Abstract
Japan has the highest proportion of older adults globally, and the average life expectancy of the Japanese population has increased in recent decades. Given that the incidence of cancer ...increases with age, it is a major health concern for older adults. However, geriatric oncology is a relatively new field and collaboration between oncologists and geriatricians in Japan is limited. Hence, oncologists and other healthcare professionals engaged in cancer care have not been able to adequately understand geriatric care, and information and experience are insufficient for this specific population. Thus, they may struggle with the assessment and management of older adults with cancer. Recently, several Japanese academic societies for cancer have developed practical guidelines and research policy with regard to geriatric research in older adults with cancer, in addition to organizing symposia and workshops focusing especially on geriatric oncology. Furthermore, because the Japan Geriatrics Society established a discipline committee on cancer, close collaboration between oncologists and geriatricians has grown steadily. Geriatric oncology is currently recognized as an important field of cancer care in Japan. The integration of oncology and geriatric care is anticipated in the near future. However, understanding the aspects of geriatric care and meanings of technical jargons used in geriatric oncology is difficult. Accordingly, this article provides an overview of the current knowledge and recent advancements in geriatric oncology. In addition, it outlines the current status and problems of geriatric oncology in Japan.
We performed a validation study to confirm the prognostic importance of the presence of a ground-glass opacity component based on data of the Japan Clinical Oncology Group study, JCOG0201, which was ...a prospective observational study to predict the pathological noninvasiveness of clinical stage IA lung cancer in Japan.
Among the 811 patients registered in JCOG0201, 671 were confirmed eligible by study monitoring and a central review of computed tomography. Registered c-stage IA lung cancer was less than 30 mm in maximum tumor size, which was classified into a with ground-glass opacity group (pure ground-glass opacity and part-solid tumor) or solid group based on the status of a ground-glass opacity component. T staging was reassigned in accordance with the 8th edition of the TNM staging system. To validate the prognostic impact, overall survival was estimated.
Of the cases, 432 (64%) were in the with ground-glass opacity group and 239 (36%) were in the solid group with a median follow-up time of 10.1 years. The 5-year overall survival was significantly different between the with ground-glass opacity group and solid group (95.1% vs 81.1%). The 5-year overall survival was excellent regardless of the solid component size in the with ground-glass opacity group (c-T1a or less: 97.2%, c-T1b: 93.4%, c-T1c: 91.7%). In contrast, prognostic impact of the tumor size was definitive in the solid group (c-T1a: 87.5%, c-T1b: 85.9%, c-T1c: 73.7%).
Favorable prognostic impact of the presence of a ground-glass opacity component was demonstrated in JCOG0201. The presence or absence of a ground-glass opacity should be considered as an important parameter in the next clinical T classification.
This supplemental analysis aimed to confirm the prognostic importance of the presence of a GGO component based on data of the JCOG study, JCOG0201. Among the 671 eligible patients, 432 (64%) were classified in the with GGO group and 239 (36%) were classified in the solid group according to the radiological central review board. The 5-year OS was excellent regardless of the solid component size in the with GGO group, whereas prognostic impact of the tumor size was definitive in the solid group. The presence or absence of a GGO would be considered as an important parameter in the next clinical T classification. GGO, Ground-glass opacity. Display omitted
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
A randomized Phase III trial was commenced to confirm the clinical benefit of lobe-specific nodal dissection in comparison to systematic nodal dissection for clinical Stage I–II non-small cell lung ...cancer.
Abstract
In January 2017, the Lung Cancer Surgical Study Group of the Japan Clinical Oncology Group commenced a randomized Phase III trial to confirm the clinical benefit of lobe-specific nodal dissection for clinical Stage I–II non-small cell lung cancer. The primary endpoint is overall survival, and the main objective is to confirm the non-inferiority of lobe-specific in comparison to systematic nodal dissection with regard to lobectomy. The secondary endpoints are relapse-free survival, %local recurrence, %regional lymph node recurrence, operation time, blood loss, length of hospitalization, duration of chest tube placement and adverse events. A total of 1700 patients will be accrued from 44 Japanese institutions within 5 years. This study is the first and large prospective trial to evaluate whether the difference in the area of nodal dissection affects the overall survival of patients with relatively early-stage non-small cell lung cancer. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000025530.
Due to the rapid aging of Japan's population, clinical research focusing on older patients with cancer is urgently needed. The Japan Clinical Oncology Group (JCOG) has conducted several such clinical ...trials, but there has been no formal policy for geriatric research. We have therefore established a JCOG policy for geriatric cancer research. We defined the patient selection policy based on treatment tolerance and chronological age. Older patients are categorized into three conceptual groups: 'fit patients' who can undergo the same standard treatment given to younger patients, 'frail patients' for whom best supportive or palliative care is indicated and 'vulnerable patients' who fall between the fit and frail categories. Unmet needs often exist for vulnerable patients. The policy recommends that study endpoints include not only survival but also other endpoints such as physical and cognitive function because the objective of therapy in older patients is not only extended life expectancy but also maintenance of the patient's general condition. In this viewpoint, co-primary or composite endpoints that incorporate geriatric assessment in the study design are often applicable. Study design will differ depending on the study population, clinical question, and treatment. Even for older patients, a randomized clinical trial is still the gold standard when the clinical question asks which treatment is better. An observational study of a broader population is applicable for investigating actual conditions of older patients. This JCOG Geriatric Research Policy includes several practical solutions for various issues in geriatric research. We plan to revise this policy periodically to guide future geriatric research.
