| 1. |
- du Bois, Andreas, et al.
(författare)
-
Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer.
- 2010
-
Ingår i: Journal of Clinical Oncology. - : American society of clinical oncology. - 0732-183X .- 1527-7755. ; 28:27, s. 4162-4169
-
Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: One attempt to improve long-term survival in patients with advanced ovarian cancer was thought to be the addition of more non-cross-resistant drugs to platinum-paclitaxel combination regimens. Gemcitabine was among the candidates for a third drug.PATIENTS AND METHODS: We performed a prospective, randomized, phase III, intergroup trial to compare carboplatin plus paclitaxel (TC; area under the curve [AUC] 5 and 175 mg/m(2), respectively) with the same combination and additional gemcitabine 800 mg/m(2) on days 1 and 8 (TCG) in previously untreated patients with advanced epithelial ovarian cancer. TC was administered intravenously (IV) on day 1 every 21 days for a planned minimum of six courses. Gemcitabine was administered by IV on days 1 and 8 of each cycle in the TCG arm.RESULTS: Between 2002 and 2004, 1,742 patients were randomly assigned; 882 and 860 patients received TC and TCG, respectively. Grades 3 to 4 hematologic toxicity and fatigue occurred more frequently in the TCG arm. Accordingly, quality-of-life analysis during chemotherapy showed a disadvantage in the TCG arm. Although objective response was slightly higher in the TCG arm, this did not translate into improved progression-free survival (PFS) or overall survival (OS). Median PFS was 17.8 months for the TCG arm and 19.3 months for the TC arm (hazard ratio [HR], 1.18; 95% CI, 1.06 to 1.32; P = .0044). Median OS was 49.5 for the TCG arm and 51.5 months for the TC arm (HR, 1.05; 95% CI, 0.91 to 1.20; P = .5106).CONCLUSION: The addition of gemcitabine to carboplatin plus paclitaxel increased treatment burden, reduced PFS time, and did not improve OS in patients with advanced epithelial ovarian cancer. Therefore, we recommend no additional clinical use of TCG in this population.
|
|
| 2. |
- Kurzeder, Christian, et al.
(författare)
-
Double-blind, placebo-controlled, randomized phase III trial evaluating pertuzumab combined with chemotherapy for low tumor human epidermal growth factor receptor 3 mRNA-Expressing platinum-resistant ovarian Cancer (PENELOPE)
- 2016
-
Ingår i: Journal of Clinical Oncology. - 0732-183X. ; 34:21, s. 25-2516
-
Tidskriftsartikel (refereegranskat)abstract
- Purpose The AGO-OVAR 2.29/ENGOT-ov14/PENELOPE prospectively randomized phase III trial evaluated the addition of pertuzumab to chemotherapy in patients with platinum-resistant ovarian carcinoma with low tumor human epidermal growth factor receptor 3 (HER3)mRNA expression. We report the results of the primary efficacy analysis. Patients and Methods Eligible patients had ovarian carcinoma that progressed during or within 6 months of completing four or more platinum cycles, centrally tested low tumor HER3 mRNA expression (concentration ratio # 2.81 by quantitative reverse transcriptase polymerase chain reaction on cobas z480 [Roche Molecular Diagnostics, Pleasanton, CA]), and no more than two prior lines of chemotherapy. After investigators selection of the chemotherapy backbone (single-agent topotecan, weekly paclitaxel, or gemcitabine), patientswere randomly assigned to also receive either placebo or pertuzumab (840-mg loading dose followed by 420 mg every 3 weeks). Stratification factors were selected chemotherapy, prior antiangiogenic therapy, and platinum-free interval. The primary end point was independent review committee-assessed progression-free survival (PFS). Additional end points included overall survival, investigator-assessed PFS, objective response rate, safety, patient-reported outcomes, and translational research. Results Overall, 156 patientswere randomly assigned. Adding pertuzumab to chemotherapy did not significantly improve independent review committee-assessed PFS for the primary analysis (stratified hazard ratio, 0.74; 95% CI, 0.50 to 1.11; P = .14; median PFS, 4.3 months for pertuzumab plus chemotherapy v 2.6 months for placebo plus chemotherapy). Sensitivity analyses and secondary efficacy end point results were consistent with the primary analysis. The effect on PFS favoring pertuzumab was more pronounced in the gemcitabine and paclitaxel cohorts. No new safety signals were seen. Conclusion Although the primary objective was not met, subgroup analyses showed trends in PFS favoring pertuzumab in the gemcitabine and paclitaxel cohorts, meriting further exploration of pertuzumab in ovarian cancer.
|
|
| 3. |
- Kannisto, Päivi, et al.
(författare)
-
Implementation of robot-assisted gynecologic surgery for patients with low and high BMI in a German gynecological cancer center.
- 2014
-
Ingår i: Archives of Gynecology and Obstetrics. - : Springer Science and Business Media LLC. - 1432-0711 .- 0932-0067. ; 290:1, s. 143-148
-
Tidskriftsartikel (refereegranskat)abstract
- Purpose To present a single center outcome from an initial series of gynecological robotic cases with a special reference to obese patients. Methods A retrospective evaluation of 116 women, undergoing elective gynecologic robot-assisted surgery from February 2011 to December 2012. Procedures included hysterectomy (HE), radical HE, adnexectomy, myomectomy, pelvic lymphadenectomy and paraaortic lymphadenectomy, sentinel node extraction, and omentectomy. The feasibility and outcome were investigated in relation to normal and high body mass index (BMI < 30 and BMI ≥ 30). Results The overall complication rate was low (15/116; 12.9 %). The number of perioperative complications was not different between the patients with normal BMI compared to those with high BMI. Five operations were converted to open surgery due to vascular injury (2), intestinal injury (2) and one insufficiently exposed paraaortic field in an endometrial cancer patient. Urinary bladder was injured once. Late complications included vaginal dehisce (2), vaginal hemorrhage (1), cuff hematoma (4), lymphocyst (1) and two urinary tract injuries. The rate of the late complications was not significantly different in the two groups of patients (p = 0.139). A significant difference in patients’ positioning time was observed between normal weighted and obese patients (35 and 55 min, p < 0.001). Conclusion Robotic procedure was feasible and could be implemented for treating the first setting of mixed indications for gynecologic surgery. Robotic surgery may offer particular advantages in obese patients with no conversions and no wound complications.
|
|
