Multidisciplinary management of immunotherapy-related adverse events in solid tumors: An inter-institutional and telemedicine-based working team.

BACKGROUND: Although immune checkpoint inhibitors (ICIs) show a more favorable toxicity profile than classical cytotoxic drugs, their mechanism of action is responsible for peculiar new toxicities. There is an urgent need for a multidisciplinary approach to advice on how to manage organ-specific toxicities. METHODS: Our project aims to integrate the practices of two different hospitals into a single Italian regional collaborative model to treat immune-related adverse events (irAEs). The team structure is a multi-professional and multidisciplinary cooperative network that consists of different medical specialists. The team referrer is the medical oncologist and an existing telematic platform is used for specialists' cooperation. The leading oncologist first evaluates patients' clinical condition, therefore team intervention and teleconsultation are planned to activate proper management. After a first phase structured for general setting, outcomes analysis, data collection, and identification of critical issues, it is planned to define appropriate key performance indicators (KPIs) in quality, structure, process, and outcome settings. Therefore, a second phase would serve to implement KPIs. In the third phase, the proposal for the enlargement of the network with the extension to more centers in the context of the Regional Health Service will be performed. DISCUSSION: The multidisciplinary management of irAEs based on telemedicine fits into the debate on the renewal of healthcare systems and the push for change toward multidisciplinary with the rising use of telemedicine. To our knowledge, this is the first project reporting a multi-institutional experience for change of service in irAEs management.

From Pregnancy to Lactation: When the Pathway is Complicated by Cancer.

BACKGROUND: Women with a cancer history report high distress during pregnancy and infant feeding. Despite the clear advantages of breastfeeding, little is known about factors influencing infant feeding behavior in women with cancer history. RESEARCH AIM: This three-time point longitudinal study aimed to explore the centrality of pregnancy and infant feeding experiences in 17 pregnant women with a cancer history (cases) compared to 17 pregnant women without cancer history (controls). METHODS: During pregnancy, participants filled out the Centrality of Events Scale and an ad hoc questionnaire about specific emotions, concerns, and expectations about infant feeding (T1), and their childbirth and infant feeding experiences during hospitalization (T2), and at 3-months postpartum (T3). RESULTS: Results at T1 demonstrated that participants with a history of cancer reported a higher perception of negative judgment and moral choice about breastfeeding than participants without a history of cancer. At T2 they reported a more positive childbirth experience than controls. From T2 to T3 participants with a history of cancer breastfed at a higher percentage than controls, and at T3 they reported higher levels of emotional and physical pleasure about the infant feeding experiences. CONCLUSIONS: Women with cancer history may experience a higher emotional and physical pleasure with infant feeding. Despite initial difficulties, a greater prevalence of breastfeeding was present for women with a history of cancer. Although this is a small sample, this research suggests that support and promotion of breastfeeding might be very effective after a serious medical diagnosis.

Psychological Well-Being, Prenatal Attachment, and Quality of Early Mother-Infant Interaction: A Pilot Study With a Sample of Mothers With or Without Cancer History.

Given the positive impact of high-quality mother-infant interaction on child development, and that such relationship might be hindered by maternal stresses such past cancer, research is needed to understand protective and risk factors in this clinical population. As almost no data is available on the impact of history of cancer on the quality of mother-infant interaction, a multicentric and longitudinal pilot study was conducted. Differences in women's prenatal psychological well-being and attachment (T1, third trimester), and postnatal quality of mother-infant interaction (T2, 2-5 months) were assessed in a sample of Italian mothers with (N = 11) or without cancer history (N = 13). Results showed that women did not differ significantly in their prenatal well-being (assessed with the Profile of Mood States questionnaire) and levels of attachment (assessed with the Prenatal Attachment Inventory). Looking at mother-infant interactions (assessed using the Global Rating Scale at T2), while maternal sensitivity, warmth and intrusiveness, and infant distress and attentiveness did not differ between the two groups, in the clinical group, mothers were more remote and less absorbed in the infant, and infants showed fewer positive communications. These findings might shed light on potential protective and risk factors for early parenting and later child outcomes in this clinical population.

Motherhood during or after breast cancer diagnosis: A qualitative study.

OBJECTIVE: Little is known about the process of becoming a mother in women who experienced a breast cancer diagnosis (BC). In this qualitative study, we investigated maternal representations in pregnant women with experience of BC and those with no oncological history. METHODS: A total of 38 women were recruited, 19 women who experienced a BC diagnosis and 19 who had not. To explore maternal representations, semi-structured interviews were conducted and analysed through thematic analysis. RESULTS: Four main themes were identified: fears and worries, meaning of motherhood, mother-foetus relationship and partner support. Across themes, differences between primiparous and multiparous are reported. Women with gestational breast cancer (GBC) described fear for their own and their child's survival. Women with previous BC recall contrasting emotions. All women with experience of BC perceived breastfeeding as fundamental and inability to do so provoked worry. Relationship with the partner was considered central, while healthy women were projected towards the future triadic relationship. CONCLUSIONS: Finding a mental space during pregnancy for the representation of the future child could be hard for women with GBC. Dissimilarities in the experience of motherhood in cancer patients provide insight into psychological aspects that should be taken into account in clinical practice.

