therapy employed immunomodulatory drugs (n = 83), proteasome inhibitors (n = 48), combination of both (n = 29), or dexamethasone alone (n = 1). Progression-free survival (PFS) was significantly prolonged in the maintenance group compared with the no maintenance group (median 37.7 and 21.9 months, p = 0.0002, respectively). Prolongation of PFS was observed in both transplanted and non-transplanted patients (p = 0.017 and p = 0.0008, respectively), with standard risk (p < 0.00001), R-ISS stage I (p = 0.037) and stage II (p = 0.00094), and those without obtaining complete response (p = 0.0018). There was no significant benefit in overall survival (OS), but it tended to be better in the maintenance group in non-transplanted patients. Regarding the treatment pattern, the substitution or addition of drugs different from the induction therapy and the combination with immunomodulatory drugs and proteasome inhibitors appeared to be more beneficial for PFS but not OS. CONCLUSION: These results support the benefit of current maintenance/continuous approach in routine clinical practice in the management of MM.
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