Thalidomide–Containing Regimens Induce Recovery of Normal Immunoglobulins in Newly Diagnosed Patients with Multiple Myeloma; Recovery of Normal Immunoglobulins Improves Survival.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2738-2738
Author(s):  
Eirini Katodritou ◽  
Evgenia Verrou ◽  
Anastasia Banti ◽  
Dimitra Mihou ◽  
Vassiliki Gastari ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Median Time ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
Time To Progression ◽  
First Line ◽  
Group 2 ◽  
First Line Treatment ◽  
Group 1

Abstract Normal immunoglobulins, which are important for the host defense, are often decreased in Multiple myeloma (MM), either at the time of diagnosis or even after achieving response. Thalidomide, which is an immunomodulatory drug, in combination with other chemotheraputic drugs is effective for the treatment of newly diagnosed multiple myeloma (MM) patients, yielding 60–80% response rate. The purpose of this study was to examine, if the addition of Thalidomide to standard regimens, in newly diagnosed MM patients, induces recovery of normal immunoglobulins and whether this normalization has any impact on time to progression and overall survival. Two hundred twenty–six newly diagnosed symptomatic MM patients were evaluated. One hundred sixty–nine patients, 95 males and 74 females, with a median age of 66 years (range 29–90) who presented with normal immunoglobulins’ value below the minimum normal limit at the time of diagnosis, were selected for analysis. One hundred twenty-seven patients (group 1) received standard regimens not containing Thalidomide (93 received Vincristine /Adriamycin /Dexamethasone and 34 received Melphalan /Prednisone). Forty-two patients (group 2) received regimens containing Thalidomide (27 patients received Vincristine /Adriamycin /Dexamethasone /Thalidomide, 10 patients Dexamethasone /Thalidomide and 5 patients Melphalan /Prednisone /Thalidomide). All patients were evaluated after at least 4 cycles of treatment (median time of evaluation 6mo, range 4-8mo) for recovery of normal immunoglobulins (defined as the return of the normal immunoglobulins within the normal range). Statistical analysis was performed with the Pearson’s chi square test, Mann Whitney-U test and binary logistic regression analysis. The patients in both groups were well-balanced concerning age, sex, ISS score, B2-micriglobulin, creatinine and LDH (p<0.05). Recovery of normal immunoglobulins was achieved in 14,2% in group 1 and 33,3% in group 2 (p=0.006). The multivariate analysis, including age, ISS, type of myeloma and addition of Thalidomide in the first line treatment regimens, showed that the addition of Thalidomide in first line treatment was the only factor predicting for recovery of normal immunoglobulins (p=0.04). With a median follow up of 32mo (range 4–231mo), the median overall survival of patients in whom recovery of normal immunoglobulins was observed and of patients without any immunoglobulin recovery, was 35mo (SD=23mo) and 31mo (SD=31,6mo), respectively (p=0.004) and the median time to progression was 16mo (SD=23mo) and 6mo (SD=22mo), respectively (p=0.005). These results suggest that, Thalidomide-containing regimens used as first–line treatment, induce significant recovery of normal immunoglobulins compared to regimens without Thalidomide and that, the recovery of normal immunoglobulins overall, positively influences time to progression and overall survival. Conclusively, this study highlights the important role of normal immunoglobulins in MM biology and outcome and may suggest that the recovery of normal immunoglobulins could be possibly another criterion for defining complete remission.

Late Appearance of 14q32/IGH Translocation in Chronic Lumphocytic Leukemia

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2429-2429
Author(s):  
Francesco Cavazzini ◽  
Gian Matteo Rigolin ◽  
Lara Rizzotto ◽  
Antonella Bardi ◽  
Elisa Tammiso ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clonal Evolution ◽  
Fish Analysis ◽  
Line Treatment ◽  
First Line ◽  
Group 2 ◽  
First Line Treatment ◽  
14Q32 Translocation ◽  
Group 1

