RESUMEN
This study presents a safety analysis of infusion reactions (IRs) in gastric cancer patients who switched from reference trastuzumab to its biosimilar, trastuzumab-NK, at the Saitama Cancer Center in Japan from April 2018 to March 2022. IRs were identified if patients developed symptoms such as fever, chills, infusion-related reactions, hypersensitivity, rash, pruritus, urticaria, systemic disorders, or immune system disorders on the day of administration or the following day. The incidence of IRs was 14% in the reference trastuzumab group, 33% in the trastuzumab-NK group, and 33% in the switching group. There was no significant difference in IR incidence between the reference trastuzumab and trastuzumab-NK groups (p = 0.235). Among the switching group, only one of the three patients who experienced an IR had a reaction associated with the switch. These findings suggest that the frequency of IRs in the switching group gastric cancer is comparable to the other groups, indicating that switching is a viable treatment option with appropriate management. Additionally, 37 of the 45 patients in the study were male, provides new safety information on switching in gastric cancer for male patients that has not been previously reported.
Asunto(s)
Biosimilares Farmacéuticos , Receptor ErbB-2 , Neoplasias Gástricas , Trastuzumab , Humanos , Neoplasias Gástricas/tratamiento farmacológico , Trastuzumab/efectos adversos , Trastuzumab/uso terapéutico , Masculino , Biosimilares Farmacéuticos/efectos adversos , Biosimilares Farmacéuticos/uso terapéutico , Biosimilares Farmacéuticos/administración & dosificación , Femenino , Persona de Mediana Edad , Anciano , Receptor ErbB-2/metabolismo , Antineoplásicos Inmunológicos/efectos adversos , Antineoplásicos Inmunológicos/uso terapéutico , Adulto , Japón , Anciano de 80 o más Años , Sustitución de Medicamentos , Infusiones IntravenosasRESUMEN
The simple suspension method (SSM) involves administering tablets or capsules using a tube after disintegration and suspension in hot water without crushing or opening the capsule. Particularly, for anticancer drugs, it is an excellent method of administration that reduces the risk of exposure during dispensing. In contrast, information on SSM for individual drugs is insufficient. Anticancer drugs present a therapeutic challenge because their information is limited. We investigated whether SSM is possible with 36 anticancer drugs. Furthermore, we examined the pH of the suspension of these drugs, for which no information on SSM is available. We found that suspension was possible for 24 of the 36 drugs. Furthermore, the pH of the suspension was measured, which provided important information when considering dissolution solutions other than hot water. Little changes in the pH were observed before or after passing through the tube. The results of this study may improve medication adherence in patients with cancer experiencing dysphagia.
Asunto(s)
Agua , Humanos , Comprimidos , Suspensiones , Administración OralRESUMEN
PURPOSE: The intensity of adjuvant treatment for pancreatic ductal adenocarcinomas (PDACs) has not been stratified according to the risk after resection. This study was designed to identify patients with PDACs in whom the current S-1 adjuvant treatment is ineffective. METHODS: This single-center, retrospective study included patients who underwent pancreatectomy for PDACs from 2009 to 2020 at Sendai Open Hospital and were receiving S-1 adjuvant treatment. The independent risk factors for recurrence and survival were determined by using a Cox proportional hazards regression model. The effects of S-1 adjuvant treatment and detailed patterns of recurrence were evaluated in patients with high-risk factors. RESULTS: Overall, 118 patients with PDAC received S-1 adjuvant treatment. Postoperative nonnormalized carbohydrate antigen (CA19-9) was a predictive risk factor for recurrence (p < 0.010; hazard ratio [HR], 3.87; 95% confidence interval [CI], 2.26-6.62) and survival (p = 0.008; HR, 2.25; 95% CI, 1.24-4.11) after S-1 adjuvant treatment. In 24 patients with nonnormalized postoperative CA19-9, S-1 monotherapy was ineffective in preventing recurrence, even during the treatment period, compared with that noted in patients who did not receive adjuvant treatment. The recurrence rate during adjuvant treatment was 41.7%; in all cases, recurrence was caused by distant metastasis. The total recurrence rate was up to 95.8%, and distant recurrence was especially frequent. CONCLUSIONS: The current S-1 adjuvant treatment regimen is ineffective for patients with postoperative nonnormalized CA19-9. The postoperative CA19-9 level may be a good indicator for further aggressive treatment. This study may lead to further discussions on intensity stratification of adjuvant treatments for PDAC.
