RESUMEN
The influence of pulmonary dysfunction on postoperative outcomes in older patients with gastric cancer was assessed. In this retrospective study, 352 older patients (age ≥ 75 years) with gastric cancer who underwent preoperative spirometry and curative gastrectomy were enrolled. Of these patients, 200 underwent laparoscopic gastrectomy. Restrictive and obstructive pulmonary dysfunction were defined as percentage of vital capacity (%VC) < 80% and percent of forced expiratory volume in one second (FEV1.0%) < 70%, respectively. Twenty-six (7.3%) and 123 (34.9%) exhibited restrictive and obstructive pulmonary dysfunction, respectively. The low-%VC group showed a higher incidence of postoperative pneumonia (p = 0.018) while the low-FEV1.0% group did not (p = 0.677). Multivariate analysis identified a decreased %VC as a significant risk factor for postoperative pneumonia. However, this association was not observed in patients who underwent laparoscopic gastrectomy. Concerning the long-term outcomes, restrictive dysfunction was a significant prognostic factor in older patients with gastric cancer who underwent either laparotomy or laparoscopy, whereas obstructive dysfunction did not. Restrictive pulmonary dysfunction increased the risk of postoperative pneumonia and had a negative prognostic effect in older patients with gastric cancer, whereas obstructive pulmonary dysfunction did not.
Asunto(s)
Gastrectomía , Complicaciones Posoperatorias , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/complicaciones , Anciano , Masculino , Femenino , Pronóstico , Gastrectomía/efectos adversos , Anciano de 80 o más Años , Estudios Retrospectivos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Factores de Riesgo , Volumen Espiratorio Forzado , Capacidad Vital , Laparoscopía , Neumonía/fisiopatologíaRESUMEN
INTRODUCTION: This study compared the short-term outcomes of older adult patients with locally advanced gastric cancer who underwent open distal gastrectomy (ODG) with those who underwent laparoscopic distal gastrectomy (LDG) using propensity score matching analysis. METHODS: Overall, 341 consecutive older adult patients aged 75 years with gastric cancer who underwent ODG or LDG between January 2013 and December 2020 were retrospectively assessed. Among them, 121 patients with locally advanced gastric cancer were included. To compare short-term outcomes, a 1:1 propensity score matching analysis was performed. RESULTS: After matching, 29 patients were included in both groups. Compared with the ODG group, the LDG group had a longer operative time (mean, 290 vs. 190 min; p < .0001) and lower estimated blood loss (mean, 39 vs. 223 mL; p < .0001). Overall postoperative complications of grade 2 and higher were observed in 2 (6.9%) and 12 (41%) patients in the LDG and ODG groups, respectively (p = .0046). Of these, the LDG group had a significantly lower incidence rate of infectious complications than the ODG group (3.4% vs. 27.6%; p = .025). Furthermore, in multivariate analysis, the laparoscopic approach was an independent protective factor against postoperative complications (p = .029). CONCLUSIONS: LDG is safe and feasible for locally advanced gastric cancer in patients aged ≥75 years. Moreover, it may be a promising alternative to ODG with better short-term outcomes, including significantly lower incidence rates of postoperative complications.
Asunto(s)
Gastrectomía , Laparoscopía , Complicaciones Posoperatorias , Puntaje de Propensión , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirugía , Gastrectomía/efectos adversos , Gastrectomía/métodos , Laparoscopía/efectos adversos , Anciano , Masculino , Femenino , Estudios Retrospectivos , Incidencia , Anciano de 80 o más Años , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Tempo Operativo , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/etiologíaRESUMEN
BACKGROUND: Nivolumab + chemotherapy is now a standard of care for HER2-negative, previously untreated, unresectable or recurrent gastric/gastroesophageal junction cancer (advanced gastric cancer), but long-term follow-up data of clinical trials are limited. METHODS: ATTRACTON-4 was a phase 3, double-blind, placebo-controlled trial in Japan, South Korea, and Taiwan. Patients were randomized to either nivolumab or placebo, both combined with the physician's choice of SOX (oral S-1 [tegafur-gimeracil-oteracil potassium] + oxaliplatin) or CAPOX (capecitabine + oxaliplatin). We report the primary endpoints-centrally assessed progression-free survival (PFS) and overall survival (OS)-and landmark analyses of OS among patients alive using 3-year follow-up data. RESULTS: At the cutoff date (May 10, 2021), 17/359 patients in the nivolumab + chemotherapy group and 6/358 in the placebo + chemotherapy group were continuing study treatment. PFS (centrally assessed) was longer in the nivolumab + chemotherapy group (median 10.94 vs. 8.48 months; hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.55-0.82). Although OS did not differ between the two groups (median 17.45 vs. 17.15 months; HR 0.89, 95% CI 0.75-1.05), the landmark analysis of OS, calculating HRs at each landmark time point (every month), was getting numerically better in the nivolumab + chemotherapy group over time. Approximately 80% of patients who achieved complete response in the nivolumab + chemotherapy group were alive at 3 years. No new safety signals or major late-onset select treatment-related adverse events were observed for nivolumab + chemotherapy. CONCLUSION: This 3-year follow-up of ATTRACTION-4 confirmed the long-term clinical benefit and manageable safety of nivolumab + chemotherapy in patients with previously untreated advanced gastric cancer. TRIAL REGISTRATION: NCT02746796.
