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Background: The purpose of this study was to investigate the prevalence of ypNþ status according to ypT category in patients with locally advanced rectal cancer treated with chemoradiotherapy and total mesorectal excision, and to assess the impact of ypNþ on disease recurrence and survival by pooled analysis of individual-patient data. Methods: Individual-patient data from 10 studies of chemoradiotherapy for rectal cancer were included. Pooled rates of ypNþ disease were calculated with 95 per cent confidence interval for each ypT category. Kaplan-Meier and Cox regression analyses were undertaken to assess influence of ypN status on 5-year disease-free survival (DFS) and overall survival (OS). Results: Data on 1898 patients were included in the study. Median follow-up was 50 (range 0-219)months. The pooled rate of ypNþ disease was 7 per cent for ypT0, 12 per cent for ypT1, 17 per cent for ypT2, 40 per cent for ypT3, and 46 per cent for ypT4 tumours. Patients with ypNþ disease had lower 5-year DFS and OS (46.2 and 63.4 per cent respectively) than patients with ypN0 tumours (74.5 and 83.2 per cent) (P<0.001). Cox regression analyses showed ypNþ status to be an independent predictor of recurrence and death. Conclusion: Risk of nodal metastases (ypNþ) after chemoradiotherapy increases with advancing ypT category and needs to be considered if an organ-preserving strategy is contemplated. [ABSTRACT FROM AUTHOR]

Summary: Background: Basal cell carcinoma (BCC) is the most common type of skin cancer and incidence rates are increasing. Photodynamic therapy (PDT) is a frequently used treatment, especially for superficial BCC (sBCC). Two topical photosensitizing agents are currently used to treat sBCC, namely 5‐aminolaevulinic acid (ALA) and its ester, methyl aminolaevulinate (MAL). Previous research showed a high efficacy for ALA‐PDT using a twofold fractionated illumination scheme in which two light fractions of 20 J cm−2 and 80 J cm−2 were delivered 4 h and 6 h after ALA application. Objectives: To evaluate whether twofold ALA‐PDT is superior to conventional MAL‐PDT for sBCC. Methods: We performed a single‐blind, randomized, multicentre trial in the Netherlands. Results: Overall, 162 patients were randomized either to conventional MAL‐PDT or twofold ALA‐PDT. After 12 months, a total of six treatment failures occurred following ALA‐PDT and 13 treatment failures occurred following MAL‐PDT. The 12‐month cumulative probability of remaining free from treatment failure was 92·3% [95% confidence interval (CI) (83·7–96·5)] for ALA‐PDT and 83·4% (95% CI 73·1–90·0) for MAL‐PDT (P = 0·091). Conclusions: The twofold ALA‐PDT scheme resulted in fewer recurrences, although the difference between both treatment groups was not statistically significant. However, ALA‐PDT resulted in higher pain scores and more post‐treatment side‐effects compared with MAL‐PDT. [ABSTRACT FROM AUTHOR]

Background A recent noninferiority randomized trial showed that in terms of clinical effectiveness imiquimod was superior and topical fluorouracil noninferior to methylaminolaevulinate photodynamic therapy (MAL-PDT) for treatment of superficial basal-cell carcinoma ( sBCC). Although it was expected that MAL-PDT would be more costly than either cream, a full cost-effectiveness analysis is necessary to determine the balance between effectiveness and costs. Objective To determine whether imiquimod or topical fluorouracil are cost-effective treatments for sBCC compared with MAL-PDT. Methods An economic evaluation was performed from a healthcare perspective. Data on resource use and costs were collected alongside the randomized clinical trial. The incremental cost-effectiveness ratio was expressed as the incremental costs per additional patient free of tumour recurrence. Results At 12 months follow-up, the total mean costs for MAL- PDT were €680, for imiquimod cream €526 and for topical fluorouracil cream €388. Both imiquimod and topical fluorouracil were cost-effective treatments compared with MAL- PDT. Comparing costs and effectiveness of both creams led to a incremental investment of €4451 to achieve an additional patient free of tumour recurrence. The acceptability curve showed that, for a threshold value of €4451, the probability of imiquimod being more cost-effective than topical fluorouracil was 50%. Conclusion Based on the 12 months follow-up results, imiquimod and topical fluorouracil cream are more cost-effective than MAL-PDT for treatment of sBCC. Hence, substituting MAL-PDT with either imiquimod or topical fluorouracil results in cost savings; these savings will be larger for topical fluorouracil. Long-term follow-up effectiveness data are necessary to confirm the cost-effectiveness of imiquimod vs. topical 5-fluorouracil cream. [ABSTRACT FROM AUTHOR]

