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

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)1546-1552
Number of pages7
JournalAnnals of Oncology
Volume17
Issue number10
DOIs
Publication statusPublished - Oct 2006

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Non-Hodgkin's Lymphoma
Drug Therapy
Multicenter Studies
Survival
Therapeutics
Esophagitis
Lymphoma, Large B-Cell, Diffuse
Stomach Ulcer
Deglutition Disorders
Disease-Free Survival
Fever
Stem Cells
Observation
Incidence
Infection

Keywords

  • Aggressive lymphoma
  • Autologus bone marrow transplantation
  • Diffuse large cell lymphoma
  • Sequential high dose chemotherapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Sequential high dose chemotherapy as initial treatment for aggressive sub-types of Non-Hodgkin Lymphoma : Results of the international randomized phase III trial (MISTRAL). / Betticher, D. C.; Martinelli, G.; Radford, J. A.; Kaufmann, M.; Dyer, M. J S; Kaiser, U.; Aulitzky, W. E.; Beck, J.; von Rohr, A.; Kovascovics, T.; Cogliatti, S. B.; Cina, S.; Maibach, R.; Cerny, T.; Linch, D. C.

In: Annals of Oncology, Vol. 17, No. 10, 10.2006, p. 1546-1552.

Research output: Contribution to journalArticle

Betticher, DC, Martinelli, G, Radford, JA, Kaufmann, M, Dyer, MJS, Kaiser, U, Aulitzky, WE, Beck, J, von Rohr, A, Kovascovics, T, Cogliatti, SB, Cina, S, Maibach, R, Cerny, T & Linch, DC 2006, 'Sequential high dose chemotherapy as initial treatment for aggressive sub-types of Non-Hodgkin Lymphoma: Results of the international randomized phase III trial (MISTRAL)', Annals of Oncology, vol. 17, no. 10, pp. 1546-1552. https://doi.org/10.1093/annonc/mdl153
Betticher, D. C. ; Martinelli, G. ; Radford, J. A. ; Kaufmann, M. ; Dyer, M. J S ; Kaiser, U. ; Aulitzky, W. E. ; Beck, J. ; von Rohr, A. ; Kovascovics, T. ; Cogliatti, S. B. ; Cina, S. ; Maibach, R. ; Cerny, T. ; Linch, D. C. / Sequential high dose chemotherapy as initial treatment for aggressive sub-types of Non-Hodgkin Lymphoma : Results of the international randomized phase III trial (MISTRAL). In: Annals of Oncology. 2006 ; Vol. 17, No. 10. pp. 1546-1552.
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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.",
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T1 - Sequential high dose chemotherapy as initial treatment for aggressive sub-types of Non-Hodgkin Lymphoma

T2 - Results of the international randomized phase III trial (MISTRAL)

AU - Betticher, D. C.

AU - Martinelli, G.

AU - Radford, J. A.

AU - Kaufmann, M.

AU - Dyer, M. J S

AU - Kaiser, U.

AU - Aulitzky, W. E.

AU - Beck, J.

AU - von Rohr, A.

AU - Kovascovics, T.

AU - Cogliatti, S. B.

AU - Cina, S.

AU - Maibach, R.

AU - Cerny, T.

AU - Linch, D. C.

PY - 2006/10

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N2 - 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.

AB - 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.

KW - Aggressive lymphoma

KW - Autologus bone marrow transplantation

KW - Diffuse large cell lymphoma

KW - Sequential high dose chemotherapy

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