RESUMEN
BACKGROUND: In Asia, adjuvant chemotherapy after gastrectomy with D2 or more extensive lymph-node dissection is standard treatment for people with pathological stage III gastric or gastro-oesophageal junction (GEJ) cancer. We aimed to assess the efficacy and safety of adjuvant nivolumab plus chemotherapy versus placebo plus chemotherapy administered in this setting. METHODS: ATTRACTION-5 was a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial conducted at 96 hospitals in Japan, South Korea, Taiwan, and China. Eligible patients were aged between 20 years and 80 years with histologically confirmed pathological stage IIIA-C gastric or GEJ adenocarcinoma after gastrectomy with D2 or more extensive lymph-node dissection, with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 and available tumour tissue for PD-L1 expression analysis. Patients were randomly assigned (1:1) to receive either nivolumab plus chemotherapy or placebo plus chemotherapy via an interactive web-response system with block sizes of four. Investigational treatment, either nivolumab 360 mg or placebo, was administered intravenously for 30 min once every 3 weeks. Adjuvant chemotherapy was administered as either tegafur-gimeracil-oteracil (S-1) at an initial dose of 40 mg/m2 per dose orally twice per day for 28 consecutive days, followed by 14 days off per cycle, or capecitabine plus oxaliplatin consisting of an initial dose of intravenous oxaliplatin 130 mg/m2 for 2 h every 21 days and capecitabine 1000 mg/m2 per dose orally twice per day for 14 consecutive days, followed by 7 days off treatment. The primary endpoint was relapse-free survival by central assessment. The intention-to-treat population, consisting of all randomly assigned patients, was used for analysis of efficacy endpoints. The safety population, defined as patients who received at least one dose of trial drug, was used for analysis of safety endpoints. This trial is registered with ClinicalTrials.gov (NCT03006705) and is closed. FINDINGS: Between Feb 1, 2017, and Aug 15, 2019, 755 patients were randomly assigned to receive either adjuvant nivolumab plus chemotherapy (n=377) or adjuvant placebo plus chemotherapy (n=378). 267 (71%) of 377 patients in the nivolumab group and 263 (70%) of 378 patients in the placebo group were male; 110 (29%) of 377 patients in the nivolumab group and 115 (31%) of 378 patients in the placebo group were female. 745 patients received assigned treatment (371 in the nivolumab plus chemotherapy group; 374 in the placebo plus chemotherapy group), which was the safety population. Median time from first dose to data cutoff was 49·1 months (IQR 43·1-56·7). 3-year relapse-free survival was 68·4% (95% CI 63·0-73·2) in the nivolumab plus chemotherapy group and 65·3% (59·9-70·2) in the placebo plus chemotherapy group; the hazard ratio for relapse-free survival was 0·90 (95·72% CI 0·69-1·18; p=0·44). Treatment-related adverse events occurred in 366 (99%) of 371 patients in the nivolumab plus chemotherapy group and 364 (98%) of 374 patients in the placebo plus chemotherapy group. Discontinuation due to adverse events was more frequent in the nivolumab plus chemotherapy group (34 [9%] of 371 patients) than the placebo plus chemotherapy group (13 [4%] of 374 patients). The most common treatment-related adverse events were decreased appetite, nausea, diarrhoea, neutrophil count decreased, and peripheral sensory neuropathy. INTERPRETATION: The results of this trial do not support the addition of nivolumab to postoperative adjuvant therapy for patients with untreated, locally advanced, resectable gastric or GEJ cancer. FUNDING: Ono Pharmaceutical and Bristol Myers Squibb.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica , Unión Esofagogástrica , Gastrectomía , Escisión del Ganglio Linfático , Estadificación de Neoplasias , Nivolumab , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/tratamiento farmacológico , Neoplasias Gástricas/patología , Gastrectomía/métodos , Masculino , Femenino , Método Doble Ciego , Persona de Mediana Edad , Unión Esofagogástrica/patología , Quimioterapia Adyuvante/métodos , Anciano , Nivolumab/uso terapéutico , Nivolumab/efectos adversos , Nivolumab/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Adulto , Adenocarcinoma/tratamiento farmacológico , Adenocarcinoma/patología , Adenocarcinoma/cirugía , Neoplasias Esofágicas/patología , Neoplasias Esofágicas/tratamiento farmacológico , Neoplasias Esofágicas/cirugía , Resultado del Tratamiento , Anciano de 80 o más AñosRESUMEN
OBJECTIVES: Anastomotic leakage in esophageal cancer surgery may be reduced by evaluating the blood flow to the reconstructed organ, but quantitative evaluation of arterial and venous blood flow is difficult. This study aimed to quantitatively assess blood flow using a new technique, as well as determine the relationship between the blood flow in the gastric tube and anastomotic leakage using near-infrared spectroscopy. METHODS: This single-center, observational study included 50 patients aged 51-82 years who underwent radical esophagectomy with gastric tube reconstruction for esophageal cancer between June 2022 and January 2023. Regional tissue oxygen saturation was measured at the antrum (point X), the anastomotic point (point Z), and the midpoint between points X and Z (point Y) before and after gastric tube formation. These three points of oxygen saturation were investigated in relation to anastomotic leakage. RESULTS: When comparing the presence of leakage to its absence, regional tissue oxygen saturation at points X and Z after gastric tube formation was significantly lower (X: p = 0.03, Z: p = 0.02), with the decreasing rate significantly higher at point Z (p = 0.01). There was no significant difference in the decreasing rate of regional tissue oxygen saturation between points X and Y (X: p = 0.052, Y: p = 0.83). CONCLUSION: Regional tissue oxygen saturation levels may be useful for measuring blood flow and could be a predictor of anastomotic leakage.