Abstract Abstract 2429 Up to 80% of Chronic Lymphocytic Leukemia (CLL) harbour clonal chromosome aberrations having important clinical implications (i.e. 13q deletion, +12, 11q/ATM and 17p/TP53 deletions). 14q32/IGH rearrangements were recently found in 6–19% of CLL patients and were associated with therapy-demanding disease and inferior outcome. Whereas evidence was provided that some of the classical aberrations, such as 11q-, 17p-, may appear late in CLL clinical history, no information is presently available concerning 14q32/IGH translocations. The aim of this study was i) to analyze the incidence of 14q32/IGH translocations occurring at clonal evolution in CLL, ii) to analyze the clinicobiologic significance of late-appearing 14q32/IGH translocations. One hundred-five CLL cases seen at our institution in a 10-year period were submitted to FISH analysis at diagnosis or before 1st line treatment as part of routine diagnostic workup. In 47 patients with indolent disease (untreated or treated with 1 line without relapse, group 1) FISH analysis was repeated after 48–96 months (median 72). In 58 relapsed patients who started 2nd line treatment (group 2), FISH was performed sequentially before administration of the 2nd line and before each subsequent line of therapy. These 105 patients fulfilled the following criteria: a) diagnosis of bona fide CLL based on morphology and immunophenotyping (CD5/CD19+, CD23+ as minimal requirement), b) clinical records available for review, c) successful FISH analysis at diagnosis and during follow-up. Those cases with t (11;14)(q13;q32)/CCND1-IGH or other 14q32/IGH translocations present at diagnosis were excluded from this study. Sequential FISH studies were performed in all patients on peripheral blood (PB) samples using commercially available probes for the identification of deletions at 13q14, 11q22/ATM, 17p13/TP53, of trisomy 12 and of 14q32/IGH translocations. In 10 patients bone marrow (BM) aspiration and/or lymph node (LN) biopsy were studied by FISH as well. The patients were treated at disease progression as defined by NCI criteria. Refractory disease was defined by stable disease or progressive disease during treatment or disease progression within 6 months of from antileukemic treatment using fludarabine alone or in combination with other agents. Time to chemorefractoriness was measured from date of first line treatment to date of refractoriness to fludarabine containing regimen or date of last follow-up. Overall survival was measured from diagnosis to date of last follow-up or death and from initiation of first line treatment to the date of death or last follow-up. At diagnosis 39% of the cases had 13q-, 14% had +12, 7% had 11q- and 3% had 17p-. A late-appearing 14q32/IGH rearrangement was not detected among 47 patients in group 1, whereas 7/58 cases (12,1%) in group 2 showed a 14q32/IGH break in 16–25% of the cells. These 7 patients had the following aberrations at diagnosis: 13q- and 11q- in 1 case, 13q- in 2 cases; 11q- in 1 case, +12 in 2 cases, no aberrations 1 case. The 14q32 translocation appeared after a median time of 64 months (range 51–91). It was associated with the appearance of 17p- in 3/7 cases with one of these presenting also biallelic del13q. In two cases paired BM or LN sample and PB samples were available for FISH studies and the appearance of IgH translocation in the BM or in the LN sample preceded its appearance in PB by 13–58 months. All 7 cases with late appearing 14q32/IGH translocation developed chemorefractoriness to fludarabine regimen with a median TTC of 27 months (range 12–40 months), as compared with a TTC of 67 months (range 1–143 months) in 51 treated patients who did not develop the 14q32 translocation (p=0.0002). Overall survival did not differ significantly either when measured from diagnosis or from 1st line treatment in 7 patients with 14q32 translocation as compared with the appropriate control. We arrived at the following conclusions: i) a late-appearing 14q32/IGH translocation occurred at a relatively high incidence (12,1%) in patients with relapsing disease and not in patients with stable disease, ii) this aberration involved a minority of cells and, in approximately half of the cases, it was associated with other aberrations, reflecting complex clonal evolution, iii) in 2 assessable cases it first appeared first in the BM or LN; iv) the appearance of 14q32/IGH translocation was associated with shorter TTC. Disclosures: No relevant conflicts of interest to declare.

The Addition of Thalidomide in Any Line of Treatment of Multiple Myeloma, Improves Overall Survival: Single Center Experience in 246 Patients.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4813-4813
Author(s):  
Eirini Katodritou ◽  
Evgenia Verrou ◽  
Anastasia Banti ◽  
Vassiliki Gastari ◽  
Dimitra Mihou ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Dose ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
First Line ◽  
High Dose Therapy ◽  
Dose Therapy ◽  
Group 2 ◽  
First Line Treatment

