Cost effectiveness of tac versus fac in adjuvant treatment of node-positive breast cancer

Background

This economic analysis aimed to determine, from the perspective of a Canadian provincial government payer, the cost-effectiveness of docetaxel (Taxotere: Sanofi–Aventis, Laval, QC) in combination with doxorubicin and cyclophosphamide (tac) compared with 5-fluorouracil, doxorubicin, and cyclophosphamide (fac) following primary surgery for breast cancer in women with operable, axillary lymph node–positive breast cancer.

Methods

A Markov model looking at two time phases—5-year treatment and long-term follow-up—was constructed. Clinical events included clinical response (based on disease-free survival and overall survival) and rates of febrile neutropenia, stomatitis, diarrhea, and infections. Health states were “no recurrence,” “locoregional recurrence,” “distant recurrence,” and “death.” Costs were based on published sources and are presented in 2006 Canadian dollars. Model inputs included chemotherapy drug acquisition costs, chemotherapy administration costs, relapse and follow-up costs, costs for management of adverse events, and costs for granulocyte colony-stimulating factor (g-csf) prophylaxis. A 5% discount rate was applied to costs and outcomes alike. Health utilities were obtained from published sources.

Results

For tac as compared with fac, the incremental cost was $6921 per life-year (ly) gained and $6,848 per quality-adjusted life-year (qaly) gained. The model was robust to changes in input variables (for example, febrile neutropenia rate, utility). When g-csf and antibiotics were given prophylactically before every cycle, the incremental ratios increased to $13,183 and $13,044 respectively.

Conclusions

Compared with fac, tac offered improved response at a higher cost. The cost-effectiveness ratios were low, indicating good economic value in the adjuvant setting of node-positive breast cancer patients.     

Surgical margins and handling of soft-tissue sarcoma in extremities: a clinical practice guideline

Questions

1. In limb salvage surgery for extremity soft-tissue sarcoma (sts), what is an adequate surgical margin?
2. What is the appropriate number of samples to take from the margins of a surgical resection specimen?
3. What is the appropriate handling of surgical resection specimens?

Background

Surgery is the primary treatment for extremity sts. The combination of radiotherapy with surgery allows for limb salvage by using radiation to biologically “sterilize” microscopic extensions of tumour and to spare neurovascular and osseous structures. Adjuvant chemotherapy in sts—except for rhabdomyosarcoma and Ewing sarcoma—continues to be controversial.

Methods

The medline and embase databases (1975 to June 2011) and the Cochrane Library were searched for pertinent studies. The Web sites of the main guideline organizations and the American Society of Clinical Oncology conference proceedings (2007–2010) were also searched.

Results and Conclusions

Thirty-three papers, including four guidelines, one protocol, and one abstract, were eligible for inclusion.The data suggest that patients with clear margins have a better prognosis, but no prospective studies have indicated how wide margins should be. In limb-salvage surgery for extremity sts, the procedure should be planned to achieve a clear margin. However, to preserve functionality, surgery may result in a very close (<1 cm) or even microscopically positive margin. In this circumstance, the use of preoperative or postoperative radiation should be considered.No studies described the optimal number of tissue sections required to assess adequacy of excision nor the appropriate handling of surgical resection specimens. The Sarcoma Disease Site Group made its recommendations based on expert opinion and consensus.     

Treatment and follow-up strategies in desmoid tumours: a practice guideline

Objectives

We set out to

• determine the optimal treatment options—surgery, radiation therapy (rt), systemic therapy, or any combinations thereof—for patients with desmoid tumours once the decision to undergo active treatment has been made (that is, monitoring and observation have been determined to be inadequate).
• provide clinical-expert consensus opinions on follow-up strategies in patients with desmoid tumours after primary interventional management.

Methods

This guideline was developed by Cancer Care Ontario’s Program in Evidence-Based Care and the Sarcoma Disease Site Group. The medline, embase, and Cochrane Library databases, main guideline Web sites, and abstracts of relevant annual meetings (1990 to September 2012) were searched. Internal and external reviews were conducted, with final approval by the Program in Evidence-Based Care and the Sarcoma Disease Site Group.

