NEOADJUVANT CHEMOTHERAPY IN LOCALLY ADVANCED CERVICAL-CANCER - 2 RANDOMIZED STUDIES

Between August 1990 and January 1992, 184 patients with squamous cell carcinoma of the cervix, FIGO stage II B IV A were randomised (study 1 ) to receive either two cycles of bleomycin, ifosfamide-mesna and cisp latin (BIP) chemotherapy (CT) followed by radiotherapy (RT) 'CT-RT Gro up' n=94 or RT alone, RT Group n=90. In the 'CT-RT Group', of evaluabl e 89 patients, 64 responded: complete response (CR) four (4.5%) and pa rtial response (PR) 60 (67.5%). Of the remaining 25 patients 23 had st able disease and two progressed. Eighty of 89 patients completed RT as planned. Following RT 56 (70% achieved CR, 19 (23. 7%) had residual d isease and five (6.3%) had progressed. Patients aged 245 and those wit h Hb >10 gm/dL had significantly better response to CT Further, CT res ponders had a better response to RT; 83% (49/59) vs 33.3% (seven/21), p<0.01. In the 'RT Group' 88 patients were evaluable; 61 (69.3%) patie nts achieved CR, 25 had residual disease and two progressed The estima ted overall survival at 48 months in the 'CT-RT Group' and the 'RT Gro up' is 38%+2.01 (SE) and 36%+1.85 (SE), p=0.59 respectively. In a subs equent randomised study (study 2) 36 patients with stage IIIB cervical cancer received three cycles of BIP (as above) followed by RT vs 36 p atients who received RT alone. In the 'CT-RT Group' 29 patients respon ded; CR-8 (22.2%, PR-21 (58.3%). Six patients had no response to CT an d one patient died of CT toxicity. Following RT - 24 of 35 (68.6%) pat ients achieved CR, eight had residual disease and three patients progr essed while on RT In the 'RT Group' - 21 of 36 (58.4%) achieved CR, 12 had residual disease and three progressed. Estimated survival was 71% in the 'CT-RT Group' and 69% in the 'RT Group', p=ns. Nausea/vomiting , alopecia, grade I-II myelosuppression, diarrhoea and mucositis were the major side effects of CT Three patients died of CT toxicity - two in study I and one in study 2. Cystitis, proctitis and local skin reac tion after RT occurred equally in the two groups in both the studies. BIP CT prior to RT in patients with locally advanced cervical cancer r esults in a high response rate. Response to CT predicts response to RT There is no increase in the toxicity to subsequent RT Our studies hav e failed to demonstrate any significant difference in overall and dise ase-free survival when neoadjuvant CT is added prior to the standard R T regimen.