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BACKGROUND: Colorectal cancer ranks second in terms of cancer associated deaths worldwide, whereas miRNA play a pivotal role in the etiology of cancer and its metastases. AIMS: Studying the expression and cellular function of miR-18a in metastatic colorectal cancer and association to progression-free survival. METHODS AND RESULTS: Colorectal liver metastases (N = 123) and primary colorectal cancer (N = 27) where analyzed by RT-PCR and correlated with clinical follow up data. Invasion and migration assays were performed with the liver metastatic cell line LIM2099 after miR-18a knockdown. Cell viability under FOLFOX treatment and knockdown was measured. We found that the expression of miR-18a was increased 4.38-fold in liver metastases and 3.86-fold in colorectal tumor tissue compared to healthy liver tissue and colorectal mucosa, respectively (p ≤ .001). Patients with a high miR-18a expression in liver metastases had a progression-free survival (PFS) of 13.6 months versus 8.9 months in patients with low expression (N = 123; p = .024). In vitro migration of LIM2099 cells was reduced after miR-18a knockdown and cell viability was significantly increased after miR-18a knockdown and treatment with folinic acid or oxaliplatin. Subgroup analysis of PFS revealed significant benefits for patients with high miR-18a expression receiving 5-FU, folinic acid or oxaliplatin. CONCLUSIONS: High expression of miR-18a in colorectal liver metastases might have a protective effect after resection of metastases and FOLFOX treatment regarding PFS.
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Neoplasias Colorrectales , Neoplasias Hepáticas , MicroARNs , Humanos , Oxaliplatino/farmacología , Oxaliplatino/uso terapéutico , Leucovorina , MicroARNs/genética , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/genética , Neoplasias Colorrectales/patología , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/genéticaRESUMEN
BACKGROUND: Gastric cancer is the fifth most common cancer worldwide. One of the chemotherapy agents, taxanes is important in increasing patients' survival. The purpose of this study is to assess the efficacy of taxane-based drugs versus non-taxanes in neoadjuvant chemotherapy in non-metastatic gastric adenocarcinoma (GA) in Iranian patients. MATERIALS AND METHODS: In a historical cohort method, 65 patients between 18 and 75 years old who suffered from non-metastatic GA were included. Nineteen and 21 and 25 patients, had undergone DCF (docetaxel, cisplatin, 5fluorouracil) and FLOT (5fluorouracil, leucovorin, oxaliplatin, docetaxel) and FOLFOX6 (oxaliplatin, leucovorin, 5fluorouracil) regimens, respectively, between 2018 and 2021. Survival criteria consisting of progression-free survival (PFS), overall survival (OS), progression rate, and mortality rate were evaluated using the Kaplan-Meier method, in a three-year follow-up period. RESULTS: The majority of patients were male (72.3%), with a median age of 65 years. Most of the patients had lesions with tumor, node, metastasis (TNM) stage IIIb (27.7%) and poor differentiated pathological grade (49.2%). OS time had a significant correlation with the low TNM stage (P = 0.01), well-differentiated pathological grade (P = 0.005), and FLOT vs. FOLFOX protocol (20.3 vs. 12.2 months, respectively. P =0.04). FLOT regimen had significantly better OS survival vs. DCF regimen (20.3 vs. 15.4 months, respectively, P = 0.03). No significant correlation was observed between survival criteria and other factors like gender, age, past medical history, Karnofsky scale, and tumor location in the stomach. The taxane-based arm (sum of DSF and FLOT) had no superiority over the non-taxane arm in survival criteria. CONCLUSION: FLOT protocol, as a taxane-based regimen had better survival compared to FOLFOX protocol in neoadjuvant chemotherapy in gastric non-metastatic adenocarcinoma.
