Short communication: Epidemiological assessment of Strongyloides stercoralis in Fijian children.

As a part of the lymphatic filariasis (LF) transmission assessment survey (TAS)/soil-transmitted helminths (STH) prevalence survey in Western Division of Fiji, a pilot screen for Strongyloides stercoralis (SS) in school children was undertaken using a combination of the Baermann concentration (BC) method and real-time PCR assays. Using BC, faecal samples collected from 111 children of 7 schools were examined. A single child was positive for larvae of SS and underwent a clinical examination finding an asymptomatic infection. Other members of this child's household were screened with BC, finding none infected. Aliquots of 173 faecal samples preserved in ethanol originating from all schools were examined by real-time PCR, and the prevalence of SS infection was 3.5%. Our study confirms the existence of SS infection on Fiji and showed that assessing SS prevalence alongside TAS/STH survey is a convenient access platform, allowing introduction of other surveillance techniques such as BC and real-time PCR.

Growth modulation index as metric of clinical benefit assessment among advanced soft tissue sarcoma patients receiving trabectedin as a salvage therapy.

BACKGROUND: The growth modulation index (GMI) is the ratio of time to progression with the nth line (TTP(n)) of therapy to the TTP(n)(-1) with the n-1th line. GMI >1.33 is considered as a sign of activity in phase II trials. PATIENTS AND METHODS: This retrospective analysis evaluated the concordance between the GMI and the efficacy outcomes in 279 patients with advanced soft tissue sarcoma (ASTS) treated with trabectedin 1.5 mg/m² (24-h infusion every 3 weeks) in four phase II trials. RESULTS: One hundred and forty-two (51%) patients received one prior line and 137 ≥ 2 lines. The median TTP(n) was 2.8 months (range 0.2-26.8), whereas the median TTP(n)(-1) was 4.0 months (0.3-79.5). The median GMI was 0.6 (0.0-14.4). Overall, 177 patients (63%) had a GMI <1; 21 (8%) a GMI equal to 1-1.33 and 81 (29%) a GMI >1.33, which correlated with the median overall survival in those patients (9.1, 13.9 and 23.8 months, respectively, P = 0.0005). A high concordance rate between the GMI and response rate (P < 0.0001) and progression-free survival (PFS, P < 0.0001) was observed. Good performance status (PS) was the only factor associated with GMI >1.33 (PS = 0; P < 0.04). CONCLUSIONS: A high GMI was associated with favorable efficacy outcomes in patients treated with trabectedin. Further research is needed to assess GMI as an indicator in this setting.

The price of success: cost-effectiveness of molecularly targeted agents.

The advent of molecularly targeted agents has brought major breakthroughs in oncology. However, because these drugs are expensive and financial resources are limited, attention to their cost-effectiveness is rapidly increasing. It seems that establishment of cost-effectiveness is complex but is determined for the most part by the cost of drug acquisition and the drug's efficacy. This article examines the cost-effectiveness of molecularly targeted drugs.

Application of a circulating-cathodic-antigen (CCA) strip test and real-time PCR, in comparison with microscopy, for the detection of Schistosoma haematobium in urine samples from Ghana.

In the detection of parasitic infection, the traditional methods based on microscopy often have low sensitivity and/or specificity compared with the newer, molecular tests. An assay based on real-time PCR and a reagent strip test for detecting circulating cathodic antigen (CCA) have both now been compared with urine filtration and microscopy, in the detection of Schistosoma haematobium infections. Urine samples, obtained from 74 'cases' in areas of Ghana with endemic S. haematobium and 79 'controls' from non-endemic areas, were each checked using the three methods. With the results of the filtration and microscopy taken as the 'gold standard', real-time PCR was found to be 100% specific and 89% sensitive whereas the CCA strips were 91% specific and 41% sensitive. With the samples found to contain > or =50 eggs/10 ml (indicating relatively intense infections), the sensitivities of the PCR and CCA were higher, at 100% and 62%, respectively. As expected, egg counts were negatively correlated with the number of amplification cycles needed, in the PCR, to give a signal that exceeded the background (r=-0.38; P<0.01). Although the real-time PCR and CCA strip tests are very different, both show promise in the detection of S. haematobium infections. The PCR has optimal specificity and high sensitivity but the specificity of the CCA strips and the sensitivity of both tools could still be improved. A more thorough re-evaluation of the sensitivity and specificity of microscopy and these newer diagnostic methods, with an estimation of the cost-effectiveness of each technique, is recommended.

RECIST revisited: a review of validation studies on tumour assessment.

The response evaluation criteria in solid tumours (RECIST) was developed in the late 1990s to replace the WHO criteria for response evaluation. The new criteria included important changes such as unidimensional tumour measurement, selection of target lesions with a minimum size, details concerning imaging modalities and a new threshold for assignment of objective progression. RECIST was published in February 2000 and very quickly came into operation first in clinical trials performed under the auspices of EORTC, US NCI or NCI Canada Clinical Trials Group but was adopted quickly thereafter by the entire cancer clinical research community. As several key features of RECIST were based on analysis of retrospective clinical data, it was felt important to carefully monitor the implementation of the guidelines and stimulate prospective validation studies. This paper reviews the literature that has been published on RECIST from 2000 up to November 2005. In total 60 papers and ASCO, abstracts directly refer to research studies or reviews related to RECIST and its implementation. Amongst the 60 references identified for this review, 11 papers refer to validation studies (seven prospective and four retrospective), six papers refer to the comparison of unidimensional measurements versus bi or tri-dimensional measurements, 12 papers address issues raised with the implementation of RECIST in Mesothelioma and Gastro-Intestinal Stromal Tumours and four papers report on an adaptation of RECIST for specific tumour types. In general, RECIST has been well received by the scientific community and most validation studies fully support the implementation of the new criteria. As expected, however, some issues have been identified. In keeping with the mathematical differences in definition of progression, RECIST delays the identification of progression as compared to WHO criteria in some instances. RECIST criteria are not easily applicable in some types of trials such as those in paediatric tumours and in mesothelioma. Furthermore, anatomical changes in the tumour as described by RECIST may be detected later than functional changes in some circumstances, as for example in Gastro-Intestinal Stromal Tumours treated with Imatinib. However, there is no other universal method of tumour assessment as yet and functional imaging methods have not been validated and will not be widely available for some time. The findings of this review, together with experience acquired thus far and the results of some ongoing research projects, have paved the way for RECIST 2.0 to be hopefully announced later this year.

[The Dutch Health Council report on palliative chemotherapy: possible confusion on ideas]. / Het Gezondheidsraadrapport 'Palliatieve chemotherapie'; risico van begripsverwarring.

The Dutch Health Council has issued a report advising the government on the care of cancer patients and on palliative chemotherapy in particular. The term palliative chemotherapy is ambiguous and may lead to confusion because it does not mean intention of cure and because the Council makes the assumption that palliative chemotherapy is used to enhance the quality of life, which is not in fact the case. In daily oncological clinical practice, prolonging life is the main objective. The report should have focused on better objectives for the systemic treatment of cancer. Four recommendations are contained within the report: (a) participation in clinical trials should be encouraged; the current implementation of good clinical practice guidelines and the Medical Research (Human Subjects) Act do not provide much support for this recommendation; (b) medication for palliative chemotherapy should be assessed for cost effectiveness; this is a political assessment and the responsibility for its implementation should not lie with the medical profession; (c) the quality of palliative chemotherapy should be ensured, therefore its application should be restricted to the trained medical oncologists; (d) in view of the complexity of the treatment nationwide guidelines are needed.