Association of hemoglobin level with survival in cervical carcinoma patients treated with concurrent cisplatin and radiotherapy: a Gynecologic Oncology Group Study
Introduction
Last year in the United States, there were approximately 13,000 new cases of cervix cancer and 4100 deaths associated with that diagnosis [1]. Although the incidence of cervix cancer has decreased due to the implementation of screening programs, approximately 25% of patients will be diagnosed with locally advanced disease (Stage IIB through IVA) according to International Federation of Gynecology and Obstetrics (FIGO) criteria [2]. Several randomized trials revealed that treatment regimens combining radiotherapy (RT) with cisplatin-containing chemotherapy improve rates of survival and progression-free interval (PFI) in women with Stage IIB through IVA cervix cancer [3], [4], [5], [6]. Chemoradiation has subsequently become the accepted standard of care in the treatment of advanced cervix cancer.
Recurrence of disease in patients with locally advanced cervical cancer has been associated with anemia before [7] and during radiotherapy alone. Retrospective studies have suggested that poor survival associated with anemia may be improved with correction of hematologic indices [8]. Clinical trials are currently underway to confirm these findings. The effects of anemia on outcome in patients treated with a contemporary regimen of radiation and cisplatin are relatively unknown. However, preliminary data from Austria and Australia suggest that the nadir hemoglobin level was highly predictive of clinical response to chemoradiation, but the small number of patients and absence of follow-up data limited the analysis of disease recurrence and survival in these patients [9].
To analyze the effects of anemia on the outcome in a large population of patients treated with concurrent cisplatin and radiation, we conducted a retrospective study of data from the Gynecologic Oncology Group (GOG). The purpose of this study was to determine whether hemoglobin levels before and during treatment were associated with disease recurrence and survival in patients with locally advanced cervical cancer; and, secondly, to explore whether there is an interval during treatment when the association between low hemoglobin and poor outcome is particularly significant.
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Methods
The current study was a retrospective review of data from patients treated on two prospective, randomized trials conducted by the GOG: Protocol 120 and Protocol 165. Both of these evaluated patient outcomes after combined radiotherapy and cisplatin in the treatment of locally advanced node-negative cervical carcinoma, FIGO Stage IIB-IVA. All participating institutions' Institutional Review Boards approved both trials. The Radiological Physics Center in Houston reviewed all technical aspects of
Results
Four hundred ninety-four patients entered onto GOG Protocol 120 (n = 335) and GOG Protocol 165 (n = 159) who received any treatment including cisplatin and radiation were included in this retrospective analysis. From GOG 120, 346/383 (90%) patients who were randomized to the two arms containing cisplatin and radiation were protocol eligible. Eleven patients were excluded from the current analysis due to outlier hemoglobin values >25 g/dl or hemoglobin data not collected; thus, 335 patients
Discussion
In the two GOG trials reviewed, the proportion of patients with locally advanced cervix cancer who presented with anemia was substantial. Approximately 63% of patients presented with a hemoglobin level <12 g/dl before treatment, one-fourth of whom had levels <10 mg/dl. Hemoglobin levels steadily declined throughout therapy in patients receiving cisplatin and radiation, with 35% of patients having levels <10 mg/dl by week 6 of treatment. The slope of decline in hemoglobin throughout treatment
Acknowledgements
This study was supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469) and the Gynecologic Oncology Group Statistical Office (CA 37517). The following member institutions participated in this study: University of Alabama at Birmingham, Oregon Health Sciences University, Duke University Medical Center, Abington Memorial Hospital, University of Rochester Medical Center, Walter Reed Army Medical Center, Wayne State University, University of
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- 1
Currently: Faculty, Division of Gynecologic Oncology, Brooke Army Medical Center, Fort Sam Houston, TX 78234, USA.