Asunto(s)
Carcinoma Ductal Pancreático , Neoplasias Pancreáticas , Humanos , Estudios Retrospectivos , Antígeno CA-19-9 , Carcinoma Ductal Pancreático/tratamiento farmacológico , Carcinoma Ductal Pancreático/cirugía , Neoplasias Pancreáticas/tratamiento farmacológico , Neoplasias Pancreáticas/cirugía , Quimioterapia Adyuvante , Pancreatectomía , Carbohidratos , Recurrencia Local de Neoplasia/patología , PronósticoRESUMEN
PURPOSE: Sarcopenia influences the short- and long-term outcomes of various medical conditions including malignancy. Ishii's screening test estimates the probability of sarcopenia based on a score calculated by three simple variables: age, grip strength, and calf circumference. We investigated the clinical significance of Ishii's score for patients with non-metastatic obstructive colorectal cancer (OCRC) who underwent curative surgery after intraluminal decompression. METHODS: Ishii's score was calculated in 79 patients with OCRC. Muscle volume loss and decreased muscle quality were evaluated by computed tomography (CT) images as skeletal muscle index (SMI) and intramuscular adipose tissue content (IMAC), respectively. RESULTS: There were 46 men and 33 women, with a median age of 70 years old. The cutoff value for Ishii's score was 155.1 and 15 patients were in the high-score group. The high-score group was significantly associated with worse time to recurrence (TTR) and overall survival (OS), and a high Ishii's score was an independent negative prognostic factor for TTR (hazard ratio = 2.93, P = 0.015). A high Ishii's score was significantly associated with a low SMI value but not with the IMAC value. CONCLUSION: A high Ishii's score was independently associated with poorer TTR in patients with non-metastatic OCRC.
RESUMEN
Objectives: The geriatric nutritional risk index (GNRI) is a nutrition-related risk index calculated easily from serum albumin and the ratio of body weight to ideal body weight. We investigated the prognostic values of the GNRI in elderly patients with obstructive colorectal cancer (OCRC) who had a self-expandable metallic stent inserted as a bridge to curative surgery. Methods: We retrospectively evaluated 61 patients aged ≥65 years with pathological stage I to III OCRC. Associations of preoperative GNRI and pre-stenting GNRI (ps-GNRI) with short- and long-term outcomes were examined. Results: Multivariate analyses revealed GNRI of <85.3 and ps-GNRI of <92.9 were independently associated with worse cancer-specific survival (CSS; P = 0.016, and P = 0.041, respectively), and overall survival (OS; P = 0.020, and P = 0.024, respectively). A ps-GNRI of <92.9 was correlated with poorer relapse-free survival (RFS) only in the univariate analysis (P = 0.034). For the OCRC cohort without age restriction (n = 86), GNRI of <85.3 and ps-GNRI of <92.9 were independently associated with worse CSS (P = 0.021), and OS (P = 0.023), respectively. In univariate analysis, ps-GNRI of <92.9 was significantly correlated with poorer RFS (P = 0.006). Moreover, ps-GNRI of <92.9 was significantly associated with Clavien-Dindo grade of ≥III postoperative complications (P = 0.037), anastomotic leak (P = 0.032), infectious complications (P = 0.002), and longer postoperative hospital stay (17 days vs. 15 days; P = 0.048). Conclusions: In OCRC patients, decreased preoperative and pre-stenting GNRI were significantly correlated with poorer survival, and decreased pre-stenting GNRI was significantly associated with worse short- and long-term outcomes.
