Treatment Stratification According to Early Response to Mega-CHOP

Aim: To assess the efficacy of PBSCT in patients with poor prognosis aggressive NHL according to previous early response to Mega-CHOP evaluated with CT & Ga67S. Those in CR (CT scan, Ga67S negative) or uCR (CT scan positive, Ga67S negative) received a 4th Mega-CHOP followed by BEAM and PBSCT. Those with positive Ga67S received IFE or ESHAP (x2) regimens followed by BEAM and PBSCT.

Conclusions: These preliminary results suggest that early salvage therapy can overcome the poor outcome of patients with bad prognosis aggressive lymphoma. Moreover, this early evaluation could identify patients with poor prognosis who only need a short treatment.

Official Title

Treatment Stratification According to Early Response to Mega-CHOP, Based on CT and Gallium 67 Scan (G67S) with or without IFE Salvage Therapy Followed by Peripheral Autologous Stem Cell Transplant (PBSCT) in Patient with Poor Prognosis Aggressive Lymphoma.

Conditions

Study Type

Phase II

Study Design

Patients:G67S positive large cell B cell lymphoma with IPI score > 2 or IPI <2 with high B2 microglobulin or peripheral T cell lymphoma (PTCL), except ALK+anaplastic lymphoma regardless of IPI. Patients were evaluated after 3 cycles of Mega-CHOP.112 patients emrolled and 87 finished treatment. Median age was 52 years (20-67 years) and 49% were males. 71 pts (72%) had a DBLCL, 8 (7%) a grade 3 FL and, 24 (21%) PTCL62 pts (88%) had IPI > 2, and 12% IPI 1Treatment:Mega- CHOP: Cy 1,5 g/m2, ADR 65 mg /m2 and VCR 2 mg on day 1 andPred 60 mg /m2 days 1 – 5) on a 21 day schedule IFE: Ifosfamide 10 gr/m2 and VP16 900 mg/m2 (days 1- 3) with Mesna.

Further Details

Results:After 3 Mega-CHOP, CR or Ucr = 47 pts (42%) PR =48(43%) PR and 16 (14%) were refractory. 2 early deaths. After IFE CR,= 18/46 (39%) 19 PR =(41%) and PD= 9 (20%). Overall, 87 patients received PBSCT and are valuable for response. 29 pts (26%) died, 20% due to lymphoma and 6% due to toxicity. With 24 months of median follow-up (8 to 51 months), 81 patients are alive, 67 (60%), disease free. Overall Survival for Ga67S negative patients after 3 Mega-CHOP was 69 % vs. 67% for Ga67S positive (p=0,14) Event free survival 68% vs. 61% (p=0,84). In the univariate analysis, the only significant variable associated with outcome was non CR or PR after MEGACHOP + IFE vs. RD (p=0,007).

Study Start

Eligibility & Criteria

Indication: Poor prognosis aggressive NHL

Total Enrolment

Contact Details

Eulogio Conde et alA Preliminary Report from a Prospective GEL/TAMO Trial Abstract 3335 ASH 2005Servicio de Hematologica, Hospital Valdecilla, 39008. Santander, Spain