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Previous studies have documented that FOLFOX and XELOX therapies negatively impact the metabolism of skeletal muscle and extra-muscle districts. This pilot study tested whether three-month FOLFOX or XELOX therapy produced changes in plasma amino acid levels (PAAL) (an estimation of whole-body amino acid metabolism) and in plasma levels of malondialdehyde (MDA), a marker of lipid hyper oxidation. Fourteen ambulatory, resected patients with colorectal cancer scheduled to receive FOLFOX (n = 9) or XELOX (n = 5) therapy, after overnight fasting, underwent peripheral venous blood sampling, to determine PAAL and MDA before, during, and at the end of three-month therapy. Fifteen healthy matched subjects (controls) only underwent measures of PAAL at baseline. The results showed changes in 87.5% of plasma essential amino acids (EAAs) and 38.4% of non-EAAs in patients treated with FOLFOX or XELOX. These changes in EAAs occurred in two opposite directions: EAAs decreased with FOLFOX and increased or did not decrease with XELOX (interactions: from p = 0.034 to p = 0.003). Baseline plasma MDA levels in both FOLFOX and XELOX patients were above the normal range of values, and increased, albeit not significantly, during therapy. In conclusion, three-month FOLFOX or XELOX therapy affected plasma EAAs differently but not the baseline MDA levels, which were already high.
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Aminoácidos , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias Colorretais , Fluoruracila , Oxaloacetatos , Humanos , Neoplasias Colorretais/sangue , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/cirurgia , Masculino , Feminino , Pessoa de Meia-Idade , Aminoácidos/sangue , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Idoso , Fluoruracila/uso terapêutico , Leucovorina/uso terapêutico , Capecitabina/uso terapêutico , Malondialdeído/sangue , Desoxicitidina/análogos & derivados , Desoxicitidina/uso terapêutico , Compostos Organoplatínicos/uso terapêutico , Projetos Piloto , Oxirredução , Adulto , Peroxidação de Lipídeos/efeitos dos fármacos , Metabolismo dos Lipídeos/efeitos dos fármacosRESUMO
The COVID-19 outbreak has drastically changed practices inside hospitals, which include oncology routines. In oncology, malnutrition was and certainly still is a frequent problem associated with an increase in treatment-related toxicity, a reduced response to cancer treatment, an impaired quality of life, and a worse overall prognosis. Even in this situation of healthcare crisis, nutritional support in cancer care is an essential element. During the current COVID-19 pandemic, there is a concrete high risk to see a dramatic worsening of cancer patients' nutritional status, who are left without adequate clinical and nutritional support. The consequences are already reasonably foreseeable and will have a severe negative impact after the emergency. Therefore, we believe that it is essential to try to continue, as far as possible, the activity of clinical nutrition in oncology, by revolutionizing the setting and the approach to patients. For this purpose, the Clinical Nutrition and Dietetics Unit and the Medical Oncology Unit of our hospital, one of the largest community hospital in Lombardy that has been involved in the COVID-19 outbreak management since its inception, have reorganized the clinical routine activity in strict collaboration since the very beginning of the emergency, to better face up to the challenge, while preserving cancer patients' needs.
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Infecções por Coronavirus/epidemiologia , Desnutrição/terapia , Neoplasias/terapia , Estado Nutricional/fisiologia , Apoio Nutricional , Pneumonia Viral/epidemiologia , Betacoronavirus , COVID-19 , Atenção à Saúde , Hospitais , Humanos , Itália/epidemiologia , Pandemias , Qualidade de Vida , SARS-CoV-2RESUMO
BACKGROUND: Pancreatic adenocarcinoma is a high-mortality neoplasm with a documented 5-years-overall survival around 5%. In the last decades, a real breakthrough in the treatment of the disease has not been achieved. Here we propose a prospective, phase II, multicentre, single-arm study aiming to assess the efficacy and the feasibility of a therapeutic protocol combining chemotherapy, carbon ion therapy and surgery for resectable and borderline resectable pancreatic adenocarcinoma. METHOD: The purpose of this trial (PIOPPO Protocol) is to assess the efficacy and the feasibility of 3 cycles of FOLFIRINOX neoadjuvant chemotherapy followed by a short-course of carbon ion radiotherapy (CIRT) for resectable or borderline resectable pancreatic adenocarcinoma patients. Primary outcome of this study is the assessment of local progression free survival (L-PFS). The calculation of sample size is based on the analysis of the primary endpoint "progression free survival" according to Fleming's Procedure. DISCUSSION: Very preliminary results provide initial evidence of the feasibility of the combined chemotherapy and CIRT in the neoadjuvant setting for resectable or borderline resectable pancreatic cancer. Completion of the accrual and long term results are awaited to see if this combination of treatment is advisable and will provide the expected benefits. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03822936 registered on January 2019.
