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There are five pilot studies within the iHelp designed to help test and validate the personalised healthcare solution developed in the project. Pilot settings cover from community based (general population) to hospital based (patients). All pilots provide different aspects in relation to disease prevention, personalised health monitoring and decision support. More specifically, Pilot#1 (UNIMAN) focuses on pancreatic cancer risk prediction and risk mitigation. In the risk mitigation process, biomarkers will be assessed and be used as part of motivational change in health habits. Pilot#2 (FPG) focuses on predict outcomes and toxicity using real-world data (RWD) analysis approach. Data on Patient Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROMs) for pancreatic cancer patients with indication to radiotherapy will be systematically collected using a mobile application connected with Internet of Thing (IoT) devices. Pilot#3 (HDM) sets to investigate lifestyle choices on elevating the Risk Factors for Pancreatic Cancer. In addition, this pilot will employ case-control study design to explore new as well as established risk factors associate with pancreatic cancer. Pilot#4 (MUP) will also investigate factors associated with pancreatic risk to derive personalised recommendations and measures to raise awareness. Finally, Pilot#5 (TMU) will explore factors that predict high-risk individuals towards pancreatic and liver cancer for early-stage management of the disease and further explore the effect of digital therapeutics solutions among these individuals. This deliverable describes details of each pilot in more in-depth.

Treatment of a relapsed glioma is a clinical challenge nowadays. New active treatments are required to treat these difficult diseases. Here we present a durable complete remission of a relapsed glioblastoma that has achieved a complete radiologic response with the combination of cetuximab and bevacizumab, in a third-line setting, that has offered a progression-free survival of 20 months. We consider here both potential mechanisms for the explanation of this result. First, the potential target of the cancer stem cells (CSCs) with these two antibodies, and second, the potential recruitment of the immune system to directly pursue the CSCs.

Hormone-resistant prostate cancer (HRPC) occurs when prostate cancer is no longer responsive to hormone therapy. Treatment options are limited, and there is a clear necessity for therapies that improve outcome. Preclinical and clinical evidence supports the role of the immunomodulatory agent lenalidomide in HRPC. In this paper, we report that lenalidomide showed antitumoral activity in a patient with HRPC and bone metastases pre-treated with chemotherapy, decreased the PSA level and improved the patient’s health status for the first 5 months. It is important to emphasize that it was not associated with hematologic toxicity.

Thyroid cancer is the endocrine tumor that bears the highest incidence with 33 550 new cases per year. It bears an excellent prognosis with a mortality of 1530 patients per year (Jemal et al.; 2007). We have been treating patients with thyroid carcinoma during many years without many innovations. Recently, we have assisted to the development of new agents for the treatment of this disease with unexpected good results. Here we present a review with the old and new methods for the treatment of this disease.

Resumen Las neoplasias de ovario suelen presentarse en estadios avanzados. La citorreduccion primaria completa continua teniendo una importancia clara en el pronostico de las pacientes. Hemos asistido a una progresiva mejoria en el resultado de los tratamientos, desde la aparicion de los taxanos, asi como de la importancia de la via intraperitoneal. Sin embargo, esta ultima no acaba de imponerse como practica clinica habitual dadas las dificultades que presenta. Tras el final de la quimioterapia adyuvante, la mayoria de las pacientes presentara una recaida. La identificacion de las pacientes con mayor riesgo puede permitir el establecimiento de una pauta terapeutica que mejore las perspectivas de este subgrupo de pacientes. La enfermedad residual tras citorreduccion primaria y quimioterapia adyuvante tiene una importancia pronostica y su manejo no responde a pautas estandarizadas.

Metastatic prostate cancer is an incurable disease. After a period of hormone sensitivity that allows for the use of antiandrogens, the disease invariably progresses to a situation of androgen-independent growth, which deserves the consideration or the use of chemotherapy. As many of these patients are elderly and fragile, treatment with chemotherapy is challenging. Therefore, new drugs are required. Preclinical evidence supports the role of estrogen receptor (ER) signaling in prostate cancer. In this paper, we report the first published evidence of PSA control in a patient with metastatic prostate cancer treated with fulvestrant acetate.

