Seminars in oncology
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Seminars in oncology · Feb 2003
Review Randomized Controlled Trial Clinical TrialDose-comparative monotherapy trials of ZD1839 in previously treated non-small cell lung cancer patients.
Patients with non-small cell lung cancer (NSCLC) frequently present, or relapse, with unresectable disease that is resistant to standard chemotherapy. There is, therefore, an urgent need for new treatments for NSCLC and other solid tumors. ZD1839 (Iressa; AstraZeneca Pharmaceuticals LP, Wilmington, DE), an orally active, selective epidermal growth factor receptor-tyrosine kinase inhibitor, has shown promising antitumor responses in phase I clinical trials in heavily pretreated patients with advanced NSCLC and other solid tumors. ⋯ Symptom improvement rates (increase of at least two points on the Lung Cancer Subscale) were 43% and 35%, respectively. Both doses of ZD1839 were well tolerated in this trial. The results of IDEAL-1 and IDEAL-2 indicate that ZD1839 monotherapy may offer a single-agent alternative for patients with advanced solid tumors who have received and progressed on prior chemotherapy, many of whom have exhausted their therapy options.
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Seminars in oncology · Dec 2002
Randomized Controlled Trial Clinical TrialA phase III randomized evaluation of amifostine in stage IIIA/IIIB non-small cell lung cancer patients receiving concurrent carboplatin, paclitaxel, and radiation therapy followed by gemcitabine and cisplatin intensification: preliminary findings.
Despite the progress in pharmaceutical therapeutics and the hardware and software advances supporting radiation oncology, the major advance in the treatment of locally advanced nonmetastatic non-small cell lung cancer during the previous decade has been the adoption of integrated combined-modality therapy. This has resulted in an appreciation of the associated increase in treatment-related morbidity that has fostered new efforts to maximize the therapeutic index, including evaluation of cytoprotective agents. ⋯ The data to date do not support a cytoprotective advantage to the use of intravenous amifostine targeting esophagitis at 200 mg/m2/d before radiation. Further efforts to assess the role and potential of amifostine in the treatment of patients with non-small cell lung cancer are recommended.
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Seminars in oncology · Aug 2001
Randomized Controlled Trial Clinical TrialPrevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience.
The National Surgical Adjuvant Breast and Bowel Project (NSABP) conducted two sequential randomized clinical trials to aid in resolving uncertainty about the treatment of women with small, localized, mammographically detected ductal carcinoma in situ (DCIS). After removal of the tumor and normal breast tissue so that specimen margins were histologically tumor-free (lumpectomy), 818 patients in the B-17 trial were randomly assigned to receive either radiation therapy to the ipsilateral breast or no radiation therapy. B-24, the second study, which involved 1,804 women, tested the hypothesis that, in DCIS patients with or without positive tumor specimen margins, lumpectomy, radiation, and tamoxifen (TAM) would be more effective than lumpectomy, radiation, and placebo in preventing invasive and noninvasive ipsilateral breast tumor recurrences (IBTRs), contralateral breast tumors (CBTs), and tumors at metastatic sites. ⋯ Thus, if it is accepted from the P-1 findings that women at increased risk for invasive cancer are candidates for an intervention such as TAM, then it would seem that women with a history of DCIS should also be considered for such therapy in addition to radiation therapy. That statement does not imply that, as a result of the findings presented here, all DCIS patients should receive radiation and TAM. It does suggest, however, that, in the treatment of DCIS, the appropriate use of current and better therapeutic agents that become available could diminish the significance of breast cancer as a public health problem.
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Seminars in oncology · Dec 2000
Randomized Controlled Trial Clinical TrialHigh-dose rituximab therapy in chronic lymphocytic leukemia.
Rituximab (Rituxan; Genentech, Inc, South San Francisco, CA and IDEC Pharmaceutical Corporation, San Diego, CA) is a chimeric monoclonal antibody that targets mature B cells in most lymphoid B-cell malignancies. Rituximab is approved by the US Food and Drug Administration for therapy for recurrent B-cell lymphoma. In initial clinical trials the activity in small lymphocytic lymphoma, the counterpart of chronic lymphocytic leukemia (CLL), was less than 20%. ⋯ No unusual toxicity was noted at higher doses. Further exploration of the dosing schedule of rituximab in CLL and development of combination therapies is necessary. This agent shows promise for interaction in combined chemoimmunotherapy strategies for front-line and relapsed patients with CLL.
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Seminars in oncology · Jun 1999
Review Randomized Controlled Trial Clinical TrialDocetaxel (Taxotere) plus doxorubicin-based combinations: the evidence of activity in breast cancer.
The high individual response rates of doxorubicin and docetaxel (Taxotere; Rhône-Poulenc Rorer, Collegeville, PA) as single agents in breast cancer and their lack of cross-resistance provide the rationale for investigation of the combination of these two uniquely acting agents. A dose-finding study defined the recommended doses for the combination given every 3 weeks as docetaxel 75 mg/m2 plus doxorubicin 50 mg/m2, or docetaxel 60 mg/m2 plus doxorubicin 60 mg/m2. Phase II studies conducted with these doses in first-line treatment of metastatic breast cancer patients resulted in overall response rates ranging between 57% and 77% with long durations of response. ⋯ Preliminary results reveal a superior overall response rate of 60% with docetaxel plus doxorubicin versus 47% with doxorubicin plus cyclophosphamide (p = .008). Time to disease progression and overall survival results are awaited. The results of these trials, in addition to others being conducted in the adjuvant and the neoadjuvant settings, will establish the ultimate place in therapy for the docetaxel and doxorubicin combination in the management of patients with breast cancer.