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Stereotactic radiotherapy (SRT) offers a treatment option for hepatocellular carcinoma (HCC) patients that are not eligible for surgery, embolization, chemotherapy, or radiofrequency ablation. We have evaluated the feasibility, tolerance and toxicity of SRT for 25 HCC patients who were not eligible for these other modalities. The patients (6 women and 19 men) were treated with CyberKnife stereotactic radiotherapy using respiratory motion tracking. All patients had liver cirrhosis with an Eastern Cooperative Oncology Group (ECOG) performance score of less than 2 and pre-treatment Child scores ranging from A5 to B9. A total dose of 45 Gy in three fractions of 15 Gy each was prescribed to the 80% isodose line (95% of the PTV received 45 Gy) and delivered to the target volume over 10 to 12 days. Overall the treatment was well tolerated with two Grade 3 acute toxicities and no acute Grade 4 toxicities. Late toxicity was minimal with all observed late toxicities occurring within the first six months of follow-up. Three hepatic recurrences at a distance from the target and one metastasis were observed. The actuarial 1- and 2-year local control rate was 95% (95% CI: 69-95%). At a median overall follow-up of 12,7 months (range, 1-24 months), six of the twenty-five (24%) patients have died. Overall actuarial survival at 1- and 2-years was 79% (95% CI: 52-92%) and 52% (95% CI: 19-78%), respectively. Our results suggest promising therapeutic efficacy and good clinical tolerance to CyberKnife SRT treatment for HCC patients not eligible for other treatment modalities.

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ObjectiveTo describe post-CyberKnife® imaging characteristics of liver metastases as an aid in assessing response to treatment, and a novel set of combined criteria (CC) as an alternative to response according to change in size (RECIST).Subjects and MethodsImaging data and medical records of 28 patients with 40 liver metastases treated with stereotactic body radiotherapy (SBRT) were reviewed. Tumor size, CT attenuation coefficient, and contrast enhancement of lesions were evaluated up to 2 years post SBRT. Rates of local control, progression-free survival, time to progression, and overall survival according to RECIST and CC were estimated.ResultsComplete response (CR) was 3.6% (95% CI: 0.1–18%) and 18% (95% CI: 6–37%) according to RECIST and combined criteria, respectively. Two progressive diseases and two partial responses according to RECIST were classified as CR by the combined criteria and one stable response according to RECIST was classified as progressive by CC (Stuart-Maxwell test, p = 0.012). The disease control rate was 60.7% (95% CI: 41–78%) by RECIST and 64% (95% CI: 44%–81%) by CC.ConclusionUse of response criteria based on change in size alone in the interpretation of liver response to SBRT may be inadequate. We propose a simple algorithm with a combination of criteria to better assess tumor response. Further studies are needed to confirm their validity.

BACKGROUND: To evaluate the antitumour activity and safety of metronomic cyclophosphamide vs megestrol acetate in progressive and advanced cancer patients having exhausted all effective therapies under standard care. METHODS: Patients were randomly assigned to receive orally metronomic cyclophosphamide (50 mg b.i.d) or megestrol acetate (160 mg only daily) until intolerance or progression (RECIST 1.0). The primary efficacy end point was a 2-month progression-free rate (PFR 2m ). According to Optimal Simon's design and the following assumptions, namely, P0 ¼ 5%, P1 ¼ 20%, a ¼ b ¼ 10%, the treatment is considered as effective if atleast 5 out of 44 patients achieved PFR 2m . RESULTS: Between September 2006 and January 2009, 88 patients were enrolled. Two patients experienced grade 3 -4 toxicities in each arm (4%). One toxic death occurred in the megestrol acetate arm as a consequence of thrombosis. The metronomic cyclophosphamide arm reached the predefined level of efficacy with a PFR 2m rate of 9 out of 44 and a PFR 4m rate of 5 out of 44. The MA arm failed to achieve the level of efficacy with a PFR 2m of 4 out of 44 and a PFR 4m of 1 out of 44. The median overall survival was 195 and 144 days in the metronomic cyclophosphamide arm and megestrol acetate arm, respectively. CONCLUSION: Metronomic cyclophosphamide is well tolerated and provides stable disease in such vulnerable and poor-prognosis cancer patients. This regimen warrants further evaluations.

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Background: Prospective trials have demonstrated the advantage of dose-escalated radiotherapy for the biochemical and clinical control of intermediate risk prostate cancer. Dose escalation improves outcomes but increases risks of urinary and bowel toxicity. Recently the contribution of "spacers" positioned in the septum between the rectum and the prostate could improve the functional results of intensity modulated radiation therapy (IMRT). To date most of the evaluated devices were polyethylen glycol (PEG) and hyaluronic acid (HA). Men on the Spacer arm had decreased bowel toxicity and less decline in both urinary and bowel quality of life as compared to Control men in a randomized trial.Methods: This is an interventional, multi-center study to evaluate the use of biodegradable inflatable balloon for patients with intermediate risk prostate cancer treated by IMRT (74 to 80 Gy, 2 Gy/fraction) with daily image guided radiotherapy. Discussion: This multicenter prospective study will yield new data regarding dosimetric gain and implantation stages of Bioprotect balloon. Acute and late toxicities and quality of life will be registered too.