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Introduction: The use of oral anti-cancer therapies is becoming increasingly common in the management of cancers, raising the question of adherence. The objective of this study was to assess adherence to oral anti-cancer therapies, as well as the impact of various factors that may influence it. Methods: Patients starting oral chemotherapy (tyrosine kinase inhibitor or cytotoxic) were followed up for 3 months using a medication diary, which was given to the patient by the pharmacist during a multidisciplinary consultation. Adherence was assessed using the diary, as well as by counting the tablets they brought back. Results: One hundred and fifty patients were included in the study. The main oral chemotherapy agents prescribed were palbociclib (23.3%), everolimus (18.7%), and capecitabine (13.3%). The adherence at the end of the 3 months, by means of dose intensity (i.e. percent of the dose prescribed that has been taken), was 95.5%. No significant difference in adherence was found based on age, sex, family circumstances, health status, co-medication, type of oral therapy, tumor location, number of previous treatment lines, or presence of toxicity. The main reasons for non-adherence were forgetting (50%) and toxicity (21%). Fifty-seven patients prematurely discontinued the study: 40.3% for toxicity and 36.8% for disease progression. Conclusion: Adherence in this study is high in comparison to literature, which can be explained by close multidisciplinary follow-up. Moreover, no significant difference was observed between younger and older patients. [ABSTRACT FROM AUTHOR]

Simple Summary: Surgical resection is the only potentially curative treatment for pancreatic cancer, and its indication relies on precise imaging criteria and on patients' operability. Chemotherapy is recommended, except for patients a with very short life expectancy. We sought to provide real-world information on the management and outcomes of pancreatic cancer. Among patients with a surgically resectable tumor, only half of those aged 75–84 and none after 85 actually underwent resection, even though the prognosis following pancreatectomy in elderly patients was similar to that in younger patients. Patients' refusal of chemotherapy increased from 7% before 75 years to 73% after 85 years. These results underline the need to develop guidelines for the management of elderly patients with pancreatic cancer and to generalize geriatric assessments. Background: Our objective was to describe real-world patterns of care and outcomes in pancreatic cancer. Methods: 912 patients diagnosed with pancreatic cancer from 2014 to 2017 were registered by the population-based cancer registry of Burgundy (France). Progression-free and net survival were estimated. Results: at diagnosis, 52% of tumors were associated with metastases. Among the 20% of patients fulfilling resectability criteria, half of those aged 75–84 years and none of those ≥85 years actually underwent resection. Age was not associated with 3-year observed survival in patients who underwent resection. Overall, 77% of patients aged <75 years, 55% of those aged 75–84 years and 8% of those ≥85 years received chemotherapy. Among patients who were offered chemotherapy, 73% of those aged ≥85 years refused. Chemotherapy toxicity was higher with Gemcitabine_Oxaliplatin/Gemcitabine_Abraxane and FOLFIRINOX than with Gemcitabine alone. Patients resected after induction FOLFIRINOX and those treated with adjuvant Gemcitabine presented the lowest risk of progression. Three-year net survival was 35% in patients with non-metastatic resectable tumors and under 10% for other patients. Conclusions: Only half of patients aged 75–84 years with a resectable tumor actually underwent resection. Two thirds of patients aged ≥85 years refused chemotherapy, thus underlining the need to expand geriatric assessments. [ABSTRACT FROM AUTHOR]

Despite fluoropyrimidines (FPs) constituting the main component of the chemotherapy combination protocols in 50% of chemotherapies for solid tumour treatments, incidence data for FP-related toxicity are poorly documented in real life. This study evaluated the number of patients receiving FP-based chemotherapies in France, along with the true incidence of FP-related serious adverse effects (SAEs) before the recent mandatory dihydropyrimidine dehydrogenase (DPD)-screening was introduced by French health authorities, DPD being the rate-limiting enzyme of 5-fluorouracil (5-FU) catabolism. Exhaustive data on the number of patients treated with FP-based chemotherapy in 2013–2014 were collected in the Centre-Val de Loire region of France. True incidence of SAEs was extracted from a cohort of 513 patients with incident solid tumours receiving first-line FP-based chemotherapy. After extrapolation at national level, we estimated that 76,200 patients are currently treated annually with 5FU (53,100 patients, 62% digestive system-related versus 26% breast cancers versus 12% head and neck cancers) or capecitabine (23,100 patients, 45% digestive system-related versus 37% breast cancers versus 18% non-documented). Earlier (in the first two cycles) the SAE incidence rate was 19.3% (95% confidence interval (CI) 16–23%) including one toxic death (0.2%, 95%CI 0–1%). SAE incidence rate was 32.2% (95%CI 28–36%) over the first 6 months of treatment. Incidence of death, life-threatening prognosis or incapacity/disability was 1.4% (95%CI 0.4–2.4%) and 1.6% (95%CI 0.5–2.6%) during first two cycles and first 6 months, respectively. These data highlight the significant public health issue related to FP toxicity, with around 1200 patients developing FP-related life-threatening prognosis or incapacity/disability annually in France, including 150 toxic deaths. It is hoped that DPD-deficiency screening will reduce such iatrogenic events and eradicate toxic deaths. • Early incidence rate of serious adverse events with fluoropyrimidines is 19.3%. • The number of FP-related toxic deaths is estimated around 150/year in France. • Death, life-threatening prognosis or incapacity affect 1200 patients/year in France. • These are declared to a pharmacovigilance centre in only 12.5% of cases. • Systematic pre-therapeutic screening of DPD deficiency is urgently needed. [ABSTRACT FROM AUTHOR]

