Operative Risks Associated with Contralateral Prophylactic Mastectomy: A Single Institution Experience

Background

The purpose of this study was to determine if newly diagnosed breast cancer patients undergoing contralateral prophylactic mastectomy (CPM) experience more complications than patients undergoing unilateral mastectomy (UM).

Methods

A total of 600 patients underwent either UM or CPM between January 2009 and March 2012 for unilateral breast cancer. Operative complications were classified as minor (aspirations, infection requiring antibiotics, partial flap and nipple necrosis, minor bleeding, delayed wound healing) or major (hematoma or seroma requiring operation, infection requiring rehospitalization, blood product transfusion, total flap or nipple loss, implant removal), mixed (both minor and major complications), or multiple. Chi-square and multivariate logistic regressions were used for the analysis.

Results

Of the 600 patients, 391 (65 %) underwent UM and 209 (35 %) underwent CPM. Across all complication groups, there were significantly more complications in the CPM group versus the UM group (41.6 vs. 28.6 %, p = 0.001). Major complications alone were significantly greater in the CPM versus the UM group (13.9 vs. 4.1 %, p < 0.001). When adjusting for age, body mass index, smoking and diabetes history, AJCC stage, reconstruction, previous radiation therapy, and adjuvant therapy, CPM patients were 1.5 times more likely to have any complication (odds ratio [OR] 1.53; 95 % CI 1.04–2.25, p = 0.029) and 2.7 times more likely to have a major complication compared with UM patients (OR 2.66; 95 % CI 1.37–5.19, p = 0.004).

Conclusions

CPM patients have an increased risk of complications, especially major complications requiring rehospitalization or reoperation. These complications may influence patient and physician decisions to choose CPM.     

Aprepitant vs. Multimodal Prophylaxis in the Prevention of Nausea and Vomiting following Extended‐Release Epidural Morphine

Background: Extended‐release epidural morphine (EREM) is an effective option for postoperative analgesia following major orthopedic surgery; however, postoperative nausea/vomiting (PONV) is a recognized limitation. The incidence of PONV following prophylactic aprepitant, a neurokinin‐1 antagonist, was compared with prophylactic multimodal antiemetic therapy in patients receiving EREM for postoperative analgesia following unilateral primary total knee arthroplasty (TKA). Methods: Prospectively collected quality assurance data were examined with Institutional Review Board approval. A sequential, open‐label, active matched case‐control study compared PONV following EREM in patients receiving ondansetron and dexamethasone, and either metoclopramide, diphenhydramine, or prochlorperazine every 6 hours for the 48‐hour study period, to patients receiving aprepitant 40 mg given as a single oral dose in the preoperative holding area. Cases were matched for procedure (TKA), age, epidural morphine dose, and known major risk factors for PONV (sex, smoking, previous PONV/motion sickness). Results: Twelve consecutive patients (3 male; 9 female) receiving aprepitant prior to EREM were matched to 12 patients of the same sex of similar age (range 51 to 84 years.) and EREM dose (range 5 to 12.5 mg) receiving the multimodal regime. The incidence of PONV was significantly less for the aprepitant group where 3 of 12 (25%) had PONV compared with 9 of 12 (75%) in the multimodal group (P = 0.039, Fisher's Exact Test; odds ratio = 0.11; 95% CI: 0.018 to 0.706, P = 0.03). Conclusion: While aprepitant significantly reduced the incidence of PONV compared with a multimodal antiemetic regime, used alone it did not eliminate PONV.     

Outcomes of Minimal and Moderate Support Versions of an Internet-Based Diabetes Self-Management Support Program

OBJECTIVE

Internet and other interactive technology-based programs offer great potential for practical, effective, and cost-efficient diabetes self-management (DSM) programs capable of reaching large numbers of patients. This study evaluated minimal and moderate support versions of an Internet-based diabetes self-management program, compared to an enhanced usual care condition.

RESEARCH DESIGN AND METHODS

A three-arm practical randomized trial was conducted to evaluate minimal contact and moderate contact versions of an Internet-based diabetes self-management program, offered in English and Spanish, compared to enhanced usual care. A heterogeneous sample of 463 type 2 patients was randomized and 82.5% completed a 4-month follow-up. Primary outcomes were behavior changes in healthy eating, physical activity, and medication taking. Secondary outcomes included hemoglobin A1c, body mass index, lipids, and blood pressure.

RESULTS

The Internet-based intervention produced significantly greater improvements than the enhanced usual care condition on three of four behavioral outcomes (effect sizes [d] for healthy eating = 0.32; fat intake = 0.28; physical activity= 0.19) in both intent-to-treat and complete-cases analyses. These changes did not translate into differential improvements in biological outcomes during the 4-month study period. Added contact did not further enhance outcomes beyond the minimal contact intervention.

CONCLUSIONS

The Internet intervention meets several of the RE-AIM criteria for potential public health impact, including reaching a large number of persons, and being practical, feasible, and engaging for participants, but with mixed effectiveness in improving outcomes, and consistent results across different subgroups. Additional research is needed to evaluate longer-term outcomes, enhance effectiveness and cost-effectiveness, and understand the linkages between intervention processes and outcomes.     

