A phase I/II trial of pixantrone (BBR2778), methylprednisolone, cisplatin, and cytosine arabinoside (PSHAP) in relapsed/refractory aggressive non-Hodgkin's lymphoma

References

• Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D, et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med 1995; 23: 1540–1545
   Web of Science ®Google Scholar
• Vose J M, Zhang M J, Rowlings P A, Lezarus H M, Bowell B J, Freybes C O, et al. Autologous transplantation for diffuse aggressive non-Hodgkin's lymphoma in patients never achieving remission: a report from the Autologous Blood and Marrow Transplant Registry. J Clin Oncol 2001; 19: 406–413
   PubMed Web of Science ®Google Scholar
• Cortelazzo S, Rambaldi A, Rossi A, Oldani E, Ghielmini M, Benedetti F, et al. Intensification of salvage treatment with high-dose sequential chemotherapy improves the outcome of patients with refractory or relapsed aggressive non-Hodgkin's lymphoma. Br J Haematol 2001; 114: 333–341
   PubMed Web of Science ®Google Scholar
• Hamlin P A, Zelenetz A D, Kewalramani T, Qin J, Satagopan J M, Verbel D, et al. Age-adjusted International Prognostic Index predicts autologous stem cell transplantation outcome for patients with relapsed or primary refractory diffuse large B-cell lymphoma. Blood 2003; 102: 1989–1996
   PubMed Web of Science ®Google Scholar
• Rodriguez-Monge E J, Cabanillas F. Long-term follow-up of platinum-based lymphoma salvage regimens. The MD Anderson Cancer Center experience. Hematol Oncol Clin North Am 1997; 11: 937–947
   PubMed Web of Science ®Google Scholar
• Krapcho A P, Petry M E, Getahun Z, Landi J J, Jr, Stallman J, Polsenberg J F, et al. 6,9-Bis[(aminoalkyl)amino]benzo[g]isoquinoline-5,10-diones. A novel class of chromophore-modified antitumor anthracene-9,10-diones: synthesis and antitumor evaluations. J Med Chem 1994; 37: 828–837
   PubMed Web of Science ®Google Scholar
• Hazlehurst L A, Krapcho A P, Hacker M P. Comparison of aza-anthracenedione-induced DNA damage and cytotoxicity in experimental tumor cells. Biochem Pharmacol 1995; 28: 1087–1094
   Web of Science ®Google Scholar
• De Isabella P, Palumbo M, Sissi C, Capranico G, Carenini N, Menta E, et al. Topoisomerase II DNA cleavage stimulation, DNA binding activity, cytotoxicity, and physico-chemical properties of 2-aza- and 2-aza-oxide-anthracenedione derivatives. Mol Pharmacol 1995; 48: 30–38
   PubMed Web of Science ®Google Scholar
• Beggiolin G, Pezzoni G, Giuliani F G. BBR2778 (6,9-Bis[(aminoalkyl)amino]benzo[g]isoquinoline-5,10-dione dimaleate): in vitro cytoxicity activity. 1994, BM Italy Report, 02/onc
   Google Scholar
• Manzotti C, Pezzoni G, Giuliani F G. BBR2778 (6,9-Bis[(aminoalkyl)amino]benzo[g]isoquinoline-5,10-dione dimaleate): in vitro anti-tumor toxicity activity. 1994, BM Italy Report, 03/onc
   Google Scholar
• BBR 2778 Investigator's Brochure, Edition no.4 March 2001.
