Utility values and its time to deterioration in breast cancer patients after diagnosis and during treatments.

BACKGROUND: The potential effects of breast cancer (BC) on health-related quality of life (HRQoL) should be considered in clinical and policy decision-making, as the economic burden of BC management is currently assessed. In the last decades, time-to-HRQoL score deterioration (TTD) has been proposed as an approach to the analysis of longitudinal HRQoL in oncology. The main objectives of the current study were to investigate the evolution of the utility values in BC patients after diagnosis and during follow-ups and to evaluate the TTD in utility values among women in all stages of BC. METHODS: Health-state utility values (HSUV) were assessed using the EuroQol 5-Dimension 3-Level at diagnosis, at the end of the first hospitalization and 3 and 6 months after the first hospitalization. For a given baseline score, HSUV was considered to have deteriorated if this score decreased by ≥ 0.08 points of the EQ-5D utility index score and ≥ 7 points of the EQ visual analogue scale. TTD curves were calculated using the Kaplan-Meier estimation method. RESULTS: Overall 381 patients were enrolled between February 2006 and February 2008. The highest proportions of respondents at the baseline and all follow-ups reporting some and extreme problems were in pain discomfort and anxiety/depression dimensions; more than 80% of patients experienced a deterioration in EQ-5D utility index score and EQ VAS score with a median TTD of 3.15 months and 6.24 Months, respectively. CONCLUSIONS: BC patients undergoing therapy need psychological support to cope with their discomfort, pain, depression, anxiety, and fear during the process of diagnosis and treatment to improve their QoL.

Impact of the occurrence of a response shift on the determination of the minimal important difference in a health-related quality of life score over time.

BACKGROUND: An important challenge of the longitudinal analysis of health-related quality of life (HRQOL) is the potential occurrence of a Response Shift (RS) effect. While the impact of RS effect on the longitudinal analysis of HRQOL has already been studied, few studies have been conducted on its impact on the determination of the Minimal Important Difference (MID). This study aims to investigate the impact of the RS effect on the determination of the MID over time for each scale of both EORTC QLQ-C30 and QLQ-BR23 questionnaires in breast cancer patients. METHODS: Patients with breast cancer completed the EORTC QLQ-C30 and the EORTC QLQ-BR23 questionnaires at baseline (time of diagnosis; T0), three months (T1) and six months after surgery (T2). Four hospitals and care centers participated in this study: cancer centers of Dijon and Nancy, the university hospitals of Reims and Strasbourg At T1 and T2, patients were asked to evaluate their HRQOL change during the last 3 months using the Jaeschke transition question. They were also asked to assess retrospectively their HRQOL level of three months ago. The occurrence of the RS effect was explored using the then-test method and its impact on the determination of the MID by using the Anchor-based method. RESULTS: Between February 2006 and February 2008, 381 patients were included of mean age 58 years old (SD = 11). For patients who reported a deterioration of their HRQOL level at each follow-up, an increase of RS effect has been detected between T1 and T2 in 13/15 dimensions of QLQ-C30 questionnaire, and 4/7 dimensions of QLQ-BR23 questionnaire. In contrast, a decrease of the RS effect was observed in 8/15 dimensions of QLQ-C30 questionnaire and in 5/7 dimensions of QLQ-BR23 questionnaire in case of improvement. At T2, the MID became ≥ 5 points when taking into account the RS effect in 10/15 dimensions of QLQ-C30 questionnaire and in 5/7 dimensions of QLQ-BR23 questionnaire. CONCLUSIONS: This study highlights that the RS effect increases over time in case of deterioration and decreases in case of improvement. Moreover, taking the RS into account produces a reliable and significant MID.

Item response theory and factor analysis as a mean to characterize occurrence of response shift in a longitudinal quality of life study in breast cancer patients.