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OBJECTIVES: Hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen (oxaliplatin plus fluorouracil and leucovorin) is a promising option for advanced hepatocellular carcinoma (Ad-HCC). As identifying patients with Ad-HCC who would obtain objective response (OR) to HAIC preoperatively remains a challenge, we aimed to develop an automatic and non-invasive model for predicting HAIC response. METHODS: A total of 458 patients with Ad-HCC who underwent HAIC were retrospectively included from three hospitals (310 for training, 77 for internal validation, and 71 for external validation). The deep learning and radiomic features were extracted from the automatically segmented liver region on contrast-enhanced computed tomography images. Then, a deep learning radiomic nomogram (DLRN) was constructed by integrating deep learning scores, radiomic scores, and significant clinical variables with multivariate logistic regression. Model performance was assessed by AUC and Kaplan-Meier estimator. RESULTS: After automatic segmentation, only a few modifications were needed (less than 30 min for 458 patients). The DLRN achieved an AUC of 0.988 in the training cohort, 0.915 in the internal validation cohort, and 0.896 in the external validation cohort, respectively, outperforming other models in HAIC response prediction. Moreover, survival risk stratification was also successfully performed by the DLRN. The overall survival (OS) of the predictive OR group was significantly longer than that of the predictive non-OR group (median OS: 26.0 vs. 12.3 months, p < 0.001). CONCLUSIONS: The DLRN provided a satisfactory performance for predicting HAIC response, which is essential to identify Ad-HCC patients for HAIC and may potentially benefit personalized pre-treatment decision-making. CLINICAL RELEVANCE STATEMENT: This study presents an accurate and automatic method for predicting response to hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma, and therefore help in defining the best candidates for this treatment. KEY POINTS: ⢠Deep learning radiomic nomogram (DLRN) based on automatic segmentation of CECT can accurately predict hepatic arterial infusion chemotherapy (HAIC) response of advanced HCC patients. ⢠The proposed prediction model can perform survival risk stratification and is an easy-to-use tool for personalized pre-treatment decision-making for advanced HCC patients.
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Carcinoma Hepatocelular , Aprendizaje Profundo , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/diagnóstico por imagen , Carcinoma Hepatocelular/tratamiento farmacológico , Carcinoma Hepatocelular/patología , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/patología , Nomogramas , Estudios Retrospectivos , Cisplatino , Resultado del Tratamiento , Infusiones IntraarterialesRESUMEN
Objective: To explore and establish an artificial neural network (ANN) model for predicting the efficacy of first-line FOLFOX chemotherapy for metastatic colorectal cancer. Methods: A set of FOLFOX chemotherapy data from a group of patients with metastatic colorectal cancer (mCRC) (GSE104645) was downloaded from the GEO database as a training set. According to the FOLFOX protocol, the efficacy was divided into two groups: the chemo-sensitive group (including complete response and partial response) and the chemo-resistant group (including stable disease and progressive disease), including 31 cases in the sensitive group and 23 in the resistant group. Then, chip data (accessible number: GSE69657) from Fujian Medical University Union Hospital were chosen as a test set. A total of 30 patients were enrolled in the study, including 13 in the sensitive group and 17 in the resistant group. The batch effect correction was performed on the expression values of the two sets of matrices using the R 3.5.1 software Combat package. The gene expression difference of sensitive and resistant group in GSE104645 was analyzed by the GEO2R platform. P<0.05 and the absolute value of log(2)FC>0.33 (FC abbreviation of fold change) were used as the threshold value to screen the drug resistance and sensitive genes of the FOLFOX regimen. An ANN was constructed using the multi-layer perceptron (MLP) to perform the FOLFOX regimen on the GSE104645 dataset. The GSE69657 expression matrix and clinical efficacy parameters were then used for retrospective verification. Receiver operating characteristic(ROC) curves were used to evaluate the test results and predictive power. Results: A total of 2, 076 differentially expressed genes in GSE104645 were selected, of which 822 genes were up-regulated and 1, 254 genes were down-regulated in the chemo-resistance group. The down-regulated genes were sensitive genes. GO analysis of the biological processes in which the differentially expressed genes were involved, revealed that they were mainly involved in the regulation of substance metabolism. A total of 39 genes were included in the final model construction. This was a neural network model with two hidden layers. The accuracy of predicting training samples and test samples was 75.7% and 76.5%, respectively, and the area under the ROC curve was 0.875. The chip data set of our department (GSE69657) was set as the test set, and the area under the ROC curve was 0.778. Conclusions: In this study, an artificial neural network model is successfully constructed to predict the efficacy of first-line FOLFOX regimen for metastatic colorectal cancer based on the microarray, and an independent external verification is also conducted. The model has good stability and well prediction efficiency. Besides, the results of this study suggest that the gene functions related to oxaliplatin resistance are mainly enriched in the regulation process of substance metabolism.
