scholarly journals Autologous stem cell transplantation is safe and effective for fit older myeloma patients: exploratory results from the Myeloma XI trial

Haematologica ◽  
2020 ◽  
pp. 0-0
Author(s):  
Charlotte Pawlyn ◽  
David Cairns ◽  
Tom Menzies ◽  
John Jones ◽  
Matthew Jenner ◽  
...  

Autologous stem cell transplant (ASCT) remains standard of care for consolidation after induction therapy for eligible newly diagnosed myeloma patients. In recent clinical trials comparing ASCT to delayed ASCT, patients aged over 65 were excluded. In real-world practice stem cell transplants are not restricted to those aged under 65 and clinicians decide on transplant eligibility based on patient fitness rather than a strict age cut off. Data from the UK NCRI Myeloma XI trial, a large phase III randomised controlled trial with pathways for transplant-eligible (TE) and ineligible (TNE) patients, was used in an exploratory analysis to examine the efficacy and toxicity of ASCT in older patients including analysis using an agematched population to compare outcomes for patients receiving similar induction therapy with or without ASCT. Older patients within the TE pathway were less likely to undergo stem cell harvest at the end of induction than younger patients and of those patients undergoing ASCT there was a reduction in PFS associated with increasing age. ASCT in older patients was well tolerated with no difference in morbidity or mortality between patients aged

2020 ◽  
Author(s):  
Amy M Dennett ◽  
Judi Porter ◽  
Stephen B Ting ◽  
Nicholas F Taylor

Abstract BackgroundAutologous stem cell transplant is a common procedure for people with haematological malignancies. While effective at improving survival, autologous stem cell transplant recipients may have a lengthy hospital admission and experience debilitating side-effects such as fatigue, pain and deconditioning that may prolong recovery. Prehabilitation comprising exercise and nutrition intervention before stem cell transplant aims to optimise physical capacity before the procedure to enhance functional recovery after transplant. However, few studies have evaluated prehabilitation in this setting. We aim to determine preliminary efficacy of improving physical capacity of prehabilitation for people undergoing autologous stem cell transplant. MethodsThe PIRATE study is a single-blinded, parallel two-armed pilot randomised trial of multidisciplinary prehabilitation delivered prior to autologous stem cell transplantation. Twenty-two patients with haematological malignancy waitlisted for transplant will be recruited from a tertiary haematology unit. The intervention will include up to 8 weeks of twice-weekly, in-person, supervised tailored exercise and fortnightly nutrition education delivered via phone, in the lead up to autologous stem cell transplant. Blinded assessments will be completed at week 13, approximately 4 weeks after transplant and health service measures collected at week 25 approximately 12 weeks after transplant. The primary outcome is to assess changes in physical capacity using the 6-minute walk test. Secondary measures are time to engraftment, C-reactive protein, physical activity (accelerometer), grip strength, health-related quality of life (EORTC QLQ-C30 and HDC29 supplement), self-efficacy and recording of adverse events. Additionally, health service data including hospital length of stay, hospital readmissions, emergency department presentations and urgent symptom clinic presentation at 6 months will be recorded. DiscussionThis trial will provide valuable information that will inform a future definitive randomised controlled trial and implementation of prehabilitation for people receiving autologous stem cell transplant by providing data on efficacy and safety. Trial registrationThe PIRATE Trial has been approved by the Eastern Health Human Research Ethics Committee (E20/003/61055) and is funded by the Eastern Health Foundation. This trial is registered with the Australian New Zealand Clinical Trials Registry ACTRN12620000496910. Registered April 20, 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379441&isReview=true


2022 ◽  
Vol 2 (1) ◽  
Author(s):  
Sarah Goring ◽  
Lory Picheca

One relevant systematic review and network meta-analysis (which included 1 relevant randomized controlled trial), 4 non-randomized studies, and 6 evidence-based guideline reports, representing 5 evidence-based guidelines were identified in this report. The clinical effectiveness regarding response, relapse, progression-free survival, and overall survival broadly favoured bortezomib-lenalidomide-dexamethasone (RVd) over bortezomib-cyclophosphamide-dexamethasone (CyBorD), although the magnitude and direction of association was not always consistent, and few estimates were statistically significant. Limited evidence on the safety of RVd relative to CyBorD was found. No evidence on the cost-effectiveness of RVd as induction therapy before autologous stem cell transplant for multiple myeloma was found. Among the 5 included guidelines, 3 specifically recommend RVd as a first option for induction therapy among transplant-eligible newly diagnosed multiple myeloma patients, and 2 recommend more broadly defined 3-drug induction regimens that include RVd.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7511-7511 ◽  
Author(s):  
J. Vose ◽  
F. Loberiza ◽  
P. Bierman ◽  
G. Bociek ◽  
J. Armitage

