Can the referring surgeon enhance accrual of breast cancer patients to medical and radiation oncology trials? The ENHANCE study.

INTRODUCTION: The accrual rate to clinical trials in oncology remains low. In this exploratory pilot study, we prospectively assessed the role that engaging a referring surgeon plays in enhancing nonsurgical oncologic clinical trial accrual. METHODS: Newly diagnosed breast cancer patients were seen by a surgeon who actively introduced specific patient-and physician-centred strategies to increase clinical trial accrual. Patient-centred strategies included providing patients, before their oncology appointment, with information about specific clinical trials for which they might be eligible, as evaluated by the surgeon. The attitudes of the patients about clinical trials and the interventions used to improve accrual were assessed at the end of the study. The primary outcome was the clinical trial accrual rate during the study period. RESULTS: Overall clinical trial enrolment during the study period among the 34 participating patients was 15% (5 of 34), which is greater than the institution's historical average of 7%. All patients found the information delivered by the surgeon before the oncology appointment to be very helpful. Almost three quarters of the patients (73%) were informed about clinical trials by their oncologist. The top reasons for nonparticipation reported by the patients who did not participate in clinical trials included lack of interest (35%), failure of the oncologist to mention clinical trials (33%), and inconvenience (19%). CONCLUSIONS: Accrual of patients to clinical trials is a complex multistep process with multiple potential barriers. The findings of this exploratory pilot study demonstrate a potential role for the referring surgeon in enhancing nonsurgical clinical trial accrual.

Acquisition of metastatic tissue from patients with bone metastases from breast cancer.

Biopsies of metastatic tissue are increasingly being performed. Bone is the most frequent site of metastasis in breast cancer patients, but bone remains technically challenging to biopsy. Difficulties with both tissue acquisition and techniques for analysis of hormone receptor status are well described. Bone biopsies can be carried out by either by standard posterior iliac crest bone marrow trephine/aspiration or CT-guided biopsy of a radiologically evident bone metastasis. The differential yield of these techniques is unknown. Results from three prospective studies of similar methodology were pooled. Patients underwent both an outpatient posterior iliac crest bone marrow trephine/aspiration and a CT-guided biopsy of a radiologically evident bone metastasis. Samples were assessed for the presence of malignant cells and where possible also for estrogen (ER) and progesterone receptor (PgR) expression. 40 patients were enrolled. Bone marrow aspiration/trephine biopsy was completed in 39/40 (97.5%) and CT-guided biopsy was completed in 34/40 (85%) of patients. Sufficient tumor cells for hormone receptor analysis were available in 19/39 (48.8%) and 16/34 (47%) of and bone marrow aspiration/trephine and CT-guided biopsies, respectively. Significant discordance in ER and PgR between the primary and the bone metastasis was also seen. Nine patients had tissue available from both bone marrow and CT-guided bone biopsies. ER and PgR concordance between these sites was 100 and 78%, respectively. Performing studies on human bone metastases is technically challenging, with relatively low yields regardless of technique. Given resource issues and similar success rates when comparing both techniques, bone marrow examination may be utilized first and if inadequate tissue is obtained, CT-guided biopsies can then be used.

Endocrine therapy for male breast cancer: rates of toxicity and adherence.

PURPOSE: Most male breast cancer tumours are hormone receptor-positive; the patients therefore receive endocrine therapy. There is, however, a paucity of published data on toxicities experienced by male breast cancer patients who are prescribed endocrine therapy. In the present study, we examined rates of adherence to and toxicity from endocrine treatments in male breast cancer patients treated at a single institution. PATIENTS AND METHODS: We conducted a retrospective study of male patients diagnosed with breast cancer at The Ottawa Hospital Cancer Centre during 1981-2003. Data collected included patient age, hormone receptor status, therapy adherence, self-reported toxicities, and type and duration of endocrine therapies. RESULTS: The review located 59 cases of early-stage and metastatic male breast cancer. Median patient age was 68.0 years. Tamoxifen was given to 38 patients (64.4%), anastrozole to 8 (13.6%), and letrozole to 5 (8.5%). Of patients who received endocrine therapy, 10 (25%) received adjuvant systemic chemotherapy. Toxicity was reported by 19 patients taking tamoxifen (50%), with hot flashes being the most common complaint (18.4%). Decreased libido, weight gain, and malaise were reported by 5 patients (13.2%). Rash and erectile dysfunction were reported by 3 patients (7.9%). Increased liver enzymes, pulmonary embolism, superficial thrombophlebitis, myalgia, depression, visual blurring, and loose stools were each reported in 1 patient (2.6%). Tamoxifen therapy was discontinued secondary to toxicity in 9 patients (23.7%). Of the patients treated with anastrozole, 3 (37.5%) reported toxicity, with 1 report each of decreased libido, leg swelling, and depression (12.5%). Toxicity was reported in 2 patients taking letrozole (40%), with both reporting peripheral edema, and 1 reporting hot flashes. No patient discontinued anastrozole or letrozole because of toxicity. CONCLUSIONS: Few studies specifically report data on adherence to and toxicities from endocrine therapies in male breast cancer patients. The rate of discontinuation at our institution because of toxicity (23.7%) is similar to that reported in the female breast cancer population. Future prospective studies should explore strategies to improve adherence to endocrine therapy in this population.