Relationship of Health Literacy to Intentional and Unintentional Non-Adherence of Hospital Discharge Medications

BACKGROUND  

Inadequate health literacy is prevalent among seniors and is associated with poor health outcomes. At hospital discharge, medications are frequently changed and patients are informed of these changes via their discharge instructions.     

Differences in cancer information-seeking behavior, preferences, and awareness between cancer survivors and healthy controls: A national, population-based survey

Background. No research has examined how cancer diagnosis and treatment might alter information source preferences or opinions. Methods. We examined data from 719 cancer survivors (CS group) and 2012 matched healthy controls (NCC group) regarding cancer-related information-seeking behavior, preferences, and awareness from the population-based 2003 Health Information National Trends Survey. Results. The CS group reported greater consumption of cancer-related information, but the CS and NCC groups did not differ in information source use or preferences. The CS group was more confident of their ability to get cancer information, reported more trust in health care professionals and television as cancer information sources, but evaluated their recent cancer information-seeking experiences more negatively than the NCC group. Awareness of cancer information resources was surprisingly low in both the CS and NCC groups. Conclusions. Cancer diagnosis and treatment subtly alters cancer information-seeking preferences and experience. However, awareness and use of cancer information resources was relatively low regardless of personal history of cancer.     

A phase 1/2a safety,pharmacokinetics, and efficacy study of the novel nucleoside analog FF-10502-01 for the treatment of advanced solid tumors

Background

The nucleoside FF-10502-01, structurally similar to but with different biologic effects than gemcitabine, shows promising activity both alone and combined with cisplatin in preclinical gemcitabine-resistant tumor models. We conducted an open-label, single-arm, 3 + 3 first-in-human trial to explore the safety, tolerability, and antitumor activity of FF-10502-01 in patients with solid tumors.

Methods

Patients with inoperable metastatic tumors refractory to standard therapies were enrolled. Escalating intravenous FF-10502-01 doses (8–135 mg/m²) were administered weekly for 3 weeks in 28-day cycles until progressive disease or unacceptable toxicity was observed. Three expansion cohorts were subsequently evaluated.

Results

A phase 2 dose of 90 mg/m² was determined after evaluating 40 patients. Dose-limiting toxicities included hypotension and nausea. Phase 2a enrolled patients with cholangiocarcinoma (36), gallbladder cancer (10), and pancreatic/other tumors (20). Common adverse events were grade 1–2 rash, pruritus, fever, and fatigue. Grade 3 or 4 hematologic toxicities were observed at low incidences, including thrombocytopenia (5.1%) and neutropenia (2%). Confirmed partial responses (PRs) occurred in five patients with gemcitabine-refractory tumors, including three with cholangiocarcinoma and one each with gallbladder and urothelial cancer. Median progression-free and overall survival rates in patients with cholangiocarcinoma were 24.7 and 39.1 weeks, respectively. Prolonged progression-free survival in patients with cholangiocarcinoma was associated with BAP1 and PBRM1 mutations.

Conclusion

FF-10502-01 was well tolerated with manageable side effects and limited hematologic toxicity. Durable PRs and disease stabilizations were observed in heavily pretreated biliary tract patients who had received prior gemcitabine. FF-10502-01 is distinct from gemcitabine and may represent an effective therapy.     

A double‐blind,randomized trial of pyridoxine versus placebo for the prevention of pegylated liposomal doxorubicin‐related hand‐foot syndrome in gynecologic oncology patients

BACKGROUND:

The objective of this study was to compare the incidence of hand‐foot syndrome (HFS) in patients who received pyridoxine versus placebo during pegylated liposomal doxorubicin (PLD) chemotherapy for recurrent ovarian, breast, or endometrial cancer.

METHODS:

Patients received PLD 40 mg/m² for a maximum of 6 cycles. Patients were assigned randomly to receive pyridoxine 100 mg twice daily (Group A) or placebo (Group B) and received standard HFS education. Patients completed the Functional Assessment of Cancer Therapy quality‐of‐life (QOL) questionnaire. The incidence of HFS as measured by common toxicity criteria was compared between groups. Analyses were conducted according to an intent‐to‐treat basis. Chi‐square tests or Fisher exact tests were used.

RESULTS:

Thirty‐four patients were enrolled (18 in Group A and 16 in Group B), and 5 patients were unevaluable for HFS assessment. Overall, 15 of 29 patients (52%) had HFS (all grades), and 10 of 29 patients (35%) had grade 2/3 events. Eight of 15 patients in Group A (53%) and 7 of 14 patients in Group B (50%) had HFS (P = .857). For grade 2/3 events, there was no difference between groups: Six of 15 events (40%) occurred in Group A, and 4 of 14 events (29%) occurred in Group B (P = .70). There was no difference in QOL scores between patients who had grade 2/3 HFS and patients who had grade 0/1 HFS. QOL analysis revealed that all patients had elevated social well being.

CONCLUSIONS:

Pyridoxine as administered in the current study did not prevent HFS in patients who received PLD. It is possible that QOL is not compromised in patients with HFS because they may have increased social well being while coping with their disease. Cancer 2010. © 2010 American Cancer Society.