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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS - page 3 / 6

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COOPER et al

BLOOD, 15 MARCH 2002 VOLUME 99, NUMBER 6

anti-D, 1 with IVIG and then rituximab, and 1 with low-dose prednisone. One patient received prednisone for lupus, 1 received 3 infusions of IVIG, and 1 IV anti-D during pregnancy. Eight (29%) underwent splenectomy (group C). The patient lost to follow-up at 10 months, who had not received anti-D for 5 months as of his last visit, is not included in the analyses of long-term outcome. The background demographics for each outcome group, including months from diagnosis to study entry, age, gender, and previous treatments are summarized in Table 1.

Figure 1. A bar chart representing the percentage of patients in each outcome group for each month up to and including month 12. The x-axis is time in months. The y-axis is the percentage of patients in each outcome group. Outcome groups are identified as follows: Patients who underwent splenectomy are represented in yellow; patients who received other medical therapy such as chemotherapy for breast cancer are shown in dark blue; patients who received other ITP therapy such as IVIG, prednisone, or danazol are shown in intermediate blue; patients who were still on intermittent anti-D are shown in light blue; and patients who came off treatment are shown in pink.

6 stopped responding within the first 4 months. Four of the 8 nonresponders underwent splenectomy, and 4 chose alternative therapy for their ITP (described below).

Group A. The 12 patients who are now off all treatment were enrolled a median of 4 months (range, 1-11 months) from diagnosis. They received a median of 11.5 months (range, 3-41 months) of treatment on study. The median time from diagnosis to their last treatment was 16 months (range, 7-45 months). Eight of the 12 continuously responded to intermittent anti-D and received it alone for a median of 8.5 months (range, 3-41 months) before stopping treatment altogether. Two of the 12 stopped responding to anti-D within 5 months of study initiation and transiently used either prednisone or danazol (patient nos. 9 and 12). One received chemotherapy for breast cancer and then temporarily resumed IV anti-D (no. 11), and 1 discontinued anti-D because of toxicity (no. 10) and received 12 months of IVIG before coming off all treatment.

As of the last follow-up platelet counts above 100 3 maintaining normal counts

visit, 6 of the 12 have maintained 109/L (100 000/mL), with 3 of these

(

150 3 109/L

[150 000/mL])

for

Long-term outcome

more than 4 months. Strikingly, these 6 patients were on median 15 months (range 8-35 months) and had been

study for a diagnosed

The long-term outcome (to March 2001) of all patients, including their month-by-month treatment from diagnosis until their last month of follow-up, is illustrated in Figure 2 and discussed by groups below. As of their last follow-up, 12 (43%) of the initial 28 patients have been off all treatment for at least 6 months with a stable platelet count above 30 3 109/L (30 000/mL) (group A). Seven (25%) continue to receive treatment (group B): 3 with IV

with ITP for a median of 22.5 months (range 13-38 achieving platelet counts above 100 3 109/L (100

months) before 000/mL). They

were treated

for

diagnosis to

last

a median of 16 months (range treatment, including a median

7-20 months) from of 9 months (range

5-14 months) beginning the

on study. The platelet counts of these 6 patients, month after they stopped treatment, are shown in

Figure

3A.

These

patients

continued

to

improve

their

counts

even

Figure 2. All 28 patients from diagnosis to last platelet count and their month-by-month treatment for their ITP from diagnosis to last known platelet count. The x-axis represents time in months; the y-axis is composed of individual patients divided according to outcome group into which they fall: group A, “off treatment”; group B, “receiving treatment (anti-D or other)”; and group C, those undergoing “splenectomy.” The letters represent ITP treatments (explained in the key). The number at the end of each line is the last known platelet count for each patient. I indicates anti-D treatment; –, no treatment; S, splenectomy; D, danazol; G, IVIG; P, prednisone; M, IV methylprednisolone; A, azathioprine; R, rituxan; E, dexamethasone; 1, IVIG for surgery; 2, lost to follow-up; 3, prednisone for SLE (not low platelets); 4, IVIG for obstetric reasons; 5, chemotherapy for breast cancer; T, toxicity; C, chemotherapy; X, radiotherapy; and *, intermittent counts less than 30 000/uL, no treatment given.

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