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Neoplasias del Colon , Neoplasias Colorrectales , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/genética , Fluorouracilo/uso terapéutico , Humanos , Leucovorina/uso terapéutico , Redes Neurales de la Computación , Oxaliplatino/uso terapéutico , Estudios RetrospectivosRESUMEN
PURPOSE: This study investigated how adding Korean red ginseng extract (KRG) to folinic acid, fluorouracil and oxaliplatin (FOLFOX) chemotherapy affected the rate of splenomegaly in colon cancer. METHODS: This retrospective study analyzed 42 patients who were randomly assigned to receive a FOLFOX regimen with or without KRG. Spleen volume change was assessed by computed tomography scans measured before surgery (presurgery volume) and 3 weeks after cessation of the 12th cycle of FOLFOX (postchemotherapy volume). RESULTS: All patients showed increased spleen volume. No difference was observed in median presurgery and postchemotherapy volume between the KRG and control groups. However, a ratio defined as postchemotherapy volume divided by presurgery volume was significantly lower in the KRG group than the control group (median, 1.38 [range, 1.0-2.8] in KRG group vs. median, 1.89 [range, 1.1-3.0] in control group, P = 0.028). When splenomegaly was defined as a >61% increase in spleen volume, the rate of splenomegaly was significantly lower in the KRG group than the control group (28.6% vs. 61.9%, P = 0.03). KRG consumption was inversely associated with developing splenomegaly in multivariate analysis. CONCLUSION: Adding KRG during FOLFOX chemotherapy for colon cancer might protect against oxaliplatin-induced splenomegaly. The protective effect of Korean red ginseng should be investigated with further research.
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PURPOSE: An oxaliplatin-based regimen is the most common adjuvant chemotherapy for patients with stage II/III colorectal cancer, but many patients experience dose reduction or early termination of chemotherapy due to side effects. We conducted this study to verify the range of reduction with oncologic safety. METHODS: Patients with stage II/III colorectal cancer who received adjuvant FOLFOX chemotherapy were enrolled in this study. The total amount of oxaliplatin administered per patient was calculated as a percentile based on 12 cycles of full-dose FOLFOX as a standard dose. The cutoff values showing significant differences in survival were calculated, and the clinicopathologic outcomes of patient groups classified by the value were compared. RESULTS: Among a total of 611 patients, there were 107 stage II patients, and 504 stage III patients. At 60% of the standard dose of oxaliplatin, the patients in the dose reduction group were older (62 years vs. 58 years, P = 0.003), had lower body mass index (BMI) (23.1 kg/m2vs. 24.0 kg/m2, P = 0.005), and were more exposed to neoadjuvant treatment (18.0% vs. 9.1%, P = 0.003) in comparison to the standard group. At 60% of the standard dose, there were no significant differences in 5-year disease-free survival (DFS) and overall survival (OS) between the 2 groups (5-year DFS: 73.5% vs. 74.2%, P = 0.519; 5-year OS: 71.9% vs. 81.5%, P = 0.256, respectively). CONCLUSION: Patients with old age, low BMI, and more frequent exposure to neoadjuvant treatment tended to show lower compliance with chemotherapy. More than 60% dose should be administered to patients with stage II/III colorectal cancer as adjuvant chemotherapy to achieve acceptable oncologic outcomes.
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PURPOSE: An oxaliplatin-based regimen is the most common adjuvant chemotherapy for patients with stage II/III colorectal cancer, but many patients experience dose reduction or early termination of chemotherapy due to side effects. We conducted this study to verify the range of reduction with oncologic safety. METHODS: Patients with stage II/III colorectal cancer who received adjuvant FOLFOX chemotherapy were enrolled in this study. The total amount of oxaliplatin administered per patient was calculated as a percentile based on 12 cycles of full-dose FOLFOX as a standard dose. The cutoff values showing significant differences in survival were calculated, and the clinicopathologic outcomes of patient groups classified by the value were compared. RESULTS: Among a total of 611 patients, there were 107 stage II patients, and 504 stage III patients. At 60% of the standard dose of oxaliplatin, the patients in the dose reduction group were older (62 years vs. 58 years, P = 0.003), had lower body mass index (BMI) (23.1 kg/m2 vs. 24.0 kg/m2, P = 0.005), and were more exposed to neoadjuvant treatment (18.0% vs. 9.1%, P = 0.003) in comparison to the standard group. At 60% of the standard dose, there were no significant differences in 5-year disease-free survival (DFS) and overall survival (OS) between the 2 groups (5-year DFS: 73.5% vs. 74.2%, P = 0.519; 5-year OS: 71.9% vs. 81.5%, P = 0.256, respectively). CONCLUSION: Patients with old age, low BMI, and more frequent exposure to neoadjuvant treatment tended to show lower compliance with chemotherapy. More than 60% dose should be administered to patients with stage II/III colorectal cancer as adjuvant chemotherapy to achieve acceptable oncologic outcomes.
