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1.
Curr Oncol ; 31(2): 801-817, 2024 02 01.
Article in English | MEDLINE | ID: mdl-38392053

ABSTRACT

OBJECTIVE: This study investigated if fear of cancer recurrence (FCR) levels and the proportion of women having a clinical level of FCR differed by whether women had or had not experienced disruptions in their cancer tests and treatments due to the pandemic. METHODS: We conducted a mixed-methods study between November 2020 and March 2021 among women diagnosed with breast cancer in the previous five years at the time of their entry in the study. Women completed a questionnaire online assessing disruptions in breast cancer tests and treatments due to the pandemic and the severity subscale of the Fear of Cancer Recurrence Inventory. Semi-structured interviews were also conducted with a subsample of 24 participants and were thematically analyzed. RESULTS: The proportion of patients with a clinical level of FCR was significantly higher among those who experienced the postponement or cancellation of diagnostic and disease progression tests (e.g., blood tests, X-rays, or magnetic resonance imaging; adjusted PR = 1.27 95% CI = 1.13-1.43). Qualitative findings suggest that FCR was exacerbated by the pandemic context. In particular, perceived or actual barriers to care access due to the pandemic were identified as significant FCR-enhancing factors. CONCLUSIONS: These results highlight the need to keep diagnostic and progression tests as timely as possible to prevent increases in FCR levels and offer counselling about FCR when postponing or cancellation are inevitable.


Subject(s)
Breast Neoplasms , COVID-19 , Humans , Female , Breast Neoplasms/therapy , Breast Neoplasms/pathology , Pandemics , Neoplasm Recurrence, Local , Survivors , COVID-19/epidemiology , Fear
2.
Breast J ; 2024: 5920505, 2024.
Article in English | MEDLINE | ID: mdl-38223556

ABSTRACT

Aim: To examine the clinical management of metaplastic breast cancer (MeBC), particularly the role of chemotherapy. Methods: This retrospective study included patients with MeBC (n = 73) from a tertiary breast cancer center: the "Centre des Maladies du Sein of the CHU de Québec-Université Laval." The specimens were reviewed by two pathologists. Patient and tumor characteristics, systemic therapy (neoadjuvant and adjuvant), disease-free survival (DFS), and overall survival (OS) were recorded. Results: The median follow-up was 57.2 months. The mean tumor size was 39.5 ± 32.1 (range, 1-200) mm. Most were in grade 3 (75.3%), without evidence of clinical nodal involvement (75.3%), and triple-negative (79.5%). Chemotherapy was given to 49 (67.1%) patients. Thirty-seven patients (50.7%) underwent a mastectomy, and 22/37 (59.5%) received radiotherapy. Adjuvant chemotherapy was given to 36 patients (49.3%), and nine (12.3%) patients were treated with neoadjuvant chemotherapy. The 5-year OS and DFS rates were 60.2% and 66.8%. Among the nine patients who received neoadjuvant chemotherapy, three (33.3%) achieved a partial response, three (33.3%) had stable disease, and three (33.3%) had disease progression. The use of chemotherapy, especially in the adjuvant setting, had a significant positive effect on 5-year OS (P=0.003) and 5-year DFS (P=0.004). Nodal involvement was associated with worse OS (P=0.049) but similar DFS (P=0.157). Lumpectomy was associated with better 5-year OS (P < 0.0001) and DFS (P=0.0002) compared with mastectomy. Conclusion: MeBC represents a rare heterogeneous group of malignancies with poor prognosis. Adjuvant chemotherapy was associated with improved OS and DFS. Patients should be carefully selected for neoadjuvant chemotherapy.


Subject(s)
Breast Neoplasms , Carcinoma , Humans , Female , Breast Neoplasms/pathology , Mastectomy , Retrospective Studies , Radiotherapy, Adjuvant , Disease-Free Survival , Chemotherapy, Adjuvant , Carcinoma/surgery , Neoadjuvant Therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Prognosis
3.
Ann Surg Oncol ; 29(4): 2202-2208, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34825283

