Melphalan-prednisone versus alternating combination VAD/MP or VND/MP as primary therapy for multiple myeloma: final analysis of a randomized clinical study.

نویسندگان

  • Michele Cavo
  • Monica Benni
  • Sonia Ronconi
  • Mauro Fiacchini
  • Alessandro Gozzetti
  • Elena Zamagni
  • Claudia Cellini
  • Patrizia Tosi
  • Michele Baccarani
  • Sante Tura
چکیده

BACKGROUND AND OBJECTIVES In the absence of a cure for multiple myeloma (MM) with standard-dose therapy, any strategy that can be expected to increase tumor reduction and to extend survival duration is likely to be of clinical relevance. The primary end-point of the present study was to investigate whether the alternating combination of vincristine-doxorubicin-dexamethasone (VAD) and melphalan-prednisone (MP) or vincristine-mitoxantrone-dexamethasone (VND) and MP could improve the clinical outcome of MM patients thus treated in comparison with those receiving MP alone. DESIGN AND METHODS Between November 1990 and April 1994, 527 previously untreated, stage I-III, MM patients from 29 Italian institutions were randomized to receive one of three remission induction chemotherapy regimens consisting of 8-monthly courses of either MP alone or alternating VAD/MP or VND/MP. RESULTS On an intent-to-treat basis, the objective response rates were 53% with MP (objective + minor: 67%), 47% with VAD/MP (objective + minor: 61%) and 49% with VND/MP (objective + minor: 61%). Median survival duration was 36.5 months with MP, 29 months with VAD/MP and 32.5 months with VND/MP. The difference among these groups was not statistically significant, even after stratifying patients into high-risk and low-risk subgroups, as assessed by a multifactor proportional hazard analysis. In both younger and elderly patients, severe granulocytopenia and related infections were significantly more frequent with VND/MP compared to the remaining arms of treatment (p < 0.001 and p = 0.009, respectively). Similarly, the frequency of WHO grade III-IV cardiovascular events was significantly higher for patients receiving anthracycline-containing regimens (VND/MP and VAD/MP) than for those treated with MP alone (p = 0.04). INTERPRETATION AND CONCLUSIONS Alternating VAD/MP and VND/MP failed to improve the clinical outcome for MM patients, at the cost of increased toxicity and morbidity. Resistance to standard-dose chemotherapy remains a significant obstacle to the treatment of MM.

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عنوان ژورنال:
  • Haematologica

دوره 87 9  شماره 

صفحات  -

تاریخ انتشار 2002