To determine the efficacy of a definitive radiotherapy protocol using high-dose-rate
intracavitary brachytherapy (HDR-ICBT) with a low cumulative dose schedule in nonbulky
early-stage cervical cancer patients, we conducted a prospective multi-institutional
study.
Eligible patients had squamous cell carcinoma of the intact uterine cervix, Federation
of Gynecologic Oncology and Obstetrics (FIGO) stages Ib1, IIa, and IIb, tumor size
<40 mm in diameter (assessed by T2-weighted magnetic resonance imaging), and no pelvic/para-aortic
lymphadenopathy. The treatment protocol consisted of whole-pelvis external beam radiotherapy
(EBRT) of 20 Gy/10 fractions, pelvic EBRT with midline block of 30 Gy/15 fractions,
and HDR-ICBT of 24 Gy/4 fractions (at point A). The cumulative biologically effective
dose (BED) was 62 Gy(10) (α/β = 10) at point A. The primary endpoint was the 2-year
pelvic disease progression-free (PDPF) rate. All patients received a radiotherapy
quality assurance review.
Between September 2004 and July 2007, 60 eligible patients were enrolled. Thirty-six
patients were assessed with FIGO stage Ib1; 12 patients with stage IIa; and 12 patients
with stage IIb. Median tumor diameter was 28 mm (range, 6-39 mm). Median overall treatment
time was 43 days. Median follow-up was 49 months (range, 7-72 months). Seven patients
developed recurrences: 3 patients had pelvic recurrences (2 central, 1 nodal), and
4 patients had distant metastases. The 2-year PDPF was 96% (95% confidence interval
[CI], 92%-100%). The 2-year disease-free and overall survival rates were 90% (95%
CI, 82%-98%) and 95% (95% CI, 89%-100%), respectively. The 2-year late complication
rates (according to Radiation Therapy Oncology Group/European Organization for Research
and Treatment of Cancer of Grade ≥ 1) were 18% (95% CI, 8%-28%) for large intestine/rectum,
4% (95% CI, 0%-8%) for small intestine, and 0% for bladder. No Grade ≥ 3 cases were
observed for genitourinary/gastrointestinal late complications.
These results suggest that definitive radiotherapy using HDR-ICBT with a low cumulative
dose schedule (BED, 62 Gy(10) at point A) can provide excellent local control without
severe toxicity in nonbulky (<4-cm) early-stage cervical cancer.
Copyright © 2012 Elsevier Inc. All rights reserved.