Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial).

PURPOSE: Chemotherapy-related amenorrhea (CRA) is a surrogate for ovarian toxicity and associated risk of infertility and premature menopause. Here, we compare CRA rate with paclitaxel (T)-trastuzumab (H) to that with ado-trastuzumab emtansine (T-DM1). METHODS: Patients with T1N0 HER2 + early-stage breast cancer (eBC) enrolled on the ATEMPT trial and were randomized 3:1 to T-DM1 3.6 mg/kg IV every (q) 3 weeks (w) × 17 vs. T 80 mg/m2 with H IV qw × 12 (4 mg/kg load → 2 mg/kg), followed by H (6 mg/kg IV q3w × 13). Enrollees who self-reported as premenopausal were asked to complete menstrual surveys at baseline and every 6-12 months for 60 months. 18-month CRA (no periods reported during prior 6 months on 18-month survey) was the primary endpoint of this analysis. RESULTS: Of 512 ATEMPT enrollees, 123 who began protocol therapy and answered baseline and at least one follow-up menstrual survey were premenopausal at enrollment. 76 had menstrual data available at 18 months without having received a gonadotropin-releasing hormone agonist or undergone hysterectomy and/or oophorectomy. Median age was 45 (range 23-53) among 18 who had received TH and 46 (range 34-54) among 58 who had received T-DM1. The 18-month rate of CRA was 50% after TH and 24% after T-DM1 (p = 0.045). CONCLUSION: Amenorrhea at 18 months was less likely in recipients of adjuvant T-DM1 than TH. Future studies are needed to understand how T-DM1 impacts risk of infertility and permanent menopause, and to assess amenorrhea rates when T-DM1 is administered after standard HER2-directed chemotherapy regimens.

Prevalence of off-label use of oral oncolytics at a community cancer center.

PURPOSE: Oral oncolytics are becoming increasingly utilized for cancer treatment, but the frequency of off-label oral oncolytic use is not well described. The extent of off-label oral oncolytic use is a concern because the clinical benefits of such use to patients may not outweigh adverse health outcomes or cost concerns. METHODS: Prescription data for January 2011 through November 2013 from the St. Lukes Mountain States Tumor Institute (MSTI) Oral Chemotherapy program (OCP) was retrospectively analyzed. Use was classified as "on-label" if the cancer site, stage, and line of therapy met the FDA-approved indication. All other uses were classified as "off- label." Off-label use was further evaluated by whether it conformed to and was supported by National Comprehensive Cancer Network (NCCN) guideline recommendations. RESULTS: Twelve hundred and six first-fill oral chemotherapy prescriptions were reviewed, representing 990 unique patients and 44 individual medications. On-label use amounted to 71% and off-label use amounted to 29%. Eighty-eight percent of off-label uses were supported by NCCN guideline recommendations. A total of 3.3% of all prescriptions analyzed were for off-label uses not supported by NCCN guideline recommendations. The top five oral chemotherapies prescribed for off-label uses were capecitabine, temozolomide, lenalidomide, abiraterone, and everolimus. CONCLUSION: Oral chemotherapies are more often used on label than off label in current practice at our community cancer center. The majority of off-label use of oral oncolytics in this study was supported by NCCN guideline recommendations.

Comprehensive survivorship care with cost and revenue analysis.

PURPOSE: The 2015 Commission on Cancer standards require that cancer survivors receive an individualized survivorship care plan (SCP). To meet this new standard, St Luke's Mountain States Tumor Institute (MSTI), with support from the National Community Cancer Centers Program, implemented a successful survivorship model. PATIENTS AND METHODS: At MSTI, the patient's SCP is prepared in the electronic health record by a registered health information technician. This document is reviewed during an appointment with a nurse practitioner and social worker. The provider's dictation is mailed to the primary care physician with the SCP. From August 2011 to Oct 2012, 118 patients with breast cancer were seen for survivorship appointments. Medical record audit and follow-up telephone call were completed to evaluate patient survivorship needs and satisfaction with the appointment. Patient accounts were reviewed for reimbursement. RESULTS: From medical record review, the most common patient concerns were weight management (35%), fatigue (30%), sexuality (27%), anxiety (23%), caregiver stress (17%), and depression (16%). Telephone calls showed high patient satisfaction and understanding. Patients rated the following statements on a Likert scale from 1 (strongly disagree) to 5 (strongly agree): I understand my treatment summary and care plan (88% strongly agree or agree), and I feel the survivorship visit met my survivorship needs (86% strongly agree or agree). At 1 month, 80% of participants were still working on wellness goals. Patient accounts analysis showed revenue covered costs. CONCLUSION: Survivorship care at MSTI meets new standards, allows for patient engagement and satisfaction, and improves care coordination. Costs are covered by reimbursement.

American Society of Clinical Oncology executive summary of the clinical practice guideline update on the role of bone-modifying agents in metastatic breast cancer.