RESUMEN
The present study is a safety survey of patients with human epidermal growth factor receptor type 2-positive, chemotherapy-naive breast cancer treated with trastuzumab plus paclitaxel at the Saitama Cancer Center (Saitama, Japan) between April 2018 and March 2022. The expression of infusion reaction (IR) and the effect on cardiac function were investigated in patients who switched from reference trastuzumab (HERCEPTIN®) to biosimilar trastuzumab (Trastuzumab-NK) and continued treatment (switching group). The two groups (reference vs. biosimilar trastuzumab) had no significant difference in the expression of IR (P>0.999). In the switching group, IR associated with switching did not occur in all nine eligible patients. Left ventricular ejection fraction (LVEF) was used to assess cardiac function, and no patient in either group experienced a significant decrease in LVEF with treatment, meaning that there was no effect of switching on the decrease in LVEF. These results suggested that switching from reference to biosimilar trastuzumab may not have a significant effect on the frequency of IR expression or the occurrence of cardiac dysfunction.
RESUMEN
Aim: Whether a laparoscopic procedure can contribute to the improvement of clinical outcomes in obese patients with stage II/III rectal cancer compared to an open procedure remains unclear. Objective: This study evaluated the technical and oncological safety of laparoscopic surgery versus open surgery in obese patients (body mass index [BMI] ≥25 kg/m2) with rectal cancer. Patients and Methods: Data were collected from patients with pathological stage II/III rectal cancer and analyzed. Operations were performed via laparoscopic or open surgery from 2009 to 2013. A comparative analysis was performed after applying propensity score matching to the two cohorts (laparoscopic group and open group). The primary endpoint was 3-y relapse-free survival (RFS). Results: Overall, 524 eligible cases were collected from 51 institutions. Equal numbers of propensity score-matched patients were included in the laparoscopic (n = 193) group and open (n = 193) group. Although the rate of D3 lymph node dissection did not differ between the laparoscopic group (87.0%) and the open group (88.6%), the median number of harvested lymph nodes was significantly lower in the laparoscopic group versus open group (17.5 vs 21, P = 0.0047). The median postoperative hospital stay was also significantly shorter in the laparoscopic group (14 d) vs the open group (17 d) (P = 0.0014). Three-y RFS was not significantly different between the two groups (hazard ratio 1.2454, 95% confidence interval 0.9201-1.6884, P = 0.4689). Conclusion: The short- and long-term results of this large cohort study (UMIN ID: UMIN000033529) indicated that laparoscopic surgery in obese rectal cancer patients has advantageous short-term outcomes and no disadvantageous long-term outcomes.
RESUMEN
PURPOSE: Inflammation is one of the hallmarks of cancer, and inflammation-based markers that are calculated easily from laboratory results have shown predictive abilities. We investigated the prognostic values of the preoperative platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), and pan-immune-inflammation value (PIV) in patients with non-metastatic obstructive colorectal cancer (OCRC) and a self-expandable metallic stent inserted as a bridge to curative surgery. METHODS: The subjects of this retrospective study were 86 patients with pathological stage I to III OCRC. We examined the associations of these biomarkers with short- and long-term outcomes. RESULTS: Multivariate analyses revealed that a preoperative PLR < 149, SII < 597, and PIV < 209 were independently associated with poorer relapse-free survival (RFS) (P = 0.007, P < 0.001, and P = 0.002, respectively) and that a PIV < 209 was independently associated with poorer cancer-specific survival (P = 0.030). A platelet count < 240 was significantly associated with worse RFS, whereas the lymphocyte count was not. Pre-stenting PLR < 221 was an independent poor prognostic factor for RFS (P = 0.045). CONCLUSION: This study showed that decreased preoperative PLR, SII, PIV, and pre-stenting PLR were associated with poorer RFS, contrary to the findings of most previous studies. Our results suggest that platelets and obstruction contributed primarily to the opposite relationships, which might provide new insight into the possible pathophysiology of platelet-tumor interactions generated in the OCRC environment.