ABSTRACT

BACKGROUND: Data on the benefits of preoperative prophylactic antibiotics for breast surgery are conflicting, and there is no specific guideline for their use in wire-localized lumpectomy. PATIENTS AND METHODS: This is a proof-of-concept, single-blind randomized controlled trial carried out from April 2018 to June 2019 at the Centre des Maladies du Sein du CHU de Québec - Université Laval. The objectives were to determine whether a single dose of preoperative antibiotics reduces surgical site infection (SSI) after wire-localized lumpectomy and to identify the risk factors for SSI. The patients were randomized to receive preoperative prophylactic antibiotics or not. SSI was defined by positive breast wound cultures, abscess drainage, and/or antibiotics given for clinical signs of breast infection within 30 days of the operation. This study was registered with ClinicalTrials.gov, NCT04818931. RESULTS: A total of 330 patients were enrolled. Eighteen patients were excluded. The SSI rate was 3.1% (5/160) in the antibiotic group versus 5.9% (9/152) in the control group (p = 0.28). Only obesity was a significant risk factor for SSI. All cases of SSI were treated routinely with antibiotics; one patient required wound re-opening. None of the SSIs delayed the adjuvant treatment. CONCLUSION: Preoperative antibiotic prophylaxis does not significantly decrease the occurrence of breast SSI. It is safe to omit prophylactic antibiotics for a wire-localized lumpectomy. This could also decrease the treatment costs and avoid unnecessary side effects.


Subject(s)
Mastectomy, Segmental , Surgical Wound Infection , Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis/adverse effects , Humans , Mastectomy, Segmental/adverse effects , Single-Blind Method , Surgical Wound Infection/epidemiology , Surgical Wound Infection/etiology , Surgical Wound Infection/prevention & control
4.
Cancers (Basel) ; 13(11)2021 May 31.
Article in English | MEDLINE | ID: mdl-34072979

ABSTRACT

Medical genetic services are facing an unprecedented demand for counseling and testing for hereditary breast and ovarian cancer (HBOC) in a context of limited resources. To help resolve this issue, a collaborative oncogenetic model was recently developed and implemented at the CHU de Québec-Université Laval; Quebec; Canada. Here, we present the protocol of the C-MOnGene (Collaborative Model in OncoGenetics) study, funded to examine the context in which the model was implemented and document the lessons that can be learned to optimize the delivery of oncogenetic services. Within three years of implementation, the model allowed researchers to double the annual number of patients seen in genetic counseling. The average number of days between genetic counseling and disclosure of test results significantly decreased. Group counseling sessions improved participants' understanding of breast cancer risk and increased knowledge of breast cancer and genetics and a large majority of them reported to be overwhelmingly satisfied with the process. These quality and performance indicators suggest this oncogenetic model offers a flexible, patient-centered and efficient genetic counseling and testing for HBOC. By identifying the critical facilitating factors and barriers, our study will provide an evidence base for organizations interested in transitioning to an oncogenetic model integrated into oncology care; including teams that are not specialized but are trained in genetics.

5.
JAMA Oncol ; 6(3): 367-374, 2020 03 01.
Article in English | MEDLINE | ID: mdl-31566680

ABSTRACT

Importance: A high 21-gene recurrence score (RS) by breast cancer assay is prognostic for distant recurrence of early breast cancer after local therapy and endocrine therapy alone, and for chemotherapy benefit. Objective: To describe clinical outcomes for women with a high RS who received adjuvant chemotherapy plus endocrine therapy in the TAILORx trial, a population expected to have a high distant recurrence rate with endocrine therapy alone. Design, Setting, and Participants: In this secondary analysis of data from a multicenter randomized clinical trial, 1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100 were prospectively assigned to receive adjuvant chemotherapy in addition to endocrine therapy. The analysis was conducted on May 12, 2019. Interventions: The adjuvant chemotherapy regimen was selected by the treating physician. Main Outcomes and Measures: Freedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS]). Results: Among the 9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100. The most common chemotherapy regimens included docetaxel/cyclophosphamide in 589 (42%), an anthracycline without a taxane in 334 (24%), an anthracycline and taxane in 244 (18%), cyclophosphamide/methotrexate/5-fluorouracil in 52 (4%), other regimens in 81 (6%), and no chemotherapy in 89 (6%). At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%). Conclusions and Relevance: The estimated rate of freedom from recurrence of breast cancer at a distant site in women with an RS of 26 to 100 treated largely with taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy in the prospective TAILORx trial was 93% at 5 years, an outcome better than expected with endocrine therapy alone in this population. Trial Registration: ClinicalTrials.gov identifier: NCT00310180.


