High response and disease free survival (DPS) rates have been reported for the SV regimen in single institution and multi-center phase II studies. We have initiated a randomized phase II study of Stanford V versus ABVD to determine the feasibility, response rate and early regimen related toxicity of Stanford V in comparison with standard chemotherapy in a multi-institutional setting. Eligibility: CSIIB - IVB HD, aged >18 years, previously untreated. Pts were randomized to receive SV chemotherapy for 12 weeks or ABVD x 6-8. Any pt experiencing dose reduction or delay due to neutropenia received GCSF with all subsequent myelosuppressive cycles of chemotherapy.AH pts with bulky disease (mediastinal diseasoone third of CTR, nodal masses>5cm, macroscopic splenic nodules on CT scan) received involved field radiotherapy (IFRT). Since March 1998, 90 patients(pts)have been randomized (46, SV; 44 ABVD). Pt characteristics are as follows: median age - 33 (17 - 61 ; male - 51, female - 39; Stage II-35, HI-24, IV-31; B symptoms - 56. To date, 56 pts have completed all therapy (31, SV; 24, ABVD). 35 have received IFRT (20, SV; 15, ABVD).Results: SV (%) ABVD (%) CR 8(26) 5(21) CRu 4(13) 1(4) PR 17(55) 17(71) PD 1(3) 0 inev 1(3) 1(4) 2 deaths have occured in the SV arm (both from PD) and 3 in the ABVD arm (2, PD; 1 pneumocystis pneumonia). Toxicity: grade 1 & 2 leukoepenia: SV-21(68%), ABVD- 14 (58%). G-CSF was required for 16 pts (52%) receiving SV and 22 pts (92%) receiving ABVD (p = 0.003, Fisher's exact test). 3 episodes of grade 3/4 non-hematologic toxicity were reported for SV, and none for ABVD.These preliminary data confirm the feasibility of the SV regimen in a multi-center context. Overall response rates and non-hematologic toxicities for the 2 regimens are comparable. More pts receiving ABVD received G-CSF support. Longer follow-up and larger pt numbers are required to determine the rates of tumor control with these regimens.
|Original language||English (US)|
|Issue number||11 PART II|
|State||Published - Dec 1 2000|
ASJC Scopus subject areas
- Cell Biology