One hundred twenty-four patients with metastatic breast cancer were treated with 40 mg of megestrol acetate four times daily. Complete responses (CR) or partial responses (PR) were seen in 29 patients (23%). CR, PR, or stable disease (S) was seen in 80 patients (65%). The median duration of response was 22 months for CR and PR and ten months for S. A significantly higher response rate (CR + PR) was seen in estrogen-receptor-positive (ER-positive) patients (26%) and in patients who had not received prior therapy (39%). A significant relationship to response could not be established for menopausal status, progesterone-receptor (PrR) status, dominant site of disease, or prior administration of chemotherapy. Median survival was 66+ months for responders, 35 months for patients with stable disease, and 9 months for nonresponders. These differences are all statistically significant (P less than .001). Toxicity was minimal, and side effects consisted primarily of weight gain, which was seen in 18 patients (14.5%). Megestrol acetate can provide effective palliation in patients with advanced breast cancer.

Bone marrow sampling remains essential in the evaluation of hematopoietic and many non-hematopoietic disorders. One common limitation to these procedures is the discomfort experienced by patients. To address whether a Powered biopsy system could reduce discomfort while providing equivalent or better results, we performed a randomized trial in adult volunteers. Twenty-six subjects underwent bilateral biopsies with each device. Core samples were obtained in 66.7% of Manual insertions; 100% of Powered insertions (P=0.002). Initial mean biopsy core lengths were 11.1±4.5 mm for the Manual device; 17.0±6.8 mm for the Powered device (P<0.005). Pathology assessment for the Manual device showed a mean length of 6.1±5.6 mm, width of 1.0±0.7 mm, and volume of 11.0±10.8 mm3. Powered device measurements were mean length of 15.3±6.1 mm, width of 2.0±0.3 mm, and volume of 49.1±21.5 mm3 (P<0.001). The mean time to core ejection was 86 seconds for Manual device; 47 seconds for the Powered device (P<0.001). The mean second look overall pain score was 33.3 for the Manual device; 20.9 for the Powered (P=0.039). We conclude that the Powered biopsy device produces superior sized specimens, with less overall pain, in less time.

Recently, a new FDA-cleared battery powered bone marrow biopsy system was developed to allow operators access to the bone marrow space quickly and efficiently. A pre-clinical evaluation of the device (OnControl, Vidacare Corporation, San Antonio, TX, USA) on anesthetized pigs was conducted, in addition to a clinical evaluation in hematology clinic patients requiring a bone marrow biopsy. Twenty-six samples were collected from the swine model. No cellular artifact or thermal damage was reported in any of the samples obtained. For the clinical evaluation of the device, 16 patients were recruited. Mean time from needle contact with skin to needle removal was 38.5 +/- 13.94 seconds. No complications were reported. In this study, the manual and powered samples were equivalent in specimen quality. In the patients evaluated, the device was safe, easy to use and the mean procedural time was significantly faster than previously reported with a manual technique.

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The importance of bone marrow examination in the evaluation of leukemia, multiple myeloma, anemia, pancytopenia, and other disorders is well established. The objective for this study was to evaluate the ability of a powered bone marrow aspiration device to penetrate the intraosseous medullary space of the iliac crest, and to aspirate bone marrow samples for the ultimate purpose of diagnosing disease and monitoring the course of disease and medical therapy. The device was used to obtain bone marrow samples in accordance with accepted practice guidelines and device’s directions for use. Among other data, insertion success, time to insertion, and complications were recorded. Patient pain levels were rated from 0 to 10 (10=extreme pain). Device operators rated the use of the device from 0 to 10 (10=outstanding). There were 55 patients in the study from three centers. Successful insertion and aspiration of bone marrow samples were achieved in 54 of the 55 patients (98.1%). Mean insertion time was 4.9±3.0 seconds; significantly faster than the 7.3 minutes reported by Kuball et al* (one-sample t-test, p<0.001). There were no complications. The mean insertion pain score was 2.5±2.2 and the mean aspiration pain score was 3.7±2.5. On a scale of 0 to 10, the six operators rated the ease of use of the device at a mean score of 8.3±1.7. Findings suggest that the powered aspiration device is safe and effective for bone marrow aspirations.