Artikel
Epoetin alfa Improves Survival and Local Control after Chemoradiation for Stage III Esophageal Cancer: Final Results of a Prospective Study
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Veröffentlicht: | 20. März 2006 |
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Gliederung
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Background: Tumor oxygenation can be negatively impacted by anemia or, contrary to intuition, by a high hemoglobin level which is associated with an increase in viscous resistance to flow. Hemoglobin levels of 12-14 g/dl appear optimal for tumor oxygenation This prospective non-randomized study evaluates the effectiveness of Epoetin alfa (ERYPO 10000, Janssen-Cilag) to maintain the hemoglobin at 12-14 g/dl during chemoradiation for stage III esophageal cancer, and its impact on overall survival (OS), metastatic-free survival (MFS), and loco-regional control (LC).
Methods and Materials: 90 patients, treated 1/01-7/05, were included. 19 patients received 45-50.4 Gy plus surgery, 8 patients 50-50.4 Gy alone, 63 patients 59.4-66 Gy alone. Concurrent chemotherapy consisted of 1000 mg/m2 5-FU (d 1-5+29-33) and 75 mg/m2 CDDP (d 1+29). 40 patients received Epoetin alfa (150 IU/kg, 3x/week) during RT using an “on-and-off“ strategy. Administration was started at hemoglobin <13 g/dl and stopped at ≥14 g/dl. Hemoglobin was measured weekly during RT. Potential prognostic factors were investigated for outcome: age (≤60 vs. >60 years), ECOG performance status (1 vs. 2-3), tumor length (<7 vs. ≥7 cm), histology (SCC vs. adeno-ca.), grading (G1-2 vs. 3), T (T3 vs. 4), N (N0 vs. 1), treatment (45-50.4 Gy plus surgery vs. 50-50.4 Gy vs. 59.5-66 Gy), hemoglobin before RT (<12 g/dl vs. 12-14 g/dl vs. >14 g/dl), and Epoetin alfa during RT.
Results: Both groups were balanced for potential prognostic factors. Median change of hemoglobin was +0.3 g/dl/week with Epoetin alfa, and –0.5 g/dl/week without Epoetin alfa. In 26/40 patients (65%) with Epoetin alfa and in 8/50 patients (16%) without Epoetin alfa, >=60% of the hemoglobin levels during RT were at 12-14 g/dl (P<0.001). Better OS was associated with ECOG 1 (P=0.049), tumor length <7 cm (P=0.040), and hemoglobin before RT 12-14 g/dl (P=0.014). MFS was associated with tumor length (P=0.027), and LC with hemoglobin before RT (P=0.003). Patients receiving Epoetin alfa had significantly better OS (32% vs. 8% at 2 years, P=0.009) and LC (67% vs. 15% at 2 years, P=0.001). For MFS, a trend was observed (42% vs. 18% at 2 years, P=0.09). The results were supported by a multivariate analysis. Epoetin alfa related toxicity was not observed.
Conclusions: The findings suggest that Epoetin alfa when used to maintain the hemoglobin levels at 12-14 g/dl can improve both survival and loco-regional control in stage III esophageal cancer patients.