Does a 6-point scale approach to post-treatment 18F-FDG PET-CT allow to improve response assessment in head and neck squamous cell carcinoma? A multicenter study.

PURPOSE: Response assessment to definitive non-surgical treatment for head and neck squamous cell carcinoma (HNSCC) is centered on the role of 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET-CT) 12 weeks after treatment. The 5-point Hopkins score is the only qualitative system available for standardized reporting, albeit limited by suboptimal positive predictive value (PPV). The aim of our study was to explore the feasibility and assess the diagnostic accuracy of an experimental 6-point scale ("Cuneo score"). METHODS: We performed a retrospective, multicenter study on HNSCC patients who received a curatively-intended, radiation-based treatment. A centralized, independent qualitative evaluation of post-treatment FDG-PET/CT scans was undertaken by 3 experienced nuclear medicine physicians who were blinded to patients' information, clinical data, and all other imaging examinations. Response to treatment was evaluated according to Hopkins, Cuneo, and Deauville criteria. The primary endpoint of the study was to evaluate the PPV of Cuneo score in assessing locoregional control (LRC). We also correlated semi-quantitative metabolic factors as included in PERCIST and EORTC criteria with disease outcome. RESULTS: Out of a total sample of 350 patients from 11 centers, 119 subjects (oropharynx, 57.1%; HPV negative, 73.1%) had baseline and post-treatment FDG-PET/CT scans fully compliant with EANM 1.0 guidelines and were therefore included in our analysis. At a median follow-up of 42 months (range 5-98), the median locoregional control was 35 months (95% CI, 32-43), with a 74.5% 3-year rate. Cuneo score had the highest diagnostic accuracy (76.5%), with a positive predictive value for primary tumor (Tref), nodal disease (Nref), and composite TNref of 42.9%, 100%, and 50%, respectively. A Cuneo score of 5-6 (indicative of residual disease) was associated with poor overall survival at multivariate analysis (HR 6.0; 95% CI, 1.88-19.18; p = 0.002). In addition, nodal progressive disease according to PERCIST criteria was associated with worse LRC (OR for LR failure, 5.65; 95% CI, 1.26-25.46; p = 0.024) and overall survival (OR for death, 4.81; 1.07-21.53; p = 0.04). CONCLUSIONS: In the frame of a strictly blinded methodology for response assessment, the feasibility of Cuneo score was preliminarily validated. Prospective investigations are warranted to further evaluate its reproducibility and diagnostic accuracy.

Fatigue in patients undergoing radiation therapy: an observational study.

AIM: Fatigue can be defined as an unpleasant feeling of tiredness, weakness and lack of energy. It is found in about 80% of the patients receiving radiation therapy and has a significant impact on quality of life. The aim of this paper was to assess the frequency, severity and changes of fatigue before, during and after administration of a nutraceutical (mixture of whey protein with an high biological value, with an high content in native cysteine, albumin and lactoferrin in patients undergoing treatment for breast and prostate cancer. METHODS: Thirty patients (20 breast and 10 prostate ones) were enrolled in our test and they received a questionnaire about Fatigue developed by the University of Texas, MD Anderson Cancer Center, 1999. The patients who achieved a score between 4 and 6 were administered the nutraceutical (Prother) at a dose of 20 g / day for the first 10 days of radiation treatment and then 10 g/day for the following 20 days without considering the terms of the radiation oncology treatment [corrected]. Each patient was reassessed using the same Fatigue test after 10 and 30 days from the start of the administration of nutraceutical. We enrolled 30 control patients who did not receive Prother. RESULTS: The results showed the effectiveness of Prother in all patients with moderate-to-mild fatigue. CONCLUSION: The administration of Prother has therefore been effective in terms of both improving the compliance of the radiation treatment and the quality of life.

Piercing the upper ear: a simple infection, a difficult reconstruction.

Piercing the upper ear to retain jewellery is now commonplace. When infection ensues, devastating chondritis leads to collapse of the ear. To our knowledge, the surgical reconstruction of post-piercing deformities has not been documented in the literature. We present five such cases referred for autogenous-tissue ear reconstruction. In four of these, the destroyed segments of ear cartilage were replaced with a carved costal-cartilage framework. One patient declined surgery. The importance of preventing infection is stressed.

[Evaluation of the tolerability of Hydrogel breast implants: a pilot study]. / Studio pilota per la valutazione della tollerabilità delle protesi tipo hydrogel.