Protect, promote and support: a warm chain of breastfeeding for oncological women-results from a survey of young Italian cancer mothers.

The topic of lactation following cancer diagnosis will become increasingly more current. Although oncological research confirms that breastfeeding after cancer might be possible, there is a lack of guidelines and a good recommendation for oncological women. In the absence of specific recommendations, women with past cancer may be at higher risk for psychological distress related to breastfeeding. The objective of this article was to analyse the experience of breastfeeding in new mothers with a history of cancer compared to women without a cancer diagnosis. First, we explored the impact of the cancer diagnosis on the breastfeeding choice. Second, we evaluated the relationship between different feeding methods and the mother's mood states in women with and without a history of cancer. The sample was composed of 74 mothers divided into two groups: 34 with a cancer history (clinical sample) and 40 without a cancer diagnosis (control group). Participants were requested to complete a questionnaire three months after childbirth which assessed: socio-demographic and clinical data, feeding modes (breastfeeding, formula and mixed feeding) and the profile of mood states (POMS). Results showed that women in the clinical group breastfeed significantly less and use formula more than those in the control group. Moreover, in the clinical group, women who breastfeed feel reported higher levels of confusion (according to POMS) than mothers who bottle-feed or use a mixed feeding method. On the contrary, in the control sample, women who breastfeed feel significantly more vigorous than puerperae who bottle-feed or use mixed methods according to POMS. Our findings suggest the need for a specific warm chain of support and the development of guidelines with clear and specific information for women with a cancer diagnosis in order to reduce their confusion around breastfeeding.

Exploring differences in psychological aspects during pregnancy between cancer survivors and women without a history of cancer.

Young cancer survivors often wish to bear a child after oncological treatments, as they might not have started or completed their families. As young cancer survivors have a higher risk of developing psychological difficulties, this study investigated whether there were significant differences in psychological aspects between pregnant women who received a cancer diagnosis in the past and pregnant women without a history of cancer. A total of 123 pregnant women, of which 36 were cancer survivors and 87 women without a history of cancer, were recruited during their last trimester at different hospitals in Northern Italy. Patients were asked to complete a socio-demographic profile and questionnaires measuring mood states, post-traumatic symptoms, centrality of the pregnancy and cancer event, quality of life, and prenatal attachment. Cancer survivors had significantly higher levels of PTSD symptoms, perceived pregnancy as more central to their identity and life story, perceived lower quality of life and had lower intensity of prenatal attachment compared with the control group. Centrality of the cancer event did not correlate with any psychological variables. Preliminary results suggest that a past cancer diagnosis can influence the mother's psychological functioning and the development of the relationship with their child.

Case report of a 65-year-old man with biatrial metastatic localisation from poorly differentiated cutaneous squamous cell carcinoma.

We report the case of an immunocompetent 65-year-old man affected by cutaneous squamous cell carcinoma (cSCC) with lung and biatrial metastatic localisation. In May 2018, the patient underwent lower limb amputation due to the finding of a large ulceration which upon biopsy was found to be a poorly differentiated squamous cell carcinoma (SCC), ulcerated, full-thickness infiltrating from the skin to the underlying bone tissue. After 1 month, a radiological restaging found multiple pulmonary localisations and a right-atrial metastatic localisation. The patient was then studied in-depth and a transesophageal echocardiogram found that the patient had two 2 and 5 cm metastatic localisations in the left atrium and a 3-cm metastatic localisation in the right atrium. Informed about the clinical situation and about the risks of a chemotherapeutic treatment, the patient decided not to start any treatment. This case represents, to our knowledge, the only case of a biatrial metastatic localisation from cSCC and is representative of how cardiac symptoms and signs in patients affected by this disease must be evaluated.

Adjuvant low-dose interleukin-2 (IL-2) plus interferon-α (IFN-α) in operable renal cell carcinoma (RCC): a phase III, randomized, multicentre trial of the Italian Oncology Group for Clinical Research (GOIRC).

There is currently no standard therapy to reduce the recurrence rate after surgery for renal cell carcinoma (RCC). The aim of this study was to assess efficacy and safety of adjuvant treatment with low doses of interleukin-2 (IL-2)+interferon-α (IFN-α) in operable RCC. The patients were randomized 1:1 to receive a 4-week cycle of low-dose IL-2+IFN-α or observation after primary surgery for RCC. Treatment cycles were repeated every 4 months for the first 2 years and every 6 months for the subsequent 3 years. The primary endpoint was recurrence-free survival (RFS); safety; and overall survival (OS) were secondary endpoints. ClinicalTrials.gov registration number was NCT00502034. 303/310 randomized patients (156 in the immunotherapy arm and 154 in the observation group) were evaluable at the intention-to-treat analyses. The 2 arms were well balanced. At a median follow-up of 52 months (range, 12-151 mo), RFS, and OS were similar, with an estimated hazard ratio (HR) of 0.84 [95% confidence interval (CI), 0.54-1.31; P=0.44] and of 1.07 (95% CI, 0.64-1.79; P=0.79), respectively in the 2 groups. Unplanned, subgroup analysis showed a positive effect of the treatment for patients with age 60 years and younger, pN0, tumor grades 1-2, and pT3a stage. Among patients with the combined presence of ≥ 2 of these factors, immunotherapy had a positive effect on RFS (HR=0.44; 95% CI, 0.24-0.82; P ≤ 0.01), whereas patients with <2 factors in the treatment arm exhibited a significant poorer OS (HR=2.27; 95% CI, 1.03-5.03 P=0.037). Toxicity of immunotherapy was mild and limited to World Health Organization grade 1-2 in most cases. Adjuvant immunotherapy with IL-2+IFN-α showed no RFS or OS improvement in RCC patients who underwent radical surgery. The results of subset analysis here presented are only hypothesis generating.

