In a high-dose melphalan setting, palifermin compared with placebo had no effect on oral mucositis or related patient’s burden

Blijlevens, N.M.A.; Chateau, Maarten de; Kriván, Gergely; Rabitsch, Werner; Szomor, Árpád; Pytlik, Robert; Lissmats, Agneta; Johnsen, Hans Erik; Witte, Théo de; Einsele, Hermann; Ruutu, Tapani; Niederwieser, Dietger

doi:10.1038/bmt.2012.257

Cited by 43 publications

(41 citation statements)

References 20 publications

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“…Palifermin administered pre-and post-HDM was studied in a randomized fashion with no beneficial effect on mucositis incidence and on fever. 63 Other studies, however, found a positive impact of palifermin on infection rate after BEAM-like conditionings or after TBI. [64][65][66] Furthermore, some studies suggested that, though palifermin was not effective in reducing overall infection rate (mostly central venous catheter related), its use may reduce 'severe' infections such as those due to Gramnegative pathogens or accompanied by focal pneumonia.…”

Section: Hdc Administration Hpc Infusionmentioning

confidence: 98%

Italian consensus conference for the outpatient autologous stem cell transplantation management in multiple myeloma

Martino¹,

Lemoli

Girmenia

et al. 2016

Bone Marrow Transplant

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Multiple myeloma (MM) is the leading indication for autologous stem cell transplantation (ASCT) worldwide. The safety and efficacy of reducing hospital stay for MM patients undergoing ASCT have been widely explored, and different outpatient models have been proposed. However, there is no agreement on the criteria for selecting patients eligible for this strategy as well as the standards for their clinical management. On the basis of this rationale, the Italian Group for Stem Cell Transplantation (GITMO) endorsed a project to develop guidelines for the management of outpatient ASCT in MM, using evidence-based knowledge and consensus-formation techniques. An expert panel convened to discuss the currently available data on the practice of outpatient ASCT management and formulated recommendations according to the supporting evidence. Evidence gaps were filled with consensus-based statements. Three main topics were addressed: (1) the identification of criteria for selecting MM patients eligible for outpatient ASCT management; (2) the definition of standard procedures for performing outpatient ASCT (model, supportive care and monitoring during the aplastic phase); (3) the definition of the standard criteria and procedures for re-hospitalization during the aplastic phase at home. Herein, we report the summary and the results of the discussion and the consensus. INTRODUCTIONMultiple myeloma (MM) remains the leading indication for highdose chemotherapy and autologous stem cell transplantation (ASCT) worldwide 1,2 and the International Guidelines recommend that ASCT should be offered at some point during the treatment program for a medically fit patient. 3,4 High-dose melphalan (HDM) at 200 mg/m 2 is the standard conditioning for ASCT 5,6 and, today, the treatment should be considered a safe procedure with a very low transplant-related mortality (TRM). 7-9 The significant increase in the waiting lists generated concerns about the appropriate use of health care resources and, over the past years, some studies have investigated the safety, efficacy and potential cost advantages of reducing hospital stay for patients undergoing ASCT. [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] The ease of administering HDM, the relatively low extra-hematological toxicity and the short period of neutropenia 5,6 make MM patients ideal candidates for outpatient ASCT programs. Standardization of criteria for the outpatient ASCT policy is a relevant goal of the Italian hematology and transplant community and may facilitate comparison of retrospective and prospective data. The Italian Group for Stem Cell Transplantation (GITMO) endorsed a panel of 10 experts in the transplant field (MMa, RML, CG, LC, BB, MO, IL, MMo, GM and AO) to propose a consensus for the selection criteria and management of MM patients for ASCT procedure in the outpatient setting. METHODSA working group of 10 experts from 7 GITMO centers, with specific expertise in the field of ASCT, convened four times to: (a) identify common criteria for selecti...

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Section: Hdc Administration Hpc Infusionmentioning

confidence: 98%

Italian consensus conference for the outpatient autologous stem cell transplantation management in multiple myeloma

Martino¹,

Lemoli

Girmenia

et al. 2016

Bone Marrow Transplant

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“…Şiddetli oral mukozit ve süresi yüksek doz kemoterapi alma ile önemli oranda ilişkilidir. (12) HKHN yapılan hastalarla yürütülen çalışmalara bakıldığında temel ağız bakımı, oral kriyoterapi veya düşük-düzeyli lazer tedavisi oral mukoziti önleme ve tedavisinde etkin yaklaşımlar arasındadır. (13) …”

Section: öZunclassified

“…Şiddetli oral mukoziti önlemeye yönelik HKHN uygulanan hastalarda Food and Drug Administration (FDA) tarafından onaylanan ilk ajandır. (31) Blijlevens ve arkadaşları (12) paliferminin etkisini yüksek doz Melphalan alan otolog HKHN hastalarında oral mukozit şiddetini değerlendirmek üzere yaptıkları randomize kontrollü çalışmada 277 hastayı dahil etmişlerdir. Plasebo (n=57), preyüksek doz melphalan (YDM) alan hasta (n=107) ve pre/post yüksek doz melphalan hasta (n=107) grubu olmak üzere 3 grup oluşturulmuştur.…”

