Recombinant human erythropoietin as an adjunct to radiation therapy and cisplatin for stage IIB-IVA carcinoma of the cervix: a Southwest Oncology Group study.

Abstract

OBJECTIVE:

The survival of cervix cancer patients is associated with their hemoglobin (Hgb) level during radiotherapy. The Southwest Oncology Group (SWOG) conducted a phase II trial to determine whether recombinant human erythropoietin (rHuEPO) safely corrects anemia during chemoradiotherapy for cervix cancer.

METHODS:

Patients had stage IIB-IVA cervix cancer and a Hgb between 8.0 and 12.5 g/dl. All patients received rHuEPO thrice weekly and oral iron starting 10-15 days before their 5-week course of whole pelvic irradiation and weekly cisplatin followed by intracavitary brachytherapy.

RESULTS:

Fifty-three patients from 26 institutions received the protocol treatment. The mean Hgb was 10.4 +/- 1.3 g/dl on the first day of rHuEPO administration (baseline), 11.0 +/- 1.6 g/dl on the first day of chemoradiotherapy, 11.6 +/- 1.9 g/dl at the midpoint of chemoradiotherapy, and 11.8 +/- 2.2 g/dl at the end of chemoradiotherapy. The target Hgb level of 12.5 g/dl was achieved in 40% of patients (95% CI 26-56%) by the midpoint of Chemoradiotheraphy. Change in Hgb was associated with baseline serum iron (P = 0.008) and transferrin saturation (P = 0.05) levels, but not with baseline Hgb or serum ferritin, or patient age. Seven patients developed deep vein thrombosis. Two-year progression-free survival (PFS) was 43% and overall survival (OS) was 51%. Survival was significantly associated with Hgb level at the end of chemoradiotherapy, but not with the baseline Hgb level.

CONCLUSIONS:

rHuEPO and iron gradually increased Hgb levels in anemic women with local advanced cervix cancer during chemoradiotherapy. There was a higher than expected incidence of deep vein thrombosis. The progression-free and overall survival rates were lower than reported for women with normal Hgb levels.

• Authors: Robert S Lavey, P Y Liu, Benjamin E Greer, William R Robinson 3rd, Pui C Chang, Raymond B Wynn, Marcel E Conrad, Caroline Jiang, Maurie Markman, David S Alberts
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 95 Issue 1 Pg. 145-51 (Oct 2004) ISSN: 0090-8258 [Print] United States
• PMID: 15385124 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Hemoglobins
• Recombinant Proteins
• Erythropoietin
• Iron
• Cisplatin

Topics

• Adult
• Aged
• Chemotherapy, Adjuvant
• Cisplatin (adverse effects, therapeutic use)
• Combined Modality Therapy
• Disease-Free Survival
• Drug Administration Schedule
• Erythropoietin (adverse effects, therapeutic use)
• Female
• Hemoglobins (metabolism)
• Humans
• Iron (blood)
• Middle Aged
• Recombinant Proteins
• Uterine Cervical Neoplasms (blood, drug therapy, radiotherapy)