Subject(s)
Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/genetics , Chemotherapy, Adjuvant , Neoplasm Recurrence, Local/genetics , Adult , Aged , Anthracyclines/therapeutic use , Bridged-Ring Compounds/therapeutic use , Cyclophosphamide/therapeutic use , Docetaxel/therapeutic use , Female , Fluorouracil/therapeutic use , Humans , Methotrexate/therapeutic use , Middle Aged , Taxoids/therapeutic use , Treatment Outcome , Young Adult
7.
J Surg Oncol ; 117(6): 1137-1143, 2018 May.
Article in English | MEDLINE | ID: mdl-29205352

ABSTRACT

BACKGROUND AND OBJECTIVES: Pure tubular carcinomas (TC) of the breast are generally considered to have an excellent prognosis. This study aimed to analyze the characteristics and survival of patients with TC. METHODS: This was a retrospective study conducted at the CHU de Québec-Université Laval. Databases were searched for all cases treated between April 1997 and December 2010. Survival was retrieved from the Province of Quebec Ministry of Health. Follow-up was censored on December 31, 2011. Overall survival (OS) was compared to patients with invasive ductal carcinoma (ICD) matched for age, tumor size, lymph node involvement, year of diagnosis, ER, PgR, and HER2, histological grade, lymphovascular invasion, and chemotherapy. RESULTS: The frequency of TC was 2.9% (n = 223/7563). Tumors size was 7.4 ± 8.8 mm, without lymphovascular invasion (95.1%), ER-positive (98.2%), PgR-positive (69.5%), and HER2-negative (100%). Patients were followed up for 7.1 ± 2.7 years. The actuarial 13-year OS was 89.0% for TC, compared to 85.8% for IDC (P = 0.13). For TC, the 13-year OS was 95.8% in NO patients compared to 90.0% for N1-3 (P = 0.01). CONCLUSION: Despite the general popular belief that patients with TC fare better than patients with IDC, the 13-year OS of TC was similar to that of grade I IDC.


Subject(s)
Adenocarcinoma/mortality , Breast Neoplasms/mortality , Carcinoma, Ductal, Breast/mortality , Adenocarcinoma/pathology , Adenocarcinoma/surgery , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/pathology , Carcinoma, Ductal, Breast/surgery , Female , Follow-Up Studies , Humans , Lymphatic Metastasis , Middle Aged , Prognosis , Receptor, ErbB-2/metabolism , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism , Retrospective Studies , Survival Rate
8.
Breast ; 35: 8-13, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28624715

ABSTRACT

BACKGROUND: Physical activity improves the quality of life of cancer survivors, but whether there is a difference between individual vs. group physical activity is unknown. OBJECTIVES: To compare fatigue at 12 weeks in breast cancer survivors after participation in a program of group vs. individual video-assisted physical activity. METHODS: This was a randomized phase II pilot study carried out in breast cancer survivors at a tertiary breast cancer center. Eligible patients were randomized to individual or group 12-week physical activity program. The primary outcome was fatigue (FACT-F). Aerobic capacity (6-min walk test), muscular strength, and quality-of-life (FACT-G and FACT-B) were assessed. Because of poor accrual, 200 consecutive breast cancer patients were surveyed about their physical activity habits to assess reasons for low recruitment. RESULTS: For all participants (n = 26; n = 12 for group vs. n = 14 for individual), there were some improvement in FACT-F, FACT-G, FACT-B, physical activity level, aerobic capacity, and shoulder strength. Among the 200 patients surveyed, 58% were interested to increase their physical activity level, 15% declared that they were already exercising enough, 9% declared being unable to, 3% declared having no time, and 2% declared having no interest, and other reasons (13%). Among the 200 patients surveyed, 25% preferred in group, 57% preferred alone, and 18% had no preference. CONCLUSION: Low recruitment precluded conclusions about the efficacy of physical activity practiced in group vs. individually, but both groups derived a benefit. Low willingness to change exercising habits could be the biggest barrier to physical activity in breast cancer survivors.


