Impact of the COVID-19 pandemic on gastric surgery in Japan: A nationwide study using interrupted time-series analyses.

BACKGROUND AND AIM: Changes in the number of surgeries for gastric cancer during the coronavirus disease 2019 (COVID-19) pandemic have been reported, but data are insufficient to understand the impact at the national level. This study aimed to determine the impact of the COVID-19 pandemic on gastric surgery in Japan. METHODS: Insurance claims data registered from January 2015 to January 2021 were used. Changes in the number of endoscopic resections and gastrectomies for gastric cancer were estimated using an interrupted time-series analysis. RESULTS: The number of endoscopic resections significantly decreased in July 2020 (-1565; 95% confidence interval [CI]: -2022, -1108) and January 2021 (-539; 95% CI: -970, -109), and the number of laparoscopic surgeries significantly decreased in July 2020 (-795; 95% CI: -1097, -492), October 2020 (-313; 95% CI: -606, -19), and January 2021 (-507; 95% CI: -935, -78). Meanwhile, the number of open gastrectomies remained unchanged, and the number of robot-assisted gastrectomies steadily increased since their coverage by public health insurance in April 2018. CONCLUSIONS: The decreased number of endoscopic resections and laparoscopic surgeries in Japan suggests a decline in early-stage gastric cancer diagnosis, likely due to the suspension of gastric cancer screening and diagnostic testing during the pandemic. Meanwhile, the number of open and robot-assisted gastrectomies remained unchanged and increased, respectively, indicating that these applications were not affected by the pandemic-related medical crisis. These findings highlight that procedures for cancer diagnosis, including screening, should still be provided during pandemics.

Impact of the coronavirus disease 2019 pandemic on primary and metastatic lung cancer treatments in Japan: A nationwide study using an interrupted time series analysis.

BACKGROUND: The coronavirus disease 2019 pandemic prompted healthcare providers to use different approaches from the current standards of care. We aimed to identify the changes in the number of treatments for primary non-small cell lung cancer (NSCLC) and metastatic lung cancer during the pandemic. METHODS: We used nationwide insurance claims data from January 2015 to January 2021, and estimated changes in the number of treatments using an interrupted time series analysis. RESULTS: The number of surgical resections for primary NSCLC significantly decreased in April 2020 (-888; 95% confidence interval [CI]: -1530 to -246) and July 2020 (-1314; 95% CI: -1935 to -694), while the number of stereotactic body radiotherapies (SBRTs) increased in April 2020 (95; 95% CI: 8-182) and July 2020 (111; 95% CI: 24-198). The total number of treatments for primary NSCLC remained unchanged; however, non-significant decreases were observed in 2020. The number of surgical resections for metastatic lung cancer significantly decreased in April 2020 (-201; 95% CI: -337 to -65), but it eventually increased in July 2020 (170; 95% CI: 32-308). Additionally, the number of SBRTs significantly increased in April 2020 (37; 95% CI: 3-71) and October 2020 (57; 95% CI: 23-91). The total number of treatments for metastatic lung cancer was maintained, with an initial decrease in April 2020 followed by a subsequent increase in July and October 2020. CONCLUSION: In Japan, surgical triage for primary and metastatic lung cancer are likely to have been implemented during the pandemic. Despite these proactive measures, patients with primary NSCLC may have been untreated, likely owing to their undiagnosed disease, potentially leading to a deterioration in prognosis. By contrast, patients diagnosed with cancer prior to the pandemic are presumed to have received standard management throughout the course of the pandemic.

Outcomes of carbon ion radiotherapy compared with segmentectomy for ground glass opacity-dominant early-stage lung cancer.

PURPOSE: This study aimed to compare the outcomes of patients with ground-grass opacity (GGO)-dominant non-small cell lung cancer (NSCLC) who were treated with carbon ion radiotherapy (CIRT) versus segmentectomy. METHODS: A retrospective review of medical records was conducted. The study included 123 cases of clinical stage 0/IA peripheral NSCLC treated with single-fraction CIRT from 2003 to 2012, 14 of which were determined to be GGO-dominant and were assigned to CIRT group. As a control, 48 consecutive patients who underwent segmentectomy for peripheral GGO-dominant clinical stage IA NSCLC were assigned to segmentectomy group. RESULTS: The patients in CIRT group, compared with segmentectomy group, were significantly older (75 ± 7.2 vs. 65 ± 8.2 years, P = 0.000660), more likely to be male (13/14 vs. 22/48, P = 0.00179), and had a lower forced vital capacity (91 ± 19% vs. 110 ± 13%, P = 0.0173). There was a significant difference in the 5-years overall survival rate (86% vs. 96%, P = 0.000860), but not in the 5-years disease-specific survival rate (93% vs. 98%, P = 0.368). DISCUSSION: Compared with segmentectomy, CIRT may be an alternative option for patients with early GGO-dominant NSCLC who are poor candidates for, or who refuse, surgery.