Recommendations

Treatments

• Surgery with or without rt can be a reasonable treatment option for patients with desmoid tumours whose surgical morbidity is deemed to be low.
• The decision about whether rt should be offered in conjunction with surgery should be made by clinicians and patients after weighing the potential benefit of improved local control against the potential harms and toxicity associated with rt.
• Depending on individual patient preferences, systemic therapy alone or rt alone might also be reasonable treatment options, regardless of whether the desmoid umours are deemed to be resectable.

Follow-Up Strategies

• Undergo evaluation for rehabilitation (occupational therapy or physical therapy, or both).
• Continue with rehabilitation until maximal function is achieved.
• Undergo history and physical examinations with appropriate imaging every 3–6 months for 2–3 years, and then annually.

     

Clinical features of AIDS patients with Hodgkin’s lymphoma with isolated bone marrow involvement: report of 12 cases at a single institution

Objective

To study the main clinical and histopathological features of 12 patients with Hodgkin’s lymphoma (HL) diagnosed primarily from bone marrow (BM) involvement.

Methods

We included 12 acquired immunodeficiency syndrome (AIDS) patients with HL assisted in the F. J. Muñiz Infectious Diseases Hospital since January 2002 to December 2013. The diagnosis of HL with primary BM involvement in patients was confirmed by clinical, histopathological, and immunohistochemical findings.

Results

All patients presented “B” symptoms and pancytopenia. All of them had stage IV neoplasm disease because of BM infiltration. The median of CD4⁺ T-cell counts was 114 cells/μL, and mixed cellularity (MC) was the most frequent histopathological subtype of 92% cases.

Conclusion

When other causes are excluded, BM biopsy should be performed in AIDS patients with “B” symptoms and pancytopenia to evaluate BM infiltration by atypical lymphocytes.KEYWORDS : Acquired immunodeficiency syndrome (AIDS), Hodgkin’s lymphoma (HL), bone marrow (BM)     

Diagnosing lung cancer in the 21st century: are we ready to meet the challenge of individualized care?

Background

Histologic and molecular subtyping have become increasingly important as predictors of treatment benefit in lung cancer. The objective of the present study was to determine whether current diagnostic approaches provide adequate tissue to allow for individualized treatment decisions.

Methods

Our retrospective cohort study of new lung cancer patients seen at an academic centre between July 2007 and June 2008 collected baseline demographic and diagnostic information, including mode of diagnosis, type of diagnostic material, and pathology diagnosis.

Results

Of the 431 study patients, 20% had stage i or ii non-small-cell lung cancer (nsclc), 24% stage iii disease, and 39% stage iv nsclc. Three quarters of the small-cell lung cancer (sclc) cases were extensive stage. Diagnostically, 18% of patients had sclc; 30%, adenocarcinoma; 27%, squamous-cell cancer; 2%, large-cell carcinoma; 1%, bronchoalveolar carcinoma; 1%, mixed histology; 18%, nsclc not otherwise specified; 4%, other; and 2%, no pathology diagnosis. Surgical pathology material was available in 80% of cases, and cytology material alone in 20%. Surgical pathology material was more common in patients with early-stage than with advanced disease (89% for stages i and ii vs. 74% for stages iii and iv, p < 0.0001). The pathology report included ambiguous terms in 24% of cases: “consistent” (12%), “suspicious” (3%), “favour” (2%), “suggestive” (2%), “likely” (1%), “compatible” with malignancy (1%), “at least” (1%), “atypical” (0.5%), and “no pathology” (1.5%).

Conclusions

Current diagnostic approaches in most lung cancer patients appear adequate, but complete histopathologic identification is missing in nearly 20% of cases, and some uncertainty as to the final diagnosis is expressed in 24% of pathology reports. Some improvement in diagnostic sampling and pathology reporting are required to allow for implementation of current treatment approaches.     

Diet and supplements and their impact on colorectal cancer

Background

Colorectal cancer is the third commonest cancer and the third leading cause of cancer death among men and women. It has been proposed that dietary factors are responsible for 70-90% of colorectal cancer and diet optimization may prevent most cases.

Aim

To evaluate the role of dietary components and supplements in colorectal cancer.

Methods

Bibliographical searches were performed in Pubmed for the terms “diet and colorectal cancer”, “diet and colon cancer”, “diet and rectal cancer”, “nutrition and colorectal cancer”, “probiotics and colorectal cancer”, “prebiotics and colorectal cancer”, “alcohol and cancer” and “colorectal cancer epidemiology”.