Asunto(s)
Neoplasias Colorrectales , Recurrencia Local de Neoplasia , Stents , Humanos , Neoplasias Colorrectales/cirugía , Inflamación , Linfocitos , Recurrencia Local de Neoplasia/cirugía , Neutrófilos , Pronóstico , Estudios RetrospectivosRESUMEN
PURPOSE: The prognostic significance of the mean corpuscular volume (MCV) and red cell distribution width (RDW) in patients with malignancy have not been intensely investigated and are largely overlooked. We, therefore, investigated the clinical significance of MCV and RDW in non-metastatic obstructive colorectal cancer (OCRC) patients with a self-expandable metallic stent inserted as a bridge to curative surgery. METHODS: Eighty-five pathological stage II and III OCRC patients were retrospectively evaluated. The associations of the preoperative MCV and RDW values with short- and long-term outcomes were examined. RESULTS: There were 50 males and 35 females, and the median age was 71 years old. The median interval between stenting and surgery was 17 days, and the median postoperative hospital stay was 16 days. Fifty-six patients were in the MCV ≥ 87 group, and 47 were in the RDW ≥ 13.8 group. Multivariate analyses revealed the MCV ≥ 87 status to be independently associated with a poor relapse-free survival (hazard ratio [HR] = 4.70, 95% confidence interval [CI] 1.52-14.58, P = 0.007). The RDW ≥ 13.8% was an independent predictor of postoperative infectious complications (HR = 7.28, 95% CI 1.24-42.70, P = 0.028). CONCLUSION: The MCV and RDW are simple but strong predictors of postoperative outcomes in OCRC patients.
Asunto(s)
Neoplasias Colorrectales , Índices de Eritrocitos , Masculino , Femenino , Humanos , Anciano , Pronóstico , Estudios Retrospectivos , Complicaciones Posoperatorias/epidemiología , Stents , Neoplasias Colorrectales/cirugíaRESUMEN
OBJECTIVES: Understanding the relationship between sarcopenia and malignancy is increasingly important since they inevitably affect the aging population. We investigated the clinical significance of sarcopenia in nonmetastatic obstructive colorectal cancer (OCRC) patients who were inserted self-expandable metallic stent and underwent curative surgery. METHODS: Plain cross-sectional CT images obtained before stenting were retrospectively analyzed in 92 patients. Muscle volume loss (myopenia) and decreased muscle quality (myosteatosis) were evaluated as skeletal muscle index (SMI) and intramuscular adipose tissue content (IMAC), respectively. RESULTS: This study included 54 men and 38 women, with a median age of 70.5 years. The median interval between SEMS placement and the surgery was 17 days (range, 5-47). There were 35 postoperative complications. The median postoperative hospital stay was 15.5 days (range, 8-77). Twenty-eight patients (41.3%) were classified as SMI-low, and 31 (34.1%) patients were classified as IMAC-high. In multivariate analysis, IMAC-high [hazard ratio (HR) = 7.68, 95% confidence interval (CI) 2.22-26.5, P = 0.001] and right-sided tumor (HR = 5.79, 95% CI 1.36-24.7, P = 0.018) were independent predictors of postoperative complications. IMAC-high (HR = 23.2, 95% CI 4.11-131, P < 0.001) and elevated modified Glasgow prognostic score (mGPS) (HR = 5.85, 95% CI 1.22-28.1, P = 0.027) were independent predictors of infectious complications. Relapse-free survival and overall survival were not significantly different regardless of the SMI or IMAC status. CONCLUSIONS: IMAC was associated with postoperative complications and infectious complications. Myosteatosis might be a stronger predictor of postoperative complications than myopenia.