Abstract Thalidomide is effective for the treatment of either newly diagnosed or relapsed/refractory multiple myeloma (MM) patients. However, the contribution of Thalidomide to the overall survival in MM has not yet been clarified. The aim of this study was to examine, if the incorporation of Thalidomide either in first or in any line regimens, positively influences overall survival, in a large cohort of MM patients, with a long follow up. Two hundred forty-six newly diagnosed symptomatic MM patients, 139 males and 107 females, with a median age of 67 years (range 29–90) were studied. One hundred ninghty-two patients (group 1A) received regimens not containing Thalidomide as first line treatment (129 received Vincristine /Adriamycin /Dexamethasone, 58 received Melphalan /Prednisone and 5 received Dexamethasone). Fifty-four patients (group 2A) received regimens containing Thalidomide as first line treatment (32 patients received Vincristine /Adriamycin /Dexamethasone /Thalidomide 14 patients Dexamethasone /Thalidomide and 8 patients Melphalan /Prednisone /Thalidomide). One hundred-ninety patients received second or more than second line therapy. One hundred twenty-three patients received standard regimens not containing Thalidomide (group 1B) and 77, regimens containing Thalidomide (group 2B). The standard regimens in group 1B and 2B were similar to first line regimens. Totally, 100 patients received regimens containing Thalidomide at any time of the disease. Twenty and 8 patients in group 1A+1B and 2A+2B, respectively, received high dose therapy. The evaluated parameters, for predicting overall survival were: age, ISS score, creatinine, B2 microglobulin, LDH, Thalidomide-containing regimens in first line (group 2A) and in any line of treatment (group 2, A and B), time to response to first line treatment and quality of response (CR+PR versus less than PR). Cox regression was used for the univariate and multivariate analysis and Mann Whitney-U test and Pearson’s chi square test, for comparisons of patients’ characteristics. The median follow up was 31 months (range 1–231). Patients in both groups were well-balanced concerning age, sex, ISS score, B2-micriglobulin, creatinine and LDH (p<0.05). There was no statistical difference concerning the number of patients who proceeded to high dose therapy in both groups at any time of treatment (P>0.05). The univariate analysis showed that, age, ISS score, creatinine, B2 microglobulin, LDH, Thalidomide-containing regimens either in first or in any line of treatment and time to response to first line treatment, predicted for survival. The multivariate analysis demonstrated that age, ISS score and regimens containing Thalidomide in any line of treatment (group 2, A and B), independently predicted for overall survival (p<0.05). The median survival in the group 1 and 2 was 28mo (SD=35mo) and 34mo (SD=26mo), respectively (p=0.04). This study showed that, the incorporation of Thalidomide in any line of treatment, improves overall survival. Considering that the type of the standard regimens applied, either including or not Thalidomide, were similar and there was no statistical difference in the percentage of patients who underwent high dose therapy, between the two groups, these results produced by the analysis of a large cohort of newly diagnosed MM patients, with a long follow up offer important information about the impact of Thalidomide on the overall survival.

scholarly journals Survival Analysis of Newly Diagnosed Transplant-Eligible Multiple Myeloma Patients in Czech Republic

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4894-4894
Author(s):  
Tereza Popkova ◽  
Ludek Pour ◽  
Ivan Spicka ◽  
Jakub Radocha ◽  
Alexandra Jungova ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Survival Analysis ◽  
Czech Republic ◽  
Partial Response ◽  
Complete Response ◽  
High Dose ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
First Line ◽  
First Line Treatment