Epithelioid cell tumors presenting in the gastrointestinal tract are uncommon, but when they arise, arriving at a correct diagnosis is important. We report a case of anal malignant melanoma in an 82-year-old man who microscopically showed an epithelioid malignant tumor simulating a gastrointestinal stromal tumor. C-kit stain and Melan-A were diffusely and strongly positive, while HMB-45 was focally positive. This case illustrates the potential pitfall of relying on a single antibody or inadequate panel of immunohistochemical stains to confirm the diagnosis. We recommend to apply an adequate immunohistochemical panel which includes S-100 protein, HMB-45 and Melan-A in order to make an accurate diagnosis, and discuss the differential diagnosis and surgical treatment modalities.

Breast cancer is the most common type of cancer among women, and clinicians have long recognized its heterogeneity. Its detection and treatment in early stages allow for reduction of mortality. Despite the advances and new strategies for combining surgical, radiotherapy, and chemotherapy options, however, the percentage of patients developing metastases and advanced stages remains high. Even though serum tumor markers have been used for the early diagnosis of metastases, their systematic determination has not had an effect on survival. Methods that are more reliable are needed to detect metastases earlier than with the common clinical methods and thus start treatment before overt relapse. Early indicators of response or resistance to treatment are also an issue in clinical practice. Imaging techniques are time consuming, and it is difficult to detect changes that indicate response limited to therapy, and approaches to defining changes in tumor mass are time and resource consuming. In contrast, detection of circulating tumor cells (CTC) could be a useful tool in early detection of relapse and response to systemic chemotherapy. Extremely sensitive techniques are available that are easily applied to peripheral blood samples, which might provide enormous research possibilities in this area.

Background: Androgen-independent prostate cancer (AIPCA) is a difficult disease to treat. Fulvestrant has shown activity inhibiting estrogen receptor dimerization, and the androgen receptor has been shown to stimulate growth in prostate cancer cell lines. Case Report: A 79-year-old metastatic prostate cancer patient with AIPCA was treated with fulvestrant acetate with a loading dose strategy. Without recording any significant side effects, the prostate-specific antigen (PSA) level decreased from 154 ng/ml to 0.45 ng/ml 8 weeks after the first treatment administration. Conclusion: Fulvestrant was able to reduce the PSA level in this AIPC patient without any toxicity.

A 52-year-old woman with a rising carcinoembryonic antigen CEA, no clinical or radiological findings, a negative colonoscopy, and a positron emission tomography (PET) scan that revealed an isolated hypermetabolic lesion in the spleen. The patient underwent splenectomy by laparoscopic surgery. The pathological study confirmed the presence of an isolated metastasis to the spleen. This case reveals the rare occurrence of isolated splenic metastases in the context of colorectal cancer and illustrates the role of PET when a patient shows a rising CEA with negative clinicoradiological studies.

The purposes of this study are to evaluate the activity and safety of preoperative intensity-modulated radiotherapy and concurrent capecitabine and oxaliplatin (Xelox), the accuracy of preoperative magnetic resonance (MRI) for predicting pathologic results, and the correlation between carcinoembryonic antigen (CEA) and the existence of a pathologic complete response (pCR). Twenty-seven patients (pt) with T3/T4N0/N+ rectal cancer were included. Capecitabine was administered at 825 t.i.d. mg/m2 the days of the radiotherapy (RT), and oxaliplatin was administered weekly at 50 mg/m2. RT was planned to 50.4 Gy. Surgery was scheduled 6 to 8 weeks after completion of Xelox RT. Before the intervention, a pelvic MRI was performed and a CEA level was determined. After Xelox RT, 7 pt had pCR (26%), 2 pt progression disease, and 18 pt tumor downstaging. Presurgical MRI did not predict the pathological result in 21 pt. Main side effects were diarrhea grade (G) 3 in four pt, hand and foot G1 five Pt and G2 four pt. Paresthesias G1 ten pt, G2 seven pt, and leukopenia six pt G1. Median RT dose was 49.7 Gy (47.5–50.4 Gy). At a mean follow-up of 22.5 months, four pt presented metastatis. Mean pretreatment CEA was 6.8 ng/mL (2.1–17.0). A difference statistically significant when compared pretreatment CEA with presurgical CEA (p

[EN] Introduction: Docetaxel plus prednisone is the current standard of care in first-line chemotherapy for metastatic hormone-refractory prostate cancer. However, there is no agent proven as effective after progression to standard docetaxel-based therapy. Platins and capecitabine have shown activity in this setting. Patients and Methods: A total of 14 patients were included in this prospective, single-center trial. All patients had progressed to first-line docetaxel-based treatment. Patients received oxaliplatin 100 mg/sqm on D1 and capecitabine 1000 mg/sqm/bid on days 1 to 14 every 21 days. Results: Median number of cycles was 3. No unexpected toxicity was observed. Only grade 3 toxicity reported was grade 3 anemia. Of the 14 patients, 3 presented grade 2 neuropathy which was spontaneously resolved. Prostate-specific antigenresponse rate was 57%, with a median time to progression of 14.5 weeks, and overall survival of 24 weeks. Conclusions: In the second-line setting, after receiving docetaxel-based chemotherapy, the combination of oxaliplatin and capecitabine offers promising activity with an excellent safety profile.

