Contrasting treatment‐specific survival using double‐robust estimators

Epirubicin is the 4' epimer of the anthracycline antibiotic doxorubicin, and has been used alone or in combination with other cytotoxic agents in the treatment of a variety of malignancies. Comparative and noncomparative clinical trials have demonstrated that regimens containing conventional doses of epirubicin achieved equivalent objective response rates and overall median survival as similar doxorubicin-containing regimens in the treatment of advanced and early breast cancer, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma, ovarian cancer, gastric cancer and nonresectable primary hepatocellular carcinoma. Recently, dose-intensive regimens of epirubicin have achieved high response rates in a number of malignancies including early and advanced breast cancer and lung cancer. The major acute dose-limiting toxicity of anthracyclines is myelosuppression. In vitro and clinical studies have shown that, at equimolar doses, epirubicin is less myelotoxic than doxorubicin. The lower haematological toxicity of epirubicin, as well as the recent introduction of supportive measures such as colony-stimulating factors, has allowed dose-intensification of epirubicin-containing regimens, which is particularly significant because of the definite dose-response relationship of anthracyclines. Cardiotoxicity, which is manifested clinically as irreversible congestive heart failure and/or cardiomyopathy, is the most important chronic cumulative dose-limiting toxicity of anthracyclines. Epirubicin has a lower propensity to produce cardiotoxic effects than doxorubicin, and its recommended maximum cumulative dose is almost double that of doxorubicin, thus allowing for more treatment cycles and/or higher doses of epirubicin. In summary, dose-intensive epirubicin-containing regimens, which are feasible due to its lower myelosuppression and cardiotoxicity, have produced high response rates in early breast cancer, a potentially curable malignancy, as well as advanced breast, and lung cancers. Furthermore, there is evidence to suggest that improved response rates can improve quality of life in some clinical settings, but whether this leads to prolonged survival has not yet been determined. Recently implemented supportive measures such as colony-stimulating factors, prophylactic antimicrobials and peripheral blood stem cell support may help achieve other potential advantages of dose-intensive epirubicin-containing regimens such as reductions in morbidity and length of hospital admissions.

Epirubicin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cancer chemotherapy.

Background: Although fertility preservation (FP) treatment options have increased, the existing evidence suggests that many women with cancer do not feel well supported in making these decisions, but find them stressful and complex and fail to take up fertility care at this crucial time Whilst existing reviews have all made important contributions to our understanding of the FP decision-making process, none of them examine solely and specifically these processes for women of reproductive age with a diagnosis of any cancer, leaving a gap in the knowledge base Given the expectation that care is patient-centred, our review aims to address this gap which may be of help to those managing patients struggling to make difficult decisions in the often brief period before potentially sterilising cancer treatment is started Objective and rationale: Underpinning this narrative review was the question “What factors hinder the decision-making process for women with any cancer and contemplating FP treatment?” Our objectives were to i) assess and summarise this existing literature, ii) identify the factors that hinder this decision-making process, iii) explore to what extent these factors may differ for women choosing different methods of FP, and iv) make recommendations for service delivery and future research Search methods: A systematic search of the medical and social science literature from the 1st January 2005 up to the end of January 2016 was carried out using three electronic databases (Web of Science (PubMed), Ovid SP Medline and CINAHL via Ebsco) Included in the review were quantitative, qualitative and mixed-method studies Reference lists of relevant papers were also hand searched From the 983 papers identified, 46 papers were included Quality assessment was undertaken using the Mixed Methods Appraisal Tool and thematic analysis was used to analyse the data Outcomes: From the analysis, six key themes with 15 sub-themes emerged: 1) fertility information provision (lack of information, timing of the information, patient-provider communication); 2) fear concerning the perceived risks associated with pursuing FP (delaying cancer treatment, aggravating a hormone positive cancer, consequences of a future pregnancy); 3) non-referral from oncology (personal situation, having a hormone positive cancer, not a priority, transition between service issues); 4) the dilemma (in survival mode, whether to prioritise one treatment over another); 5) personal situation (parity, relationship status); and 6) costs (financial concerns) Wider implications: This review has found that a wide range of internal and external factors impact the FP decision-making process Key external issues related to current service delivery such as the provision and timing of FP information, and lack of referral from oncology to the fertility clinic However, internal issues such as women’s fears concerning the perceived risks associated with pursuing FP also hindered decision-making but these ‘risks’ were typically overestimated and non-evidence based These findings suggest that the implementation of a range of decision support interventions may be of benefit within the clinical care pathway of FP and cancer Women would benefit from the provision of more evidence-based FP information, ideally received at cancer diagnosis, in advance of seeing a fertility specialist, for example through the implementation of patient decision aids Health care professionals in both oncology and fertility services may also benefit from the implementation of training programs and educational tools targeted at improving the communication skills needed to improve collaborative decision-making and deliver care that is patient-centred Exploration of the current barriers, both intellectual and practical, that prevent some patients from accepting FP will help care providers to do better for their patients in the future Finally, the extent to which a poor prognosis and moral, ethical and religious beliefs influence the FP decision-making process also warrant further research

