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1.
Lancet ; 399(10335): 1607-1617, 2022 04 23.
Artigo em Inglês | MEDLINE | ID: mdl-35461558

RESUMO

BACKGROUND: Lobectomy is the standard of care for early-stage non-small-cell lung cancer (NSCLC). The survival and clinical benefits of segmentectomy have not been investigated in a randomised trial setting. We aimed to investigate if segmentectomy was non-inferior to lobectomy in patients with small-sized peripheral NSCLC. METHODS: We conducted this randomised, controlled, non-inferiority trial at 70 institutions in Japan. Patients with clinical stage IA NSCLC (tumour diameter ≤2 cm; consolidation-to-tumour ratio >0·5) were randomly assigned 1:1 to receive either lobectomy or segmentectomy. Randomisation was done via the minimisation method, with balancing for the institution, histological type, sex, age, and thin-section CT findings. Treatment allocation was not concealed from investigators and patients. The primary endpoint was overall survival for all randomly assigned patients. The secondary endpoints were postoperative respiratory function (6 months and 12 months), relapse-free survival, proportion of local relapse, adverse events, proportion of segmentectomy completion, duration of hospital stay, duration of chest tube placement, duration of surgery, amount of blood loss, and the number of automatic surgical staples used. Overall survival was analysed on an intention-to-treat basis with a non-inferiority margin of 1·54 for the upper limit of the 95% CI of the hazard ratio (HR) and estimated using a stratified Cox regression model. This study is registered with UMIN Clinical Trials Registry, UMIN000002317. FINDINGS: Between Aug, 10, 2009, and Oct 21, 2014, 1106 patients (intention-to-treat population) were enrolled to receive lobectomy (n=554) or segmentectomy (n=552). Patient baseline clinicopathological factors were well balanced between the groups. In the segmentectomy group, 22 patients were switched to lobectomies and one patient received wide wedge resection. At a median follow-up of 7·3 years (range 0·0-10·9), the 5-year overall survival was 94·3% (92·1-96·0) for segmentectomy and 91·1% for lobectomy (95% CI 88·4-93·2); superiority and non-inferiority in overall survival were confirmed using a stratified Cox regression model (HR 0·663; 95% CI 0·474-0·927; one-sided p<0·0001 for non-inferiority; p=0·0082 for superiority). Improved overall survival was observed consistently across all predefined subgroups in the segmentectomy group. At 1 year follow-up, the significant difference in the reduction of median forced expiratory volume in 1 sec between the two groups was 3·5% (p<0·0001), which did not reach the predefined threshold for clinical significance of 10%. The 5-year relapse-free survival was 88·0% (95% CI 85·0-90·4) for segmentectomy and 87·9% (84·8-90·3) for lobectomy (HR 0·998; 95% CI 0·753-1·323; p=0·9889). The proportions of patients with local relapse were 10·5% for segmentectomy and 5·4% for lobectomy (p=0·0018). 52 (63%) of 83 patients and 27 (47%) of 58 patients died of other diseases after lobectomy and segmentectomy, respectively. No 30-day or 90-day mortality was observed. One or more postoperative complications of grade 2 or worse occurred at similar frequencies in both groups (142 [26%] patients who received lobectomy, 148 [27%] who received segmentectomy). INTERPRETATION: To our knowledge, this study was the first phase 3 trial to show the benefits of segmentectomy versus lobectomy in overall survival of patients with small-peripheral NSCLC. The findings suggest that segmentectomy should be the standard surgical procedure for this population of patients. FUNDING: National Cancer Center Research and the Ministry of Health, Labour, and Welfare of Japan.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Mastectomia Segmentar , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Pneumonectomia
2.
Surg Today ; 53(1): 135-144, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35780275

RESUMO

PURPOSE: The effect of postoperative tegafur-uracil on overall survival (OS) after resection of stage I adenocarcinoma has been shown in clinical trials. The purpose of this study was to investigate whether findings from randomized trials of adjuvant tegafur-uracil are reproducible in a real-world setting. METHODS: A retrospective cohort study was performed using a multi-institutional database that included all patients who underwent complete resection of pathological stage I adenocarcinoma between 2014 and 2016. Survival outcomes for patients managed with and without tegafur-uracil were analyzed using the Kaplan-Meier method and a Cox proportional hazards model for the whole patient cohort and in a selected cohort based on eligibility criteria of a previous randomized trial. Propensity score matching was used to adjust for confounding effects. RESULTS: After propensity score matching, the hazard ratios for OS were 0.57 (95% confidence interval (CI) 0.29-1.14, P = 0.11) in the whole cohort and 0.69 (95% CI 0.32-1.50, P = 0.35) in the selected cohort. CONCLUSIONS: The effects of tegafur-uracil in this retrospective study appear to be consistent with those found in randomized clinical trials. These effects may be maximized in patients aged from 45 to 75 years.


