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

Abstract

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.

The Efficacy and Safety of Neoadjuvant Chemotherapy in Treatment of Locally Advanced Carcinoma Cervix

“…There are many regimens for neoadjuvant chemotherapy in carcinoma cervix. PVB (cisplatin, vincristine, bleomycin), BOMP (bleomycin, ifosamide, cisplatin), BIP (bleomycine, ifosamide, cisplatin), and a quick VBP regimen were used by different investigators [6,7], and modified VBP regimen consists of (vincristine 1 mg/m 2 on day 1 and cisplatin 50 mg/m 2 on day 1, bleomycin 25 mg/m 2 on day 1 and 2) on weekly basis for three courses [8]. TIP (ifosamide 5 gm/m 2 on day 1, cisplatin 75 mg/m 2 and paclitaxel 175 mg/m 2 on day 3) was given every 3 weeks for a total of three courses [9].…”

“…After three cycles of chemotherapy, downstaging was observed in 50 % of patients. A prospective randomized trial was carried out in patients with squamous cell carcinoma stage IIIB in three different arms-radiotherapy, neoadjuvant chemotherapy followed by radiotherapy, neoadjuvant chemotherapy followed by surgery and whole pelvic irradiation [6]. The overall survival after 4-year follow-up was 37, 53, and 63 % indicating that surgery is the best treatment after NACT.…”

“…In our study, post-chemotherapy operability was better, no increase in vascularity observed, and the dissection was not difficult. Sardi et al [6] commented that response to NACT was strongly associated with the initial volume of the tumor. Our patients with a tumor size \4 cm showed a complete response in 64.2 %, while in patients with a tumor size [4 cm, complete response was seen in 33.3 %, reflecting similar results.…”

Neoadjuvant Chemotherapy in the Treatment of Cervical Cancer

“…The primary endpoint of the analysis was survival. In 3 trials (Sardi et al, 1996;Sardi et al, 1998;Benedetti-Panici et al, 2002) patients receiving neoadjuvant chemotherapy followed by surgery demonstrated improved survival compared to those receiving radiotherapy alone. When all 5 trials were combined together, the direction of effect remained significant, with a Hazard Ratio of 0.65 (p = 0.0004) suggesting a 35% reduction in the risk of death and a 14% absolute improvement in survival at 5 years (from 50% to 64%).…”

Concomitant and Neoadjuvant Chemotherapy for Cervical Cancer

“…More importantly perhaps, in the neoadjuvant chemotherapy group, additional pelvic radiotherapy was given to most of the women in two trials [39], [40] and to around 30% of women in another two trials [38]; [41]. This makes it difficult to assess the precise benefit associated with the neoadjuvant chemotherapy plus surgery in comparison with radical radiotherapy.…”