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1.
J Clin Med ; 10(19)2021 Oct 04.
Article in English | MEDLINE | ID: mdl-34640601

ABSTRACT

This network meta-analysis (NMA) evaluates the safety of first-line programmed death-ligand 1 (PD-L1) inhibitor monotherapy in advanced NSCLC patients compared to platinum-based chemotherapy. We also compared the risk of adverse events (AEs) according to programmed cell death-1 receptor (PD-1) or PD-L1 inhibitors therapy. To that end, we conducted a series of metanalyses (MAs) using data from six phase III clinical trials, including 4053 patients. Our results show a reduced risk of any grade treatment-related AEs (risk ratio (RR) = 0.722 95% CI: 0.667-0.783, p = 0.002), and grade 3-5 AEs (RR = 0.406 95% CI: 0.340-0.485, p = 0.023) in immunotherapy as compared to chemotherapy. In contrast, a higher risk of immune-related AEs (irAEs) was estimated for immunotherapy versus chemotherapy. The subgroup MAs comparing PD-L1 to PD-1 inhibitors, determined a lower risk of AEs leading to treatment discontinuation in the anti-PD-L1 subgroup (RR = 0.47 95% CI: 0.29-0.75, p = 0.001); however, this statistically significant difference between anti-PD-L1 and anti-PD-1 subgroups was not reached for other safety outcomes analyzed. In conclusion, our findings show that PD-L1 inhibitor monotherapy improves safety outcomes in the 1L treatment of advanced NSCLC patients as compared to chemotherapy except for irAEs.

2.
Lung Cancer ; 137: 136-143, 2019 11.
Article in English | MEDLINE | ID: mdl-31586771

ABSTRACT

OBJECTIVES: Necitumumab, an anti-EGFR antibody, and abemaciclib, a CDK4/6 inhibitor, have shown activity in patients with non-small cell lung cancer (NSCLC) and have non-overlapping toxicities. A 2-part, single-arm, multicenter, phase 1b trial was conducted to test the safety and efficacy of necitumumab plus abemaciclib in patients with advanced NSCLC who had received ≤2 lines of chemotherapy, including a platinum-based one. MATERIALS AND METHODS: Part A was a dose-escalation phase for abemaciclib (100, 150, 200 mg, Q12 H) in combination with necitumumab 800 mg D1D8 Q3W to determine the recommended dose for the expansion cohort, Part B. The primary endpoint was progression-free survival (PFS) rate at 3 months. RESULTS: Sixty-six patients entered the study: 71% male, 41% squamous histology, 15% never-smokers. In Part A (n = 15), the maximum tolerated dose of abemaciclib was 150 mg Q12H in combination with necitumumab 800 mg. In 57 patients treated at this dose level, the 3-month PFS rate was 32.3% (95% CI: 20.4-44.8); median PFS was 2.14 months (1.41-2.76). The overall response rate (ORR) was 5.3% (1.1-14.6). The median OS was 6.93 months (4.96-12.85). In the exploratory subgroup analysis of EGFR expression-negative patients (n = 10), both the 3-month PFS and ORR were 0.0%. The most common grade 3 treatment-emergent adverse events were fatigue (14%), dyspnea (9%), diarrhea (7%), vomiting (7%), and hypokalemia (7%). CONCLUSIONS: Abemaciclib 150 mg Q12H with necitumumab 800 mg did not produce an additive effect over single-agent activity in patients with Stage IV NSCLC. The safety profile was consistent with the individual study drugs.