Assuntos
Adenocarcinoma de Pulmão , Adenocarcinoma , Neoplasias Pulmonares , Humanos , Tegafur , Neoplasias Pulmonares/patologia , Estudos Retrospectivos , Estadiamento de Neoplasias , Uracila , Adenocarcinoma de Pulmão/patologia , Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/cirurgia , Adenocarcinoma/patologia , Quimioterapia Adjuvante , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
3.
Cancer Sci ; 113(1): 287-296, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34689382

RESUMO

The mutation status of tumor tissue DNA (n = 389) of resected stage II-III non-squamous non-small-cell lung cancer (Ns-NSCLC) was analyzed using targeted deep sequencing as an exploratory biomarker study (JIPANG-TR) for the JIPANG study, a randomized phase III study of pemetrexed/cisplatin (Pem/Cis) vs vinorelbine/cisplatin (Vnr/Cis). The TP53 mutation, common EGFR mutations (exon 19 deletion and L858R), and KRAS mutations were frequently detected. The frequency of the EGFR mutation was significant among female patients. Patients with an EGFR mutation-positive status had a significantly shorter recurrence-free survival (RFS) time (24 mo vs not reached) (HR, 1.64; 95% CI, 1.22-2.21; P = .0011 for EGFR mutation status). Multivariable analysis identified both the pathological stage and EGFR mutation status as independent prognostic factors for RFS (HR, 1.78; 95% CI, 1.30-2.44; P = .0003 for disease stage; and HR, 1.57; 95% CI, 1.15-2.16; P = .0050 for EGFR mutation status). This study demonstrated that the EGFR mutation has either a poor prognostic or predictive impact on a poor response to postoperative chemotherapy with platinum doublet chemotherapy for stage II-III Ns-NSCLC patients. This result supports a role for mandatory molecular diagnosis of early-stage Ns-NSCLC for precision oncology and signifies the importance of adjuvant for the 3rd generation tyrosine kinase inhibitor rather than platinum-based chemotherapy. This study is registered with the UMIN Clinical Trial Registry (UMIN 000012237).


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Mutação , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Quimioterapia Adjuvante , Cisplatino/uso terapêutico , Receptores ErbB/genética , Feminino , Sequenciamento de Nucleotídeos em Larga Escala , Humanos , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/cirurgia , Masculino , Pemetrexede/uso terapêutico , Medicina de Precisão , Prognóstico , Análise de Sequência de DNA , Análise de Sobrevida , Resultado do Tratamento , Vinorelbina/uso terapêutico
4.
Surg Today ; 52(10): 1463-1471, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35211804

RESUMO

PURPOSE: To establish the prognostic significance of C-reactive protein (CRP) and albumin in octogenarians with non-small cell lung cancer (NSCLC) based on the study of the Japanese Association for Chest Surgery (JACS 1303). METHODS: A total of 618 octogenarians with pathological stage I NSCLC, who underwent pulmonary resection, were included in the analysis. We conducted multivariable Cox regression analysis to evaluate the CRP to albumin ratio (CAR) as a potential prognostic factor. Other clinicopathological factors were also evaluated. RESULTS: The median age was 82 years. Operations included lobectomy (n = 388; 62.8%) segmentectomy (n = 95; 15%), and wedge resection (n = 135; 22%). Pathological stage IA was diagnosed in 380 (61.5%) patients. The 3-year (OS) and cancer-specific survival (CS) rates were 86.7% and 94.6%, respectively. OS was significantly higher for patients with low CAR (< 0.106) than for those with high CAR (≥ 0.106) (hazard ratio = 3.13, 95% confidence interval: 1.99-4.93, p < 0.0001). Univariate analysis identified sex, poor performance status, smoking status, comorbidity, solid tumor, histology, high Glasgow prognostic scale, and high CAR as significant prognostic factors. Multivariate analysis identified only the CAR as a significant prognostic factor for both OS and CS. CONCLUSIONS: Our analysis of the nationwide data demonstrated that the CAR is a useful prognostic factor for elderly patients with stage I NSCLC.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Idoso , Idoso de 80 Anos ou mais , Albuminas , Proteína C-Reativa/análise , Carcinoma Pulmonar de Células não Pequenas/patologia , Humanos , Neoplasias Pulmonares/patologia , Estadiamento de Neoplasias , Prognóstico , Estudos Retrospectivos
5.
Cancer Sci ; 112(1): 388-396, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33185928

RESUMO

The JIPANG study is a randomized phase III study of pemetrexed/cisplatin (Pem/Cis) versus vinorelbine/cisplatin (Vnr/Cis) for completely resected stage II-IIIA non-squamous non-small cell lung cancer (Ns-NSCLC). This study did not meet the primary endpoint (recurrence-free survival, RFS) but Pem/Cis had a similar efficacy to Vnr/Cis with a better tolerability. Tumor mutation burden (TMB) is thought to have a predictive value of immune checkpoint inhibitors. However, the relevance of TMB to cytotoxic chemotherapy remains unknown. This exploratory study investigates the relationship between tumor mutation profiles and clinical outcome of Pem/Cis. Formalin-fixed, paraffin-embedded tumor tissues (n = 389) were obtained from the patients. Mutation status of tissue DNA was analyzed by targeted deep sequencing. Epidermal growth factor receptor (EGFR) mutations were detected frequently in Ns-NSCLC (139/374). Patients without any EGFR mutations experienced longer RFS in the Pem/Cis arm versus Vnr/Cis arms. Pem/Cis in patients with high TMB (≥12-16 mut/Mb) tended to have improved survival. In patients with wild-type EGFR, TMB ≥ 12 mut/Mb was significantly associated with improved RFS with Pem/Cis versus Vnr/Cis (not reached vs 52.5 months; hazard ratio (HR) 0.477). It could be proposed that TMB was predictive of RFS benefit with Pem/Cis versus Vnr/Cis in Ns-NSCLC. Further investigation is required to determine whether TMB combined with EGFR mutation status could be used as a predictive biomarker.