Subject(s)
Breast Neoplasms/therapy , Cancer Survivors/psychology , Exercise/psychology , Fatigue/prevention & control , Quality of Life/psychology , Adult , Breast Neoplasms/complications , Fatigue/etiology , Female , Humans , Middle Aged , Pilot Projects , Treatment Outcome
10.
Breast J ; 23(3): 315-322, 2017 May.
Article in English | MEDLINE | ID: mdl-27901301

ABSTRACT

The surgical management of phyllodes tumors (PTs) is still controversial. Some studies have suggested surgical margins ≥1 cm, but recent studies suggested that negative margins could be appropriate regardless of their width. To evaluate recurrence rates of PTs following surgery according to margins. Retrospective study of women who attended a tertiary breast cancer reference center between 1998 and 2010: 142 patients with a PT diagnosis, either at minimally invasive breast biopsy or at surgery, were identified. Clinical, pathologic and follow-up characteristics were assessed. Among 140 patients who underwent surgery, 64.3% of biopsies accurately predicted the final PT diagnosis at surgery. Forty-two (42/87, 48.3%) PTs had positive margins. Twenty-one (21/42, 50.0%) patients had a surgical revision of margins. Only one (1/42, 2.4%) had margins greater or equal to 1 cm. After a median follow-up of 1.29 years in benign PTs, 4.99 years in borderline PTs, and 5.42 years in malignant PTs, there were five local recurrences, three in originally benign PTs and two in borderline PTs. All were managed with surgery. Four had initial margins ≤1 mm. One patient with borderline PT had a local recurrence and later progressed to regional recurrence and metastasis. Free surgical margins are necessary to treat PT, and margins of at least 1 mm might be sufficient to prevent recurrence. Core needle biopsy might not be the best diagnostic tool for PTs.


Subject(s)
Breast Neoplasms/surgery , Margins of Excision , Phyllodes Tumor/surgery , Adult , Aged , Biopsy, Fine-Needle/statistics & numerical data , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/epidemiology , Breast Neoplasms/pathology , Female , Follow-Up Studies , Humans , Mastectomy/statistics & numerical data , Middle Aged , Neoplasm Recurrence, Local/pathology , Phyllodes Tumor/diagnostic imaging , Phyllodes Tumor/epidemiology , Phyllodes Tumor/pathology , Quebec/epidemiology
11.
J Surg Oncol ; 114(5): 543-547, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27406466

ABSTRACT

BACKGROUND AND OBJECTIVES: Breast invasive ductal carcinoma (IDC) and invasive lobular carcinoma (ILC) have different metastatic patterns, but the exact pattern of metastases from ILC is poorly known. This study aimed to determine the frequency of ILC metastases in atypical locations, with an emphasis on gastric metastases. METHODS: Patients with ILC treated at the Saint-Sacrement Hospital (Quebec City, Canada) and the Maisonneuve-Rosemont Hospital (Montreal, Canada) between January 2003 and December 2009 were retrospectively reviewed. Demographic, clinical, and follow-up data were retrieved from the medical charts. Metastases that were diagnosed during follow-up were recorded. RESULTS: Among the 481 patients with ILC, 74 (15.4%) were diagnosed with metastases after a median follow-up of 46 months. Among these 74 patients, 41.9% had metastases in atypical sites. Five patients were diagnosed with histologically confirmed gastric metastases of ILC. CONCLUSION: Metastases of breast ILC to atypical sites might be more frequent than previously reported. Clinicians should keep a high level of suspicion when a patient with a history of ILC develops digestive symptoms. It is important to differentiate metastases from a primary GI tumor by using immunohistochemical markers. J. Surg. Oncol. 2016;114:543-547. © 2016 Wiley Periodicals, Inc.


Subject(s)
Breast Neoplasms/pathology , Carcinoma, Lobular/secondary , Stomach Neoplasms/secondary , Adult , Aged , Canada , Carcinoma, Lobular/epidemiology , Female , Humans , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Retrospective Studies , Stomach Neoplasms/epidemiology
12.
Breast J ; 22(2): 173-9, 2016.
Article in English | MEDLINE | ID: mdl-26662058