Changes in colorectal cancer treatment during the COVID-19 pandemic in Japan: Interrupted time-series analysis using the National Database of Japan.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic forced us to accept changes in our usual diagnostic procedures and treatments for colorectal cancer. This study aimed to determine the impact of the pandemic on colorectal cancer treatment in Japan. METHODS: The number of colorectal surgeries, stoma constructions, stent placements or long tube insertions, and neoadjuvant chemoradiotherapies were determined each month using sampling datasets from the National Database of Health Insurance Claims and Specific Health Checkups of Japan. The observation periods before and during the pandemic were January 2015 to January 2020 and April 2020 to January 2021, respectively. An interrupted time-series analysis was used to estimate the changes in the number of procedures during the pandemic. RESULTS: The number of endoscopic surgeries for colon cancer significantly decreased in April and July 2020 and for rectal cancer in April 2020. Additionally, the number of laparoscopic and open surgeries for colon cancer significantly decreased in July 2020 and October 2020, respectively. The number of stoma constructions and stent placements or long tube insertions did not increase during the observation period. Neoadjuvant chemoradiotherapy for rectal cancer significantly increased in April 2020 but levels returned shortly thereafter. These results suggest that the recommendations to overcome the pandemic proposed by expert committees, including the replacement of laparoscopic surgery with open surgery, stoma construction to avoid anastomotic leak, and replacement of surgery on the ileus with stent placement, were not widely implemented in Japan. However, as an exception, neoadjuvant chemoradiotherapy for rectal cancer was performed as an alternative treatment to delay surgery in small quantities. CONCLUSION: A declining number of surgeries raises concerns about cancer stage progression; however, we found no evidence to suggest cancer progression from the trajectory of the number of stoma constructions and stent placements. In Japan, even during the pandemic, conventional treatments were performed.

Impact of coronavirus disease 2019 pandemic on breast cancer surgery using the National Database of Japan.

Various countries have reported a decrease in breast cancer surgeries during the coronavirus disease 2019 (COVID-19) pandemic; however, inconsistent results have been reported in Japan. This study revealed changes in the number of surgeries during the pandemic using the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) from January 2015 to January 2021, where insurance claims data from Japan as a whole are comprehensively accumulated. The number of breast-conserving surgeries (BCS) without axillary lymph node dissection (ALND) significantly decreased in July (- 846; 95% confidence interval (CI) - 1190 to - 502) and October 2020 (- 540; 95% CI - 861 to - 218). No decrease was observed for other types of surgery, BCS with ALND, and mastectomy with or without ALND. In the age-specific subgroup analysis, significant and transient reduction in BCS without ALND was observed in all age groups (0-49, 50-69, and ≥ 70 years). The number of BCS without ALND significantly decreased for a relatively short period in the early pandemic stages, suggesting reduced surgery for patients with a relatively low stage of cancer. Some patients with breast cancer might have been left untreated during the pandemic, and an unfavorable prognosis would be a concern.

Changes in the number of cancer diagnosis practices due to the COVID-19 pandemic: interrupted time-series analysis using the National Database of Japan.

PURPOSE: This study aimed to reveal the impact of coronavirus disease 2019 on the number of practices commonly used for cancer diagnosis in Japan. METHODS: The sampling dataset of the National Database of Japan from January 2015 to January 2021 was used to generate 25-point time-series data for the number of practices (21 points before and 4 points during the pandemic outbreak). The decreased number was estimated by interrupted time-series analysis using a seasonal autoregressive integrated moving average model. Using the pre-pandemic data, expected counterfactual numbers during the pandemic were predicted, and decreased rate was calculated. RESULTS: In most practices, the number dramatically decreased in the early stage of the pandemic and recovered rapidly thereafter. As of April 2020, gastric endoscopy decreased at the top of the practices (- 42.1%, with 95% confidence intervals of - 50.5% and - 33.7%), followed by gastric biopsy (- 38.6%, with 95% confidence intervals of - 46.7% and - 30.6%). The period of declined practices for lung cancer was relatively prolonged. The number of sentinel lymph node biopsies for breast cancer and colposcopies and biopsies for cervical cancer did not decrease in April 2020, but significantly decreased later in July 2020, which is assumed to be the time lapse after the primary testing before surgical treatment or intense scrutiny. CONCLUSION: In general, the number of practices for cancer diagnosis in Japan showed only a temporary decline, which was concordant with reports from several other countries.