Assuntos
Biomarcadores Tumorais/genética , Carcinoma Pulmonar de Células não Pequenas/genética , Cisplatino/administração & dosagem , Neoplasias Pulmonares/genética , Pemetrexede/administração & dosagem , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Análise Mutacional de DNA , Receptores ErbB/genética , Feminino , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Mutação , Resultado do Tratamento
6.
Ann Surg Oncol ; 28(12): 7219-7227, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33900499

RESUMO

BACKGROUND: Anatomic resection with lymph node dissection or sampling is the standard treatment for early non-small cell lung cancer (NSCLC), and wedge resection is an option for compromised patients. This study aimed to determine whether wedge resection can provide comparable prognoses for elderly patients with NSCLC. METHODS: The study analyzed the clinicopathologic findings and surgical outcomes during a median follow-up period of 39.6 months for 156 patients with solid dominant (consolidation-to-tumor ratio > 0.5) small (whole tumor size ≤ 2 cm) NSCLC among 892 patients 80 years of age or older with medically operable lung cancer between April 2015 and December 2016. RESULTS: The 3-year overall survival (OS) rates after wedge resection and after segmentectomy plus lobectomy did not differ significantly (86.5 %; 95 % confidence interval [CI], 74.6-93.0 % vs 83.7 % 95 % CI, 74.0-90.0 %; P = 0.92). Multivariable Cox regression analysis of OS with propensity scores showed that the surgical procedure was not an independent prognostic predictor (hazard ratio [HR], 0.84; 95 % CI, 0.39-1.8; P = 0.64). The 3-year OS rates were slightly better after wedge resection for 97 patients who could tolerate lobectomy than after segmentectomy plus lobectomy (89.4 %; 95 % CI, 73.8-95.9 % vs 75.8 %; 95 % CI, 62.0-85.2 %; P = 0.14). The cumulative incidence of other causes for death was marginally higher after segmentectomy plus lobectomy than after wedge resection (P = 0.079). CONCLUSIONS: Wedge resection might be equivalent to lobectomy or segmentectomy for selected patients 80 years of age or older with early-stage NSCLC who can tolerate lobectomy.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Carcinoma de Pequenas Células do Pulmão , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Humanos , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/cirurgia , Estadiamento de Neoplasias , Pneumonectomia
7.
BMC Cancer ; 21(1): 506, 2021 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-33957881

RESUMO

BACKGROUND: The aim of this multicenter, randomized phase II study was to analyze the feasibility and safety of alternate-day S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in patients with completely resected pathological stage I (tumor diameter > 2 cm) non-small cell lung cancer (NSCLC). METHODS: Patients were randomly assigned to receive adjuvant chemotherapy for 1 year comprising either alternate-day oral administration of S-1 (80 mg/m2/day) for 4 days a week (Group A) or a 2-week oral administration of S-1 (80 mg/m2/day) followed by 1 week of rest (Group B). The primary endpoint was feasibility, which was defined as the proportion of patients who completed the allocated intervention for 6 months with a relative dose intensity (RDI) of 70% or more. RESULTS: Ninety-three patients were enrolled of whom 90 patients received S-1 treatment. Median follow-up was 66.9 months. The treatment completion rate based on an RDI of 70% or more for 6 months was 84.4% (95%CI; 70.5-93.5%) in group A and 64.4% (95%CI; 48.8-78.1%) in group B. There were no grade 4 adverse events in either group. Moderate or severe adverse events (grade 2 or grade 3) were significantly more frequent in group B (67%) compared with group A (29%, P = 0.001). The 5-year relapse-free survival rate was 87.0 and 80.9% for group A and B, respectively (P = 0.451). The 5-year overall survival rate for all patients (n = 93) was 100 and 89.4% for group A and B, respectively (P = 0.136). CONCLUSION: Alternate-day oral administration of S-1 for 1 year as adjuvant chemotherapy was demonstrated to be feasible with low toxicity in completely resected stage I (tumor diameter > 2 cm) NSCLC. TRIAL REGISTRATION: Trial registration number: UMIN000011994 . Date of registration: 10/8/2013.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Ácido Oxônico/administração & dosagem , Tegafur/administração & dosagem , Adulto , Idoso , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/patologia , Quimioterapia Adjuvante , Esquema de Medicação , Combinação de Medicamentos , Feminino , Humanos , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Ácido Oxônico/efeitos adversos , Tegafur/efeitos adversos
8.
Kyobu Geka ; 74(13): 1127-1131, 2021 Dec.
Artigo em Japonês | MEDLINE | ID: mdl-34876546

RESUMO

A 80-year-old man who underwent right S1 segmentectomy three years ago was pointed out a mass shadow in the right upper lobe by chest computed tomography( CT). Because the mass was suspected of 2nd lung cancer, right upper lobectomy was performed. Air leakage from the chest tube appeared the day after the operation did not improve with the autologous blood patch pleurodesis. Since neither surgery nor invasive pleurodesis was thought to be possible because of the risk of acute respiratory failure due to the severe pulmonary emphysema, the administration of factor was challenged based on the result of its reduced activity. After the administration, the air leaks ceased promptly. Blood coagulation factor supplement may be effective in the treatment for intractable air leaks after lobectomy.


