Study Results




(1)
Department of Health Management, New York Medical College, Valhalla, New York, USA

(2)
University of British Columbia, Vancouver, British Columbia, Canada

(3)
Misdiagnosis Association, Seattle, Washington, USA

 



Keywords
Psoralen and ultraviolet A (PUVA)InterferonIFNMycosis fungoidesStudy results


The main purpose of the study presented herein (previously unpublished) was to determine and compare the efficacy of two treatment methods—one being psoralen and ultraviolet A (PUVA) monotherapy and the other being PUVA combined with interferon (IFN)-alpha-2a—in mycosis fungoides (MF) patients referred to the Razi Dermatology Hospital in Tehran, Iran. Our efforts focused on the comparison of these two treatment regimens with respect to complete remission, partial remission, different phases of MF, and effect of gender.


Study Results


Patient characteristics can be found in Table 12.1. In our study, there were 50 patients with MF, 28 (56 %) of which were in the PUVA monotherapy treatment group, and 22 (44 %) were in PUVA + IFN-α(alpha) treatment group. The average patient age was 63 years, ranging between 30 and 83 years. In terms of gender distribution, 14 patients (28 %) were female and 36 patients (72 %) were male as seen in Fig. 12.1. It is important to note that all patients in the IA phase were treated with PUVA monotherapy, but as the disease progressed to later stages, a significantly greater percentage of patients were treated with PUVA + IFN-α(alpha) treatment. As would be expected, a greater percentage of patients in the advanced phases of the disease were placed in the PUVA + IFN treatment group.


Table 12.1
Patient characteristics

























































Patient characteristics

Number of patients (%)

Gender

Male

36 (72 %)

Female

14 (28 %)

Age

Mean

63 years

Range

30–83

Stage of disease

IA

14 (28 %)

IB

14 (28 %)

IIA

4 (8 %)

IIB

8 (16 %)

III

6 (12 %)

IVA

4 (8 %)

Response to treatment

No response

11 (22 %)

Partial response

13 (26 %)

Complete response

26 (52 %)


A419310_1_En_12_Fig1_HTML.gif


Fig. 12.1
Gender distribution of MF patients

As illustrated in Fig. 12.2, 32 patients (64 %) were in the early phase of the disease, 14 of which were in stage IA, 14 in stage IB, and 4 in stage IIA; and 18 patients (36 %) were in the advanced phase of the disease, 8 of which were in stage IIB, 6 were in stage III, and 4 were in stage IVA. Of these patients, 11 (22 %) had no response (NR) to treatment, 13 patients (26 %) achieved partial remission (PR), and 26 patients (52 %) achieved complete remission (CR). Overall response was calculated among 39 patients to be 78 %. In patients with early phases of the disease, 22 of them (68 %) achieved CR and 8 people (25 %) had PR, and 2 patients (7 %) had NR to treatment, so the overall response was 30 patients (93 %). In patients with advanced phases of the disease, 4 patients (22 %) achieved CR, 5 patients had PR, and 9 patients (50 %) had NR to treatment, so the overall response was 9 people (50 %). The difference in the response to treatment in terms of early or advanced phases of the disease is statistically significant. In other words, the complete remission and overall response is reduced in advanced phases of the disease, and a greater percentage of patients at advanced phases do not respond to the treatment.

A419310_1_En_12_Fig2_HTML.gif


Fig. 12.2
Distribution of disease stages of the MF patients

PUVA monotherapy patient characteristics can be found in Table 12.2 and Fig. 12.3. There were 28 patients in this treatment group: 20 male patients and 8 female patients. The average age in this treatment group was 65.7 years with a range of 30–83 years. In this treatment group, all patients in IA phase (14 patients) achieved the overall response (CR or PR); however, patients in III or IVA phase did not respond to the treatment. In this group, 17 patients (61 %) achieved CR, 7 patients (25 %) had PR, and 4 patients (14 %) had NR to treatment, so the overall response was 24 patients (86 %).


