It is concluded that fludarabine is effective even in patients with advanced chronic lymphocytic leukemia refractory to multiple chemotherapy regimens. However, fludarabine has a remarkable suppressive effect on T-lymphocytes, predominantly CD4(+)-lymphocytes. Long-term antibiotic prophylaxis is recommended.
We studied the prognostic value of the initial radiologic stage, the serum-angiotensin-converting enzyme (SACE) and T helper cells in blood (OKT-4-Bl) and in bronchoalveolar lavage (OKT-4-BAL) for patients with biopsy-proven pulmonary sarcoidosis. Thirty-seven patients without prior treatment were followed up for a period of 2 years. A BAL was performed in 22 of them as part of the diagnostic workup. Clinical examination, chest radiographs, vital capacity, diffusion capacity for CO, airway resistance and PaO2 at rest and during exercise were determined initially and after 6, 12 and 24 months. According to these results, patients were classified as having progressive or nonprogressive disease. The radiologic stage and the initial SACE (38.3 ± 10.2 vs. 43.7 ± 13.0 nmol/ml/min) could not discriminate between the two groups. Patients with progressive disease had significantly fewer OKT-4-B1 cells (403.3/μl ± 146.7/μl vs. 842.0/μl ± 430.1/μl) and more OKT-4-BAL cells (24.5 ± 15.4% vs. 7.0 ± 2.6%) than patients with stable disease (p < 0.01). A negative correlation between OKT-4-Bl and OKT-4-BAL cells was shown (Rs = -0.79; p < 0.001). We conclude that the number of OKT-4-Bl and OKT-4-BAL cells can be used as prognostic parameter for patients with sarcoidosis.
Aggressive chemotherapy of advanced myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) evolving from MDS, subacute AML and secondary AML has usually been associated with low complete remission (CR) rates, a high incidence of early death, and low disease-free survival. We therefore have initiated a phase-III trial of aggressive chemotherapy consisting of idarubicin, cytosine arabinoside, and VP-16 to improve the CR rate. Each chemotherapy cycle is followed by G-CSF to accelerate neutrophil recovery and to reduce the incidence of infections. Until now, 19 patients with high-risk AML have been entered. The CR rate is 47%, with only one death during induction. Patients achieving CR are randomized to receive either high-dose or low-dose interleukin-2 to eliminate residual leukemic cells and to prolong the duration of remission.
A total of 149 consecutive de novo AML patients aged 50 years or less (median age = 37 years) were enrolled in this prospective multicenter trial initiated in May 1985. All patients received the same induction and early consolidation therapy with daunorubicin (DNR), cytosine arabinoside (Ara-C), and etoposide (DAV). High-dose Ara-C/DNR therapy included Ara-C at 3 g/m2, in 12 doses (HD-Ara-C/DNR I) and eight doses (HD-Ara-C/DNR II), followed by DNR 30 mg/m2 for 3 days. A complete remission (CR) was achieved in 104 (70%) patients; 61 complete responders received at least one cycle with HD-Ara-C/DNR. If those patients who were transplanted in first CR (n = 26), were not considered, the median relapse-free-survival (MRFS) of the remaining 78 patients was 15 months, with a probability of relapse-free survival (RFS) at 116 months of 30% (95% CI, 20-40%) after a median follow-up of 95 months. The MRFS of the HD-Ara-C/DNR consolidated patients was 25 months, with a probability of RFS at 116 months of 37% (95% CI, 24-50%). If all patients who were transplanted (n = 44) were not considered, the median survival time (MST) was 18 months with a probability of being alive at 118 months of 24% (95% CI, 16-33%). MST of the HD-Ara-C/DNR consolidated patients was 58 months with a survival probability of 46% (95% CI, 31-60%) at 118 months. Prognostic factor analysis did not reveal any significant influence of age, sex, FAB subtype, white blood cell count, hemoglobin level, thrombocyte count, LDH, or response to the first induction course on RFS of the HD-Ara-C/DNR consolidated patients. In summary, HD-Ara-C/DNR consolidation can improve the long-term outcome of a subgroup of de novo AML patients. Further improvement of the outcome seems to depend on the identification of patients with an inferior outcome under that strategy who might benefit from alternative treatment strategies.
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