Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study.

BACKGROUND: Uveal melanoma (UM) has a poor prognosis once liver metastases occur. The melphalan/Hepatic Delivery System (melphalan/HDS) is a drug/device combination used for liver-directed treatment of metastatic UM (mUM) patients. The purpose of the FOCUS study was to assess the efficacy and safety of melphalan/HDS in patients with unresectable mUM. METHODS: Eligible patients with mUM received treatment with melphalan (3.0 mg/kg ideal body weight) once every 6 to 8 weeks for a maximum of six cycles. The primary end point was the objective response rate (ORR). The secondary end points included duration of response (DOR), overall survival (OS), and progression-free survival (PFS). RESULTS: The study enrolled 102 patients with mUM. Treatment was attempted in 95 patients, and 91 patients received treatment. In the treated population (n = 91), the ORR was 36.3 % (95 % confidence interval [CI], 26.44-47.01), including 7.7 % of patients with a complete response. Thus, the study met its primary end point because the lower bound of the 95 % CI for ORR exceeded the upper bound (8.3 %) from the benchmark meta-analysis. The median DOR was 14 months, and the median OS was 20.5 months, with an OS of 80 % at 1 year. The median PFS was 9 months, with a PFS of 65 % at 6 months. The most common serious treatment-emergent adverse events were thrombocytopenia (15.8 %) and neutropenia (10.5 %), treated mostly on an outpatient basis with observation. No treatment-related deaths were observed. CONCLUSION: Treatment with melphalan/HDS provides a clinically meaningful response rate and demonstrates a favorable benefit-risk profile in patients with unresectable mUM (study funded by Delcath; ClinicalTrials.gov identifier: NCT02678572; EudraCT no. 2015-000417-44).

S1-Guideline Sebaceous Carcinoma.

Sebaceous gland carcinomas are rare malignant cutaneous adnexal tumors with sebocytic differentiation. The typical predilection area is the head and neck region, where sebaceous gland carcinomas are the most common malignant adnexal tumors of the skin. According to their localization a distinction is made between periocular and extraocular sebaceous gland carcinomas. Muir-Torre syndrome (MTS) should always be ruled out if it is suspected. In terms of prognosis, sebaceous gland carcinomas are potentially aggressive tumors with a clear tendency to recur and metastasize. Only small extraocular sebaceous gland carcinomas that have been completely resected have a very good prognosis. Sebaceous gland carcinomas most frequently metastasize lymphogenously to regional or distant lymph nodes; organ metastasis occurs less frequently. Periocular sebaceous gland carcinomas have a higher metastasis rate (up to 15%) than extraocular sebaceous gland carcinomas (up to 2%). Complete micrographically controlled surgery (MCS) of the primary tumor is the therapy of first choice, regardless of periocular or extraocular localization. Adjuvant or therapeutic radiotherapy may be considered. There is currently no established standard therapy for advanced, inoperable, or metastatic sebaceous gland carcinomas. Local procedures and systemic therapies such as chemotherapy or immunotherapy can be considered. The procedure should be determined individually by an interdisciplinary tumor board. Close follow-up care is recommended for these potentially aggressive carcinomas.

Pain management in German hospices: a cross-sectional study.

BACKGROUND AND OBJECTIVES: Pain management is a necessary component of palliative care as most patients suffer from pain during the final phase of life. Due to the complex causation of pain in the last phase of life, it is important to utilize methods other than pharmacotherapeutic options in order to achieve adequate pain control. As little is known about treatment of pain in German hospices, a nationwide survey was conducted. MATERIALS AND METHODS: All German hospices (259) were contacted by post in June 2020 and asked to participate in an anonymous cross-sectional survey. RESULTS: A total of 148 (57%) German hospices took part in the survey. A broad variety of medication is used in the hospice setting. Metamizole is the most commonly used non-opiod analgesic , hydromorphone the most commonly used opioid, and pregabalin is the most commonly prescribed co-analgesic drug. The pain medication is usually prescribed as an oral slow-release substance. Standardized treatment schemes are rare among the responding hospices. Most of the respondents also use complementary treatment options, such as aroma (oil) therapy or music therapy, in the treatment of pain. Palliative sedation is used by nearly all responding hospices if all other treatment options fail. CONCLUSION: This survey provides an overview of the treatment options for pain management in German hospices. A broad variety of pain medication is used. Compared to international literature, it is debatable whether such a large variety of different types of pain medication is necessary, or whether a reduction in the type of medication available and the use of standardized treatment schemes could benefit everyone involved.

End-of-Life Care Preferences of Patients with Advanced Urological Malignancies: An Explorative Survey Study at a Tertiary Referral Center.

