Sacituzumab Govitecan for the treatment of advanced triple negative breast cancer patients: a multi-center real-world analysis.

Objective: The objective of this multicenter, observational, retrospective analysis was to evaluate the safety and efficacy of sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC) patients managed according to common clinical practice in Italy. Methods: Data were retrieved by 7 sites. Triple-negative BC was defined by the lack of expression of estrogen receptor (ER <1%), progesterone receptor (PgR <1%) and human-epidermal growth factor receptor-2 (HER2 0, 1+, 2+ ISH-not amplified) according to standard ASCO-CAP criteria. Demographic and clinical characteristics were collected. Premedication, dose modifications and treatment schedule were based on the approved label of the product. Adverse events (AEs) were assessed according to NCI-CTCAE v5.0. Results: Fifty-seven eligible patients who received sacituzumab govitecan for mTNBC were included. Median age was 53 years (range 25-75). Approximately 70% of patients had an initial diagnosis of TNBC. Median time from the diagnosis of metastatic BC to start of sacituzumab govitecan was 17 months (range 0-97) and median number of previous therapies was 3 (range 1-7). The most common sites of metastasis were lymph nodes (63.1% of patients), lung (57.9%), bone (50.8%) and liver (38.6%). Eight (14.0%) patients had a disease-free interval ≤12 months. A total of 32 (56.1%) deaths were observed and the median overall survival (OS) was 12.43 months (95% CI, 7.97 months-not reached). At a median follow-up of 10.6 months, 45 patients (78.9%) had progression and the median progression-free survival (PFS) was 4.9 months (95% CI, 3.7-7.1 months). Partial tumour response was observed in 19 patients (33.3%), stable disease in 16 (28.1%) and disease progression in 22 patients (38.6%). The most common treatment-related AEs were anemia (66.6% of patients), alopecia (66.6%), neutropenia (59.6%), nausea (42.1%) and diarrhea (38.6%). Neutropenia was the most common serious treatment-related AE: 21.0% and 8.7% of patients experienced grade 3 or 4 neutropenia, respectively. Twenty-two patients (38.6%) reduced the dose and 5.3% permanently discontinued treatment. Conclusion: The results of this real-world analysis showed that both safety and efficacy of sacituzumab govitecan in mTNBC patients are consistent with that previously reported in regulatory trials. The use of premedication and supportive measures was associated with a satisfactory toxicity profile.

[Value-based cancer care. From traditional evidence-based decision making to balanced decision making within frameworks of shared values]. / La decisione oncologica basata sui valori Dal tradizionale processo decisionale oncologico evidence-based a scelte basate su valori bilanciati e condivisi.

Clinical decision making in oncology is based so far on the evidence of efficacy from high-quality clinical research. Data collection and analysis from experimental studies provide valuable insight into response rates and progression-free or overall survival. Data processing generates valuable information for medical professionals involved in cancer patient care, enabling them to make objective and unbiased choices. The increased attention of many scientific associations toward a more rational resource consumption in clinical decision making is mirrored in the Choosing Wisely campaign against the overuse or misuse of exams and procedures of little or no benefit for the patient. This cultural movement has been actively promoting care solutions based on the concept of "value". As a result, the value-based decision-making process for cancer care should not be dissociated from economic sustainability and from ethics of the affordability, also given the growing average cost of the most recent cancer drugs. In support of this orientation, the National Comprehensive Cancer Network (NCCN) has developed innovative and "complex" guidelines based on values, defined as "evidence blocks", with the aim of assisting the medical community in making overall sustainable choices.

Topical Application of a Galenical Formulation for the Management of Everolimus-Induced Mucositis in Patients with Metastatic Cancer: a Retrospective Study.