BACKGROUND: The occurrence of response shift (RS) in longitudinal health-related quality of life (HRQoL) studies, reflecting patient adaptation to disease, has already been demonstrated. Several methods have been developed to detect the three different types of response shift (RS), i.e. recalibration RS, 2) reprioritization RS, and 3) reconceptualization RS. We investigated two complementary methods that characterize the occurrence of RS: factor analysis, comprising Principal Component Analysis (PCA) and Multiple Correspondence Analysis (MCA), and a method of Item Response Theory (IRT). METHODS: Breast cancer patients (n = 381) completed the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires at baseline, immediately following surgery, and three and six months after surgery, according to the "then-test/post-test" design. Recalibration was explored using MCA and a model of IRT, called the Linear Logistic Model with Relaxed Assumptions (LLRA) using the then-test method. Principal Component Analysis (PCA) was used to explore reconceptualization and reprioritization. RESULTS: MCA highlighted the main profiles of recalibration: patients with high HRQoL level report a slightly worse HRQoL level retrospectively and vice versa. The LLRA model indicated a downward or upward recalibration for each dimension. At six months, the recalibration effect was statistically significant for 11/22 dimensions of the QLQ-C30 and BR23 according to the LLRA model (p ≤ 0.001). Regarding the QLQ-C30, PCA indicated a reprioritization of symptom scales and reconceptualization via an increased correlation between functional scales. CONCLUSIONS: Our findings demonstrate the usefulness of these analyses in characterizing the occurrence of RS. MCA and IRT model had convergent results with then-test method to characterize recalibration component of RS. PCA is an indirect method in investigating the reprioritization and reconceptualization components of RS.

Diagnostic performance of one-step nucleic acid amplification for intraoperative sentinel node metastasis detection in breast cancer patients.

The purpose of this prospective multicenter study was to assess one-step nucleic acid amplification (OSNA) for intraoperative sentinel lymph node (SLN) metastasis detection in breast cancer patients, using final histology as the reference standard. OSNA results were also compared to intraoperative histology SLN evaluation and to standard clinicopathological risk markers. For this study, fresh SLNs were cut in four blocks, and alternate blocks were used for OSNA and histology. CK19 mRNA copy number was categorized as strongly positive, positive or negative. Positive histology was defined as presence of macrometastasis or micrometastasis. When discrepancies occurred, the entire SLNs were subjected to histological studies and the node lysates to additional molecular studies. Five hundred three SLN samples from 233 patients were studied. Mean time to evaluate two SLNs was 40 min. Sensitivity per patient was 91.4% (95% CI, 76.9-98.2%), specificity 93.3% (95% CI, 88.6-96.6%), positive likelihood ratio 13.7 and negative likelihood ratio 0.1. Sensitivity was 63.6% for frozen sections and 47.1% for touch imprint cytology. Both methods were 100% specific. Positive histology and positive OSNA were significantly associated with highest clinical stage, N1 status and vascular invasion; and OSNA results correlated with HER2/neu status and benefited patients with negative histology. These findings show that OSNA assay can allow detection of SLN metastasis in breast cancer patients intraoperatively with a good sensitivity, thus minimizing the need for second surgeries for axillary lymph node detection.

Time to deterioration in quality of life score as a modality of longitudinal analysis in patients with breast cancer.

PURPOSE: This prospective multicenter study explored different definitions of time to deterioration (TTD) in quality of life (QoL) scores, according to different cutoffs of the minimal clinically important difference (MCID) as a modality for longitudinal QoL assessment in breast cancer patients. METHODS: QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and BR-23 before surgery, after surgery, and 6 and 12 months later. The global health score, arm symptoms score (BRAS), and breast symptoms score were analyzed. For a given baseline score, QoL was considered to have deteriorated if this score decreased by ≥5 points at any time point after baseline. Analyses were repeated using an MCID of 10 points and taking the score after surgery as the reference score (to explore the occurrence of response shift). TTD was calculated using the Kaplan-Meier method and Cox regression was used to identify independent factors associated with TTD. RESULTS: Two hundred thirty-five patients underwent axillary lymph node dissection (ALND), 222 underwent sentinel lymph node biopsy (SLNB), and 61 underwent SLNB plus ALND. Patients who underwent SLNB had a significantly longer TTD for the BRAS dimension than those who underwent ALND. Cox multivariate analyses showed that treatment using SLNB and age >59 years were independently associated with longer TTD for the BRAS, whereas surgery elsewhere than at the Centre Georges François Leclerc was associated with a shorter TTD. CONCLUSION: Exploration of different definitions of TTD in QoL provides meaningful longitudinal QoL results for clinicians.

