What is the evidence for using mesna in patients treated with cyclophosphamide?

Comment by InpharmD Researcher

According to the 2008 update of American Society of Clinical Oncology (ASCO) guidelines, mesna plus saline diuresis is recommended to prevent hemorrhagic cystitis when cyclophosphamide is administered in the setting of bone marrow transplantation. However, one recent comprehensive review revealed inconsistent results regarding the uroprotective benefit of mesna for hemorrhagic cystitis prophylaxis (see Table 1). Hyperhydration with forced diuresis combined with aggressive mesna dosing may be an effective strategy in preventing cyclophosphamide-associated hemorrhagic cystitis, but high-quality randomized controlled trials are warranted to determine the definitive therapeutic benefits of mesna.

Background

According to the 2008 update of American Society of Clinical Oncology (ASCO) guidelines, mesna plus saline diuresis is recommended with cyclophosphamide to prevent hemorrhagic cystitis in the setting of bone marrow transplantation. There are also insufficient data to make a recommendation on a specific monitoring protocol for hemorrhagic cystitis in patients receiving mesna to ameliorate high-dose cyclophosphamide–associated urothelial toxicity. [1]

A 2020 comprehensive literature review included 14 studies (nine prospective and five retrospective) to evaluate the incidence of hemorrhagic cystitis (HC) in patients receiving cyclophosphamide with or without mesna. Several studies supported utilizing mesna to prevent cyclophosphamide-induced HC, whereas other studies either revealed no significant difference between the patients using mesna vs the control group or indicated mesna can increase the risk of HC (see table 1 for the summary of related studies). Additionally, a 2020 retrospective cohort study (N= 718) did not support the benefit of mesna in preventing HC. There was a significantly greater incidence of hemorrhagic cystitis (3.5% vs. 0.4%, p <0.004) as well as a significantly greater cumulative dose (mg) of cyclophosphamide therapy (3,103 ± 1,696 vs. 2,465 ± 1,528; p <0.001) in the mesna group versus those patients who were not given therapy with mesna. Overall, large differences among the published trials and various study designs as well as patient populations warrant the need for future quality prospective trials to reflect the benefit of mesna in preventing HC. [2]

A 2016 review article discussed the protective effect of mesna in cyclophosphamide- and ifosfamide-induced HC. One cohort study revealed there was no protective effect of mesna in patients who received cyclophosphamide for their rheumatic disease (1.53% of HC in mesna groups vs. 1.8% HC in the non-mesna group; p= 0.08). Moreover, studies have demonstrated that mesna has been linked to significant adverse events such as urothelial and mucosal changes. Overall, the authors concluded that although mesna is the most widely used agent that neutralizes the destructive metabolite, acrolein, its uroprotective benefit for HC prophylaxis can not be affirmed by evidence-based studies. [3]

An article providing a general overview on mesna recommends that the agent be first administered as an injection concurrently with cyclophosphamide or ifosfamide chemotherapy. If the physician deems that it is still necessary after the initial dosage, an oral form (400 mg tablet) is usually administered 2 to 6 hours following subsequent therapy. [4]

According to the Electronic Medicines Compendium (EMC), which provides prescribing information for medications licensed for use in the United Kingdom, mesna is given by intravenous injection over 15-30 minutes at 20% of the simultaneously administered oxazaphosphorine (i.e., cyclophosphamide or ifosfamide) IV bolus on a weight for weight basis (w/w). The same dose of mesna is repeated after 4 and 8 hours. The total dose of mesna is 60% (w/w) of the oxazaphosphorine dose. This is repeated on each occasion that the cytotoxic agents are used. If necessary, the dose of mesna can be increased to 40% of the oxazaphosphorine dose given four times at three-hourly intervals (0, 3, 6, and 9 hours; total dose= 160% [w/w] of the oxazaphosphorine dose). This larger dose is recommended in children, in patients whose urothelium may be damaged from previous treatment with oxazaphosphorine or pelvic irradiation, or in patients who are not adequately protected by the standard dose of mesna. When cyclophosphamide is used orally, the same dosage regimen of mesna applies as though cyclophosphamide were used as an IV bolus. See Table 3 for an example dosage schedule of mesna given with cyclophosphamide/ifosfamide. [5]

A published abstract describes one hospital’s protocol for mesna administration to prevent the development of cyclophosphamide-associated hemorrhagic cystitis in autologous transplant patients. Mesna IV is given at the same dose of cyclophosphamide in four equally divided doses at 15 minutes before, then 3, 6, and 8 hours after the administration of cyclophosphamide. Following a retrospective review evaluating the effectiveness of this dosing schedule with aggressive IV hydration in preventing the development of hemorrhagic cystitis (HC) in autologous stem cell transplant patients, the authors concluded these methods were effective. [6]

References:

