Sequential Adjuvant Chemo-Radiotherapy With Vs. Without Erythropoeitin For Patients With High-Risk Cervical Cancer-Second Analysis Of A Prospective, Randomized, Open And Controlled AGO- AND Sequential Adjuvant Chemo-Radiotherapy With Vs. Without Erythropoeitin For Patients With High-Risk Cervical Cancer-Second Analysis Of A Prospective, Randomized, Open And Controlled AGO- And NOGGO-Intergroup Study

Reviewer: Roberto Santiago, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: May 19, 2002

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Presenter: Jens U Blohmer
Presenter's Affiliation: Humboldt University, Berlin, Germany
Type of Session: Poster

Background

  • The aim of the study was to compare the disease-free survival achieved by an adjuvant sequential chemoradiotherapy regimen with vs. without Erythropoeitin (EPO) for patients with high-risk cervical cancer
  • The second endpoints of the study included toxicity, number of transfusions, quality of life, and survival

Materials and Methods

  • All patients underwent a radical hysterectomy and adjuvant chemotherapy and radiation therapy was recommended postoperatively
  • Patients were stratified according to pelvic nodes (pN0 vs. pN1), stage (Ib, IIa vs. IIb), and resection (R0 vs. R1)
  • Patients were randomized to sequential chemotherapy followed by radiotherapy with EPO or without EPO
  • All patients received 4 cycles (q21d) of ifosphamide (1.6 mg/m2, d1-3), carboplatin (AUC 4, d1) and subsequent radiotherapy (5 weekly fractions of 1.8-2 Gy up to 50-50.5 Gy)
  • EPO arm: EPO 10,000 IU three times a week + oral iron supplements up to a Hb target value of 13 g/dl
  • No EPO arm: only transfusions were allowed
  • 128 patients from 63 clinics were randomized to each arm between 01/1999 and 03/2001

Results

  • EPO was given as planned in about half of the patients analyzed in the EPO-arm
  • The EPO-application was stopped in 33% of patients because a Hb > 14g/dl was achieved
  • The EPO dose was reduced (10.000 IE/3x/week) in 8% of patients because a Hb > 13 g/dl was achieved
  • The median doses of carboplatin and ifosphamide (in both arms) were AUC 4 and 1.6 g/m2, respectively
  • 84% of the patients completed the 4 cycles of chemotherapy
  • Median radiation dose was 50.4 Gy
  • Median follow-up was 64.5 weeks
  • There was a significantly higher recurrence-free survival rate in the EPO-arm (89% vs. 78%, p=0.04)
  • There was a significant reduction of grade 2 anemia (20% vs. 51%, p=0.01) and in the number of red blood cell (no transfusion required: 91% vs. 67%; p=0.0046) as well as platelet transfusions (p=0.0025) in the EPO-arm

Author's Conclusions

  • Adjuvant sequential chemoradiotherapy with EPO support in patients with high-risk cervical cancer was demonstrated to be easily tolerated and associated to few treatment interruptions
  • After a short follow-up period, support with EPO appeared to afford a lower rate of recurrences

Clinical/Scientific Implications

  • It is plausible that the benefit seen is due to re-oxygenation of hypoxic tumors but further research is needed to confirm this hypotesis.
  • If these findings are confirmed with further follow-up routine EPO support could become a standard component of chemoradiotherapy for cervical cancer.

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.



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