Metastatic melanoma is one of the most resistant tumors to standard chemotherapy approaches. The median overall survival of patients diagnosed with metastatic melanoma is lower than 9 months. Current approved treatments offer only marginal survival advantages. New immunotherapeutic targets have appeared recently trying to modulate the host immune response against the tumor. New targeted agents have changed the standard of care of other solid tumor types like breast cancer. Here, we discuss the new advances and achievements in the treatment of this highly resistant disease.

A 64-year-old man was admitted to the emergency room in May 2000 due to pelvic pain, functional disability of the lower limb, and bleeding from a rectal fistula. The patient was diagnosed with a rectum-sigma adenocarcinoma (pT1N0M0 stage). After surgery by left hemicolectomy, the patient received adjuvant chemotherapy with tegafur for 6 months. Due to the development of subsequent recurrences (infravesical relapse, bone and lung progression) associated with CEA progression and pain worsening, the patient received treatment by every available agent for the metastatic colorectal cancer, including oxaliplatin and radiotherapy; irinotecan; FOLFOX schema; oral capecitabine; raltitrexed; irinotecan and cetuximab; cetuximab as a single agent; always in combination with zolendronic acid-based treatment for pain control. Once the patient had progressed to all the approved drugs available in the market, sunitinib (50mg/day given for 4 weeks followed by 2 weeks of rest) was proposed as compassionate use. The patient received sunitinib for a total of 6 months (four cycles). On account of the nonmeasurable disease nature of the metastatic presentation in the present case, the clinical benefit was measured in terms of reduction of painkiller intake, improvement in performance status of the patient, and CEA serum levels. In addition to all of these clinical and biological data, CT images showed an increase in necrotic area of the bone lesion without any decrease in tumor size by classical RECIST criteria. The patient is still under sunitinib treatment and has recovered his normal daily activity.

Platinum resistant ovarian cancer is a current challenge in Oncology. Current approved therapies offer no more of a 20% of response. New therapeutic options are urgently needed. Patients were treated with the combination of Pemetrexed 500 mg/m2 d1 and Gemcitabine 1000 mg/m2 d1, 8 in a 21 days basis. 10 platinum-resistant ovarian cancer patients were treated under compassionate use. Mean previous chemotherapy lines were 3.3. Mean administered cycles were 4. Mean CA 125 decrease was on average of 47%, with one patient experiencing a 95% decrease in her CA 125 level. 1 patient had a complete clinical remission, and 2, had partial radiological responses. Mean Progression free survival was 16.5 weeks, and Overall Survival was 21.2 weeks. Treatment was well tolerated. Deemd to the observed activity, the combination of Pemetrexed and Gemcitabine deserves deeper investigation in platinum-resistant ovarian cancer patients.

Bilateral synchronous testicular cancer is a rare disease and is usually associated with similar histological findings in each testicle. The standard therapy of bilateral testis cancer is generally considered to be inguinal orchiectomy. We present a case of synchronous bilateral testicular germ cell tumour, with different histology, initially treated with testis-sparing surgery. After pathology review, the margin of the partial orchiectomy was considered affected, and an inguinal orchiectomy was planned. Options for testis-sparing surgery are discussed.

Langerhans cell histiocytosis (LCH) is a poorly understood proliferative disease, with different patterns of clinical presentation. Currently it is classified according to the number and type of system involved and the degree of organ dysfunction. The aetiology of the disease remains uncertain, and in some cases the disease is polyclonal, suggesting a reactive condition. Many cytokines have been implicated in the pathogenesis of LCH. Different therapeutic approaches can be considered depending on the affected organ, including surgery, radiotherapy and chemotherapy. Long-term organ dysfunction may remain, despite disease control and/or eradication, making indefinite supportive treatment mandatory. Here we present a literature review on all of the aspects of the disease, treatment approaches and existing protocols, and finally an adult clinical case.