Results

Consumption of processed or red meat, especially when cooked at high temperatures may be associated with increased risk of colorectal cancer. The evidence for dietary fibre is unclear but foods that contain high amounts of fibre are usually rich in polyphenols which have been shown to alter molecular processes that can encourage colorectal carcinogenesis. Meta-analyses provide evidence on the benefits of circulating, diet-derived and supplemented, vitamin D and Calcium. We also found that diets rich in Folate may prevent colorectal carcinoma. The evidence on dietary micronutrients such as Zinc and Selenium in association with colorectal cancer is not conclusive. It has been suggested that there may be a direct association between alcohol intake and colorectal cancer. In vitro and in vivo studies have highlighted a possible protective role of prebiotics and probiotics.

Conclusions

The lack of randomized trials and the presence of confounding factors including smoking, physical activity, obesity and diabetes may often yield inconclusive results. Carefully designed randomized trials are recommended.Key Words: Colorectal cancer, nutrition, diet, carcinogenesis     

Conditional survival estimate of acute-on-chronic hepatitis B liver failure: A dynamic prediction based on a multicenter cohort

Objectives

Counseling patients with acute-on-chronic hepatitis B liver failure (ACHBLF) on their individual risk of short-term mortality is challenging. This study aimed to develop a conditional survival estimate (CSE) for predicting individualized mortality risk in ACHBLF patients.

Methods

We performed a large prospective cohort study of 278 ACHBLF patients from December 2010 to December 2013 at three participating medical centers. The Kaplan-Meier method was used to calculate the cumulative overall survival (OS). Cox proportional hazard regression models were used to analyze the risk factors associated with OS. 4-week CSE at “X” week after diagnostic established were calculated as CS₄ = OS_(X+4)/OS_(X).

Results

The actual OS at 2, 4, 6, 8, 12 weeks were 80.5%, 71.8%, 69.3%, 66.0% and 63.7%, respectively. Using CSE, the probability of surviving an additional 4 weeks, given that the patient had survived for 1, 3, 5, 7, 9 weeks was 74%, 86%, 92%, 93%, 97%, respectively. Patients with worse prognostic feathers, including MELD > 25, Child grade C, age > 45, HE, INR > 2.5, demonstrated the greatest increase in CSE over time, when compared with the “favorable” one (Δ36% vs. Δ10%; Δ28% vs. Δ16%; Δ29% vs. Δ15%; Δ60% vs. Δ12%; Δ33% vs. Δ12%; all P < 0.001; respectively).

Conclusions

This easy-to-use CSE can accurately predict the changing probability of survival over time. It may facilitate risk communication between patients and physicians.     

Percutaneous “Y” biliary stent placement in palliative treatment of type 4 malignant hilar stricture

Background

This study evaluated the technical and clinical efficacy of percutaneous bilateral biliary stent-in-stent (SIS) deployment technique with a “Y” configuration using open-cell-design stents in type 4 Klatskin tumor patients.

Methods

Retrospective evaluation ten patients with type IV Bismuth malignant hilar stricture (MHS) treated with percutaneous bilateral “Y” SIS deployment technique placement followed in our institution between March of 2012 and November of 2014.

Results

Bilateral SIS deployment was technically successful in all patients. One patient (10%) had major complications (episode of cholangitis); one patient (10%) had minor complications, including self-limiting hemobilia. Successful internal drainage was achieved in nine (90%) patients. Stent occlusion by tumor overgrowth and sludge formation occurred in two patient (20%). The median survival and stent patency time were 298 and 315 days respectively.

Conclusions

Percutaneous bilateral metal stenting using a Y-stent is a valid option for the palliative treatment of type 4 Bismuth MHS, improving quality patient’ life.     

Prospective evaluation of unmet needs of rural and aboriginal cancer survivors in Northern British Columbia

Background

The unmet needs of cancer survivors in rural, remote, and aboriginal communities are largely unexplored. We explored potential differences between rural survivors (rss) in 4 general population (gp) and 4 First Nations (fn) communities.