Background: Many people want to die at home, but it is often not possible because they do not share their wishes with family members. This study was conducted to find out the extent to which patients with advanced urological malignancies had wishes regarding their final stage of life, made arrangements accordingly, and communicated their wishes to relatives and health care professionals. Methods: We conducted a survey among advanced urological tumor patients during their clinic visit at a German university hospital using a 31-item questionnaire. Inclusion criteria were metastatic or irresectable prostate cancer, urothelial carcinoma, or renal cell carcinoma. Results: In total, 88 patients (76 male, 12 female) completed the questionnaire, and 62 of those respondents (70%) had received their tumor diagnosis within the past 5 years. Symptoms were reported by 80%, and 18% described five or more symptoms. The majority (88%) stated that they had thought about their preferred place of death but 58% had not informed anyone about it. The preference for a hospice as the place of death correlated statistically significantly with the absence of a domestic partnership (p = 0.001) or marriage (p < 0.001) and with a high number of symptoms (≥5; p = 0.009). However, 73% had not talked with their urological oncologist about care options in case their health deteriorated though 36% of those were interested in having a conversation about it. Conclusions: Our results showed that 9 out of 10 patients reflected on their preferred place of death but only a few discussed it with anyone. Based on this finding, physicians and healthcare staff should initiate discussions about early care planning so that patients in incurable situations can express their wishes regarding their preferred place of death.

End-of-life wishes and care planning for patients with advanced skin cancer.

BACKGROUND: Patients with advanced or metastatic skin cancer have a limited life expectancy and the majority die as a result of the tumor despite modern treatment options. The preferences of these patients concerning care during their last phase of life are currently unknown. PATIENTS AND METHODS: 150 patients with advanced skin cancer (AJCC/UICC stage III or IV) were interviewed using a structured questionnaire. RESULTS: 75% of the respondents wished to die in their domestic environment, although a more advanced tumor stage and increased reflection upon end-of-life care lead away from this wish. However, only 42% reported having communicated this wish to someone else. 55% of the respondents had completed advance directives, while younger patients did this significantly less often (95% CI: 0.11-0.56; p  =  0.001). The majority of patients (62%) would like to have discussions about possibilities for end-of-life care with the attending dermato-oncologist. CONCLUSIONS: Although the moment of death is unpredictable, early initiation of end-of-life advance care planning appears prudent. The attending dermato-oncologists should take the initiative to raise the subject with their patients during routine control visits. In this context, it may be useful to present available care options to patients and relatives and to design strategies for the event of deteriorating health.

How to Enable Participation until the End of Life? A Survey of German Occupational Therapists Working in Palliative Care.

BACKGROUND: In palliative care, the needs of people with life-limiting illnesses must be addressed with the support of a multidisciplinary team. Occupational therapy is a profession that focuses on activity and participation. In Germany, there are no surveys to date that demonstrate the work of occupational therapists in palliative care and which problems can occur in this field. AIM: The aim of this study is to describe the work and problems of occupational therapists in German palliative care. DESIGN: The survey consists of 17 questions and could be conducted anonymously. Descriptive statistics and a thematic analysis of the free text responses were used to analyze data. SETTING/PARTICIPANTS: Respondents were German occupational therapists who are members of the "German Association of Occupational Therapy". RESULTS: A total of 281 valid responses were evaluated, of which 120 respondents work in the context of palliative care. Most of them provide needs-based therapies (74%), train relatives (69%), or help patients with positioning (69%) or relaxation therapy (66%). Four themes were developed in the free text responses that describe problems in the utilization of occupational therapy in palliative care. CONCLUSIONS: The evaluation shows that occupational therapy in palliative care offers a variety of possible applications and approaches. The findings urgently need to be implemented in daily practice to improve the status of occupational therapists. This requires appropriate billing modalities and clear guidelines. There is still a significant need for research and training in this area.

Perioperative pain management in dermatosurgery - current practice in Germany: Data analysis of a Germany-wide online survey among dermatosurgeons.

BACKGROUND: Adequate pain management should be part of the standard of care in surgical procedures. However, there is a paucity of data in the field of dermatosurgery. In a standardized online survey among dermatosurgeons working in Germany, the current practice of perioperative pain management was investigated. METHODS: Members of the German Society for Dermatosurgery (DGDC) and heads of dermatosurgical departments were asked to participate. Questions were related to practical implementation of perioperative pain management, pain documentation and personal sources of information on the topic. RESULTS: 116 questionnaires were analyzed. While prophylactic analgesia is rarely used, the vast majority (86%) reported the use of postoperative on-demand medication. The majority of surgeons do not have a fixed regimen. Mostly NSAIDs and occasionally low potency opioids are used. Pain is documented by the majority (59.1%) as free text. Personal experience (69%) and in-house standards (51%) are the most important factors in pain management. The use of guidelines (25%) plays a minor role. CONCLUSIONS: Perioperative pain management in dermatosurgery is strongly influenced by personal experience and may vary depending on the surgery performed. Consensus-based standardized recommendations are lacking. For adequate perioperative analgesia, the development of demand-oriented pain concepts is desirable. This requires prospective studies that address the specific patient population and surgical procedures in dermatology.

[Pain management in German specialized outpatient palliative care : A cross-sectional study to present the current pain management of palliative patients in the home environment]. / Schmerztherapie in der deutschen spezialisierten ambulanten Palliativversorgung : Eine Querschnittsstudie zur Darstellung der aktuellen schmerzmedizinischen Versorgung von palliativen Patienten im häuslichen Umfeld.