ABSTRACT

Management of pure mucocele-like lesion (MLL) diagnosed on percutaneous breast biopsy (PBB) is controversial. To assess surgical upgrade rate and clinical outcome of pure MLL obtained as sole diagnosis on PBB. Patients diagnosed with a MLL as the most advanced lesion on PBB from April 1997 to December 2010 were reviewed for radiologic presentation, biopsy technique, and pathologic and clinical outcomes. Of the 21,340 image-guided PBB performed during the study period, 50 women with 51 MLL (0.24%) were identified. Mean age was 53.1 ± 7.7 years. Radiologic findings were mostly microcalcifications (n = 47, 92.2%). Stereotactic PBB was performed for 49 lesions (96.1%). Surgery was performed shortly after biopsy in 35 women, with benign final pathology in 33, and upgrade to ductal carcinoma in situ (DCIS) in two patients (2/35, 5.7%). Mean follow-up was 4.2 ± 2.5 years (3.7 ± 2.1 years for surgical patients; 5.9 ± 2.9 years for follow-up only patients); three women were lost to follow-up (3/50). Three invasive cancers (3/47, 6.4%) were diagnosed 1.2, 1.2, and 2.8 years after biopsy: two in surgical patients, and one in a follow-up only patient. No cancer occurred at the same site as the original MLL. Pure MLL lesion of the breast is a rare entity and is mostly associated with a benign outcome. We observed an upgrade to DCIS slightly superior to 5%, but no invasive cancer. It is therefore unclear if these lesions should be excised or clinically and radiologically followed up when such lesions are found at PBB.


Subject(s)
Biopsy/methods , Breast Diseases/pathology , Breast Diseases/surgery , Breast Neoplasms/pathology , Calcinosis/pathology , Female , Follow-Up Studies , Humans , Middle Aged , Mucocele/pathology , Retrospective Studies , Stereotaxic Techniques , Treatment Outcome
13.
J Oncol Pract ; 11(3): e296-303, 2015 May.
Article in English | MEDLINE | ID: mdl-25980018

ABSTRACT

PURPOSE: Choosing Wisely Canada, modeled after Choosing Wisely in the United States, is intended to identify low-value or potentially harmful practices relevant to the Canadian health care environment. Our objective was to use multidisciplinary, pan-Canadian, physician-based consensus to identify a list of low-value or harmful cancer practices frequently used in Canada. METHODS: A Task Force convened by the Canadian Partnership Against Cancer included physician representation from the Canadian Society of Surgical Oncology, Canadian Association of Medical Oncologists, and Canadian Association of Radiation Oncology, and an expert advisor. The methodology included four phases: identify potentially relevant items, develop a long list, refine and reduce the long list to a short list, and select and endorse a final list. A framework-driven consensus process and a series of electronic surveys and voting processes were used to capture consensus. RESULTS: Sixty-six potentially relevant cancer-related practices were identified. The long list (41 practices) was reduced to a short list of 19 practices. Of the 10 practices on the final list, five are completely new, and five are revisions or adaptations of practices from previous US society lists. Six of the 10 involve multiple disease sites, and four are disease-site specific. One relates to diagnosis, six relate to treatment, two relate to surveillance/survivorship, and one practice spans the cancer care continuum. CONCLUSION: The cancer list was developed in partnership with the Canadian Society of Surgical Oncology, Canadian Association of Medical Oncologists, and Canadian Association of Radiation Oncology. Using knowledge translation and exchange efforts, this list should empower patients with cancer and physicians to assist in a targeted conversation about the appropriateness and quality of individual patient care.


Subject(s)
Medical Oncology/methods , Neoplasms/therapy , Patient Safety , Practice Patterns, Physicians' , Process Assessment, Health Care , Unnecessary Procedures , Advisory Committees , Canada , Consensus , Cooperative Behavior , Delphi Technique , Humans , Interdisciplinary Communication , Medical Oncology/standards , Neoplasms/diagnosis , Patient Safety/standards , Practice Patterns, Physicians'/standards , Process Assessment, Health Care/standards , Quality Improvement , Quality Indicators, Health Care , Risk Assessment , Risk Factors , Treatment Outcome , Unnecessary Procedures/standards
14.
Breast ; 23(4): 385-92, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24679829

ABSTRACT

Objectives of the study were to measure recruitment rates in clinical trials and to identify patients, physicians or trials characteristics associated with higher recruitment rates. Among patients who had a clinical trial available for their cancer, 83.5% (345/413) met the eligibility criteria to at least one clinical trial. At least one trial was proposed to 33.1% (113/341) of the eligible patients and 19.7% (68/345) were recruited. Overall recruitment was 16.5% (68/413). In multivariate analyses, trial proposal and enrollment were lower for elderly patients and higher in high cancer stages. Trials from pharmaceutical industry had higher recruitment rates and trials testing hormonal therapy enrolled more patients. Breast cancer patients' accrual to a clinical trial could be improved by trying to systematically identify all eligible patients and propose a trial to those eligible and to whom the treatment is planned to be equivalent to the standard arm of the trial.