Assuntos
Neoplasias Pulmonares , Pleurodese , Idoso de 80 Anos ou mais , Fatores de Coagulação Sanguínea , Humanos , Pulmão , Neoplasias Pulmonares/cirurgia , Masculino , Pneumonectomia , Tomografia Computadorizada por Raios X
9.
Int J Clin Oncol ; 24(11): 1367-1376, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31312931

RESUMO

BACKGROUND: Pathological stage (pStage) and histological subtype are strong determinants of the treatment strategy for non-small cell lung cancer (NSCLC). Setouchi Lung Cancer study Group (SLCG) recently reported the results of a multicenter trial (SLCG0401) indicating that paclitaxel plus carboplatin (CBDCA/PTX) as adjuvant chemotherapy does not yield better survival than uracil-tegafur (UFT) in NSCLC patients with pStage IB-IIIA disease, while stratified analyses considering the pStage and histological subtype have not been performed. METHODS: We reanalyzed the overall survival (OS) and relapse-free survival (RFS) in 402 patients who had been randomly assigned to receive CBDCA/PTX or UFT by multivariate analysis with adjustments for the pStage and histological subtype. RESULTS: There were no significant differences in the OS or RFS between the two treatment settings either in the entire cohort (n = 402) and in some of subsets: pStage IB (n = 228), pStage II (n = 117), adenocarcinoma (AD, n = 265), and squamous cell carcinoma (SQ, n = 101). In pStage IIIA patients (n = 57), CBDCA/PTX yielded superior RFS to UFT [hazard ratio (HR) 0.44; P = 0.016]. Among the patients with non-AD and non-SQ histology (n = 36), UFT yielded both superior OS and RFS to CBDCA/PTX (HRs 0.16 and 0.23; P = 0.046 and 0.011, respectively). CONCLUSIONS: There are subsets of patients in which one or the other between UFT and CBDCA/PTX is significantly more effective. Selection of adjuvant therapy for NSCLC patients needs to be made taking into consideration the pStage and histological subtype.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/patologia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/patologia , Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/mortalidade , Adenocarcinoma/patologia , Administração Oral , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Carboplatina/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/mortalidade , Carcinoma de Células Escamosas/patologia , Quimioterapia Adjuvante , Feminino , Humanos , Neoplasias Pulmonares/mortalidade , Masculino , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Tegafur/administração & dosagem , Resultado do Tratamento , Uracila/administração & dosagem
10.
Thorac Cardiovasc Surg ; 67(4): 306-314, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29843187

RESUMO

BACKGROUND: In the eighth edition of the TNM classification, the lung tumors that have the same solid components are categorized either as part-solid or pure-solid tumors. However, this is debatable since the tumors in the same T component categories were evaluated without considering this categorization, and was based on a more malignant behavior and a poorer prognosis of pure-solid tumors. The aim of this study was to investigate and compare the prognosis between part-solid and pure-solid tumors. METHODS: We retrospectively analyzed 530 patients who were diagnosed with clinical-T1a-cN0M0 non-small-cell lung cancer (NSCLC) and were treated surgically. The subjects were divided into part-solid and pure-solid tumor groups using thin-section computed tomography. The prognosis was compared between the groups. RESULTS: Although relapse-free survival (RFS) was significantly shorter in the pure-solid tumor group (p = 0.016), no significant differences were observed in the overall survival (OS) between the two groups (p = 0.247). In 137 propensity score-matched pairs, including variables such as age, gender, Brinkman index, body mass index, forced expiratory volume in 1 second/forced vital capacity, Charlson comorbidity index, carcinoembryonic antigen levels, clinical-T status, surgical procedure, and extent of surgery, no significant differences were seen in the RFS and OS between the two groups (p = 0.709 and p = 0.517, respectively). CONCLUSION: In the eighth edition of the TNM classification of clinical-T1a-cN0M0 NSCLC, the prognosis of part-solid and pure-solid tumors showed no significant differences. Solid component size of the tumor is considered important prognostic factor in early-stage NSCLC.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/patologia , Neoplasias Pulmonares/patologia , Estadiamento de Neoplasias/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/diagnóstico por imagem , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Feminino , Humanos , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/cirurgia , Masculino , Pessoa de Meia-Idade , Pneumonectomia/métodos , Valor Preditivo dos Testes , Intervalo Livre de Progressão , Estudos Retrospectivos , Fatores de Risco , Cirurgia Torácica Vídeoassistida , Tomografia Computadorizada por Raios X
11.
Kyobu Geka ; 72(7): 496-500, 2019 Jul.
Artigo em Japonês | MEDLINE | ID: mdl-31296798