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Humanos , Índice de Masa Corporal , Quimioterapia Adyuvante , Neoplasias Colorrectales , Adaptabilidad , Supervivencia sin Enfermedad , Quimioterapia , Terapia NeoadyuvanteRESUMEN
PURPOSE: This study investigated how adding Korean red ginseng extract (KRG) to folinic acid, fluorouracil and oxaliplatin (FOLFOX) chemotherapy affected the rate of splenomegaly in colon cancer. METHODS: This retrospective study analyzed 42 patients who were randomly assigned to receive a FOLFOX regimen with or without KRG. Spleen volume change was assessed by computed tomography scans measured before surgery (presurgery volume) and 3 weeks after cessation of the 12th cycle of FOLFOX (postchemotherapy volume). RESULTS: All patients showed increased spleen volume. No difference was observed in median presurgery and postchemotherapy volume between the KRG and control groups. However, a ratio defined as postchemotherapy volume divided by presurgery volume was significantly lower in the KRG group than the control group (median, 1.38 [range, 1.0–2.8] in KRG group vs. median, 1.89 [range, 1.1–3.0] in control group, P = 0.028). When splenomegaly was defined as a >61% increase in spleen volume, the rate of splenomegaly was significantly lower in the KRG group than the control group (28.6% vs. 61.9%, P = 0.03). KRG consumption was inversely associated with developing splenomegaly in multivariate analysis. CONCLUSION: Adding KRG during FOLFOX chemotherapy for colon cancer might protect against oxaliplatin-induced splenomegaly. The protective effect of Korean red ginseng should be investigated with further research.
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Humanos , Colon , Neoplasias del Colon , Quimioterapia , Fluorouracilo , Leucovorina , Análisis Multivariante , Panax , Estudios Retrospectivos , Bazo , EsplenomegaliaRESUMEN
BACKGROUND: Currently, metastatic colorectal cancer is treated as a homogeneous disease and only RAS mutational status has been approved as a negative predictive factor in patients treated with cetuximab. The aim of this study was to evaluate if recently identified molecular subtypes of colon cancer are associated with response of metastatic patients to first-line therapy. PATIENTS AND METHODS: We collected and analysed 143 samples of human colorectal tumours with complete clinical annotations, including the response to treatment. Gene expression profiling was used to classify patients in three to six classes using four different molecular classifications. Correlations between molecular subtypes, response to treatment, progression-free and overall survival were analysed. RESULTS: We first demonstrated that the four previously described molecular classifications of colorectal cancer defined in non-metastatic patients also correctly classify stage IV patients. One of the classifications is strongly associated with response to FOLFIRI (P=0.003), but not to FOLFOX (P=0.911) and FOLFIRI + Bevacizumab (P=0.190). In particular, we identify a molecular subtype representing 28% of the patients that shows an exceptionally high response rate to FOLFIRI (87.5%). These patients have a two-fold longer overall survival (40.1 months) when treated with FOLFIRI, as first-line regimen, instead of FOLFOX (18.6 months). CONCLUSIONS: Our results demonstrate the interest of molecular classifications to develop tailored therapies for patients with metastatic colorectal cancer and a strong impact of the first-line regimen on the overall survival of some patients. This however remains to be confirmed in a large prospective clinical trial.