Abstract Introduction: Although highly effective agents and novel therapeutic strategies are being developed, high-dose chemotherapy followed by autologous stem cell transplantation (HDT/ASCT) has not been overcome in the first-line treatment for fit patients (pts) with multiple myeloma. The objective of this work is to retrospectively analyze the use of this procedure in newly diagnosed Czech patients. Methods: Data were derived using the Czech Myeloma Group Registry of Monoclonal Gammopathies. By February 2 nd 2021, a total of 2154 newly diagnosed multiple myeloma patients who underwent HDT/ASCT were identified. Results: At the time of multiple myeloma diagnosis, the median age was 59 years; 24%/56%/14%/5%/1% pts were ECOG 0/1/2/3/4; 44%/32%/24% pts were ISS stage I/II/III; 14.5%/17.5%/68% and 84%/16% pts were Durie-Salmon stage I/II/III and subclassification A/B, respectively. The combinations of agents used in the induction regimen were proteasome inhibitor (PI), immunomodulatory drug (IMiD) and glucocorticoid (GC) in 28.5% (613/2154) pts; PI, GC and chemotherapy (CHT) in 24.8% (534/2154) pts; GC and CHT in 22,5% and IMiD, GC and CHT in 16.1% (346/2154). Other combination of drugs was used in 8.2% (177/2154) pts. It was registered that 3.7% (79/2154) induction regimens were switched to a different combination because of toxicity, patient's choice, poor peripheral venous access or other reasons. Single HDT/ASCT was performed in 77.3% (1665/2154) cases whereas tandem HDT/ASCT was given to 11.8% (254/2154) patients. In 10% (215/2154) cases, the transplantation technique was not specified. Nine percent (193/2154) patients were treated within a clinical study. The median progression free survival (mPFS) and the median overall survival (mOS) of the whole cohort was 28.9 and 92.1 months, respectively. Information about response to treatment before and after the high-dose therapy were available for 75.7% (1627/2154) and 92.2% (1987/2154) patients, respectively. Disease status at the time of HDT/ASCT was defined as stringent complete response (sCR) at 2.2% (36/1627), complete response (CR) at 11.9% (194/1627), very good partial response (VGPR) at 38.2% (621/1627), partial response (PR) at 40.9% (666/1627), minimal response (MR) at 3.6%, (58/1627), stable disease (SD) at 2.2% (36/1627), progressive disease (PD) at 1% (16/1627) patients. The overall response rate (ORR) on day 100 was 92.8% (sCR: 10.5% [209/1987], CR: 22.4% [446/1987], VGPR: 35% [696/1987], PR: 24.8% [493/1987], MR: 2.7% [54/1987], SD: 1.4% [27/1987], PD: 3.1% [62/1987]). We also performed a survival analysis of patients progressing up to 18 months after HDT/ASCT (n=1219) versus patients progressing in more than 18 months (n=935). The median OS was 41.5 versus 124.9 months, respectively. An analysis of the role of tandem HDT/ASCT in this real-world cohort will be presented at the conference. Conclusion: Globally as well as in the Czech Republic, HDT/ASCT is an important therapeutic approach in the first-line treatment of multiple myeloma. Our analysis of 2154 newly diagnosed transplant-eligible patients confirms high effectiveness - ORR of 92.8%, mPFS of 28.9 months, and long-term survival reaching mOS of 92.1 months. Disclosures Minarik: Amgen: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Takeda: Consultancy, Honoraria.

Single-agent docetaxel (TXT) as first-line treatment in metastatic breast cancer (MBC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11515-11515
Author(s):  
D. Guarneri ◽  
R. Ratti ◽  
A. Venturino ◽  
G. Addamo ◽  
Z. Coccorullo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Single Agent ◽  
Metastatic Breast ◽  
Line Treatment ◽  
First Line ◽  
Group 2 ◽  
Agent Treatment ◽  
First Line Treatment ◽  
Group 1

11515 Background: Historically anthracyclines have been considered the most active agents in metastatic breast cancer (MBC). Docetaxel (TXT) has challenged this belief. Aims: Evaluate response rates, toxicity and time to progression in patients with MBC receiving single agent TXT as first line treatment. Methods: MBC patients received first line single agent treatment according to one of the following schedules: TXT 35 mg/m2 iv weekly for 6 wks q 8 wks (Group 1) or TXT 100 mg/m2 iv day 1 q 3 weeks (Group 2). Adjuvant chemotherapy was FAC (600,50,600) day 1 q 21 days for 6 courses in all cases so treated. Results: Conclusions: It appears that results with single agent TXT obtained in clinical practice are comparable to those reported in Phase II-III trials (Group 1 and Group 2, respectively ) using the same regimens. [Table: see text] No significant financial relationships to disclose.

Influence of First-Line Regimens on the Outcomes of High-Dose Chemotherapy with Autologous Hematopoietic Stem-Cell Transplantation for Patients with Newly Diagnosed Multiple Myeloma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 931-931 ◽  
Author(s):  
Bimalangshu R. Dey ◽  
Benjamin Cox ◽  
A. Jo Chien ◽  
Martin Caron ◽  
Steven L. McAfee ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Newly Diagnosed ◽  
First Line ◽  
Conventional Chemotherapy ◽  
Hematopoietic Stem ◽  
Group 2 ◽  
Group 1