Streptococcus bovis endocarditis and colon cancer: myth or reality? A case report and literature review.

A relationship between infective endocarditis and colon cancer was established in 1950, and Streptococcus bovis was successfully isolated in 1970. However, this association and its pathogenesis still remain unclear. In this paper, we describe the clinical case of a patient with a history of colon cancer and infective endocarditis caused by Streptococcus bovis. The role of S bovis as an aetiological agent in the development of colon cancer is intriguing but uncertain. S bovis infection should be considered a silent sign of gastrointestinal malignancy or hepatic disease. We believe that in order to demonstrate the presence of colon cancer, all patients with S bovis infection require an endoscopic investigation of the colon.

The progression of non-motor symptoms in Parkinson's disease and their contribution to motor disability and quality of life.

Non-motor symptoms are gaining relevance in Parkinson's disease (PD) management but little is known about their progression and contribution to deterioration of quality of life. We followed prospectively 707 PD patients (62 % males) for 2 years. We assessed non-motor symptoms referred to 12 different domains, each including 1-10 specific symptoms, as well as motor state (UPDRS), general cognition, and life quality. Hoehn & Yahr (H&Y) stage was used to categorize patient status (I-II mild; III moderate; IV-V severe). We found that individual non-motor symptoms had variable evolution over the 2-year follow-up with sleep, gastrointestinal, attention/memory and skin disturbances (hyperhidrosis and seborrhea) becoming more prevalent and psychiatric, cardiovascular, and respiratory disorders becoming less prevalent. Development of symptoms in the cardiovascular, apathy, urinary, psychiatric, and fatigue domains was associated with significant life-quality worsening (p < 0.0045, alpha with Bonferroni correction). During the observation period, 123 patients (17 %) worsened clinically while 584 were rated as stable. There was a fivefold greater increase in UPDRS motor score in worse compared with stable patients over 24 months (p < 0.0001 vs. baseline both in stable and worse group). The total number of reported non-motor symptoms increased over 24 months in patients with motor worsening compared to stable ones (p < 0.001). Thirty-nine patients died (3.4 % of patients evaluable at baseline) with mean age at death of 74 years. Deceased patients were older, had significantly higher H&Y stage and motor score, and reported a greater number of non-motor symptoms at baseline. In conclusion, overall non-motor symptom progression does not follow motor deterioration, is symptom-specific, and only development of specific domains negatively impacts quality of life. These results have consequences for drug studies targeting non-motor features.

Oxycodone controlled-release as first-choice therapy for moderate-to-severe cancer pain in Italian patients: results of an open-label, multicentre, observational study.

BACKGROUND AND OBJECTIVES: Cancer pain affects patients at all stages of the disease and there are clear guidelines for its management. Morphine is considered the first-choice strong opioid in the treatment of moderate-to-severe pain; however, numerous studies have shown that oxycodone controlled-release (CR) has a similar efficacy and safety profile. The purpose of this study was to evaluate the efficacy and tolerability of oxycodone CR as a first-line strong opioid for the treatment of moderate-to-severe pain in Italian cancer patients. METHODS: This was a prospective, open-label, multicentre, observational trial carried out at 15 locations across Italy. Patients with a referral for cancer-related pain of > or =5 on a 10-point numerical rating scale were enrolled. Patients were treated with oral oxycodone CR and monitored for 21 days. Dosage was individualized for each patient and up-titrated until effective pain control was achieved. Pain, adverse events and quality-of-life scores were assessed throughout the study. RESULTS: 390 patients (174 females and 216 males) with a mean age of 66 +/- 11 years were evaluated. The average daily dose ranged from 22.84 on day 1 to 40 mg/day on day 21. Pain intensity (assessed on a 10-point numerical rating scale) decreased significantly within 1 day of treatment commencement (p = 0.00001) and continued to decrease throughout the study period (from a mean 7.22 at baseline to a mean 2.11 points on day 21). Adverse events were mild to moderate in intensity and consisted of common opioid-related events. Ten patients (2.6%) discontinued the study because of adverse events and four (1%) because of uncontrolled pain. All aspects of activities of daily life assessed were improved by study end. CONCLUSIONS: Oxycodone CR is efficacious and well tolerated as a first-line strong opioid for the treatment of moderate-to-severe cancer-related pain in Italian patients.