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Clinical Trial
. 2012 Feb 16;119(7):1665-70.
doi: 10.1182/blood-2011-10-388058. Epub 2011 Dec 19.

Normalization of pre-ASCT, FDG-PET imaging with second-line, non-cross-resistant, chemotherapy programs improves event-free survival in patients with Hodgkin lymphoma

Affiliations
Clinical Trial

Normalization of pre-ASCT, FDG-PET imaging with second-line, non-cross-resistant, chemotherapy programs improves event-free survival in patients with Hodgkin lymphoma

Craig H Moskowitz et al. Blood. .

Abstract

We previously reported that remission duration < 1 year, extranodal disease, and B symptoms before salvage chemotherapy (SLT) can stratify relapsed or refractory Hodgkin lymphoma (HL) patients into favorable and unfavorable cohorts. In addition, pre-autologous stem cell transplant (ASCT) (18)FDG-PET response to SLT predicts outcome. This phase 2 study uses both pre-SLT prognostic factors and post-SLT FDG-PET response in a risk-adapted approach to improve PFS after high-dose radio-chemotherapy (HDT) and ASCT. The first SLT uses 2 cycles of ICE in a standard or augmented dose (ICE/aICE), followed by restaging FDG-PET scan. Patients with a negative scan received a transplant. If the FDG-PET scan remained positive, patients received 4 biweekly doses of gemcitabine, vinorelbine, and liposomal doxorubicin. Patients without evidence of disease progression proceeded to HDT/ASCT; those with progressive disease were study failures. At a median follow-up of 51 months, EFS analyzed by intent to treat as well as for transplanted patients is 70% and 79%, respectively. Patients transplanted with negative FDG-PET, pre-HDT/ASCT after 1 or 2 SLT programs, had an EFS of > 80%, versus 28.6% for patients with a positive scan (P < .001). This prospective study provides evidence that the goal of SLT in patients with Hodgkin lymphoma should be a negative FDG-PET scan before HDT/ASCT.

Trial registration: ClinicalTrials.gov NCT00255723.

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Figures

Figure 1
Figure 1
Treatment schema. aOne patient died of sudden death, and 1 patient did not complete ICE; b3 FDG-PET–negative patients did not receive GVD because they progressed on ICE; and c2 patients failed to mobilize cells, 3 patients progressed after ICE and GVD, 1 patient had an adverse reaction to liposomal doxil, and 1 patient was treated off study due to physician discretion.
Figure 2
Figure 2
Survival curves. (A) Intent-to-treat cohort. (B) Transplanted cohort.
Figure 3
Figure 3
EFS intent to treat by pre-ASCT response.
Figure 4
Figure 4
EFS for patients who received GVD.
Figure 5
Figure 5
EFS by PET and ENS results.

References

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    1. Moskowitz CH, Nimer SD, Zelenetz AD, et al. A 2-step comprehensive high-dose chemoradiotherapy second-line program for relapsed and refractory Hodgkin disease: analysis by intent to treat and development of a prognostic model. Blood. 2001;97(3):616–623. - PubMed
    1. Goodman KA, Riedel E, Serrano V, Gulati S, Moskowitz CH, Yahalom J. Long-term effects of high-dose chemotherapy and radiation for relapsed and refractory Hodgkin's lymphoma. J Clin Oncol. 2008;26(32):5240–5247. - PubMed

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