Journal of Clinical Apheresis 30:359–363 (2015)
Brief Report Successful Implementation of a Rural Extracorporeal Photopheresis Program for the Treatment of Cutaneous T-cell Lymphoma and Chronic Graft-Versus-Host Disease in a Rural Hospital Litchia L. Weber,1 Nancy M. Dunbar,2 Kenneth R. Meehan,3 Zbigniew M. Szczepiorkowski,2 and Frederick Lansigan3* 1
2
Department of Medicine, Dartmouth-Hitchcock Medical Center Department of Pathology and Medicine, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center 3 Department of Hematology, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center Objective: Extracorporeal photopheresis (ECP) is currently standard therapy for cutaneous T-cell lymphoma (CTCL) and Graft-versus-host disease (GVHD). Of the many challenges associated with outpatient ECP treatments, commuter travel to capable facilities can fragment and compromise the patient care. In 2008, our hospital implemented an ECP program providing patients to a treatment center over 120 minutes away. This study was undertaken to describe our experience with the establishment of a regional ECP program. Methods: A retrospective review using a standardized template was performed of patients treated from May 2008 to 2012. The response to treatment was analyzed after a minimum of eight procedures. A partial response to treatment in individuals with CTCL, was more than 50% skin improvement, and GVHD, a reduction in steroid dose by 50%, liver function test improvement or documented improvement in skin findings. Results: Of the 34 patients treated, 11 were for CTCL and 23 for GVHD. 95.8% of the 1,071 planned procedures were successfully. The average procedure time was 186 min for the UVAR-XTSTM and 93 min for the CELLEXTM. Patients travelled a median of 65.7 miles (range 4–133 miles). The median duration of therapy was 6 months (range 2–23) for CTCL and 5 months (range 1–27) for GVHD. A clinical benefit was observed in 7 of 11 (63.6%) patients with CTCL and in 15 of 23 (65.2%) with GVHD. Conclusion: Our regional ECP program was a viable option in improving access to care for patients requiring C 2015 Wiley Periodicals, Inc. treatment for CTCL and chronic GVHD. J. Clin. Apheresis 30:359–363, 2015. V Key words: extracorporeal photopheresis; ECP; implementation; cutaneous T-cell lymphoma; graftversus-host disease
Extracorporeal photopheresis (ECP) is a form of apheresis and photodynamic therapy in which the mononuclear cells in peripheral blood are treated with 8-methoxypsoralen, which is then activated with ultraviolet light [1–4]. ECP is currently a standard therapy for cutaneous T-cell lymphoma (CTCL), and is considered a category I indication (first line therapy) by the American Society for Apheresis (ASFA) [4]. It is also considered a category II indication (supportive or adjunctive therapy) for chronic graft-versus-host disease (GVHD) [5]. ECP has an established safety profile and is not associated with immunosuppression, opportunistic infections, secondary malignancies, or lipid abnormalities [1,6]. In the United States, the most commonly used devices to perform ECP are the UVARXTSTM and the CELLEXTM, developed by Therakos, Inc. [4]. C 2015 Wiley Periodicals, Inc. V
Our institution serves as the state’s only academic medical center and a major tertiary care referral for a rural community spanning a vast landscape. In May 2008, we established a single, regional ECP program at our facility, providing patients that had previously been referred to an ECP treatment center over 2 h away access to therapy 5 days a week during regular business
*Correspondence to: Frederick Lansigan, MD, Dartmouth-Hitchcock Medical Center, Department of Hematology, Norris Cotton Cancer Center, One Medical Center Drive, Lebanon, NH. E-mail: [email protected] Received 18 June 2012; Accepted 6 January 2015 Published online 17 February 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jca.21382
360
Weber et al.
TABLE I. Cutaneous T-Cell Lymphoma Patient Characteristics ID
Gender
Age at 1st ECP
Total procedures
Procedures completed
Procedures aborted
Best response
1 2 3 4 5 6 7 8 8a 9 10 Mean
Male Female Male Male Male Female Female Male Male Male Male
75 63 57 77 59 48 59 84 85 73 63 67.54
43 11 58 42 16 43 14 12 12 19 10 25.45
42 11 56 42 16 41 14 10 11 19 10 24.72
1
Partial Response Stable disease Stable disease Stable disease Stable disease Partial Response Progression of disease Partial Response Partial Response Stable disease Stable disease
2
2 2 1
The mean for age at 1st ECP was 67.54, with a total procedure per patient at 25.45 and 24.72 of completed procedure, which represents >97% of the procedure were completed successfully. a Indicates that the same patient returned for ECP after a period without treatment.