Table 12.2
A comparison of patient characteristics in both treatment groups












































































Patient characteristics

Number of PUVA monotherapy patients

Number of PUVA + IFN-α(alpha) patients

Number of patients

28

22

Gender

Male

20 (71 %)

16 (73 %)

Female

8 (29 %)

6 (27 %)

Age

Mean

65.7 years

59.7 years

Range

30–83

31–79

Stage of disease

IA

14 (50 %)

0

IB

7 (25 %)

7 (32 %)

IIA

3 (11 %)

1 (4 %)

IIB

2 (7 %)

6 (27 %)

III

1 (3.5 %)

5 (23 %)

IVA

1 (3.5 %)

3 (14 %)

Response to treatment

No response

4 (14 %)

7 (32 %)

Partial response

7 (25 %)

6 (27 %)

Complete response

17 (61 %)

9 (41 %)


A419310_1_En_12_Fig3_HTML.gif


Fig. 12.3
Distribution of treatment types of patients with respect to stages of MF

PUVA + IFN-α(alpha) patient characteristics can be found in Table 12.2 and Fig. 12.3. There were 22 patients in this treatment group: 16 male and 6 female. The average age in this treatment group was 59.7 years with a range of 31–79 years. In this treatment group, all patients in IB phase (7 patients) achieved overall response (CR or PR); however, like the PUVA monotherapy treatment group, patients in III or IVA phase did not respond to the treatment. In this group, 9 patients (41 %) achieved CR, 6 patients (27 %) achieved PR, and 7 patients (32 %) had NR to treatment, so the overall response was 15 patients (68 %).

Overall, the difference in response to treatment was not statistically significant in comparison between the two treatment groups. In other words, in this study, there was no difference in the response to treatment between the two groups. Moreover, CR was observed in 78.6 % of patients in IA phase, 57.1 % in IB phase, and 75 % in IIA phase. PR was seen in 21.4 % of patients in IA phase, 28.6 % in IB phase, and 25 % in IIA phase. In addition, 66.7 % of patients in III phase and 75 % of patients in IVA phase did not respond to the treatment (p = 0.007). The patient response to PUVA monotherapy treatment can be observed in Table 12.3 and Fig. 12.4, and as seen in the figure all patients in stage IA reached an overall response. Patients in stages III and IVA did not respond to treatment. The patient response to PUVA + IFN treatment can be observed in Table 12.4 as well as Fig. 12.5. All patients in stage IB improved (CR or PR), but similar to the PUVA monotherapy group, patients in stages III and IVA did not respond to treatment. It is important to note that gender did not affect treatment response, and there was no significant difference found between the two treatment groups and between various phases of the disease in terms of gender.


Table 12.3
Patient response to PUVA monotherapy

































































































Response

No response

Partial response

Complete response

Total

Disease type

IA

Male

0

2

8

10

Female

0

1

3

4

IB

Male

1

2

2

5

Female

1

0

1

2

IIA

Male

0

1

1

2

Female

0

0

1

1

IIB

Male

0

1

1

2

Female

0

0

0

0

III

Male

1

0

0

1

Female

0

0

0

0

IVA

Male

1

0

0

1

Female

0

0

0

0


A419310_1_En_12_Fig4_HTML.gif


Fig. 12.4
Patient response to PUVA monotherapy with respect to the different disease stages



Table 12.4
Patient response to PUVA + IFN

































































































Response

No response

Partial response

Complete response

Total

Disease type

IA

Male

0

0

0

0

Female

0

0

0

0

IB

Male

0

1

4

5

Female

0

1

1

2

IIA

Male

0

0

1

1

Female

0

0

0

0

IIB

Male

1

2

1

4

Female

1

1

0

2

III

Male

3

0

1

4

Female

0

0

1

1

IVA

Male

1

1

0

2

Female

1

0

0

1


A419310_1_En_12_Fig5_HTML.gif


Fig. 12.5
Patient response to PUVA + INF with respect to the different disease stages

Table 12.5 and Fig. 12.6 present relative frequency of treatment response based on disease stage. Complete remission was observed in 78.6 % of IA-stage patients, 57.1 % in IB stage, and 75 % in IIA stage. Furthermore, partial remission was also seen in 21.4 % of patients in IA, 28.6 % in IB, and 25 % in IIA stages; 66.7 % of patients in III stage and 75 % of patients in IVA stage did not respond to treatment (p = 0.007).


Table 12.5
Relative frequency of treatment response based on disease stage










































































Stage of disease

Variables measured

No response

Partial response

Complete response

Total

IA

Frequency

0

11

3

14

% in this stage

0

78.6

21.4

100

% of response

0

42.3

23.1

28.0

Total %

0

22.0

6.0

28.0

IB

Frequency

2

8

4

14

% in this stage

14.3

57.1

28.6

100.0

% of response

18.2

30.8

30.8

28.0

Total %

4.0

16.0

8.0

28.0

IIA

Frequency

0

3

1

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Dec 3, 2017 | Posted by in Dermatology | Comments Off on Study Results
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