Subject(s)
Adenocarcinoma of Lung/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Squamous Cell/drug therapy , Lung Neoplasms/drug therapy , Adenocarcinoma of Lung/pathology , Adult , Aged , Aged, 80 and over , Aminopyridines/administration & dosage , Antibodies, Monoclonal, Humanized/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics , Benzimidazoles/administration & dosage , Carcinoma, Non-Small-Cell Lung/pathology , Carcinoma, Squamous Cell/pathology , Female , Follow-Up Studies , Humans , Lung Neoplasms/pathology , Male , Maximum Tolerated Dose , Middle Aged , Neoplasm Staging , Survival Rate , Tissue Distribution , Treatment Outcome
3.
Nutr Hosp ; 35(2): 428-433, 2018 02 27.
Article in English | MEDLINE | ID: mdl-29756979

ABSTRACT

OBJECTIVES: to evaluate the efficacy of glutamine in the prevention of the incidence of oral mucositis secondary to cancer therapies in patients with head and neck cancer (HNC). Secondary objectives were to know the incidence of odynophagia, interruptions of treatment and the requirements of analgesia and nasogastric tube. MATERIAL AND METHODS: prospective cohort study of patients with squamous cell carcinoma of HNC treated with radiotherapy ± concomitant chemotherapy. We compared 131 patients receiving glutamine orally at a dose of 10 g/8 hours with 131 patients who did not receive it. RESULTS: patients not taking glutamine had a hazard ratio 1.78 times higher of mucositis (95% CI [1.01-3.16], p = 0.047). Regarding odynophagia, patients not taking glutamine had a hazard ratio 2.87 times higher (95% CI [1.62-5.18], p = 0.0003). The 19.8% of patients who did not take glutamine discontinued treatment versus6.9% of patients who took (p = 0.002). Regarding support requirements, 87.8% of patients without glutamine required analgesia versus 77.9% of patients with glutamine (p = 0.03) and nasogastric tube was indicated in 9.9% and 3.1% respectively (p = 0.02). CONCLUSION: oral glutamine in patients receiving cancer treatments for HNC prevents the incidence of oral mucositis and odynophagia, and decreases treatment interruptions and the use of analgesia and nasogastric tube.


Subject(s)
Antineoplastic Agents/adverse effects , Carcinoma, Squamous Cell/complications , Dietary Supplements , Glutamine/therapeutic use , Head and Neck Neoplasms/complications , Stomatitis/prevention & control , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Carcinoma, Squamous Cell/drug therapy , Chemoradiotherapy/adverse effects , Cohort Studies , Female , Head and Neck Neoplasms/drug therapy , Humans , Incidence , Male , Middle Aged , Prospective Studies , Stomatitis/epidemiology
4.
Nutr. hosp ; 35(2): 428-433, mar.-abr. 2018. tab
Article in English | IBECS | ID: ibc-172757

ABSTRACT

Objectives: to evaluate the efficacy of glutamine in the prevention of the incidence of oral mucositis secondary to cancer therapies in patients with head and neck cancer (HNC). Secondary objectives were to know the incidence of odynophagia, interruptions of treatment and the requirements of analgesia and nasogastric tube. Material and methods: prospective cohort study of patients with squamous cell carcinoma of HNC treated with radiotherapy ± concomitant chemotherapy. We compared 131 patients receiving glutamine orally at a dose of 10 g/8 hours with 131 patients who did not receive it. Results: patients not taking glutamine had a hazard ratio 1.78 times higher of mucositis (95% CI [1.01-3.16], p = 0.047). Regarding odynophagia, patients not taking glutamine had a hazard ratio 2.87 times higher (95% CI [1.62-5.18], p = 0.0003). The 19.8% of patients who did not take glutamine discontinued treatment versus 6.9% of patients who took (p = 0.002). Regarding support requirements, 87.8% of patients without glutamine required analgesia versus 77.9% of patients with glutamine (p = 0.03) and nasogastric tube was indicated in 9.9% and 3.1% respectively (p = 0.02). Conclusion: oral glutamine in patients receiving cancer treatments for HNC prevents the incidence of oral mucositis and odynophagia, and decreases treatment interruptions and the use of analgesia and nasogastric tube


