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Background Trastuzumab prolongs survival of human epidermal growth factor receptor 2-positive breast cancer patients in both the adjuvant and metastatic settings. Currently toxicity data are not available on retreatment of metastatic breast cancer patients who relapse after adjuvant trastuzumab. We report one patient with metastatic breast cancer who developed acute thrombocytopenia after trastuzumab infusion. This patient had trastuzumab treatment in the adjuvant setting. Case presentation A 70-year-old Caucasian woman received a diagnosis of metastatic breast cancer four years after her initial diagnosis of locally advanced, hormone receptors-positive, human epidermal growth factor receptor 2-positive breast cancer. Trastuzumab retreatment was planned. Less than 24 hours after trastuzumab infusion, the patient was admitted to the hospital for the appearance of diffuse petechial hemorrhages and ecchymosis. The patient was confirmed to have a severe trastuzumab-induced thrombocytopenia. A rapid and complete recovery was observed after high-dose intravenous corticosteroids and immunoglobulin. No trastuzumab retreatment was attempted. Conclusion Among the reported cases of trastuzumab-induced thrombocytopenia, this is the first report in the literature occurring in a patient retreated with trastuzumab after adjuvant therapy.

The triplet FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab showed improved outcomes for patients with metastatic colorectal cancer, compared with FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab. However, the actual benefit of the upfront exposure to the three cytotoxic drugs compared with a preplanned sequential strategy of doublets was not clear, and neither was the feasibility or efficacy of therapies after disease progression. We aimed to compare a preplanned strategy of upfront FOLFOXIRI followed by the reintroduction of the same regimen after disease progression versus a sequence of mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) and FOLFIRI doublets, in combination with bevacizumab. TRIBE2 was an open-label, phase 3, randomised study of patients aged 18–75 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 2, with unresectable, previously untreated metastatic colorectal cancer, recruited from 58 Italian oncology units. Patients were stratified according to centre, ECOG performance status, primary tumour location, and previous adjuvant chemotherapy. A randomisation system incorporating a minimisation algorithm was used to randomly assign patients (1:1) via a masked web-based allocation procedure to two different treatment strategies. In the control group, patients received first-line mFOLFOX6 (85 mg/m2 of intravenous oxaliplatin concurrently with 200 mg/m2 of leucovorin over 120 min; 400 mg/m2 intravenous bolus of fluorouracil; 2400 mg/m2 continuous infusion of fluorouracil for 48 h) plus bevacizumab (5 mg/kg intravenously over 30 min) followed by FOLFIRI (180 mg/m2 of intravenous irinotecan over 120 min concurrently with 200 mg/m2 of leucovorin; 400 mg/m2 intravenous bolus of fluorouracil; 2400 mg/m2 continuous infusion of fluorouracil for 48 h) plus bevacizumab after disease progression. In the experimental group, patients received FOLFOXIRI (165 mg/m2 of intravenous irinotecan over 60 min; 85 mg/m2 intravenous oxaliplatin concurrently with 200 mg/m2 of leucovorin over 120 min; 3200 mg/m2 continuous infusion of fluorouracil for 48 h) plus bevacizumab followed by the reintroduction of the same regimen after disease progression. Combination treatments were repeated every 14 days for up to eight cycles followed by fluorouracil and leucovorin (at the same dose administered at the last induction cycle) plus bevacizumab maintenance until disease progression, unacceptable adverse events, or consent withdrawal. Patients and investigators were not masked. The primary endpoint was progression-free survival 2, defined as the time from randomisation to disease progression on any treatment given after first disease progression, or death, analysed by intention to treat. Safety was assessed in patients who received at least one dose of their assigned treatment. Study recruitment is complete and follow-up is ongoing. This trial is registered with Clinicaltrials.gov, NCT02339116. Between Feb 26, 2015, and May 15, 2017, 679 patients were randomly assigned and received treatment (340 in the control group and 339 in the experimental group). At data cut-off (July 30, 2019) median follow-up was 35·9 months (IQR 30·1–41·4). Median progression-free survival 2 was 19·2 months (95% CI 17·3–21·4) in the experimental group and 16·4 months (15·1–17·5) in the control group (hazard ratio [HR] 0·74, 95% CI 0·63–0·88; p=0·0005). During the first-line treatment, the most frequent of all-cause grade 3–4 events were diarrhoea (57 [17%] vs 18 [5%]), neutropenia (168 [50%] vs 71 [21%]), and arterial hypertension (25 [7%] vs 35 [10%]) in the experimental group compared with the control group. Serious adverse events occurred in 84 (25%) patients in the experimental group and in 56 (17%) patients in the control group. Eight treatment-related deaths were reported in the experimental group (two intestinal occlusions, two intestinal perforations, two sepsis, one myocardial infarction, and one bleeding) and four in the control group (two occlusions, one perforation, and one pulmonary embolism). After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients). Serious adverse events after disease progression occurred in 20 (15%) patients in the experimental group and 25 (12%) in the control group. Three treatment-related deaths after first disease progression were reported in the experimental group (two intestinal occlusions and one sepsis) and four in the control group (one intestinal occlusion, one intestinal perforation, one cerebrovascular event, and one sepsis). Upfront FOLFOXIRI plus bevacizumab followed by the reintroduction of the same regimen after disease progression seems to be a preferable therapeutic strategy to sequential administration of chemotherapy doublets, in combination with bevacizumab, for patients with metastatic colorectal cancer selected according to the study criteria. The GONO Cooperative Group, the ARCO Foundation, and F Hoffmann–La Roche.