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Adenocarcinoma/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Camptotecina/análogos & derivados , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Hepáticas/tratamiento farmacológico , Transcriptoma , Adenocarcinoma/clasificación , Adenocarcinoma/genética , Adenocarcinoma/secundario , Anciano , Anciano de 80 o más Años , Bevacizumab/administración & dosificación , Camptotecina/administración & dosificación , Camptotecina/uso terapéutico , Neoplasias Colorrectales/clasificación , Neoplasias Colorrectales/genética , Neoplasias Colorrectales/patología , Femenino , Fluorouracilo/uso terapéutico , Humanos , Irinotecán , Leucovorina/uso terapéutico , Neoplasias Hepáticas/clasificación , Neoplasias Hepáticas/genética , Neoplasias Hepáticas/secundario , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Compuestos Organoplatinos/uso terapéutico , Pronóstico , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
Colorectal cancer metastasizes predictably, with liver predominance in most cases. Because liver involvement has been shown to be a major determinant of survival in this population, liver-directed therapies are increasingly considered even in cases where there is (limited) extrahepatic disease. Unfortunately, these patients carry a known risk of recurrence in the liver regardless of initial therapy choice. Therefore, there is a demand for minimally invasive, non-surgical, personalized cancer treatments to preserve quality of life in the induction, consolidation, and maintenance phases of cancer therapy. This report aims to review evidence-based conceptual, pharmacological, and technological paradigm shifts in parenteral and percutaneous treatment strategies as well as forthcoming evidence regarding next-generation systemic, locoregional, and local treatment approaches for this patient population.
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Neoplasias Colorrectales/patología , Neoplasias Colorrectales/terapia , Medicina Basada en la Evidencia , Neoplasias Hepáticas/secundario , Neoplasias Hepáticas/terapia , Oncología Médica , Radiología Intervencionista , Técnicas de Ablación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioembolización Terapéutica , Quimioterapia Adyuvante , Neoplasias Colorrectales/mortalidad , Humanos , Inmunoterapia , Neoplasias Hepáticas/mortalidad , Estadificación de Neoplasias , Radiografía Intervencional , Resultado del TratamientoRESUMEN
PURPOSE: The survival of advanced colon cancer patients has increased due to the development of surgical techniques and adjuvant chemotherapy. The administration of adjuvant chemotherapy after curative resection is generally accepted as a standard of care. The primary endpoint of chemotherapy should include not only tumor response and survival, but also impact on the quality of life (QoL). We evaluated changes in QoL during adjuvant chemotherapy in patients with colon cancer.METHODS: Between October 2009 and February 2012, 56 patients with stage II and III colon cancer received the combination adjuvant chemotherapy 5-flurouracil/folinic acid with oxaliplatin (FOLFOX). Patients were asked to complete the QoL questionnaire QLQ-C30 version 3 before and after 6 cycles of adjuvant chemotherapy.RESULTS: There was no significant difference in the QoL between the start of chemotherapy and after the completion of 6 cycles. After completion of 6 cycles, global QoL was worse in patients >70 years of age. The functional scale score was low in patients with chemotherapy schedules delayed more than 2 times due to adverse events. Patients with body weight increases greater than 5% scored lower on symptom scales. Interestingly, patients with peripheral neuropathy scored higher on symptom scales.CONCLUSION: QoL changes during adjuvant chemotherapy did not show significant differences. After the sixth chemotherapy, QoL was affected by age, body weight gain, delay of the scheduled chemotherapy, and peripheral neuropathy. Therefore, the proper attitude of physicians focused on reassurance and education of patients is very important during chemotherapy.
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Humanos , Citas y Horarios , Peso Corporal , Quimioterapia Adyuvante , Colon , Neoplasias del Colon , Quimioterapia , Educación del Paciente como Asunto , Enfermedades del Sistema Nervioso Periférico , Calidad de Vida , Nivel de Atención , Pesos y MedidasRESUMEN
PURPOSE: Great progress has been made in the adjuvant treatment of colon cancer. The aim of this study was to evaluate the efficacy of postoperative adjuvant chemotherapy using the FOLFOX regimen in patients with stage III and high-risk stage II colon cancer. METHODS: Eighty-two patients who underwent a potentially curative resection for stage III or high-risk stage II colon cancer were enrolled in this retrospective study. They received FOLFOX4 or modified FOLFOX6. The primary endpoint was disease-free survival. RESULTS: During the median follow-up of 37 months (range, 21 to 61 months), 14 patients experienced disease relapse. The disease-free survival rate at 3 years was 82.9%: 84.6% for stage II and 82.6% for stage III. At the time of the analysis, 8 patients were dead from recurrence. The probability of overall survival at 5 years was 74.5%: 90% for stage II and 74.6% for stage III. Grade 3 or 4 hematologic adverse events included neutropenia (40.2%), anemia (2.4%), and thrombocytopenia (1.2%). Gastrointestinal toxicities included grade 3 or 4 nausea (4.9%) and stomatitis (2.4%). Peripheral sensory neuropathy was observed in 81.7% of the patients during treatment. Of the 11 patients (13.4%) who had grade 3 peripheral sensory neuropathy during treatment, grade 3 symptoms were persistent in 3 patients with gait disturbance at the time of analysis. No treatment-related deaths were recorded. CONCLUSION: Postoperative chemotherapy using the FOLFOX regimen, oxaliplatin in combination with 5-fluorouracil and leucovorin, is effective and tolerable in patients with stage III and high-risk stage II colon cancer.