The increasing number of unfit patients calls for better risk assessment prior to initiating anti-tumor treatment. This is a major concern in the prevention and reduction of treatment-related complications. The aim of our study was to evaluate the nutritional status for the risk assessment of patients qualifying to receive the gemcitabine and oxaliplatin (GEMOX) regimen. This single-center, retrospective study examined baseline clinical and biological characteristics in a cohort of 165 unselected, consecutive cancer patients receiving GEMOX. Malnutrition was defined as either body mass index (BMI) <18.5 kg/m2, body weight loss >10% over 3 mo, or albuminemia <35 g/L. A total of 165 patients (median age 61 yr, PS 0–1: 71%) were studied. Malnutrition was seen in 43% of PS 0–1 patients, vs. 60% of PS 2 and 66% of PS 3 patients (P> 0.05). Median relative dose-intensity was 0.90 (0.17–1.04). GEMOX dose-intensity correlated negatively with loss of baseline weight (r = −0.24,P< 0.02). In patients who did not complete more than 2 cycles of chemotherapy, median PS (P< 0.01), mean C-reactive protein (CRP;P< 0.01), and mean albuminemia (P< 0.05) were, respectively, significantly higher, higher, and lower. Malnutrition is associated with a high risk of early discontinuance of treatment. Systematic basal evaluation of the nutritional status, including albuminemia and BMI, is recommended. [ABSTRACT FROM PUBLISHER]

The Centralized Chemotherapy Reconstitution Unit (CCRU) of Paul Brousse Hospital Pharmacy Department assessed the reliability of its Cytotoxics Compounded Sterile Products (CCSP) preparation method in order to improve its CCSP quality assurance system. Five cytotoxic drugs — gemcitabine, 5-fluorouracil, docetaxel, paclitaxel, and oxaliplatin — were assayed by high performance liquid chromatography (HPLC) to determine CCSP concentration. During the observation period, 23,892 CCSP were prepared. Overall, 12,964 preparations contained one of the five analyzed drugs; 7382 (56.9%) out of 12,964 CCSP were analyzed by HPLC; 646 (8.8%) out of 7382 concentrations were outside ± 20% of the prescribed dose; 544 (84.2%) out of 646 were post-administration results and could not be verified. Out of 102 (15.8%) pre-administration results that were re-tested after re-shaking, 94 (92.2%) were found to be acceptable upon re-testing, and 8 (7.8%) were confirmed to be unacceptable and needed to be re-compounded. The 8.8% of tested CCSP were outside ± 20% of the prescribed dose, but extrapolating the results on re-tested CCSP, we can say that our CCSP preparation is reliable with an estimation of only 0.7% of 7382 CCSP analyzed, confirmed as being ± 20% outside the prescribed dose. Nevertheless, this ± 20% magnitude of error should be reduced. Based on pre-administration results, the primary cause of concentration errors appeared to be insufficient mixing of the finished product. Most CCSP dosages occurred after it had been administered, the organization should, therefore, be improved to include testing all CCSP prior to administration. Pharmaceutical companies should endeavor to manufacture compounded injectible drugs in a ‘ready to use’ form and provide vehicles in accurate volumes in order to improve compounding precision. [ABSTRACT FROM PUBLISHER]

REGNIER DENOIS V., POIRSON J., NOURISSAT A., JACQUIN J.-P., GUASTALLA J. P. & CHAUVIN F. (2010) European Journal of Cancer Care Oral chemotherapy is increasingly used in oncology. Poor adherence, that is, non-respect of medical advice about taking the therapy and surveillance of adverse effects, is the main risk associated with this administration route. Poor adherence may be explained by non-adherence by the patient to the treatment, misunderstanding the advice or it could also reflect the poor adaptation of the healthcare team to a new administration route. Here we report the results from a qualitative study that aimed to describe and understand existing practice for capecitabine, an oral chemotherapy, which is used for the treatment of metastatic breast and colon cancer. We interviewed 42 patients who were receiving oral capecitabine in groups and individually as well as 10 prescribers. This study was carried out in two specialist cancer centres. The results showed a wide diversity in the prescribers' practices, who make decisions based on their experience of practice guidelines for intravenous chemotherapies. Although the results for the patients do not suggest deliberate non-adherence, they show poor observance of the dose schedule. The most important result of this study is the patient's inability to identify and to report important signs of harmful toxicity. [ABSTRACT FROM AUTHOR]