Abstract Randomized trials that incorporated high-dose chemotherapy (HDC) plus autologous hematopoietic stem-cell transplantation (Au-HSCT) into the early treatment of patients with newly diagnosed multiple myeloma demonstrated superior overall and event-free survival (EFS) in patients 65 years of age or younger, who received Au-HSCT, as compared with patients who received conventional chemotherapy. Based on these encouraging results, Au-HSCT is recommended for patients with myeloma as part of their initial treatment, and today, myeloma is the most common indication for HSCT in the world. All patients in these trials received four to six months of conventional chemotherapy prior to HDC and Au-HSCT. In practice, however, both in the community as well as in academic hospitals, patients are undergoing Au-HSCT after being treated with various first-line regimens, including chemotherapeutics, high-dose dexamethasone (HDex), immunomodulatory drugs such as thalidomide and recently, proteasome inhibitors. In this retrospective study, we examined the impact of first-line therapy on the outcomes following Au-HSCT. Our objective was to compare two treatment groups - chemotherapy versus non-chemotherapy, prior to Au-HSCT - with respect to survival after Au-HSCT. Between 1997 and 2004, 37 previously untreated evaluable patients with myeloma, received either chemotherapy (group 1, n=25; vincristine, adriamycin and dexamethasone (VAD), n=24; melphalan and prednisone (MP), n=1) or non-chemotherapy regimens (group 2, n=12; HDex, n=9; thalidomide plus HDex, n=3), then received HDC followed by cyclophosphamide plus granulocyte colony stimulating factor-mobilized HSCT. The median age of patients in group 1 was 58 (range, 44–73) years and in group 2 was 55 (range, 41–67) years; 22 patients in group 1 (88%) and 10 patients in group 2 (83%) had stage III disease; the median times from diagnosis to HSCT were 6 (range, 5–16) and 8 (range, 5–25) months, respectively, in groups 1 and 2. The rates of complete and near-complete response were 44% in group 1 and 42% in group 2; the rates of partial responses were also similar: 48% and 42% respectively. The median duration of EFS was 31 (range, 7–89) months, and the median overall survival (OS) was 55 (range, 12–98) months in group 1, as compared with group 2 where EFS and OS were 21 (range, 12–40) and 31 (range, 16–76) months, respectively. The EFS at 3 years was 44% in group 1 and 25% in group 2, and OS at 5 years was 32% in group 1 and 8% in group 2 (statistically not significant). In conclusion, patients with newly diagnosed myeloma, when treated with chemotherapy prior to Au-HSCT, may have long-term overall and EFS advantages, as compared with patients who are treated with first-line non-chemotherapy regimens. The reasons for the longer duration of response in the chemotherapy group despite similar response rates in the two groups are unknown, but may be due to more effective suppression of residual disease or non-specific damage to the marrow microenvironment, which is necessary for the growth of myeloma cells. Although, the difference in survival outcomes following Au-HSCT between the two groups did not achieve statistical significance, our results raise an important question regarding the “adequacy” of different first-line regimens prior to Au-HSCT, and therefore, justify the need for prospective randomized studies to evaluate optimal pre-AuHSCT induction therapy.

Lenalidomide, Adriamycin and Dexamethasone (RAD) As An Induction Regimen In Newly Diagnosed Multiple Myeloma – Interim Results From a German Multicenter Phase II Trial

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1987-1987 ◽  
Author(s):  
Stefan Knop ◽  
Christian Langer ◽  
Monika Engelhardt ◽  
Lars O Muegge ◽  
Wolf Roesler ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Phase Ii ◽  
Research Funding ◽  
Phase Ii Trial ◽  
Phase Iii ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
First Line ◽  
First Line Treatment

