ctuaciones sobre la autonomía, información y participación de los pacientes con cáncer colorrectal en un Hospital de Día de Oncología Médica

Introducción: La Ley 41/2002, de Autonomía del Paciente, obliga a informar para que el paciente participe activamente en la toma de decisiones respecto al diagnóstico y al tratamiento de la enfermedad. Sin embargo, el cáncer conlleva una información adversa y la toma de decisiones por los pacientes oncológicos es un proceso complejo. Objetivo: Conocer las necesidades de los pacientes con cáncer colorrectal atendidos en el Hospital de Día en los aspectos relacionados con la autonomía, información y la participación. Metodología: El estudio se dividió en 3 fases: medición preintervención; intervención y medición postintervención. Resultados: Entre Nov/2007 y Feb/2008, se incluyeron 119 pacientes. Las mejoras solicitadas fueron una consulta de enfermería (68%), más información por escrito (14%) y otras (18%). Se elaboraron 15 documentos informativos y se creó la consulta de enfermería. Los resultados de la primera (n=80) versus (vs) tercera etapa (n= 39) son: información adecuada (83% vs 87%); cree que su diagnóstico es cáncer (57% vs 59%); a quién quiere el paciente que se informe (paciente y familia 85% vs 77%, solo al paciente 10% vs 20%); opinión sobre el CI (buena/muy buena 80% vs 86%); conoce sus derechos (47% vs 84%); conoce la Ley de Autonomía (1% vs 21%), y conoce las Instrucciones previas (0% vs 10%). Conclusiones: Estas intervenciones han modificado el conocimiento de los derechos de los pacientes, de la Ley de Autonomía y las Instrucciones Previas, pero no se ha incrementado el número de pacientes que reconocen que su enfermedad es un cáncer

SEOM-GEMCAD-TTD clinical guidelines for the systemic treatment of metastatic colorectal cancer (2022)

Colorectal cancer; Metastatic disease; Systemic treatmentCàncer colorectal; Malaltia metastàtica; Tractament sistèmicCáncer colorrectal; Enfermedad metastásica; Tratamiento sistémicoColorectal cancer (CRC) is the second leading cause of cancer deaths in Spain. Metastatic disease is present in 15–30% of patients at diagnosis and up to 20–50% of those with initially localized disease eventually develop metastases. Recent scientific knowledge acknowledges that this is a clinically and biologically heterogeneous disease. As treatment options increase, prognosis for individuals with metastatic disease has steadily improved over recent decades. Disease management should be discussed among experienced, multidisciplinary teams to select the most appropriate systemic treatment (chemotherapy and targeted agents) and to integrate surgical or ablative procedures, when indicated. Clinical presentation, tumor sidedness, molecular profile, disease extension, comorbidities, and patient preferences are key factors when designing a customized treatment plan. These guidelines seek to provide succinct recommendations for managing metastatic CRC

A randomised phase 2 study comparing different dose approaches of induction treatment of regorafenib in previously treated metastatic colorectal cancer patients (REARRANGE trial)

Colorectal cancer; Metastasis; RegorafenibCàncer colorectal; Metàstasi; RegorafenibCáncer colorrectal; Metástasis; RegorafenibPurpose: The purpose of this article is to evaluate the safety of two regorafenib dose-escalation approaches in refractory metastatic colorectal cancer (mCRC) patients. Patients and methods: Patients with mCRC and progression during or within 3 months following their last standard chemotherapy regimen were randomised to receive the approved dose of regorafenib of 160 mg QD (arm A) or 120 mg QD (arm B) administered as 3 weeks of treatment followed by 1 week off, or 160 mg QD 1 week on/1 week off (arm C). The primary end-point was the percentage of patients with G3/G4 treatment-related adverse events (AEs) in each arm. Results: There were 299 patients randomly assigned to arm A (n = 101), arm B (n = 99), or arm C (n = 99); 297 initiated treatments (arm A n = 100, arm B n = 98, arm C n = 99: population for safety analyses). G3/4 treatment-related AEs occurred in 60%, 55%, and 54% of patients in arms A, B, and C, respectively. The most common G3/4 AEs were hypertension (19, 12, and 20 patients), fatigue (20, 14, and 15 patients), hypokalemia (11, 7, and 10 patients), and hand-foot skin reaction (8, 7, and 3 patients). Median overall survival was 7.4 (IQR 4.0-13.7) months in arm A, 8.6 (IQR 3.8-13.4) in arm B, and 7.1 (IQR 4.4-12.4) in arm C. Conclusions: The alternative regorafenib dosing schedules were feasible and safe in patients with mCRC who had been previously treated with standard therapy. There was a higher numerical improvement on the most clinically relevant AEs in the intermittent dosing arm, particularly during the relevant first two cycles

