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Annals of Oncology Advance Access originally published online on August 3, 2006
Annals of Oncology 2006 17(10):1546-1552; doi:10.1093/annonc/mdl153
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© 2006 European Society for Medical Oncology

hematologic malignancies

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

DC Betticher1,*, G Martinelli2, JA Radford3, M Kaufmann4, MJS Dyer3, U Kaiser4, WE Aulitzky4, J Beck4, A von Rohr1, T Kovascovics1, SB Cogliatti1, S Cina1, R Maibach1, T Cerny1 and DC Linch3

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

*Correspondence to: Dr D. Betticher, Clinic of Med. Oncology, Hospital of Fribourg, 1700 Fribourg, Switzerland. E-mail: betticherd{at}hopcantfr.ch

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.

Key words: aggressive lymphoma, autologus bone marrow transplantation, diffuse large cell lymphoma, sequential high dose chemotherapy


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Poor results and patient selection bias
Alessandro M Gianni, et al.
Annals of Oncology, 10 Oct 2006 [Full text]
Reply: Poor results and patient selection bias
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Annals of Oncology, 13 Oct 2006 [Full text]

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