Methods

We approached 4 gp and 4 fn rs communities to participate in a mixed-methods project. Participants completed the Hospital Anxiety and Depression Scale (hads) and the Survivor Unmet Needs Survey (suns) and provided demographic information. Each question on the suns can be scored from 0 to 4, with 0 representing “no unmet need” and 4 representing “very high unmet need.” A directed approach to content analysis of focus group and interview data was used to triangulate the hads and suns results.

Results

We prospectively accrued 23 fn rss and 56 gp rss for this study. More fn rss had borderline or abnormal anxiety (5% vs. 21%, p = 0.02). Compared with gp rss, fn rss had higher unmet needs scores in all categories: Information (2.29 vs. 0.8, p < 0.001), Work and Financial (1.66 vs. 0.5, p < 0.001), Access and Continuity of Health Care (1.83 vs. 0.44, p < 0.001), Coping and Sharing (2.22 vs. 0.62, p < 0.001), and Emotional (2.12 vs. 0.63, p < 0.001). The qualitative findings provided examples and insight into the unmet needs experienced by rss.

Conclusions

First Nations rss had significantly higher anxiety and unmet needs compared with their gp rs counterparts. In addition, different qualitative themes were identified in the groups. Our findings support the development of tailored approaches to survivorship for these populations.     

Anti-HER2 CD4+ T-helper type 1 response is a novel immune correlate to pathologic response following neoadjuvant therapy in HER2-positive breast cancer

Introduction

A progressive loss of circulating anti-human epidermal growth factor receptor-2/neu (HER2) CD4⁺ T-helper type 1 (Th1) immune responses is observed in HER2^pos-invasive breast cancer (IBC) patients relative to healthy controls. Pathologic complete response (pCR) following neoadjuvant trastuzumab and chemotherapy (T + C) is associated with decreased recurrence and improved prognosis. We examined differences in anti-HER2 Th1 responses between pCR and non-pCR patients to identify modifiable immune correlates to pathologic response following neoadjuvant T + C.

Methods

Anti-HER2 Th1 responses in 87 HER2^pos-IBC patients were examined using peripheral blood mononuclear cells pulsed with 6 HER2-derived class II peptides via IFN-γ ELISPOT. Th1 response metrics were anti-HER2 responsivity, repertoire (number of reactive peptides), and cumulative response across 6 peptides (spot-forming cells [SFC]/10⁶ cells). Anti-HER2 Th1 responses of non-pCR patients (n = 4) receiving adjuvant HER2-pulsed type 1-polarized dendritic cell (DC1) vaccination were analyzed pre- and post-immunization.

Results

Depressed anti-HER2 Th1 responses observed in treatment-naïve HER2^pos-IBC patients (n = 22) did not improve globally in T + C-treated HER2^pos-IBC patients (n = 65). Compared with adjuvant T + C receipt, neoadjuvant T + C — utilized in 61.5 % — was associated with higher anti-HER2 Th1 repertoire (p = 0.048). While pCR (n = 16) and non-pCR (n = 24) patients did not differ substantially in demographic/clinical characteristics, pCR patients demonstrated dramatically higher anti-HER2 Th1 responsivity (94 % vs. 33 %, p = 0.0002), repertoire (3.3 vs. 0.3 peptides, p < 0.0001), and cumulative response (148.2 vs. 22.4 SFC/10⁶, p < 0.0001) versus non-pCR patients. After controlling for potential confounders, anti-HER2 Th1 responsivity remained independently associated with pathologic response (odds ratio 8.82, p = 0.016). This IFN-γ⁺ immune disparity was mediated by anti-HER2 CD4⁺T-bet⁺IFN-γ⁺ (i.e., Th1) — not CD4⁺GATA-3⁺IFN-γ⁺ (i.e., Th2) — phenotypes, and not attributable to non-pCR patients’ immune incompetence, host-level T-cell anergy, or increased immunosuppressive populations. In recruited non-pCR patients, anti-HER2 Th1 repertoire (3.7 vs. 0.5, p = 0.014) and cumulative response (192.3 vs. 33.9 SFC/10⁶, p = 0.014) improved significantly following HER2-pulsed DC1 vaccination.

Conclusions

Anti-HER2 CD4⁺ Th1 response is a novel immune correlate to pathologic response following neoadjuvant T + C. In non-pCR patients, depressed Th1 responses are not immunologically “fixed” and can be restored with HER2-directed Th1 immune interventions. In such high-risk patients, combining HER2-targeted therapies with strategies to boost anti-HER2 Th1 immunity may improve outcomes and mitigate recurrence.