Cost-effectiveness of managing HBV reactivation in patients with resolved HBV infection treated with anti-CD20 antibody for B-cell non-Hodgkin lymphoma.

There is no universal recommendation for managing the reactivation of HBV in patients with resolved HBV infection treated with anti-CD20 monoclonal antibodies for B-cell non-Hodgkin lymphoma. This study compared the cost-effectiveness of two commonly used strategies: prophylactic anti-HBV nucleos(t)ide analog therapy (Pro NAT), and HBV DNA monitoring followed by on-demand antiviral therapy (HBV DNA monitoring). Using a decision tree model, the incremental cost-effectiveness ratio (ICER) expressed as cost per quality-adjusted life-year (QALY) gained was calculated. The threshold for cost-effectiveness was set at 5,000,000 JPY, equivalent to 45,662 USD. In a base-case analysis, HBV DNA monitoring was found to be more cost-effective based on the calculation of ICER as 132,048 USD per QALY, a value that far exceeds 45,662 USD. The same results were consistently obtained by a one-way deterministic sensitivity analysis, even after changing each parameter value within the predetermined range. A probabilistic sensitivity analysis with 10,000 simulations also revealed that HBV DNA monitoring is more cost-effective than Pro NAT in 96.8% of cases. Therefore, this study suggests that HBV DNA monitoring is an appropriate managing measure in Japan from a cost-effectiveness perspective.

Additional outreach effort of providing an opportunity to obtain a kit for fecal immunochemical test during the general health check-up to improve colorectal cancer screening rate in Japan: A longitudinal study.

OBJECTIVES: A sufficient screening rate is indispensable to optimize the positive impact of colorectal cancer (CRC) screening. This study aimed to evaluate the effect of an additional outreach of providing an opportunity to obtain a kit for fecal immunochemical test (FIT) during the general health check-up to increase CRC screening rate. METHODS: This was a longitudinal study using pre-existing data in Kujukuri Town, Japan. The town provided CRC screening in the fiscal year (FY) 2017 using an existing procedure for all beneficiaries of the National Health Insurance, whereas in FY 2018, an additional outreach effort was made to only those with an even number of age (exposed group), who were offered an opportunity to obtain a kit for FIT at the time of general health check-ups but not to those with an odd number of age (control group). To estimate the effectiveness, generalized estimating equation (GEE) with individuals as clusters was performed. RESULTS: In total, 3,530 individuals were included (1,708 in the control group and 1,822 in the exposed group). GEE showed significant interaction between the groups (control and exposed) and FYs (2017 and 2018) (p<0.001), indicating that the change in CRC screening rate from 2017 to 2018 was significantly different between the two groups. Although an achieved actual rate of 17.1% in the exposed group in FY 2018 was low, the additional outreach increased the rate by 5.8 percentage point (95% confidence interval, 3.5-8.1) compared with an existing rate. CONCLUSIONS: Additional outreach of providing an opportunity to obtain a kit for FIT at the time of the general health check-up improved the CRC screening rate. However, screening rate achieved by this strategy remained low, indicating further efforts is required.

Handheld flow meter improves COPD detectability regardless of using a conventional questionnaire: A split-sample validation study.

BACKGROUND AND OBJECTIVE: Improved detectability of chronic obstructive pulmonary disease (COPD) using a handheld flow meter (HFM) with symptom-based questionnaires has not been sufficiently evaluated. This study aimed to identify the benefit of using an HFM in COPD screening. METHODS: A total of 2008 participants, who were ≥ 40 years of age, from Isumi City, Japan, were recruited. We developed two novel point systems for detecting COPD, one incorporated score of HFM alone (sHFM) and the other incorporated the score of International Primary Care Airway Group questionnaire (IPAG) and HFM (sIPAG + HFM). Validation using random sample allocation (split-sample validation) was carried out to assess the predictive performance of these models. RESULTS: Participants were assigned to a data set for model creation (n = 1007) or a data set for model assessment (n = 1001) to perform split-sample validation. Decision curve analysis showed that the net benefits of sHFM and sIPAG + HFM were higher than that of the IPAG score (sIPAG) and specificity of the former two were also significantly higher than that of sIPAG. However, the curves of sHFM and sIPAG + HFM were crossing and practically the same with no significant difference in sensitivity and specificity. CONCLUSION: This study confirms that HFM is significantly advantageous in detecting COPD despite the use of a conventional questionnaire.

Sex difference in the association between surrogate markers of insulin resistance and arterial stiffness.

