Diagnosis and Treatment of Patients Utilizing Complementary Medicine at a Tertiary Referral Hospital in Eastern Switzerland.

BACKGROUND: In 2012, the Cantonal Hospital of St. Gallen, a tertiary referral hospital in Eastern Switzerland, opened its Center for Integrative Medicine (ZIM). This study aims to characterize disease and treatment characteristics of adult patients treated at the ZIM. PATIENTS AND METHODS: For all new patients, physicians at the ZIM completed questionnaires on patients' diagnoses and treatments. Descriptive statistics for categorical variables were reported as percentages. Univariable logistic regression analysis was used to assess the data. The analysis was performed with the statistical software package SPSS (IBM). RESULTS: From 2015 to 2020, 4,592 new patients were seen at the ZIM. The most common diagnosis in the supergroups was cancer (48%), followed by pain diagnoses (33%). Chronic pain as a subgroup was represented the most in patients (29%). Anthroposophical medication was the most commonly prescribed therapy, in 74% of patients with cancer and 73% with pain diagnosis. The latter was associated with the prescription of eurythmy therapy (OR: 3.80, p < 0.001), traditional Chinese medicine (OR: 3.34, p < 0.001), or art therapy (OR: 5.15, p < 0.001), whereas mistletoe therapy was the preferred treatment option (OR: 59.0, p < 0.001) for a cancer diagnosis. CONCLUSION AND OUTLOOK: The results will help adapt CM services to patients' needs and provide a good basis for the planning of future services in CM in major hospitals. Further research should be conducted focusing on specific health outcomes.

Acupuncture in chemotherapy-induced dysgeusia (AcuDysg): study protocol of a randomised controlled trial.

INTRODUCTION: Dysgeusia is a common side effect of chemotherapy in patients with cancer, but to date, there is no effective treatment. Many patients with cancer request complementary medicine treatment in addition to their cancer treatments, and acupuncture is highly accepted for patients with cancer; however, evidence regarding the effectiveness of acupuncture for dysgeusia is scarce.The study investigates the effectiveness of an additional dysgeusia-specific acupuncture plus self-acupressure intervention compared with supportive acupuncture plus self-acupressure intervention alone for chemotherapy-induced dysgeusia in patients with cancer. METHODS AND ANALYSIS: This is a multicentre, randomised, controlled and two-armed parallel-group, single-blind trial involving 130 patients. Both groups will receive eight sessions of acupuncture treatment over a period of 8 weeks and will be trained to perform self-acupressure (eLearning combined with therapist instruction) at predefined acupressure points once a day during the whole treatment period. Patients in the control group will receive supportive routine care acupuncture and self-acupressure treatment only; in addition to this treatment, the intervention group will receive the dysgeusia-specific acupuncture and acupressure within the same treatment session. The primary outcome is the perceived dysgeusia over 8 weeks, measured weekly after the acupuncture treatment. Secondary outcomes include the indices from the objective taste and smell test, weight loss, perceived dysgeusia, fatigue, distress, nausea and vomiting, odynophagia, xerostomia and polyneuropathy, as well as quality of life at the different time points. ETHICS AND DISSEMINATION: The study has been approved by the Cantonal Ethics Committee (CEC) (Kanton Zürich Kantonale Ethikkommission) (approval no. KEK-ZH-Nr. 2020-01900). The results will be submitted to a peer-reviewed journal for publication. TRIAL REGISTRATION NUMBERS: DRKS00023348, SNCTP000004128.

The price of tumor control: an analysis of rare side effects of anti-CTLA-4 therapy in metastatic melanoma from the ipilimumab network.

BACKGROUND: Ipilimumab, a cytotoxic T-lymphocyte antigen-4 (CTLA-4) blocking antibody, has been approved for the treatment of metastatic melanoma and induces adverse events (AE) in up to 64% of patients. Treatment algorithms for the management of common ipilimumab-induced AEs have lead to a reduction of morbidity, e.g. due to bowel perforations. However, the spectrum of less common AEs is expanding as ipilimumab is increasingly applied. Stringent recognition and management of AEs will reduce drug-induced morbidity and costs, and thus, positively impact the cost-benefit ratio of the drug. To facilitate timely identification and adequate management data on rare AEs were analyzed at 19 skin cancer centers. METHODS AND FINDINGS: Patient files (n = 752) were screened for rare ipilimumab-associated AEs. A total of 120 AEs, some of which were life-threatening or even fatal, were reported and summarized by organ system describing the most instructive cases in detail. Previously unreported AEs like drug rash with eosinophilia and systemic symptoms (DRESS), granulomatous inflammation of the central nervous system, and aseptic meningitis, were documented. Obstacles included patients delay in reporting symptoms and the differentiation of steroid-induced from ipilimumab-induced AEs under steroid treatment. Importantly, response rate was high in this patient population with tumor regression in 30.9% and a tumor control rate of 61.8% in stage IV melanoma patients despite the fact that some patients received only two of four recommended ipilimumab infusions. This suggests that ipilimumab-induced antitumor responses can have an early onset and that severe autoimmune reactions may reflect overtreatment. CONCLUSION: The wide spectrum of ipilimumab-induced AEs demands doctor and patient awareness to reduce morbidity and treatment costs and true ipilimumab success is dictated by both objective tumor responses and controlling severe side effects.