Asunto(s)
Fuga Anastomótica , Neoplasias Esofágicas , Esofagectomía , Flujo Sanguíneo Regional , Humanos , Fuga Anastomótica/etiología , Fuga Anastomótica/fisiopatología , Persona de Mediana Edad , Masculino , Femenino , Anciano , Esofagectomía/efectos adversos , Esofagectomía/métodos , Anciano de 80 o más Años , Neoplasias Esofágicas/cirugía , Neoplasias Esofágicas/fisiopatología , Espectroscopía Infrarroja Corta , Saturación de Oxígeno , Estómago/irrigación sanguínea , Estómago/cirugía , Resultado del Tratamiento , Procedimientos de Cirugía Plástica/métodos , Velocidad del Flujo SanguíneoRESUMEN
PURPOSE: In this study, we assessed the relationship between remnant gastritis and muscle mass loss and then investigated the potential relationship between Helicobacter pylori (HP) infection and remnant gastritis and muscle loss. METHODS: We reviewed the medical records of 463 patients who underwent distal gastrectomy between January 2017 and March 2020. Of these patients, 100 with pStage I after laparoscopic surgery were included in this analysis. RESULTS: A multivariate analysis showed that the total Residue, Gastritis, Bile (RGB) classification score, which indicates the degree of gastritis, was significantly associated with the rate of change (rate of decrease) in the psoas muscle area (PMA) during the first 6 months after surgery (p = 0.014). Propensity score matching was performed according to HP infection, and the rate of change in the PMA and the degree of remnant gastritis in 56 patients were compared. Neither was significantly associated with HP infection. CONCLUSIONS: Remnant gastritis did contribute to psoas muscle mass loss during the initial 6 months after gastrectomy, and HP infection was not significantly associated with either remnant gastritis or psoas muscle mass loss. Nevertheless, the potential for HP eradication to prevent muscle loss and improve the survival prognosis for gastrectomy patients merits further research.
Asunto(s)
Gastritis , Infecciones por Helicobacter , Helicobacter pylori , Neoplasias Gástricas , Humanos , Gastrectomía/efectos adversos , Mucosa Gástrica , Infecciones por Helicobacter/complicaciones , Infecciones por Helicobacter/cirugía , Músculos , Estudios Retrospectivos , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/complicacionesRESUMEN
BACKGROUND: A previous report confirmed the safety of laparoscopy-assisted total and proximal gastrectomies (LATG and LAPG) (JCOG1401). This report demonstrates the 5-year relapse-free survival (RFS) and overall survival (OS) after long-term follow-up to confirm the efficacy of these surgical methods as key secondary endpoints for cStage I gastric cancer. METHODS: This study enrolled patients who had histologically proven gastric adenocarcinoma and were diagnosed with clinical T1N0, T1N(+), or T2N0 tumors according to the 14th edition of the Japanese Classification of Gastric Carcinoma (3rd English edition). RESULTS: Between April 2015 and February 2017, 246 patients were enrolled, although one patient was excluded because of misregistration. Meticulous follow-up was continued for > 5 years for each patient, and the data were analyzed in March 2022. The 5-year RFS was 90.0% (95% confidence interval [CI] 85.5-93.2%), and the 5-year OS was 91.2% (95% CI 86.9-94.2%) in all enrolled patients. Grade 3 or 4 late postoperative complications were detected in 12.7% of patients. CONCLUSIONS: This single-arm study showed that the long-term outcomes of LATG/LAPG for cStage I gastric cancer were acceptable, which is considered one of the standard treatments when performed by experienced surgeons. Trail registration UMIN000017155 ( http://www.umin.ac.jp/ctr/ ).