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Adenocarcinoma/patologia , Adenocarcinoma/terapia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos Clínicos , Radioterapia com Íons Pesados , Neoplasias Pancreáticas/patologia , Neoplasias Pancreáticas/terapia , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Terapia Combinada , Feminino , Radioterapia com Íons Pesados/efeitos adversos , Radioterapia com Íons Pesados/métodos , Humanos , Masculino , Estadiamento de Neoplasias , Cuidados Pré-OperatóriosRESUMO
BACKGROUND: Sacral chordoma (SC) is a neoplasm arising from residual notochordal cells degeneration. SC is difficult to manage mainly because of anatomic location and tendency to extensive spread. Carbon ion radiotherapy (CIRT) is highly precise to selectively deliver high biological effective dose to the tumor target sparing the anatomical structure on its path even if when SC is contiguous to the intestine, and a surgical spacer might be an advantageous tool to create a distance around the target volume allowing radical curative dose delivery with a safe dose gradient to the surrounding organs. This paper describes a double approach-open and hand-assisted laparoscopic-for a silicon spacer placement in patients affected by sacral chordoma undergoing carbon ion radiotherapy. METHODS: Six consecutive patients have been enrolled for surgical spacer placement-open (three) or hand-assisted (three)-prior carbon ion radiotherapy treatment in order to increase efficacy of carbon ion radiotherapy minimizing its side effects. RESULTS: Results showed that silicon spacer placement for SC treatment is feasible both via laparoscopic and laparotomic approach. CONCLUSIONS: Its use might improve CIRT safety and thus efficacy for SC treatment.
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Cordoma/radioterapia , Radioterapia com Íons Pesados/métodos , Sacro , Neoplasias da Coluna Vertebral/radioterapia , Cavidade Abdominal/cirurgia , Adulto , Materiais Biocompatíveis/efeitos da radiação , Fracionamento da Dose de Radiação , Feminino , Seguimentos , Laparoscopia Assistida com a Mão , Humanos , Masculino , Pessoa de Meia-Idade , Elastômeros de Silicone/efeitos da radiação , Adulto JovemRESUMO
OBJECTIVES: Surgical excision is the standard strategy for managing liver metastases from colorectal carcinoma. The achievement of negative (R0) margins is a major determinant of disease-free survival in these patients. Current imaging techniques are of limited value in achieving this goal. A new approach to the intraoperative detection of colorectal liver metastatic tissue based on the emission of indocyanine green (ICG) fluorescence was evaluated. METHODS: A total of 25 consecutive patients with liver metastases from primary colorectal cancers who were eligible for liver resection received a bolus of ICG (0.5 mg/kg body weight) 24 h before surgery. During surgery, ICG fluorescence, which accumulates around lesions as a result of defective biliary clearance, was detected with a near-infrared camera system, the Photodynamic Eye (PDE). Numbers of lesions detected by, respectively, PDE + ICG, intraoperative ultrasound (IOUS) and preoperative computed tomography (CT) were recorded. RESULTS: The near-infrared camera plus ICG revealed a total of 77 metastatic liver nodules. Preoperative CT demonstrated 45 (58.4%) and IOUS showed 55 (71.4%). Preoperative CT and IOUS alone were inferior to the combined use of PDE + ICG and IOUS in the detection of lesions of ≤ 3 mm in size. CONCLUSIONS: This experience suggests that PDE + ICG, combined with IOUS, may represent a safe and effective tool for ensuring the complete surgical eradication of liver metastases from colorectal cancer.