BACKGROUND: During the 90s the widely publicised controversy regarding the use of silicone gel breast implants stimulated research into alternative alloplastic filling materials. In this context, a new type of breast implant, containing Carboxymethylcellulose at 3.7% in the form of Hydrogel, was introduced into the European market. METHODS: A preliminary pilot study was carried out to evaluate the tolerability and reliability of breast implants pre-filled with Hydrogel. A group of 12 consecutive patients was recruited for this purpose and underwent plastic surgery for breast augmentation or reconstruction (20 implants) at the Department of Plastic and Reconstructive Surgery at the University of Genoa between December 1996 and October 1997. All patients were then followed up for a minimum of 3.5 years. The mean age of patients was 50 years and ranged from 28 to 67 years old. After surgery the patients were examined at 4 weeks (evaluation of any immediate complications), 3 months, 6 months and 1 year (evaluation of any delayed complications). RESULTS: No immediate complications were reported in any patient. After 3.5 years of follow-up, the degree of capsular contraction according to Baker in these patients varies between 1 and 2. In general, the implants were very soft to touch even some time after surgery, above all in patients undergoing breast augmentation. Four implants (20%) were removed from 3 patients for reasons unconnected to the implants themselves (because of neoplasm in one case and due to inadequate volume in the other two patients). No case of rupture has been reported. CONCLUSIONS: This pilot study appears to confirm the validity of implants prefilled with Hydrogel in reconstructive or cosmetic breast surgery. A larger population and longer periods of minimum follow-up are obviously required to confirm these results over the long term.

Two case reports of vinorelbine extravasation: management and review of the literature.

Vinorelbine tartrate (Navelbine, Burroughs Wellcome Company, Research Triangle Park, NC, USA) is a semisynthetic vinca alkaloid approved in many countries for the first-line treatment of patients with advanced non-small-cell lung cancer. It is also used in the treatment of advanced breast and ovarian cancers and lymphoma. Like other vinca alkaloids, Navelbine can cause skin necrosis as a consequence of inadvertent extravasation in surrounding tissues during intravenous administration. In such cases, early treatment is strongly advocated. There is no documented case of vinorelbine extravasation in the literature. The authors herein report two cases successfully treated with hyaluronidase injections plus saline flushout under local anesthesia.

Can the cost affect the choice of various methods of postmastectomy breast reconstruction?

AIM AND BACKGROUND: A wide range of methodologies for breast reconstruction is now available. For immediate breast reconstruction we prefer to use implants, whereas reconstruction using autologous tissues, such as transverse rectus abdominis musculocutaneous flaps (TRAMF) and muscular latissimus dorsi flaps, is applied only in selected cases. In contrast, for delayed reconstruction the choice between prostheses and autologous tissue depends on various conditions. The different reconstructive methods can be adopted as a single procedure or as a combination of surgical procedures. Following the issue of legislation defining the new structure of the Italian Health Service, the need to accurately assess the costs incurred for the execution of surgical operations has taken on paramount importance. The aim of the study was to evaluate not only the clinical limits of each surgical technique, but also its cost, in order to optimize the choice of the same procedures, conditions being equal. METHODS: The study population included 105 patients who underwent breast reconstruction in the period 1st January 1994-30th June 1995. The reconstructive procedures included 48 immediate implants, 7 immediate TRAMF, 17 delayed implants, 30 delayed TRAMF, and 3 delayed latissimus dorsi muscular flaps. RESULTS: After data evaluation, we concluded that reconstruction using permanent expandable implants is the most convenient among implant reconstructions for its low global treatment cost. In fact, reconstructive procedures using temporary expanders, which require two surgical operations, have a higher cost than breast reconstruction using permanent expandable implants. Breast reconstruction using TRAMF is the most convenient because it limits the cost of surgical materials and because flap versatility limits the number of modifications on the contralateral breast. In contrast, breast reconstruction using latissimus dorsi flaps has high costs. CONCLUSIONS: There is no balance between price list and effective cost of the different surgical reconstructive procedures, which may be a point of departure to see whether it is impossible to improve the efficiency of the Health Care System and in any case open a debate between the Regions and hospitals to improve the service, keeping it at a good level.

Mammographic visualization of a nonpalpable breast mass through a radiolucent breast implant.

We report a woman who underwent augmentation mammaplasty as part of a clinical trial of the Trilucent (soybean oil-filled) breast implant in Genoa, Italy. Five months after surgery a mammography was performed in response to the patient's complaints of pressure and tightness in the area of her left breast. The mammogram clearly demonstrated a 5-mm fibroadenoma of the left breast. This is the first documented case of a nonpalpable breast lesion that was detected by mammography through the new radiolucent, triglyceride-filled implant.