13.11.2014 Views

Haematologica 2003 - Supplements

Haematologica 2003 - Supplements

Haematologica 2003 - Supplements

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

227<br />

MELPHALAN/PREDNISONE VS.<br />

MELPHALAN/DEXAMETASONE AS FIRST LINE<br />

TREATMENT IN ELDERLY MULTIPLE MYELOMA<br />

PATIENTS<br />

J.M.Hernández Martín, E.Golvano, R,García-Sanz,<br />

G.Mateo, J.Trujillo, F.J.Fdez-Calvo, J.A.Soler, S.Gardella,<br />

F.Carbonell, M.Fontanillas,J.Bladé, J.J.Sánchez,<br />

J.F.SanMiguel.<br />

PETHEMA Group<br />

Melphalan/Prednisone (MP) remains as the standard therapy for<br />

elderly Multiple Myeloma (MM) patients. High doses<br />

Dexametasone is one of the most active agents in MM. However,<br />

there aren’t controlled studies to explore the efficacy and safety<br />

of the combination of Dexamethasone with Melphalan.<br />

For this reason, the PETHEMA group (Spanish Program for the<br />

Therapeutic of Malign Hemopathies) designed a multicentric<br />

randomized study in order to compare if<br />

Melphalan/Dexametasone (MD) is superior to conventional MP.<br />

Response rates, event-free survival (EFS), survival and toxicity<br />

have been analyzed.<br />

MATHERIALS AND METHODS: Patients: 201 MM patients<br />

(proceeding of 27 Spanish Hospitals) > 65 year old or not<br />

candidates for autologous transplantation were included in the<br />

study. Patients were centrally randomized at diagnosis to receive<br />

6 courses of MP or MD (this with double pulse of<br />

Dexametasone). Patients who achieved any grade of response<br />

(Complete Response (CR), Partial Response (PR) or Minimal<br />

Response (MR) received six additional courses of the same<br />

schema; then, those achieving CR or PR went into maintenance<br />

therapy with Interpheron alfa-2b plus Dexametasone. Both arms<br />

were well balanced according to the most relevant clinicalbiologic<br />

disease characteristics. Median of follow-up was 46.8<br />

months. The study was approved for the local ethical committees<br />

RESULTS: In 27 cases (10 MP and 17 MD) there were lost of<br />

follow-up or major protocol violation. Although the overall<br />

response rate was similar in both arms after six courses (MP:<br />

65.4% vs. MD: 65%) (p=0.85) and after twelve courses (MP:<br />

46.1% vs. MD: 46.7%) (p=0.94), the proportion of CR was<br />

significantly higher in patients receiving MD than in those treated<br />

with MP, and this occurred both after six cycles (MP: 2.6% vs.<br />

MD: 9.3%) (p

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!