Section: Diğer Uygulamalarunclassified

Review of Oral Mucositis Studies in Post Stem Cell Transplant Patients

Yildirim¹,

Baykal²,

Can³

2018

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ÖZKök hücre transplantasyonu yapılan hastaların büyük kısmında oral mukozit, hastaların yaşam kalitesini olumsuz yönde etkileyen önemli sorunlardan biridir. Hastanın beslenmesini olumsuz etkileyerek, parenteral beslenmenin ve ağrıya neden olarak opioid tedavilerin baş-lanmasına neden olur. Hastanın hastanede kalış süresinin uzamasına neden olarak, hastane maliyetlerinin artmasına yol açmaktadır. Bazı hastalarda uzun süreli tedavi sonuçlarını da olumsuz etkileyebilmektedir. Yönetiminde, nakil öncesi hastanın diş hekimliğine yönlendirilerek diş bakımının yapılması, düşük doz lazer tedavi (DDLT) uygulanması, nakil sırasında temel ağız bakımının sürdürülmesi ve kriyoterapinin uygulanması etkinliği gösterilmiş non-farmakolojik yaklaşımlardır.Farklı çalışmalarda, kapsamlı ağız bakımının düzenli yapılması, var olan oral mukozitlerin şiddetini ve süresini azalttığı, DDLT şiddetli oral mukozitin gelişimini engellediği ve oluşan mukozitin iyileşme sürecini hızlandırdığı, tek başına DDLT uygulanması ile kıyaslandığında DDLT ile birlikte kriyoterapinin uygulanmasının oral mukozitlerin iyileştiril-mesinde daha yararlı olduğu saptanmıştır.Bu derleme kök hücre transplantasyonu tedavisi uygulanan hastalarda oral mukozite yönelik çalışmaların gözden geçirilmesi amacıyla yazıl-mıştır. ABSTRACTOral mucositis is one of the most important issues affecting the quality of life in the majority of patients undergoing stem cell transplantation. It negatively affects the nutrition of the patient and leads to the administration of parenteral nutrition as well as opioid therapies due to the onset of pain, a prolonged hospital stay, and an increase in hospital costs. It may also adversely affect long-term treatment results in some patients.Non-pharmacological approaches such as administering low-dose laser treatment (LDLT), maintaining basic oral care during transfer, and administering cryotherapy have been shown to be effective in oral care management.In different studies, it was found that regular oral care decreases the severity and duration of existing oral mucositis, LDLT prevents the development of severe oral mucositis and accelerates the mucositis recovery process, and cryotherapy with LDLT is more effective in the treatment of oral mucositis compared to LDLT alone. This review has been written to overview oral mucositis studies in post stem cell transplant patients.

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“…The importance of conditioning is suggested, in fact, by studies from Herbers et al who reported that palifermin administration in patients treated using a BEAM conditioning schedule leads to a reduction in the rate of some infections such as 'fever of unknown origin' (FUO), 9 while the same group did not find this effect in patients treated with high-dose melphalan (HD-PAM). 10 In a previous work we indeed found that conditioning significantly interacts with the effects of palifermin and that this agent is able to reduce the rate of severe mucositis only after conditioning based on BEAM or on BU/Thiothepa treatment but not after 'HD-PAM' conditioning. 11 Now we present an analysis in which we have assessed the effect of palifermin on infection risk according to the conditioning regimen used.…”

Section: Introductionmentioning

confidence: 99%

Palifermin reduces infection rate and hyperfibrinogenemia in patients treated with high-dose chemotherapy based on beam or BU-thiothepa

Milone

Leotta

Cupri

et al. 2014

Bone Marrow Transplant

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We performed a retrospective study in patients who underwent high-dose chemotherapy and auto-SCT because of haematological malignancies. Forty patients were treated with palifermin while 80 were controls selected after being matched for diagnosis and length of neutropenia. Patients treated with BEAM or BU-CY or THIO-CY (BEAM/BUS) displayed, after palifermin, a lower rate of severe oral mucositis (P = 0.03). This beneficial effect of palifermin was not evident in the stratum of patients treated with high-dose melphalan (HD-PAM). After palifermin, we observed in the whole treated population a reduced rate of 'fever of unknown origin' (FUO, P = 0.02) and of severe infections not related to Gram-positive bacteria (FUO, Gram-negative bacteremia or pneumonia) (P = 0.003). This effect of palifermin on infections not related to Gram-positive bacteria was evident only in patients receiving BEAM/BUS (P = 0.01) and not in patients treated with HD-PAM (P = 0.11). Fibrinogen peak in plasma was found to be reduced after palifermin in the whole population (P = 0.01) and in the stratum who received BEAM/BUS (P = 0.02) but not in the stratum of HD-PAM. In conclusion, antiinfectious beneficial effects of palifermin are more evident in BEAM/BUS-treated patients and toward some types of infections. Reduction of fibrinogen level after palifermin suggests that this agent reduces not only the rate of infections but also their severity.

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In a high-dose melphalan setting, palifermin compared with placebo had no effect on oral mucositis or related patient’s burden

Cited by 43 publications

References 20 publications

Italian consensus conference for the outpatient autologous stem cell transplantation management in multiple myeloma

Italian consensus conference for the outpatient autologous stem cell transplantation management in multiple myeloma

Review of Oral Mucositis Studies in Post Stem Cell Transplant Patients

Palifermin reduces infection rate and hyperfibrinogenemia in patients treated with high-dose chemotherapy based on beam or BU-thiothepa

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