INTRODUCTION: Stomatitis is a common and potentially dose-limiting adverse event of the mammalian target of rapamycin (mTOR) inhibitor therapy. To minimize dose reductions or treatment delays that may affect therapeutic outcomes, management includes patient education, pain management strategies, and drug treatment. The aim of this study was to evaluate the effectiveness of a topically-applied galenical preparation to minimize the impact of everolimus-associated oral mucositis in patients with advanced cancer. METHODS: Patients receiving everolimus plus exemestane for advanced breast cancer or everolimus alone for advanced renal cancer were eligible for inclusion. All patients were advised on procedures to maintain good oral hygiene and directed to use a dexamethasone-containing galenical preparation at the first signs of mucositis. Questionnaires were administered at baseline, and after cycles one, two, and three to evaluate the presence, duration, and intensity of oral mucositis. RESULTS: Of the 19 patients included in the study (mean age 66 years; 16% male), mucositis developed in 10.5%, 47.4%, and 52.6% of patients after the first, second, and third cycles of everolimus, respectively. The median time to development of mucositis was 18.0 days, and the median time to mucositis resolution was 30.0 days. After the first, second, and third cycles of therapy, 5.3%, 10.5%, and 10.5% of patients required interruption of everolimus therapy; however, no dosage reductions for mucositis were necessary. CONCLUSIONS: Patient education and the provision of an effective galenical preparation can minimize the effect of mTOR inhibitor-related mucositis.

Targeted therapy in renal carcinoma: a case of long-term effect with complete control of toxicity.

Although advances in imaging techniques have allowed earlier diagnosis of renal cell carcinoma (RCC) in recent decades, one-third of patients who have undergone radical resection of organ-confined disease will eventually develop metastases. The treatment of metastatic RCC was revolutionized by the advent of targeted therapy with tyrosine kinase inhibitors. We have followed seven patients with metastatic RCC who were treated with first-line pazopanib at our center. The case of one of these patients is described here in detail. The patient was first diagnosed with RCC in 1999 and metastases were detected in 2006 and 2012. Treatment with pazopanib at the standard dose of 800 mg/day for 29 months led to a partial response that persisted over time. Side effects (hypertension and painful mucositis) were successfully managed with supportive care at our oral therapy clinic. Early management of adverse events using a multidisciplinary approach is paramount to the favorable outcome of treatment with pazopanib and other targeted agents.

Improvement of quality of life in third-line chemotherapy with lapatinib in a case of metastatic breast cancer.

We describe a case of a 72-year-old patient suffering from metastatic breast cancer. The disease had progressed slowly and was almost asymptomatic for a significant time. Toxicity, following third-line treatment with lapatinib, was not significant, and side effects were well controlled. The case is an excellent example of a chronic neoplastic disease in a patient who could be defined as "long-surviving".

The Pan European Emesis Registry (PEER): a critical appraisal of the Italian experience.

PURPOSE: Data from a large European prospective observational study were analysed to describe the antiemetic prescribing pattern for chemotherapy-induced nausea and vomiting (CINV) in Italian clinical practice. METHODS: Post hoc analysis of the Pan European Emesis Registry in chemo-naïve adults initiating single-day highly or moderately emetogenic chemotherapy (HEC or MEC) for cancer. RESULTS: A total of 211 eligible patients were enrolled in the Italian centres, 180 were included in the analyses for cycle 1; 50·6% received MEC. The use of guideline-consistent CINV prophylaxis (GCCP) varied substantially between acute and delayed phases (54·4% during the acute phase vs. 29·4% in the overall 120-hour study period, acute plus delayed phases). Neurokinin-1 receptor antagonist was added to the prophylaxis with dexamethasone+5-hydroxytryptamine type 3 receptor antagonists in only 11·1% of patients (vs. 57·2% of the entire European study population). In the GCCP group, the complete response rate was significantly higher than that recorded in the guideline-inconsistent CINV prophylaxis (GICP) group (75·5 vs. 53·5%, P = 0·006). CONCLUSION: The proportion of guideline-consistent antiemetic therapy was quite low in the Italian population as it was in the overall European population. The implementation of specific guidelines' recommendations for chemotherapeutic regimens administered according to standard protocols could be considered as a means to reduce the burden of CINV.

