Benefits of Homeopathic Complementary Treatment in Patients With Breast Cancer: A Retrospective Cohort Study Based on the French Nationwide Healthcare Database.

BACKGROUND: Complementary therapy in oncology aims to help patients better cope with the illness and side effects (SEs) of cancer treatments that affect their quality of life (QOL). This study aimed to assess the benefits of homeopathic treatment on the health-related QOL (HRQOL) of patients with non-metastatic breast cancer (BC) prescribed in postsurgical complementary therapy. PATIENTS AND METHODS: An extraction from the French nationwide healthcare database targeted all patients who underwent mastectomy for newly diagnosed BC between 2012 and 2013. HRQOL was proxied by the quantity of medication used to palliate the SEs of cancer treatments. RESULTS: A total of 98,009 patients were included (mean age: 61 ± 13 years). Homeopathy was used in 11%, 26%, and 22% of patients respectively during the 7 to 12 months before surgery, the 6 months before, and 6 months after. Thereafter, the use remained stable at 15% for 4 years. Six months after surgery, there was a significant overall decrease (RR = 0.88, confidence interval (CI)95 = 0.87-0.89) in the dispensing of medication associated with SEs in patients treated with ≥ 3 dispensing of homeopathy compared to none. The decrease appeared to be greater for immunostimulants (RR = 0.79, (CI)95 = 0.74-0.84), corticosteroids (RR = 0.82, (CI)95 = 0.79-0.85), and antidiarrheals (RR = 0.83, (CI)95 = 0.77-0.88). CONCLUSION: The study showed an increasing use of homeopathy in patients with BC following diagnosis. This use was maintained after surgery and seemed to play a role in helping patients to better tolerate the SEs of cancer treatments.

Phase I study of sorafenib in combination with docetaxel and prednisone in chemo-naïve patients with metastatic castration-resistant prostate cancer.

PURPOSE: We performed a dose-escalation study to investigate the safety of sorafenib in combination with docetaxel and prednisone in chemo-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). METHODS: Six patients were included per dose level. Following docetaxel infusion on day 1 (75 mg/m(2)/q3 weeks), sorafenib was administered at 200 mg BID on days 2-19 (dose level 1), at 200 mg BID on days 1-21 (dose level 2), at 400 mg BID on days 2-19 (dose level 3), at 400 mg BID on days 1-21 (dose level 4). Maximal tolerated dose (MTD) was exceeded if ≥2 patients experienced dose-limiting toxicities (DLT) during cycle 1. The recommended phase 2 dose for sorafenib was defined as one dose level below MTD. If MTD was not reached, the highest feasible dose would be selected to treat an expanded cohort to confirm safety. RESULTS: Two DLTs were observed during sorafenib dose-escalation consisting of grade 4 febrile neutropenia (dose level 2) and grade 3 hand-foot syndrome (HFS) (dose level 3). Our pharmacokinetic results showed an increased exposure to docetaxel across all dose levels during sorafenib comedication. The main grade ≥3 toxicities were neutropenia (35 %), HFS (27 %), and febrile neutropenia (19 %). The prostate-specific antigen (PSA) response rate was 74 %. Median overall survival was 25.2 months. CONCLUSION: Three-weekly docetaxel and prednisone could be combined with sorafenib at 400 mg BID on days 1-21 without reaching MTD. However, we observed a pharmacokinetic interaction between sorafenib and docetaxel, associated with significant toxicities, raising concerns about the safety of this combination in mCRPC.

Long-term response and postsurgical complete remissions after treatment with sunitinib malate, an oral multitargeted receptor tyrosine kinase inhibitor, in patients with metastatic renal cell carcinoma.

Receptor tyrosine kinase (RTK) inhibitors have revolutionized the treatment of metastatic renal cell carcinoma (mRCC) and significantly extended survival in these patients. Sunitinib is an oral multitargeted inhibitor of vascular endothelial growth factor receptors (VEGFRs-1, -2, and -3), platelet-derived growth factor receptors (PDGFRs-α and -ß), stem-cell factor receptor (KIT), FMS-like tyrosine kinase 3 (FLT3), colony-stimulating factor 1 receptor (CSF-1R), and glial cell line-derived neurotrophic factor receptor (REarranged during Transfection; RET). Sunitinib is approved multinationally for the treatment of advanced RCC, and is considered the reference standard of care for first-line treatment. In clinical trials, sunitinib has been associated with a consistent, distinct profile of adverse events. Here we describe three cases that show that it is possible to manage adverse events occurring during sunitinib therapy, and thus allow patients with mRCC to receive an effective dose of sunitinib in order to achieve long-term disease control. These cases also show that surgical resection, performed whenever possible, can help to improve control of metastatic disease and so avoid the unnecessary toxicity and high costs of prolonged antiangiogenic therapy.

Evolution of renal function in patients treated with antiangiogenics after nephrectomy for renal cell carcinoma.

