Influence of migrant background on patient preference and expectations in breast and gynecological malignancies (NOGGO-expression V study): results of a prospective multicentre study in 606 patients in Germany.

BACKGROUND: An effective cross-cultural doctor-patient communication is vital for health literacy and patient compliance. Building a good relationship with medical staff is also relevant for the treatment decision-making process for cancer patients. Studies about the role of a specific migrant background regarding patient preferences and expectations are lacking. We therefore conducted a multicentre prospective survey to explore the needs and preferences of patients with a migrant background (PMB) suffering from gynecological malignancies and breast cancer to evaluate the quality of doctor-patient communication and cancer management compared to non-migrants (NM). METHODS: This multicentre survey recruited patients with primary or recurrence of breast, ovarian, peritoneal, or fallopian tube cancer. The patients either filled out a paper form, participated via an online survey, or were interviewed by trained staff. A 58-item questionnaire was primarily developed in German and then translated into three different languages to reach non-German-speaking patients. RESULTS: A total of 606 patients were included in the study: 54.1% (328) were interviewed directly, 9.1% (55) participated via an online survey, and 36.8% (223) used the paper print version. More than one quarter, 27.4% (166) of the participants, had a migrant background. The majority of migrants and NM were highly satisfied with the communication with their doctors. First-generation migrants (FGM) and patients with breast cancer were less often informed about participation in clinical trials (p < 0.05) and 24.5% of them suggested the help of an interpreter to improve the medical consultation. Second and third-generation migrants (SGM and TGM) experienced more fatigue and nausea than expected. CONCLUSIONS: Our results allow the hypothesis that training medical staff in intercultural competence and using disease-related patient information in different languages can improve best supportive care management and quality of life in cancer patients with migrant status.

Expression III: patients' expectations and preferences regarding physician-patient relationship and clinical management-results of the international NOGGO/ENGOT-ov4-GCIG study in 1830 ovarian cancer patients from European countries.

Backround: The primary aim of this study was to investigate information needs and treatment preferences of patients with ovarian cancer, focusing especially on physician-patient relationship and treatment. Patients and methods: A questionnaire was developed based on the experiences of the national German survey 'Expression II', and was provided to patients with ovarian cancer either at initial diagnosis or with recurrent disease via Internet (online-version) or as print-out-version. Results: From December 2009 to October 2012, a total of 1830 patients with ovarian cancer from eight European countries (Austria, Belgium, France, Germany, Italy, Poland, Romania, Spain) participated, 902 (49.3%) after initial diagnosis and 731 (39.9%) with recurrent ovarian cancer. The median age was 58 years (range 17-89). Nearly all patients (96.2%) had experienced upfront surgery followed by first-line chemotherapy (91.8%). The majority of patients were satisfied with the completeness and comprehensibility of the explanation about the diagnosis and treatment options. The three most important aspects, identified by patients to improve the treatment for ovarian cancer included: 'the therapy should not induce alopecia' (42%), 'there must be more done to counter fatigue' (34.5%) and 'the therapy should be more effective' (29.7%). Out of 659 (36%) patients, who were offered participation in a clinical trial, 476 (26%) were included. Conclusion: This study underlines the high need of patients with ovarian cancer for all details concerning treatment options irrespective of their cultural background, the stage of disease and the patient's age. Increased information requirements regarding potential side effects and treatment alternatives were recorded. Besides the need for more effective therapy, alopecia and fatigue are the most important side effects of concern to patients.

Expectations and perspectives of ovarian cancer patients about cancer management in Romania. The international NOGGO-ENGOT trial: EXPRESSION III.