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BACKGROUND: Decision analysis (DA) is commonly used to perform economic evaluations of new pharmaceuticals. Using multiples of Malaysia's per capita 2010 gross domestic product (GDP) as the threshold for economic value as suggested by the World Health Organization (WHO), DA was used to estimate a price per dose for bevacizumab, a drug that provides a 1.4-month survival benefit in patients with metastatic colorectal cancer (mCRC). METHODS: A decision model was developed to simulate progression-free and overall survival in mCRC patients receiving chemotherapy with and without bevacizumab. Costs for chemotherapy and management of side effects were obtained from public and private hospitals in Malaysia. Utility estimates, measured as quality-adjusted life years (QALYs), were determined by interviewing 24 oncology nurses using the time trade-off technique. The price per dose was then estimated using a target threshold of US$44 400 per QALY gained, which is 3 times the Malaysian per capita GDP. RESULTS: A cost-effective price for bevacizumab could not be determined because the survival benefit provided was insufficient According to the WHO criteria, if the drug was able to improve survival from 1.4 to 3 or 6 months, the price per dose would be $567 and $1258, respectively. CONCLUSION: The use of decision modelling for estimating drug pricing is a powerful technique to ensure value for money. Such information is of value to drug manufacturers and formulary committees because it facilitates negotiations for value-based pricing in a given jurisdiction.
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Background: Decision analysis (DA) is commonly used to perform economic evaluations of new pharmaceuticals. Using multiples of Malaysia’s per capita 2010 gross domestic product (GDP) as the threshold for economic value as suggested by the World Health Organization (WHO), DA was used to estimate a price per dose for bevacizumab, a drug that provides a 1.4-month survival benefit in patients with metastatic colorectal cancer (mCRC). Methods: A decision model was developed to simulate progression-free and overall survival in mCRC patients receiving chemotherapy with and without bevacizumab. Costs for chemotherapy and management of side effects were obtained from public and private hospitals in Malaysia. Utility estimates, measured as quality-adjusted life years (QALYs), were determined by interviewing 24 oncology nurses using the time trade-off technique. The price per dose was then estimated using a target threshold of US$44 400 per QALY gained, which is 3 times the Malaysian per capita GDP. Results: A cost-effective price for bevacizumab could not be determined because the survival benefit provided was insufficient According to the WHO criteria, if the drug was able to improve survival from 1.4 to 3 or 6 months, the price per dose would be $567 and $1258, respectively. Conclusion: The use of decision modelling for estimating drug pricing is a powerful technique to ensure value for money. Such information is of value to drug manufacturers and formulary committees because it facilitates negotiations for value-based pricing in a given jurisdiction.