Background A recent noninferiority randomized trial showed that in terms of clinical effectiveness imiquimod was superior and topical fluorouracil noninferior to methylaminolaevulinate photodynamic therapy (MAL-PDT) for treatment of superficial basal-cell carcinoma (sBCC). Although it was expected that MAL-PDT would be more costly than either cream, a full cost-effectiveness analysis is necessary to determine the balance between effectiveness and costs. Objective To determine whether imiquimod or topical fluorouracil are costeffective treatments for sBCC compared with MAL-PDT. Methods An economic evaluation was performed from a healthcare perspective. Data on resource use and costs were collected alongside the randomized clinical trial. The incremental cost-effectiveness ratio was expressed as the incremental costs per additional patient free of tumour recurrence. Results At 12 months follow-up, the total mean costs for MAL-PDT were €680, for imiquimod cream €526 and for topical fluorouracil cream €388. Both imiquimod and topical fluorouracil were cost-effective treatments compared with MAL-PDT. Comparing costs and effectiveness of both creams led to a incremental investment of €4451 to achieve an additional patient free of tumour recurrence. The acceptability curve showed that, for a threshold value of €4451, the probability of imiquimod being more cost-effective than topical fluorouracil was 50%. Conclusion Based on the 12 months follow-up results, imiquimod and topical fluorouracil cream are more cost-effective than MAL-PDT for treatment of sBCC. Hence, substituting MAL-PDT with either imiquimod or topical fluorouracil results in cost savings; these savings will be larger for topical fluorouracil. Longterm follow-up effectiveness data are necessary to confirm the cost-effectiveness of imiquimod vs. topical 5-fluorouracil cream. [ABSTRACT FROM AUTHOR]

Background: New minimally invasive treatment modalities, such as ultrasound-guided foam sclerotherapy (UGFS), are becoming more popular. In a multicentre randomized controlled non-inferiority trial, the effectiveness and costs of UGFS and surgery for treatment of the incompetent great saphenous vein (GSV) were compared. Methods: Patients with primary great saphenous varicose veins were assigned randomly to either UGFS or surgical stripping with high ligation. Recurrence, defined as reflux combined with venous symptoms, was determined on colour duplex scans at baseline, 3 months, 1 year and 2 years after initial treatment. Secondary outcomes were presence of recurrent reflux (irrespective of symptoms), reduction of symptoms, health-related quality of life (EQ-5D™), adverse events and direct hospital costs. Results: Two hundred and thirty patients were treated by UGFS and 200 underwent GSV stripping. The 2-year probability of recurrence was similar in the UGFS and surgery groups: 11·3 per cent (24 of 213) and 9·0 per cent (16 of 177) respectively ( P = 0·407). At 2 years, reflux irrespective of venous symptoms was significantly more frequent in the UGFS group (35·0 per cent) than in the surgery group (21·0 per cent) ( P = 0·003). Mean(s.d.) hospital costs per patient over 2 years were €774(344) per patient for UGFS and €1824(141) for stripping. Conclusion: At 2-year follow-up, UGFS was not inferior to surgery when reflux associated with venous symptoms was the clinical outcome of interest. UGFS has the potential to be a cost-effective approach to a common health problem. Registration numbers: NCT01103258 () and NTR654 (). Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background Skin cancer incidence rates have been increasing for decades and this increase is expected to continue. Surgical excision (SE) is the treatment of first choice for nodular basal cell carcinoma (nBCC). Photodynamic therapy (PDT) has proven to be an effective treatment for superficial basal cell carcinoma. Its long-term efficacy in nBCC has not yet been established. Objectives Prospectively compare the efficacy of 5-aminolaevulinic acid (ALA)–PDT and SE in terms of failure rates with long-term follow-up. Determinants of failure in the study population, such as the effect of tumour depth, were analysed retrospectively. Methods A randomized controlled trial in 173 primary nBCCs in 149 patients. Primary nBCCs were randomly assigned either to PDT ( n = 85) or to SE ( n = 88). Tumours treated with PDT were illuminated twice on the same day, 4 h after application of ALA cream, 3 weeks after debulking. SE was performed under local anaesthesia with a 3-mm margin, followed by histological examination. An intention-to-treat analysis was performed. Results In total, 171 primary nBCCs in 149 patients were treated. A 3-year interim analysis revealed that the cumulative incidence of failure was 2·3% for SE and 30·3% for PDT ( P < 0·001). Tumour depth and other analysed determinants of failure were not significantly related to treatment failure. Conclusions SE proved to be significantly more effective than treatment with fractionated illumination ALA–PDT. Therefore, in the treatment of primary nBCC, SE is preferred over PDT following this treatment regimen. [ABSTRACT FROM AUTHOR]