BACKGROUND: With the help of specialized outpatient palliative care teams (German abbreviation: SAPV), seriously ill and dying patients in Germany can be adequately cared for in their home environment until the end of their lives; however, there are no uniform standards or guidelines for well-executed pain management right now. OBJECTIVE: This approach serves as basic research in the field of public health research. This is intended to present which methods (use of different professional groups, use of pain medications, alternative medical treatment etc.) the individual SAPV teams use for pain management. From this it can be deduced which procedures can be considered particularly effective. MATERIAL AND METHODS: This cross-sectional study was conducted in May 2021. All German SAPV teams (n = 307) listed on the homepage of the German Association for Palliative Medicine (DGP) were contacted by post and invited to participate. A total of 175 teams (57%) responded to the request and were included in the evaluation. A descriptive data analysis was performed. RESULTS: Pain management in the German outpatient care of palliative patients is based on several components. All common pain medications are used, but primarily metamizole (99.4%) as a non-opioid analgesic, morphine (98.3%) from the opiate series and pregabalin (96.6%) as a co-analgesic are mainly prescribed. If pain therapy fails, 22.5% of the SAPV teams perform palliative sedation for symptom control on a regular basis. CONCLUSION: This cross-sectional study is the first of its kind to provide a general overview of the treatment options for pain management in German outpatient palliative care. In comparison with international studies, the question arises as to whether uniform therapy schemes and a reduction in the medication available in the individual SAPV teams could lead to an improvement in patient care.

[Physical therapy and occupational therapy in German palliative care: Where do we stand?] / Physio- und Ergotherapie in der deutschen Palliativmedizin ­ wo stehen wir?

INTRODUCTION: Physical therapy (PT) and occupational therapy (OT) as supportive forms of treatment in palliative care, together with other treatment measures, can create participation for seriously ill patients in the form of a life that is as autonomous as possible until the end of life. However, specially trained staff are needed for the care of palliative patients in order to do justice to the clients' special life situation. In Germany, no corresponding survey on the subject has so far been conducted. So it is unclear to what extent PT and OT are offered in palliative care structures in this country, which tasks are assigned to the respective professional groups, and what the level of knowledge is that caregivers have about treatment options. AIM: Compilation of an overview of the provision, need and use of PT and OT in the various areas of palliative care in Germany. If there is a lack of provision, the reasons for this will be identified. METHODS: In this cross-sectional survey, a self-designed 9-item questionnaire was sent out to a total of 260 hospices, 323 palliative care units and 304 specialized outpatient palliative care services (SOPC) listed on the homepage of the German Society for Palliative Medicine (DGP). The respondents' answers were analysed using a purely descriptive approach. RESULTS: The response rate was 439 (49.5%). A total of 434 questionnaires (49%) were included in the analysis. A heterogeneous distribution of PT and OT offers between outpatient, inpatient, and hospice palliative care can be seen, with the outpatient area showing a significantly fewer offerings. 29% of the SOPC teams can offer neither PT nor OT. This is mostly due to a shortage of skilled workers or a lack of funding opportunities. The different areas of responsibility of physiotherapists and occupational therapists are known to the majority of respondents (hospice 87%, palliative care unit 83%, SOPC 81%) and are also reflected in the distribution of tasks between the two professional groups. Especially palliative care units and SOPC teams state that they would like to offer more PT and OT (palliative care units 42% more PT and 58% more OT; SOPC 65% more PT and 50% more OT). DISCUSSION: This cross-sectional survey is the first of its kind to provide an overview of the PT and OT offerings in the different sectors of German palliative care. In a comparison of the two forms of therapy, occupational therapists are used less frequently than physiotherapists. An international comparison of the study situation also shows that the use of OT in palliative care, in particular, has not yet been implemented satisfactorily. Outside Germany, the main reasons for this are a shortage of specialists and a lack of knowledge about the tasks of OT. CONCLUSION: PT and OT are frequently used treatment options in all areas of German palliative care. In order to better classify structural problems in care, further differentiated surveys should be conducted. Furthermore, a better knowledge base should be created through research and information activities of both professional groups in palliative care.

[Anaesthesia in Electrochemotherapy]. / Narkoseführung bei Elektrochemotherapie.

Electrochemotherapy (ECT) is a symptom control method for inoperable or exulcerating cutaneous metastases or skin cancer. With the help of electroporation, an enhancement of the efficacy of the administered chemotherapeutic agent, bleomycin or cisplatin, is achieved, which leads to a local reduction of the metastases and thereby has a low impact on the systemic health.ECT can be performed under local, regional or general anaesthesia, whereby the form of anaesthesia depends on the number and extent of the metastases as well as the affected body site. For general anaesthesia, there are some special aspects to consider. To prevent lung damage from bleomycin, the patient has to be ventilated with a low FiO2 (< 0.3), or preferably with room air. To avoid drug interactions and postoperative pain, general anaesthesia is performed as TIVA in deep relaxation. The anaesthesia team should be aware of the necessary precautions when applying chemotherapeutic agents and should recognize contraindications to performing anaesthesia in ECT in advance.