Clinical evidence supporting genomic tests in early breast cancer: Do all genomic tests provide the same information?

Breast cancer (BC) has historically been treated as a single disease entity; however, in the last decade, insights into its molecular heterogeneity have underpinned the development/commercialisation of several genomic tools whose goal is to guide patient management in early BC. These include the Oncotype DX® Breast Recurrence Score™ assay, MammaPrint®, Prosigna®, and EndoPredict®. Although these assays are similar in that they are all multigene assays reflecting risk of recurrence, they differ substantially in the technological platform used to measure gene expression; the number and identity of genes assessed; the patient populations used for development and validation; and the level of evidence supporting clinical utility. They also differ in the amount of evidence demonstrating their impact on treatment decisions and cost effectiveness in different countries. This review discusses these 4 assays, highlighting the clinical evidence that supports each of them, while focussing on the Recurrence Score assay. This assay has the greatest body of evidence supporting its clinical utility and decision impact/effectiveness, and currently is the only one validated as a predictor of response to adjuvant chemotherapy in hormone-receptor positive early BC patients treated with endocrine therapy and to be included as such in international/national BC treatment guidelines. The review also discusses ongoing prospective trials investigating the 4 assays, recent outcome studies, as well as analyses comparing different assays on the same tumour blocks.

Patients' experiences following breast cancer treatment: an exploratory survey of personal and work experiences of breast cancer patients from three European countries.

Improved treatments for early breast cancer have led to a significant increase in overall survival. While evidence regarding potential long-term sequelae of adjuvant treatments exists, relatively little research reports patients' own perceptions of change before and after adjuvant chemotherapy (AC). This study aimed to identify key ongoing issues associated with AC in daily life. An online survey developed for this study was completed by 198 women (mean age 49.7 years) in the UK, France and Germany who had AC 1-5 years previously for oestrogen receptor positive, HER2 negative early breast cancer. Women without AC and endocrine therapy, those treated with Trastuzumab or who had recurrent disease were excluded. A third of women who responded were currently unable to perform their former family role. The majority had needed support, particularly with child care, during treatment. While 54% were in full-time employment before diagnosis this had reduced to 32% following AC. Of those women still working, over half reported difficulties with tiredness or concentration. Most (85.8%) were satisfied with healthcare professionals' treatment information, but only 29.7% received information about returning to work. This exploratory survey highlights areas of women's lives affected 1-5 years following AC for early breast cancer. The impact on returning to work and issues surrounding childcare particularly, require further study.

Chemotherapy by the intravenous and intraperitoneal routes combined in ovarian cancer.

Intraperitoneal (ip) administration allows delivery of concentrations of cytotoxic drugs to the site of tumor development that could not be attained by the intravenous (iv) route. Rather than leaving ip delivery systems (Tenckhoff catheter, Port à Cath, etc.) in position for several months, with the attendant risk of complications, we prefer to use a simple needle for lumbar puncture and leave it in place between 1 and 2 hr at each infusion of chemotherapy. Results observed at second-look laparotomy in 31 patients with stage III (FIGO) common epithelial carcinoma, treated from January 1980 to December 1986, are reported after six to ten courses of ip and iv chemotherapy combined. In five patients in whom complete surgical excision had been possible, there was still complete remission (CR). In 26 patients in whom initial surgical excision had been incomplete, there was complete remission in 20 (76%). In the other 6 cases, there were small residual masses (incomplete remission), which could readily be excised by the surgeon. Following second-look laparotomy, these 6 patients received ip maintenance chemotherapy for a further 6 months. During follow-up periods of 22 to 105 months (average 45 months), 8 recurrences were observed (4 of them died); 23 of 31 patients are disease free. At 4 years, actuarial survival was 81.5% and actuarial disease-free survival was 66.2%.

Secondary cytoreductive surgery in ovarian cancer.

During the 8-year period from 1976 to 1984, 202 patients with a primary ovarian cancer underwent a second-look laparotomy at the Institut Gustave-Roussy (Villejuif). One hundred and nine patients had a macroscopic tumour, in 77 of which there was clinical evidence of disease before the laparotomy. Fifty-seven patients underwent an optimal resection of the tumour (largest residual tumour less than 2 cm) and 52 underwent non-optimal cytoreductive surgery or isolated biopsies. In 22 cases the optimal resection necessitated a bowel resection. Survival curves suggest: (1) that the removal of macroscopic residual disease does not improve life expectancy except in the cases of optimal resection without bowel resection. (2) When there is evidence of disease before the second-look operation the prognosis remains the same whatever the surgery performed.

[Sarcoma of the uterus. A clinical study apropos of 50 surgically treated cases at the Gustave Roussy Institute. Review of the literature]. / Sarcomes utérins. Etude clinique à propos de 50 cas opérés à l'Institut Gustave Roussy. Revue de la littérature.

From 1970 to 1987 fifty patients with uterine sarcoma who have been operated at the G. Roussy Institute (IGR) were studied. The histological material was reviewed according to the W.H.O. classification and the Hendrickson and Kempson's criteria. Staging was done on surgical and histological findings according to the pTNM classification of the UICC for endometrial carcinoma. There were 22 cases of heterologous malignant mixed müllerian tumor (MMT), 5 cases of homologous MMT, 20 cases of leiomyosarcoma (LS), 1 high grade stromal sarcoma, 1 low grade stromal sarcoma (stromal myosis (SM], 1 adenosarcoma. There were 22 cases of stage T1 T2, 23 cases of stage T3 T4 and 5 TX (first surgery outside IGR). Total hysterectomy with bilateral salpingo-oophorectomy was performed in 86% of the cases. Radiation therapy was performed in 26 cases mostly external pelvic irradiation associated with endobrachytherapy. "Cyvadic" combination chemotherapy was used in 16 cases associated with platinum in few cases. There were 2 postoperative deaths, 11 cases of progression and 37 cases of complete remission (CR). Of the 37 cases of CR, 10 patients are alive with NED 6 months to 10 years after diagnosis in 2 cases of MMT. 27 patients presented recurrence or metastasis. Of the 22 patients with pelvi-abdominal recurrence, 10 had debulking surgery (one total pelvic exenteration (PE), three posterior PE). Among them five are alive 14 to 78 months later (3 LS, 1 AS, 1 SM). Thirty percent of the patients developed lung metastasis. The overall five-year survival was 42 +/- 16% (28 patients) (Kaplan-Meier's method), similar to literature data.(ABSTRACT TRUNCATED AT 250 WORDS)