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Neoplasias Colorretais/patologia , Corantes Fluorescentes , Hepatectomia , Verde de Indocianina , Neoplasias Hepáticas/secundário , Neoplasias Hepáticas/cirurgia , Imagem Molecular/métodos , Imagem Multimodal/métodos , Micrometástase de Neoplasia , Adulto , Idoso , Meios de Contraste , Feminino , Humanos , Cuidados Intraoperatórios , Neoplasias Hepáticas/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Tomografia Computadorizada Multidetectores , Valor Preditivo dos Testes , UltrassonografiaRESUMO
The increasing number of effective agents allows rescue therapy of patients with light-chain (AL) amyloidosis refractory to ≥2 previous treatments. Lenalidomide is effective in this disease and its toxicity profile encourages its use in salvage regimens. All the patients with AL amyloidosis refractory to both melphalan and bortezomib referred to our center between July 2007 and July 2009 were treated with the combination of lenalidomide and dexamethasone. Twenty-four consecutive patients were enrolled. Seventy-nine percent were also refractory to thalidomide. Two patients died before evaluation of response, and 50% experienced severe adverse events. Survival was significantly shorter in subjects with troponin I >0.1 ng/mL and in patients diagnosed <18 months before treatment initiation. Hematologic response was observed in 41% of patients and prolonged survival (median 10 months vs. not reached, P = 0.005) independently from troponin I concentration and from pre-treatment disease duration. Salvage therapy beyond second line of treatment can improve survival in AL amyloidosis and lenalidomide plus dexamethasone is a valuable option in this setting.
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Amiloidose/tratamento farmacológico , Antineoplásicos/uso terapêutico , Ácidos Borônicos/uso terapêutico , Dexametasona/uso terapêutico , Resistencia a Medicamentos Antineoplásicos , Melfalan/uso terapêutico , Pirazinas/uso terapêutico , Talidomida/análogos & derivados , Talidomida/uso terapêutico , Adulto , Idoso , Amiloidose/fisiopatologia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Bortezomib , Humanos , Imunossupressores/uso terapêutico , Lenalidomida , Masculino , Pessoa de Meia-Idade , Recidiva , Terapia de Salvação/métodos , Taxa de Sobrevida , Resultado do TratamentoRESUMO
Gastric cancer is the sixth most common malignancy in the world. However, its mortality has been decreasing in the last years thanks to improvement in diagnostics and therapeutics. Nevertheless, the high rate of malnutrition in patients with gastric cancer still has a major impact on the overall survival and quality of life of patients. The narrative review presents the most recent data on nutritional support in the resectable stages of gastric cancer, with a particular focus on perioperative strategies, and discusses malnutrition in gastric cancer, nutritional support before and after surgery, and the relationship between nutritional support and chemotherapy. Despite the predominantly methodological limitations related to the difficulty of performing randomized controlled trials on nutritional support in cancer patients, this review highlights important points. Nutritional counselling is essential starting from diagnosis. In limited or locally advanced forms (about 40% of cases), the therapeutic cornerstone is represented by gastric surgery. In most of these cases, perioperative chemotherapy is also indicated. Of note, nutritional support varies before and after surgery. In the preoperative period, the goal is to prepare the body for surgery, with available evidence recommending the prescription of immunonutrition (both oral and artificial, as appropriate). In the postoperative period, on the other hand, the objective is to facilitate recovery and adaptation to the new anatomy; an early and combined strategy (oral and enteral) seems to be the most suitable to pursue this. Unfortunately, rigorous data on the relationship between nutritional support and chemotherapy treatments used in resectable gastric cancer are not available. In the absence of strong scientific evidence, it may be useful to adopt a personalized multidisciplinary strategy for each patient wherein the chemotherapy programme is modulated based on nutritional status.
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Background Systemic inflammation is a critical component of the development and progression of several types of cancer. Neutrophil-lymphocyte ratio (NLR) and lymphocyte-monocyte ratio (LMR) are simple, inexpensive, and reliable predictors of the systemic inflammatory response to the therapy in different malignant tumors, including colorectal cancer. Methods Metastatic colorectal cancer (mCRC) patients treated with panitumumab plus chemotherapy at first-line at the medical oncology unit of Fondazione Institute for Research, Hospitalization and Health Care (IRCCS) Policlinico San Matteo di Pavia between January 1st 2016 and February 1st 2021 were retrospectively analyzed. NLR and LMR were divided into two groups (high and low) based on the cut-off points, with the estimation of the prognostic accuracy of NLR for the early treatment response as the primary end-point of this study. Results The receiver operating characteristic (ROC) analysis showed a fair prognostic accuracy of NLR for early treatment response (area under the curve (AUC)=0.76, 95% CI: 0.62-0.89). A slightly lower prognostic accuracy was found for LMR (AUC=0.71, 95% CI: 0.57-0.85). In the univariable proportional hazard Cox model, no effect of NLR on PFS was found (NLRHigh vs. NLRLow HR=1.3; 95% CI: 0.7-2.4, p=0.414). Patients with higher levels of LMR showed a trend towards higher PFS (LMRHigh vs. LMRLow HR=0.4; 95% CI: 0.2-1.1, p=0.066). No association was found between NLR (or LMR) and skin toxicity. Conclusions NLR and LMR may be used as biomarkers of prognostic accuracy for the early treatment response in mCRC patients treated with panitumumab.