A signature of circulating microRNAs predicts the response to treatment with FOLFIRI plus aflibercept in metastatic colorectal cancer patients

Antiangiogenic therapy; Circulating miRNAs; Colorectal cancerTerapia antiangiogénica; MiARN circulantes; Cáncer colorrectalTeràpia antiangiogènica; MiARN circulants; Càncer colorectalThe benefit of adding the antiangiogenic drug aflibercept to FOLFIRI regime in metastatic colorectal cancer (CRC) patients resistant to or progressive on an oxaliplatin-based therapy has been previously demonstrated. However, the absence of validated biomarkers to predict greater outcomes is a major challenge encountered when using antiangiogenic therapies. In this study we investigated profiles of circulating microRNAs (miRNAs) to build predictive models of response to treatment and survival. Plasma was obtained from 98 metastatic CRC patients enrolled in a clinical phase II trial before receiving FOLFIRI plus aflibercept treatment, and the circulating levels of 754 individual miRNAs were quantified using real-time PCR. A distinct signature of circulating miRNAs differentiated responder from non-responder patients. Remarkably, most of these miRNAs were found to target genes that are involved in angiogenic processes. Accordingly, some of these miRNAs had predictive value and entered in predictive models of response to therapy, progression of disease, and survival of patients treated with FOLFIRI plus aflibercept. Among these miRNAs, circulating levels of hsa-miR-33b-5p efficiently discriminated between responder and non-responder patients and predicted the risk of disease progression. Moreover, the combination of circulating VEGF-A and miR-33b-5p levels improved clinical stratification of metastatic CRC patients who were to receive FOLFIRI plus aflibercept treatment. In conclusion, our study supports circulating miRNAs as valuable biomarkers for predicting better outcomes in metastatic CRC patients treated with FOLFIRI plus aflibercept.Funding was provided by Sanofi

Actuaciones sobre la autonomía, información y participación de los pacientes con cáncer colorrectal en un Hospital de Día de Oncología Médica

Introduction: In Spain, the Law 41/2002 on the Autonomy of the Patients and their Rights and Obligations states that all patients have to be informed in order to participate actively in the decision making process regarding the diagnosis and treatment of their diseases. However, cancer usually implies not pleasant information and the patient’s decision making process is therefore not easy. Objective: To determine the unmet needs of colorectal cancer patients regarding the autonomy, information and participation in a Day Care Unit. Methodology: This study was conducted in 3 steps: pre-intervention, intervention and post-intervention. Results: Between Nov/2007 and Feb/2008, 119 patients were included. The proposed improvements were to have a nurse office (68%), more written information (14%) and others (18%). Fifteen informative documents were created and a nurse office was open. Results of first (n=80) versus (vs) third (n= 39) steps were: accurate information (83% vs 87%), the patient thinks “that his disease is cancer” (57% vs 59%), to whom the patient wants to be informed (patient and relatives 85% vs 77%, only patient 10% vs 20%), their opinion about Informed Consent Form (very good/good 80% vs 86%), the patient knows his rights (47% vs 84%), knows the Law 41/2002 about Autonomy (1% vs 21%) and knows the Vital Will (0% vs 10%). Conclusions: These interventions have modified the patient knowledge of the Rights, the Law of Autonomy and the Vital Will. However, the number of patients that recognizes that their disease is a cancer has not been increased

Actuaciones sobre la autonomía, información y participación de los pacientes con cáncer colorrectal en un Hospital de Día de Oncología Médica