Advanced adult esthesioneuroblastoma successfully treated with cisplatin and etoposide alternated with doxorubicin, ifosfamide and vincristine.

The esthesioneuroblastoma is a rare neuroendocrine tumor that derives from the olfactory cells. In the last 20 years, around 1,000 cases have been described, with an overall survival rate of 60-70% at 5 years. The most common symptoms are nasal bleeding, nasal clogging and, in locally advanced cases, signs/symptoms of intracranic hypertension such as papilla edema, cefalea, and vomiting. The standard treatments are surgery and radiotherapy. Chemotherapy can be used in an adjuvant/neoadjuvant setting and in the metastatic phase, even if its role is still not established with certainty. Here, the case is reported of a young man (38 years old) with a locally advanced esthesioneuroblastoma. Two months before coming to our clinic, he had been treated elsewhere with debulking surgery through bilateral frontal craniotomy. After surgery, MRI showed residual disease in the nasal cavities and in the medial wall of the orbits responsible for blindness and bilateral exophthalmos within a month: a very short time. Octreoscan and whole body CT scan confirmed a locally advanced disease, in the absence of metastases. Chemotherapy was begun with cisplatin and etoposide alternated with doxorubicin, ifosfamide and vincristine with granulocyte colony-stimulating factor (G-CSF) support after every cycle. Soon after the first cycle, an important reduction of pain and decrease of the exophthalmos and vertigos was observed. No improvement in blindness was seen. The patient is still stable after 24 months of follow up.

Preferences of patients with advanced colorectal cancer for treatment with oral or intravenous chemotherapy.

BACKGROUND: In recent years, patient-reported outcomes such as health-related quality of life have become important areas of clinician focus in general cancer management. Patients' preferences for, and/or satisfaction with, oral versus intravenous (IV) chemotherapy schedules may have a major impact on such outcomes. OBJECTIVE: To evaluate preferences for oral or IV chemotherapy in patients with advanced colorectal cancer. METHODS: A multicenter, randomized, crossover trial was conducted in 12 hospitals in Southern Italy, in which 22 patients with advanced colorectal cancer received one cycle of oral capecitabine ± irinotecan or oxaliplatin, followed by one cycle of an IV de Gramont or similar regimen (arm A), or the same regimens in reverse order (arm B). Patients were aged 50-70 years and 21% had a higher level of education (graduate or similar). Patients received oral capecitabine 3500 mg/m/day for 7 days (± irinotecan 180 mg/m or oxaliplatin 85 mg/m on day 1 only), followed by an IV de Gramont regimen ± irinotecan (FOLFIRI) or oxaliplatin (FOLFOX); or the two schedules administered in reverse order.The main outcome measure was patients' preferences for oral versus IV chemotherapy, as determined by a pre- and post-treatment therapy preference questionnaire (TPQ). RESULTS: Before treatment, 75% of patients preferred oral therapy. Characteristics that patients considered to be important were that treatment should not interfere with daily activities (100% of patients) and should not cause fatigue (95%), diarrhea (76%), or painful mouth ulcers (76%); other factors considered important were the risk of infection and nausea (90%), and that treatment could be administered at home (65%). After receiving both chemotherapy schedules, only 45% of patients preferred oral therapy, while 55% preferred IV therapy. Among the latter, the most important characteristics influencing treatment choice were less nausea (66%), fewer mood effects (65%), the safety of hospital IV treatment (62%), less interference with family relationships (55%), less vomiting (55%), less interference with daily activities (50%), and less diarrhea (50%). Although the order in which patients received therapy did not influence treatment preference, significantly fewer patients with a lower rather than higher educational level preferred oral therapy (47% vs 80%; chi-square test = 9.9; p = 0.002). CONCLUSION: These results suggest that there may be a correlation between educational level and the preference of patients with advanced colorectal cancer for oral or IV chemotherapy.