Catherine Doyle

Improving care for women after gynecological cancer: the development of a sexuality clinic.

&NA;The impact of a gynecological cancer diagnosis and the subsequent treatment on women is profound, both physically and psychologically, in particular with respect to sexual function and sexuality. We describe our experience creating a specialized clinic to address concerns about sexual health and rehabilitation. We used a case study approach to describe the clinic’s inception and first 2 years of operation. Fifty-six survivors of gynecological cancer were seen at the clinic in the first 2 years. These patients had a significant symptom burden, many related to menopause, as well as those aftereffects of radiation therapy, chemotherapy, and surgical operation as well as psychological and emotional responses to cancer. The most common interventions were education and counseling. Patients reported high levels of satisfaction with their experience at the clinic. We hope our experience may be of assistance to others considering a similar endeavor.

Eligibility criteria in randomized phase II and III adjuvant and neoadjuvant breast cancer trials: Not a significant barrier to enrollment

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.

Comparison of Serious Adverse Events Between the Original and a Generic Docetaxel in Breast Cancer Patients

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.

Toward clinical care guidelines for supporting rehabilitative vaginal dilator use with women recovering from cervical cancer

PurposeBuilding upon the findings of a recent qualitative investigation of women’s experiences with rehabilitative vaginal dilator use, the primary goal of this article is to outline a set of preliminary clinical care recommendations that health care professionals may draw upon in addressing women’s unique experiences with vaginal dilator use including their multifaceted struggles with the procedure, possibly enhancing adherence to this practice.MethodsTen women participated in in-depth interviews regarding their experiences with using the dilator as prescribed by their health care providers. Following the analysis of these interviews, members of the interdisciplinary research team met to review and discuss the development of clinical care recommendations stemming from these findings.ResultsEight care recommendations aimed at addressing the concerns expressed by the women interviewed and at improving women’s overall experiences with rehabilitative dilator use emerged: (1) introduce the dilator in a light and straightforward manner; (2) enhance dilator accessibility; (3) introduce the vaginal dilator early on in treatment; (4) emphasize health maintenance over intercourse as a benefit of dilator use; (5) explore and acknowledge women’s values and views of sexuality; (6) increase awareness and sensitivity to emotional reactions; (7) enhance psychoeducational resources for supporting vaginal dilator use; and (8) ensure consistent institutional practice when introducing the dilator.ConclusionThe clinical care recommendations proposed here reflect the various challenges women may encounter when using the vaginal dilator—which vary from practical to, for some, profoundly emotional—and are designed to better position health care providers to help women navigate these challenges.

Does breast cancer tumor size really matter that much

Tumor size should be taken into consideration when planning treatments, but final decisions should also be made on the basis of the biological characteristics of the tumor in order to achieve a personalized approach to each individual cancer and to offer the best possible treatment to each patient.

Characteristics and long-term survival of patients diagnosed with pure tubular carcinoma of the breast

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.

Evaluation of Factors Associated with Recruitment in Breast Cancer Clinical Trials in a Specialized Breast Cancer Centre.

Background: Recruitment of patients (pts) in cancer clinical trials has been reported to be between 3-5%. Very few data come from Canada. Methods: The objective was to measure the recruitment and its associated characteristics in breast cancer clinical trials for non-metastatic breast cancer pts. This was a retrospective cohort study at the Centre des Maladies du Sein Deschenes-Fabia, a specialized breast cancer centre in Quebec City, Canada. Clinical trials opened between 2004 and 2008 were used. For each protocol, main criteria were used to define the population under study (e.g. triple negative breast cancer). Charts were identified from our database and reviewed in decreasing chronological order of diagnosis. Staging, hormone receptors status and Her2 status were available from the database. All charts were reviewed to assess eligibility criteria (inclusion and exclusion criteria). Also, information was sought in the notes about whether or not the protocol has been proposed to the pt, if the pt accepted and if not, reason(s) for refusal. Protocol and physicians characteristics were collected. Results: A total of 9 protocols were studied and 244 charts identified (relates to 704 pt-protocols because one pt could be assessed for more than one protocol if applicable). Eligibility could not be assessed for 19% (n=138) pt-protocols. Among all pt-protocols, 74.4% met all the eligibility criteria. There was a note in the chart, about protocol being proposed to a potentially eligible pt, in 13.8% of the pt-protocols. Overall, 9.7% of pt-protocols were recruited. Among patients who had a protocol offered, 74.2% accepted. Data on characteristics associated with recruitment will be presented at the meeting. Conclusion: Enrollment in clinical trials in a specialized breast cancer centre is slightly higher than the 3-5% generally reported but still low. Interventions should focus on finding ways to offer a clinical trial when available to every suitable eligible patient. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5122.

In response to: Long-term overall survival of patients diagnosed with pure tubular carcinoma of the breast might be affected by increased co-morbidities

To the Editor, We thank Dr. Altundag for raising these interesting points. We took the decision to compare out patients with tubular carcinoma (TC) with patients with invasive ductal carcinoma (IDC) of the same grade, but we agree that TC fairs better than grade II–III IDC, as previously suggested by a study using the SEER data. Nevertheless, our results are supported by Kader et al. Regarding age and comorbidities, the median age of our TC patients was 58 years, compared with 60 years in our patients with IDC. In the Province of Quebec, breast cancer screening is available to women of 50–69 years of age and, in our study population, most cases of TC and grade I IDC were detected in the context of this program. Therefore, there were no differences in comorbidities between the two groups. Finally, we agree that breast cancer-specific survival (BCSS) would have been more interesting than overall survival, but because of the relatively good survival of grade I breast cancer, an insufficient number of breast-specific events was observed for BCSS analysis. Our study population was mostly Caucasian and French Canadian in origin, and we cannot exclude regional disparities among countries, possibly leading to different results. Additional international studies would be necessary to address this issue.