RESUMO

INTRODUCTIONS: Recently, reports of segmentectomy using indocyanine green (ICG) infrared thoracoscopy is gradually increasing. This method enables the clear identification of intersegmental line without the effect of collateral air drift, and seems useful especially for complex segmentectomy. On the other hand, the division of intersegmental plane using auto stapler recently seems to have some evidence of superiority of avoiding air-leakage over that using electrocautery. For these reasons, we have performed thoracoscopic stapler-based segmentectomy using ICG-infrared thoracoscopy. METHODS: Consecutive 92 patients who underwent thoracoscopic segmentectomy using ICG-infrared thoracoscopy between July, 2016 and March, 2019 in our hospital were retrospectively evaluated. RESULTS: Forty-seven patients were men, and the average age was 70 years (range, 30 to 90). The most target illness was primary lung cancer( 80.4%), but metastatic pulmonary tumor or inflammatory lung disease were also involved. Fifty-four patients (58.7%) underwent complex segmentectomy. Intersegmental borders were generally well recognized with ICG-infrared thoracoscopy. Only 2 cases needed small thoracotomy, but all the cases were completed segmentectomy. Neither 30-day nor 90-day mortality was observed. Postoperative complications [Common Terminology Criteria for Adverse Events( CTCAE)≥Grade 2] were seen in 11 patients( 12.0%). There was no complication related with the use of ICG. Postoperative air-leakage was seen in 2 patients( 2.2%). There was no case of delayed air-leakage who needed reinsertion of chest tube. Duration of chest tube insertion was 1 to 7 days after surgery( median 3 days). Length of stay after surgery was 3 to 18 ( median 5) days. CONCLUSIONS: Thoracoscopic stapler-based segmentectomy using ICG-infrared thoracoscopy seems feasible and useful surgical procedure.


Assuntos
Verde de Indocianina , Pneumonectomia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Toracoscopia
12.
Kyobu Geka ; 71(8): 563-572, 2018 08.
Artigo em Japonês | MEDLINE | ID: mdl-30185752

RESUMO

OBJECTIVE: The aim of this study is to investigate the outcomes of induction chemoradiotherapy (ICRT) followed by surgery in patients with non-small cell lung cancer( NSCLC). METHODS: We retrospectively analyzed consecutive patients with NSCLC who underwent ICRT followed by surgery at our hospital between January 2006 and December 2015. RESULTS: A total of 102 patients were eligible for evaluation (cStage/I B/II A/II B/III A/III B, 1/8/14/75/4). The median age was 66 years. Forty-one patients had adenocarcinoma, 42 patients had squamous cell carcinoma, and 19 patients had others. The regimen consisted of carboplatin and paclitaxel in 94 patients, and the others in 8 patients plus concurrent radiation at a dose of 28 Gy in 1 patient, 30 Gy in 28 patients, 40 Gy in 42 patients, 45 Gy in 3 patients, and 50 Gy in 28 patients. Major response was obtained in 84 patients. Grade 3/4 toxicity of ICRT reported in 57 patients. The 5-year relapse-free and overall survival rate was 51.4% and 62.7%, respectively. CONCLUSION: ICRT (carboplatin and paclitaxel plus concurrent standard radiation) followed by surgery in NSCLC can be safely performed and may contribute to satisfactory outcomes in locally advanced NSCLC. It is likely that 28~50 Gy radiation dose contributes to satisfactory outcomes in ICRT.


Assuntos
Adenocarcinoma/terapia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/terapia , Carcinoma de Células Escamosas/terapia , Quimiorradioterapia/métodos , Neoplasias Pulmonares/terapia , Adenocarcinoma/cirurgia , Idoso , Carboplatina/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Carcinoma de Células Escamosas/cirurgia , Humanos , Neoplasias Pulmonares/cirurgia , Recidiva Local de Neoplasia , Estadiamento de Neoplasias , Paclitaxel/administração & dosagem , Dosagem Radioterapêutica , Estudos Retrospectivos
13.
Int J Clin Oncol ; 22(2): 274-282, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27921177

RESUMO

BACKGROUND: This multicenter study evaluated the feasibility of novel adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent, long-term maintenance with S-1 in patients with completely resected stage II-IIIA non-small-cell lung cancer (NSCLC). METHODS: Patients received four cycles of S-1 (80 mg/m2/day for 2 weeks, followed by 2 weeks rest) plus carboplatin (area under the curve 5, day 1) followed by S-1 (80 mg/m2/day for 2 weeks, followed by a 1-week rest). Patients unable to continue S-1 plus carboplatin because of severe toxicity converted to single-agent S-1 maintenance. The duration of adjuvant chemotherapy was 10 months in both situations. The primary endpoint was feasibility, defined as the proportion of patients who completed four cycles of S-1 plus carboplatin and single-agent S-1 maintenance for 10 months. The treatment completion rate was determined; treatment was considered feasible if the lower 90% confidence interval (CI) was ≥50%. RESULTS: Eighty-nine patients were enrolled, of whom 87 were eligible and assessable. Seventy-eight patients (89.7%) completed four cycles of S-1 plus carboplatin and 55 (63.2%) completed the following S-1 maintenance therapy for a total of 10 months. The treatment completion rate was 63.2% (90% CI, 54.4-71.2%), indicating feasibility. There were no treatment-related deaths. Grade 3/4 toxicities included neutropenia (13.8%), thrombocytopenia (11.5%), and anorexia (4.6%). The 2-year relapse-free survival rate was 59.8%. CONCLUSIONS: We concluded that adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 is feasible and tolerable in patients with completely resected NSCLC. CLINICAL REGISTRATION NUMBER: UMIN000005041.