7511 Background: Although patients (pts) with MCL have a high response rate to standard chemotherapy, they continue to relapse with no plateau in long term disease-free survival. The use of dose intense induction therapy such as HyperCVAD (M-C) ±Rituximab(R) and high-dose therapy and stem cell may improve these results. In this analysis the outcomes of pts receiving a standard anthracycline induction therapy or HyperCVAD(M-C)(±R) then followed by a stem cell transplant in first complete (CR1) or partial remission (PR1) were compared. Methods: Between 6/91 and 11/05, 124 pts with MCL received high-dose chemotherapy and a stem cell transplant. Of these pts, 80 received an autologous stem cell transplant in CR1 (N = 47) or PR1 (N = 33). A standard anthracycline based CHOP-like (±R) induction therapy was given to 48 pts compared with 32 pts who received HyperCVAD(M-C)(±R) prior to transplant. Results: The median age of pts was 56 years (range 33–70). The male:female ratio was 33:57. Bone marrow involvement prior to conditioning was present in 52% of pts. An elevated lactic dehydrogenase (LDH) was present in 58% of pts. 65% of patients received one prior chemotherapy before coming to stem cell transplant. The median follow up of pts is 38 months (range 3–143). Progression-free survival (PFS) and overall survival (OS) are outlined in table 1 . Characteristics associated with an improved OS by multivariate analysis included receiving HyperCVAD induction (p = 0.04), transplant in CR1 (p = 0.009), ≤ 3 prior chemotherapy regimens (p = 0.02) and no B symptoms at transplant (p = 0.05). Conclusions: To improve the long term disease free survival for pts with MCL, Hyper-CVAD(M-C)(±R) induction should be given to eligible patients with autolgous stem cell transplantation in CR1. [Table: see text] No significant financial relationships to disclose.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8607-8607
Author(s):  
Jonathan L. Kaufman ◽  
Joanne Willey ◽  
Michael E. Williams ◽  
Brynn Tiscione ◽  
Arden Buettner ◽  
...  

8607 Background: Maintenance lenalidomide improves survival in patients who have undergone induction therapy and then autologous stem cell transplant (ASCT) as first line management for MM. We studied how the extent of cytoreduction after induction therapy à ASCT (as measured by CR, VGPR, or PR as best response) influences MAINTRX prescribing preferences among American Hematology-Oncology physicians (AHOP). Methods: We studied 284 individual AHOPs using a proprietary, live, case-based market research tool to assess prescribing preferences. A core case scenario and variations based on extent of response to induction à ASCT was constructed. Preference data were acquired using blinded audience response technology. All responses for each scenario were obtained contemporaneously prior to any display of respondent selections. All sources of research support were double blinded. The core scenario involved a 59-year-old patient (42% plasma cells in BM, no cytogenetic abnormalities, CrCl 65ml/min, B2M 5.8, PS 1) treated with induction therapy of choice à ASCT. The same query was then posed in each of 3 settings: Following CR (or following VGPR or following PR) as best response, what, if any, further therapy would you recommend now? Results: See Table. Conclusions: Among patients with myeloma getting first-line therapy, MaintRx is almost uniformly preferred by AHOPs. Specific single or doublet therapy preferences are dependent upon best response to induction à ASCT treatment. Compared to the CR setting, preferences for 2 drug MaintRx are significantly increased in patients with VGPR (p <.0.001) or with PR (p < 0.001)] as best overall response. The potential for benefit from intensified MaintRx in these response subsets needs prospective phase III testing. [Table: see text]


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4905-4905
Author(s):  
Hannah McNally ◽  
Luke Mountjoy ◽  
Alison Collings

Abstract Olanzapine has been shown to significantly decrease nausea and emetic episodes associated with chemotherapy in patients undergoing hematopoietic stem cell transplant (Monson, Greer, Kreikemeier, & Liewer, 2020). Additionally, Olanzapine has been shown to improve clinical outcomes in autologous stem cell transplant patients when added to triplet anti-emetic therapy of ondansetron, fosaprepitant and dexamethasone without any negative effects on time to engraftment (Clemmons, et al., 2018). Although this study did not show any delay in time to engraftment, there is only a small amount of data looking at this question, including Clemmons et al. (2016) and Trifilio et al. (2017). Other studies (Navari et al., 2016) demonstrated a decrease in chemotherapy related nausea and vomiting in patients receiving Olanzapine, but did not provide data on engraftment times as this was in standard chemotherapy recipients. At Colorado Blood Cancer Institute (CBCI), Olanzapine was used for a period of time for anti-emetic prophylaxis both pre and post autologous stem cell transplant. There was concern regarding whether or not Olanzapine was causing delays in time to engraftment or even potentially graft failure and use of the drug in transplant anti-emetic regimens was discontinued. We hypothesized that Olanzapine does not cause higher incidence of graft failure, as compared to patients who do not receive Olanzapine as part of their anti-emetic regimen during the pre and post autologous stem cell transplant period. A retrospective analysis (n = 272) was conducted on patients who underwent autologous stem cell transplant between 2019 and 2020. 134 of these patients received Olanzapine during conditioning and up until time of engraftment, and 138 patients had no Olanzapine exposure throughout their conditioning and transplant. Conditioning regimens were equal between the two groups (Table 1). The average number of days on Olanzapine was 10.7, and the average dose was 7.5mg daily. For the purposes of this study engraftment was defined as the first day post stem cell infusion that the patient had an absolute neutrophil count (ANC) of greater than or equal to 500. Findings showed that the mean day of engraftment in the patients with Olanzapine exposure was 14.69; in the non-Olanzapine group, the mean day of engraftment was 12.64 (Table 2). Using the two-sample t-test, this difference (2.05 days, 95% CI (1.60-2.51)) is significant (p&lt;.0001). Based on our findings, there is evidence to support Olanzapine causing a slightly delayed time to engraftment in autologous stem cell transplant patients, but not a higher incidence of graft failure, although a randomized controlled trial would be needed to fully investigate. There is clear data showing increased ability to manage chemo therapy induced nausea and vomiting. While a randomized controlled trial would be needed to fully investigate, given there is not a proven increase in graft failure, Olanzapine should be considered as a desirable option to treat and prevent chemotherapy induced nausea and vomiting in autologous stem cell transplant patients. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: Olanzapine (Zyprexa) - Used off-label for the treatment and prevention of chemotherapy induced nausea and vomiting


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