/pdf/what-factors-hinder-the-decision-making-process-for-women-1dn02zujzl.pdf

What factors hinder the decision-making process for women with cancer and contemplating fertility preservation treatment?

Invasive lobular carcinoma is the second most frequent histological type of breast cancer and its incidence is increasing. It has unique clinical, biological, and molecular features. Invasive lobular carcinoma is almost invariably positive for the oestrogen receptor and, when compared with invasive ductal carcinoma, it is typically of a lower grade. Even though invasive lobular carcinoma represents a distinct clinical entity, the same criteria used for invasive ductal carcinoma are currently applied to establish the need for primary or adjuvant systemic chemotherapy. We reviewed randomised trials of neoadjuvant and adjuvant chemotherapy and noted that insufficient evidence is available to support or withhold use of chemotherapy in patients with invasive lobular carcinoma. Thus, the benefit from systemic chemotherapy for individuals with this form of breast disease is unclear. Invasive lobular carcinoma deserves to be investigated separately in prospective clinical trials to define the best treatment and prevention strategies.

https://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-2045(06)71011-7.pdf

Primary systemic chemotherapy of invasive lobular carcinoma of the breast

Myelosuppression that occurs during chemotherapy has been reported to be a predictor of better survival in patients with breast or lung carcinomas. We evaluated the prognostic implications of chemotherapy-induced neutropenia in advanced gastric carcinoma. Data from a prospective survey of oral fluoropyrimidine S-1 for advanced gastric cancer patients in Japan were reviewed. We identified 1055 untreated patients with adequate baseline bone marrow function. During treatment with S-1, a total of 293 (28%) patients experienced grade 1 or higher neutropenia. The adjusted hazard ratio of death for the presence of neutropenia, as compared with the absence of such toxicity, from a multivariate Cox model was 0.72 (95% confidence interval, 0.54–0.95; P=0.0189) for grade 1 neutropenia, 0.63 (0.50–0.78; P<0.0001) for grade 2 neutropenia and 0.71 (0.51–0.98; P=0.0388) for grade 3–4 neutropenia. These findings suggest that the occurrence of neutropenia during chemotherapy is an independent predictor of increased survival in patients with advanced gastric cancer, whereas the absence of such toxicity indicates that the dosages of drugs are not pharmacologically adequate. Monitoring of neutropenia in patients who receive chemotherapy may contribute to improved drug efficacy and favourable survival.

/pdf/predictive-value-of-chemotherapy-induced-neutropenia-for-the-4upc2lp225.pdf

Predictive value of chemotherapy-induced neutropenia for the efficacy of oral fluoropyrimidine S-1 in advanced gastric carcinoma.

In 1986 the true benefit of adjuvant medical treatment in postmenopausal patients with pathological node-positive breast adenocarcinoma was still controversial. The French Adjuvant Study Group (FASG) initiated a randomised trial to elucidate the respective roles of adjuvant chemo-and/or hormonotherapy in this group of patients.

Postmenopausal Patients with Node-Positive Resectable Breast Cancer

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Postmenopausal Patients with Node-Positive Resectable Breast Cancer