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| A randomized placebo-controlled trial of recombinant human interleukin-11 in cancer patients with severe thrombocytopenia due to chemotherapy |
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| Author(s): Tepler I, Elias L, Smith JW, Hussein M, Rosen G, Chang AYC, Moore JO, Gordon MS, Kuca B, Beach KJ, Loewy JW, Garnick MB, Kaye JA |
| Source: BLOOD Volume: 87 Issue: 9 Pages: 3607-3614 Published: MAY 1 1996 |
| Times Cited: 167 References: 35 |
| Abstract: Thrombocytopenia is a complication of cancer treatment that can limit dose intensity. Interleukin-11 (IL-11) is a growth factor that increases platelet production. We conducted a multicenter, randomized, placebo-controlled trial of recombinant human IL-11 (rhIL-11) in 93 patients with cancer who had already been transfused platelets for severe thrombocytopenia resulting from chemotherapy. The patients had received platelet transfusions for nadir platelet counts of less than or equal to 20,000/mu L during the chemotherapy cycle immediately preceding study entry, Chemotherapy was continued during the study without dose reduction. Patients were randomized to receive placebo or rhIL-11 at 50 or 25 mu g/kg subcutaneously once daily for 14 to 21 days beginning 1 day after chemotherapy. Eight of 27 (30%) evaluable patients treated with rhIL-11 at a dose of 50 mu g/kg did not require platelet transfusions versus 1 of 27 (4%) patients who received placebo (P < .05). Five of 28 (18%) patients treated with rhIL-11 at 25 mu g/kg avoided platelet transfusions (P = .23). Side effects were fatigue and cardiovascular symptoms, including a low incidence of atrial arrhythmias and syncope. There were no differences among treatment groups in the incidence of neutropenic fever, days of hospitalization, or number of red blood cell transfusions. This study shows that rhIL-11 treatment at a dose of 50 mu g/kg significantly increases the likelihood that patients who have already been transfused platelets for severe chemotherapy-induced thrombocytopenia will not require platelet transfusions during a subsequent chemotherapy cycle. (C) 1996 by The American Society of Hematology. |
| Document Type: Article |
| Language: English |
Addresses:
1. GENET INST INC, CAMBRIDGE, MA 02140 USA 2. BETH ISRAEL HOSP, DEPT MED, DIV HEMATOL ONCOL, BOSTON, MA 02215 USA 3. UNIV NEW MEXICO, DIV HEMATOL ONCOL, ALBUQUERQUE, NM 87131 USA 4. UNIV MICHIGAN, MED CTR, DEPT INTERNAL MED, DIV HEMATOL & ONCOL, ANN ARBOR, MI 48109 USA 5. CLEVELAND CLIN FDN, DEPT HEMATOL & MED ONCOL, CLEVELAND, OH 44195 USA 6. CEDARS SINAI MED CTR, CTR COMPREHENS CANC, LOS ANGELES, CA USA 7. UNIV ROCHESTER, GENESSEE HOSP, DIV HEMATOL ONCOL, ROCHESTER, NY 14607 USA 8. DUKE UNIV, MED CTR, DEPT MED, DEPT HEMATOL ONCOL, DURHAM, NC 27710 USA 9. INDIANA UNIV, SCH MED, DEPT MED, DIV HEMATOL ONCOL, INDIANAPOLIS, IN USA |
| Publisher: W B SAUNDERS CO, INDEPENDENCE SQUARE WEST CURTIS CENTER, STE 300, PHILADELPHIA, PA 19106-3399 |
| Subject Category: Hematology |
| IDS Number: UH142 |
| ISSN: 0006-4971 |
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