Subject(s)
Breast Neoplasms/therapy , Clinical Trials as Topic , Patient Selection , Adolescent , Adult , Age Factors , Aged , Breast Neoplasms/pathology , Cohort Studies , Female , Humans , Middle Aged , Neoplasm Staging , Retrospective Studies , Young Adult
15.
Anticancer Res ; 34(3): 1183-91, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24596358

ABSTRACT

BACKGROUND/AIM: Ductal carcinoma in situ (DCIS) is a non-invasive malignant breast lesion. Patients diagnosed with a DCIS on percutaneous biopsy usually undergo resection, and the final pathology may reveal that the lesion was in fact invasive (upgrading at surgery), this leading to treatment strategy change during its course. The aim of the present study was to identify factors associated with DCIS-upgrading to invasive carcinoma at surgery, and to identify a subgroup of patients more likely to have an invasive cancer. PATIENTS AND METHODS: A retrospective study was performed in patients diagnosed with DCIS on percutaneous biopsy between April 1997 and December 2010. Based on available data and on previous studies, 21 clinical, radiological and pathological variables were evaluated using univariate analyses. Variables identified in univariate analyses, when p≤0.10, were included in a multivariate model. RESULTS: Among 608 DCIS lesions, 177 (29.1%) were invasive carcinomas after surgery. Using univariate analyses, core needle biopsy (odds ratio (OR)=1.8), physical symptoms (OR=2.9), palpable masses (OR=4.1), number of specimen obtained (1-9 cores, OR=2.2) and a measurable mammographic lesion (OR=1.7) were significantly associated with upgrading at surgery. However, using multivariate analysis, no factor was significantly associated. CONCLUSION: No characteristic was identified to be independently associated with DCIS upgrading at surgery, and no sub-group of patients could be identified in whom the appropriate surgery could have been performed first.


Subject(s)
Biopsy, Needle/methods , Breast Neoplasms/diagnosis , Carcinoma, Ductal, Breast/pathology , Carcinoma, Intraductal, Noninfiltrating/diagnosis , Aged , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/surgery , Carcinoma, Intraductal, Noninfiltrating/surgery , Female , Follow-Up Studies , Humans , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Prognosis , Prospective Studies , Retrospective Studies
16.
Ann Pharmacother ; 48(4): 447-55, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24321851

ABSTRACT

BACKGROUND: Generic formulations are not necessarily identical to the original in terms of efficacy and adverse events. Generic docetaxel has been available in Canada since 2011. OBJECTIVE: To compare the occurrence of grade III to IV adverse events between original docetaxel and a generic formulation in breast cancer patients. METHODS: A consecutive series of 400 patients were assessed retrospectively: 200 who received the original docetaxel and 200 who received a generic formulation. Patients who received both formulations or received their chemotherapy outside our center were excluded. The primary outcome was the occurrence of grade III to IV adverse events related to docetaxel (febrile neutropenia, hand and foot syndrome, intestinal perforation, thrombotic event, and death). RESULTS: Three hundred-sixty-four patients were available for analysis (182/group). The use of a granulocyte colony-stimulating factor (G-CSF) was more frequent in the generic group (44.5% vs 28.8%), as well as treatment discontinuation (26.4% vs 14.8%). The occurrence of grade III to IV febrile neutropenia, hand and foot syndrome, intestinal perforation, thrombotic event, and docetaxel-related deaths were similar between the 2 formulations. However, grade IV febrile neutropenia was more frequent with the generic formulation (78.8% vs 56.3%). Limitations were the retrospective nature of the study and the variety of chemotherapy regimens. CONCLUSION: Adverse events occurrence was similar between the 2 formulations. However, febrile neutropenia was more serious with generic docetaxel, despite increased G-CSF use. Results suggest that the studied generic formulation may be safe, but more caution during treatments might be warranted, especially concerning febrile neutropenia events.