Electronic supplementary material

The online version of this article (doi:10.1186/s13058-015-0584-1) contains supplementary material, which is available to authorized users.     

Advance care planning: identifying system-specific barriers and facilitators

Background

Advance care planning (acp) is an important process in health care today. How to prospectively identify potential local barriers and facilitators to uptake of acp across a complex, multi-sector, publicly funded health care system and how to develop specific mitigating strategies have not been well characterized.

Methods

We surveyed a convenience sample of clinical and administrative health care opinion leaders across the province of Alberta to characterize system-specific barriers and facilitators to uptake of acp. The survey was based on published literature about the barriers to and facilitators of acp and on the Michie Theoretical Domains Framework.

Results

Of 88 surveys, 51 (58%) were returned. The survey identified system-specific barriers that could challenge uptake of acp. The factors were categorized into four main domains. Three examples of individual system-specific barriers were “insufficient public engagement and misunderstanding,” “conflict among different provincial health service initiatives,” and “lack of infrastructure.” Local system-specific barriers and facilitators were subsequently explored through a semi-structured informal discussion group involving key informants. The group identified approaches to mitigate specific barriers.

Conclusions

Uptake of acp is a priority for many health care systems, but bringing about change in multi-sector health care systems is complex. Identifying system-specific barriers and facilitators to the uptake of innovation are important elements of successful knowledge translation. We developed and successfully used a simple and inexpensive process to identify local system-specific barriers and enablers to uptake of acp, and to identify specific mitigating strategies.     

Sunitinib malate for gastrointestinal stromal tumour in imatinib mesylate–resistant patients: recommendations and evidence

Question

Is sunitinib malate—marketed as Sutent (Pfizer Canada, Kirkland, QC)—superior to placebo or other interventions for primary outcomes of interest in adult patients with gastrointestinal stromal tumour (gist) who have developed resistance or who exhibit intolerance to imatinib mesylate (im)?

Background

In patients with resectable disease, surgery is the mainstay of treatment for gist; in patients with unresectable or metastatic disease, the tyrosine kinase inhibitor im is the therapy of choice. However, some patients have primary resistance or intolerance to im, or they progress after optimal exposure (including an escalated dose). Here, we review the evidence for treating im-resistant gist with sunitinib malate.

Methods

Studies of sunitinib malate were identified through medline, embase, the Cochrane Library databases, and Web sites of guideline organizations. Outcomes of interest included time to progression, progression-free survival, overall survival, and toxicity.

Results

One phase iii randomized controlled trial, and one abstract and presentation describing that trial, served as the evidentiary base for this clinical practice guideline. Trial data confidently show that both time to progression and progression-free survival are highly statistically significant (p < 0.0001) in favour of sunitinib malate over placebo. Overall survival was improved with sunitinib malate (hazard ratio: 0.49; 95% confidence interval: 0.29 to 0.83; p = 0.007; absolute difference in weeks not reported). The most frequent of all adverse effects (experienced in greater proportion by patients on sunitinib malate) were grades 1 and 2 leucopenia (52% vs. 5% with placebo), neutropenia (43% vs. 4%), and thrombocytopenia (36% vs. 4%). Grade 3 hematologic adverse events were also reported more frequently in the sunitinib malate group, including leucopenia (4% vs. 0%), neutropenia (8% vs. 4%), lymphopenia (9% vs. 2%), and thrombocytopenia (4% vs. 0%). Toxicity comparisons did not include p values.The incidence of grades 1–3 fatigue was greater for the sunitinib malate group (34% vs. 22% with placebo). Other grade 3 nonhematologic treatment-related adverse events that occurred more frequently on sunitinib malate included hand–foot syndrome (4% vs. 0%), diarrhea (3% vs. 0%), and hypertension (3% vs. 0%). No grade 4 adverse events were observed.

Conclusions

In the target population, sunitinib malate is the recommended option for second-line therapy of metastatic gist.     

Impact of systemic targeted agents on the clinical outcomes of patients with brain metastases

Background

To determine the clinical benefits of systemic targeted agents across multiple histologies after stereotactic radiosurgery (SRS) for brain metastases.