RESUMEN
PURPOSE: Intestinal decompression using self-expandable metallic colonic stents (SEMSs) as a bridge to surgery is now considered an attractive alternative to emergency surgery. However, data regarding the optimal timing of surgery after stenting are limited. METHODS: We investigated the impact of the interval between stenting and surgery on short- and long-term outcomes in 92 obstructive colorectal cancer (OCRC) patients who had a SEMS inserted and subsequently received curative surgery. RESULTS: The median age of the patients was 70.5 years, and the median interval between SEMS insertion and the surgery was 17 (range 5-47) days. There were 35 postoperative complications, including seven major postoperative complications. An interval of more than 16 days was an independent predictor of a poor relapse-free survival (hazard ratio [HR] = 3.12, 95% confidence interval [CI] 1.24-7.81, p = 0.015). An interval of more than 35 days was independently associated with major postoperative complications (HR = 16.6, 95% CI 2.21-125, p = 0.006). CONCLUSION: A longer interval between stenting and surgery significantly compromised the short- and long-term outcomes. Surgery within 16 days after stenting might help maximize the benefit of SEMS without interfering with short- and long-term outcomes.
Asunto(s)
Neoplasias Colorrectales , Obstrucción Intestinal , Anciano , Humanos , Obstrucción Intestinal/etiología , Obstrucción Intestinal/cirugía , Recurrencia Local de Neoplasia , Estudios Retrospectivos , Stents/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVES: It has been increasingly recognized that the progression of cancer is dependent not only on the tumor characteristics but also on the nutritious and inflammatory condition of the host. We investigated the relationship between the globulin-to-albumin ratio (GAR) and long-term outcomes in obstructive colorectal cancer (OCRC) patients who were inserted self-expandable metallic stent as a bridge to curative surgery. METHODS: A total of 75 pathological stage II and III OCRC patients between 2013 and 2020 were retrospectively evaluated. The associations of the preoperative GAR with clinicopathological factors and patient survival were examined. RESULTS: Receiver operating characteristic curve analysis demonstrated that the optimal cutoff value was 0.88. The GAR ≥ 0.88 status was significantly associated with the absence of lymph node metastasis (P = 0.011), longer postoperative hospital stay (17 days vs 15 days, P = 0.042), and not receiving adjuvant chemotherapy (P = 0.011). Relapse-free survival and cancer-specific survival were significantly shorter in the GAR ≥ 0.88 group (P = 0.007 and P = 0.023, respectively). Multivariate analyses revealed that the GAR ≥ 0.88 was independently associated with relapse-free survival [hazard ratio (HR) = 4.17, 95% confidence interval (CI) 1.32-13.14, P = 0.015)]. Moreover, CA19-9 ≥ 37 (HR = 6.56, 95% CI 2.12-20.27, p = 0.001) and not receiving adjuvant chemotherapy (HR = 4.41, 95% CI 1.28-15.26, p = 0.019) were independent poor prognostic factors for relapse-free survival. CONCLUSIONS: The results demonstrated that the GAR was a significant prognostic factor for OCRC patients.
RESUMEN
BACKGROUND: Elastomeric pumps (EPs) are devices that allow quantitative and continuous drug administration without the need for electronic control, and they are used by being filled with anticancer agents. Although the package inserts of several manufacturers that provide EPs describe the relationship between the flow rate per unit time and temperature, the solution is only saline solution or 5% glucose solution, and data on anticancer drugs have not been published. In this study, we focused on 5-fluorouracil (5-FU), a drug frequently used in cancer chemotherapy, and examined the effect of changes in standard of EPs and temperature on drug emission. METHODS: We evaluated the EP data of patients treated with Baxter Infusor® LV5 and SV2.5 in terms of emission rate, relationship between 5-FU prescription amount and emission rate, and relationship between emission rate and monthly air temperature in LV5 and SV2.5. The number of EPs sampled in the study was N = 5708 (n = 2988 for LV5 and n = 2720 for SV2.5). RESULTS: In LV5, the emission rate varied from 88 to 97% (median 94.0%), whereas in SV2.5, the emission rate was observed as 97 to 98% (median 97.4%). The 5-FU prescription amount and the emission rate were not correlated in LV5 and SV2.5, respectively (LV5; y = - 0.0015x + 97.305, R2 = 0.0226, SV2.5; y = - 0.001x + 100.25, R2 = 0.0466). LV5 showed a higher emission rate in the months with higher air temperature and a lower emission rate in the month with lower air temperature. In addition, LV5 showed a significant reduction in emission rate compared with SV2.5 in all months (P < 0.001). CONCLUSIONS: In this study, we clarified that air temperature is an important factor that affects the drug emission of EPs. Therefore, it is necessary to examine the conditions for total fluid volume suitable for the air temperature in each region and to provide sufficient information to patients.