hours. Services also included emergent apheresis, available 7 days a week, 24 h a day. Alternative ECP centers in Boston and New Haven were available to patients receiving care at our program. It is important to note that multiple factors other than mileage and decreased travel time influenced our patient’s decisions to choose care at our rural facility including: location of their primary hematologist/oncologist, scheduling flexibility, and the avoidance of nuisances associated with urban driving. In 2008 our hospital was treating 10 patients with CTCL and our Bone Marrow Transplant Program was gradually expanding with seven allogeneic transplants performed in 2006, 13 in 2007, and 20 in 2008. Since initiation, our ECP program has dramatically grown with 83 procedures in the first year, 253 the second, 365 the third, and 370 in the fourth year. This growth represents both in-house and outside referrals and has been supported by listings on institutional, manufacturer (Therakos, Inc.), and Cutaneous Lymphoma Foundation websites. This study was undertaken to describe our experience with the establishment of a regional ECP program. METHODS
A retrospective review of medical records was performed of patients receiving ECP during a 4-year period (May 2008 to May 2012). At the initiation of our program, the only ECP device available was the UVAR-XTSTM. In February 2010, a CELLEXTM machine was acquired and expanded access to care. Both instruments were used according to manufacturer’s guidelines. Patient data were extracted from the medical record by two of the authors using a standardized data collection template. The response to ECP treatment was analyzed after a minimum of eight procedures. For Journal of Clinical Apheresis DOI 10.1002/jca
patients with CTCL, a partial response to treatment was defined as a more than 50% skin improvement documented in the medical record. For patients with GVHD, a response to treatment was defined as a decrease in steroid dose by 50% and/or skin or liver function test improvement or documented subjective improvement in skin findings. Clinical benefit was defined by documented report of symptom improvement by physician, nurse, or patient. This study was approved by the Institutional Review Board (IRB) and each patient signed an informed consent. RESULTS
During the study period, 1,026 of 1,071 planned procedures were successfully completed (95.8%). There were 57 complications during or prior to procedures, and the procedure was aborted 45 times. Thirteen complications were related to instrument malfunction. Eight of these 13 malfunctions were restarted using a new kit (5 UVAR-XTSTM and 3 CELLEXTM) and five were aborted (2 UVAR-XTSTM and 3 CELLEXTM). The remaining complications were related to line occlusion (2 restarted and 19 aborted), patient clinical status (0 restarted and 12 aborted), inability to obtain venous access (0 restarted and 3 aborted), or unspecified (2 restarted and 6 aborted). Of the 1,026 completed procedures, 506 were performed on the UVAR-XTSTM and 520 were performed on the CELLEXTM. The selection of the instrument was based on multiple factors including scheduling, patient preference, and safe extracorporeal blood volume. The average procedure time was 186 min for the UVAR-XTSTM and 93 min for the CELLEXTM. Of the 34 patients treated during the study period, 11 patients were treated for CTCL and 23 patients were treated for GVHD (Tables (I and II)). Patients travelled a median
Male
Female
Male
Male
Male
Male
Male Male
Female Female
Male Female
Male
Male
Male
Female
Female
Male Female
1
2
3
3b
4
5
6 7
8 9
10 11
12
12b
13
14
15
16 17
55 47
58
28
68
21
20
65 55
13 35
54 52
37
55
66
64
66
43
Age at 1st ECP
10 32
27
40
36
146
22
51 54
52 20
9 41
58
57
18
20
40
38
Total procedures
9 26
27
39
35
134
18
50 51
49 19
9 41
58
53
16
19
33
37
Procedures completed
1 6
1
1
12
4
1 3
3 1
4
2
1
7
1
Procedures aborted
Graft-Versus-Host Disease Patient Characteristics
Acute lymphocytic leukemia Acute myelogenous leukemia
Acute lymphocytic leukemia
Hodgkin’s disease
Chronic myeloid leukemia
Aplastic anemia
Aplastic anemia
Acute lymphocytic leukemia Chronic myelomonocytic leukemia Chronic lymphocytic leukemia Chronic myeloid leukemia
Paroxysmal nocturnal hemoglobinuria Acute lymphocytic leukemia Acute myelogenous leukemia Acute myelogenous leukemia
Chronic myeloid leukemia
Chronic myeloid leukemia
Chronic lymphocytic leukemia
Chronic myeloid leukemia
Diagnosis
b
information not provided by referring institution. Indicates that the same patient returned for ECP after a period without treatment.
a
Gender
ID
TABLE II.