To our knowledge, no data are available regarding the tolerance of vaccination in patients who have received radiotherapy in the past 6 months. Because radiotherapy might affect the immune system by both suppressing and enhancing the immune response, the safety of the COVID-19 vaccines might be different in this specific setting. [...]the American Society for Radiation Oncology encourages patients with cancer who are receiving radiotherapy to consult with their oncologist about the timing for vaccination.7 Therefore, data on the tolerability of COVID-19 vaccines in this population might be of interest to radiation oncologists because there is a paucity of data to help in patient counselling. [...]we decided to assess tolerance to the Moderna mRNA-1273 vaccine (elasomeran) among patients treated with radiotherapy at our centre (Radiation Oncology Unit, Santa Maria Annunziata Hospital, Department of Oncology, Azienda USL Toscana Centro, Florence, Italy). Side-effects were graded according to the US Centers for Disease Control and Prevention (CDC) vaccine adverse event reporting system.8 The hypothesis of a worse tolerance in patients who have had or are undergoing radiotherapy would have been confirmed if a proportion lower than 1·0% in the reference group had grade 3 adverse events up to 28 days after the first dose (one-sided α value of 0·05).

Introduction. Medical Oncology was founded in Italy in the early 1970s, and with it those head doctors who with much effort made it grow. Today a fair number of them, honorary members of CIPOMO (Italian College of Hospital Medical Oncology Chiefs), have retired. In a situation of shortage of medical specialists in oncology and in light of clinical evidence, CIPOMO wanted to understand their situation and their attitude to get back into the work and continue to serve the community. Materials and methods. In March-April 2024, a survey was done via a web-based questionnaire consisting of 20 questions to 112 retired primary, and 82 responses (73.2%) were obtained, demonstrating the great interest and attention they perceived for this initiative. The questions were about their family situation, their activity, life outside the hospital, their financial situation and quality of life compared to before, and finally how they envisioned their future. Results. Thirty-five percent of physicians said they would return to work at the hospital, more than 50% work as private practice or consultants on a limited time basis. Family commitments occupy them most of the time. Social life has improved as has their quality of life. Most report having a good economic situation and a few miss the hospital. About their willingness to put their skills back into work, 60.7% said they are available, especially for management-organizational activities, clinical consulting, training and mentoring young oncologists. In their future they see involvement in the world of healthcare mainly in non-clinical activities. Conclusions. The survey results show a reality of socially and economically satisfied oncology professionals, with great desire to do and willingness to get involved again should they be given the opportunity. The health system should find ways to enhance them especially in organizational and/or teaching skills.

