This paper is only available as a PDF. To read, Please Download here.
Abstract
Objective.The objective of this study was to evaluate the benefits and risk of adjuvant pelvic
radiotherapy aimed at reducing recurrence in women with Stage IB cervical cancer treated
by radical hysterectomy and pelvic lymphadenectomy.
Methods.Two hundred seventy-seven eligible patients were entered with at least two of the
following risk factors: >1/3 stromal invasion, capillary lymphatic space involvement,
and large clinical tumor diameter. Of 277 patients, 137 were randomized to pelvic
radiotherapy (RT) and 140 to no further treatment (NFT).
Results.Twenty-one (15%) in the RT group and 39 (28%) in the NFT group had a cancer recurrence,
18 of whom were vaginal/pelvic in the RT and 27 in the NFT group. In the RT group,
of 18 (13%) who died, 15 died of cancer. In the NFT group, of the 30 (21%) who died,
25 died from cancer. Life table analysis indicated a statistically significant (47%)
reduction in risk of recurrence (relative risk = 0.53,P= 0.008, one-tail) among the RT group, with recurrence-free rates at 2 years of 88%
versus 79% for the RT and NFT groups, respectively. Severe or life-threatening (Gynecologic
Oncology Group grade 3 or 4) urologic adverse effects occurred in 4 (3.1%) in the
RT group and 2 (1.4%) in the NFT group; 3 (2.3%) and 1 (0.7%) hematologic; 4 (3.1%)
and 0 gastrointestinal (GI); and 1 (0.8%) and 0 neurologic, respectively. One patient's
death was attributable to grade 4 GI adverse effects.
Conclusions.Adjuvant pelvic radiotherapy following radical surgery reduces the number of recurrences
in women with Stage IB cervical cancer at the cost of 6% grade 3/4 adverse events
versus 2.1% in the NFT group.
To read this article in full you will need to make a payment
Subscribe to Gynecologic Oncology
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
REFERENCES
- Annual report on the results of treatment in gynecologic cancer (FIGO).Int J Gynecol Obstet. 1991; 21: 36
- Stage IB squamous cancer of the cervix: The choice of treatment.Obstet Gynecol Surv. 1978; 33: 174-183
- Analysis of factors contributing to treatment failure in stage IB and IIA carcinoma of the cervix.Am J Obstet Gynecol. 1980; 138: 550-556
- Prognostic factors in stage I carcinoma of the cervix.Gynecol Oncol. 1981; 12: 154-165
- The significance of vascular invasion and lymphocytic infiltration in invasive cervical cancer.Cancer. 1978; 41: 228-234
- Selective radiation therapy in Stage IB uterine cervical carcinoma following radical pelvic surgery.Gynecol Oncol. 1980; 10: 84-92
- Vascular invasion in stage I carcinoma of the cervix.Cancer. 1984; 53: 1175-1180
- Prospective surgical pathological study of disease-free interval in patients with stage IB squamous cell carcinoma of the cervix: A Gynecologic Oncology Group study.Gynecol Oncol. 1990; 38: 352-357
- Prognostic factors in cervical carcinoma: Implications in staging and management.Cancer. 1981; 48: 560-567
- Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation.J Chronic Dis. 1981; 34: 469
- Sample-sizes for the proportional hazards regression model.Biometrics. 1983; 39: 499-503
- Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification.Biometrics. 1986; 42: 507-519
- Nonparametric estimation from incomplete observations.J Am Stat Assoc. 1958; 53: 457-481
- Evaluation of survival data and two new rank order statistics arising in its consideration.Cancer Chemo Rep. 1966; 50: 163-170
- Regression model and life tables (with discussion).J R Statistical Soc, B. 1972; 34: 187
- Statistical Methods. The Iowa State University Press, Ames1967
- Categorical Data Analysis. John Wiley & Sons, 1990
- Local control and patient survival.Int J Radiat Oncol Biol Physics. 1992; 23: 653-660
- Is there a role for adjuvant pelvic radiotherapy after radical hysterectomy in early stage cervical cancer.Int J Gynecol Cancer. 1991; 1: 1-8
- Microinvasive carcinoma of cervix—The significance of lymphatic invasion and confluent patterns of stromal growth.Cancer. 1975; 36: 180-186
- Microinvasion carcinoma of the uterine cervix: A clinical pathologic study.Am J Obstet Gynecol. 1979; 133: 64-74
- The influence of tumor size and morphology on the outcome of patients with FIGO stage IB squamous cell carcinoma of the uterine cervix.Int J Radiat Oncol Biol Physics. 1994; 29: 9-15
- Histopathologic predictors of behavior of surgically treated stage IB squamous cell carcinoma of the cervix: A Gynecologic Oncology Group study.Cancer. 1992; 69: 1750-1758
- Stage Ib carcinoma of the cervix, the Norwegian Radium Hospital: Results and complications. III Urinary and gastrointestinal complications.Gynecol Oncol. 1983; 15: 42-47
Article Info
Publication History
Received:
September 29,
1998
Footnotes
☆Presented at the 29th Annual Meeting of the Society of Gynecologic Oncologists, Orlando, FL, February 7–11, 1998.
☆☆Reprint requests should be addressed to GOG Administrative Office, Suite 1945, 1234 Market Street, Philadelphia, PA 19107.
★The Radiological Physics Center (RPC) through its comprehensive quality assurance program ensured that the radiation doses delivered to all patients in this study are clinically comparable. The RPC reviewed all technical aspects of the treatment, verified the reported doses, and participated in the clinical evaluation of all patients. In addition, the RPC monitored the calibration of the therapy units using mailed dosimeters at all participating institutions and on-site evaluations of selected institutions as needed.
Identification
Copyright
© 1999 Academic Press. Published by Elsevier Inc. All rights reserved.