Assuntos
Adenocarcinoma/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma de Células Grandes/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma de Células Escamosas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Adenocarcinoma/patologia , Adulto , Idoso , Carboplatina/administração & dosagem , Carcinoma de Células Grandes/patologia , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma de Células Escamosas/patologia , Quimioterapia Adjuvante , Combinação de Medicamentos , Estudos de Viabilidade , Feminino , Humanos , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/tratamento farmacológico , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Ácido Oxônico/administração & dosagem , Prognóstico , Taxa de Sobrevida , Tegafur/administração & dosagem , Adulto Jovem
14.
BMC Pulm Med ; 17(1): 166, 2017 Dec 04.
Artigo em Inglês | MEDLINE | ID: mdl-29202834

RESUMO

BACKGROUND: Previously reported prognostic tools for patients with resected non-small cell lung cancer (NSCLC) include factors found postoperatively, but not preoperatively. However, it would be important to predict patient prognosis before NSCLC resection. To suggest a novel preoperative prognostic tool, we evaluated the relationship of preoperative prognostic factors with the survival of patients with resected NSCLC. METHODS: We retrospectively reviewed the data of two independent cohorts of patients with completely resected NSCLC. To develop the prognostic index in one cohort, the overall survival (OS) was evaluated using the Cox proportional hazards model. We assessed the disease-free survival (DFS) and OS of three risk groups defined according to the prognostic index. Then, the prognostic index was validated in the other cohort. RESULTS: Seven independent risk factors for OS were selected: age ≥ 70 years, ever-smokers, vital capacity <80%, neutrophil-to-lymphocyte ratio ≥ 2.1, cytokeratin 19 fragment >normal limit, non-usual interstitial pneumonia (UIP) pattern, and UIP pattern. Three risk groups were defined: low-risk (36.9%), intermediate-risk (54.0%), and high-risk (9.1%). In the derivation cohort, the 5-year DFS rate was 77.8%, 58.8%, and 22.6% (P < 0.001), and the 5-year OS rate was 95.2%, 70.4%, and 28.9% (P < 0.001), respectively. Multivariate analyses showed that the prognostic index predicted DFS and OS, independent of pathological stage and tumor histology, in both derivation and validation cohorts. CONCLUSIONS: We developed and validated a simple preoperative prognostic index composed of seven variables, which may help clinicians predict prognosis before surgery in patients with NSCLC.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/cirurgia , Neoplasias Pulmonares/cirurgia , Medição de Risco/métodos , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/complicações , Carcinoma Pulmonar de Células não Pequenas/fisiopatologia , Carcinoma Pulmonar de Células não Pequenas/secundário , Intervalo Livre de Doença , Feminino , Humanos , Fibrose Pulmonar Idiopática/complicações , Queratina-19/sangue , Neoplasias Pulmonares/complicações , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/fisiopatologia , Contagem de Linfócitos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neutrófilos , Fragmentos de Peptídeos/sangue , Valor Preditivo dos Testes , Período Pré-Operatório , Estudos Retrospectivos , Fatores de Risco , Fumar , Taxa de Sobrevida , Capacidade Vital , Adulto Jovem
15.
Jpn J Clin Oncol ; 46(8): 741-7, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27207886

RESUMO

OBJECTIVE: The aim of this multicenter study was to determine the appropriate administration schedule for S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in patients with completely resected pathological-Stage IA (tumor diameter, 2-3 cm) non-small-cell lung cancer. METHODS: Patients were randomly assigned to receive adjuvant chemotherapy consisting of either the 4-week oral administration of S-1 (80-120 mg/body/day) followed by a 2-week rest (Group A), or the 2-week oral administration of S-1 (80-120 mg/body/day) followed by a 1-week rest (Group B). The duration of adjuvant chemotherapy was 1 year in both arms. The primary endpoint was compliance, namely drug discontinuation-free survival, which was calculated using the Kaplan-Meier method with log-rank test. RESULTS: Eighty patients were enrolled in this study, and 76 patients actually received S-1 treatment. The drug discontinuation-free survival rates at 1 year were 49.1% in Group A and 52.7% in Group B (P = 0.373). The means of the relative dose intensities were 55.3% in Group A and 64.6% in Group B (P = 0.237). There were no treatment-related deaths. Patients with grade 3/4 toxicities were significantly more frequent in Group A (40.5%) than in Group B (15.4%, P = 0.021). The 2-year relapse-free survival rates were 97.5% in Group A and 92.5% in Group B, and the 2-year overall survival rates were 100% in both groups. CONCLUSIONS: The feasibility showed no significant difference between the two groups among patients with completely resected Stage IA (tumor diameter, 2-3 cm) non-small-cell lung cancer.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Administração Oral , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/patologia , Quimioterapia Adjuvante , Intervalo Livre de Doença , Esquema de Medicação , Estudos de Viabilidade , Feminino , Doenças Hematológicas/etiologia , Humanos , Estimativa de Kaplan-Meier , Estudos Longitudinais , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Estadiamento de Neoplasias , Ácido Oxônico/administração & dosagem , Piridinas/administração & dosagem , Piridinas/efeitos adversos , Taxa de Sobrevida , Tegafur/administração & dosagem , Tegafur/efeitos adversos , Resultado do Tratamento
16.
Cancer Manag Res ; 16: 965-976, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39099761

