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Results. Twenty-five studies were included. A negative prognostic role for low serum vitD level was observed in five cohort studies including patients with breast cancer (one study), colon cancer (two studies), prostate cancer (one study), and melanoma (one study), but not in two studies on non-small cell lung cancer and one study on breast cancer. Three of four studies showed that VDR ؉ tu-

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Chromogranin A expression in prostate cancer biopsies is an independent predictive factor of hormone refractory disease in patients with newly diagnosed prostate cancer on early androgen deprivation therapy. Plasma chromogranin A is also a reliable predictive marker and the predictive significance is maintained over time. These results deserve validation in another data set.

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SummaryMycobacterial preparations have been used with limited success against cancer apart from superficial bladder cancer. Recently, a therapeutic vaccine derived from Mycobacterium vaccae has been given to patients with prostate cancer and melanoma indicating a possible beneficial effect on disease activity in such patients. We have recently initiated a series of randomized studies to test the feasibility and toxicity of combining a preparation of heat-killed Mycobacterium vaccae (designated SRL172) with a multidrug chemotherapy regimen to treat patients with inoperable non-small cell lung cancer (NSCLC) and mesothelioma. 28 evaluable patients with previously untreated symptomatic NSCLC and mesothelioma were randomized to receive either 3 weekly intravenous combination chemotherapy alone, or chemotherapy given with monthly intra-dermal injections of SRL172. Safety and tolerability were scored by common toxicity criteria and efficacy was evaluated by survival of patients and by tumour response assessed by CT scanning. The toxicity of chemotherapy was similar in the two groups. SRL172 caused mild inflammation at the injection site. In the group of patients randomized to receive chemotherapy combined with SRL172, there was a trend towards improved response rate (54% vs. 33%) with more patients in the combined arm receiving radical surgery and radiotherapy, improved median survival (9.7 months vs. 7.5 months) and improved 1 year survival (42% vs. 18%). SRL172 appeared to improve sleep (P = 0.08) and improved appetite (P = 0.01). There was no detectable change in serum cytokine levels for gamma-interferon and TNF-α before and after treatment. In patients with NSCLC and mesothelioma, there may be a beneficial interaction when chemotherapy is administered in combination with SRL172. Confirmation of this effect and further investigation is underway in a randomized phase III trial and in laboratory models.

The aim of this study is to compare the quality of life and the levels of anxiety and depression in a relatively large group of subjects undergoing chemotherapy for soft tissue sarcoma and a control group of subjects undergoing chemotherapy for the most common types of cancer. 56 soft tissue sarcoma affected patients and 56 patients with common tumours, homogeneous in regards to stages of disease and sociodemographic characteristics, were enrolled in two oncological centres in Turin, Italy. Quality of life was assessed by Functional Assessment of Cancer Therapy-General and anxiety and depression by Hospital Anxiety and Depression Scale. All patients had ongoing chemotherapy. The comparison between the two groups shows no difference in either quality of life or in anxiety and depression. There are instead gender differences, since females in the group of common tumours show higher levels of anxiety in comparison to those affected by sarcomas, while males show, at a lower degree, the opposite trend. This study suggest that levels of Quality of Life, anxiety and depression are similar in rare and common tumours. The majority of patients are able to cope with the disease in an adaptive manner. However, for some patients the disease poses a threat to their physical and mental integrity; psychological support of these patients may reduce the development of significant morbidity and help patients to better manage the course of the disease and the effects of the treatment

We performed a multicentre randomised trial to compare the efficacy and toxicity of 12 weeks of 5-fluorouracil (5-FU) delivered by protracted intravenous infusion (PVI 5-FU) against the standard bolus regimen of 5-FU and folinic acid (5-FU/FA) given for 6 months as adjuvant treatment in colorectal cancer. A total of 716 patients with curatively resected Dukes' B or C colorectal cancer were randomised to 5-FU/FA (5-FU 425 mg m À2 i.v. and FA 20 mg m À2 i.v. bolus days 1 -5 every 28 days for 6 months) or to PVI 5-FU alone (300 mg m À2 day for 12 weeks). With a median follow-up of 19.8 months, 133 relapses and 77 deaths have been observed. Overall survival did not differ significantly (log rank P ¼ 0.764) between patients receiving 5-FU/FA and PVI 5-FU (3-year survival 83.2 vs 87.9%, respectively). Patients in the 5-FU/FA group had significantly worse relapse-free survival (RFS, log rank P ¼ 0.023) compared to those receiving PVI 5-FU (3-year RFS, 68.6 vs 80%, respectively). Grades 3 -4 neutropenia, diarrhoea, stomatitis and severe alopecia were significantly less (Po0.0001) and global quality of life scores significantly better (Po0.001) for patients in the PVI 5-FU treatment arm. In conclusion, infused 5-FU given over 12 weeks resulted in similar survival to bolus 5-FU and FA over a 6 month period, but with significantly less toxicity.