Subject(s)
Antineoplastic Agents/adverse effects , Breast Neoplasms/drug therapy , Drugs, Generic/adverse effects , Taxoids/adverse effects , Aged , Anecdotes as Topic , Chemotherapy-Induced Febrile Neutropenia/drug therapy , Chemotherapy-Induced Febrile Neutropenia/etiology , Docetaxel , Female , Granulocyte Colony-Stimulating Factor/adverse effects , Humans , Middle Aged , Retrospective Studies
17.
Bull Cancer ; 100(3): 201-11, 2013 Mar.
Article in French | MEDLINE | ID: mdl-23501099

ABSTRACT

UNLABELLED: Prophylactic mastectomy is an effective, although controversial strategy to reduce the risk of breast cancer in women carrying a BRCA1/2 mutation. A multidisciplinary pre- and post-operative clinical management is recommended for women who consider or undergo this surgery, because of its radical and irreversible nature as well as its possible impact on quality of life. OBJECTIVE: This study aims to report on the experience of patients having undergone prophylactic mastectomy within a medical setting offering such a clinical management. METHODS: A retrospective qualitative study was conducted with patients having had a prophylactic mastectomy between 2002 and 2006 at the centre des maladies du sein Deschênes-Fabia (CMSDF) in Quebec City. Fifteen women were interviewed and the narratives were analyzed using thematic content analysis method. RESULTS: The participants generally appreciated the multidisciplinary approach that was used at the CMSDF and believed it was necessary. Improvements were suggested regarding information and post-surgical medical follow-up, some of which are now implemented. CONCLUSION: The study results confirm the utility and the acceptability of a multidisciplinary clinical follow-up for women who undergo prophylactic mastectomy.


Subject(s)
Breast Neoplasms/prevention & control , Mastectomy , Adult , Breast Neoplasms/genetics , Breast Neoplasms/psychology , Cancer Care Facilities , Female , Genes, BRCA1 , Genes, BRCA2 , Humans , Mastectomy/psychology , Middle Aged , Mutation/genetics , Patient Care Team , Patient Education as Topic/standards , Patient Satisfaction , Postoperative Care/standards , Qualitative Research , Quality Improvement/standards , Quality of Life , Quebec , Retrospective Studies
18.
Clin Trials ; 9(5): 652-9, 2012 Oct.
Article in English | MEDLINE | ID: mdl-23060323

ABSTRACT

BACKGROUND: Clinical trial recruitment can be impeded by eligibility criteria being too numerous or too restrictive. PURPOSE: This study's principal objective was to determine whether a specific category of eligibility criteria could be identified as a major barrier to patient enrollment. METHODS: Nine phase II or III clinical trials, opened between June 2004 and July 2008, were selected. A retrospective cohort of women diagnosed with invasive, nonmetastatic breast cancer and potentially eligible for these clinical trials was used. All eligibility criteria were sorted into the following categories: definition of disease, precision, safety, ethical and legal, or administrative. A total of 985 patient-trials were evaluated, defined as the experimental unit since one patient could be eligible to more than one trial. Proportions of cases with 'not met' eligibility criteria were assessed for each category in each trial. RESULTS: Two clinical trials had a 'not met' subcategory criterion of over 20%. 'Pathology' and 'consent' subcategory criteria were 'not met' in 24.2% and 92.7% of cases for the NEOCAN and NCIC CTG MA.27 trials, respectively. NCIC CTG MA.27 had the highest proportion of 'not met' subcategory due to an inclusion criterion requiring participation to two companion studies. National Surgical Adjuvant Breast and Bowel Project (NSABP) B-38 had a proportion of 18.8% of cases 'not meeting' the receptor status subcategory criterion. All other subcategories of eligibility criteria assessed were 'not met' by less than 15% of patients. Overall, few subcategories had over 10% of ineligible patients. LIMITATIONS: Many eligibility criteria were considered 'nonevaluable' because the information evaluated would have required additional procedures not performed as part of the general practice. CONCLUSION: The subjects from the study population are not precluded from entry in a trial because of stringent eligibility criteria. Eligibility criteria should reflect as much as possible the whole population to whom the treatment will be offered, with the exception of drugs targeting a specific receptor or pathway where only a subpopulation is hypothesized to benefit from the therapy. In the breast cancer clinical trials evaluated for the present study, no criterion precluding recruitment was shared by many or all trials and no specific eligibility criterion was consistently the reason for patients' ineligibility.


