Oncology
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Review Randomized Controlled Trial Comparative Study Clinical Trial
First-line Herceptin monotherapy in metastatic breast cancer.
The pivotal phase II and III Herceptin trials proved the efficacy and safety of second- or third-line single-agent Herceptin and first-line Herceptin in combination with chemotherapy, respectively. In the current trial, 114 patients were randomized to one of two dose groups of first-line Herceptin monotherapy: standard dose of 4 mg/ kg initial dose followed by 2 mg/kg intravenous (i.v.) weekly; or high dose of 8 mg/kg initial dose followed by 4 mg/kg i.v. weekly. The regimen was generally well tolerated. ⋯ When women with stable disease for > or =6 months were included with responders, the clinical benefit rate in IHC 3+ patients was 47%. Median survival was 24.4 months, which is comparable with the survival rate seen in the pivotal phase III combination trial (25 months). Therefore, single-agent Herceptin is an important new option for the first-line treatment of HER2-positive metastatic breast cancer patients.
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Review Comparative Study
New combinations with Herceptin in metastatic breast cancer.
Preclinical data indicate that trastuzumab (Herceptin) has the potential for synergistic or additive effects in combination with therapies including chemotherapy and hormonal agents, providing the rationale for a number of clinical trials in women with HER2-positive metastatic breast cancer. A recently reported phase II trial has demonstrated that trastuzumab plus vinorelbine is both effective (overall response rate 75%) and well tolerated, with the major side effects being typical of single-agent vinorelbine. ⋯ In addition, trials are investigating whether trastuzumab can reverse the resistance to hormonal therapy that develops in most women with metastatic breast cancer. These and other studies will identify the regimens that produce the best outcomes with the fewest possible side effects in women with HER2-positive breast cancer.
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Preclinical and phase I/II studies of Herceptin demonstrated a dose-related, non-linear pharmacokinetic profile. The results of a dose-finding study supported a regimen comprising an initial intravenous (i.v.) dose of 4 mg/kg with subsequent weekly doses of 2 mg/kg. However, pharmacokinetic and safety data suggested that increased dose and reduced frequency of Herceptin administration are feasible. ⋯ Subcutaneous (s.c.) administration of Herceptin would further simplify administration and studies are also underway to clinically evaluate s.c. administration of Herceptin in combination with paclitaxel. With the recent development of oral taxanes, it is predicted that combinations including an oral taxane, Xeloda and either 3-weekly or possibly s.c. Herceptin may become future therapies for breast cancer patients.
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To evaluate the feasibility of conducting a patient satisfaction survey in the oncology hospital setting, using a multidimensional patient satisfaction questionnaire to be completed at home. ⋯ Conducting a patient satisfaction survey in an oncology hospital setting proved feasible; however, further surveys should attempt to obtain the opinion of patients with more severe physical conditions. The assessment of the patients' satisfaction provided indications for improvement of care in a particular hospital. Although the results of this study are specific to one hospital, the methods could be reproduced in other hospital settings, but may possibly lead to other conclusions.
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Somatostatin (SST) analogues are cornerstones in the symptomatic management of patients suffering from carcinoid tumors, and antiproliferative activity has also been reported for these agents. The most commonly applied SST analogues are octreotide (OCT) and lanreotide (LAN), which are both available in a slow release formulation. To the current knowledge, both OCT and LAN are thought to be equally effective for the management of various disorders. We report the case of a patient with a disseminated carcinoid, who progressed during dose-intensified treatment with slow-release LAN in combination with interferon-alpha, but developed a pronounced response after treatment was switched to the application of a depot formulation of OCT. ⋯ To our knowledge, this is the first case demonstrating both a symptomatic as well as objective response to OCT following progression during therapy with LAN in a patient with a carcinoid tumor. Our results suggest that refractoriness to treatment including a long-acting SST analogue does not automatically imply resistance to a related agent and should alert clinicians to the potential of non-cross-resistance between SST analogues in neuroendocrine malignancies.