Topotecan, Ara-C, cisplatin and prednisolone (TOPOSHAP) for patients with refractory and relapsing lymphomas: results of a phase I trial

Autor: Fernando Coutinho, Ana Rita Manhani, William S. Velasquez, Auro del Giglio
Rok vydání: 2003
Předmět:
Zdroj: Acta haematologica. 112(3)
ISSN: 0001-5792
Popis: We designed a phase I trial to assess the feasibility of the combination of topotecan, Ara-C, cisplatin and solumedrol (TOPOSHAP) in patients with relapsed or primary refractory lymphomas. We included 9 patients with mesurable non-Hodgkin’s (n = 8) and Hodgkin’s (n = 1) lymphomas. Level 1 consisted of topotecan 1.0 mg/m2/day, i.v., given on days 1–3, cisplatin 25 mg/m2/day, i.v., on days 1–3, Ara-C 500 mg/m2, i.v., on day 4, methylprednisolone 250 mg, i.v., on days 1–4. The regimen was repeated every 3–4 weeks. The maximum tolerated dose was already reached at level 1. G-CSF was added systematically after the 5th patient was included. The most significant toxicity in this trial was hematologic (all had neutropenia WHO grade 4 and 7 had grade 4 thrombocytopenia). Three patients had neutropenic fever. We observed two instances of WHO grade 3 and one of grade 4 diarrhea. Two patients achieved a complete response and 6 a partial response. We conclude that TOPOSHAP with G-CSF support is feasible and should be further studied in phase II studies.
Databáze: OpenAIRE