Asunto(s)
Laparoscopía , Neoplasias Gástricas , Humanos , Estudios Retrospectivos , Neoplasias Gástricas/patología , Japón , Complicaciones Posoperatorias/cirugía , Laparoscopía/métodos , Gastrectomía/métodos , Oncología Médica , Resultado del TratamientoRESUMEN
BACKGROUND: Laparoscopic gastrectomy is a common procedure for early gastric cancer treatment. Improving postoperative pain control enhances patient recovery after surgery. The use of multimodal analgesia can potentially enhance the analgesic effect, minimize side effects, and change the postoperative management. The purpose of this study was to evaluate and compare the efficacies of the use of patient-controlled intravenous analgesia with regular acetaminophen (PCIA + Ace) and patient-controlled thoracic epidural analgesia (PCEA) for postoperative pain control. METHODS: We retrospectively collected the data of 226 patients who underwent laparoscopic distal gastrectomy (LDG) with delta-shaped anastomosis between 2016 and 2019. After 1:1 propensity-score matching, we compared 83 patients who used PCEA alone (PCEA group) with 83 patients who used PCIA + Ace (PCIA + Ace group). Postoperative pain was assessed using a numeric rating scale (NRS) with scores ranging from 0 to 10. An NRS score ≥ 4 was considered the threshold for additional intravenous rescue medication administration. RESULTS: Although NRS scores at rest were comparable between the PCEA and PCIA + Ace groups, NRS scores of patients in the PCIA + Ace group during coughing or movement were significantly better than those of patients in the PCEA group on postoperative days 2 and 3. The frequency of additional rescue analgesic use was significantly lower in the PCIA + Ace group than in the PCEA group (1.1 vs. 2.7, respectively, p < 0.001). The rate of reduction or interruption of the patient-controlled analgesic dose was higher in the PCEA group than in the PCIA + Ace group (74.6% vs. 95.1%, respectively, p = 0.0002), mainly due to hypotension occurrence in the PCEA group. Physical recovery time, postoperative complication occurrence, and liver enzyme elevation incidence were not significantly different between groups. CONCLUSIONS: PCIA + Ace can be safely applied without an increase in complications or deterioration in gastrointestinal function; moreover, PCIA + Ace use may provide better pain control than PCEA use in patients following LDG.
Asunto(s)
Analgesia Epidural , Laparoscopía , Neoplasias Gástricas , Humanos , Analgesia Epidural/métodos , Acetaminofén/uso terapéutico , Neoplasias Gástricas/cirugía , Estudios Retrospectivos , Puntaje de Propensión , Analgesia Controlada por el Paciente/métodos , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , Analgésicos/uso terapéutico , Gastrectomía , Analgésicos Opioides/uso terapéuticoRESUMEN
BACKGROUND: Cervical esophageal cancer accounts for a small proportion of all esophageal cancers. Therefore, studies examining this cancer include a small patient cohort. Most patients with cervical esophageal cancer undergo reconstruction using a gastric tube or free jejunum after esophagectomy. We examined the current status of postoperative morbidity and mortality of cervical esophageal cancer based on big data. METHODS: Based on the Japan National Clinical Database, 807 surgically treated patients with cervical esophageal cancer were enrolled between January 1, 2016, and December 31, 2019. Surgical outcomes were retrospectively reviewed for each reconstructed organ using gastric tubes and free jejunum. RESULTS: The incidence of postoperative complications related to reconstructed organs was higher in the gastric tube reconstruction (17.9%) than in the free jejunum (6.7%) for anastomotic leakage (p < 0.01), but not significantly different for reconstructed organ necrosis (0.4% and 0.3%, respectively). The incidence rates of overall morbidity, pneumonia, 30-day reoperation, tracheal necrosis, and 30-day mortality using these reconstruction methods were 64.7% and 59.7%, 16.7% and 11.1%, 9.3% and 11.4%, 2.2% and 1.6%, and 1.2% and 0.0%, respectively. Only pneumonia was more common in the gastric tube reconstruction group (p = 0.03), but was not significantly different for any other complication. CONCLUSIONS: The incidence of overall morbidities and reoperation, especially anastomotic leakage after gastric tube reconstruction, suggested a necessity for further improvement. However, the incidence of fatal complications, such as tracheal necrosis or reconstructed organ necrosis, was low for both reconstruction methods, and the mortality rate was acceptable as a means of radical treatment.