   Google Scholar
• Beggiolin G, Crippa L, Menta E, Manzottic, Cavalletti E, Pezzoni G, et al. BBR 2778, an aza-anthracenedione endowed with preclinical anticancer activity and lack of delayed cardiotoxicity. Tumori 2001; 87: 407–416
   PubMed Web of Science ®Google Scholar
• Bertazzoli C, Bellini O, Magrini U, Tosana M. Quantitative experimental evaluation of adriamycin cardiotoxicity in the mouse. Cancer Treat Rep 1979; 63: 1877–1883
   PubMedGoogle Scholar
• Borchmann P, Schnell R, Knippertz R, Staak J O, Camboni G M, Bernareggi A, et al. Phase I study of BBR 2778, a new aza-anthracenedione, in advanced or refractory non-Hodgkin's lymphoma. Ann Oncol 2001; 12: 661–667
   PubMed Web of Science ®Google Scholar
• Faivre S, Raymond E, Boige V, Gatineau M, Buthaut X, Rixe O, et al. A phase I and pharmacokinetic study of the novel aza-anthracenedione compound BBR 2778 in patients with advanced solid malignancies. Clin Cancer Res 2001; 7: 43–50
   PubMed Web of Science ®Google Scholar
• Dawson L K, Jodrell D I, Bowman A, Rye R, Byrne B, Bernareggi A, et al. A clinical phase I and pharmacokinetic study of BBR 2778, a novel anthracenedione analogue, administered intravenously, 3 weekly. Eur J Cancer 2000; 36: 2353–2359
   PubMed Web of Science ®Google Scholar
• Borchmann P, Morschhauser F, Parry A, et al. Phase-II study of the new aza-anthracenedione, BBR 2778, in patients with relapsed aggressive non-Hodgkin's lymphomas. Haematologica 2003; 88: 888–894
   PubMed Web of Science ®Google Scholar
• Cavalli F, Jungi W F, Nissen N I, Parry A, Schnell R, Harousseau J L, et al. Phase II trial of cis-dichlorodiammineplatinum (II) in advanced malignant lymphoma: a study of the cancer and acute leukemia group B. Cancer 1981; 48: 1927–1930
   PubMed Web of Science ®Google Scholar
• O'Reilly S E, Klimo P, Connors J M. The evolving role of etoposide in the management of lymphomas and Hodgkin's disease. Cancer 1991; 67(Suppl 1)271–280
   PubMed Web of Science ®Google Scholar
• Prescott R J, Leonard R C. Pilot study and randomised trial of mitozantrone and ifosfamide for relapsed non-Hodgkin's lymphoma. Scotland and Newcastle Lymphoma group (SNLG) working party on therapy. Leuk Lymphoma 1993; 11: 111–114
   PubMed Web of Science ®Google Scholar
• Ozer H, Miller L L, Schiff C A. Update of recommendations for the use of hematopoietic colony-stimulating factors: evidence-based clinical practice guidelines. American Society of Clinical Oncology. J Clin Oncol 1996; 14: 1957–1960
   PubMed Web of Science ®Google Scholar
• Cheson B D, Horning S J, Coiffier B, Shipp M A, Fisher R I, Connors J M, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol 2000; 18: 1244–1253
   Google Scholar
• Dawson L K, Jodrell D I, Bowman A, Rye R, Byrne B, Bernareggi A, et al. A clinical phase I and pharmacokinetic study of BBR 2778, a novel anthracenedione analogue, administered intravenously, 3 weekly. Eur J Cancer 2000; 36: 2353–2359
   PubMed Web of Science ®Google Scholar
• Vermorken J B, van der Vijgh W JF, Klein I, Gall H E, van Groeningen C J, Hart G A, et al. Pharmacokinetics of free and total platinum species after rapid and prolonged infusion of cisplatin. Clin Pharmacol Ther 1986; 39: 136–144
   PubMed Web of Science ®Google Scholar
• Leone R, Fracasso M E, Soresi E, Cimino G, Tedeschi M, Castoldi D, et al. Influence of glutathione administration on the disposition of free and total platinum in patients after administration of cisplatin. Cancer Chemother Pharmacol 1992; 29: 385–390
   PubMed Web of Science ®Google Scholar
• Vermorken J B, van der Vijgh W J, Klein I, Gall H E, Pinedo H M. Pharmacokinetics of free platinum species following rapid, 3-hr and 24-hr infusions of cis-diamminedichloroplatinum (II) and its therapeutic implications. Eur J Cancer Clin Oncol 1982; 18: 1069–1074
   PubMedGoogle Scholar
• Ho D H, Frei E, III. Clinical pharmacology of 1-1-β-arabinofuranosyl cytosine. Clin Pharmacol Ther 1971; 6: 944–954
   Google Scholar
• Damon L E, Plunkett W, Linker C A. Plasma and cerebrospinal fluid pharmacokinetics of 1-β-d-arabino-furanosylcytosine and 1-β-d-arabinofuranosyluracil following the repeated intravenous administration of high- and intermediate-dose 1-β-d-arabino-furanosylcytosine. Cancer Res 1991; 51: 4141–4145
   PubMed Web of Science ®Google Scholar
• Kewalramani T, Zelenetz A D, Nimer S D, Portlock C, Straus D, Noy A, et al. Rituximab and ICE as second-line therapy before autologous stem cell transplantation for relapsed or primary refractory diffuse large B-cell lymphoma. Blood 2004; 10: 3684–3688
   Web of Science ®Google Scholar