RESUMO

Background: Induction therapy followed by surgery is recommended as an alternative treatment strategy for locally advanced non-small cell lung cancer (NSCLC). Patients who achieve pathologic response after induction therapy have better outcomes than non-responders; therefore, therapeutic response must be evaluated. Recently, new approaches for monitoring therapeutic responses, which are based on 18F-Fluorodeoxyglucose positron emission tomography (FDG-PET), have been developed. In this study, we evaluated the predictive value of Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST), which uses standardized uptake values corrected for lean body mass (SUL) and total lesion glycolysis (TLG). Methods: A total of 130 patients in the Setouchi Lung Cancer Group who underwent FDG-PET imaging before and after induction therapy prior to a planned surgical resection for NSCLC between 2007 and 2016 were studied retrospectively. The pathologic responses of the primary lung tumors and metastatic lymph nodes were compared with their responses based on evaluation using PERCIST. Results: Postoperative pathologic studies revealed pathologic complete response (pCR) in 42 (32.3%) patients. PERCIST was significantly correlated with pathologic response (p < 0.001). The sensitivity, specificity, and accuracy of PERCIST for predicting pCR were 16.7% (7/42), 88.6% (78/88), and 65.4% (85/130), respectively. Patients with pCR had significantly higher reduction rates in SULpeak for both primary lung tumors and metastatic lymph nodes and TLG for primary tumors than non-responders. In a multivariate Cox regression analysis, tumor site in upper lobes, reduction rate of TLG in primary tumor, and pathologic N0 were independent predictors of favorable recurrence-free survival (RFS). Conclusion: Our study suggested that PERCIST, especially the rate of TLG reduction rate, are useful to predict the pathological response and prognosis after induction therapy. Although improvement is necessary, PERCIST can be a promising method of the post-induction status in lung cancer. Further research is needed to confirm our findings.

17.
J Thorac Cardiovasc Surg ; 168(2): 401-410.e1, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38348845

RESUMO

OBJECTIVES: This study aimed to evaluate the safety and feasibility of early chest tube removal after anatomic pulmonary resection, regardless of the drainage volume. METHODS: We conducted a multicenter, randomized, controlled, noninferiority trial. Patients with greater than 300 mL drainage volume during postoperative day 1 were randomly assigned to group A (tube removed on postoperative day 2) and group B (tube retained until drainage volume ≤300 mL/24 hours). The primary end point was the frequency of respiratory-related adverse events (grade 2 or higher based on the Clavien-Dindo classification) within 30 days postoperatively. RESULTS: Between April 2019 and October 2021, 175 patients were assigned to group A (N = 88) or group B (N = 87). One patient in group B who experienced chylothorax was excluded from the study. Respiratory-related adverse events were observed in 10 patients (11.4%) in group A and 12 patients (14.0%) in group B (P = .008). The frequencies of thoracentesis or chest tube reinsertion were not significantly different (8.0% and 9.3% in groups A and B, respectively, P = .752). Additionally, the duration of chest tube placement was significantly shorter in group A than in group B (median, 2 vs 3 days; P < .001). No significant difference between groups A and B was found in postoperative hospital stay (median, 6 vs 7 days, P = .231). CONCLUSIONS: Early chest tube removal, regardless of drainage volume, was safe and feasible in patients who underwent anatomic pulmonary resection.


Assuntos
Tubos Torácicos , Remoção de Dispositivo , Drenagem , Pneumonectomia , Humanos , Masculino , Feminino , Pneumonectomia/efeitos adversos , Pneumonectomia/métodos , Drenagem/instrumentação , Drenagem/efeitos adversos , Pessoa de Meia-Idade , Remoção de Dispositivo/efeitos adversos , Idoso , Fatores de Tempo , Resultado do Tratamento , Complicações Pós-Operatórias/etiologia , Estudos de Viabilidade
18.
Ann Thorac Surg ; 116(3): 543-551, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37004802

RESUMO

BACKGROUND: Segmentectomy is a good surgical option for peripheral, early, non-small cell lung cancer (NSCLC) ≤2 cm. However, the role of sublobar resection including wedge resection and segmentectomy remains unclear for octogenarians with >2-cm but ≤4-cm early-stage NSCLC, for which lobectomy is a standard treatment. METHODS: By use of a prospective registry, 892 patients aged ≥80 years with operable lung cancer were enrolled at 82 institutions. Of these, we analyzed the clinicopathologic findings and surgical outcomes of 419 patients with NSCLC tumors of 2 to 4 cm during a median follow-up of 50.9 months between April 2015 and December 2016. RESULTS: Five-year overall survival (OS) was slightly but not significantly worse after sublobar resection than after lobectomy in the entire cohort (54.7% [95% CI, 43.2%-93.0%] vs 66.8% [95% CI, 60.8%-72.1%]; P = .09). Multivariable Cox regression analysis of OS revealed that these surgical procedures were not independent prognostic predictors (hazard ratio, 0.8 [0.5-1.1]; P = .16). The 5-year OS was comparable between 192 patients who could tolerate lobectomy but were treated by sublobar resection or lobectomy (67.5% [95% CI, 48.8%-80.6%] vs 71.5% [95% CI, 62.9%-78.4%]; P = .79). Recurrence after sublobar resection and lobectomy was locoregional in 11 (11%) of 97 and in 23 (7%) of 322 patients, respectively. CONCLUSIONS: OS might be equivalent between sublobar resection with a secure surgical margin and lobectomy for selected patients aged ≥80 years with peripheral early-stage NSCLC tumors of 2 to 4 cm who can tolerate lobectomy.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Carcinoma de Pequenas Células do Pulmão , Idoso de 80 Anos ou mais , Humanos , Neoplasias Pulmonares/patologia , Octogenários , Pneumonectomia/métodos , Estadiamento de Neoplasias , Estudos Retrospectivos , Carcinoma de Pequenas Células do Pulmão/patologia
19.
Lancet Respir Med ; 11(6): 540-549, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36893780