Outcome, quality of life and cognitive function of patients with brain metastases from non-small cell lung cancer treated with whole brain radiotherapy combined with gefitinib or temozolomide. A randomised phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 70/03).

PURPOSE: Patients with brain metastases (BM) rarely survive longer than 6months and are commonly excluded from clinical trials. We explored two combined modality regimens with novel agents with single agent activity and radiosensitizing properties. PATIENTS AND METHODS: In this randomised phase II trial patients with BM from NSCLC were randomly assigned to 30Gy WBRT with either concomitant gefitinib (GFT) 250mg/day continuously or temozolomide (TMZ) 75mg/m(2) for 21/28days. The primary end-point was overall survival, with quality of life and cognitive function as secondary end-points. RESULTS: We enrolled 59 patients (GFT 16, TMZ 43), and 56 patients have died, mainly (80%) from disease progression. Four patients succumbed complications of the disease or corticosteroids (intestinal perforation (2), CNS haemorrhage and pulmonary emboli). Median overall survival in the gefitinib arm was 6.3months (95% CI 2.1-14.6), and 4.9months (95% CI 2.3-5.6) in TMZ treated patients. Fatigue was the main complaint. CONCLUSIONS: No relevant toxicity with those therapeutic regimens was observed. Fatal outcome in three patients may have been related to corticosteroids. Cognitive function improved during treatment. However, median overall survival for all patients was only 4.9months (95% CI 2.3-5.7) and 1-year survival 25.4% (95% CI 15.4-37.0%).

[Limits and benefits of non-controlled therapy-related observations]. / Grenzen und nutzen nichtkontrollierter therapiebezogener fallbeobachtungen.

In the age of evidence-based medicine, results from prospective controlled interventional studies are awarded the highest priority for determining the efficacy of a therapeutic measure. In contract, the role of non-controlled therapy-related observations is very low. This conception is due to the fact that in the absence of a control group it is impossible to assess a causal relationship between an administered therapy and the subsequent clinical outcome.Nevertheless, non-controlled therapeutic observations may be clinically relevant. Four domains may be distinguished : besides their importance for learning and teaching, such observations can contribute to evaluate which benefits results gained in controlled studies have in daily practice. On the other hand, they may point to hitherto unknown phenomena, such as the detection of new indications or unexpected therapeutic side effects. Finally, they may act as an important source for the generation of hypotheses about therapeutic measures, thus fostering further research.

Sarcoidosis induced by interferon-α in melanoma patients: incidence, clinical manifestations, and management strategies.

Treatment with interferon-α has been recommended for patients with melanoma in case of micrometastases, or high risk melanoma, for example, ulcerated melanoma. Furthermore, regular dermatologic examination and regular imaging to detect recurrence or progression of disease is part of the management of melanoma patients. Sarcoidosis has been described as an adverse effect of treatment with interferon-α. Especially in hepatitis C patients, there is a series of case reports on sarcoidosis induced by interferon treatment whereas in melanoma this has rarely been reported. In a retrospective study, all melanoma patients treated with interferon-α at our hospital between 2007 and 2009 were screened for occurrence of sarcoidosis. Three of 16 melanoma patients treated with interferon-α (19%) presented with sarcoidosis. All 3 patients showed lesions with higher uptake in the positron emission tomography-computed tomography scan leading to the differential diagnosis of melanoma metastases or inflammation. Skin lesions were present in 1 patient. Diagnosis was confirmed by histologic assessment of lesions showing epithelioid granuloma-negative on Ziehl Neelson. Additional work-up included blood and urinalysis, electrocardiography, and ophthalmologic examination. Cessation of interferon-α led to regression of granulomas. Sarcoidosis induced by interferon-α in melanoma patients could be more common than previously thought. This is an important complication to be aware of as it can be mistaken for metastatic spread of melanoma and thus lead to incorrect therapy.

Successful treatment of acute disseminated intravascular coagulation in a patient with metastatic melanoma.

BACKGROUND: Acute disseminated intravascular coagulation (DIC) in cancer is rare and often fatal, whereas chronic forms are more frequent. CASE REPORT: A 37-year-old man with a known history of melanoma excised 6 years ago, presented with abdominal pain, fatigue and epistaxis. A computed tomography scan revealed diffuse metastatic disease of the liver, and laboratory analysis was consistent with accentuated DIC. After chemotherapy with dacarbacine, vinblastine and cisplatine, the acute DIC improved rapidly. After a second cycle, the tumor marker S-100 dropped from 15 to 3.1 microg/l (< 0.15 microg/l), suggesting that the improvement of the DIC was associated with a response to chemotherapy. After 2 cycles of chemotherapy, a palliative right hemihepatectomy was performed followed by 4 additional postoperative chemotherapy cycles. The patient survived 1 more year without relapse of the DIC. CONCLUSION: The cornerstone of managing DIC in cancer consists in treatment of the underlying disease. The rapid control of DIC in our patient can be explained by early diagnosis of the coagulopathy and the fast response of the tumor to the multidrug therapy. Thus, combination chemotherapy of metastatic melanoma is justified if an effective response has to be obtained in a limited time.