Info

4 mg/m2,

IV q.2 weeks

N/Af

N/A

18%f

9.3 years

a National Cancer Institute - Canadian Clinical Trials Group. b Eastern Cooperative Oncology Group.

c All patients in the study had attained a CR, and were followed for relapse, survival, and long-term toxicity. d 38% good PR (bone marrow involvement <5%), 19% PR.

e Southwest Oncology Group, Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, National Cancer Institute- Canadian Clinical Trials Group.

f Long-term follow-up of the randomized Intergroup study, which included all patients treated with DCF initially or on crossover from interferon. The 5- and 10-year relapse-free survival were 85% and 67%, respectively.

a National Cancer Institute - Canadian Clinical Trials Group. b Eastern Cooperative Oncology Group.

c All patients in the study had attained a CR, and were followed for relapse, survival, and long-term toxicity. d 38% good PR (bone marrow involvement <5%), 19% PR.

e Southwest Oncology Group, Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, National Cancer Institute- Canadian Clinical Trials Group.

f Long-term follow-up of the randomized Intergroup study, which included all patients treated with DCF initially or on crossover from interferon. The 5- and 10-year relapse-free survival were 85% and 67%, respectively.

dose of 4 mg/m2, again until a CR was attained.27 Only 1 of the patients died, but 11 of the remaining 23 patients had relapsed at a median time of 30 months from therapy. There were no serious infectious complications, nor was there a dramatic increase in second malignancies, with the exception of epithelial skin cancers.

Similar results were observed in 50 patients treated with an identical regimen of every-other-week DCF in a French study reported by Ribeiro et al.28 With a median follow-up of 33 months, responses were documented in 96% of the patients, including 44% of those who achieved a CR, 36% with a "good" PR (bone marrow involvement of <5%), and 16% with a PR. There were two deaths. The toxicity included Grade 3/4 neutropenia in 13 of the patients (26%), fever with infection in 13 patients (26%), nausea and vomiting despite the prophylactic use of antiemetics in 14 (28%), and rash in 9 patients. Second malignancies were observed in 10% of the patients.

In an Intergroup study, the response and duration of relapse-free survival in patients with hairy cell leukemia treated with interferon-a or DCF were compared and their toxicities described.29 Three hundred and thirteen eligible patients were randomized to either interferon a-2a, 3 million units subcutaneously three times per week for 6 months (prolonged to a full year for an objective response) versus DCF at 4 mg/m2 administered intravenously every other week (given two doses past a CR, continued to 12 months if a PR was achieved, and stopped at 6 months in the absence of a response). Crossover was allowed. While only 11% of the interferon-a treated patients achieved a CR and 27% a PR with no early deaths, 76% of the DCF patients achieved a CR and 3% a PR, with three early deaths. Grade 4 myelosuppression was significantly greater with DCF than with interferon-a, as was the incidence of suspected infections in the DCF group (53% vs 35%, respectively). The median relapse-free survival of the 134 patients who achieved a CR was significantly longer in the DCF treated group (and had not yet been reached) than the 20-month relapse-free survival calculated in the interferon-a group, after a median follow-up of 57 months. Once a median follow-up of 9.3 years had been reached, the updated relapse, toxicity, and survival data of the 154 patients initially treated with DCF, and the 87 patients treated upon crossover from interferon-a failure, was reported by Flinn et al.30 The 5- and 10-year survival of 90% and 81% was no different from that calculated from an age and sex matched control population. The 5- and 10-year relapse-free survival were 85% and 67%, respectively, based on the 173 patients who achieved a CR. After lymphoid, hematologic, and epithelial skin cancers were excluded, the 25 diagnoses of solid tumors recorded was not any greater than that expected in the general population.

In summary, complete remission can be achieved in a high percentage of patients with hairy cell leukemia treated with DCF at the standard dose of 4 mg/m2 intravenously given every other week until the attainment of remission. It appears that these remissions are durable despite a lack of clear evidence that the therapy is, in fact, curative.

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