Asunto(s)
Neoplasias Esofágicas , Yeyuno , Humanos , Yeyuno/cirugía , Fuga Anastomótica/epidemiología , Fuga Anastomótica/etiología , Fuga Anastomótica/cirugía , Estudios Retrospectivos , Japón/epidemiología , Neoplasias Esofágicas/cirugía , Resultado del Tratamiento , NecrosisRESUMEN
Importance: Evidence of implementation of laparoscopic gastrectomy for locally advanced gastric cancer is currently insufficient, as the primary end point in previous prospective studies was evaluated at a median follow-up time of 3 years. More robust evidence is necessary to verify noninferiority of laparoscopic gastrectomy. Objective: To compare 5-year survival outcomes between laparoscopy-assisted distal gastrectomy (LADG) and open distal gastrectomy (ODG) with D2 lymph node dissection for locally advanced gastric cancer. Design, Setting, and Participants: This was a multicenter, open-label, noninferiority, prospective randomized clinical trial. Between November 26, 2009, and July 29, 2016, eligible patients with histologically proven gastric carcinoma from 37 institutes in Japan were enrolled. Two interim analyses and final analysis were performed in October 2014, May 2018, and November 2021, respectively. Interventions: Patients were randomly assigned (1:1) to either the ODG or LADG group. The procedures were performed exclusively by qualified surgeons. Main Outcomes and Measures: The primary end point was 5-year relapse-free survival, and the noninferiority margin for the hazard ratio (HR) was set at 1.31. The secondary end points were 5-year overall survival and safety. Results: A total of 502 patients were included in the full-analysis set: 254 (50.6%) in the ODG group and 248 (49.4%) in the LADG group. Patients in the ODG group had a median (IQR) age of 67 (33-80) years and included 168 males (66.1%). Patients in the LADG group had a median (IQR) age of 64 (34-80) years and included 169 males (68.1%). No significant differences were observed in severe postoperative complications between the 2 groups in the safety analysis (ODG, 4.7% [11 of 233] vs LADG, 3.5% [8 of 227]; P = .64). The median (IQR) follow-up for all patients after randomization was 67.9 (60.3-92.0) months. The 5-year relapse-free survival was 73.9% (95% CI, 68.7%-79.5%) and 75.7% (95% CI, 70.5%-81.2%) for the ODG and LADG groups, respectively, and the HR was 0.96 (90% CI, 0.72-1.26; noninferiority 1-sided P = .03). Further, no significant difference was observed in overall survival time between the 2 groups, and the HR was 0.83 (95% CI, 0.57-1.21; P = .34). The pattern of recurrence was similar between the 2 groups. Conclusions and Relevance: Results of this study show that on the basis of 5-year follow-up data, LADG with D2 lymph node dissection for locally advanced gastric cancer, when performed by qualified surgeons, was proved noninferior to ODG. This laparoscopic approach could become a standard treatment for locally advanced gastric cancer. Trial Registration: UMIN Clinical Trial Registry: UMIN000003420.
Asunto(s)
Laparoscopía , Neoplasias Gástricas , Masculino , Humanos , Anciano , Anciano de 80 o más Años , Persona de Mediana Edad , Neoplasias Gástricas/patología , Estudios Prospectivos , Complicaciones Posoperatorias/etiología , Gastrectomía/métodos , Laparoscopía/métodos , Escisión del Ganglio Linfático/métodosRESUMEN
BACKGROUND: Higher relative dose intensity (RDI) of chemotherapy improves the clinical outcomes of various cancers. The psoas muscle index (PMI) is related to sarcopenia, and patients with low PMI have worse prognoses. However, few studies have demonstrated its clinical relevance in gastric cancer. METHODS: This retrospective study included 188 stage II/III gastric cancer patients who had undergone curative gastrectomy between January 2013 and March 2017, 124 of whom had received postoperative S-1 adjuvant chemotherapy. RESULTS: Per receiver operating characteristic analysis, patients were divided into high and low RDI groups, between which relapse-free survival differed marginally significantly and disease-specific survival differed significantly. In patients who received adjuvant chemotherapy, multivariate analysis found that high RDI and low PMI reduction rate 1 year after surgery were significantly associated with better relapse-free survival. Low RDI can be predicted by a combination of low preoperative PMI and non-distal gastrectomy, whereas high PMI reduction rate at 1 year can be affected by non-distal gastrectomy. CONCLUSION: High RDI with preserved psoas muscle up to 1 year after gastrectomy may be associated with prognoses in gastric cancer requiring postoperative adjuvant chemotherapy. Since RDI and PMI reduction rate can be predicted preoperatively, respectively, interventional consideration is possible for optimal adjuvant therapy in gastric cancer.
Asunto(s)
Neoplasias Gástricas , Humanos , Neoplasias Gástricas/tratamiento farmacológico , Neoplasias Gástricas/cirugía , Pronóstico , Músculos Psoas , Estudios Retrospectivos , Recurrencia Local de Neoplasia/cirugía , Quimioterapia Adyuvante , GastrectomíaRESUMEN
BACKGROUND: Although the American Society of Anesthesiologists (ASA) score of 3 is relatively common in elderly patients, there have been few debates on the indications for gastrectomy in elderly gastric cancer (GC) patients with ASA3. Therefore, this study aimed to investigate gastrectomy's clinical relevance in elderly patients with GC and ASA3. METHODS: We retrospectively analyzed 228 consecutive elderly GC patients (aged ≥ 75 years) without prior treatments who underwent curative gastrectomy between 2013 and 2017. RESULTS: Thirty-three patients with ASA3 showed significantly poorer prognosis than those with ASA1 and 2 (p = 0.004). The multivariate Cox proportional hazards model showed that ASA3 (p = 0.021) and pStage (p = 0.007) were independent prognostic factors, respectively. Elderly GC patients with pStage III and ASA3 exhibited uniquely dismal prognosis (p < 0.001); however, several survivors were still confirmed. Postoperative complications (PCs) were only the final remnant independent prognostic factor (p = 0.020) among the 33 elderly GC patients with ASA3, where dead patients included cancer-specific and other deaths, especially pneumonia. PCs were independently associated with prognostic nutritional index (PNI) (< 42.7) in elderly GC patients, and the most frequent complication was pneumonia, which was significantly associated with ASA3 and marginally associated with PNI in a multivariate analysis. CONCLUSIONS: ASA3 has a dismal prognosis after curative gastrectomy in the elderly GC patients, but the number of survivors was confirmed. Curative gastrectomy is not considered contraindicated even in elderly GC with ASA3. Preoperative malnutrition is associated with PCs, which proposing preoperative nutritional intervention in the context of treatment strategy for the elderly GC patients with ASA3.
