The Skeptical Oncologist

By BISHAL GYAWALI, MD Why conduct post approval studies at all? Atezolizumab previously received accelerated approval in second-line metastatic or advanced urothelial cancer based on response rates from a single arm trial. The results of post approval confirmatory phase 3 are now published and demonstrate that atezolizumab did not improve survival versus chemotherapy (11.1 v 10.6 months, HR 0.87, p = 0.41). The concept of accelerated approval is to grant early and conditional approval and access to drugs in diseases of unmet need, and that the decision to fully approve or revoke be made based on results of confirmatory phase 3 trials. That means, if the confirmatory larger phase 3 trial shows that the assumed benefit with the drug didn’t exist, the approval be revoked. Naturally, the FDA has decided to revoke the approval. No, I am joking. The post approval studies don’t seem to matter at all. You can improve response rate in a single arm trial, gain an expedited approval and your approval will always remain. Previously, we also saw that a drug that was given accelerated approval based on response rates in a phase 2 received full approval after it failed to improve survival in a subsequent confirmatory phase 3.  Why bother conducting confirmatory studies at all? (Im)precision in precision oncology It goes without question that precision medicine requires precise measurement and validation of biomarkers. So it was very pleas...
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: Uncategorized Source Type: blogs

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PMID: 29784188 [PubMed - in process]
Source: Canadian Journal of Ophthalmology - Category: Opthalmology Authors: Tags: Can J Ophthalmol Source Type: research
PMID: 29784183 [PubMed - in process]
Source: Canadian Journal of Ophthalmology - Category: Opthalmology Authors: Tags: Can J Ophthalmol Source Type: research
Abstract PURPOSE: Radiation-induced oral mucositis is one of the main side effects during and after the treatment of head and neck cancer patients. The study was designed to provide evidence on the effectiveness of thyme honey on oral mucositis management. METHODS: This was a randomised controlled trial (RCT) with 72 head and neck cancer patients who were divided either to the intervention group (thyme honey rinses) or to the control group (saline rinses). Oral mucositis was assessed according to the Radiation Therapy Oncology Group (RTOC criteria), and assessments were performed weekly starting at the 4th we...
Source: European Journal of Oncology Nursing - Category: Nursing Authors: Tags: Eur J Oncol Nurs Source Type: research
CONCLUSIONS: Initiatives emphasising the timeliness of diagnosis and treatment are reflected in the ways some patients experience their care. However, these accounts were open to further contextualisation about what speed of healthcare processes meant for evaluating the quality of their care. Healthcare professionals could therefore be an important patient resource in providing reassurance and support about the timeliness of diagnosis or treatment. PMID: 29784144 [PubMed - in process]
Source: European Journal of Oncology Nursing - Category: Nursing Authors: Tags: Eur J Oncol Nurs Source Type: research
CONCLUSIONS: Individual evaluation and appropriate explanation is significant to further children's understanding of their mother's illness. Future studies with larger sample size are needed to explore the understanding for children of different ages, in order to provide specific help for these children. PMID: 29784143 [PubMed - in process]
Source: European Journal of Oncology Nursing - Category: Nursing Authors: Tags: Eur J Oncol Nurs Source Type: research
CONCLUSION: The study highlights the importance of recognizing symptoms as a combination of different experiences that may each cause different levels of distress. Initial evidence is provided that the emotional work involved for patients to self-manage each separate element of breathlessness should be considered in its treatment. PMID: 29784142 [PubMed - in process]
Source: European Journal of Oncology Nursing - Category: Nursing Authors: Tags: Eur J Oncol Nurs Source Type: research
CONCLUSIONS: This study reveal that nurses have difficulty delivering psychosocial care, which they perceive in abstract terms, in an environment where the disease is still considered fatal, the conditions of the patients change constantly, and they cannot receive the necessary support. It can be important that, as well as supportive institutional regulations, the nurses are in need of necessary assistance to help them change their own perceptions on cancer, to become emotionally stronger, and to acquire necessary knowledge and skills to give psychosocial care. PMID: 29784141 [PubMed - in process]
Source: European Journal of Oncology Nursing - Category: Nursing Authors: Tags: Eur J Oncol Nurs Source Type: research
CONCLUSIONS: Alternative models of care such as TFU provided by CNSs provides the care, information and support to enable women treated for endometrial cancer to self-manage and live well. PMID: 29784140 [PubMed - in process]
Source: European Journal of Oncology Nursing - Category: Nursing Authors: Tags: Eur J Oncol Nurs Source Type: research
CONCLUSIONS: Health professionals need to develop a better understanding of Gypsy and Travellers' health beliefs and practices in order to successfully interact with them. Information about cancer has to be delivered in an understandable form and to places where it reaches these communities. Because of historical societal discrimination, including by some health services, engaging with Gypsies and Travellers may require considerably more time and effort. PMID: 29784138 [PubMed - in process]
Source: European Journal of Oncology Nursing - Category: Nursing Authors: Tags: Eur J Oncol Nurs Source Type: research
CONCLUSIONS: These data provide the first national, population-based estimates of fertility documentation for AYA cancer patients in Australia. Documentation of fertility-related discussions was poor, with higher rates observed in hospitals with greater experience of treating AYA patients. PMID: 29784137 [PubMed - in process]
Source: European Journal of Oncology Nursing - Category: Nursing Authors: Tags: Eur J Oncol Nurs Source Type: research
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