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OBJECTIVES: To assess the toxicity patterns and effectiveness of doublet chemotherapy when administered at reduced doses of 20% (FOLFOX or FOLFIRI) in combination with anti-EGFR antibodies (cetuximab or panitumumab) in old, vulnerable patients with metastatic colorectal cancer (mCRC). PATIENTS AND METHODS: We performed a retrospective observational study of RAS and BRAF wild-type, vulnerable patients aged ≥70 years with previously untreated mCRC. The primary endpoint was safety, and secondary endpoints were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). RESULTS: One hundred and eighteen patients were collected from 14 selected Italian centres. The median age was 75 (range, 70-85). Geriatric screening by G8 tool gave a score ≤ 14 in all patients. In total, 75 and 43 patients received FOLFOX or FOLFIRI, respectively, in combination with panitumumab (53%) or cetuximab (47%). The overall incidence of grade (G) 3-4 neutropenia was 11.8%, and for skin rash 11%. The most frequent adverse events were G1-2 skin rash (49.1%), G1-2 diarrhea (21.1%) and G1-2 nausea (17.7%). The ORR was 57.3%. Stable disease was observed in 29.1% of patients, with a disease control rate of 86.4%. With a median follow-up of 18 months, the median PFS was 10.0 months (95% confidence interval [CI]: 8.5-11.4), while the median OS was 18.0 months (95% CI: 16.0-19.9). No statistically significant difference was observed between the regimens in terms of ORR, PFS (p = 0.908), and OS (p = 0.832). CONCLUSION: This study shows that with an appropriate design, including reduced doses, vulnerable older patients best tolerate chemotherapy when combined with anti-EGFR antibodies.
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Neoplasias do Colo , Neoplasias Colorretais , Exantema , Neoplasias Retais , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Cetuximab/efeitos adversos , Neoplasias do Colo/tratamento farmacológico , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/patologia , Exantema/induzido quimicamente , Exantema/tratamento farmacológico , Fluoruracila , Humanos , Leucovorina/efeitos adversos , Panitumumabe/uso terapêuticoRESUMO
The spleen is an infrequent site for metastatic lesions, and solitary splenic metastases from squamous cell carcinoma of the esophagus are very rare: only 4 cases have been reported thus far. These lesions are whitish nodules that are macroscopically and radiologically similar to primary splenic lymphomas. We report a case of metachronous splenic metastases from esophageal cancer and multiple splenic abscesses, which developed nine months after apparently curative esophagectomy without adjuvant chemotherapy. The patient underwent splenectomy dissection followed by adjuvant chemotherapy, but liver and skin metastases developed, and the patient died 9 months later.
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Carcinoma de Células Escamosas/secundário , Neoplasias Esofágicas/patologia , Neoplasias Esplênicas/secundário , Biópsia , Carcinoma de Células Escamosas/diagnóstico , Carcinoma de Células Escamosas/cirurgia , Diagnóstico Diferencial , Endoscopia Gastrointestinal , Neoplasias Esofágicas/cirurgia , Esofagectomia , Evolução Fatal , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Esplenectomia , Neoplasias Esplênicas/diagnóstico , Neoplasias Esplênicas/cirurgia , Tomografia Computadorizada por Raios XRESUMO
AIMS AND BACKGROUND: Palonosetron, a unique second-generation 5-HT3 receptor antagonist, has been demonstrated to control emesis related to chemotherapy-induced nausea and vomiting (CINV). The aim of this study was to evaluate the efficacy and tolerability of palonosetron followed by a single dose of dexamethasone in patients with breast cancer (BC) or colorectal cancer (CRC) receiving moderate emetogenic chemotherapy (MEC). METHODS AND STUDY DESIGN: Chemotherapy-naive BC and CRC patients were given MEC as adjuvant or first-line treatment. Palonosetron (0.25 mg IV) and dexamethasone (8 mg IV) were administered before chemotherapy on day 1. The primary endpoint was complete response (CR; no vomiting and no use of rescue medication) during the overall study period (days 1-5). The antiemetic response was evaluated during the acute (day 1) and delayed (days 2-5) phases. RESULTS: Sixty-eight patients were enrolled (median age 61 years, 56 females; BC = 40, CRC = 28). CR was observed in 46 of 68 patients (67.6%), while CR during the acute and delayed phases was 75.0% in each cancer group. The antiemetic regimen was well tolerated. CONCLUSIONS: A single administration of palonosetron and dexamethasone on day 1 in BC and CRC patients adequately controls CINV during the entire period of emetic risk.