PURPOSE: Side effects of antiangiogenic agents are moderate compared with other therapies. The most frequent adverse events are of a renovascular origin and manifest as hypertension (HTN) and thrombotic microangiopathy. To date, data are scanty on the renal tolerance of such drugs regarding renal function as itself, i.e., glomerular filtration rate (GFR). We report on the evolution of GFR in patients receiving antiangiogenic therapy after unilateral nephrectomy for kidney cancer. PATIENTS AND METHODS: Data from 73 patients followed in our oncology department for kidney cancer, who had undergone unilateral nephrectomy, and received any antiangiogenic therapy were reviewed. Their GFR was calculated using the aMDRD formula. RESULTS: All patients showed a declining renal function over time (-1.23 and -2.51 mL/min/1.73 m(2) using the slope of the curve or the difference between GFR at baseline and that at the end of treatment, respectively). Among them, patients who were recorded as having HTN before initiation of antiangiogenic therapy showed a higher decrease in their GFR of -13.28 and -12.06 mL/min/1.73 m(2). CONCLUSION: We recommend that blood pressure should be measured closely in those patients before initiation of antiangiogenic therapy. When HTN is diagnosed, it should be treated and renal function should be monitored since those patients may be at risk for rapidly decreasing renal function under therapy.

Metastatic renal carcinoma: evaluation of antiangiogenic therapy with dynamic contrast-enhanced CT.

PURPOSE: To determine whether tumor perfusion parameters assessed by using dynamic contrast material-enhanced computed tomography (CT) could help predict and detect response in patients receiving antiangiogenic therapy for metastatic renal cell carcinoma. MATERIALS AND METHODS: Institutional ethics committee approval and informed consent were obtained. In two phase-III trials involving 51 patients with metastatic renal cell carcinoma (38 men, 13 women; age range, 30-80 years) receiving antiangiogenic drugs (sorafenib [n = 10], sunitinib [n = 22]), a placebo (n = 12), or interferon alfa (n = 7), serial dynamic contrast-enhanced CT was performed, during 90 seconds before and after injection of 80 mL of iobitridol. Perfusion parameters of a target metastatic tumor (tumor blood flow [TBF], tumor blood volume [TBV], mean transit time, and vascular permeability-surface area product) were calculated. Values before and after treatment were compared by using a Wilcoxon signed rank test, and relative changes in groups were compared by using the Wilcoxon rank sum test. Results were compared with Response Evaluation Criteria in Solid Tumors response and with progression-free and overall survival by using Kaplan-Meier curves. RESULTS: Among patients receiving antiangiogenic drugs, baseline perfusion parameters were higher in responders than in stable patients (TBF = 245.3 vs 119.5 mL/min/100 mL, P = .04; TBV = 15.5 vs 8.2 mL/100 mL, P = .02) but were not significantly predictive of survival. After the first cycle of treatment, there was a significant decrease in TBF (162.5 vs 76.7 mL/min/100 mL, P = .0002) and TBV (9.1 vs 3.9 mL/100 mL, P < .0001) in patients receiving antiangiogenic treatment. CONCLUSION: Renal carcinoma perfusion parameters determined with dynamic contrast-enhanced CT can help predict biologic response to antiangiogenic drugs before beginning therapy and help detect an effect after a single cycle of treatment.

Screening for psychological distress in two French cancer centers: feasibility and performance of the adapted distress thermometer.

OBJECTIVE: Little is known about the prevalence of psychiatric disorders in French cancer patients. This study aimed to assess the feasibility of a screening procedure using the Psychological Distress Scale (PDS). The PDS is a French adaptation of the National Comprehensive Cancer Network Distress Thermometer. The screening performance of the PDS was assessed by comparison with the established clinical case threshold on the Hospital Anxiety and Depression Scale (HADS). METHODS: Among 598 consecutive cancer outpatients recruited in two cancer centers in Paris, 561 (94%) agreed to complete the PDS, the HADS, the European Organisation for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30), and study-specific psychosocial questions. RESULTS: A receiver operating characteristic (ROC) analysis was performed, using a HADS cutoff score of 15 or greater to identify patients with psychological distress. This yielded a PDS cutoff score of 3, giving 76% sensitivity and 82% specificity. With this cutoff score, the prevalence of psychological distress was 38%. PDS scores were significantly related to scores from the HAD total scale (r=.64), HAD anxiety (r=.61) and HAD depression (r=.39) subscales, and EORTC QLQ-C30 emotional functioning (r=.56) and global health state (r=.44). In multivariate analyses, factors associated with psychological distress were female gender, taking analgesics, receiving professional psychological help, perceived psychosocial difficulties and lack of social support. SIGNIFICANCE OF RESULTS: Using the PDS appeared feasible, acceptable and effective for psychological distress screening in French ambulatory cancer care settings.

[Chemotherapy for prostate cancer]. / Chimiothérapie du cancer de la prostate.

Chemotherapy treatment for patients with prostate cancer has advanced considerably during the past decade. The first demonstration of the efficacy of palliative chemotherapy in patients with hormone-resistant prostate cancer was followed by FDA approval of mitoxantrone in this setting and by studies showing the usefulness of several different drugs in these patients. Docetaxel became the standard treatment for them. The development of new cytotoxic molecules and targeted therapies as well as the evaluation of the efficacy of docetaxel in earlier stages of prostate cancer, with many ongoing studies, are the current lines of research for improving management of these hormone-refractory patients.