Introduction: In Spain, the Law 41/2002 on the Autonomyof the Patients and their Rights and Obligations statesthat all patients have to be informed in order to participateactively in the decision making process regarding the diagnosisand treatment of their diseases. However, cancerusually implies not pleasant information and the patient’sdecision making process is therefore not easy. Objective:To determine the unmet needs of colorectal cancer patientsregarding the autonomy, information and participation in aDay Care Unit.Methodology: This study was conducted in 3 steps:pre-intervention, intervention and post-intervention.Results: Between Nov/2007 and Feb/2008, 119 patientswere included. The proposed improvements were tohave a nurse office (68%), more written information (14%)and others (18%). Fifteen informative documents were createdand a nurse office was open. Results of first (n=80)versus (vs) third (n= 39) steps were: accurate information(83% vs 87%), the patient thinks “that his disease is cancer”(57% vs 59%), to whom the patient wants to be informed(patient and relatives 85% vs 77%, only patient10% vs 20%), their opinion about Informed Consent Form(very good/good 80% vs 86%), the patient knows his rights(47% vs 84%), knows the Law 41/2002 about Autonomy(1% vs 21%) and knows the Vital Will (0% vs 10%).Conclusions: These interventions have modified thepatient knowledge of the Rights, the Law of Autonomy andthe Vital Will. However, the number of patients that recognizesthat their disease is a cancer has not been increased.Introducción: La Ley 41/2002, de Autonomía del Paciente, obliga a informar para que el paciente participe activamente en la toma de decisiones respecto al diagnóstico y al tratamiento de la enfermedad. Sin embargo, el cáncer conlleva una información adversa y la toma de decisiones por los pacientes oncológicos es un proceso complejo. Objetivo: Conocer las necesidades de los pacientes con cáncer colorrectal atendidos en el Hospital de Día en los aspectos relacionados con la autonomía, información y la participación. Metodología: El estudio se dividió en 3 fases: medición preintervención; intervención y medición postintervención. Resultados: Entre Nov/2007 y Feb/2008, se incluyeron 119 pacientes. Las mejoras solicitadas fueron una consulta de enfermería (68%), más información por escrito (14%) y otras (18%). Se elaboraron 15 documentos informativos y se creó la consulta de enfermería. Los resultados de la primera (n=80) versus (vs) tercera etapa (n= 39) son: información adecuada (83% vs 87%); cree que su diagnóstico es cáncer (57% vs 59%); a quién quiere el paciente que se informe (paciente y familia 85% vs 77%, solo al paciente 10% vs 20%); opinión sobre el CI (buena/muy buena 80% vs 86%); conoce sus derechos (47% vs 84%); conoce la Ley de Autonomía (1% vs 21%), y conoce las Instrucciones previas (0% vs 10%). Conclusiones: Estas intervenciones han modificado el conocimiento de los derechos de los pacientes, de la Ley de Autonomía y las Instrucciones Previas, pero no se ha incrementado el número de pacientes que reconocen que su enfermedad es un cáncer

Capecitabine and irinotecan with bevacizumab 2-weekly for metastatic colorectal cancer: the phase II AVAXIRI study

Background: The optimal sequence of chemotherapeutic agents is not firmly established for the treatment of metastatic colorectal cancer (mCRC). This phase II multi-centre study investigated the efficacy and tolerability of a standard capecitabine plus irinotecan (XELIRI) regimen with bevacizumab in previously untreated patients with mCRC. Methods: Patients received intravenous irinotecan 175 mg/m2 on day 1 and oral capecitabine 1000 mg/m2 (800 mg/m2 for patients >65 years of age) twice daily on days 2–8, followed by a 1-week rest, and bevacizumab 5 mg/kg as an intravenous infusion on day 1 every 2 weeks. Results: Seventy-seven patients were included in the intention-to-treat and safety populations. Progression-free survival at 9 months was 61%. The overall response and disease control rates were 51% and 84%, respectively. Median progression-free and overall survival times were 11.9 and 24.8 months, respectively. 48 patients (62%) had at least one grade 3/4 adverse event, the most common being asthenia, diarrhoea and neutropenia. Quality of life varied little over the study period with mean visual analogue scale general health scores ranging from 71 to 76 over cycles 1–11. Conclusion: Our study found irinotecan and capecitabine administered fortnightly with bevacizumab in patients with mCRC to be an effective and tolerable regimen. Trial registration: clinicaltrials.gov identifier NCT00875771. Trial registration date: 04/02/2009. Keywords: Irinotecan, Capecitabine, Bevacizumab, Metastatic colorectal cancer, Chemotherap

A randomized phase II study of capecitabine-based chemoradiation with or without bevacizumab in resectable locally advanced rectal cancer: clinical and biological features

