scholarly journals A phase III, open label, randomized multicenter controlled trial of oral versus intravenous treosulfan in heavily pretreated recurrent ovarian cancer: a study of the North-Eastern German Society of Gynecological Oncology (NOGGO)

2016 ◽  
Vol 143 (3) ◽  
pp. 541-550 ◽  
Author(s):  
Jalid Sehouli ◽  
Oliver Tomè ◽  
Desislava Dimitrova ◽  
Oumar Camara ◽  
Ingo Bernhard Runnebaum ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Controlled Trial ◽  
Recurrent Ovarian Cancer ◽  
German Society ◽  
Phase Iii ◽  
Open Label ◽  
Gynecological Oncology ◽  
The North ◽  
North Eastern ◽  
Heavily Pretreated

The influence of chemotherapy induced nausea and vomiting (CINV) on survival: An individual participant data meta-analysis of the North-Eastern German Society of Gynecological Oncology (NOGGO) of 1213 recurrent ovarian cancer patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17062-e17062
Author(s):  
Hannah Woopen ◽  
Rolf Richter ◽  
Guelhan Inci ◽  
Radoslav Chekerov ◽  
Gulten Oskay-Oezcelik ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cox Regression ◽  
Progression Free Survival ◽  
German Society ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Gynecological Oncology ◽  
The North ◽  
North Eastern ◽  
Grade Iii

e17062 Background: Nausea and vomiting are frequent side effects of chemotherapy and are the most feared toxicities of our patients. Aim of this study is to evaluate the potential influence of chemotherapy induced nausea and vomiting (CINV) on survival. Methods: Synthesized raw data of three phase II/III studies (“Tower”, “Topotecan phase III” and “Hector”) of the North-Eastern German Society of Gynecological Oncology (NOGGO) including 1213 patients were analyzed using logistic regression and cox regression analyses. Results: In this analysis 661 patients (54.5%) developed grade I/II and 44 patients (3.6%) grade III/IV nausea. 343 patients (28.3%) had grade I/II vomiting and 33 patients (2.7%) grade III/IV. There were no differences between severity of CINV regarding FIGO, grading, histology and amount of recurrences. Patients <65 years developed more frequently grade III/IV nausea than patients ≥ 65 years (p<0.001, OR 1.29, 95% CI 0.68-2.46). Polypharmacy was also associated with grade III/IV CINV (p<0.001 and p=0.002 respectively). Progression free survival was worse in patients with grade III/IV nausea (p=0.023, HR 1.58, 95% CI 1.14-2.20). Median overall survival (OAS) in patients without nausea was 19.0 months compared to patients with grade III/IV nausea with 11.0 months (p<0.001, HR for grade III/IV 2.35, 95% CI 1.64-3.37). Grade III/IV vomiting was also highly associated with worse OAS (median of 22.0 months in patients without vs. 5.9 months in patients with grade III/IV vomiting, p<0.001, HR for grade III/IV vomiting 3.4, 95% CI 2.32-5.00). However, dose reductions and prior discontinuation of chemotherapy were not more frequent in patients with nausea and vomiting. Conclusions: Patients with nausea and vomiting had a decreased progression and overall survival. This study underlines once again the importance of early best supportive care on survival.

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