Introduction/BackgroundIn early stages endometrial cancer (EC) patients, the standard surgical approach is hysterectomy and bilateral salpingoophorectomy, with pelvic lymphadenectomy or with sentinel lymph node staging, based on clinical and molecular risk factors.The role of 3D imaging reconstruction is currently under debate.The aim of this research is to assess the clinical value of a 3D imaging reconstruction model of pelvic lymphnodes to be used simultaneously in the operating room to identify lymphatic tissue in obese patients.Abstract #704 Figure 1MethodologyA study was performed on obese patients with EC treated between March and October 2022 in Santa Maria Annunziata Hospital (Florence) using REAL 3D-MIC device (group 1). Prior to surgery, we performed a 3D imaging reconstruction of pelvic lymphnodes used to guide the intraoperatively lymphadenectomy. This group was compared with a historical series of EC patients treated without the 3D model (group 2).ResultsThe two groups (group1=13 patients and group2=11 patients) showed homogeneous clinical characteristics. The correspondence between virtual 3D model and real anatomy was analyzed comparing lymphnodes location in virtual 3D model and operative data. We recorded a consistency of 85% (85% for group 1 vs 45% for group 2, p=0,06). In REAL 3D MIC group we found one nodal EC metastasis and one case of B cells Lymphoma synchronous to EC.ConclusionREAL-3D MIC could improve the identification of lymphnodes simultaneously with surgery, especially in obese women. Further studies are needed to demonstrate the effectiveness of REAL- 3D MIC in lymphnodal mapping.DisclosuresThe Authors have no conflicts of interests to declare.

Ministerial Decrete 77 (DM 77) promotes dehospitalization for chronic patients and defines out-of-hospital health facilities at this purpose. It has never been investigated how much patients with cancer know and judge this decree law. The Collegio italiano dei primari oncologi medici ospedalieri (Cipomo) carried out a survey with a dedicated questionnaire on oncological patients attending public hospital to investigate the liking of DM 77. Anonymous responses were obtained from 1.443 patients. Median age 64ys, 42% males, 21% live alone, 70% have a companion. 19% thinks that oral chemotherapy could be managed outside the hospital, 26.68% carried out follow-up (FU),19.15% parenteral therapy, 32.16% basic examinations. Home is preferred by 21.8%, a health facility close to home by 36.3%, hospital by 37.54%. 59.67% would like FU in hospital by their personal oncologist, 5.47% by GP, 35.41% by both together and 9.45% by oncologist outside the hospital. Asked what they might feel about being followed out of the hospital, 29.94% say of not being treated at its best, 12.68% of not being able to be visited in hospital anymore, 5.27% of being abandoned, 30.7% of being freer and 10.88% of feeling less sick. Regarding the use of new technical tools to favor dehospitalisation, 44.15% answered yes, 15.88% no and 30.07% did not know. About the distance or traveling time from home to the therapy administration side, 20.26% answered this should be no more than 15 km or 30 mins, 9.91% no more than 30 km or 45 mins, 5.47% no more than 50 km or 60 mins but 39.5% say that the distance does not matter to them but only the continuity of care. The question related to the inconveniences with going to hospital for therapy: 40.81% waiting time, 20.47% lack of parking, 17.02% rotation of doctors,12.76% travel time and 5.62% bureaucracy. The patients' answers suggest that dehospitalization could improve their quality of life, but at the condition of being able to maintain a close relationship with the personal oncologist.