Transplant type
a
a
Myeloablative
Myeloablative
a
Myeloablative
Myeloablative
Myeloablative
a
Myeloablative
a
Non-myeloablative
a
Non-myeloablative
Non-myeloablative
Non-myeloablative
Non-myeloablative
Non-myeloablative
a
Unrelated Unrelated
Related
Syngeneic
Unrelated
Unrelated
Unrelated
Unrelated Related
Related Unrelated
Unrelated Unrelated
Unrelated
Related
Unrelated
Unrelated
Related
Unrelated
Donor type
Transplant regimen
Cyclophosphamide, total body irradiation
a
Cyclophosphamide, total body irradiation
Carmustine, etoposide, cytarabine, cyclophosphamide
a
Cyclophosphamide, total body irradiation Fludarabine, busulfan Cyclophosphamide, total body irradiation Cyclophosphamide, antithymocyte globulin Cyclophosphamide, antithymocyte globulin
a
Fludarabine, total body irradiation
a
Fludarabine, total body irradiation Fludarabine, total body irradiation
Fludarabine, total body irradiation Fludarabine, total body irradiation
Fludarabine, cyclophosphamide
a
Steroid Steroid, tacrolimus
Steroid, sirolimus
Steroid
Steroid, mycophenolate, mofetile, thalidomide
Steroid
Steroid
Steroid Steroid, imatinib
Steroid, thalidomide None
Steroid Steroid, imatinib
Steroid
Steroid, cyclosporine
Rituximab, intravenous immunoglobulin
Steroid
Steroid, mycophenolate, mofetile, cyclosporine
Steroid, mycophenolate, mofetile
Immunosuppression
Implementation of Rural ECP Program 361
Journal of Clinical Apheresis DOI 10.1002/jca
362
Weber et al.
of the disease, resulting in a total of 11 ECP starts for CTCL. Of the 11 ECP prescriptions for CTCL, we determined the best response of each patient (Tables I and II). Three of 11 starts resulted in a partial response (27.2%), 6 of 11 resulted in stable disease (54.5%), and 2 of 11 (18.2%) resulted in disease progression. A clinical benefit, defined as a documented report of symptom improvement by physician, nurse, or patient, was observed in 7 of 11 (63.6%) of patients with CTCL. Thirteen of 23 GVHD patients had complete documentation of steroid use. All 13 (100%) were able to taper their dose by more than 50% in the first 3 months of treatment (Fig. 2). A clinical benefit was observed in 15 of 23 (65.2%) patients with GVHD in an intention-to-treat analysis. Four patients had fewer than eight ECP treatments: two patients died early during the course of ECP treatments, and two were considered not yet evaluable for clinical benefit.
Fig. 1. Area of ECP program coverage by Dartmouth-Hitchcock Medical Center. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
CONCLUSION
Our experience is that ECP is a well-tolerated therapy that is typically completed without complications. Due to performance characteristics, the CELLEXTM is usually selected for our patients with lower safe extracorporeal blood volumes and those with hyperlipidemia. The CELLEXTM machine resulted in lower average treatment times compared to UVAR-XTS. ECP can usually be performed using peripheral venous access in patients with CTCL, while patients with GVHD usually require long-term apheresis catheter placement. The response rates to ECP at our institution are comparable to previously published studies [1,2,6–10]. Since the distance to travel for treatment can be a barrier, the establishment of a regional ECP program is a viable option to improve access to care for patients requiring treatment for CTCL and chronic GVHD.