Mycosis fungoides (MF) and Sézary syndrome (SS) are the most frequent cutaneous T-cell lymphomas. These tumors have a chronic progradient course. Hitherto there is no evidence of effective therapy, particularly of the late-stage of the diseases. About 30% of the patients are not effected by interferon, radiotherapy and combined treatment regimens. Patients' age (median age 62 years) limits therapy options. Several lines of previous treatment could lead to tumor resistance and higher accumulated toxicity. Thus, use of potentially effective chemotherapeutic agents in lower doses will reduce myelotoxicity and expand the cohort of patients. Gemcitabine is an effective medication in treatment of MF/SS. Its efficacy is preserved in small doses with prolonged duration of infusion and allows to decrease myelotoxicity. It was firstly discovered in therapy of solid tumors. In current study 14 patients were involved with resistant forms of MF/SS (10 patients with MF, 3 with SS, and 1 case of MF with transformation into large cell lymphoma). We used 6-hour infusion of gemcitabine at dosage of 250 mg/m2. 86% of patients achieved a general response: 29% complete remission, 50% partial remission, 21% stabilization of disease, 14% (2 patients) progression. Present study showed promising results in treatment of patients with advanced stages of MF/SS which had at least two preceding lines of therapy without an effect. Common response (PR/CR) was received in high percent of cases. This treatment protocol is reproducible in elderly patients. For long-term conclusions further studies are required. [ABSTRACT FROM AUTHOR]

Objective: To compare chemotherapy with no chemotherapy as palliative treatment for oesophageal squamous cell carcinoma. Design: Randomised study. Setting: Multicentre trial in France. Subjects: Of 161 patients with histologically confirmed oesophageal squamous cell carcinoma located more than 5 cm from the mouth of the oesophagus, five were withdrawn because of protocol violation. The remaining 156 patients, 149 men and 7 women, mean (SD) age 58 (9) years range 36 to 77, were randomly allocated to either a control group without chemotherapy (n = 84) or a group treated by chemotherapy (n = 72). Patients were divided into four strata: I = complete resection of the tumour but with lymph node involvement (n = 62) ; II = incomplete resection of tumour leaving gross tumour behind (n = 58) ; III = no resection because of local or regional invasion (n = 22) ; and IV = no resection because of distant metastasis (n = 14). Exclusion criteria were histologically confirmed tracheobronchial involvement, oesophagotracheal fistula, Karnosky score < 50, cerebral metastases, or hepatic metastases occupying more than 30% of the liver, peritoneal carcinomatosis, associated or previously treated ear-nose-throat carcinoma, or complete resection of tumour without lymph node involvement. Interventions: 5 fluorouracil (5FU) and cisplatin (CDDP) were given in 5-day courses, once every 28 days, for a maximum of eight cycles. 5 FU, 1g/m[sup 2], was infused for 24 hours after a water overload, during five days. Cisplatin was given either in one dose of 100 mg/m[sup 2] at the beginning of the cycle or 20 mg/m[sup 2]/day over three hours for five days. Duration of treatment ranged from 6–8 months. Outcome measures: Median and actuarial survival. The subsidiary endpoint was quality of survival judged by complications of treatment, swallowing disorders, and the duration of ability to feed normally. Results: There was no difference in survival, either overall (median = 12 months) or in any of the strata. There were however significantly more patients with neurological (p < 0.003), haematological (p < 0.0001), and renal (p < 0.0002) complications in the treated group compared with the control group. Four patients (6%) died of complications of chemotherapy. The course of swallowing disorders did not differ between the two groups. The duration of autonomous oral feeding was exactly the same in both groups (median = 10.5 months). Conclusion: The results suggest that 5FU and CDDP do not help in patients with squamous cell carcinoma of the oesophagus whether or not the tumour has been resected. [ABSTRACT FROM AUTHOR]

(1) Valaciclovir, a metabolic precursor of aciclovir, improves the bioavailability of the active compound. It is licensed for the prevention of ocular complications of herpes zoster ophthalmicus in immunocompetent subjects. (2) The clinical file on valaciclovir in this indication is very thin. Only two (uninterpretable) trials have been done, both versus aciclovir. Note that oral aciclovir has also been assessed inadequately in this indication. (3) Over 10% of patients treated with valaciclovir in the two trials had nausea or headache.