Analysis of immune-mediated reactions in patients with non-small cell lung cancer treated with nivolumab and its association with effectiveness.

OBJECTIVE: To study immune-related adverse events (irAEs) in non-small cell lung cancer (NSCLC) patients treated with nivolumab, as well as to assess whether these reactions could be predictors of further effectiveness of therapy. METHODS: Retrospective, observational and longitudinal study. All NSCLC patients who received nivolumab between February 2015-May 2020 were included. In terms of safety, irAEs and their severity were registered and to evaluate the effectiveness, overall survival (OS) and progression free survival (PFS) were calculated. RESULTS: 75 patients were included. 32 patients (43%) were reported irAES. Mainly the irAEs affected the skin (36%). Followed by pneumonitis (20%), gastrointestinal reactions (12%), endocrine (12%) and hepatitis (12%). Regarding severity, 92% were moderate. The median PFS was 9.49 months on the group with irAEs versus 1.99 months on the group without irAEs group (p < 0.0001). The median OS was 17.44 months versus 7.67 months respectively (p = 0.0001). According to the incidence of irAEs developed ( = > 2 vs. 1 vs. 0), the median PFS was 20.53 versus 5.35 versus 1.99 months respectively (p < 0.0001). The median OS was 23.41 versus 15.80 versus 7.67 months, respectively (p = 0.0002). CONCLUSION: In a significant number of patients irAEs occur, generally of grade 1-2 severity, affecting mainly the skin, lungs and gastrointestinal system. We confirm that the development of irAEs in patients with NSCLC treated with nivolumab is a strong predictor of treatment effectiveness in both PFS and OS, with statistically significant results. On those patients who experience two or more immunorelated adverse events the greatest benefit has been observed.

Subcutaneous versus intravenous administration of trastuzumab: preference of HER2+ breast cancer patients and financial impact of its use.

PURPOSE: To investigate the preference of HER2+ breast cancer patients and nursing professionals for subcutaneous (SC) versus intravenous (IV) trastuzumab and to evaluate the financial impact derived from the use of the SC formulation. METHODS: A cross-sectional questionnaire-based study was carried out to investigate preferences of all patients who started treatment with SC trastuzumab while they had received the IV formulation before. The preference of nursing staff in charge of preparation and administration was also analysed. The financial impact was evaluated considering the number of preparations of SC trastuzumab and the cost of IV and SC trastuzumab, the consumables used for preparation and administration and nursing staff time for preparation. RESULTS: 76 female patients were included, 84% completed the questionnaire. Of the patients, 94% declared to be satisfied with the SC route and 88% would prefer SC administration if they had to choose between IV and SC. Time saving was the main reason to justify satisfaction and preference (48 and 45% respectively). The most common adverse event related to SC trastuzumab was post-injection pain in the injection site, experienced by 77% of the patients. SC trastuzumab was preferred by 100% of the nursing staff. Total annual savings using SC formulation instead of the IV were 35.332€. CONCLUSIONS: SC trastuzumab is preferred by patients and the nursing staff versus the IV administration. The use of SC trastuzumab reduced the cost derived from trastuzumab administration.

Risk factors associated with Clostridium difficile infection in adult oncology patients.

PURPOSE: Clostridium difficile infection (CDI) prevention is particularly important for cancer patients, because diarrhea often results in dose reductions or delays of chemotherapy or radiotherapy. We conducted this study to better ascertain the incidence, susceptibility, and risk factors for CDI in cancer patients receiving chemotherapy at our hospital. METHODS: We performed a retrospective study among adult cancer patients admitted at "12 de Octubre" University Hospital between January 2009 through April 2013 who were diagnosed with diarrhea. Inpatient data were available on hospital medical records. We screened by immunochromatography system detecting glutamate dehydrogenase antigen, and C. difficile toxins A and B. Later, a polymerase chain reaction for detecting toxin B gene was performed. RESULTS: A total of 225 patients were included in the study, and 39 of them (17.3 %) were diagnosed with CDI. Type of tumor significantly differed between CDI patients, thus relative risk in each type of cancer was calculated after adjusting for age, antibiotic exposure, corticosteroid, and proton-pump inhibitor use. Patients with gastrointestinal tumors were less prone to CDI. Conversely, breast cancer patients have a greater predisposition to CDI. Antibiotic treatment was found to be associated with an increasing risk for CDI in breast cancer patients. Curiously, exposure to proton-pump inhibitors appeared protective in our cohort, except for lung cancer patients. However, we have not been able to find an association between a particular type of chemotherapy and CDI. CONCLUSIONS: We underscore the urgent need for early recognition and diagnosis of CDI in cancer patients. Our findings indicate a probable association between antibiotic use and CDI incidence, at least in certain cancer, such as breast cancer.

Effectiveness of oxaliplatin desensitization protocols.

INTRODUCTION: Hypersensitivity reaction (HSR) to antineoplastic drugs can force doctors to stop treatment and seek other alternatives. These alternatives may be less effective, not as well tolerated and/or more expensive. Another option is to use desensitization protocols that induce a temporary state of tolerance by gradually administering small quantities of the antineoplastic drug until the therapeutic dosage is reached. The aim of this study is to assess the effectiveness of oxaliplatin desensitization protocols. MATERIALS AND METHODS: A retrospective observational study was carried out between January 2006 and May 2011. The inclusion criteria were patients undergoing chemotherapy treatment with oxaliplatin who had developed an HSR to the drug and who were candidates for continuing the treatment using a desensitization protocol. The patients' clinical records were reviewed and variables were gathered relating to the patient, the treatment, the HSR, and the desensitization protocol administered. The data were analysed using version 18.0 of the statistics program SPSS. RESULTS: A total of 53 desensitization protocols were administered to 21 patients. In 89 % of these cases, no new reactions occurred while the drug was being administered. New reactions of mild severity only occurred in 11 % of cases, and none of these reactions were severe enough for treatment to be stopped. All patients were able to complete the desensitization protocol. CONCLUSION: This study confirms that oxaliplatin desensitization protocols are safe and effective and allow patients to continue with the treatment that initially caused an HSR.