We have investigated a relational model of expectations and preferences among ovarian cancer patients centred on physician-patient communication, treatment approach, and the need for information. Consecutive patients anonymously filled in the EXPRESSION III questionnaire between 2009 and 2012. Following descriptive statistics, structural equation modelling was used to analyse the relationships between physician's evaluation by the patient (PEP), result of therapy (RT), need for changes in treatment (NCT) and patient's desire to be informed (PD). From a total of 108 patients, 53 (49.1%) knew their disease stage, 103 (95.4%) underwent surgery, 91 (84.3%) had chemotherapy and 51 (46.3%) relapsed. The final model demonstrated a good fit of data with fit indices >0.90. There was a significant positive effect of PEP on RT and a significant negative effect of PEP on NCT, with the final model explaining 84% of the NCT variance. Physicians represent the main point of contact, not only as a source of information about the disease and various treatment options, but also in the coping processes. As patients benefit from completeness of medical consultations, their awareness of the treatment outcome increases, while a negative perception of the physician leads to a desire to make changes in therapy.

A survey of treatment approaches of malignant ascites in Germany and Austria.

BACKGROUND: Malignant ascites (MA) is a common manifestation of advanced cancer. Currently, there are no evidence-based guidelines for the management of MA. We conducted a survey with physicians throughout Germany and Austria, to get an overview of current approaches and opinions in the treatment of MA. METHODS: One hundred and twenty-eight medical oncologists (MO), gastroenterologists (GE), and gynecologists (GYN) completed an electronic questionnaire consisting of 33 questions. RESULTS: Ninety percent of the physicians were from Germany and 10% from Austria; 48% of those were MO, 30% were GYN, and 14% were GE. Most physicians treated an average of 34 patients (pts)/year with MA. Twenty-six percent of these pts suffered from ovarian, 20% from pancreatic, 17% from gastric, and 14% from colorectal cancer. The majority of the physicians associated MA with poor prognosis (92%) and significant reduction in quality of life (87%). One third felt that MA was a contraindication for full dosing of systemic chemotherapy. Paracentesis (PC) was performed in 70% of pts with symptom relieve and quality of life being the main reasons. Almost half of the pts required 3-5 PC, 50% even more than 5 PC during the course of their disease. Only 15% of pts needed multiple PC per week; the majority (79%) needed the procedure either once a week or every 14 days. In 61% of pts, 3-5 L of ascites fluid was drained. Only in 8%, 5 L and more were removed. Volume substitution with IV albumin was performed in 40% of pts. Most pts (55%) had to stay 1-3 h in a healthcare facility for the procedure. However, 21% had to stay ≥1 day. While almost all physicians (89%) performed a PC at some point in the treatment of MA, 75% felt that a systemic chemotherapy and 55% thought a concomitant diuretic therapy were a necessary adjunct. Seven percent of the pts received a targeted treatment with catumaxomab. CONCLUSIONS: Repeated PC is the main pillar of treatment of MA; its effect is only temporary and requires significant hospital resources. Further treatment strategies of MA have to be evaluated in prospective studies. Targeted therapies like catumaxomab and VEGF inhibitors should be integrated into these.

Use of paclitaxel for advanced ovarian cancer in clinical practice: analysis of 541 patients. Results from a German multi-centre observational study.

UNLABELLED: Paclitaxel is one of the most common antitumour agents paclitaxel for the treatment of primary and relapsed ovarian cancer. Based on a German multicentre observational study, this article reflects the use of paclitaxel in German daily clinical practice. PATIENTS AND METHODS: Data for a total of 541 patients in Germany were analysed, including 315 patients with primary ovarian cancer and 226 patients treated with paclitaxel with relapsed ovarian cancer. RESULTS: The mean age was 61.2 years, ranging from 22 to 85 years. No unexpected toxicities were ascertained. In general, grade III/IV haematological toxicities were rare. Only 15% of the patients suffered from grade III/IV leucopenia and 5% from thrombocytopenia. Alopecia and polyneuropathy were the most frequent non-haematological side-effects noticed. Response evaluation was provided in 183 patients with primary ovarian cancer (CR 39.8%, of these achieved a complete response (CR), and 27.9% a partial response (PR), resulting in an overall response rate (ORR) of 67.7%. In 13.7%, stable disease (SD) and in 19.7%, tumour progression (PD) were documented. In 196 patients with recurrent ovarian cancer, response evaluation was provided. A total of 28.6% of the patients achieved a CR, and 31.6% a PR, which produced an ORR of 60.2%. In 33.2%, SD and in 6.6%, PD were documented. CONCLUSION: Paclitaxel is broadly used in the management of patients with primary and relapsed ovarian cancer. The toxicity profile observed seems to be within the range of the results of clinical phase-III studies. The doses applied and the schedules based on the official recommendation of the working groups seem to have been influenced by international studies.

