The aim of this study was to evaluate the efficacy of low dose oral clodronate in palliation of pain arising from bone metastases (BM) and to determine the optimal oral clodronate dose which inhibits osteolysis caused by tumor. Fifty patients with bone pain caused by BM were included in this study. All were receiving antitumor chemotherapy or hormonal therapy. The patients were randomized into three groups according to the dose of clodronate. Groups A and B were given 800 mg/d and 1600 mg/d of oral clodronate respectively for 3 months. Group C was the control group. The effect of clodronate in pain palliation was evaluated with pain score, performance status, and changes in analgesic use. The effect on osteolysis was examined with urinary calcium, hydroxyproline (OHP) and serum cross-linked carboxyterminal telopeptide region of type I collagen (ICTP) levels. Group A contained 16 patients, and groups B and C contained 17 patients each. After 3 months use of oral clodronate, significant decrease in the pain score of groups A and B was noted when compared to group C (P = 0.024 and P = 0.007, respectively). The analgesic use of 11 patients in group A (69%) and 8 patients in group B (47%) was decreased, but only the decrease in group A was statistically significant (P = 0.038). Pain score increased in 5 patients in group C (29%), and 3 patients in groups A (19%) and B (18%) each. Urinary calcium, OHP and serum ICTP levels increased in group C and decreased in groups A and B, but only the decrease of urinary calcium levels of group B was significant (P = 0.003). In conclusion, low dose (800 mg/d) oral clodronate seems to be as effective as standard dose (1600 mg/d) in palliation of bone pain secondary to BM.
e14610 Background: Suicide gene therapy is one of the promising treatment modalities in cancer treatment. Combination of an immunotherapy modality with suicide gene therapy would increase the tumor eradciating efficacy of either treatment strategy used alone. Methods: In the current study, we constructed adenoviral vectors carying ytosine deaminase (CD), granulocyte macrophage-colony stimulating factor (GM-CSF) vectors. We tested the in vitro efficacy of the vectors in both human and mouse tumor cell lines and in a syngeneic mouse model of colon cancer with tumor explants of CRL 2638 cells. Results: Our results show that the vectors carrying CD/GM-CSF transcription units are effective in terms of killing of tumor cells when 5-FC added. Addition of GM-CSF transgene induced a significant amount of GM-CSF secretion (250 pg/ml/105 cells) of infected cells. In the syngeneic colon cancer model, addition of GM-CSF significantly increased tumor-specific cellular immune response when compared to suicide gene therapy alone. (p<0.01). Likewise, GM-CSF addition caused a 8 times reduction in the ratio of Tregs infiltrating the tumor nodules (p<0.001). Accordingly, GM-CSF decreased the tumor growth by 2 times an d increased the median survival time by 50% (p<0.01). Conclusions: These impressive results of in-vitro cytotoxicity and encouraging results of in-vivo testing of the our newly constructed GM-CSF carrying vector suggest a potential for the use of the vector for the treament of established tumors by inducing tumor specific immune response. No significant financial relationships to disclose.
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