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Antieméticos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Neoplasias Colorretais/tratamento farmacológico , Dexametasona/administração & dosagem , Isoquinolinas/administração & dosagem , Náusea/prevenção & controle , Quinuclidinas/administração & dosagem , Vômito/prevenção & controle , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Neoplasias da Mama/patologia , Neoplasias Colorretais/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Palonossetrom , Estudos Prospectivos , Antagonistas da Serotonina/administração & dosagem , Resultado do Tratamento , Vômito/induzido quimicamenteRESUMO
Pancreatic Carcinoma (PC) cells have the ability to induce patient immunosuppression and to escape immunosurveillance. Low circulating lymphocytes are associated with an advanced stage of PC and reduced survival. Blood lymphocytes expressed as a percentage of Total White Blood Cells (L% TWBC) could predict chemotolerance (n° of tolerated cycles), survival time and Body Weight (BW) more effectively than lymphocytes expressed as an absolute value (LAB > 1500 n°/mm3) or lymphocytes >22%, which is the lowest limit of normal values in our laboratory. Forty-one patients with advanced PC, treated with chemotherapy, were selected for this observational retrospective study. Patients were evaluated at baseline (pre-chemotherapy), and at 6, 12 and 18 months, respectively, after diagnosis of PC. The study found L ≥ 29.7% to be a better predictor of survival (COX model, using age, sex, BW, serum creatinine, bilirubin and lymphocytes as covariates), chemotolerance (r = +0.50, p = 0.001) and BW (r = +0.35, p = 0.027) than LAB > 1500 or L > 22%. BW did not significantly correlate with chemotolerance or survival. The preliminary results of this study suggest that L ≥ 29.7% is more effective than LAB > 1500 or L > 22% at predicting chemotolerance, survival time and nutritional status. A possible impact of nutritional status on chemotherapy and survival seems to be lymphocyte-mediated given the association between BW and L%. This study may serve as the basis for future research to explore whether nutritional interventions can improve lymphopenia, and if so, how this may be possible.
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Estado Nutricional , Neoplasias Pancreáticas , Imunidade Adaptativa , Humanos , Linfócitos , Neoplasias Pancreáticas/tratamento farmacológico , Prognóstico , Estudos Retrospectivos , Neoplasias PancreáticasRESUMO
The limited efficacy of Natural Killer (NK) cell-based immunotherapy results in part from the suboptimal expansion and persistence of the infused cells. Recent reports suggest that the generation of NK cells with memory-like properties upon in vitro activation with defined cytokines might be an effective way of ensuring long-lasting NK cell function in vivo. Here, we demonstrate that activation with IL-12, IL-15 and IL-18 followed by a one-week culture with optimal doses of Interleukin (IL-2) and IL-15 generates substantial numbers of memory-like NK cells able to persist for at least three weeks when injected into NOD scid gamma (NSG) mice. This approach induces haploidentical donor-derived memory-like NK cells that are highly lytic against patients' myeloid or lymphoid leukemia blasts, independent of the presence of alloreactive cell populations in the donor and with negligible reactivity against patients' non-malignant cells. Memory-like NK cells able to lyse autologous tumor cells can also be generated from patients with solid malignancies. The anti-tumor activity of allogenic and autologous memory-like NK cells is significantly greater than that displayed by NK cells stimulated overnight with IL-2, supporting their potential therapeutic value both in patients affected by high-risk acute leukemia after haploidentical hematopoietic stem cell transplantation and in patients with advanced solid malignancies.