Prognostic role of platinum sensitivity in patients with brain metastases from ovarian cancer: results of a German multicenter study.

BACKGROUND: Ovarian cancer is the leading cause of death in women with gynecological malignancies. Brain metastases are considered an uncommon metastatic site. Only few data exist on prognostic factors for this patient collective. PATIENTS AND METHODS: A multicenter retrospective chart review was carried out including all patients with histologically confirmed ovarian cancer from six different German hospitals from 1981 to 2008. Overall, 4277 cases of patients with ovarian cancer were screened and patients with brain metastasis were identified and analyzed regarding various clinical variables and survival. RESULTS: A total of 74 women with brain metastases were identified, resulting in an incidence of 1.73%. In multivariate analysis, the following clinical parameters had a significant impact on overall survival: multiple lesions [hazard ratio (HR) 4.4, 95% confidence interval (CI) 2.0-9.7] and low grading (HR 3.1, 95% CI 1.7-5.8) were associated with a negative impact. Platinum sensitivity (HR 0.23, 95% CI 0.12-0.48) was significantly associated with a favorable outcome. Good performance status (60%-80% HR 0.48, 95% CI 0.23-0.99 and 90%-100% HR 0.21, 95% CI 0.08-0.53) also had a positive impact on overall survival. CONCLUSIONS: Platinum sensitivity is the most important prognostic factor in patients with ovarian cancer metastatic to the brain. This novel finding should be considered in the strategy of multimodal therapy for brain metastases in ovarian cancer.

Sequential chemotherapy with carboplatin followed by weekly paclitaxel in advanced ovarian cancer: results of a multicenter phase II study of the northeastern German society of gynecological oncology.

BACKGROUND: For the adjuvant setting of advanced ovarian cancer (AOC) after primary radical surgery the combination of paclitaxel and platinum in a 3-week schedule has emerged as the current standard. In preclinical studies additional anti-angiogenic effects of low dose paclitaxel infusion were demonstrated. A sequential schedule of carboplatin and paclitaxel has the potential to improve the therapeutic index. METHODS: In this multicenter phase II trial four cycles of carboplatin at a dose of AUC 5 (d1/q21d) followed by 12 cycles of weekly paclitaxel at a dose of 80 mg/m(2) (d1/q7d) were applied after primary radical surgery. Eligible were all optimally or sub-optimally debulked patients with FIGO IA-IV ovarian cancer. All patients with hemoglobin levels <12 mg/dl received erythropoietin additionally. RESULTS: Between July 2003 and May 2005, 105 patients from 27 institutions were enrolled. The median age was 60 years (range: 23-80 years). A median number of 16 courses (range 1-16) were applied. The incidence of non-hematological toxicities was very low. Only 41% of patients experienced alopecia (grade 1-2). Neurotoxicity (grade 3-4) was not observed. Grade 3-4 hematological toxicity (43% of all patients) included thrombocytopenia (17%), anemia (3%), leucopenia (23%), and neutropenic fever (0%). Ninety-seven percent received erythropoietin. Thromboembolic events (4%) were not increased in patients who received erythropoietin. After a median time of 23 months (range: 1-42 months) 32 patients had died, and the median overall survival was not reached. The progression-free survival was 25.4 months (95% CI: 18.8-40+). CONCLUSION: These results suggest that this sequential regimen using weekly paclitaxel represents an efficacious and well-tolerated regimen. A randomized study comparing this new schedule with the conventional 3-week protocol is warranted.

The pathogenetic mechanism of anthracycline-induced palmar-plantar erythrodysesthesia.

