Gülten Oskay-Özcelik

Participation of elderly gynecological cancer patients in clinical trials

BackgroundElderly patients are underrepresented in clinical trials in gynecological cancer, even though they are disproportionally often affected. This study aimed to evaluate the disposition and apprehension of elderly patients toward study participation.Methods112 elderly gynecological cancer patients (median age 70) were surveyed in a multicenter cross-sectional study. Besides fitness, state of disease, education and domestic situation, questions aimed at the general willingness to participate in a clinical trial. Personal reasons for refusal and anticipated advantages/disadvantages that might evolve from participation were inquired.ResultsWillingness to participate in a clinical study was generally high (72%, 74/102). Reasons for potential study participation were: ‘better monitoring of the disease’ (67.1%), ‘better medical care’ (46.1%), ‘to help medical research’ (44.7%), ‘better medication’ (35.5%) and ‘because of my doctor’s recommendation’ (22.4%). Reasons for potential refusal were: ‘too time consuming’ (24.4%), ‘fear of side effects’ (21.8%), ‘misuse as experimental animal’ (18%), ‘long distance to clinic’ (14.1%) and ‘too little or unclear information’ (10.3%). 37.2% (29/78) of the patients stated that they had ‘no objection’ at all against study participation. The question if patients anticipated having a longer life due to study participation was answered with ‘yes’ or ‘rather yes’ in 42% (38/90); 28.9% answered ‘no’ or ‘rather no’ (29% undecided). No statistical significant relation between willingness to participate in a study and general fitness (p = 0.133), education (p = 0.122), age (p = 0.474) or domestic situation (p = 0.123) could be observed in a multivariate logistic regression model.ConclusionsElderly patients are generally willing to participate in clinical studies, in our cohort regardless of their fitness. Benefits of participation seem to be unclear among a majority of potential study participants. Therefore, it might be decisive to provide more general information regarding benefits and safety for elderly patients in a clinical trial.

Development of a Questionnaire for Monitoring Risk Factors for Chemotherapy-induced Nausea and Vomiting – A NOGGO Pilot Study

Background: Despite many years of clinical research and development, nausea and vomiting remain challenging toxicities related to chemotherapy. The aim of our study was to clarify the significance of non-pharmacological, patient-related risk factors for chemotherapy-induced nausea and vomiting. Furthermore, we aimed to develop a unique patient-related risk score predicting nausea and vomiting in patients with gynaecological malignancies under chemotherapy. Materials and Methods: Based on a literature research, 27 risk factors were identified and a preliminary questionnaire was generated. This questionnaire was assessed in 20 patients diagnosed with gynaecological malignancies. Results: The majority of questions were easy to understand and could be answered unambiguously. Questions regarding alcohol consumption and nutrition needed optimization due to problems with suitable answer option finding. Conclusion: Patient-related factors are currently not included when selecting antiemetic prophylaxis in patients under chemotherapy. After a few amendments, our questionnaire will be used in prospective study. To our knowledge, this is the first practicable questionnaire addressing these issues.

First quality-of-life data of a sequential dose-dense regimen in advanced ovarian cancer: A multicenter phase II study of the Northeastern German Society of Gynecological Oncology.

5071 Background: The objective of this study was to examine the impact of a sequential dose dense schedule of carboplatin and paclitaxel on quality of life (QoL). METHODS In this multicenter phase II trial patients with advanced ovarian cancer received four cycles of carboplatin followed by 12 cycles of weekly paclitaxel after primary radical surgery (abstr. 5533; J Clin Oncol 2007). QoL (QLQ-C30; QLQ-Ov28) was analyzed regarding the effect of carboplatin and paclitaxel separately at end of treatment (EOT) and 6, 12, and 24 months later. RESULTS Overall 87 out of 104 eligible patients (84%) participated for at least one QoL-assessment during the treatment, but only 24 patients did likewise 2 years after EOT. At baseline all QLQ-C30 scales and symptoms were significantly worse on average than age adjusted expected values of the general population. From then QoL improved in general. During chemotherapy with paclitaxel most functioning scales and symptoms worsened slightly but not significantly. But peripheral neuropathy and chemo side-effects increased with clinically important differences. After EOT most QoL scores were similar wih those of general population, but physical functioning and fatigue were worse, sexual functioning remained very low. Worries about future health and peripheral neuropathy were rated problematic for some patients. CONCLUSIONS QoL was generally favorable and was mainly affected by the paclitaxel weekly schedule. During chemotherapy and after EOT QoL was improved. Therefore the QoL data support a dose dense regimen.

What do primary and recurrent ovarian cancer patients (OC) expect from their doctors? Final results of a German survey in 608 patients.

5106 Background: The following study was conducted to explore the information needs and preferences of OC patients with special focus on doctor-patient communication. Methods: A questionnaire was d...

Impact of BRCA1 gene alterations on tumor characteristics and clinical outcome in ovarian cancer (OC) patients.

5019 Background: Patients (pts) with BRCA1-associated OC appear to have a survival advantage over those with sporadic OC. It is unclear if this is due to a greater platinum sensitivity or due to a ...