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Health Economics Aspects of Digital Therapeutics
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Jennifer Lavanture, Owen McCarthy
CUA may be utilized similarly to CAE but may be more relevant when treatment extends the life or significantly impacts the quality of life. For example, utilization is common when comparing chemotherapy regimens. An example of CUA is presented as Case Study 4 below.
Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Published in Pat Price, Karol Sikora, Treatment of Cancer, 2020
Robert D. Morgan, Andrew R. Clamp, Gordon C. Jayson
The choice of second-line cytotoxic agents generally depends on the platinum-free interval. Patients who have relapsed disease more than 6 months after the completion of platinum therapy are generally considered to have platinum-sensitive disease,106 with response rates of around 40% to a second platinum-based regimen. As the median PFS from first-line chemotherapy in advanced-stage disease is approximately 18 months, most patients fall into this category at first relapse, and the greater the time-to-relapse, the higher the chances of response to platinum re-challenge.107,108 Patients with a short remission, lasting less than 6 months after first-line chemotherapy, usually (but not always) have relatively platinum-resistant disease. It is notable that with each successive chemotherapy regimen, the treatment-free interval often becomes shorter, until ultimately chemotherapy resistance develops, and active treatment is withdrawn. Attempts to extend the platinum-free interval using non-platinum-based regimens prior to reintroducing platinum therapy for platinum-sensitive disease did not improve survival.109 The 10% of patients with disease that progresses on first-line therapy (referred to as platinum-refractory disease) have the worst prognosis.
Drug Delivery
Published in David A. Walker, Giorgio Perilongo, Roger E. Taylor, Ian F. Pollack, Brain and Spinal Tumors of Childhood, 2020
Gudrun Fleischhack, Martin Garnett, Kévin Beccaria
TMZ is an oral imidazotetrazine derivative and one of the newest alkylating agents. It decomposes spontaneously at physiological pH to its active metabolite and is characterized by a high oral bioavailability and a good penetration into the CNS (Table 9.1).19,57,58 It was first approved in 1999 for adult patients with recurrent anaplastic astrocytoma and in 2005 for use during and after radiation therapy for adult patients with newly diagnosed glioblastoma multiforme.59,60 Since then it has shown activity in a number of studies in adults and children (>3 years) with high-grade gliomas and other CNS and peripheral solid tumors as single-drug or drug combination therapy. In comparison to intensive chemotherapy regimens its adverse effects are relatively minor, but may include constipation, nausea, vomiting, fatigue, increase of liver enzymes, and hematological toxicity, such as thrombocytopenia and severe lymphopenia; lymphopenia requires Pneumocystis jirovecii prophylaxis.61–72
Pharmacovigilance of anti-cancer medicines: opportunities and challenges
Published in Expert Opinion on Drug Safety, 2020
Diana Crestan, Marta Paulina Trojniak, Sara Francescon, Giulia Fornasier, Paolo Baldo
Chemotherapy regimens often involve several different classes of drugs. Cancer patients, in addition to their cancer therapy, also often receive palliative and analgesic therapies, antiemetics, and complementary and alternative medicines to help manage ADRs. The assumption of complex combinations of medicines, involving multiple drugs, is called ‘polypharmacy’ [37]. Polypharmacy increase the risk of interactions among drugs or between drugs and other products, including natural ones. A recent retrospective observational study [38] found that one in four patients treated with parenteral antineoplastic drugs had at least one clinically relevant, potential drug-drug interaction; often the drug combinations were already known to be contraindicated. Furthermore, patients often consider natural products and food supplements (CAM – complementary and alternative products) as completely safe, without understanding that those molecules can interact with chemotherapy, increasing the risks originating from polypharmacy [39].
Implementation of contemporary chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma: a population-based analysis
Published in Acta Oncologica, 2020
Anouk E. J. Latenstein, Tara M. Mackay, Geert-Jan Creemers, Casper H. J. van Eijck, Jan Willem B. de Groot, Nadia Haj Mohammad, Marjolein Y. V. Homs, Hanneke W. M. van Laarhoven, I. Quintus Molenaar, Bert-Jan ten Tije, Judith de Vos-Geelen, Marc G. Besselink, Lydia G. M. van der Geest, Johanna W. Wilmink
For patients with metastatic PDAC, use of FOLFIRINOX was recommended in 2012 and gemcitabine with nab-paclitaxel in 2015, after positive judgement of a national commission (Commissie BOM). Therefore, the period of diagnosis was divided into a period before (2007–2011) and after (2012–2016) the implementation of the new regimens. Patients were assigned as receiving chemotherapy treatment if they started any chemotherapy regimen. Socioeconomic status (SES) was based on social deprivation scores per 4-digit postal code (reference data from The Netherlands Institute of Social Research) and categorized into three SES groups (high: 1st–3rd, intermediate 4th–7th, low: 8th–10th deciles). Primary tumor location was classified as pancreatic head (C25.0), body (C25.1), tail (C25.2), or other (C25.3, 7–9), according to the ICD-O-3. Metastatic organ site(s) was categorized as liver only, peritoneum only, lung only, extra-regional lymph nodes only, other site only, 2 sites (any combination), ≥3 sites (any combination) and unknown. Nationwide data on comorbid conditions, performance status (WHO; Karnofsky scores were converted to WHO according to the following values [17]: 90–100 to WHO 0, 80–90 to WHO 1, 60–70 to WHO 2, 40–50 to WHO 3, 20–30 to WHO 4) and type of first-line chemotherapy were available for diagnoses in 2015 and 2016 only. Survival data were obtained by annual linkage with the Municipal Personal Records Database, which contains vital status of all Dutch inhabitants. Survival time was defined as the time between the date of diagnosis and date of death or censoring (1 February 2018).
Tumor mutational burden is not predictive of cytotoxic chemotherapy response
Published in OncoImmunology, 2020
Mina Nikanjam, Paul Riviere, Aaron Goodman, Donald A. Barkauskas, Garrett Frampton, Razelle Kurzrock
Cytotoxic chemotherapy has been the mainstay of treatment for metastatic solid tumors. Chemotherapy regimens have traditionally been selected based on tumor type. Protein markers have been explored as predictive biomarkers for response to chemotherapy ,10 however these markers may not be predictive for all tumor types .11 There is evidence that somatic mutations in genes such as ATM and BRCA can predict responsiveness to platinum chemotherapy .12 Additional biomarkers predictive of response to cytotoxic chemotherapy would be of benefit for a personalized approach to cancer treatment. The relationship between TMB and chemotherapy response is unknown. Many cytotoxic therapies affect DNA replication, and specific mutations affecting DNA repair pathways have been associated with chemotherapy responsiveness .12 However, mutations can also occur in sites that are not relevant to chemotherapy response. Thus, a high TMB could theoretically make a tumor more sensitive to DNA-damaging chemotherapy; furthermore, high TMB might decrease tumor cell viability in a manner analogous to aneuploidic tumor suppression, making it vulnerable to cytotoxics .13,14 Alternatively, a high TMB might be associated with the presence of resistance mutations and, hence, attenuate chemotherapy sensitivity.