BACKGROUND: Anthracyclines, such as pegylated liposomal doxorubicin (PLD) and epirubicin (EP), are effective for the treatment of malignant tumors. Unfortunately, their implementation in therapy is limited due to severe side-effects such as palmar-plantar erythrodysesthesia (PPE). PATIENTS AND METHODS: As the exact pathogenesis of PPE still remains unclear, laser scanning microscopy was utilized to detect PLD, EP and their metabolites in and on the skin surface of patients. RESULTS: It was shown that PLD was significantly more frequently detectable on the skin than was EP (p<0.05), whereas both substances were most frequently seen in the palms and soles. Additionally, it has been visualized that the substances reach the skin surface via sweat, where they distribute and then penetrate back into the skin. CONCLUSION: It was concluded that a high density of sweat glands and a thick stratum corneum might represent important predestined factors for the development of PPE. These findings will help to develop efficient prevention and therapy strategies for PPE.

Pegylated liposomal doxorubicin (CAELYX) in patients with advanced ovarian cancer: results of a German multicenter observational study.

PURPOSE: Pegylated liposomal doxorubicin (PLD, CAELYX) has demonstrated activity in several phase-III trials and has been approved for the therapy of relapsed ovarian cancer after platinum treatment. Aim of this observational study was to analyze the efficacy and toxicity profile of PLD under routine clinical conditions and without the general restrictions of defined inclusion and exclusion criteria of clinical trials. METHODS: Between 2003 and 2005, a total of 190 patients with relapsed ovarian cancer were enrolled. 183 patients were available for evaluation; dose-intensity, modifications, treatment duration, toxicities and response were systematically analyzed. RESULTS: The median patient age was 62 years (range 23-86 years). 45.4% of the patients received PLD as second-line therapy and a median of four courses per patient were administered. The median dose of PLD was 40 mg/m(2), most frequently used every 4 weeks (68.8%). Grade 3 Leucopenia (1.6%) and grade 3 and 4 thrombocytopenia (0.5%) were the most frequent hematological toxicities. The most frequent non-hematological toxicities were skin toxicity, pain and nausea, which were observed in 38.8, 41 and 45.9% of the patients, respectively. Twenty-seven percent of the patients showed a response to therapy with 6.9% achieving complete remission and 20.1% achieving partial remission. 37.7% achieved a stable disease. The median duration of response for all patients was 4.8 months (range 0-51.8 months). Median progression-free interval and overall survival were 5.8 months (95% CI 5.1-6.6 months) and 16.6 months (95% CI 13.9-22.6 months), respectively. CONCLUSIONS: PLD is safe and effective in patients with relapsed ovarian cancer, even after numerous previous treatment regimens. A dose of 40 mg/m(2) every 28 days seems to be an effective and well-tolerated therapeutic option in advanced ovarian cancer with a low incidence of hematological toxicities and acceptable non-hematological toxicities.

Breast cancer patients' expectations in respect of the physician-patient relationship and treatment management results of a survey of 617 patients.

BACKGROUND: The following study was conducted to explore patients' information needs and preferences with a special focus on doctor-patient communication. PATIENTS AND METHODS: A 62-item questionnaire developed by a multidisciplinary team and validated in a phase-I study was given to breast cancer patients via the Internet (homepage) or in a hard copy version. RESULTS: A total of 617 patients responded, 552 on line and 65 via the hard copy questionnaire. The median age of the on-line group was 47 (21-85) and 55 (40-92) in the hard copy group. Sixty-five per cent of the patients were treated with the intention of achieving a cure and 35% of the patients had metastatic disease. The median length of the consultation communicating the information 'You have breast cancer' was 15 min (0-300). The most effective and patient-relevant source of information about the disease and the treatment options was consultation with the physician (84%). When asked to suggest areas for improvement, patients' most common answers were: more complementary therapies should be offered by the physician (54%); physicians should take more time to explain things (51%); and cooperation between the physicians involved in the patient's care should be improved (39%). The questions most relevant to patients were: 'Am I getting the right therapy?' (89%); 'How many patients with my condition does my doctor treat?' (46%) and 'Can I be enrolled into a trial?' (46%). An independent second opinion centre was desired by 94% of the respondents but only 20% knew of any such resource. CONCLUSIONS: This study underlines the need to give patients with breast cancer the full details on treatment options and cancer management. The results provide a suitable basis for a broader interdisciplinary discussion of the patient-physician relationship and should be useful in generating hypotheses for subsequent prospective studies.

