TRICIN: A Phase II Trial on the Efficacy of Topical TRIchloroacetic Acid in Patients with Cervical Intraepithelial Neoplasia.

Data on non-surgical treatment approaching persistent cervical intraepithelial neoplasia (CIN) are scarce. Retrospective analysis suggest high efficacy of topical treatment with trichloroacetic acid (TCA). This prospective phase II study set out to investigate the efficacy of a single application of 85% TCA in the treatment of CIN I/II. Patients with CIN I/II were treated a single time with 85% TCA. After three and six months colposcopic, histologic, and HPV evaluation was performed. The primary endpoint was treatment efficacy defined as complete histologic remission six months after treatment. The secondary endpoint was HPV clearance six months after treatment. A total of 102 patients with CIN I/II were included into this trial. Complete histologic remission rates were 75.5% and 78.4% three and six months after TCA treatment, respectively. Clearance rates of HPV 16, 18 and other high risk types were 76.5%, 91.7%, 68.7% after six months, respectively. Side effects of TCA were mild and lasted usually less than 30 min. This is the first prospective trial reporting high histologic complete remission rates in patients with CIN I/II after a single 85% TCA treatment. In the future, TCA may represent an effective and feasible non-surgical treatment approach for CIN.

Factors associated with post-relapse survival in patients with recurrent cervical cancer: the value of the inflammation-based Glasgow Prognostic Score.

PURPOSE: The aim of the present study was to assess the value of the Glasgow Prognostic Score (GPS) as a prognostic tool for predicting post-relapse survival (PRS) in patients with recurrent cervical cancer. METHODS: We retrospectively evaluated the data of 116 patients with recurrent cervical cancer in whom serologic biomarkers had been assessed at the time of relapse. The GPS was calculated as follows: patients with elevated serum C-reactive protein levels and hypoalbuminemia were allocated a score of 2, and those with 1 or no abnormal value were allocated a score of 1 and 0, respectively. To assess the association between factors including the GPS and PRS, we performed uni- and multivariate survival analyzes. RESULTS: After a median follow-up of 20.9 months from recurrence, a 5-year PRS rate of 25% (SE 4.7%) was observed. Only in 29.8% of the patients, recurrence was limited to the pelvis. In uni- and multivariate survival analyzes, the GPS [HR 1.6 (95% CI 0.9-2.4), p = 0.01], a history of radiation therapy as part of initial treatment [HR 2.7 (95% CI 1.1-6.9), p = 0.03], and the presence of peritoneal carcinomatosis or multiple sites of relapse [HR 4.2 (95% CI 1.9-9.3), p < 0.001] were associated with shorter PRS. The GPS correlated with higher squamous cell carcinoma antigen levels (p = 0.001), shorter median PRS (p = 0.009), and less intensive treatment for relapse (p = 0.02). CONCLUSIONS: A higher GPS at the time of relapse, a history of radiation therapy, and the presence of peritoneal carcinomatosis or multiple sites of relapse are independently associated with shorter PRS in patients with recurrent cervical cancer.

The prognostic role of metformin in patients with endometrial cancer: a retrospective study.

OBJECTIVE: Metformin has recently been discussed to possess anticancer activities and to positively affect the risk of developing cancer. We performed the present study to investigate the association of metformin and survival in patients with endometrial cancer. STUDY DESIGN: Within the present study we retrospectively reviewed the records of 465 consecutive patients with endometrial cancer. Drug intake of metformin was correlated with clinico-pathological parameters and the patients' survival. Chi-square test, Kruskal Wallis test, the product limit method of Kaplan and Meier, and multivariable Cox regression models were used to assess associations between metformin and clinico-pathological parameters and survival, as appropriate. RESULTS: Eighty-seven (18.7%) patients suffered from diabetes and of these 46 (52.8%) used metformin at the time of diagnosis. When analysing all patients, metformin did not affect the patients' survival. However, within the subgroup of overweight patients metformin was associated with a prolongation of overall survival (p=0.04). Within this subgroup, diabetic patients who did not use metformin had a 2.3 times higher risk for death (95%CI 1.1-4.7; p=0.02) compared to non-diabetic patients and diabetic patients using metformin. Metformin was not associated with prolonged recurrence-free or cancer-specific survival, irrespective of the patients' body mass index (p=0.08 and p=0.4, respectively). CONCLUSION: The results of our study might suggest a beneficial effect of metformin on overall survival in overweight diabetic patients with endometrial cancer. However, the question, if metformin can reduce the risk to die from endometrial cancer or improves all cause mortality only still remains open and needs further investigation.