Abstract Background Induction triplets utilizing at least one of the “novel drugs” and steroids with or without chemotherapy are considered current standard of care in newly diagnosed, symptomatic multiple myeloma (MM). Medically fit patients (pts) remain candidates for subsequent autologous (auto) stem cell transplant (SCT) while use of allogeneic (allo) SCT remains a matter of debate. As we had previously shown the RAD regimen to be well tolerated and highly effective in relapsed and relapsed/refractory MM, we evaluated this combination in first-line treatment. Methods The current phase II trial (DSMM XII) was designed to include a total of 190 pts up to 65 years of age with symptomatic MM. Four 4-week cycles of RAD (lenalidomide 25 mg/day, d 1-21; adriamycin 9 mg/m² as 24-hour infusion, d1-4; oral dexamethasone 40 mg, d1-4 and 17-20; pegfilgrastim 6 mg, d 6) preceded stem cell chemomobilization. Low-molecular weight heparin for prophylaxis of venous thromboembolic events (VTE) was mandatory. Pts received either tandem auto SCT (melphalan 200 mg/m²; Mel200) or auto followed by allo SCT. Allo SCT (preparative regimen: treosulfan/fludarabine) was reserved for pts featuring at least one cytogenetic or serologic risk factor who had a matched sibling or unrelated donor available. Lenalidomide maintenance was administered for one year following both tandem auto and auto/allo SCT. This is the second pre-planned interim safety and efficacy analysis. Results Eighty-nine pts with a median age of 54 (range, 30-65) years, who were recruited between August 2009 and October 2010, are evaluable. Fifty pts (56.2%) had ISS stage II/III disease and in all except three, molecular cytogenetic analysis was performed. Incidences of chromosomal abnormalities were as follows: deletion of (del) 13q, 24.7%; translocation t(4;14), 12.4%; t(14;16), 3.4%; and del 17p, 5.6%. Treatment-related mortality with RAD induction was 0% while 61.8% of pts had treatment-emergent SAEs. Seventeen pts (19%) experienced neutropenia of grades 1 to 4. Incidences of severe (grades 3/4) and febrile neutropenia were 5.6 and 1%, respectively. Seven pts each (8%) had pneumonia and VTE, respectively. Post-RAD-induction CR/sCR and at least VGPR rates were 9% and 47.2%, respectively. All 78 pts with at least stable disease successfully mobilized stem cells. Overall response rate (at least partial response, PR) following first SCT on an intention-to-treat basis was 83%. Twelve pts each (13.5%) achieved centrally confirmed complete response (CR) or stringent (s)CR, respectively, and 54 pts (60.7%) had at least very good PR (VGPR). Conclusions This interim analysis shows RAD to be very well tolerated and effective in first line treatment of symptomatic MM. Mel200 further increased rates of deep response (at least VGPR) achieved by RAD induction. We are currently comparing this regimen to bortezomib, lenalidomide and dexamethasone (VRd) in a phase III trial. Disclosures: Knop: Celgene GmbH: Honoraria. Off Label Use: Lenalidomide and doxorubicin in newly diagnosed multiple myeloma. Engelhardt:MSD, Janssen-Cilag: Research Funding. Einsele:Celgene GmbH: Consultancy, Honoraria, Research Funding. Bargou:Celgene GmbH: Research Funding.

Development of thrombocytopenia during first-line treatment and survival outcomes in newly diagnosed multiple myeloma

2019 ◽  
Vol 60 (12) ◽  
pp. 2960-2967 ◽  
Author(s):  
Patrick W. Mellors ◽  
Moritz Binder ◽  
Francis K. Buadi ◽  
Martha Q. Lacy ◽  
Morie A. Gertz ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Survival Outcomes ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
First Line ◽  
First Line Treatment

scholarly journals First-Line Treatment with a Cyclin-Dependent Kinase 4/6 Inhibitor Plus an Aromatase Inhibitor for Metastatic Breast Cancer in Alberta

2021 ◽  
Vol 28 (3) ◽  
pp. 2270-2280
Author(s):  
Carla P. Amaro ◽  
Atul Batra ◽  
Sasha Lupichuk
Keyword(s):  
Aromatase Inhibitor ◽  
Median Time ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Second Line ◽  
Cyclin Dependent Kinase ◽  
Time To Progression ◽  
First Line ◽  
First Line Treatment

In this analysis, we describe population-based outcomes for first-line treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) combined with an aromatase inhibitor (AI). All patients who were prescribed CDK4/6i + AI from January 2016 through June 2019 were included. Patient demographics, tumour and treatment characteristics were collected and described. Survival distributions were estimated using the Kaplan–Meier method. Multivariate analysis (MVA) was constructed to examine associations between potentially prognostic clinical variables and progression-free survival (PFS). In total, 316 patients were included. The median age was 61 years. After a median follow-up of 28.1 months, the median PFS was 37.9 months (95% CI, 26.7–NR). In the MVA, PR-negative tumour (HR, 2.37; 95% CI, 1.45–3.88; p = 0.001) and CDK4/6i dose reduction (HR, 1.51; 95% CI, 1.06–2.16; p = 0.022) predicted worse PFS. Median overall survival (OS) was not reached. The 30-month and 36-month OS rates were 74% and 68%, respectively. Of patients who progressed, 89% received second-line treatment. Median time to progression on second-line chemotherapy was 9.0 (5.8–17.6) months, and median time to progression on second-line hormonal therapy +/− targeted agent was 4.0 (3.4–8.6) months (p = 0.012). CDK4/6i + AI as first-line treatment for HR-positive, HER2-negative MBC in Alberta is justified based on favourable PFS and early OS outcomes.

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