A variant of ProMACE-CytaBOM chemotherapy for non-Hodgkin's lymphoma with threefold higher drug dose size but identical cumulative dose intensity. A pilot study of the Italian Lymphoma Study Group (GISL)

Paolo G. Gobbi, Maria L. Ghirardelli, Paolo Avanzini, Luca Baldini, Giovanni Quarta, Caterina Stelitano, Chiara Broglia, Carlo Loni, Vittorio Silingardi, Edoardo Ascari

Research output: Contribution to journalArticlepeer-review

Abstract

Background and Objectives. The positive results of high-dose chemotherapy followed by rescue with bone marrow progenitor cell transplantation are generally ascribed to the high dose size (DS) of the drugs given. However, a concomitant marked increase in dose Intensity (DI) is always involved. With the aim of comparing the role of DS and DI in non- Hodgkin's lymphomas, a variant of Fisher's ProMACE-CytaBOM regimen was designed in which the projected cumulative drug Dis remained the same as in the original schedule but the DSs were tripled. Design and Methods. Dosages in mg/m2, route and days of administration were the following: cyclophosphamide 1,950 iv on days 1, 64; methotrexate 360 iv days 15, 78; vincristine 1.4 iv days 15, 78, 43, 106; etoposide 360 iv days 29, 92; epirubicin 120 iv days 29, 92; bleomycin 15 iv days 43, 106; cytarabine 900 iv days 50, 113. Thirty-six outpatients with intermediate- and high-grade non-Hodgkin's lymphomas entered the pilot study; 29 were untreated and 7 had relapse disease. Clinical stage was I in 1 patient, II in 7, III in 5 and IV in 23; 10 had B symptoms; the IPI score was 0-2 in 29 cases and ≥ 3 in the remaining 7. Results. Of the 29 previously untreated patients, 16 achieved complete remission, 8 partial remission, 4 developed progressive disease and 1 was withdrawn early from the study because of acute viral hepatitis; subsequently 4 relapsed and 3 died (2 of disease progression, 1 of causes unrelated to the disease). In the pre-treated group 3 patients obtained complete remission, 2 partial remission and in 1 patient the disease progressed; 3 of these pre-treated patients died (1 of progressive disease, 1 of a new relapse, 1 of myocardial infarction during therapy). With a 20-month median follow-up, the 30-month overall and relapse-free survival were 0.58 and 0.70, respectively. G-CSF was administered to all but 2 patients, with median delivery throughout the whole regimen of 8,400 μg per patient. Actual cumulative Di was 0.82±0.11. Grade 3-4 hematologic toxicity consisted of anemia in 3 cases, of leukopenia in 8 and of thrombocytopenia in 2; the same grade of non-hematologic toxicity involved the liver in 2 cases, the heart in 1 (the above mentioned death), the digestive mucosa in 2 and the peripheral nerves in 1 patient. Interpretation and Conclusions. Th iso-DI sequential variant of the ProMACE-CytaBOM regimen can be considered feasibile, relatively non-toxic, and can use of G-CSF is required (about 3 vials after each drug administration). Thus, a randomized trial with the original ProMACE-CytaBOM regimen can be designed. (C) 2000, Ferrata Storti Foundation.

Original languageEnglish
Pages (from-to)263-268
Number of pages6
JournalHaematologica
Volume85
Issue number3
Publication statusPublished - Mar 2000

Keywords

  • Chemotherapy
  • Dose intensity
  • Dose size
  • Non-Hodgkin's lymphoma
  • Toxicity

ASJC Scopus subject areas

  • Hematology

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