[1] Hensley ML, Hagerty KL, Kewalramani T, et al. American Society of Clinical Oncology 2008 clinical practice guideline update: use of chemotherapy and radiation therapy protectants. J Clin Oncol. 2008;27:127-145. doi:10.1200/JCO.2008.17.2627
[2] Almalag HM, Alasmari SS, Alrayes MH, et al. Incidence of hemorrhagic cystitis after cyclophosphamide therapy with or without mesna: A cohort study and comprehensive literature review. J Oncol Pharm Pract. 2021;27(2):340-349. doi:10.1177/1078155220920690
[3] Matz EL, Hsieh MH. Review of Advances in Uroprotective Agents for Cyclophosphamide- and Ifosfamide-induced Hemorrhagic Cystitis. Urology. 2017;100:16-19. doi:10.1016/j.urology.2016.07.030
[4] Reddy V, Winston NR. Mesna. [Updated 2021 Oct 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. https://www.ncbi.nlm.nih.gov/books/NBK556021/
[5] Electronic Medicines Compendium (EMC). Mesna Injection. Updated October 2014. Accessed March 30, 2022. https://www.medicines.org.uk/emc/product/1838/smpc#gref
[6] McPheeters L, Kennedy D, Holmberg LA. Divided dose scheduling of mesna to prevent the development of cyclophosphamide-associated hemorrhagic cystitis in autologous transplant patients. Biology of Blood and Marrow Transplantation. 2006;12(2):98. doi:10.1016/j.bbmt.2005.11.300

Literature Review

A search of the published medical literature revealed 3 studies investigating the researchable question:

Discuss the use of Mesna in patients treated with cyclophosphamide.

Level of evidence

B - One high-quality study or multiple studies with limitations  Read more→



Please see Tables 1-3 for your response.


 

Human studies on the incidence of hemorrhagic cystitis with or without mesna

Author

Design

Intervention

Incidence

Recommendation

Hows et al

(1983/1984)

Prospective randomized study

N= 61

Mesna vs. Forced diuresis

 

12.5% vs. 35% (p < 0.05***)

Support the use of mesna

 

Luce and Simons

(1988)

Prospective follow-up of participants

N= 22

Patients with HC after CP* were treated with CP and mesna

All did not have recurrent HC except one patient The authors concluded that mesna was effective in preventing recurrent HC

Shepherd et al.

(1991)

Randomized control trial

N= 100

Mesna vs. forced diuresis

13% vs. 8% (p= 0.71)

No difference between the use of mesna and forced diuresis

Letendre et al.

(1992)

Prospective feasibility trial

N= 97

Mesna vs. hydration and bladder irrigation

50% vs. 4%

Mesna was added only to four patients, of which two had severe HC thus the authors concluded that they maintained the use of hydration and bladder irrigation due to this suboptimal response

Kohno et al.

(1993)

Prospective follow-up of participants

N= 30

All patients received mesna

HC developed in only five patients

Mesna was used with hydration, but the authors conclude that based on what was published the regimen of mesna and hydration may prevent HC

Vose et al.

(1993)

Randomized control trial

N= 200

Mesna vs. bladder irrigation

53% vs. 76% (p= 0.007***)

Support the use of mesna as prophylaxis

Bedi et al.

(1995)

Prospective randomized trial

N= 147

Mesna vs. forced diuresis

27% versus 24% (p= 0.41)

The study showed no difference between mesna and forced diuresis

Khojasteh et al.

(2000)

Prospective follow-up of participants

N= 18

None, all patients received mesna

Less than 50% developed HC and related symptoms The authors concluded that mesna was effective, although no comparison group was available

Murphy et al. 

(1994)

Retrospective cohort

N= 217

Hyperhydration vs. Hyperhydration with mesna

Macroscopic hematuria: 8% vs. 16% (p= 0.08) Against the use of mesna

Tsuboi et al.

(2003)

Retrospective cohort

N= 450

Mesna vs. no mesna

Mesna was considered a risk factor for early-onset HC with an odds ratio of 5.3 (95% CI 1.5–19.1, p < 0.0105***)

Patients using mesna appears to have a greater risk of developing early-onset HC

Yilmaz et al.

(2015)

Retrospective study

N= 1,018

Mesna vs. without mesna

1.5% vs. 1.8%, (p= 0.08)

Cumulative CP dose (HR for 10 g increments 1.24,
p < 0.001***)

No difference in HC between mesna users and non-mesna users, however, support the use of mesna

Gonella et al.

(2015)

Retrospective cohort

N= 158

Patient with HC vs. patient without HC

100% of patients with HC took mesna compared to 99% without HC (p= 0.62) No difference between HC and non-HC patients with regard to the use of mesna

Saito et al.