Long-term recurrence of secretory breast carcinoma with metastatic sentinel lymph nodes.

PURPOSE: Secretory carcinoma is a rare form of breast cancer most frequently encountered in children or young adults. Several cases have been described in adults with increased aggressiveness and a risk of metastases. CASE REPORT: We report here, in a 30-year-old woman, a case of local relapse and lymph node metastases occurring 16 years after the initial diagnosis of secretory carcinoma. CONCLUSION: We present the clinical, radiological and pathological findings that led to the diagnosis.

Sentinel lymph node biopsy in two Burgundy districts: prospective multicentric study on 528 breast cancers during the year 2005.

OBJECTIVES: Our purpose was to assess development of sentinel lymph node biopsy (SLNB) in two Burgundy districts during the year 2005. METHODS: All women undergoing breast surgery as primary care between 1 January 2005 and 1 January 2006 were eligible for inclusion. Eleven surgeons from five different breast-treatment centres took part in this prospective multicentric study. As our objective was to evaluate practices, patients were not randomized and surgeons were free to choose treatment patterns. RESULTS: The 528 enrolled cases account for 90% of all new breast cancers in 2005 in Cote d'Or and Saône et Loire. Half of these patients (286) fulfilled requirements for SLNB. The others (242) had primary full axillary clearance (AC). Four of our five centres offer double-detection of sentinel lymph nodes as well as intraoperative pathology examination. Most tumours were invasive ductal carcinomas, with an average size of 12 mm in the SLNB group (T1C) and 22 mm in the AC group (T2). Two or three lymph nodes were removed during each SLNB procedure. Whereas most SLNB studies report around 25% positive nodes, we barely recorded 18.5% (53 of our 256 patients). Moreover, 2/3 of these node-positive patients had optimal care since additional axillary clearance was done right away. CONCLUSION: Sentinel lymph node biopsy has become routine practice in our Burgundy area. It is mainly dedicated to early stage breast cancer with limited metastatic risk. Our surgeons follow the most recent guidelines and indications are the same regardless of treatment centre.

Evaluation of pelvic posterior exenteration in the management of advanced-stage ovarian cancer.

PURPOSE: The main aim of this study was to show the interest of pelvic posterior exenteration to obtain complete resection of the tumor in case of invasion of the rectum by contiguity in advanced-stage ovarian cancer. The secondary aim was to determine the morbidity of this surgery. METHODS: It is a multicentric, retrospective study of a series of 41 patients, who underwent posterior pelvectomy for advanced-stage ovarian cancer, over a period of 18 years, from July 1989 to July 2007. RESULTS: The surgery resulted in macroscopically complete resection in 19 patients (46.34%), a residual tumor <2 cm in 19 patients (46.34%) and >2 cm in 3 patients (7.32%). In 34 patients (34/41), digestive continuity with satisfactory anal sphincter function was restored immediately or in the short term. The mean delay to the start of complementary treatment was 36 days. Median overall survival was 33 months. CONCLUSION: The main aim of surgery for ovarian peritoneal carcinomatosis is to obtain a complete resection. In the case of direct invasion of the rectum by contiguity, when there is no cleavage plane between the uterus and the rectum, pelvic posterior exenteration is an effective method to achieve this objective. Morbidity is relatively high, but acceptable given the poor prognosis of this disease, the improved survival after surgery, and improvements in post-operative quality of life and functions.

Modified posterior pelvic exenteration for ovarian cancer.