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PURPOSE: Great progress has been made in the adjuvant treatment of colon cancer. The aim of this study was to evaluate the efficacy of postoperative adjuvant chemotherapy using the FOLFOX regimen in patients with stage III and high-risk stage II colon cancer. METHODS: Eighty-two patients who underwent a potentially curative resection for stage III or high-risk stage II colon cancer were enrolled in this retrospective study. They received FOLFOX4 or modified FOLFOX6. The primary endpoint was disease-free survival. RESULTS: During the median follow-up of 37 months (range, 21 to 61 months), 14 patients experienced disease relapse. The disease-free survival rate at 3 years was 82.9%: 84.6% for stage II and 82.6% for stage III. At the time of the analysis, 8 patients were dead from recurrence. The probability of overall survival at 5 years was 74.5%: 90% for stage II and 74.6% for stage III. Grade 3 or 4 hematologic adverse events included neutropenia (40.2%), anemia (2.4%), and thrombocytopenia (1.2%). Gastrointestinal toxicities included grade 3 or 4 nausea (4.9%) and stomatitis (2.4%). Peripheral sensory neuropathy was observed in 81.7% of the patients during treatment. Of the 11 patients (13.4%) who had grade 3 peripheral sensory neuropathy during treatment, grade 3 symptoms were persistent in 3 patients with gait disturbance at the time of analysis. No treatment-related deaths were recorded. CONCLUSION: Postoperative chemotherapy using the FOLFOX regimen, oxaliplatin in combination with 5-fluorouracil and leucovorin, is effective and tolerable in patients with stage III and high-risk stage II colon cancer.
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Humanos , Anemia , Protocolos de Quimioterapia Combinada Antineoplásica , Quimioterapia Adyuvante , Colon , Neoplasias del Colon , Supervivencia sin Enfermedad , Fluorouracilo , Estudios de Seguimiento , Marcha , Leucovorina , Náusea , Neutropenia , Compuestos Organoplatinos , Recurrencia , Estudios Retrospectivos , Estomatitis , TrombocitopeniaRESUMEN
PURPOSE: This study was to investigate difficulties in daily activities and tingling from patients having treatment of FOLFOX chemotherapy after colon resection. METHOD: This study included 103 patients hospitalized for FOLFOX chemotherapy in one of the university affiliated hospital from August 1, 2008 through September 30, 2009. Data were collected using the questionnaire comprised general symptoms, tingling, difficulties in daily activities and coping behavior. Using the SPSS 14.0 program, data analytic methods include Chi-Square test, ANOVA, Scheffe's test. RESULTS: The tingling sensation occurred in hands, feet, mouth, throat. Contacts with cold objects and the number of chemotherapy cycle worsen tingling sensation. Patients experienced difficulties in daily activities such as personal hygiene, kitchen work, eating cold food, sleeping cold, using fine motors like button up, writing, or using knife. The coping behavior included drinking warm water, sleeping warm, using gloves and socks, wearing comfortable shoes, massaging hands and getting help from supporters. CONCLUSION: An educational guideline for promoting coping behavior to relieve tingling sensation and difficulty in daily living in patients with FOLFOX chemotherapy is needed.
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Humanos , Actividades Cotidianas , Adaptación Psicológica , Protocolos de Quimioterapia Combinada Antineoplásica , Frío , Colon , Ingestión de Líquidos , Ingestión de Alimentos , Fluorouracilo , Pie , Mano , Higiene , Leucovorina , Boca , Compuestos Organoplatinos , Faringe , Encuestas y Cuestionarios , Sensación , Zapatos , EscrituraRESUMEN
To evaluate the toxicity and efficacy of a reduced dose intensity (mini-) FOLFOX-4 regimen as a first-line palliative chemotherapy in elderly patients (> or =70 yr of age) with advanced colorectal cancer, data from prospective databases at Seoul National University Bundang Hospital and Seoul Municipal Boramae Hospital were analyzed. A total of 20 patients were enrolled between January 2001 and August 2004, and were treated with oxaliplatin 65 mg/m2 on day 1, and with 2-hr infusions of leucovorin 150 mg/m2 followed by a 5-FU bolus (300 mg/m2) and 22-hr continuous infusions (450 mg/m2) for 2 consecutive days every 2 weeks until progression, unacceptable toxicity or patient refusal. Sixteen patients were evaluable for response with an overall response rate of 43.8%. Median progression-free survival was 4.8 months (95% CI: 3.0-6.7) and overall survival was 13.5 months (95% CI: 11.1-16.0). The main side effects were anemia and neutropenia, which were observed in 20.8% and 17.7%, respectively, of the total cycles administered. There were no grade 4 toxicities and only one patient suffered from febrile neutropenia. No grade 3 toxicities occurred except for anemia (5.2%) and vomiting (1.0%). In conclusion, the mini-FOLFOX-4 regimen was found to be well tolerated with acceptable toxicity, and to provide a benefit for elderly patients with colorectal cancer.