Fig. 2. Steroid tapering response to ECP in patients with graftversus-host disease
of 65.7 miles (range 4–133 miles) from New York, Vermont, and New Hampshire (Fig. 1). All 10 of the patients with CTCL completed treatment using peripheral venous access, while 16 of 23 GVHD patients required long-term central venous catheter placement. The median number of treatments for CTCL and GVHD patients was 16 (range 10–56) and 32 (range 3– 134), respectively. The median duration of therapy was 6 months (range 2–23) for CTCL and 5 months (range 1–27) for GVHD. The most commonly prescribed treatment was one cycle (two ECPs per week) every 3 weeks for CTCL and one cycle weekly for GVHD. Of the 10 patients with CTCL treated with ECP, 1 patient was treated two separate times over the course Journal of Clinical Apheresis DOI 10.1002/jca
REFERENCES 1. Edelson R, Berger C, Gasparro F, Jegasothy B, Heald P, Wintroub B, Vonderheid E, Knobler R, Wolff K, Plewig G, McKiernan G, Christiansen I, Oster M, Honigsmann H, Wilford H, Kokoschka E, Rehle T, Perez M, Stingl G, Laroche L. Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy. N Engl J Med 1987;316:297–303. 2. Greinix HT, Volc-Platzer B, Rabitsch W, Gmeinhart B, Guevara-Pineda C, Kalhs P, Krutmann J, H€onigsmann H, Ciovica M, Knobler R. Successful use of extracorporeal photochemotherapy in the treatment of severe acute and chronic graft-versus-host disease. Blood 1998;92:3098–3104. 3. Edelson RL. Photopheresis: a new therapeutic concept. Yale J Biol Med 1989;62:565–577. 4. Choi J. Photopheresis. In: McLeod BC, Weinstein R, Winters Jeffrey L., Szczepiorkowski Zbigniew M, editors. Apheresis: Principles and Practice, 3rd ed. Bethesda, MD: AABB Press. 2010. pp 615–629.
Implementation of Rural ECP Program 5. Winters JL. Apheresis medicine state of the art in 2010: American Society for Apheresis fifth special edition of the Journal of Clinical Apheresis. J Clin Apher 2011;26:239–242. 6. Atta M, Papanicolaou N, Tsirigotis P. The role of extracorporeal photopheresis in the treatment of cutaneous T-cell lymphomas. Transfus Apher Sci 2012;46:195–202. 7. Foss FM, DiVenuti GM, Chin K, Sprague K, Grodman H, Klein A, Chan G, Stiffler K, Miller KB. Prospective study of extracorporeal photopheresis in steroid-refractory or steroid-resistant extensive chronic graft-versus-host disease: analysis of response and survival incorporating prognostic factors. Bone Marrow Transplant 2005;35:1187–1193. 8. Greinix HT, van Besien K, Elmaagacli AH, Hillen U, Grigg A, Knobler R, Parenti D, Reddy V, Theunissen K, Michallet M, Flowers MED, UVADEX Chronic GVHD Study Group. Progressive improvement in cutaneous and extracutaneous chronic graft-versus-host disease after a 24-week course of extracorporeal photopheresis—results of a crossover randomized study. Biol Blood Marrow Transplant 2011;17:1775–1782.
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9. Jagasia MH, Savani BN, Stricklin G, Engelhardt B, Kassim A, Dixon S, Chen H, Chinratanalab W, Goodman S, Greer JP, Schuening F. Classic and overlap chronic graft-versus-host disease (cGVHD) is associated with superior outcome after extracorporeal photopheresis (ECP). Biol Blood Marrow Transplant 2009;15:1288–1295. 10. Ilhan O, Arat M, Arslan O, Ayyildiz E, Sanli H, Beksac M, Ozcan M, G€urman G, Akan H. Extracorporeal photoimmunotherapy for the treatment of steroid refractory progressive chronic graft-versus-host disease. Transfus Apher Sci 2004;30: 185–187. 11. Ratcliffe N, Dunbar NM, Adamski J, Couriel D, Edelson R, Kitko CL, Levine JE, Morgan S, Schneiderman J, Sloan S, Wu Y, Szczepiorkowski ZM, Cooling L; for the American Society for Apheresis. National Institutes of Health State of the Science Symposium in Therapeutic Apheresis: Scientific Opportunities in Extracorporeal Photopheresis. Transfus Med Rev. 2014 Oct 15. doi: 10.1016/j.tmrv.2014.09.004. [Epub ahead of print] Review.