PURPOSE: To update the recommendations on the role of bone-modifying agents in the prevention and treatment of skeletal-related events (SREs) for patients with metastatic breast cancer with bone metastases. METHODS: A literature search using MEDLINE and the Cochrane Collaboration Library identified relevant studies published between January 2003 and November 2010. The primary outcomes of interest were SREs and time to SRE. Secondary outcomes included adverse events and pain. An Update Committee reviewed the literature and re-evaluated previous recommendations. RESULTS: Recommendations were modified to include a new agent. A recommendation regarding osteonecrosis of the jaw was added. RECOMMENDATIONS: Bone-modifying agent therapy is only recommended for patients with breast cancer with evidence of bone metastases; denosumab 120 mg subcutaneously every 4 weeks, intravenous pamidronate 90 mg over no less than 2 hours, or zoledronic acid 4 mg over no less than 15 minutes every 3 to 4 weeks is recommended. There is insufficient evidence to demonstrate greater efficacy of one bone-modifying agent over another. In patients with a calculated serum creatinine clearance of more than 60 mg/min, no change in dosage, infusion time, or interval of bisphosphonate administration is required. Serum creatinine should be monitored before each dose. All patients should receive a dental examination and appropriate preventive dentistry before bone-modifying agent therapy and maintain optimal oral health. Current standards of care for cancer bone pain management should be applied at the onset of pain, in concert with the initiation of bone-modifying agent therapy. The use of biochemical markers to monitor bone-modifying agent use is not recommended.

Surveillance imaging of Hodgkin lymphoma patients in first remission: a clinical and economic analysis.

BACKGROUND: The majority of patients with Hodgkin lymphoma (HL) achieve disease remission after primary therapy. To the best of the authors' knowledge, no consensus exists for postremission surveillance imaging. METHODS: Retrospectively analyzed were 192 adult patients with classic HL in first remission. Events were defined as recurrent HL or secondary malignancies. Primary outcome was positive predictive value (PPV) of surveillance positron emission tomography/computed tomography (PET/CT) and CT scans in event detection. Secondary outcomes were costs and radiation exposures of surveillance scans. RESULTS: Sixteen events (12 recurrent HL cases and 4 secondary malignancies) were detected during a median follow-up of 31 months. The PPV of surveillance PET/CT was 22.9% compared with 28.6% for CT (P=.73). Factors that were found to significantly improve the PPV of scans in detecting recurrent HL included PET and CT concordance, involvement of a prior disease site, or the occurrence of a radiographic abnormality within 12 months. There were too few events to determine whether event detection by PET/CT versus CT or the presence of symptoms at the time of event detection affected overall outcomes. The cost to detect a single event was approximately $100,000. Radiation exposure to detect a single event was 146.6 millisieverts per patient for each of 9 patients. CONCLUSIONS: For patients with HL in first disease remission, surveillance radiography appears to be expensive, with limited clinical impact. Surveillance CT is generally adequate.

Rare lymphoid malignancies of the breast: a report of two cases illustrating potential diagnostic pitfalls.

Breast involvement by lymphoma is uncommon and poses challenges in diagnosis. Lymphomas may clinically, radiologically, and morphologically mimic both benign and neoplastic conditions. We describe two cases of lymphoid malignancies predominantly involving the breast, both presenting diagnostic dilemmas. The first case, ALK-negative anaplastic large-cell lymphoma involving a seroma associated with a breast implant, is an emerging clinicopathologic entity. Anaplastic large-cell lymphoma has been identified in association with breast implants and seroma formation relatively recently. The second case, hairy cell leukemia involving the breast and ipsilateral axillary sentinel lymph node, is, to our knowledge, the first reported case of hairy cell leukemia involving the breast at the time of diagnosis. While a localized bone lesion was present at time of diagnosis, bone marrow involvement was relatively mild in comparison to that seen in the breast and lymph node. In the first case, lymphoma occurred in a clinical setting where malignancy was unsuspected, highlighting the importance of careful morphologic evaluation of paucicellular samples, as well as awareness of rare clinicopathologic entities, in avoiding a misdiagnosis of a benign inflammatory infiltrate. In the second case, the lymphoid neoplasm exhibited classic morphologic and immunophenotypic features, but presented at an unusual site of involvement. Knowledge of the patient's concurrent diagnosis of hairy cell leukemia involving the bone marrow and bone helped avoid a misdiagnosis of carcinoma rather than lymphoma.

Systemic therapy for metastatic colorectal cancer: current questions.

A proliferation of new cytotoxic and biologic agents has led to improved survival in patients with metastatic colorectal cancer (mCRC). The ability of surgery to increase long-term survival in patients with liver and/or lung metastases also has been firmly established. It has become increasingly difficult as the numbers and types of treatment options have expanded to identify optimal drug combinations, sequences, and duration and the best way to integrate systemic chemotherapy with potentially curative surgery for metastatic lesions. For this review, the authors examined how recent clinical trials have addressed some pertinent questions regarding the use of systemic chemotherapy and biologic agents in patients with mCRC.

Adjuvant therapy for pancreatic cancer: a review.

Pancreatic cancer is uniformly fatal unless it can be surgically resected. Survival rates for the 15% to 20% of patients who have resectable disease, however, are a disappointing 10% to 30%, depending on the status of margins and surrounding lymph nodes. In the mid-1980s, a landmark study by the Gastrointestinal Tumor Study Group was the first to demonstrate a survival benefit from adjuvant therapy in the form of chemoradiation. Since then, several studies in both North America and Europe have tested the role of adjuvant chemotherapy or chemoradiation in pancreatic cancer, and the results have stirred great controversy. For this review, the evidence for adjuvant therapy in pancreatic cancer was examined, and the significant practice differences that exist between North American and European oncologists were highlighted. The authors investigated the results from the European Study Group for Pancreatic Cancer-1 trial and the reasons why that study has served to reinforce rather than resolve these trans-Atlantic differences. They also reviewed preliminary data from more recent adjuvant trials and explored the possible benefits of a neoadjuvant approach.