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Nursing Management of Patients Receiving Ibrutinib for Steroid-Dependent/Refractory Chronic Graft Versus Host Disease

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Poster 22805be

Nursing Management of Patients Receiving Ibrutinib for Steroid-Dependent/Refractory

Chronic Graft Versus Host Disease

Melissa Logue, ANP-BC1; Susan Stephenson, RN, BMT CN2; Lori Styles, MD3; Vijay Reddy, MD, PhD3; Corey S. Cutler, MD, MPH, FRCPC2; Madan Jagasia, MD, MBBS, MS4

1Vanderbilt University Medical Center, Nashville, TN, USA; 2Dana Farber Cancer Institute, Boston, MA, USA; 3Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA; 4Vanderbilt Ingram Cancer Center, Nashville, TN, USA

 

• Chronic graft versus host disease (cGVHD) is a life-threatening

complication of allogeneic stem cell transplantation with no

approved therapies if patients fail corticosteroids.1

• Ibrutinib, a first-in-class, once-daily inhibitor of Bruton’s

tyrosine kinase (BTK),2-4 is approved by the US FDA for the

treatment of adult patients with cGVHD after failure of 1 or

more lines of systemic therapy.

• Oncology nurses guide patient care and education on managing

their cGVHD symptoms while on ibrutinib treatment.5,6

OBJECTIVE

• Our objective was to evaluate nursing practice patterns in

managing symptom burden, treatment-emergent adverse

effects (TEAEs), and concomitant medications in patients

receiving ibrutinib for cGVHD after failing at least 1 prior

regimen.

METHODS

Study Design

• Multicenter, phase 1b/2 open-label study assessing the

safety and efficacy of ibrutinib in steroid-dependent/steroidrefractory

cGVHD patients who failed ≤3 lines of systemic

therapy (PCYC-1129-CA, NCT02195869)1 (Figure 1)

Patient Eligibility

• Eligible patients (N=42 evaluable) with ≤3 prior regimens

for cGVHD received 420 mg/day ibrutinib until progressive

disease or intolerable toxicity.

Oncology Nurses and Managing Adverse Events

• Managed AEs and concomitant medications via an online

messaging system and study visit forms

• Managed TEAEs based on institutional guidelines at Vanderbilt

University Medical Center (Nashville, TN) and the Dana Farber

Cancer Institute (Boston, MA)

RESULTS

Patient Baseline Characteristics

• Ibrutinib (median treatment duration, 4.4 months [range,

0.2–24.9 months]) was administered to 42 patients (median

age, 56 years [range, 19–74]; 22/42 [52%] males) who had

failed a median of 2 prior cGVHD regimens (range, 1–3).

• Most patients (37/42, 88%) had cGVHD with multiple organs

involved, including mouth (36/42, 86%), skin (34/42, 81%),

gastrointestinal system (14/42, 33%), and liver (7/42, 17%).

Efficacy

• Ibrutinib produced a high rate of response based on 2005

(with updates to align with 2014) NIH cGVHD response

criteria,7,8 with clinically meaningful improvement in Lee

Symptom Scale Scores across multiple organ domains

(Figure 2).

—— 9/28 (32%) of responders had a complete response; the

rate of sustained response for ≥20 weeks (5 months) was

71% (20/28 responders).

—— Overall, 26/42 patients (62%) achieved corticosteroid

doses <0.15 mg/kg/d by Week 52 while on ibrutinib;

5/28 responders (18%) were able to discontinue all

corticosteroid treatment.

• Oncology nurses assessed cGVHD symptoms using a

scorecard based on NIH cGVHD consensus panel response

criteria for multiple organ domains.

Safety

• Oncology nurses managed common TEAEs that occurred

with ibrutinib treatment according to institution-specific

recommendations (Figure 3, Table 1); no patients experienced

major hemorrhagic TEAEs. Follow USPI recommendations

to manage hemorrhage risk.

• Nurses guided patient education on concomitant medications,

including cytochrome P450 (CYP) 3A inhibitors (Figure 4),

anticoagulants, and antiplatelet drugs.

• Patients were taking a median of 13 concomitant medications

within the first 10 days of study drug administration, including

prednisone (100%), Bactrim (79%), acyclovir (71%), and

oxycodone (45%).

—— 8/42 patients (19%) took anticoagulants, and 9/42 (21%)

took antiplatelet drugs.

—— 10/42 patients (24%) were taking strong CYP3A inhibitors

and 20/42 patients (48%) were taking moderate CYP3A

inhibitors during the study.

—— 22/42 patients (52%) were taking immunosuppressants at

baseline, including tacrolimus (33%) and mycophenolate

mofetil (10%).

CONCLUSIONS

• Oncology nurses guided patients through their symptom

management during ibrutinib treatment for cGVHD

according to nursing best practice at individual institutions.

• In the study described here, ibrutinib therapy was tolerated

and resulted in clinically meaningful and sustained responses

in patients who had failed 1 to 3 prior treatment(s) for cGVHD.

—— AEs were consistent with those previously reported for

ibrutinib and those reported in patients with cGVHD on

concomitant corticosteroids.

—— ORR was 67%; 71% of responders had a sustained response

of ≥20 weeks.

—— Patients experienced reductions in corticosteroid doses

while on ibrutinib.

—— Patients with multiple organ involvement generally

showed responses in ≥2 organs.

• Managing TEAEs and concomitant medications by oncology

nurses requires ongoing communication between healthcare

providers and patients.

REFERENCES

1. Miklos D, et al. Blood. 2017;130(21):2243-50.

2. Dubovsky JA, et al. J Clin Invest. 2014;124(11):4867-76.

3. Ryan CE, et al. Blood. 2016;128(25):2899-908.

4. Blazar BR, et al. Nat Rev Immunol. 2012;12(6):443-58.

5. Brown C. A Guide to Oncology Symptom Management. 2nd ed. Pittsburg, PA: ONS;

2015.

6. Lee S, et al. Biol Blood Marrow Transplant. 2002;8(8):444-52.

7. Pavletic SZ, et al. Biol Blood Marrow Transplant. 2006;12(3):252-66.

8. Lee SJ, et al. Biol Blood Marrow Transplant. 2015;21(6):984-99.

9. IMBRUVICA® (ibrutinib) prescribing information. Sunnyvale, CA: Pharmacyclics LLC;

February 2018.

DISCLOSURES

ML and SS: no relevant disclosures; LS: is employed by Pharmacyclics LLC, an AbbVie

Company, and has stock ownership in AbbVie; VR: is employed by and serves a leadership

role with Pharmacyclics LLC, an AbbVie Company; has stock ownership in AbbVie, and

has received travel expenses from Pharmacyclics LLC, an AbbVie Company, and Janssen;

CSC: has served in a consulting or advisory role for Astellas, Bristol-Myers Squibb, Incyte,

Kite, Pfizer, and Pharmacyclics LLC, an AbbVie Company; MJ: has served in a consulting or

advisory role and has received research funding from Janssen and Therakos.

ACKNOWLEDGMENTS

We thank the patients who participated in the study and their supportive

families, as well as the investigators and clinical research staff from the study

centers. This study was sponsored by Pharmacyclics LLC, an AbbVie Company.

The authors also thank Stephen Chang, PhD, from Pharmacyclics LLC, an

AbbVie Company, for statistical analysis. Medical writing support was provided

by Danielle L. Ippolito, PhD, and funded by Pharmacyclics LLC, an AbbVie

Company.

Poster presented at the Oncology Nursing Society (ONS) Annual Meeting, May 17-20, 2018, Washington, DC, USA.

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