Methods

Between 2000 and 2013, 737 patients underwent upfront SRS for brain metastases. Patients were stratified by whether or not they received targeted agents with SRS. 167 (23%) received targeted agents compared to 570 (77%) that received other available treatment options. Time to event data were summarized using Kaplan-Meier plots, and the log rank test was used to determine statistical differences between groups.

Results

Patients who received SRS with targeted agents vs those that did not had improved overall survival (65% vs. 30% at 12 months, p < 0.0001), improved freedom from local failure (94% vs 90% at 12 months, p = 0.06), improved distant failure-free survival (32% vs. 18% at 12 months, p = 0.0001) and improved freedom from whole brain radiation (88% vs. 77% at 12 months, p = 0.03). Improvement in freedom from local failure was driven by improvements seen in breast cancer (100% vs 92% at 12 months, p < 0.01), and renal cell cancer (100% vs 88%, p = 0.04). Multivariate analysis revealed that use of targeted agents improved all cause mortality (HR = 0.6, p < 0.0001).

Conclusions

Targeted agent use with SRS appears to improve survival and intracranial outcomes.     

Predicting Ovarian Activity in Women Affected by Early Breast Cancer: A Meta‐Analysis‐Based Nomogram

Background.

The assessment of ovarian reserve in premenopausal women requiring anticancer gonadotoxic therapy can help clinicians address some challenging issues, including the probability of future pregnancies after the end of treatment. Anti-Müllerian hormone (AMH) and age can reliably estimate ovarian reserve. A limited number of studies have evaluated AMH and age as predictors of residual ovarian reserve following cytotoxic chemotherapy in breast cancer patients.

Materials and Methods.

To conduct a meta-analysis of published data on this topic, we searched the medical literature using the key MeSH terms “amenorrhea/chemically induced,” “ovarian reserve,” “anti-Mullerian hormone/blood,” and “breast neoplasms/drug therapy.” Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements guided the search strategy. U.K. National Health Service guidelines were used in abstracting data and assessing data quality and validity. Area under the receiver operating characteristic curve (ROC/AUC) analysis was used to evaluate the predictive utility of baseline AMH and age model.

Results.

The meta-analysis of data pooled from the selected studies showed that both age and serum AMH are reliable predictors of post-treatment ovarian activity in breast cancer patients. Importantly, ROC/AUC analysis indicated AMH was a more reliable predictor of post-treatment ovarian activity in patients aged younger than 40 years (0.753; 95% confidence interval [CI]: 0.602–0.904) compared with those older than 40 years (0.678; 95% CI: 0.491–0.866). We generated a nomogram describing the correlations among age, pretreatment AMH serum levels, and ovarian activity at 1 year from the end of chemotherapy.

Conclusion.

After the ongoing validation process, the proposed nomogram may help clinicians discern premenopausal women requiring cytotoxic chemotherapy who should be considered high priority for fertility preservation counseling and procedures.

Implications for Practice:

In general, a nomogram helps clinicians better visualize a specific risk for a single patient. In premenopausal women affected by early breast cancer who need adjuvant cytotoxic regimens, the proposed nomogram—based on the assessment of pretreatment age and anti-Müllerian hormone serum levels—can assess the personal probability of maintaining ovarian activity at 1 year from the end of chemotherapy. The ongoing validation process is also evaluating other key factors contributing to post-treatment ovarian activity (i.e., type of cytotoxic regimen) and will confirm the nomogram’s reliability and clinical utility.     

Oxaliplatin: a review in the era of molecularly targeted therapy

Objective

To review preclinical and clinical data for oxaliplatin in the current context of molecularly targeted therapy.

Methods of Study Selection

We searched the PubMed and PubChem databases by combining the search terms “oxaliplatin” or “platinum” or both, with “clinical trials,” “pharmacokinetics,” and “pharmacodynamics.”

Data Extraction and Synthesis

Oxaliplatin has a complicated pharmacokinetic profile, with activity against digestive cancers in particular. It has several mechanisms of action, but cancer cells can develop resistance. Real or potential synergism has been observed when oxaliplatin is combined with other cytotoxic agents or molecularly targeted agents. Peripheral neuropathy is a prominent toxic effect.

Conclusions

Oxaliplatin lends itself to further clinical research in combination with molecularly targeted therapy.     