Subject(s)
Breast Neoplasms/therapy , Clinical Trials, Phase II as Topic/methods , Clinical Trials, Phase III as Topic/methods , Neoadjuvant Therapy/methods , Patient Selection , Randomized Controlled Trials as Topic/methods , Age Factors , Female , Humans , Neoplasm Staging , Retrospective Studies
19.
Radiology ; 263(1): 43-52, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22344406

ABSTRACT

PURPOSE: To determine the type of mammographic abnormality leading to needle biopsy of lobular neoplasia (LN) and define the clinical evolution of low-risk LN lesions diagnosed at needle biopsy but not surgically removed. MATERIALS AND METHODS: This study was approved by the institutional review board, and the requirement to obtain informed consent was waived. Among 16 945 needle biopsies performed between April 1998 and August 2008, LN was determined to be the most suspicious lesion in 352 samples (2.1%) (pleomorphic and necrotic forms were excluded). Among 299 pure LN lesions that were not surgically removed, follow-up was available for 276 lesions in 275 women. RESULTS: Needle biopsy was performed because of mammographic calcifications in 215 of the 276 lesions (77.9%) and because of mammographic masses in 35 (12.7%). The mean follow-up was 5.0 years ± 2.4 (range, 0.6-12.2 years). All 275 women underwent one mammographic follow-up, 205 (74.5%) underwent a second mammographic follow-up, and 147 (53.5%) underwent a third mammographic follow-up. Cancer was diagnosed in 27 of the 275 cases (9.8%) after a mean of 3.9 years ± 2.6 (range, 1.2-10.8 years). Only three cancers (1.1%) occurred in the same breast quadrant as the one originally diagnosed with LN at needle biopsy. CONCLUSION: Lumpectomy of pure LN lesions may not prevent malignancy in most cases. Consequently, women with pure LN of a low-risk type diagnosed at needle biopsy are strongly encouraged to undergo a yearly breast clinical examination and yearly mammographic follow-up to detect an eventual cancer in its early stages.


Subject(s)
Biopsy, Needle , Breast Neoplasms/pathology , Carcinoma, Lobular/pathology , Neoplasm Recurrence, Local/pathology , Adult , Aged , Breast Neoplasms/diagnostic imaging , Carcinoma, Lobular/diagnostic imaging , Confidence Intervals , Female , Follow-Up Studies , Humans , Mammography , Middle Aged , Neoplasm Recurrence, Local/diagnostic imaging , Retrospective Studies
20.
Fam Cancer ; 11(1): 27-32, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22080962

ABSTRACT

Adherence to mammographic screening recommendations following BRCA1/2 testing is generally assessed through self-reports. However, the validity of self-reported mammography by women who had undergone BRCA1/2 genetic testing is still unknown. This study aimed to assess the validity of self-reported mammography use in the past 12 months among women who had undergone BRCA1/2 testing. Using a self-administered questionnaire, 307 women who never had cancer were asked 1 year following BRCA1/2 test result disclosure whether they undergone a mammography in the past 12 months. For each participant, this information was compared to that provided by the Quebec Health Insurance Board administrative data set for mammography claims during the same period, here considered as the gold standard. Sensitivity (Sn), specificity (Sp), predictive values, and Cohen's kappa (κ) were calculated. The robustness of these estimates was assessed using sensitivity analysis in which we varied the administrative data time lapses up to 18 months. Overall, the agreement between self-reports and administrative data was 88% (κ = 0.74). Among the 180 participants who had a mammography according to the administrative data, 172 adequately reported this information (Sn = 96%). Sp was moderate (76%), meaning that 24% of those who did not have a mammography reported one. Extending the time lapses to 18 months increased the Sp substantially (Sp = 90%). Self-report overestimates the use of mammography, mainly because women tend to minimize the elapsed time since their last mammography. Self-reports should be used cautiously to assess adherence to mammographic screening following BRCA1/2 testing.


Subject(s)
BRCA1 Protein/genetics , BRCA2 Protein/genetics , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/genetics , Genetic Testing , Mammography/statistics & numerical data , Mutation/genetics , Self Report , Adult , Aged , Aged, 80 and over , Early Detection of Cancer , Female , Humans , Middle Aged , Reproducibility of Results , Sensitivity and Specificity , Surveys and Questionnaires , Young Adult
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