Asunto(s)
Neoplasias Gástricas , Anciano , Humanos , Neoplasias Gástricas/cirugía , Estudios Retrospectivos , Anestesiólogos , Gastrectomía , PronósticoRESUMEN
BACKGROUND: One upside of cervical esophageal carcinoma is that radical surgery can be performed by laryngectomy, even for tumors with tracheal invasion. However, this approach drastically reduces the quality of life, such as by losing the vocal function. Cervical esophageal carcinoma is rare, and no comprehensive reports have described the current state of surgery. Using a Japanese nationwide web-based database, we analyzed the surgical outcomes of cervical esophageal carcinoma to evaluate the impact of larynx-preserving surgery. METHODS: Based on the Japan National Clinical Database, 215 surgically treated cases of cervical esophageal carcinoma between January 1, 2018, and December 31, 2019, were enrolled. Clinical outcomes were compared between the larynx-preserved group and the laryngectomy group. RESULTS: Ninety-four (43.7%) patients underwent larynx-preserving surgery. A total of 177 (82.3%) patients underwent free jejunum reconstruction. More T4b patients and more patients who underwent preoperative radiotherapy were in the laryngectomy group. There were no significant differences in the frequency and the severity of morbidities between the two groups. However, in the laryngectomy group, in-hospital death within 30 days after surgery was observed in 1 patient, and the postoperative hospital stay was significantly longer (P = 0.030). In the larynx-preserved group, recurrent nerve paralysis was observed in 24.5%. Re-operation (35.3%, P = 0.016), re-intubation (17.6%, P = 0.019) and tracheal necrosis (17.6%, P = 0.028) were significantly more frequent in patients who underwent pharyngolaryngectomy with total esophagectomy and gastric tube reconstruction than in others. CONCLUSION: Larynx-preserving surgery was therefore considered to be feasible because it was equivalent to laryngectomy regarding the short-term surgical outcomes.
Asunto(s)
Carcinoma , Neoplasias Esofágicas , Neoplasias Esofágicas/patología , Neoplasias Esofágicas/cirugía , Mortalidad Hospitalaria , Humanos , Japón/epidemiología , Laringectomía/efectos adversos , Calidad de Vida , Estudios RetrospectivosRESUMEN
BACKGROUND AND PURPOSE: We investigated the impact of postoperative changes in the psoas muscle mass index (PMI) after gastrectomy and S1 adjuvant chemotherapy (AC) on the long-term outcomes of elderly patients with gastric cancer. METHODS: We reviewed the medical records of 228 patients aged over 75 years, who underwent distal, proximal, or total gastrectomy between January, 2013 and March 2017. Among these patients, 78 with pStage IIA-IIIC who survived for at least 1 year without recurrence after gastrectomy were the subjects of this analysis. RESULTS: The log-rank test using the cut-off value from the rate of change in PMI from 6 to 12 months after gastrectomy (late rate of decrease) showed significantly poorer prognosis for the group above the cut-off value for both overall survival (OS) and recurrence-free survival (RFS) (RFS: PMI decrease ≥ 1.55%, p < 0.001; OS: PMI decrease ≥ 1.55%, p < 0.001). Patients with a relative dose intensity of S1 below 68.7% and a late rate of decrease in PMI above 1.55% were found to have a poor prognosis. CONCLUSION: It is necessary to prevent decline in the PMI of elderly patients from 6 months after gastrectomy and to administer adjuvant chemotherapy with about two-thirds or more RDI of S1 to improve their survival prognosis.
Asunto(s)
Neoplasias Gástricas , Anciano , Quimioterapia Adyuvante , Gastrectomía , Humanos , Recurrencia Local de Neoplasia , Pronóstico , Músculos Psoas , Estudios Retrospectivos , Neoplasias Gástricas/tratamiento farmacológico , Neoplasias Gástricas/cirugíaRESUMEN
BACKGROUND: The Senhance Digital Laparoscopy System (Asensus Surgical Inc, Morrisville, NC, United States), which was introduced for the first time in Japan by our hospital, is a new surgical assistive robot following the da Vinci Surgical System. We herein report the short-term outcomes of 55 colorectal cancer surgery cases using this system at our hospital to assess the feasibility and safety of our procedures. MATERIALS AND METHODS: We retrospectively reviewed the patient backgrounds and surgical outcomes of 55 patients who underwent Senhance-assisted laparoscopic colorectal cancer surgery. RESULTS: The median age was 71 years. There were 31 males and 24 females, and the median body mass index was 23.1 kg/m2 . Fifteen patients had a history of abdominal surgery. The most common surgical technique was ileocecal resection (18 cases, 32.7%), followed by high anterior resection (11 cases, 20.0%). D2 or D3 dissection was performed in each operation, and D3 dissection was performed in 41 cases (74.5%). The median operative time was 240 minutes, the median blood loss was 5 mL, there were no intraoperative complications, and there were no cases of intraoperative blood transfusion. The median postoperative hospital stay was 7 days, which was comparable to conventional laparoscopic surgery. Postoperative complications of grade 2 or higher in the Clavien-Dindo classification were observed in two cases. CONCLUSION: The short-term results of 55 colorectal cancer surgery cases using the Senhance Digital Laparoscopy System were excellent and the system was introduced and surgery was safely performed.
