Background: This study was performed to examine the efficacy and toxicity o
f the combination of adriamycin (ADR), methylprednisolone (solumedrol), cyt
arabine (Ara-C), and cisplatin (CDDP) in patients with recurrent and refrac
tory malignant lymphomas. Patients and methods: Sixty-five patients with Ho
dgkin's disease (HD) (n=14) or non-Hodgkin's lymphomas (NHL) (n = 51) were
enrolled in the study. The ASHAP therapy consisted of ADR (40 mg/m(2) by co
ntinuous infusion (CI) over 96 h), methylprednisolone (500 mg i.v., days 1-
5), Ara-C (2 g/m(2) as a 2-h infusion on day 5), and CDDP (100 mg/m2 by CI
over 96 h). Results: Twenty-five patients (38%) achieved complete remission
(CR) and 20 (31%) were taken into partial remission (PR) for an overall re
sponse rate of 69%. Thirty-two patients with CII or PR following ASHAP unde
rwent high-dose therapy (HDT) with subsequent hematopoietic stem cell trans
plantation. After a median follow-up of 52 months, 13 patients are in conti
nuous CR (CCR), the 3-year event-free survival (EFS) was 30% for responders
and 21% for all patients. The median overall survival (OS) was 12 months (
range 0-70 months), and the OS rate after 3 years was 32%. Unfavorable prog
nostic factors for EFS and OS by univariate analysis were an elevated value
of the serum lactate dehydrogenase and refractory lymphoma. The most frequ
ently observed side effects following ASHAP were leukocytopenia and thrombo
cytopenia of World Health Organization (WHO) grades III/IV in approximately
80% of all courses. Non-hematological toxicities such as gastrointestinal
side effects, infections, mucositis, renal and neurotoxicity occurred more
rarely and reached WHO grades III/IV only occasionally. No treatment-relate
d mortality with ASHAP was observed. Conclusions: ASHAP is an effective and
moderately toxic salvage therapy for patients with recurrent or refractory
IID and NHL. The results in patients responding to ASHAP and afterwards un
dergoing HDT with stem cell support are comparable with other established p
rotocols and indicate an improvement in survival if HDT is carried out as i
ntensification.