Introduction
Lobectomy has been the standard surgery for even stage I lung cancer since the validity of limited resection for stage I lung cancer was denied by the randomized study reported in 1995. ...The aim of this non-randomized confirmatory going on since September 2013 is to confirm the efficacy of a segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-slice computed tomography.
Method
A total of 390 patients from 42 Japanese institutions are recruited within 4 years. The primary endpoint of this study is a 5-year relapse-free survival in all of the patients who undergo a segmentectomy for a lung nodule. The secondary endpoints are overall survival, annual relapse-free survival, disease-free survival, proportion of local relapse, postoperative pulmonary function, proportion of segmentectomy completion, proportion of R0 resection completion by segmentectomy, adverse events, and serious adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000011819 (
http://www.umin.ac.jp/ctr/
).
Results
Patient’s accrual has been already finished in November, 2015 and the primary analysis will be performed in 2021.
Conclusion
This study is one of the pivotal trial of lung segmentectomy for early lung cancer. The result will provide a clear evidence for our daily clinics and will be possible contribution to preserving pulmonary function for lung cancer patients.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OBVAL, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
The aim of this study was to identify patients with pathological stage I lung adenocarcinoma at high risk of recurrence.
We retrieved data from 536 patients with pathological stage I lung ...adenocarcinoma who underwent lobectomy and were enrolled in a prospective multiinstitutional study (the JCOG0201 study). Invasive component size, excluding lepidic component, was used as the tumor size. Recurrence-free survival (RFS) was estimated by the Kaplan-Meier method, and a multivariable Cox proportional hazards model identified independent prognostic factors associated with worse RFS.
The all-patient 10-year RFS was 83.9% (median follow-up 10.2 years). Multivariable Cox analysis revealed that age greater than 65 years (hazard ratio HR, 2.60; 95% confidence interval (CI), 1.66-4.07), invasive component size greater than 2 cm (HR, 2.70; 95% CI, 1.40-5.23), visceral pleural invasion (HR, 2.17; 95% CI, 1.23-3.81), and vascular invasion (HR, 2.59; 95% CI, 1.47-4.55) were potential independent prognostic factors for RFS. When patients were divided into a high-risk group for recurrence (invasive component size >2 cm or positive for visceral pleural invasion or for vascular invasion; n = 124) and a low-risk group (invasive component size ≤2 cm and negative for visceral pleural invasion and vascular invasion; n = 408), there was a significant difference in RFS between the high-risk and low-risk groups (high-risk group: HR, 3.61; 95% CI, 2.35-5.55).
Pathological stage I lung adenocarcinoma patients with an invasive component size greater than 2 cm, visceral pleural invasion, or vascular invasion were at high risk for recurrence.
The development of PD-1 pathway inhibitors has dramatically altered the treatment of advanced/recurrent non-small-cell lung cancer patients. However, the prognostic significance of their ongoing ...usage is controversial, especially for patients who have not progressed for a period of time. If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients. This randomized controlled trial enrolls patients who have responded well to PD-1 pathway inhibitors for >12 months. The aim is to confirm the non-inferiority of discontinuation of PD-1 pathway inhibitors, relative to continuation, in terms of overall survival. A total of 216 patients will be enrolled over 3 years. This trial has been registered in the Japan Registry for Clinical Trials as jRCT1031190032 (https://jrct.niph.go.jp/). An ancillary study examining the prognostic and predictive role of circulating tumor DNA using Guardant360® is planned.
We previously reported the case of a 64-year-old man with mediastinitis caused by Staphylococcus aureus in which the infecting bacterium acquired linezolid resistance after only 14 days treatment ...with linezolid. We therefore investigated relevant clinical isolates for possible mechanisms of this rapid acquisition of linezolid resistance.
Using clinical S. aureus isolates, we assessed the in vitro mutation rate and performed stepwise selection for linezolid resistance. To investigate homologous recombination, sequences were determined for each of the 23S ribosomal RNA (23S rRNA) loci; analyzed sequences spanned the entirety of each 23S rRNA gene, including domain V, as well as the 16S-23S intergenic spacer regions. We additionally performed next-generation sequencing on clinical strains to identify single-nucleotide polymorphisms compared to the N315 genome.
Strains isolated from the patient prior to linezolid exposure (M5-M7) showed higher-level linezolid resistance than N315, and the pre-exposure strain (M2) exhibited more rapid acquisition of linezolid resistance than did N315. However, the mutation rates of these and contemporaneous clinical isolates were similar to those of N315, and the isolates did not exhibit any mutations in hypermutation-related genes. Sequences of the 23S rRNA genes and 16S-23S intergenic spacer regions were identical among the pre- and post-exposure clinical strains. Notably, all of the pre-exposure isolates harbored a recQ missense mutation (Glu69Asp) with respect to N315; such a lesion may have affected short sequence recombination (facilitating, for example, recombination among rrn loci). We hypothesize that this mechanism contributed to rapid acquisition of linezolid resistance.
Hypermutation and homologous recombination of the ribosomal RNA genes, including 23S rRNA genes, appear not to have been sources of the accelerated acquisition of linezolid resistance observed in our clinical case. Increased frequency of short sequence recombination may have resulted from a recQ variant in the infecting organism.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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