Chemotherapy and extended-field radiation therapy to para-aortic area in patients with histologically proven metastatic cervical cancer to para-aortic nodes: a phase II pilot study.

From November 1983 to October 1992, 22 patients with invasive cervical cancer stage IB through stage IIIB with metastasis to para-aortic nodes were entered in this study. Five patients were excluded. Of 17 remaining evaluable patients, 5 (29%) were stage IB, 6 (35%) were stage IIB, and 6 (35%) were stage IIIB. Four (24%) had grade 1, 5 (29%) had grade 2, and 8 (47%) had grade 3 tumor. Lymph node metastases were microscopic in 8 (47%) and macroscopic in 9 (53%) patients. All patients received 2 courses of chemotherapy concomitant with radiation as a sensitizer. They were randomized to receive either cisplatin (regimen A) or combination of cisplatin with 5-FU infusion (regimen B). This was followed by maintenance chemotherapy with cisplatin for a maximum of 10 additional courses. Of 17 patients, 7 (41%) received 4-6 courses, 4 (24%) received 6-8 courses, and 6 (35%) received 8-10 courses of maintenance chemotherapy. For extended-field radiation, a panhandle technique was used. External radiation therapy was delivered via 10 or 18 MeV linear accelerator photons, followed by 1 or 2 intracavitary cesium applications. Patients were followed up 8-103 months (median 21 months). Progression-free interval (PFI) for all patients was 5-103 months (median 18 months). Patients with microscopic metastasis to para-aortic nodes had median PFI of 26.5 months compared to 14 months in those with macroscopic nodal metastasis. Seven of 17 patients (41%) are alive from 17 to 103 months with median survival of 32 months. Overall survival for the entire group was 8-103 months (median 21 months). Median survival for patients with microscopic and macroscopic nodal metastasis was 30 and 21 months, respectively. Two- and five-year survival for the entire group was 35 and 12%, respectively. The survival with microscopic metastasis to para-aortic nodes was 50 and 12% compared to survival of 22% at 2 years and 11% at 5 years respectively in those with macroscopic nodal metastasis. There was no significant difference between regimen A and B for local disease control. Maintenance chemotherapy with cisplatin did not appear to significantly improve the 5-year survival. Distant metastases were the predominant sites of failure.

RCT Entities:   Population Interventions Outcomes