Randomized trial with neoadjuvant chemotherapy in stage IIIB squamous carcinoma cervix uteri: An unexpected therapeutic management

A prospective randomized study was carried out in patients with squamous carcinoma of the cervix, stage IIIB. The trial considers the randomization in three different arms: the control group, 53 evaluable patients who were treated with radiotherapy; the neoadjuvant chemotherapy plus radiotherapy group, in which 52 evaluable patients were subjected to the neoadjuvant treatment followed by radiotherapy, and the surgical group which included 50 evaluable patients who were administered neoadjuvant cytostatic treatment followed by surgery and whole pelvis irradiation. The 'quick VBP scheme' was the neoadjuvant scheme used. Overall survival is, after 4 years follow-up, 37% in the control group, 53% in the neoadjuvant radiotherapy group and 63% in the surgical group; this was due to a decrease in pelvic recurrences. Distant metastases were similar in the three groups. In those cases with good response, in the neoadjuvant radiotherapy group, an unexplained unusual incidence of distant metastasis was observed. Surgery is 'a priori' the best treatment after neoadjuvant chemotherapy because the best cure rates were obtained with it; but the patients with unresectable tumors after neoadjuvant chemotherapy constitute a high risk group. Patients with hydronephrosis, bilateral parametrial involvement or bulky lymph node metastases are another high risk group in which the development of new therapeutic strategies is wholly justified.