Weekly versus three-weekly cisplatin as an adjunct to radiation therapy in high-risk stage I-IIA cervical cancer after surgery: a randomized comparison of treatment compliance.

ABSTRACT

OBJECTIVES: To compare weekly and three-weekly cisplatin as an adjunct to radiation therapy in high-risk early-stage cervical cancer after surgery with regard to treatment compliance. MATERIAL AND METHOD: From June 1st, 2003 to February 29th, 2004, the authors performed a randomized trial of radiotherapy in combination with two concurrent chemotherapy regimens - weekly or three-weekly cisplatin--in patients with high-risk cervical cancer FIGO stage I-IIA after surgery. Women with primary invasive squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix were enrolled. The patients also had to have an absolute neutrophil count of at least 1,500 cells per cubic millimeter, a platelet count of at least 75,000 cells per cubic millimeter, a creatinine clearance higher than 40 milliliter per minute, and adequate hepatic function. All patients received external-beam radiotherapy according to a strict protocol. Patients were randomly assigned to receive one of two chemotherapy regimens 75 mg per square meter of cisplatin on days 1, 22, 43 and 64 or every three weeks for 4 cycles (group 1) or 40 mg per square meter of cisplatin per week for six cycles (group 2). RESULTS: The analysis included 40 women. The first group that received three-weekly cisplatin had a higher rate of incomplete and delayed treatments than the second group that received weekly cisplatin (p < 0.001 and p = 0.0236 respectively). The relative risks of delayed courses were 2.06 (95 percent confidence interval, 1.15 to 3.68) for group 1, compared with group 2. The toxicity-related incomplete treatments rate and G-CSF doses used were significantly higher in group 1 than in group 2. CONCLUSION: Concurrent chemoradiation with weekly cisplatin regimen has more complete treatment rate and less delayed courses than that with three- weekly cisplatin among women with high-risk cervical cancer after surgery.