Journal of Clinical Apheresis DOI 10.1002/jca
Brief Report Successful Implementation of a Rural Extracorporeal Photopheresis Program for the Treatment of Cutaneous T-cell Lymphoma and Chronic Graft-Versus-Host Disease in a Rural Hospital Litchia L. Weber,1 Nancy M. Dunbar,2 Kenneth R. Meehan,3 Zbigniew M. Szczepiorkowski,2 and Frederick Lansigan3* 1
2
Department of Medicine, Dartmouth-Hitchcock Medical Center Department of Pathology and Medicine, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center 3 Department of Hematology, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center Objective: Extracorporeal photopheresis (ECP) is currently standard therapy for cutaneous T-cell lymphoma (CTCL) and Graft-versus-host disease (GVHD). Of the many challenges associated with outpatient ECP treatments, commuter travel to capable facilities can fragment and compromise the patient care. In 2008, our hospital implemented an ECP program providing patients to a treatment center over 120 minutes away. This study was undertaken to describe our experience with the establishment of a regional ECP program. Methods: A retrospective review using a standardized template was performed of patients treated from May 2008 to 2012. The response to treatment was analyzed after a minimum of eight procedures. A partial response to treatment in individuals with CTCL, was more than 50% skin improvement, and GVHD, a reduction in steroid dose by 50%, liver function test improvement or documented improvement in skin findings. Results: Of the 34 patients treated, 11 were for CTCL and 23 for GVHD. 95.8% of the 1,071 planned procedures were successfully. The average procedure time was 186 min for the UVAR-XTSTM and 93 min for the CELLEXTM. Patients travelled a median of 65.7 miles (range 4–133 miles). The median duration of therapy was 6 months (range 2–23) for CTCL and 5 months (range 1–27) for GVHD. A clinical benefit was observed in 7 of 11 (63.6%) patients with CTCL and in 15 of 23 (65.2%) with GVHD. Conclusion: Our regional ECP program was a viable option in improving access to care for patients requiring C 2015 Wiley Periodicals, Inc. treatment for CTCL and chronic GVHD. J. Clin. Apheresis 30:359–363, 2015. V Key words: extracorporeal photopheresis; ECP; implementation; cutaneous T-cell lymphoma; graftversus-host disease
Extracorporeal photopheresis (ECP) is a form of apheresis and photodynamic therapy in which the mononuclear cells in peripheral blood are treated with 8-methoxypsoralen, which is then activated with ultraviolet light [1–4]. ECP is currently a standard therapy for cutaneous T-cell lymphoma (CTCL), and is considered a category I indication (first line therapy) by the American Society for Apheresis (ASFA) [4]. It is also considered a category II indication (supportive or adjunctive therapy) for chronic graft-versus-host disease (GVHD) [5]. ECP has an established safety profile and is not associated with immunosuppression, opportunistic infections, secondary malignancies, or lipid abnormalities [1,6]. In the United States, the most commonly used devices to perform ECP are the UVARXTSTM and the CELLEXTM, developed by Therakos, Inc. [4]. C 2015 Wiley Periodicals, Inc. V
Our institution serves as the state’s only academic medical center and a major tertiary care referral for a rural community spanning a vast landscape. In May 2008, we established a single, regional ECP program at our facility, providing patients that had previously been referred to an ECP treatment center over 2 h away access to therapy 5 days a week during regular business
*Correspondence to: Frederick Lansigan, MD, Dartmouth-Hitchcock Medical Center, Department of Hematology, Norris Cotton Cancer Center, One Medical Center Drive, Lebanon, NH. E-mail: [email protected] Received 18 June 2012; Accepted 6 January 2015 Published online 17 February 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jca.21382
360
Weber et al.
TABLE I. Cutaneous T-Cell Lymphoma Patient Characteristics ID
Gender
Age at 1st ECP
Total procedures
Procedures completed
Procedures aborted
Best response
1 2 3 4 5 6 7 8 8a 9 10 Mean
Male Female Male Male Male Female Female Male Male Male Male
75 63 57 77 59 48 59 84 85 73 63 67.54
43 11 58 42 16 43 14 12 12 19 10 25.45
42 11 56 42 16 41 14 10 11 19 10 24.72
1
Partial Response Stable disease Stable disease Stable disease Stable disease Partial Response Progression of disease Partial Response Partial Response Stable disease Stable disease
2
2 2 1
The mean for age at 1st ECP was 67.54, with a total procedure per patient at 25.45 and 24.72 of completed procedure, which represents >97% of the procedure were completed successfully. a Indicates that the same patient returned for ECP after a period without treatment.
