Phase III randomized pilot study comparing interferon alpha-2b in combination with radiation therapy versus radiation therapy alone in patients with stage III-B carcinoma of the cervix.

This randomized pilot study was designed to determine whether the addition of interferon alpha-2b to standard radiation therapy offered an advantage in loco-regional control and survival over radiation therapy alone in a homogeneous group of patients with stage IIIB carcinoma of the cervix. Thirty-six patients were treated with a combination of interferon alpha-2b plus radiation therapy, and 38 patients were treated with radiation therapy alone. Patients with evidence of ureteral obstruction were excluded from the study. Evaluation of loco-regional response was determined by pelvic examination, cervical cytology, biopsies and CT scans when indicated. Survival time was measured from initiation of treatment to date of death or last follow-up. Patient characteristics were comparable between both study arms. The objective complete response rate was 67% in the combined therapy group and 55% in the radiation alone group (P = 0.454). With a median follow-up of 17 months for all patients and 31 months for live patients, 50% of the combined group survived vs. 39.5% of the radiation alone group (P = 0.424). We conclude that the addition of interferon alpha-2b to standard radiation therapy did not significantly improve loco-regional response or survival, although such a trend was noted. We encourage the design of a larger randomized study with sufficient power to detect meaningful differences to prove whether the tendency observed in the present investigation holds any promise to improve the outcome of these patients.

Cyfra 21-1 marker in carcinoma of the cervix.

Cyfra 21-1 has been reported to be an effective tumor marker for epithelial carcinomas. The purpose of this investigation was to determine its value in evaluating response to treatment in patients with carcinoma of the cervix. Cyfra 21-1 levels were measured by immunoassay in the serum of 55 untreated patients with cervical cancer; a second sample was obtained in all of them after conventional treatment for association with clinical response. Pre-therapy levels were elevated in only 45% (25 of 55) of the patients, with a slight tendency to increase according to clinical stage: 33% (5/15) in stage I, 36% (8/22) in stage II and 67% (12/18) in stage III. In regards to association with response to therapy, and including patients with either normal or elevated pretreatment values, 46% (19/41) of women with a complete clinical response either persisted with or developed elevated levels after treatment completion. All 14 patients with persistent disease after therapy continued to have or developed elevated values. No patient with persistent disease had normal values after therapy, and all patients with negative values after treatment were truly complete clinical responders. The results of our study suggest that the test has a low sensitivity therefore and, despite our findings, a negative level after treatment may not be a safe indicator of disease-free status. On the other hand, an elevated post-treatment level is not a reliable indicator of persistence, proven by the fact that 46% of clinical responders fell in this category. Therefore, Cyfra 21-1 has a very limited role in correlating with response to treatment in carcinoma of the cervix.

[Cyto-histologic evaluation of parametrial involvement in cervico-uterine cancer using aspiration puncture guided by transvaginal echography]. / Evaluación cito-histologica del compromiso parametrial en cáncer cérvico-uterino mediante punción aspirativa guiada por ecografía transvaginal.

Vaginal tact is not sufficient for staging the extension of cervical Ca in its adnexal compromise. The use of transvaginal echography with a cytological hystological parametrial biopsy allow the diagnosis to be certified. In 23 cases studied, 21 epidermoid carcinoma and one adenocarcinoma related with of original cervical tumor were revealed. The clinical staging had a 8.3% error margin.