Open-label uncontrolled pilot study to evaluate complementary therapy with Ruta graveolens 9c in patients with advanced cancer.

BACKGROUND: Patients with advanced metastatic disease are often treated aggressively with multiple lines of chemotherapy, even in the last month of life. The benefit of such an approach remains uncertain. The objective of the study was to investigate whether Ruta graveolens 9c homeopathic medicine can improve quality of life (QoL) and tumour progression in patients with advanced cancer. MATERIAL AND METHODS: This was a single-centre, open-label, uncontrolled, pilot study. Patients (>18-years, life-expectancy ≥3 months, performance status ≤2) with locally-advanced solid tumours or metastases, previously treated with all available standard anti-cancer treatments were recruited. Oral treatment consisted of two 1-mL ampoules of Ruta graveolens (9c dilution) given daily for a minimum of 8 weeks, or until tumour and/or clinical progression. Primary outcome was QoL measured using the EORTC QLQ-C30 questionnaire. Secondary outcome measures were anxiety/depression measured using the Hospital Anxiety and Depression Scale (HADS), WHO performance status (PS), tumour progression assessed using RECIST criteria and tumour markers, survival and tolerance. RESULTS: Thirty-one patients were included (mean age: 64.3 years). Mean duration of treatment was 3.3 months (median: 2.1). QoL global health status improved significantly between baseline and week 8 (P < 0.001) and week 16 (P = 0.035), but was at the limit of significance (P = 0.057) at the end of the study. There was no significant change in anxiety/depression or PS during treatment. Ruta graveolens 9c had no obvious effect on tumour progression. Median survival was 6.7 months [95%CI: 4.8-14.9]. Ruta graveolens 9c was well-tolerated. CONCLUSION: Some patients treated with Ruta graveolens 9c had a transitory improvement in QoL, but the effectiveness of this treatment remains to be confirmed in further studies.

Depression assessment by oncologists and palliative care physicians.

OBJECTIVE: Depression is a frequent problem in cancer patients, which is known to reduce quality of life; however, many cancer patients with depression are not treated because of the difficulties in assessing depression in this population. Our aim was to evaluate and improve the depression assessment strategies of palliative care (PC) physicians and oncologists. METHOD: We invited all medical oncologists and PC physicians from three cancer centers to participate in this multicenter prospective study. They were asked to classify 22 symptoms (related and specific to depression in cancer patients, related but not specific, and unrelated) as "very important," "important," "less important," or "not important" for the diagnosis of depression in cancer patients, at three different time points (at baseline, after a video education program, and after 4 weeks). They were also asked to complete a questionnaire exploring physicians' perceptions of depression and of their role in its systematic screening. RESULTS: All 34 eligible physicians participated. Baseline performance was good, with >70% of participants correctly classifying at least seven of nine related and specific symptoms. We found no significant improvement in scores in the immediate and 4-week follow-up tests. Additionally, 24 (83%) and 23 (79%) participants expressed support for systematic depression screening and a role for oncologists in screening, respectively. SIGNIFICANCE OF RESULTS: Oncologists had good baseline knowledge about depression's main symptoms in cancer patients and a positive attitude toward being involved in screening. Underdiagnosis of depression is probably related to problems associated with the oncology working environment rather than the physicians' knowledge.

Treatment of metastatic breast cancer: a large observational study on adherence to French prescribing guidelines and financial cost of the anti-HER2 antibody trastuzumab.

OBJECTIVE: This observational study aimed at analyzing adherence to prescribing guidelines of anti-HER2 monoclonal antibody trastuzumab treatment for metastatic breast cancer. Efficacy and costs were also evaluated. METHODS: The adherence to the trastuzumab treatment plan was analyzed according to both the French postlicensing guidelines published in 2001 and clinical guidelines from the regional cancer network in a cohort of 131 consecutive patients. RESULTS: The level of appropriateness to the molecular target was very high (92% of the patients showed a positive HER2 status, defined as HER2 3+ confirmed by immunohistochemistry or 2+ confirmed by fluorescent in situ hybridization). The treatment plan was made according to the French postlicensing guidelines in 41 patients (31.3%) and to the regional clinical guidelines for 109 patients (83.2%). The main reason for the difference was the type of molecules authorized for combination to trastuzumab. The median overall survival of the studied population was 18.6 months and the median progression-free survival rate was 7.7 months. Up to death or end of the study, the overall cost for the treatment of breast cancer with trastuzumab per patient and per year was 47,832 euro. CONCLUSION: This quite low adherence of clinicians to the French postlicensing guidelines is in contrast with the high level of adherence to the regional clinical guidelines. The reason is that the latter are less rigid about previously received treatments and enlarge the potential associated cytotoxics to vinorelbine. This supports the French National Cancer Institute decision to get expert clinicians involved together with the French agency for sanitary security of health products and the high health authority in a common elaboration of guidelines.

[Targeted therapies in oncology]. / Nouvelles thérapeutiques ciblées en oncologie.

The development of anticancer targeted therapies is the result of a knowledge transfer from biology research to clinical practice. Indeed these drugs act on proliferation signal pathways involved in oncogenesis. Monoclonal antibodies (antiHER1 or cetuximab, antiHER2 or trastuzimab, antiVEGF or bevacizumab...) or inhibitor proteins (antiHER1 or cetuximab, antityrosine kinase c-Kit or imatinib...) are used in the treatment of several cancers types (breast, colon-rectum, lung, kidney...) alone or in association with chemotherapies since they improve patients' prognosis and survival. However additional clinical studies are still required to optimize their administration.