Brain metastases from solid tumors: disease outcome according to type of treatment and therapeutic resources of the treating center

Background

To evaluate the therapeutic strategies commonly employed in the clinic for the management of brain metastases (BMs) and to correlate disease outcome with type of treatment and therapeutic resources available at the treating center.

Methods

Four Cancer centres participated to the survey. Data were collected through a questionnaire filled in by one physician for each centre.

Results

Clinical data regarding 290 cancer patients with BMs from solid tumors were collected. Median age was 59 and 59% of patients had ≤ 3 brain metastases. A local approach (surgery and stereotactic radiosurgery) was adopted in 31% of patients. The local approach demonstrated to be superior in terms of survival compared to the regional/systemic approach (whole brain radiotherapy and chemotherapy, p = <.0001 for survival at 2 years). In the multivariate analysis local treatment was an independent prognostic factor for survival. When patients were divided into 2 groups whether they were treated in centers where local approaches were available or not (group A vs group B respectively, 58% of patients with ≤ 3 BMs in both cohorts), more patients in group A received local strategies although no difference in time to brain progression at 1 year was observed between the two groups of patients.

Conclusions

In clinical practice, local strategies should be integrated in the management of brain metastases. Proper selection of patients who are candidate to local treatments is of crucial importance.     

Ondansetron rapidly dissolving film for the prophylactic treatment of radiation-induced nausea and vomiting—a pilot study

Introduction

The purpose of the present study was to investigate the efficacy of an ondansetron rapidly dissolving film (rdf) in the prophylaxis of radiation-induced nausea and vomiting (rinv). Rapidly dissolving film formulations facilitate drug delivery in circumstances in which swallowing the medication might be difficult for the patient.

Methods

Patients undergoing palliative radiotherapy at risk for rinv were prescribed ondansetron rdf 8 mg twice daily while on treatment and were asked to complete a nausea and vomiting–specific daily diary, the Functional Living Index–Emesis (flie), and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–C15 Palliative (qlq-C15-pal). Patients were categorized as receiving primary or secondary prophylaxis based on whether they had already experienced emetic episodes. “Overall control” was defined as a maximum increase of 2 episodes of nausea or vomiting from baseline. “Acute phase” was defined as the days during radiation until the first day after radiation; “delayed phase” was defined as days 2–10 after radiation.

Results

The study accrued 30 patients. Rates of overall control for nausea and for vomiting during the acute phase in the primary prophylaxis group were 88% and 93% respectively; during the delayed phase, they were 73% and 75%. Rates of overall control for nausea and for vomiting during the acute phase in the secondary prophylaxis group were both 100%; during the delayed phase, they were 50%. The number of nausea and vomiting episodes was found to be significantly correlated with the flie and qlq-C15-pal questionnaires.

Conclusions

Ondansetron rdf is effective for the prophylaxis of rinv.     

The role of ultrasound and ultrasound-guided fine needle aspiration biopsy of lymph nodes in patients with skin tumours

Background

The primary aim of this study was to evaluate the diagnostic accuracy of ultrasound (US) in the study of superficial lymph nodes during the follow-up of patients surgically treated for skin tumours. The secondary objective was to compare positive cytological results with histological reports.

Patients and methods

From 2004 to 2011, 480 patients (male/female: 285/195; median age 57 years; prevalent skin tumour: melanoma) underwent US-guided fine-needle aspiration biopsy (FNAB) of suspicious recurrent lymph nodes. An expert radiologist first performed US testing of the lymph nodes, expressing either a negative or positive outcome of the test. Subsequently, US-guided FNAB was performed. FNAB positive patients were subjected to lymphadenectomy; the patients who tested negative underwent the follow-up.

Results

The size of lymph nodes was ≤ 2 cm in 90% of cases. Out of the 336 (70%) US “positive” patients, 231 (68.8%) were FNAB positives. Out of the 144 (30%) US “negatives”, 132 (91.7%) were FNAB negatives. The sensitivity and specificity of the US were 95% and 55.7%, respectively; the negative predictive value was 91.7% and the positive predictive value was 68.8%. Definitive histological results confirmed FNAB positivity in 97.5% of lymphadenectomies.

Conclusions

US is a sensitive method in the evaluation of superficial lymph nodes during the follow-up of patients with skin tumours. High positive predictive value of cytology was confirmed.