Background Erysipelas is a common skin infection that is usually caused by β-haemolytic group A streptococci. After having had erysipelas in an extremity, a significant percentage of patients develops persistent swelling or suffers from recurrent erysipelas. We hypothesize that in cases of erysipelas without a clear precipitating agent, subclinical pre-existing congenital or acquired disturbances in the function of the lymphatic system are present. The persistent swelling after erysipelas is then most likely caused by lymphoedema. Objectives We designed a study to examine if erysipelas of unknown origin is associated with a pre-existent insufficiency of the lymphatic system. If our hypothesis is correct, patients with erysipelas of unkown cause without previously evident lymphoedema should have evidence of disturbed lymphatic transport in the unaffected extremity. Methods A prospective study, in which lymphoscintigraphy of both legs was performed in patients 4 months after presenting with an episode of erysipelas only in one leg. No patient had any known risk factor for erysipelas, such as diabetes mellitus, chronic venous insufficiency or clinical signs of lymphoedema. Lymphoscintigraphy was performed in 40 patients by subcutaneous injection of Tc-99m-labelled human serum albumin in the first web space of both feet. After 30 and 120 min, quantitative and qualitative scans were performed using a computerized gamma camera. During the lymphoscintigraphy, the patients performed a standardized exercise programme. Lymph drainage was quantified as the percentage uptake of Tc-99m-labelled human serum albumin in the groin nodes at 2 h after injection. Groin uptake of < 15% is pathological; uptake between 15–20% is defined as borderline, and uptake of > 20% as normal. Results The mean ± SD percentage uptake in the groin nodes in the affected limbs was 9·6 ± 8·5% vs. 12·1% ± 8·9% in the nonaffected limbs. The mean paired difference in uptake between the nonaffected vs. affected side was 2·5% (95% confidence interval 1·1–3·9%). This indicates that lymphatic drainage in the nonaffected limb was only slightly better than in the affected limb despite the infectious event in the latter. Of 33 patients with objective impairment of lymph drainage in the affected limb, 26 (79%) also had impaired lymph drainage in the nonaffected limb. Agreement in qualitative measurements between affected and nonaffected leg was less pronounced: 21 patients had abnormal qualitative results in the affected leg of whom nine also had impairment of the nonaffected leg (43%). Conclusions Erysipelas is often presumed to be purely infectious in origin, with a high rate of recurrence and a risk of persistent swelling due to secondary lymphoedema. In this study, we show that patients presenting with a first episode of erysipelas often have signs of pre-existing lymphatic impairment in the other, clinically nonaffected, leg. This means that subclinical lymphatic dysfunction of both legs may be an important predisposing factor. Therefore, we recommend that treatment of erysipelas should focus not only on the infection but also on the lymphological aspects, and long-standing treatment for lymphoedema is essential in order to prevent recurrence of erysipelas and aggravation of the pre-existing lymphatic impairment. Our study may change the clinical and therapeutic approach to erysipelas as well as our understanding of its aetiology. [ABSTRACT FROM AUTHOR]

The incidence of skin cancer and especially basal cell carcinoma (BCC) has increased in the last decade and is still increasing. Many treatment modalities can be used to treat BCC; surgical excision is the most frequently used. Mohs' micrographic surgery (MMS) is an advanced excision technique which is often used to treat BCC in the U.S.A. In Europe it is practised less frequently. The aim of this article was to evaluate the efficiency of MMS for the treatment of facial BCC. In a retrospective study recurrence rates after the treatment of facial BCC by MMS were estimated by reviewing the records of all patients with BCCs (620 patients with 720 BCCs) treated by MMS in our department from April 1992 until December 1999. The 5-year recurrence rates estimated from this study were 3·2% for primary BCC and 6·7% for recurrent BCC. Prognostic factors for recurrence are: an aggressive histopathological subtype, more than four Mohs' stages, a large defect size and a recurrent BCC. Based on the fact that MMS provides the lowest recurrence rates, it is the treatment of first choice for primary facial BCCs with an aggressive histopathological subtype and for recurrent BCCs in the face. [ABSTRACT FROM AUTHOR]

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A response by A. Arits, P. Nelemans and N. Kelleners-Smeets to a letter to the editor about their article "Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: A single blind, non-inferiority, randomised controlled trial: A critical appraisal" in a 2014 issue is presented.