EMA licensed eribulin mesylate in 2011 for women with advanced breast cancer already treated with at least two lines of chemotherapy, including anthracyclines and taxanes. Azienda Sanitaria Firenze experience is reported to assess the efficacy and safety of eribulin in the real-life setting. Eribulin was infused as per indication. All women treated in the last 2 years were reviewed. A total of 27 women received eribulin. All but one was pretreated with anthracyclines, 97% with taxanes and 87% with capecitabine. Median age was 63 years (range: 27-80). A median of four cycles of eribulin were infused (range: 2-10). Overall response rate was 30% with a 45% of clinical benefit (response plus stable disease for at least 24 weeks). Toxicities have been as expected. Severe toxicities were rare, with one patient experiencing sepsis and 18% developing grade 3 asthenia. Eribulin maintains its activity out of clinical trials, without unexpected toxicities.

ObjectivesTo assess Italian medical oncologists’ opinion on the implications of conflict of interest (COI) on medical education, care and research, and to evaluate their direct financial relationships.DesignNational cross-sectional survey conducted between March and April 2017 among Italian oncologists.SettingOnline survey sponsored by the Italian College of Medical Oncology Chiefs through its website.ParticipantsItalian oncologists who filled out an anonymous questionnaire including 19 items and individual and working characteristics.Main outcome measureThe proportion of medical oncologists perceiving COI as an outstanding issue and those receiving direct payments from industry.ResultsThere were 321 respondents, representing 13% of Italian tenured medical oncologists. Overall, 62% declared direct payments from the pharmaceutical industry in the last 3 years. Sixty-eight per cent felt the majority of Italian oncologists have a COI with industry, but 59% suppose this is not greater than that of other specialties. Eighty-two per cent consider that most oncology education is supported by industry. More than 75% believe that current allocation of industry budget on marketing and promotion rather than research and development is unfair, but 75% consider it appropriate to receive travel and lodging hospitality from industry. A median net profit margin of €5000 per patient enrolled in an industry trial was considered appropriate for the employee institution. Sixty per cent agree to receive a personal fee for patients enrolled in industry trials, but 79% state this should be reported in the informed consent. Over 90% believe that scientific societies should publish a financial report of industry support. Finally, 79% disagree to being a coauthor of an article written by a medical writer when no substantial scientific contribution is made.ConclusionsAmong Italian oncologists COI is perceived as an important issue influencing costs, education, care and science. A more rigorous policy on COI should be implemented.

Clinical data suggest that beyond-progression, the blockade of angiogenesis is associated with improved survivals in colorectal cancer. We conducted a systematic review to investigate the therapeutic effects of antiangiogenic drugs administered as later lines of treatment in patients already progressed to a previous anti-VEGF based treatment. An extensive literature search was conducted. Hazard ratios (HR) for progression (PFS) and death (OS) were extracted. An inverse-variance meta-analysis model was implemented. 6 randomized controlled trials were retrieved, including 3407 patients, treated with different antiangiogenic drugs. All of them had progressed during or after a previous line of treatment with bevacizumab. Overall, both PFS (HR=0.63, <0.001) and OS (HR=0.81, < 0.001) were significantly increased with the use of antiangiogenic drug. No heterogeneity was observed despite different drugs. Protracted inhibition of the VEGF pathway is associated with a significant improvement of both PFS and OS, independently from the antiangiogenic agent used.

Colorectal cancer (CRC) is the third most common malignancy and cause of death from cancer among adults worldwide. In recent years, the use of 5-fluorouracil-based regimens in combination with molecularly targeted agents has greatly expanded treatment options for patients with metastatic disease. With a more capillary use of this new class of agents comes the recognition of diverse adverse events related to disturbance of critical biological pathways involved in physiological functions. Proactive management and prevention of adverse events, with a focus on the necessary compromise between adverse events and tumor control, are often effective and allows for uninterrupted, full-dose therapy with targeted agents. Quality of life does not appear deteriorated, rather improved due to efficacy in prolonging wellness.