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    Home > Active Ingredient News > Blood System > The full course of intensive treatment suitable for transplanted MM patients may be extended to 70 years old

    The full course of intensive treatment suitable for transplanted MM patients may be extended to 70 years old

    • Last Update: 2021-04-21
    • Source: Internet
    • Author: User
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    With the widespread application of new drugs such as proteasome inhibitors and immunomodulators, and the popularization of autologous hematopoietic stem cell transplantation (ASCT), the efficacy and overall prognosis of patients with multiple myeloma (MM) have been significantly improved.

    Current domestic and foreign guidelines recommend a three-drug combination regimen containing at least one new drug (such as proteasome inhibitors or immune modulators or monoclonal antibodies) for induction therapy for young (≤65 years old) MM patients who are suitable for transplantation, and give high-dose melphalan ( MEL200) combined with ASCT consolidation therapy, and then given proteasome inhibitors or immunomodulators to maintain treatment until intolerance or disease progression.

    Although previous studies have shown that age alone cannot be used as a limiting factor for ASCT, whether this full-course intensive treatment strategy can be extended to 70 years old in patients with good physical status and organ function, there is currently a lack of prospective randomized research data .

    Recently, an investigator reported in Leukemia magazine from the German-language Myeloma Multicenter Group (GMMG)-MM5 trial.
    This is a prospective, multicenter Phase III clinical study that is expected to answer the above questions.
    The editor will organize its main content.
    The following is for reference of readers.

    Research methods Newly diagnosed MM (NDMM) patients were included in the study, aged 18-70 years old, and the World Health Organization Performance Status Score (WHO-PS) was 0-2 points.

    The researchers further divided the patients into three groups based on age: ≤60 years old (S1), 61-65 years old (S2), and 66-70 years old (S3).

    The three groups of patients received the same intensity of induction therapy containing bortezomib, as well as MEL200/ASCT consolidation therapy, and then received lenalidomide maintenance therapy.

    Induction treatment options mainly include PAD (bortezomib, doxorubicin, dexamethasone) and VCD (bortezomib, cyclophosphamide, dexamethasone).

    Research results The research intention-to-treat population (ITT) included 601 NDMM patients, divided into three groups according to age: S1 (N=353), S2 (N=107) and S3 (N=141).

    Glomerular filtration rate (GFR) decreased significantly with the increase of patients' age (median GFR, S1: 103.
    9ml/min vs S2: 81.
    9ml/min vs S3: 75.
    6ml/min, P<0.
    001).

    Similarly, the proportion of patients with stage III of the International Staging System (ISS) is higher in the S2 and S3 groups than in the S1 group (S1: 24.
    4% vs S2: 31.
    8% vs S3: 31.
    9%, P=0.
    04).

    The proportion of patients who recorded at least one concomitant disease/medical condition other than MM was S1: 89.
    8% vs S2: 93.
    5% vs S3: 96.
    5% (P=0.
    04).

    The proportion of patients with previous> 1 concomitant heart and/or vascular disease was 10.
    8% (S1) vs 27.
    1% (S2) vs 29.
    1% (S3) (P<0.
    001).

    Among the three groups of patients, the proportion of ITT patients who completed induction therapy, received the first and second MEL200/ASCT consolidation treatments, and started lenalidomide maintenance therapy was similar.

    The cytogenetic status of sequential MEL200/ASCT is unknown, and the proportion of ITT patients without or with cytogenetic adverse factors is 24.
    4% vs 29.
    9% vs 15.
    8%, respectively.

    There was no significant difference in the proportion of patients in the three groups that achieved ≥ very good partial remission (VGPR) and complete remission (CR).

    However, the proportion of patients with efficacy ≥ partial remission (PR) showed a downward trend with age (S1: 94.
    7% vs S2: 98.
    1% vs S3: 89.
    8%, P=0.
    02).

    The occurrence of adverse events (AE): Compared with patients in the S2 and S3 groups, the overall AEs of the patients in the S1 group were reduced in all treatment stages (any AE and any serious AE-SAE: S1: 81.
    7% and 41.
    8% vs S2: 90.
    7% and 56.
    5% vs S3: 87.
    2% and 68.
    1%, P=0.
    05 and P<0.
    001).

    The median follow-up time of overall patient progression-free survival (PFS) was 57.
    1 months (95% CI: 55.
    6-59.
    2 months); the median follow-up time of overall survival (OS) was 57.
    6 months (95% CI : 56.
    4-59.
    2 months).

    There were no significant differences in PFS (log-rank P=0.
    73) and OS (log-rank P=0.
    54) in the three age groups, and there were no significant differences in the time to disease progression and non-recurrence mortality (NRM) in the same three groups.
    difference.

    In the S1, S2, and S3 groups of patients, the median PFS was 40.
    8 months, 35.
    0 months, and 40.
    9 months, respectively.

    The results of multivariate analysis showed that the poor prognostic factors of PFS were: male (HR=1.
    32, P=0.
    02), ISS stage II/III (HR=1.
    45/1.
    74, P=0.
    009/<0.
    001), lactate dehydrogenase ( LDH)>upper limit of normal (ULN) (HR=1.
    51, P=0.
    01) and high-risk cytogenetics (HR=1.
    77, P<0.
    001).

    The poor prognostic factors of OS are: S2 age group (HR=1.
    61, P=0.
    03), LEN-CR maintenance treatment strategy (HR=1.
    60, P=0.
    005), WHO-PS is 2-3 points (HR=1.
    95, P =0.
    003), ISS staging is stage II/III (HR=1.
    76/2.
    66, P=0.
    01/<0.
    001) and poor cytogenetics (HR=2.
    62, P<0.
    001).

    Research conclusions The research results support the expansion of induction therapy containing bortezomib, consolidation therapy of MEL200/ASCT, and maintenance therapy strategy of lenalidomide to NDMM patients under 70 years of age who are suitable for transplantation.

    References: Elias K Mai, Kaya Miah, Uta Bertsch, et al.
    Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age.
    Leukemia.
    2021 Mar;35(3):809-822 .
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