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

Abstract

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.

Radiosensitizers in cervical cancer. Cisplatin and beyond

“…Hyperthermia has shown to enhance the effects of radiation in a variety of experimental systems [ 121 , 122 ]. Based upon the biologic rationale and in view of the recent advances in heating and thermometry techniques, radiotherapy in combination with hyperthermia has been tested in cervical cancer.…”

Utilization of Interferon in Gynecologic and Breast Cancer

“…With regard to invasive neoplasia of the uterine cervix, IFN has also been utilized in cases at advanced stages (III and IV), generally in association with radiotherapy and chemotherapy. A randomized study on patients with cancer of the uterine cervix in stage IIIB, comparing the use of IFN-α-2b in association with radiotherapy with the use of radiotherapy alone, did not show any signifi cant improvement in the local response and survival of the patients who utilized this association (Yazigi R et al 2003). The combination of chemotherapy (cisplatin and 5-fl uorouracil), radiotherapy, subcutaneous IFN-α-2a and oral retinoic acid at stage IIIB of cervical cancer was well tolerated (Wilailak S et al 1990).…”

Efficacy and Safety Evaluation of the Various Therapeutic Options in Locally Advanced Cervix Cancer: A Systematic Review and Network Meta-Analysis of Randomized Clinical Trials

“…Thus, with 13 different interventions in the control and study groups, a maximum of 21 pairwise comparisons between the competing modalities was feasible. These included RT versus CTRT(wkly Pt) (n Z 5), [11][12][13][14][15] RT versus CTRT(3 wkly Pt) (n Z 3), [32][33][34] RT versus CTRT(non-Pt) (n Z 2), 16,38 RT versus CTRT(Ptþ) (n Z 4), [19][20][21][22] RT versus RT þ ACT (n Z 1), 38 RT versus CTRT þ ACT (n Z 1), 38 CTRT(non-Pt) versus CTRT þ ACT (n Z 1), 38 RT þ ACT versus CTRT(non-Pt) (n Z 1), 38 RT versus NACT þ RT (n Z 10), [1][2][3][4][5][6][7][8][9][10] RT versus NACT þ RT þ ACT (n Z 1), 40 RT versus RT þ HypCS (n Z 8), [41][42][43][44][45][46][47][48] RT versus RT þ Imm (n Z 4), [49][50][51][52][53] RT versus HTRT (n Z 4), [55][56][57][58]…”

“…Of these, most approaches have been undertaken with chemotherapy (CT) as neoadjuvant CT (NACT), [1][2][3][4][5][6][7][8][9][10] concurrent chemoradiation therapy (CTRT), adjuvant CT (ACT), 31,38,39 or various combinations of these. 38,40 Apart from CT, other interventions with RT include hypoxic cell sensitizers (HypCS) (RT þ HypCS; chemical radiosensitizers or hyperbaric oxygen), [41][42][43][44][45][46][47][48] immunomodulators (Imm) (RT þ Imm), [49][50][51][52][53][54] hyperthermia (HT) with RT (HTRT), [55][56][57][58][59][60] or HT with CTRT (HTCTRT). 61 A systematic review and critical analysis of the outcomes is thus justified to evaluate the efficacy and safety of these interventions in LACC.…”