Asunto(s)
Neoplasias Colorrectales , Laparoscopía , Procedimientos Quirúrgicos Robotizados , Robótica , Anciano , Neoplasias Colorrectales/cirugía , Femenino , Humanos , Laparoscopía/métodos , Masculino , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Little is known about the disadvantages of the coronavirus disease 2019 (COVID-19) pandemic in patients with gastric cancer. This study aimed to examine the negative impact of the COVID-19 pandemic on patients with gastric cancer in the first era in Japan. METHODS: This retrospective study included 725 patients diagnosed with gastric cancer who visited our hospital between April 2019 and March 2021. The number of patients and their characteristics before and during the COVID-19 pandemic were compared. RESULTS: The number of patients diagnosed with gastric cancer during the COVID-19 pandemic decreased by 26.2% (from 417 to 308; p = 0.013) compared to that before the COVID-19 pandemic. There was a significant decrease in cStage I cancer and an increase in cStage III cancer (p = 0.004). Patients were often symptomatic (p = 0.029), especially those with stenosis-related symptoms (p < 0.001) and longer symptom duration (p < 0.001). The number of endoscopic resections was decreased by 34.8% (p = 0.005). The number of total gastrectomy was higher than that of partial gastrectomy (p = 0.021). The median time to treatment was significantly shorter (p < 0.001). CONCLUSIONS: In Japan, delays diagnosing patients with gastric cancer, probably due to refraining from consultation, may have resulted in an increase in the diagnosis of advanced-stage cancer. Moreover, an increasing proportion of patients required more invasive gastrectomy. Therefore, it may be necessary to educate patients not to refrain from consultation, even during the COVID-19 pandemic, as it can have a negative impact on treatment, policy decision, and prognosis of gastric cancer.
Asunto(s)
COVID-19 , Neoplasias Gástricas , COVID-19/epidemiología , Humanos , Japón/epidemiología , Pandemias , Estudios Retrospectivos , SARS-CoV-2 , Neoplasias Gástricas/terapiaRESUMEN
BACKGROUND: The additive or synergistic sustained antitumour effect of immune checkpoint inhibitors in combination with oxaliplatin-based chemotherapy has previously been reported. We investigated the efficacy of nivolumab plus oxaliplatin-based chemotherapy versus placebo plus oxaliplatin-based chemotherapy as first-line therapy for patients with HER2-negative, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer. METHODS: We did a randomised, multicentre, double-blind, placebo-controlled, phase 2-3 trial (ATTRACTION-4) at 130 centres (hospitals, cancer centres, and medical centres) across Japan, South Korea, and Taiwan. We enrolled patients aged 20 years and older with previously untreated (except for neoadjuvant or adjuvant chemotherapy completed ≥180 days before recurrence), HER2-negative, unresectable, advanced or recurrent gastric or gastro-oesophageal junction cancer (regardless of PD-L1 expression), at least one measurable lesion per Response Evaluation Criteria in Solid Tumours guidelines (version 1.1), and a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were randomly assigned (1:1) to chemotherapy every 3 weeks (intravenous oxaliplatin 130 mg/m2 on day 1 plus either oral S-1 40 mg/m2 [SOX] or oral capecitabine 1000 mg/m2 [CAPOX], twice daily on days 1-14), in addition to either 360 mg nivolumab intravenously every 3 weeks (nivolumab plus chemotherapy group) or placebo (placebo plus chemotherapy group). Randomisation was done using an interactive web response system with block sizes of four and stratified by intensity of PD-L1 expression, ECOG performance status score, disease status, and geographical region. Patients, investigators, and the study sponsor were masked to treatment assignment. The primary endpoints were centrally assessed progression-free survival and overall survival in the intention-to-treat population, which included all randomly assigned patients. Safety was assessed in all patients who received at least one dose of the assigned treatment. This trial is registered with ClinicalTrials.gov, NCT02746796. Trial recruitment is complete and follow-up is ongoing. FINDINGS: Between March 23, 2017, and May 10, 2018, 724 patients were randomly assigned to treatment: 362 patients to the nivolumab plus chemotherapy group and 362 to the placebo plus chemotherapy group. At the time of data cutoff on Oct 31, 2018, with a median follow-up of 11·6 months (IQR 8·7-14·1), median progression-free survival at a prespecified interim analysis was 10·45 months (95% CI 8·44-14·75) in the nivolumab plus chemotherapy group and 8·34 months (6·97-9·40) in the placebo plus chemotherapy group (hazard ratio [HR] 0·68; 98·51% CI 0·51-0·90; p=0·0007). At the time of data cutoff on Jan 31, 2020, with a median follow-up of 26·6 months (IQR 24·1-29·0), median overall survival at the final analysis was 17·45 months (95% CI 15·67-20·83) in the nivolumab plus chemotherapy group and 17·15 months (15·18-19·65) in the placebo plus chemotherapy group (HR 0·90; 95% CI 