second-line plus (2L+) have improved outcomes in patients with recurrent/metastatic cervical cancer (r/mCC). Previous reports show potentially enhanced efficacy and tolerable safety with TV + pembrolizumab, carboplatin, or bevacizumab. We report interim safety and efficacy results from the dose-expansion cohorts evaluating 1L TV + pembrolizumab (1L-TP), 2/ 3L TV + pembrolizumab (2/3L-TP), and 1L TV + carboplatin (1L-TC) in patients with r/mCC. Methodology In the 1L-TP cohort, patients with r/mCC who had no prior systemic therapy (excluding chemoradiation) received TV 2.0 mg/kg + pembrolizumab 200 mg IV Q3W. In the 2/3L-TP cohort, patients with r/mCC who experienced disease progression on/after 1-2 prior systemic therapies received TV 2.0 mg/kg + pembrolizumab 200 mg IV Q3W. In the 1L-TC cohort, patients with r/mCC who had no prior systemic therapy (excluding chemoradiation) received TV 2.0 mg/kg + carboplatin AUC 5 IV Q3W. The primary end point was confirmed objective response rate (cORR) per RECIST v1.1. Results In the 1L-TP, 2/3L-TP, and 1L-TC cohorts, respectively, 33, 35, and 33 patients received treatment, and, at data cutoff, median follow-up was 18.8, 15.0, and 14.6 months. cORR was 41%, 38%, and 55%, with a median DOR of not reached, 14.0, and 8.6 months in the 1L-TP, 2/3L-TP, and 1L-TC cohorts, respectively. Adverse events (AEs) of special interest in patients in the 1L-TP, 2/3L-TP, and 1L-TC cohorts (grade 1-2/grade !3) included ocular events (58/9; 51/3; 58/ 9), bleeding (61/6; 61/9; 52/6), and peripheral neuropathy (49/3; 37/3; 48/12), respectively; one patient in 2/3L-TP and one patient in 1L-TP experienced grade 4 and 5 treatmentrelated bleeding, respectively. Additional data will be presented at the meeting. Conclusion TV + pembrolizumab or carboplatin in patients with r/mCC demonstrated encouraging and durable antitumour activity, with tolerable safety profiles.

second-line plus (2L+) have improved outcomes in patients with recurrent/metastatic cervical cancer (r/mCC). Previous reports show potentially enhanced efficacy and tolerable safety with TV + pembrolizumab, carboplatin, or bevacizumab. We report interim safety and efficacy results from the dose-expansion cohorts evaluating 1L TV + pembrolizumab (1L-TP), 2/ 3L TV + pembrolizumab (2/3L-TP), and 1L TV + carboplatin (1L-TC) in patients with r/mCC. Methodology In the 1L-TP cohort, patients with r/mCC who had no prior systemic therapy (excluding chemoradiation) received TV 2.0 mg/kg + pembrolizumab 200 mg IV Q3W. In the 2/3L-TP cohort, patients with r/mCC who experienced disease progression on/after 1-2 prior systemic therapies received TV 2.0 mg/kg + pembrolizumab 200 mg IV Q3W. In the 1L-TC cohort, patients with r/mCC who had no prior systemic therapy (excluding chemoradiation) received TV 2.0 mg/kg + carboplatin AUC 5 IV Q3W. The primary end point was confirmed objective response rate (cORR) per RECIST v1.1. Results In the 1L-TP, 2/3L-TP, and 1L-TC cohorts, respectively, 33, 35, and 33 patients received treatment, and, at data cutoff, median follow-up was 18.8, 15.0, and 14.6 months. cORR was 41%, 38%, and 55%, with a median DOR of not reached, 14.0, and 8.6 months in the 1L-TP, 2/3L-TP, and 1L-TC cohorts, respectively. Adverse events (AEs) of special interest in patients in the 1L-TP, 2/3L-TP, and 1L-TC cohorts (grade 1-2/grade !3) included ocular events (58/9; 51/3; 58/ 9), bleeding (61/6; 61/9; 52/6), and peripheral neuropathy (49/3; 37/3; 48/12), respectively; one patient in 2/3L-TP and one patient in 1L-TP experienced grade 4 and 5 treatmentrelated bleeding, respectively. Additional data will be presented at the meeting. Conclusion TV + pembrolizumab or carboplatin in patients with r/mCC demonstrated encouraging and durable antitumour activity, with tolerable safety profiles.

Background It has been observed that there is a high incidence of hemorrhoids in female patients with pelvic organ prolapse. Also, in these patients, hemorrhoidal disease improves after the surgical correction of the pelvic organ prolapse. Objective Our hypothesis was that a cause-effect relationship between pelvic organ prolapse, and hemorrhoids might be the key. The objective of this study was to find an element which connects these two conditions. Study Design We conducted a pilot study which consisted of two parts. An initial part, in which we asked several patients with grades III and IV pelvic organ prolapse and hemorrhoids, who have undergone surgery for prolapse, to determine the impact of the surgical restoration of the prolapsed organs on their hemorrhoidal disease. For the second part, on several patients with uncorrected uterine prolapse grades III and IV, we determined the resistive index of the hemorrhoidal branches within the rectal wall before and after manual reduction of the prolapse. Results First, more than 50% of patients who underwent uterine prolapse correction described an improvement of their hemorrhoidal disease of over 50%. Second, the resistive index of the hemorrhoidal branches was significantly lower after manual reduction of the prolapse. We consider that obstructed veins due to pelvic organ prolapse might induce the dilation of the hemorrhoids. The direct measurement of the resistive index of the hemorrhoidal branches allows us to directly assess the increased resistance in the rectal vascular system. Conclusion Venous stasis and impaired vascular flow might be the pathophysiological explanation for the association between pelvic organ prolapse and hemorrhoids. In these patients, the pathogenic treatment should aim at the restoration of a normal blood flow (prolapse surgical cure) instead of focusing on hemorrhoids only.