Background: perioperatory chemoradiotherapy (CRT) improves local control and survival in patients with locally advanced rectal cancer (LARC). The objective of the current study was to evaluate the addition of bevacizumab (BEV) to preoperative capecitabine (CAP)-based CRT in LARC, and to explore biomarkers for downstaging. Methods: patients (pts) were randomized to receive 5 weeks of radiotherapy 45 Gy/25 fractions with concurrent CAP 825 mg/m2 twice daily 5 days per week and BEV 5 mg/kg once every 2 weeks (3 doses) (arm A), or the same schedule without BEV (arm B). The primary end point was pathologic complete response (ypCR: ypT0N0). Results: ninety pts were included in arm A (44) or arm B (46). Grade 3-4 treatment-related toxicity rates were 16% and 13%, respectively. All patients but one (arm A) proceeded to surgery. The ypCR rate was 16% in arm A and 11% in arm B (p =0.54). Fifty-nine percent vs 39% of pts achieved T-downstaging (arm A vs arm B; p =0.04). Serial samples for biomarker analyses were obtained for 50 out of 90 randomized pts (arm A/B: 22/28). Plasma angiopoietin-2 (Ang-2) levels decreased in arm A and increased in arm B (p <0.05 at all time points). Decrease in Ang-2 levels from baseline to day 57 was significantly associated with tumor downstaging (p =0.02). Conclusions: the addition of BEV to CAP-based preoperative CRT has shown to be feasible in LARC. The association between decreasing Ang-2 levels and tumor downstaging should be further validated in customized studies

A phase 2 study of panitumumab with irinotecan as salvage therapy in chemorefractory KRAS exon 2 wild-type metastatic colorectal cancer patients

Targeted agents are standard treatment for RAS wild-type metastatic colorectal cancer in the first- and second-line settings. This phase 2 study determined the benefit of targeting the epidermal growth factor receptor (EGFR) with panitumumab plus irinotecan in irinotecan-refractory patients. KRAS exon-2 wild-type patients failing prior irinotecan received panitumumab (6 mg/kg) and irinotecan (180 mg/m²) every 2 weeks. The primary endpoint was the overall response rate (ORR). Secondary endpoints included safety, progression-free survival (PFS) and overall survival (OS). KRAS exon-2 status was evaluated centrally, along with NRAS, BRAF mutations, epiregulin, amphiregulin, PTEN and EGFR copy number status, and correlated with efficacy. Sixty-one patients were treated. Among the 46 wild-type RAS patients, the ORR was 15.2% (seven partial responses), with median PFS of 3.8 months (95% CI 2.7-4.3) and median OS of 12.5 months (95% CI 6.7-15.9). Wild-type BRAF patients showed a 13.0% response rate. No significant correlations between response and baseline biomarker expression were identified. Common grade 3-4 adverse events were diarrhoea and rash (18.0% each), hypomagnesaemia and asthenia (8.2% each). The addition of panitumumab to irinotecan as salvage therapy is feasible but has limited activity in irinotecan-refractory metastatic colorectal cancer. No biomarkers predictive of response were identified

Phase II randomized trial of capecitabine with bevacizumab and external beam radiation therapy as preoperative treatment for patients with resectable locally advanced rectal adenocarcinoma: long term results

Background: Preoperative chemoradiotherapy with capecitabine is considered as a standard of care for locally advanced rectal cancer. The “Tratamiento de Tumores Digestivos” group (TTD) previously reported in a randomized Ph II study that the addition of Bevacizumab to capecitabine-RT conferred no differences in the pre-defined efficacy endpoint (pathological complete response). We present the follow-up results of progression-free survival, distant relapse-free survival, and overall survival data at 3 and 5 years. Methods: Patients (pts) were randomized to receive 5 weeks of radiotherapy (45 Gy/25 fractions) with concurrent Capecitabine 825 mg/m2 twice daily, 5 days per week with (arm A) or without (arm b) bevacizumab (5 mg/kg once every 2 weeks). Results: In our study, the addition of bevacizumab to capecitabine and radiotherapy in the neoadjuvant setting shows no differences in pathological complete response (15.9% vs 10.9%), distant relapse-free survival (81.0 vs 80.4 and 76.2% vs 78.2% at 3 and 5 years respectively), disease-free survival (75% vs 71.7 and 68.1% vs 69.57% at 3 and 5 years respectively) nor overall survival at 5-years of follow-up (81.8% vs 86.9%). Conclusions: the addition of bevacizumab to capecitabine plus radiotherapy does not confer statistically significant advantages neither in distant relapse-free survival nor in disease-free survival nor in Overall Survival in the short or long term