International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
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Int. J. Gynecol. Cancer · Jan 2020
Randomized Controlled Trial Multicenter StudyA randomized phase III trial of platinum chemotherapy plus paclitaxel with bevacizumab and atezolizumab versus platinum chemotherapy plus paclitaxel and bevacizumab in metastatic (stage IVB), persistent, or recurrent carcinoma of the cervix: the BEATcc study (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030).
Patients with metastatic, recurrent, or persistent cervical cancer not amenable to local control and/or distant metastases have a very poor prognosis, only being candidates for palliative-systemic therapy. First line standard treatment in this scenario is based on cisplatin/paclitaxel plus bevacizumab (GOG 240 regimen) with a short median overall survival (16.8 months) and progression-free survival (8.2 months). ⋯ The primary hypothesis is whether the addition of atezolizumab to cisplatin-paclitaxel and bevacizumab improves overall survival in metastatic, recurrent, or persistent cervical cancer.
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Int. J. Gynecol. Cancer · Oct 2017
Randomized Controlled TrialRandomized, Controlled Trial of Dexamethasone Versus Dexamethasone Plus Hydrocortisone as Prophylaxis for Hypersensitivity Reactions Due to Paclitaxel Treatment for Gynecologic Cancer.
The aim of this study was to assess intravenous hydrocortisone (HCT) added to standard dexamethasone (DXM) prophylaxis for paclitaxel-associated hypersensitivity reactions (HSRs). ⋯ Adding HCT to routine DXM prophylaxis significantly decreased paclitaxel HSR frequency.
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Int. J. Gynecol. Cancer · Oct 2012
Randomized Controlled Trial Comparative StudyComparison of 2 contouring methods of bone marrow on CT and correlation with hematological toxicities in non-bone marrow-sparing pelvic intensity-modulated radiotherapy with concurrent cisplatin for cervical cancer.
To compare volumes and dose volume histogram (DVH) parameters for bone marrow contours using 2 methods on computed tomography (CT) and correlation with grade 2 or higher hematological toxicity (HT) in patients with cervical cancer treated with non-bone marrow-sparing intensity-modulated radiotherapy (IMRT) with concurrent cisplatin. ⋯ The FH bone marrow cavity volume is a better surrogate of active bone marrow on CT images and correlated with higher than grade 2 HT (V(40) >40%). Further prospective studies validating significance of high-dose effects and identifying correlation of bioimaging with CT contouring are warranted.
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Int. J. Gynecol. Cancer · May 2011
Randomized Controlled TrialBethanechol chloride for the prevention of bladder dysfunction after radical hysterectomy in gynecologic cancer patients: a randomized controlled trial study.
Bethanechol chloride is considered as a treatment in patients with high postvoid residual urine (PVR). It enhances detrusor muscle contraction, resulting in higher maximum flow rate, higher detrusor pressure at maximum flow, and lower PVR. The efficacy of this agent in patients after radical hysterectomy is unclear. We aim to evaluate the efficacy of bethanechol chloride compared with placebo for the prevention of bladder dysfunction after type III radical hysterectomy. ⋯ Bethanechol chloride decreases the duration of urethral catheterization in patients who underwent type III radical hysterectomy with manageable adverse events.
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Int. J. Gynecol. Cancer · Apr 2010
Randomized Controlled Trial Multicenter StudyEfficacy of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years: interim analysis of a phase 2 double-blind, randomized, controlled trial.
A phase 2 double-blind, controlled, randomized multicenter study with human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine is ongoing in healthy Japanese women aged 20 to 25 years. We assessed the vaccine efficacy in the event-triggered analysis. ⋯ The HPV-16/18 AS04-adjuvanted vaccine was as efficacious in Japan as in other countries and was generally safe and highly immunogenic in Japanese women.