(2018)

Retrospective cohort

N= 81

Patient with HC vs. patient without HC

61% of patients who did not have HC received mesna and 81% of patients with HC received mesna

Commented on factors associated with occurrence of HC including CP dose and possible supportive measures including hydration regardless of the use of mesna

CP: cyclophosphamide; HC: hemorrhagic cystitis

***Significant according to significance level of 0.05

References:

Adapted from: Almalag HM, Alasmari SS, Alrayes MH, et al. Incidence of hemorrhagic cystitis after cyclophosphamide therapy with or without mesna: A cohort study and comprehensive literature review. J Oncol Pharm Pract. 2021;27(2):340-349. doi:10.1177/1078155220920690

 

Use of high-dose mesna and hyperhydration leads to lower incidence of hemorrhagic cystitis after posttransplant cyclophosphamide-based allogeneic transplantation

Design

Single-center, retrospective chart review

N= 194

Objective

To describe the incidence and severity of hemorrhagic cystitis (HC) in patients with hematological disorders undergoing hematopoietic cell transplant (HCT )with post-transplant cyclophosphamide (PTCy) for graft-versus-host disease (GVHD) prophylaxis

Study Groups

All patients (N= 194)

Inclusion Criteria

All patients who received PTCy for GVHD prophylaxis as part of their first hematopoietic cell transplantation. Patients were required to receive mesna and hyperhydration as part of HC prevention strategy

Exclusion Criteria

Prior autologous or allogeneic HCT and death prior to PTCy

Methods

Eligible patients received cyclophosphamide 50 mg/kg on day +3 and day +4 as part of their GVHD prevention regimen. Prior to the initiation of cyclophosphamide, patients received hyperhydration at 250 mL/h with furosemide (until 24 h after the completion of the final cyclophosphamide dose) and mesna dosed at 20 mg/kg every 3 h for 16 total doses, with the daily dose of mesna being equivalent to 320% of the daily dose of cyclophosphamide. 

Duration

From 2014 to 2018

Outcome Measures

Primary: the incidence and severity of HC in patients who received PTCy, with a comparison between viral-associated HC (defined by a positive viral presence in urine) and chemical HC (defined by no positive viral presence in urine)

Secondary: onset of HC after HCT, days until HC resolution from onset, severity of HC, transplant clinical outcomes such as overall survival (OS), disease-free survival (DFS), relapse

Baseline Characteristics

 

All patients (N= 194)

 

Age at HCT (range), years

45 (2 to 73)  

Female

78 (40.2%)  

Primary diagnosis at HCT

AML

ALL

MDS/CML/MPN

Lymphoma

Nonmalignant

 

79 (40.7%)

46 (23.7%)

37 (19.1%)

10 (5.2%)

22 (11.3%)

 

Disease risk index (DRI)

Low

Intermediate

High

Very high

Nonmalignant

 

36 (18.6%)

63 (32.5%)

60 (30.9%)

13 (6.7%)

22 (11.3%) 

 

HCT comorbidity index

0

1–2

>2

 

55 (28.4%)

62 (32%)

77 (39.7%)

 

Results

Endpoint

All patients (N= 194)

 

Incidence rate of HC

61 (31.4%) --

Median onset of HC after HCT (range), days 

12 (3 to 71)  

Median resolution of HC from onset (range), days 

9 (1 to 69)  

Severity of HC

Grade 1

Grade 2

Grade 3

Grade 4 or higher

 

35 (57.4%)

19 (31.1%)

7 (11.5%)

--

Overall, HC did not impact transplant related outcomes of OS (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.45 to 1.41, p= 0.53), DFS (HR 0.94, 95% CI 0.55 to 1.61, p= 0.83), or relapse (HR 0.87, 95% CI 0.44 to 1.71, p= 0.68).

Length of stay was 4 days longer in patients who developed HC within the first 100 days after HCT compared to those without HC (33 vs. 29 days, p= 0.009).

Adverse Events

N/A 

Study Author Conclusions

As one of the largest retrospective analyses performed on HC in PTCy, the results conclude that aggressive measures in regards to mesna dosing in addition to hyperhydration are needed to prevent the morbidity associated with HC.

InpharmD Researcher Critique

Given the retrospective nature and lack of a comparator arm, a definite conclusion regarding HC prevention can not be made. While administering mesna intermittently throughout the day might have contributed to the lower incidence rates and severity of both viral and chemical HC, the benefit of preventing HC by giving mesna at doses higher than 100% of the daily cyclophosphamide dose remains uncertain.



References:

Mac S, Ngo D, Yang D, et al. Use of high-dose mesna and hyperhydration leads to lower incidence of hemorrhagic cystitis after posttransplant cyclophosphamide-based allogeneic transplantation. Bone Marrow Transplant. 2021;56(10):2464-2470. doi:10.1038/s41409-021-01364-0

Example Dosage Schedule of Mesna Given with Cyclophosphamide/Ifosfamide

 

0 hours 4 hours 8 hours -

Cyclophosphamide/Ifosfamide

2 g - - -

Mesna

400 mg 400 mg 400 mg -
 

0 hours

3 hours 6 hours 9 hours

Cyclophosphamide/Ifosfamide

2 g - - -

Mesna

800 mg 800 mg 800 mg 800 mg
References:

Adapted from: Electronic Medicines Compendium (EMC). Mesna Injection. Updated October 2014. Accessed March 30, 2022. https://www.medicines.org.uk/emc/product/1838/smpc#gref