hours. Services also included emergent apheresis, available 7 days a week, 24 h a day. Alternative ECP centers in Boston and New Haven were available to patients receiving care at our program. It is important to note that multiple factors other than mileage and decreased travel time influenced our patient’s decisions to choose care at our rural facility including: location of their primary hematologist/oncologist, scheduling flexibility, and the avoidance of nuisances associated with urban driving. In 2008 our hospital was treating 10 patients with CTCL and our Bone Marrow Transplant Program was gradually expanding with seven allogeneic transplants performed in 2006, 13 in 2007, and 20 in 2008. Since initiation, our ECP program has dramatically grown with 83 procedures in the first year, 253 the second, 365 the third, and 370 in the fourth year. This growth represents both in-house and outside referrals and has been supported by listings on institutional, manufacturer (Therakos, Inc.), and Cutaneous Lymphoma Foundation websites. This study was undertaken to describe our experience with the establishment of a regional ECP program. METHODS
A retrospective review of medical records was performed of patients receiving ECP during a 4-year period (May 2008 to May 2012). At the initiation of our program, the only ECP device available was the UVAR-XTSTM. In February 2010, a CELLEXTM machine was acquired and expanded access to care. Both instruments were used according to manufacturer’s guidelines. Patient data were extracted from the medical record by two of the authors using a standardized data collection template. The response to ECP treatment was analyzed after a minimum of eight procedures. For Journal of Clinical Apheresis DOI 10.1002/jca
patients with CTCL, a partial response to treatment was defined as a more than 50% skin improvement documented in the medical record. For patients with GVHD, a response to treatment was defined as a decrease in steroid dose by 50% and/or skin or liver function test improvement or documented subjective improvement in skin findings. Clinical benefit was defined by documented report of symptom improvement by physician, nurse, or patient. This study was approved by the Institutional Review Board (IRB) and each patient signed an informed consent. RESULTS
During the study period, 1,026 of 1,071 planned procedures were successfully completed (95.8%). There were 57 complications during or prior to procedures, and the procedure was aborted 45 times. Thirteen complications were related to instrument malfunction. Eight of these 13 malfunctions were restarted using a new kit (5 UVAR-XTSTM and 3 CELLEXTM) and five were aborted (2 UVAR-XTSTM and 3 CELLEXTM). The remaining complications were related to line occlusion (2 restarted and 19 aborted), patient clinical status (0 restarted and 12 aborted), inability to obtain venous access (0 restarted and 3 aborted), or unspecified (2 restarted and 6 aborted). Of the 1,026 completed procedures, 506 were performed on the UVAR-XTSTM and 520 were performed on the CELLEXTM. The selection of the instrument was based on multiple factors including scheduling, patient preference, and safe extracorporeal blood volume. The average procedure time was 186 min for the UVAR-XTSTM and 93 min for the CELLEXTM. Of the 34 patients treated during the study period, 11 patients were treated for CTCL and 23 patients were treated for GVHD (Tables (I and II)). Patients travelled a median
Male
Female
Male
Male
Male
Male
Male Male
Female Female
Male Female
Male
Male
Male
Female
Female
Male Female
1
2
3
3b
4
5
6 7
8 9
10 11
12
12b
13
14
15
16 17
55 47
58
28
68
21
20
65 55
13 35
54 52
37
55
66
64
66
43
Age at 1st ECP
10 32
27
40
36
146
22
51 54
52 20
9 41
58
57
18
20
40
38
Total procedures
9 26
27
39
35
134
18
50 51
49 19
9 41
58
53
16
19
33
37
Procedures completed
1 6
1
1
12
4
1 3
3 1
4
2
1
7
1
Procedures aborted
Graft-Versus-Host Disease Patient Characteristics
Acute lymphocytic leukemia Acute myelogenous leukemia
Acute lymphocytic leukemia
Hodgkin’s disease
Chronic myeloid leukemia
Aplastic anemia
Aplastic anemia
Acute lymphocytic leukemia Chronic myelomonocytic leukemia Chronic lymphocytic leukemia Chronic myeloid leukemia
Paroxysmal nocturnal hemoglobinuria Acute lymphocytic leukemia Acute myelogenous leukemia Acute myelogenous leukemia
Chronic myeloid leukemia
Chronic myeloid leukemia
Chronic lymphocytic leukemia
Chronic myeloid leukemia
Diagnosis
b
information not provided by referring institution. Indicates that the same patient returned for ECP after a period without treatment.
a
Gender
ID
TABLE II.
