Anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study.

Background: Lifastuzumab vedotin (LIFA) is a humanized anti-NaPi2b monoclonal antibody conjugated to a potent antimitotic agent, monomethyl auristatin E, which inhibits cell division by blocking the polymerization of tubulin. This study is the first to compare an antibody-drug conjugate (ADC) to standard-of-care in ovarian cancer (OC) patients. Patients and methods: Platinum-resistant OC patients were randomized to receive LIFA [2.4 mg/kg, intravenously, every 3 weeks (Q3W)] or pegylated liposomal doxorubicin (PLD) (40 mg/m2, intravenously, Q4W). NaPi2b expression and serum CA-125 and HE4 levels were assessed. The primary end point was progression-free survival (PFS) in intent-to-treat (ITT) and NaPi2b-high patients. Results: Ninety-five patients were randomized (47 LIFA; 48 PLD). The stratified PFS hazard ratio was 0.78 [95% confidence interval (95% CI), 0.46-1.31; P = 0.34] with a median PFS of 5.3 versus 3.1 months (LIFA versus PLD arm, respectively) in the ITT population, and 0.71 (95% CI, 0.40-1.26; P = 0.24) with a median PFS of 5.3 months versus 3.4 months (LIFA versus PLD arm, respectively) in NaPi2b-high patients. The objective response rate was 34% (95% CI, 22% to 49%, LIFA) versus 15% (95% CI, 7% to 28%, PLD) in the ITT population (P = 0.03), and 36% (95% CI, 22% to 52%, LIFA) versus 14% (95% CI, 6% to 27%, PLD) in NaPi2b-high patients (P = 0.02). Toxicities included grade ≥3 adverse events (AEs) (46% LIFA; 51% PLD), serious AEs (30% both arms), and AEs leading to discontinuation of drug (9% LIFA; 8% PLD). Five (11%) LIFA versus 2 (4%) PLD patients had grade ≥2 neuropathy. Conclusion: LIFA Q3W was well tolerated and improved objective response rate with a modest, nonstatistically significant improvement of PFS compared with PLD in platinum-resistant OC. While the response rate for the monomethyl auristatin E-containing ADC was promising, response durations were relatively short, thereby highlighting the importance of evaluating both response rates and duration of response when evaluating ADCs in OC. Clinical trials.gov: NCT01991210.

Prevalence of Chlamydia trachomatis infection in women with cervical lesions.

PURPOSE: The study objective was to evaluate the prevalence of Chlamydia trachomatis (C. trachomatis) infection in women with and without pathological lesions in the uterine cervix. MATERIAL AND METHODS: A total of 120 patients, aged 15-57 (mean age 29), recruited for the study, were referred by gynaecological clinics in the Podlasie province. Gynaecological examinations confirmed cervicitis accompanied by erosions in 75 patients (group I) and cervicitis alone in 45 women (group II). The comparative group (control) consisted of 35 women, aged 16-48 years (mean age 29), who had no clinical symptoms or pathological lesions in the cervix. Direct immunofluorescence tests (MicroTrack, Syva) or polymerase chain reaction assays (PCR, Roche) were used to detect C. trachomatis infection in cervical samples. Antichlamydial IgG antibodies in the serum were determined using an immunoenzymatic assay (C. trachomatis IgG, EIA medac). Two-frequencies test was used for the statistical analysis of results. P values of <0.05 were considered statistically significant. RESULTS: In the direct tests, C. trachomatis infection was found in group I in 9/75 women (12.2%), in group II in 9/45 (20%) and in the comparative group in 1/35 (2.9%) (group I vs control p > 0.1252; group II vs control p < 0.025). IgG specific antibodies were detected in group I in 17/49 patients (34.7%), in group 11 in 5/18 (27.8%) and in the comparative group in 2/35 (5.7%) women (group I vs control p < 0.0022; group II vs control p < 0.0319). CONCLUSIONS: Our results show a higher prevalence of C. trachomatis infection in female patients with cervical lesions as compared to unaffected women, thus suggesting that diagnostic tests for C. trachomatis infection should be included in the screening programs for women.