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In inoperable patients, the management of angiosarcoma of the scalp is challenging. Due to intrinsic, dosimetric and radiobiological properties, proton beam radiotherapy may be an effective and safe option to offer to these difficult-to-cure patients. Here, we report a case of angiosarcoma of the scalp treated successfully with proton beam radiotherapy. Angiosarcoma is a rare malignancy concerning around 2% of soft-tissue sarcomas and 5% of cutaneous soft-tissue sarcomas. Cutaneous angiosarcomas can occur in any part of the body, but the head and neck region is a common primary site and the scalp is a frequent site in elderly patients.
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Neoplasias de Cabeça e Pescoço/radioterapia , Hemangiossarcoma/radioterapia , Terapia com Prótons/métodos , Couro Cabeludo/patologia , Idoso de 80 Anos ou mais , Neoplasias de Cabeça e Pescoço/mortalidade , Neoplasias de Cabeça e Pescoço/patologia , Hemangiossarcoma/mortalidade , Hemangiossarcoma/patologia , Humanos , Masculino , Taxa de SobrevidaRESUMO
BACKGROUND: Malnutrition is common in cancer patients, particularly in those affected by gastrointestinal malignancies, and negatively affects treatment tolerance, survival, functional status, and quality of life (QoL). Nutritional support, including supplemental parenteral nutrition (SPN), has been recommended at the earliest opportunity in malnourished cancer patients. The limited available evidence on the efficacy of SPN in gastrointestinal cancer patients is positive, particularly with regards to QoL, body composition, and energy intake, but the evidence on survival is still scanty. Furthermore, studies regarding the early administration of SPN in combination with nutritional counseling from the beginning of first-line chemotherapy (CT) are lacking. We hypothesize that early systematic SPN in combination with nutritional counseling (NC), compared with NC alone, can benefit patients with previously untreated metastatic gastric cancer at nutritional risk undergoing first-line CT. METHODS: The aim of this pragmatic, multicenter, randomized (1:1), parallel-group, open-label, controlled clinical trial is to evaluate the efficacy in terms of survival, weight maintenance, body composition, QoL and feasibility of cancer therapy of early systematic SNP. This is in combination with NC, compared with NC alone, in treatment-naïve metastatic gastric cancer patients at nutritional risk undergoing first-line CT. DISCUSSION: Malnutrition in oncology remains an overlooked problem. Although the importance of SPN in gastrointestinal cancer patients has been acknowledged, no studies have yet evaluated the efficacy of early SPN in metastatic gastric patients undergoing CT. The present study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early intensive nutritional support in cancer patients undergoing CT. This study could stimulate further large randomized trials in different cancer types, potentially resulting in the improvement of supportive care quality. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov: NCT03949907.
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Docetaxel associated with oxaliplatin and 5-fluorouracil (FLOT) has been reported as the best perioperative treatment for gastric cancer. However, there is still some debate about the most appropriate number and timing of chemotherapy cycles. In this randomized multicenter phase II study, patients with resectable gastric cancer were staged through laparoscopy and peritoneal lavage cytology, and randomly assigned (1:1) to either four cycles of neoadjuvant chemotherapy (arm A) or two preoperative + two postoperative cycles of docetaxel, oxaliplatin, and capecitabine (DOC) chemotherapy (arm B). The primary endpoint was to assess the percentage of patients receiving all the planned preoperative or perioperative chemotherapeutic cycles. Ninety-one patients were enrolled between September 2010 and August 2016. The treatment was well tolerated in both arms. Thirty-three (71.7%) and 24 (53.3%) patients completed the planned cycles in arms A and B, respectively (p = 0.066), reporting an odds ratio for early interruption of treatment of 0.45 (95% confidence interval (CI): 0.18-1.07). Resection was curative in 39 (88.6%) arm A patients and 35 (83.3%) arm B patients. Five-year progression-free survival (PFS) was 51.2% (95% CI: 34.2-65.8) in arm A and 40.3% (95% CI: 28.9-55.2) in arm B (p = 0.300). Five-year survival was 58.5% (95% CI: 41.3-72.2) and 53.9% (95% CI: 35.5-69.3) (p = 0.883) in arms A and B, respectively. The planned treatment was more frequently completed and was more active, albeit not significantly, in the neoadjuvant arm than in the perioperative group.