Transplant type
a
a
Myeloablative
Myeloablative
a
Myeloablative
Myeloablative
Myeloablative
a
Myeloablative
a
Non-myeloablative
a
Non-myeloablative
Non-myeloablative
Non-myeloablative
Non-myeloablative
Non-myeloablative
a
Unrelated Unrelated
Related
Syngeneic
Unrelated
Unrelated
Unrelated
Unrelated Related
Related Unrelated
Unrelated Unrelated
Unrelated
Related
Unrelated
Unrelated
Related
Unrelated
Donor type
Transplant regimen
Cyclophosphamide, total body irradiation
a
Cyclophosphamide, total body irradiation
Carmustine, etoposide, cytarabine, cyclophosphamide
a
Cyclophosphamide, total body irradiation Fludarabine, busulfan Cyclophosphamide, total body irradiation Cyclophosphamide, antithymocyte globulin Cyclophosphamide, antithymocyte globulin
a
Fludarabine, total body irradiation
a
Fludarabine, total body irradiation Fludarabine, total body irradiation
Fludarabine, total body irradiation Fludarabine, total body irradiation
Fludarabine, cyclophosphamide
a
Steroid Steroid, tacrolimus
Steroid, sirolimus
Steroid
Steroid, mycophenolate, mofetile, thalidomide
Steroid
Steroid
Steroid Steroid, imatinib
Steroid, thalidomide None
Steroid Steroid, imatinib
Steroid
Steroid, cyclosporine
Rituximab, intravenous immunoglobulin
Steroid
Steroid, mycophenolate, mofetile, cyclosporine
Steroid, mycophenolate, mofetile
Immunosuppression
Implementation of Rural ECP Program 361
Journal of Clinical Apheresis DOI 10.1002/jca
362
Weber et al.
of the disease, resulting in a total of 11 ECP starts for CTCL. Of the 11 ECP prescriptions for CTCL, we determined the best response of each patient (Tables I and II). Three of 11 starts resulted in a partial response (27.2%), 6 of 11 resulted in stable disease (54.5%), and 2 of 11 (18.2%) resulted in disease progression. A clinical benefit, defined as a documented report of symptom improvement by physician, nurse, or patient, was observed in 7 of 11 (63.6%) of patients with CTCL. Thirteen of 23 GVHD patients had complete documentation of steroid use. All 13 (100%) were able to taper their dose by more than 50% in the first 3 months of treatment (Fig. 2). A clinical benefit was observed in 15 of 23 (65.2%) patients with GVHD in an intention-to-treat analysis. Four patients had fewer than eight ECP treatments: two patients died early during the course of ECP treatments, and two were considered not yet evaluable for clinical benefit.
Fig. 1. Area of ECP program coverage by Dartmouth-Hitchcock Medical Center. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
CONCLUSION
Our experience is that ECP is a well-tolerated therapy that is typically completed without complications. Due to performance characteristics, the CELLEXTM is usually selected for our patients with lower safe extracorporeal blood volumes and those with hyperlipidemia. The CELLEXTM machine resulted in lower average treatment times compared to UVAR-XTS. ECP can usually be performed using peripheral venous access in patients with CTCL, while patients with GVHD usually require long-term apheresis catheter placement. The response rates to ECP at our institution are comparable to previously published studies [1,2,6–10]. Since the distance to travel for treatment can be a barrier, the establishment of a regional ECP program is a viable option to improve access to care for patients requiring treatment for CTCL and chronic GVHD.
Fig. 2. Steroid tapering response to ECP in patients with graftversus-host disease
of 65.7 miles (range 4–133 miles) from New York, Vermont, and New Hampshire (Fig. 1). All 10 of the patients with CTCL completed treatment using peripheral venous access, while 16 of 23 GVHD patients required long-term central venous catheter placement. The median number of treatments for CTCL and GVHD patients was 16 (range 10–56) and 32 (range 3– 134), respectively. The median duration of therapy was 6 months (range 2–23) for CTCL and 5 months (range 1–27) for GVHD. The most commonly prescribed treatment was one cycle (two ECPs per week) every 3 weeks for CTCL and one cycle weekly for GVHD. Of the 10 patients with CTCL treated with ECP, 1 patient was treated two separate times over the course Journal of Clinical Apheresis DOI 10.1002/jca
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Journal of Clinical Apheresis DOI 10.1002/jca