RESUMEN
The number of elderly patients and colorectal cancer patients is increasing, so laparoscopic surgery for colorectal cancer in elderly patients is suspected to increase. In 456 patients who underwent laparoscopic surgery for colorectal cancer, we investigated whether laparoscopic surgery for elderly patients with colon cancer patients could be performed equally compared to non-elderly patients. Preoperative ASA-PS was slightly poorer in elderly patients. There was no significant difference in pStage. The 5-year overall survival rate was lower in the elderly, but there were no significant differences in blood loss, operation time, postoperative hospital stays and incidence of complications of Clavien-Dindo classification grade 3 or higher. It was suggested that laparoscopic surgery for elderly patients with colorectal cancer may be safely performed compared with non-elderly patients.
Asunto(s)
Neoplasias del Colon , Neoplasias Colorrectales , Laparoscopía , Anciano , Neoplasias del Colon/cirugía , Neoplasias Colorrectales/cirugía , Humanos , Persona de Mediana Edad , Tempo Operativo , Complicaciones Posoperatorias , Estudios Retrospectivos , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
PURPOSE: The Controlling Nutritional Status (CONUT) Score, originally developed as a nutritional screening tool, is a cumulative score calculated from the serum albumin level, total cholesterol level, and total lymphocyte count. Previous studies have demonstrated that the score has significant prognostic value in various malignancies. We investigated the relationship between the CONUT score and long-term survival in obstructive colorectal cancer (OCRC) patients who underwent self-expandable metallic colonic stent placement and subsequently received curative surgery. METHODS: We retrospectively analyzed 57 pathological stage II and III OCRC patients between 2013 and 2019. The associations between the preoperative CONUT score and clinicopathological factors and patient survival were evaluated. RESULTS: A receiver operating characteristic curve analysis revealed that the optimal cut-off value for the CONUT score was 7. A CONUT score of ≥ 7 was significantly associated with elevated CA19-9 level (p = 0.03). Multivariate analyses revealed that a CONUT score of ≥ 7 was independently associated with cancer-specific survival (hazard ratio [HR] = 10.2, 95% confidence interval [CI] 1.2-85.9, p = 0.03) and disease-free survival (HR = 7.1, 95% CI 2.3-21.7, p = 0.0006). CONCLUSION: The results demonstrated that the CONUT score was a potent prognostic indicator. Evaluating the CONUT score might result in more precise patient assessment and tailored treatment.
