The ABC community strongly calls for clinical trials addressing important unanswered clinical questions in this setting, and not just for regulatory purposes. Clinical trials should continue to be performed, even after approval of a new treatment, providing real world performance of the therapy.
Expert opinionVoters: 43 Yes: 100%Every advanced breast cancer patient must have access to optimal cancer treatment and supportive care according to the highest standards of patient centered care, as defined by:Open communication between patients and their cancer care teams as a primary goal.Educating patients about treatment options and supportive care, through development and dissemination of evidencebased information in a clear, culturally appropriate form. Encouraging patients to be proactive in their care and to share decision-making with their health care providers.Empowering patients to develop the capability of improving their own quality of life within their cancer experience. Always taking into account patient preferences, values and needs as essential to optimal cancer care. Expert opinion Voters: 44 Yes: 100% We strongly recommend the use of objective scales, such as the ESMO Magnitude of Clinical Benefit Scale or the ASCO Value Framework, to evaluate the real magnitude of benefit provided by a new treatment and help prioritize funding, particularly in countries with limited resources. Expert opinion Voters: 40 Yes: 87.5% (35) Abstain: 5% (2) The use of telemedicine oncology to help management of patients with ABC living in remote places, is an important option to consider when geographic distances are a problem and provided that issues of connectivity are solved. Expert opinion Voters: 42 Yes: 92.8% (39) Abstain: 4.7% (2) Strong consideration should be given to the use of validated PROMs (patient-reported outcome measures) for patients to record the symptoms of disease and side effects of treatment experienced as a regular part of clinical care. These PROMs should be simple, and user-friendly to facilitate their use in clinical practice, and thought needs to be given to the easiest collection platform, e.g. tablets or smartphones. Systematic monitoring would facilitate communication between patients and their treatment teams by better characterizing the toxicities of all anticancer therapies. This would permit early intervention of supportive care services enhancing quality of life 1 C Voters: 39 Yes: 87.1% (34) Abstain: 5.1% (2)As survival is improving in many patients with ABC, consideration of survivorship issues should be part of the routine care of these patients. Health professionals should therefore be ready to change and adapt treatment strategies to disease status, treatment adverse effects and quality of life, patients' priorities and life plans. Attention to chronic needs for home and family care, job and social requirements, should be incorporated in the treatment planning and periodically updated. Expert opinion Voters: 40 Yes: 95% (38) Abstain: 5% (2) ABC patients who desire to work or need to w...
The potential benefits of extended rituximab treatment have been investigated in a randomized trial comparing the standard schedule with prolonged treatment in 202 patients with newly diagnosed or refractory/relapsed follicular lymphoma (FL). All patients received standard treatment (rituximab 375 mg/m 2 weekly ؋ 4). In 185 evaluable patients, the overall response rate was 67% in chemotherapynaive patients and 46% in pretreated cases (P < .01). Patients responding or with stable disease at week 12 (n ؍ 151) were randomized to no further treatment
Crown for the 303 Study GroupPurpose: This phase III study compared docetaxel and doxorubicin in patients with metastatic breast cancer who had received previous alkylating agent-containing chemotherapy.Patients and Methods: Patients were randomized to receive an intravenous infusion of docetaxel 100 mg/m 2 or doxorubicin 75 mg/m 2 every 3 weeks for a maximum of seven treatment cycles.Results: A total of 326 patients were randomized, 165 to receive doxorubicin and 161 to receive docetaxel. Overall, docetaxel produced a significantly higher rate of objective response than did doxorubicin (47.8% v 33.3%; P ؍ .008). Docetaxel was also significantly more active than doxorubicin in patients with negative prognostic factors, such as visceral metastases (objective response, 46% v 29%) and resistance to prior chemotherapy (47% v 25%). Median time to progression was longer in the docetaxel group (26 weeks v 21 weeks; difference not significant). Median overall survival was similar in the two groups (docetaxel, 15 months; doxorubicin, 14 months). There was one death due to infection in each group, and an additional four deaths due to cardiotoxicity in the doxorubicin group. Although neutropenia was similar in both groups, febrile neutropenia and severe infection occurred more frequently in the doxorubicin group. For severe nonhematologic toxicity, the incidences of cardiac toxicity, nausea, vomiting, and stomatitis were higher among patients receiving doxorubicin, whereas diarrhea, neuropathy, fluid retention, and skin and nail changes were higher among patients receiving docetaxel.Conclusion: The observed differences in activity and toxicity profiles provide a basis for therapy choice and confirms the rationale for combination studies in early breast cancer.
AT significantly improves TTP and ORR compared with AC in patients with MBC, but there is no difference in OS. AT represents a valid option for the treatment of MBC.
An important proportion of patients experienced long-term remission after prolonged exposure to rituximab, particularly if they had no prior treatment and responded to rituximab induction.
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