Objetivos: evaluar la eficacia de la glutamina en la prevención de la incidencia de mucositis secundaria a las terapias oncológicas en pacientes con carcinoma de cabeza y cuello. Los objetivos secundarios fueron conocer la incidencia de odinofagia e interrupciones de los tratamientos y los requerimientos de analgesia y sonda nasogástrica. Material y métodos: estudio prospectivo de cohortes de pacientes con carcinoma epidermoide de cabeza y cuello tratados con radioterapia ± quimioterapia concomitante. Se compararon 131 pacientes que recibieron glutamina oral a una dosis de 10 g/8 horas con 131 pacientes que no la recibieron. Resultados: los pacientes que no tomaron glutamina tuvieron una hazard ratio 1,78 veces mayor de mucositis (IC 95% [1,01-3,16], p = 0,047). Respecto a la odinofagia, los pacientes que no tomaron glutamina tuvieron una hazard ratio 2,87 veces mayor (IC 95% [1,62-5,18], p = 0,0003]. El 19,8% de los pacientes que no tomaron glutamina interrumpieron el tratamiento versus 6,9% de los pacientes que la tomaron (p = 0,002). En cuanto a los tratamientos de soporte, el 87,8% de los pacientes sin glutamina requirieron analgesia versus 77,9% de los pacientes con glutamina (p = 0,03) y la sonda nasogástrica fue indicada en un 9,9% y 3,1% respectivamente (p = 0,02). Conclusión: la glutamina oral en pacientes que reciben tratamiento por carcinoma de cabeza y cuello, previene la incidencia de mucositis oral y odinofagia y disminuye las interrupciones de tratamientos y el uso de analgesia y sonda nasogástrica


Subject(s)
Humans , Mucositis/prevention & control , Head and Neck Neoplasms/complications , Glutamine/pharmacokinetics , Chemoradiotherapy/adverse effects , Head and Neck Neoplasms/therapy , Prospective Studies , Protective Agents/pharmacokinetics , Deglutition Disorders/etiology , Radiation Injuries/prevention & control
5.
Clin Transl Oncol ; 8(4): 296-7, 2006 Apr.
Article in English | MEDLINE | ID: mdl-16648108

ABSTRACT

Secondary cardiac tumours are rare. The new diagnostic technology and more effective chemotherapy schedules for primary tumours, leading to a longer survival, have increased the frequency of such tumors. Adenocarcinoma accounted for around 40% of all metastases to the heart; the most frequently involved sites are pericardium and epicardium. We present a patient with an unusual intraventricular metastases from adenocarcinoma of rectal-sigmoid origin.


Subject(s)
Adenocarcinoma/secondary , Heart Neoplasms/secondary , Rectal Neoplasms/pathology , Sigmoid Neoplasms/pathology , Adenocarcinoma/diagnostic imaging , Adenocarcinoma/drug therapy , Adenocarcinoma/surgery , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Capecitabine , Cardiac Tamponade/etiology , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Dyspnea/etiology , Fatal Outcome , Female , Fluorouracil/analogs & derivatives , Heart Neoplasms/diagnostic imaging , Heart Ventricles/diagnostic imaging , Humans , Liver Neoplasms/secondary , Organoplatinum Compounds/administration & dosage , Oxaliplatin , Palliative Care , Radiography , Rectal Neoplasms/drug therapy , Rectal Neoplasms/surgery , Sigmoid Neoplasms/drug therapy , Sigmoid Neoplasms/surgery , Ultrasonography
6.
Clin. transl. oncol. (Print) ; 8(4): 296-297, abr. 2006. ilus
Article in En | IBECS | ID: ibc-047672

ABSTRACT

No disponible


Secondary cardiac tumours are rare. The new diagnostictechnology and more effective chemotherapyschedules for primary tumours, leading to a longersurvival, have increased the frequency of such tumors.Adenocarcinoma accounted for around 40%of all metastases to the heart; the most frequentlyinvolved sites are pericardium and epicardium. Wepresent a patient with an unusual intraventricularmetastases from adenocarcinoma of rectal-sigmoidorigin


Subject(s)
Female , Aged , Humans , Heart Ventricles/pathology , Sigmoid Neoplasms/pathology , Heart Neoplasms/pathology , Echocardiography , Heart Neoplasms/secondary , Neoplasm Metastasis/pathology
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