0·75-1·08; p=0·26). The most common treatment-related grade 3-4 adverse events were neutrophil count decreased (71 [20%] of 359 patients in the nivolumab plus chemotherapy group vs 57 [16%] of 358 patients in the placebo plus chemotherapy group) and platelet count decreased (34 [9%] vs 33 [9%]). Treatment-related serious adverse events of any grade were observed in 88 (25%) patients in the nivolumab plus chemotherapy group and in 51 (14%) in the placebo plus chemotherapy group, of which the most common was decreased appetite (18 [5%] vs ten [3%]). Six treatment-related deaths occurred: three in the nivolumab plus chemotherapy group (one each of febrile neutropenia, hepatic failure, and sudden death) and three in the placebo plus chemotherapy group (one each of sepsis, haemolytic anaemia, and interstitial lung disease). INTERPRETATION: Nivolumab combined with oxaliplatin-based chemotherapy significantly improved progression-free survival, but not overall survival, in Asian patients with untreated, HER2-negative, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer, and could potentially be a new first-line treatment option for these patients. FUNDING: Ono Pharmaceutical and Bristol-Myers Squibb.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Esofágicas/tratamiento farmacológico , Unión Esofagogástrica , Recurrencia Local de Neoplasia/tratamiento farmacológico , Nivolumab/uso terapéutico , Neoplasias Gástricas/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Neoplasias Esofágicas/mortalidad , Femenino , Humanos , Masculino , Receptor ErbB-2/análisis , Neoplasias Gástricas/mortalidadRESUMEN
PURPOSE AND BACKGROUND: Gastrectomy for gastric cancer in overweight patients is associated with a high incidence of postoperative complications and difficulties in achieving adequate lymph node dissection. We conducted this study to compare the outcomes of laparoscopic and open distal gastrectomy (ODG) for gastric cancer in overweight Japanese patients. METHODS: This retrospective study analyzed data from 180 patients with a body mass index ≥ 25 who underwent distal gastrectomy for pStage I-III gastric cancer. Postoperative complications, the number of harvested lymph nodes, and long-term survival were compared between ODG and laparoscopic distal gastrectomy (LDG). RESULTS: Postoperative complications of Clavien-Dindo (CD) grade ≥ 2 and ≥ 3 were significantly higher after ODG than after LDG (p < 0.001 and p = 0.004). Multivariate analysis identified age and ODG as factors related to complications of CD ≥ 2 (p = 0.014 and 0.002). The number of harvested lymph nodes at region 4sb was significantly higher in LDG for patients with pStage III disease. The 5-year lymph node recurrence-free survival tended to be better in LDG; however, no difference was found between ODG and LDG at any pathological stage. There were no significant differences in the 5-year overall and recurrence-free survival rates after ODG vs. LDG. CONCLUSIONS: LDG for gastric cancer appears to be associated with a lower incidence of postoperative complications than ODG, without compromising long-term survival, even for overweight patients.
Asunto(s)
Laparoscopía , Neoplasias Gástricas , Gastrectomía/efectos adversos , Humanos , Laparoscopía/efectos adversos , Escisión del Ganglio Linfático/efectos adversos , Sobrepeso/complicaciones , Sobrepeso/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Neoplasias Gástricas/patología , Resultado del TratamientoRESUMEN
BACKGROUND: Although the novel coronavirus disease 2019 did not lead to a serious medical collapse in Japan, its impact on treatment of oesophageal cancer has rarely been investigated. This study aimed to investigate the influence of the pandemic on consultation status and initial treatment in patients with primary oesophageal cancer. METHODS: A retrospective study was conducted among 546 patients with oesophageal cancer who visited our hospital from April 2018 to March 2021. Pre-pandemic and pandemic data were compared with the clinical features, oncological factors and initial treatment as outcome measures. RESULTS: Diagnoses of oesophageal cancer decreased during the early phase of the pandemic from April to June (P = 0.048); however, there was no significant difference between the pre-pandemic and pandemic periods throughout the year. The proportion of patients diagnosed with distant metastases significantly increased during the pandemic (P = 0.026), while the proportion of those who underwent initial radical treatment decreased (P = 0.044). The rate of definitive chemoradiotherapy decreased by 58.6% relative to pre-pandemic levels (P = 0.001). CONCLUSIONS: Patients may have refrained from consultation during the early phase of the coronavirus disease 2019 pandemic. The resultant delay in diagnosis may have led to an increase in the number of patients who were not indicated for radical treatment, as well as a decrease in the number of those who underwent definitive chemoradiotherapy. Our findings highlight the need to maintain the health care system and raise awareness on the importance of consultation.