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BACKGROUNDLong‐acting release octreotide pamoate (OP‐LAR) is a synthetic octapeptide that can be administered monthly and whose activity is similar to that of endogenous somatostatin. In vitro and in vivo data suggest that OP‐LAR may act as a growth inhibitor or a modulator of growth stimulatory peptides. The potential mechanisms of action of somatostatin analogues in breast carcinoma include the suppression of insulin‐like growth factor‐1 (a putative tumor growth factor) and the binding to the somatostatin receptors expressed by breast carcinoma cells in order to induce apoptosis.METHODSThis Phase III, multicenter, randomized, double‐blind, placebo‐controlled trial involved 203 patients (13% premenopausal and 87% postmenopausal) with locally recurrent (but unsuitable for local treatment) or metastatic breast carcinoma, 199 of whom were actually treated (99 patients with OP‐LAR and 100 patients with placebo). All patients received TAM and were estrogen and/or progesteron receptor positive (receptor positivity was an eligibility criterion), and all had measurable or evaluable disease. Any patients who had received previous chemotherapy not given in an adjuvant or neoadjuvant setting were excluded.RESULTSAt the time of the interim analysis, the tumor response rates (RR) were 20.2% (9 complete responses [CR] and 11 partial responses [PR]) in the OP‐LAR arm and 21% (11 CRs and 10 PRs) in the placebo arm, and the median time to progression (TTP) was 25.0 and 26.9 weeks (P = 0.62), respectively. The adverse events experienced by 10% or more of the patients and attributed to octreotide were gastrointestinal in nature: diarrhea (53%), nausea (16%), and abdominal pain (11%).CONCLUSIONSBecause of the similar RR and TTP in both arms, the trial was stopped at the interim analysis. The current data confirm there is no indication for adding somatostatin analogues to TAM in advanced breast carcinoma. Cancer 2002;94:299–304. © 2002 American Cancer Society.

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Renal carcinoma represents about 3% of all adult tumors, with an estimate of 31,900 new cases diagnosed in 2003 in the United States. In the early phase of its natural history, renal cancer is potentially curable by surgery, but if the disease presents any signs of metastasis, the chances of survival are remote, even though anecdotal cases characterized by long survival have been reported. In fact, the treatment of metastatic renal cancer remains unsatisfactory. Systemic treatment with single agents and with polychemotherapy, with or without cytokine-based immunotherapy, has not been successful, obtaining very low response rates without a significant benefit in overall survival. This review highlights the most interesting issues regarding conventional therapeutic strategies, in localized and in advanced disease. New approaches such as monoclonal antibodies, vaccines, gene therapy, angiogenesis inhibitors and allogeneic cell transplantation and their possible clinical applications are also discussed.

PurposePancreatic carcinoma is the neoplasia with the major mortality, and main standard treatments in this cancer increase survival but do not lead to complete recovery of the patient. The aim of this study was to evaluate the efficacy of Abraxane® (nab-paclitaxel) in Italian patients with metastatic pancreatic cancer (MPC).Patients and methodsWe conducted a retrospective analysis of 80 patients. Overall survival (OS) was the primary end point for evaluating the efficacy of nab-paclitaxel in combination with gemcitabine treatment, while carbohydrate antigen 19-9 (CA 19-9) reduction, safety, progression-free survival (PFS), overall response rate and reduction in pain were secondary end points.ResultsThe median OS was 8 months, and the median PFS was 5 months. A considerable difference in CA 19-9 before and after treatment was observed. Descriptive and correlation analyses were done to examine the relationship between CA 19-9 response and OS. Linear regression analysis between OS and CA 19-9 response revealed that CA 19-9 is an important predictor of OS, showing a positive correlation.ConclusionNab-paclitaxel is a well-tolerated and effective treatment for patients affected by MPC. The drug showed an improved tolerability profile, significant pain relief and an increase in survival rate.