Improvement Of Disease Research Articles

Preliminary results of a prospective study of 18F-NAF PET/CT in prostate cancer.

103 Background: We performed a prospective study of 18F-NaF PET/CT bone scan (NaF) in the detection of bone metastases in men with prostate cancer. We previously reported that NaF identified more malignant lesions than Technetium-99m MDP bone scan (TcBS) (ASCO 2012 10589). This study evaluates the ability of NaF to detect bone metastasis in men with normal TcBS and also explores the change in NaF over 6 and 12 months compared to PSA changes. Methods: In a prospective 2-arm study, 60 men with prostate cancer (30 with and 30 without bone metastases by TcBS) were studied (ages 51-79). All had NaF and TcBS at baseline, followed by repeat NaF at 6 and 12 months. TcBS and NaF were reviewed by experienced nuclear medicine physicians. Abnormal foci of uptake on TcBS and NaF were classified as benign, malignant or indeterminate. Malignant uptake on NaF was confirmed by characteristic osteoblastic features on CT. Scan results were categorized as “positive” if any malignant lesion was present. In the 6 and 12 months follow up NaF, results were categorized as progression of disease (PD) = any new lesions or SUV increase > 30% in known lesions; stable disease (SD) = no new lesions or SUV changes < 30% in known lesions; and improvement of disease (ID) = resolution of known lesions or decrease SUV > 30% in known lesions. Results: 60 men have enrolled on study, 58 and 34 completed 6 and 12 month follow-up respectively. At baseline, 14 of 30 (47%) men with negative TcBS showed evidence of bone metastases in NaF (PSA mean 45); 7/14 had 2 baseline NaF and showed positive results in both, demonstrating reproducibility; 13/14 and 7/14 had follow up NaF at 6 and 12 months, respectively, all of which remained positive. In follow-up, 13/58 men at 6 months and 8/34 men at 12 months had PD from baseline on NaF, of whom 5/13 (38%) at 6 months and 5/8 (63%) at 12 months also had a PSA increase > 50%. All men who had PD on NaF at 6 months and had a follow-up scan at 12 months remained positive. 15 men at 6 months and 7 men at 12 months had ID on follow-up NaF, of which 11/15 (73%) and 6/7 (86%) had PSA decrease > 50% at 6 and 12 months, respectively. Conclusions: Early results of this ongoing NaF study are encouraging and suggest NaF identifies metastatic bone disease earlier than TcBS and correlates with changes in PSA. Clinical trial information: NCT01240551.

Fulvestrant (F) in metastatic breast cancer: Standard dose (Std) vs loading dose (Ld)—A retrospective study

10575 Background: Fulvestrant is shown to be an effective hormonal agent in menopausal hormone-receptor positive metastatic breast cancer (MBC) patients. This study aimed at showing if Ld of fulvestrant will improve its efficacy over the FDA approved Std schedule. Methods: We retrospectively reviewed our pharmacy electronic database over a period of two years to identify MBC patients who were treated with fulvestrant. Patients received either Std of 250 mg IM on day (d) 1 and repeated Q28d or Ld of 500 mg IM d1 and 15 and Std on d28 which was repeated every 28 days until evidence of progression. All medical records were reviewed and responses were recorded as improved disease (ID), stable disease (SD), or progressive (PD) as documented by the treating oncologist. Time to response (TTR) (the interval from first injection until response) as well the duration of response (DR), was determined. Results: Medical records of 157 consecutive, evaluable patients who received F for their MBC were identified and reviewed. Group 1 (Gp1) received std (N = 122) and Group 2 (Gp2) received loading dose (N = 35). There were no significant differences between the two groups in relation to age, pathology, grade, Her-2, ER and PR status or number of prior chemotherapy regimens (p > 0.05). Gp2 had statistically significant more prior hormone therapies (p = 0.0159). Median number of doses for Gp2 was 5 (R: 1–18) compared to 3 (R: 1–25) for Gp1 (p = 0.0169). Responses (ID) 14% for Gp1 and 18% for Gp2; clinical benefits (ID + SD) were 37.7% and 38%, respectively, NSS (p = 0.9550). TTR was 10 (R: 6–32) wks for Gp1 and 8 (R: 4–20) wks for Gp2; the DR was 15.5 (R: 4- 84) weeks for Gp1, and 12 (R: 2- 96) for Gp2. No statistical significance was detected between the 2 groups. Conclusions: This study showed there is no significant difference between the 2 dose schedules, either in the response rate or its duration. Prospective studies are needed to prove the equivalence of the Std and Ld of F. No significant financial relationships to disclose.

Efficacy of Anastrozole in a Consecutive Series of Advanced Breast Cancer Patients Treated with Multiple Prior Chemotherapies and Endocrine Agents: M. D. Anderson Cancer Center Experience.

Anastrozole is a highly selective, nonsteroidal aromatase inhibitor approved by the U.S. Food and Drug Administration (FDA) in January 1996 for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. To date, information on anastrozole's use has been limited to breast cancer patients with minimal prior therapy. The purpose of this review was to determine, in clinical practice, the benefits of anastrozole in advanced breast cancer patients treated with multiple prior cytotoxic and endocrine therapies. This was a retrospective review of a consecutive series of 117 patients who received anastrozole after marketing in January 1996. As this was not a prospective study, rigorous response criteria could not be applied. Responses were categorized as improvement in disease (ID), stable disease (SD), or progressive disease (PD). One hundred eight patients were evaluable for response with a median age of 61 years and the number of prior therapies ranging from one to nine. Response, defined as improvement of disease or stable disease >/=8 weeks, was seen in 59% of patients. Patients with three or more prior endocrine therapies demonstrated a 61% response (ID + SD) and patients with ER-negative tumors demonstrated 50% response. Patients with prior aminoglutethamide therapy exhibited similar response rates to the overall group. One male patient received anastrozole without benefit. This data determines the activity of anastrozole even in heavily pretreated patients and suggests that patients who have tumors that are ER-negative may also benefit from anastrozole therapy.