The objective of the study was to characterize salivary sex steroid levels in 56 women undergoing annual mammography who were participating in a breast density study at the Lynn Sage Breast Center of Northwestern Memorial Hospital, and to determine the predictability of the patterns within women. Saliva was collected daily by the women at home for one complete menstrual cycle and then again at approximately 6-month intervals. The occurrence of sporadic anovulatory cycles was identified in 12 subjects, and persistent oestradiol (OE2) elevation in all three cycles without significant progesterone levels occurred in another five subjects. In addition, both OE2 and progesterone were significantly lower in initial menstrual cycles than in subsequent cycles, suggestive of an effect of participation in the study on hormone levels. Initial salivary OE2 levels were not good predictors of corresponding levels in either follicular or luteal phases of the menstrual cycles at the 6-month intervals. However, after the initial cycle, progesterone levels were highly predictable within individuals over a period of 6 months (r=0·78, P<0·001). The study emphasizes the natural variation among and within women in the absence of any intervention, and indicates the need for properly controlled studies before attributing changes in hormonal levels to therapy. In addition, it emphasizes the importance of sampling at multiple time points when examining the relationship between hormones and risk.

BACKGROUNDThe treatment options of breast conservation therapy (BCT) and immediate reconstruction for patients with carcinoma of the breast have not been adopted widely. The objectives of this study were to determine how often a second opinion on the local therapy of breast carcinoma changed patient management and to identify factors predictive of remaining at the second‐opinion site for therapy.METHODSTwo hundred thirty‐one patients with intraductal carcinoma or Stage I and II breast carcinoma were reviewed retrospectively. At the time of the second opinion, patients completed a questionnaire regarding their initial surgical opinion and the reason for seeking consultation.RESULTSOnly 46% of patients had a complete discussion of treatment options prior to the second opinion. The second opinion changed management in 54 patients (20.3%). The most common finding was eligibility for BCT in patients who were offered only mastectomy. Definitive local therapy occurred at the second‐opinion site in 65.8% of patients. The only predictors of remaining at the second‐opinion site were insurance type (P = 0.008) and the patient's perception that options were not discussed at the initial opinion (P < 0.001).CONCLUSIONSSecond opinions provide useful information to patients and may change the management of their disease. They result in significant patient capture for an institution. Cancer 2002;94:889–94. © 2002 American Cancer Society.DOI 10.1002/cncr.10318

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Despite the availability of multiple therapeutic regimens, without a stem cell transplant, chronic lymphocytic leukemia (CLL) remains an incurable disease. A dramatic response rate with intensive chemo-immunotherapy in patients with CLL is frequently associated with irreversible long term consequences to the bone marrow, limiting further therapeutic options. For this reason we have initiated a clinical trial combining Rituximab (RIT) and Alemtuzumab (ALEM), two monoclonal antibodies with established activity and side effects profiles, as an initial therapy for patients with CLL requiring intervention. Methods: Data is available on 20 out of 21 enrolled patients. Therapy duration is 18 weeks. Subcutaneous (SQ) ALEM dose escalation: 3 mg - 10 mg - 30 mg on days 1, 3, 5, followed by the 30 mg Monday, Wednesday and Friday for 17 weeks. RIT at a dose of 375 mg/m2/dose IV is administered every other week staring on the 3d week for 8 doses. All patients received PCP, herpes virus, and fungal prophylaxis as well as CMV viral DNA monitoring. Responses were based on NCI-WG 1996 criteria; however, lymphadenopathy and organomegaly were also assessed by serial CT scans. Minimal residual disease (MRD) was measured in peripheral blood and bone marrow aspirate using flow cytometry for CD19+/CD5+/CD23 lymphocytes. Patients’ characteristics: Since September 2005, 21 patients have been enrolled and 20 completed the therapy. All patients met ECOG criteria for requiring treatment. Median age was 54 years (28 – 74) with 12 males and 8 females; 19 Caucasian and 1 African American. The median time from the diagnosis to treatment was 21.5 months (2–144 months). Clinical stage (Rai) was I in 2 patients, II in 8 patients, III in 4, and IV in 6 patients. Median β2 microglobulin was 3.23 (0.34–15.3). Median WBC was 56 x109/L (17.4 – 157.6), Hgb 12.6 g/dL (10 – 14.7), and platelet count 172 x 109/L (66 – 307). Cytogenetic analysis, by FISH panel, was 13q- in 7, trisomy 12 in 6, and 13q-/11q- in 3, 11q- in 1, 11q-/p53/13q- in 1, and 13q-/11q-/6q- in 1 patient. Half of the patients were Zap70+ and 3 patients were CD38+. Mutational analysis is pending. Results: Based on the NCI-WG 1996 criteria, 15 patients (75%) achieved CR, 3 patients (15%) achieved PR, and 2 patients (10%) had stable disease. With utilization of CT scans responses were: 8 CR (40%), 9 PR (45%), and 3 SD (15%). At the completion of the study 14 patients (70%) had no evidence of MRD by flow cytometry. Median duration of the response has not been reached with a median follow-up of 20 months (1–31+). All 5 patients with 11q- achieved CR based on the NCI-WG 96 criteria. Three patients (15%) required alternative therapy for the disease progression at 4, 24, and 27 months after the completion of study. Six patients (30%), all of whom were baseline CMV IgG+, had CMV reactivation by PCR. Two of them developed symptom of malaise and required hospitalization, none suffered organ involvement, and all of them cleared the infection with valgancyclovir administration. One patient suffered neutropenic fever requiring empiric antibiotic therapy followed by Clostridium difficile and adenovirus infections. No other serious infectious complications were documented. All patients developed grade 1–2 skin rash at the site of ALEM injection after the 1st dose of 3mg only; none required intervention. All patients developed grade 3–4 lymphopenia; neutropenia: grade 2 in 3, grade 3 in 5, and grade 4 in 3 patients; anemia: grade 1 in 9, grade 2 in 2 patients; thrombocytopenia: grade 1 in 8, grade 2 in 4, and grade 3 in 3 patients. Seven patients have not achieved full T cell recovery (CD4 &gt;200) by 1, 4, 5, 7, 12, and 18 months. The other 13 patients achieved T cell recovery by 1 (n=2), 4 (n=2), 6 (n=1), 7 (n=2), 9 (n=1), 10 (n=1), 15 (n=1), 16 (n=2), and 22 months. All of the patients who suffered CMV reactivation achieved faster T cell recovery than those who did not (median time 5 vs. 22 months). Two patients developed clinically significant autoimmune hemolytic anemia and none suffered Richter’s transformation. No death occurred. Discussion: Combination of ALEM and RIT is well tolerated and active regimen for patients with CLL and may represent a viable alternative to the combination chemotherapy.

Our findings, if prospectively validated, may help identify those who would obtain the greatest benefit from hormonal chemoprevention strategies for breast cancer risk reduction.