INTRODUCTION: A modified posterior pelvic exenteration (MPE) might be needed to reach an optimal tumoral reduction. The issue of this study is to relate a multicentric experience of this kind of resection. MATERIALS: Three hundred five patients who needed an MPE were analyzed from 9 French cancer centers. One hundred sixty-eight MPEs were performed during initial surgery (55.1%), 69 during interval surgery (22.6%), 36 after chemotherapy (11.8%), and 32 for recurrences (10.5%). RESULTS: Three hundred two colorectal anastomoses were realized with a protective stoma in 59 (19.5%) of cases and a stoma closure in 76.5% (51). The rate of functional anastomosis was 96% (290/302). Complications occurred in 26.9% (82/305) of the patients, with a fistula in 25 (8.2%). The reintervention rate was 8.8% (27/305). The median length of hospitalization was 15 days. The absence of a macroscopic residual disease was obtained in 58% (173/303) of cases. A residual disease that was 1 cm or smaller was observed in 73 cases (24%) and 2 cm or smaller observed in 36 (11.9%). Postoperative chemotherapy was started with a median time of 32 days.Postoperative death occurred in 1 patient (0.33%). The survival rates were 62.7% and 27.6% at 2 and 5 years, respectively. With a multivariate analysis, the 2 significant prognostic factors were residual disease and time of surgery (P < 0.0001). CONCLUSIONS: A rectal invasion should not be an obstacle to reach the aim to obtain a macroscopic minimal residual disease or, if possible, the absence of one. An MPE is useful in those cases to reach optimal cytoreduction, with comparable results whatever the patient's age is. A temporary protective stoma should be considered only exceptionally.

[Plexiform schwannoma of the delto-pectoral area]. / Schwannome plexiforme profond de la région delto-pectorale gauche.

Plexiform schwannoma is a form of schwannoma which usually involves cutaneous tissues. It cannot be easily differentiated from malignant tumors, especially deep or cellular lesions. We report a deep plexiform schwannoma which we place among the various benign or malignant nerve sheath tumors, which may or may not develop within the context of genetic disease. Finally, the differential diagnoses are discussed. Recognition of the lesion is necessary for appropriate treatment.

3' Mutation of the APC gene and family history of FAP in a patient with apparently sporadic desmoid tumors.

Desmoid tumors may occur sporadically or as part of the extraintestinal manifestations of familial adenomatous polyposis. Different phenotypes have been described and some genotype-phenotype correlations have been raised, associated with different sites of germline mutations in the adenomatous polyposis coli (APC) gene. We report on a 42-year-old woman ascertained for a large desmoid tumor of the anterior chest wall with pleural involvement, which persistently recurred despite a decade of treatment including hormone therapy, chemotherapy, and surgery. Spontaneous disappearance of the tumor was later noted after 1 year without any treatment and confirmed after 4 years of regular follow-up. Repeated colonoscopies were normal in the proband and DNA sequencing showed a frameshift mutation due to a single adenosine deletion at position 5772 (codon 1924). This mutation, located in the exon 15 at the 3' end of the APC gene, leads to an unusual and late onset phenotype. The pedigree revealed other isolated or familial adenomatous polyposis-associated cases of desmoid tumors. This family report shows that a molecular analysis of the APC gene should be performed in familial desmoid tumors for accurate genetic counseling and follow-up.

Preventing lymphedema and morbidity with an omentum flap after ilioinguinal lymph node dissection.

BACKGROUND: Pedicled omentoplasty has been advocated to prevent the formation of lymphocysts and lymphedema after pelvic lymph node dissection, We evaluated the possible benefit of a pediculated omentoplasty placed in the groin for preventing complications after ilioinguinal lymph node dissection. METHODS: In this pilot study, we report a series of four women and three men with inguinal metastatic lymph nodes. Each was treated with a pediculated omentoplasty after groin dissection. We examined complications such as lymphedema, lymphorrhea, wound breakdown, skin necrosis, and lymphocysts. RESULTS: Only one wound breakdown with skin necrosis was observed, and it healed satisfactorily in 10 days without exposing the femoral vessels. No lymphocele or infectious complications occurred, even though no antibiotic prophylaxis was used. Midthigh circumference increase ranged from 1.5 to 7 cm in four cases but remained asymptomatic. Furthermore, lymphedema of the lower limb decreased in the three remaining patients, who previously had an enlargement of the thigh. No evidence of peritoneal carcinomatosis was noted during the 4-month follow-up. CONCLUSIONS: Pedicled omentoplasty seemed to facilitate the absorption or transport of lymph fluids and resulted in less lymphedema in the lower limb even after radiotherapy. Pedicled omentoplasty reduces both short-term and long-term postoperative complications without affecting treatment outcome and could even be considered as a safe and effective therapy for lymphedema of the lower extremity.