RESUMO

BACKGROUND: Although segmentectomy is a widely used surgical procedure, lobectomy is the standard procedure for resectable non-small-cell lung cancer (NSCLC). This study aimed to evaluate the efficacy and safety of segmentectomy for NSCLC up to 3 cm in size, including ground-glass opacity (GGO) and predominant GGO. METHODS: A multicentre, single-arm, confirmatory phase 3 trial was conducted across 42 institutions (hospitals, university hospitals, and cancer centres) in Japan. Segmentectomy with hilar, interlobar, and intrapulmonary lymph node dissection was performed as protocol surgery for patients with a tumour diameter of up to 3 cm, including GGO and dominant GGO. Eligible patients were those aged 20-79 years with an Eastern Cooperative Oncology Group performance score of 0 or 1 and clinical stage IA tumour confirmed by thin-sliced CT. The primary endpoint was 5-year relapse-free survival (RFS). This study is registered with the University Hospital Medical Information Network Clinical Trials (UMIN000011819), and is ongoing. FINDINGS: A total of 396 patients were registered from Sept 20, 2013, to Nov 13, 2015, of whom 357 underwent segmentectomy. At a median follow-up of 5·4 years (IQR 5·0-6·0), the 5-year RFS was 98·0% (95% CI 95·9-99·1). This finding exceeded the 87% of the pre-set threshold 5-year RFS and the primary endpoint was met. Grade 3 or 4 early postoperative complications occurred in seven patients (2%), but no grade 5 treatment-related deaths occurred. INTERPRETATION: Segmentectomy should be considered as part of standard treatment for patients with predominantly GGO NSCLC with a tumour size of 3 cm or less in diameter, including GGO even if it exceeds 2 cm. FUNDING: National Cancer Centre Research and Development Fund and Japan Agency for Medical Research and Development.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/cirurgia , Carcinoma Pulmonar de Células não Pequenas/diagnóstico por imagem , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Carcinoma Pulmonar de Células não Pequenas/patologia , Pneumonectomia/métodos , Tomografia Computadorizada por Raios X , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Estudos Retrospectivos
20.
PLoS One ; 18(5): e0285273, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37205678

RESUMO

BACKGROUND: It is shown that the postoperative adjuvant chemotherapy for non-small cell lung cancer (NSCLC) was associated with survival benefit in an elderly population. We aimed to analyze the feasibility and efficacy of alternate-day S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in elderly patients with completely resected pathological stage IA (tumor diameter > 2 cm) to IIIA (UICC TNM Classification of Malignant Tumours, 7th edition) NSCLC. METHODS: Elderly patients were randomly assigned to receive adjuvant chemotherapy for one year consisting of either alternate-day oral administration of S-1 (80 mg/m2/day) for 4 days a week (Arm A) or a daily oral administration of S-1 (80 mg/m2/day) for 14 consecutive days followed by 7-day rest (Arm B). The primary endpoint was feasibility (treatment completion rate), which was defined as the proportion of patients who completed the allocated intervention for 6 months with a relative dose intensity (RDI) of 70% or more. RESULTS: We enrolled 101 patients in which 97 patients received S-1 treatment. The treatment completion rate at 6 months was 69.4% in Arm A and 64.6% in Arm B (p = 0.67). Treatment completion rate in Arm B tended to be lower compared to Arm A, as the treatment period becomes longer (at 9 and 12 months). RDI of S-1 at 12 months and completion of S-1 administration without dose reduction or postponement at 12 months was significantly better in Arm A than in Arm B (p = 0.026 and p < 0.001, respectively). Among adverse events, anorexia, skin symptoms and lacrimation of any grade were significantly more frequent in Arm B compared with Arm A (p = 0.0036, 0.023 and 0.031, respectively). The 5-year recurrence-free survival rates were 56.9% and 65.7% for Arm A and B, respectively (p = 0.22). The 5-year overall survival rates were 68.6% and 82.0% for Arm A and B, respectively (p = 0.11). CONCLUSION: Although several adverse effects were less frequent in Arm A, both alternate-day and daily oral administrations of S-1 were demonstrated to be feasible in elderly patients with completely resected NSCLC. TRIAL REGISTRATION: Unique ID issued by UMIN: UMIN000007819 (Date of registration: Apr 25, 2012) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009128. Trial ID issued by jRCT: jRCTs061180089 (Date of registration: Mar 22, 2019, for a shift toward a "specified clinical trial" based on Clinical Trials Act in Japan) https://jrct.niph.go.jp/en-latest-detail/jRCTs061180089.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Idoso , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/cirurgia , Tegafur/efeitos adversos , Estadiamento de Neoplasias , Quimioterapia Adjuvante , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
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