Assessing Tumor-Related Signs and Symptoms to Support Cancer Drug Approval
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Summary
15 FDA cancer drug approvals based on patient symptom assessments and/or physical signs (thought to represent symptomatic improvement) as the primary evidence of effectiveness are summarized.
- Type
- review
- Published
- 2004-12-24
- Cited by
- 42
- References
- 14
- OpenAlex
- https://openalex.org/W2000045315
- Semantic Scholar
- https://api.semanticscholar.org/CorpusID:13279353
Keywords
Medicine, Lung cancer, Cancer, Drug, Intensive care medicine
References
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- Efficacy and safety of photodynamic therapy versus Nd-YAG laser resection in NSCLC with airway obstruction.
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- Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials.
- Antineoplastic agents and FDA regulations: square pegs for round holes?
Cited by
- Recommendations for including multiple symptoms as endpoints in cancer clinical trials
- 肺癌骨转移诊疗专家共识（2014版）
- Measuring quality of life in patients with pleural mesothelioma using a modified version of the Lung Cancer Symptom Scale (LCSS): psychometric properties of the LCSS-Meso
- Perspectives on the design of clinical trials for targeted therapies and immunotherapy in veterinary oncology.
- Comparison of autologous stem cell transplantation versus consolidation chemotherapy for patients with cytogenetically normal acute myeloid leukemia and FLT3ITD
- The role of bisphosphonates in breast cancer.
- Efficacy and safety of intravenous bisphosphonates for patients with breast cancer metastatic to bone: a review of randomized, double-blind, phase III trials.
- Health services research.
- Proportions of bone marrow lymphocyte subsets at diagnosis may predict survival in patients with newly diagnosed diffuse large B‐cell lymphoma independently of the international prognostic index
- Priority symptoms in advanced breast cancer: development and initial validation of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16).
- Zoledronic acid in the management of metastatic bone disease
- Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-α in a phase III trial: final results and geographical analysis
- Hematological characteristics and effective screening for compound heterozygosity for Hb constant spring and deletional α+‐thalassemia
- Characterization of time-domain fluorescence properties of typical photosensitizers for photodynamic therapy
- A Comparison of the Renal Cell Carcinoma Symptom Index (RCC-SI) and the Functional Assessment of Cancer Therapy –Kidney Symptom Index (FKSI)
- Assessing oncologic benefit in clinical trials of immunotherapy agents.
- Emerging anti-cancer molecular mechanisms of aminobisphosphonates.
- Ramifications of severe organ dysfunction in newly diagnosed patients with small cell lung cancer: contemporary experience from a single institution.
- A preliminary study of a health related quality of life assessment of priority symptoms in advanced lymphoma: the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy – Lymphoma Symptom Index
- Bisphosphonates in breast cancer.
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