Asunto(s)
Neoplasias Colorrectales/mortalidad , Neoplasias Colorrectales/cirugía , Estado Nutricional , Stents Metálicos Autoexpandibles , Adulto , Anciano , Anciano de 80 o más Años , Biomarcadores/sangre , Colesterol/sangre , Femenino , Humanos , Masculino , Persona de Mediana Edad , Cuidados Paliativos , Pronóstico , Estudios Retrospectivos , Albúmina Sérica , Tasa de SupervivenciaRESUMEN
OBJECTIVES: Valganciclovir (VGCV) has been shown to improve sensorineural hearing loss (SNHL) and neurological outcomes in patients with neonatal symptomatic congenital cytomegalovirus (cCMV) infection. However, reports on the pharmacokinetics, efficacy and safety of oral VGCV are limited. The aim of this study is to evaluate the pharmacokinetics of VGCV for use in the treatment of cCMV. METHODS: This was a single-center, retrospective observational study conducted at Saitama Children's Medical Center in Japan between 2012 and 2017. CMV DNA copy number, maximum plasma VGCV concentration (Cmax), and adverse events (ADEs) during treatment were evaluated. RESULTS: A total of 26 patients with cCMV who received VGCV were included in this study. The median age at VGCV initiation was 9.5 months (range 0-46). Twenty-one patients (81%) had SNHL at baseline. Of these, five patients (19%) presented with improved SNHL, and none experienced worsened SNHL during treatment. The mean VGCV Cmax was 3.5 µg/mL (range 2-5.3), with no significant variation among individual values, and the values were maintained during treatment. Furthermore, there were no correlations between the Cmax values and age, sex, SNHL improvement or ADEs. Neutropenia (<1000/mm3) was observed in six patients (23%); however, no serious ADEs occurred. CONCLUSIONS: VGCV prevented the progression of SNHL without serious ADEs due to its stable pharmacokinetics. This study provides safety and tolerability of VGCV for the treatment of cCMV patients.
Asunto(s)
Infecciones por Citomegalovirus , Pérdida Auditiva Sensorineural , Antivirales/efectos adversos , Niño , Preescolar , Infecciones por Citomegalovirus/tratamiento farmacológico , Ganciclovir/efectos adversos , Pérdida Auditiva Sensorineural/tratamiento farmacológico , Humanos , Lactante , Recién Nacido , Japón , Valganciclovir/efectos adversosAsunto(s)
Encéfalo/diagnóstico por imagen , Accidente Cerebrovascular Isquémico/diagnóstico por imagen , Angiografía por Resonancia Magnética/métodos , Arteria Cerebral Media/diagnóstico por imagen , Anciano , Encéfalo/irrigación sanguínea , Imagen de Difusión por Resonancia Magnética/métodos , Femenino , Lateralidad Funcional/fisiología , Humanos , Accidente Cerebrovascular Isquémico/etiología , Arteria Cerebral Media/patología , Trastornos de la Percepción/diagnóstico , Trastornos de la Percepción/etiología , Trastornos de la Percepción/fisiopatología , Percepción Espacial/fisiologíaRESUMEN
BACKGROUND: Oxaliplatin, one of the key cytotoxic drugs for colorectal cancer, frequently causes peripheral neuropathy which leads to dose modification and decreased patients' quality of life. However, prophylactic or therapeutic measures have not yet been established. Orally administered amino acids, cystine and theanine, promoted the synthesis of glutathione which was one of the potential candidates for preventing the neuropathy. The aim of this study was to determine whether daily oral administration of cystine and theanine attenuated oxaliplatin-induced peripheral neuropathy (OXLIPN). METHODS: Twenty-eight colorectal cancer patients who received infusional 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) therapy were randomly and evenly assigned to the cystine and theanine group and the control group. OXLIPN was assessed up to the sixth course using original 7-item questionnaire as well as Common Terminology Criteria for Adverse Events (CTCAE) grading scale. RESULTS: Neuropathy scores according to our original questionnaire were significantly smaller in the cystine and theanine group at the fourth (p = 0.026), fifth (p = 0.029), and sixth course (p = 0.038). Furthermore, significant differences were also observed in CTCAE neuropathy grades at the fourth (p = 0.037) and the sixth course (p = 0.017). There was one patient in each group who required dose reduction due to OXLIPN. Except for neurotoxicity, no significant differences were noted in the incidence of adverse events, and the total amount of administered oxaliplatin. CONCLUSION: The results demonstrated the daily oral administration of cystine and theanine attenuated OXLIPN.