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Annals of Oncology Advance Access published online on August 3, 2006
Annals of Oncology, doi:10.1093/annonc/mdl153
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© 2006 European Society for Medical Oncology
Received February 18, 2006
Revised May 22, 2006
Accepted May 26, 2006

original article

Sequential high dose chemotherapy as initial treatment for aggressive sub-types of Non-Hodgkin Lymphoma: results of the international randomized phase III trial (MISTRAL)

D. C. Betticher 1 *, G. Martinelli 2, J. A. Radford 3, M. Kaufmann 4, M. J. S. Dyer 3, U. Kaiser 4, W. E. Aulitzky 4, J. Beck 4, A. von Rohr 1, T. Kovascovics 1, S. B. Cogliatti 1, S. Cina 1, R. Maibach 1, T. Cerny 1, and D. C. Linch 3

1 SAKK (Swiss Group for Clinical Cancer Research), Bern, Switzerland
2 European Institute of Oncology, Milano, Italy
3 UKCCCR Lymphoma Subcommittee, UK
4 German Lymphoma Study Group, Germany

* To whom correspondence should be addressed.
D. C. Betticher, E-mail: betticherd{at}hopcantfr.ch


  Abstract

Introduction: Sequential high dose (SHiDo) chemotherapy with stem cell support has been shown to prolong the event-free survival in patients with diffuse large B-cell lymphoma.

Methods: To confirm this result in a multicenter trial, we randomized patients with aggressive NHL, to receive either eight cycles of CHOP or SHiDo. The primary endpoint was overall survival.

Results: 129 evaluable patients were randomized to receive either CHOP or SHiDo: median age, 48 years; 62% male; stage III+IV: 73%; age adjusted International Prognostic Index 1/2/3: 21%/52%/27%. Toxicity grades 3+4 were more pronounced in the SHiDo-arm with 13% versus 3% of patients with fever; 34% versus 13% with infections; 13% versus 2% with esophagitis/dysphagia/gastric ulcer. The remission rates were similar in SHiDo and CHOP arms with 34%/37% complete remissions and 31%/31% partial remissions, respectively. After a median observation time of 48 months, there was no difference in overall survival at 3 years, with 46% for SHiDo and 53% for CHOP (P = 0.48).

Conclusion: In this multicenter trial, early intensification with SHiDo did not confer any survival benefit in previously untreated patients with aggressive NHL and was associated with a higher incidence of grades 3/4 toxicity.

Keywords: aggressive lymphoma; autologus bone marrow transplantation; diffuse large cell lymphoma; sequential high dose chemotherapy.
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Annals of Oncology, 10 Oct 2006 [Full text]
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