Biweekly pegylated liposomal doxorubicin in patients with relapsed ovarian cancer: results of a multicenter phase-II trial.

BACKGROUND: The obvious benefit of pegylated liposomal doxorubicin (PLD) for tumour control in recurrent ovarian cancer is frequently offset by severe palmar-plantar erythrodysesthesia (PPE). There is evidence that dose reduction from 50 to 40 mg/m(2) reduces the incidence of PPE without compromising cytotoxic activity. We set out to investigate whether biweekly application further improves the therapeutic index of PLD. PATIENTS AND METHODS: Patients with recurrent ovarian cancer after surgery and adjuvant chemotherapy with platinum and taxane compounds were eligible to participate in this multi-institutional phase II study. PLD was administered at a dose of 20 mg/m(2) every two weeks. Eligible patients had ECOG performance status of < or =2, and sufficient organ function. We employed an optimized two-stage design to test the hypothesis that biweekly application of PLD reduces the frequency of grade III and IV PPE from 25% to 10%. Response and survival were addressed descriptively. RESULTS: Between October 2001 and February 2004, 64 patients with median age of 59 (range 38-81) years were recruited onto this trial. We evaluated 553 (median 7, range 1-25) courses of PLD treatment. Most patients were in their third or fourth line of chemotherapy. PPE was noted in 30 patients (47.6%), but only three participants progressed to grade 3 severity (4.7%, 95% confidence interval 1.0-13.1%). Partial response, stable disease, and tumour progression were observed in 5, 13, and 24 patients, respectively. Median overall and progression-free survival were 18.2 (range, 1.4-34.0) and 4.3 (range 0.5-22.3) months. CONCLUSIONS: Biweekly PLD may reduce the incidence of PPE while retaining efficacy in relapsed ovarian cancer. Our data support the need for a randomized trial to strengthen these assumptions.

["IMO"--intraoperative mapping of ovarian cancer]. / "IMO"--Intraoperatives Mapping des Ovarialkarzinoms.

INTRODUCTION: The majority of patients diagnosed with ovarian cancer are in an advanced stage of the disease at the time of first diagnosis. The standard clinical staging (FIGO) occurs intraoperatively. The FIGO classification hides ambiguities and is useful as a means of orientation. However, an exact assessment of stage at first diagnosis, can form the basis for the evaluation of diagnostic and prognostic factors and furthermore has influence on adjuvant treatment. METHOD: We developed a systematic surgical and histopathological tumor documentation instrument, further we investigated its clinical and scientific application. RESULTS: Between September 2000 and July 2002, 128 patients with primary and recurrent ovarian cancer were operated and prospectively documented. The median age of the patients at the time of first diagnosis was 55 years. The majority of patients diagnosed with primary ovarian cancer had a diffuse tumor spread pattern (localised: 18 [32 %]; central: 14 [25 %]; diffuse: 24 [43 %]). In patients diagnosed with recurrent ovarian cancer the three defined tumor spread patterns showed a comparable distribution (localised 19 [28 %]; central: 19 [28 % ]; diffused: 29 [43 %]). While in most of the patients with primary ovarian cancer the highest tumor mass was concentrated in the lower abdomen/ pelvis, in comparison, in patients with recurrent ovarian cancer it was located mostly in the upper abdomen ("change of level", p=0,027). CONCLUSIONS: The IMO (Interoperative Mapping of Ovarian Cancer) represents a new instrument for a detailed and objective documentation of surgical and pathological results of patients with ovarian cancer and helps provide a more precise staging. Potentially this prospective documentation support the development of SOP's (Standard Operating Procedures) and could be an efficacious instrument of quality management.