AIMS: To investigate the predictive capability of insulin resistance surrogate markers for insulin resistance and arterial stiffness based on sex. METHODS: We assessed the association of triglyceride glucose (TyG) index, triglyceride to high-density lipoprotein cholesterol ratio (TG/HDL-C), visceral adiposity index (VAI), and lipid accumulation product (LAP) with homeostasis model assessment-insulin resistance (HOMA-IR) and brachial-ankle pulse wave velocity (baPWV) in both sexes. RESULTS: A total of 1720 men and 1098 women were evaluated. HOMA-IR showed good correlation with the TyG index (men: r = 0.47, women: r = 0.45), TG/HDL-C (men: r = 0.45, women: r = 0.41), VAI (men: r = 0.51, women: r = 0.48), and LAP (men: r = 0.55, women r = 0.49) (all p-values < 0.001). These markers positively correlated with increased baPWV in both sexes. The standardized partial regression coefficients were 0.11 and 0.14 for the TyG index, 0.13 and 0.16 for TG/HDL-C, 0.14 and 0.19 for VAI, and 0.12 and 0.17 for LAP in men and women, respectively (all p-values < 0.01; all p-values for sex interaction < 0.05). CONCLUSIONS: All insulin surrogate markers showed good correlation with HOMA-IR in both sexes. These indices were also associated with increased baPWV and the associations were stronger in women than in men.

Synergistic Effects of 1 h Post-Load Plasma Glucose and Smoking on Arterial Stiffness in Apparently Healthy Men: A Cross-sectional Study.

AIM: One-hour post-load plasma glucose (1h-PG) during an oral glucose tolerance test and smoking are associated with arterial stiffness. However, it remains unknown whether there are synergistic effects of these two factors on arterial stiffness. This study aimed to investigate the interaction between 1h-PG and smoking in relation to brachial-ankle pulse wave velocity (baPWV) in young men with normal glucose tolerance (NGT). METHODS: The study included 25-, 30-, 35-, 40-, and 45-year-old non-industrial male workers (n=2189) who underwent a detailed health check-up. Normotensive participants with NGT and taking no medication were included. RESULTS: A univariate linear regression analysis showed that 1h-PG correlated with baPWV (r=0.13, p＜0.001), but the correlation was not significant in the multivariate analysis (ß=0.02, p=0.24). However, we found a significant interaction between 1h-PG levels and smoking status in relation to baPWV (p=0.048). Therefore, further analyses were conducted in nonsmokers and smokers. A multivariate linear regression analysis revealed that 1h-PG significantly correlated with baPWV in smokers (ß=0.11, p=0.02), but not in nonsmokers (ß=0.01, p=0.79). The correlation remained significant even after adjustment for the number of cigarettes smoked per day (ß=0.096, p=0.048) or the Brinkman index (ß=0.097, p=0.043). CONCLUSION: A significant interaction between 1h-PG and smoking in relation to baPWV was found in apparently healthy men younger than 50 years old.

Association between 1-h post-load plasma glucose levels and arterial stiffness in normotensive subjects with normal glucose tolerance.

OBJECTIVE: To investigate the relationship between 1-h post-load plasma glucose, measured during an oral glucose tolerance test, and arterial stiffness, determined by brachial-ankle pulse-wave velocity, in normotensive subjects with normal glucose tolerance. METHODS: Study subjects were non-industrial workers aged 25-55 years ( n = 8381) who underwent a regular health check-up every 5 years. We included only normotensive subjects with normal glucose tolerance based on the American Diabetes Association criteria. Subjects taking medication and having an abnormal ankle-brachial index (⩽1.0 or ⩾1.3) were excluded. The final sample comprised 4970 participants (mean age: 38.8 ± 9.4 years; women: n = 2048). RESULTS: 1-h post-load plasma glucose correlated with brachial-ankle pulse-wave velocity in men ( ß = 0.04, p = 0.01), but not women ( ß = -0.03, p = 0.13) in multivariate linear regression analysis. We found a significant interaction between 1-h post-load plasma glucose and age in men ( p = 0.04); therefore, a subgroup analysis was performed in each 5-year age group. The correlation between 1-h post-load plasma glucose and brachial-ankle pulse-wave velocity was significant in the 55-year-old age group ( ß = 0.12, p = 0.01) and neared significant in 45-year-old ( ß = 0.08, p = 0.07) and 50-year-old ( ß = 0.09, p = 0.07) age groups. CONCLUSION: Elevated 1-h post-load plasma glucose levels were associated with arterial stiffness in normotensive, middle-aged men with normal glucose tolerance.

Carbon-ion radiotherapy for non-small cell lung cancer with interstitial lung disease: a retrospective analysis.

BACKGROUND: Lung cancer is frequently complicated by interstitial lung disease (ILD). Treatment protocols for lung cancer patients with ILD have not been established; surgery, chemotherapy, and radiotherapy can all cause acute exacerbation of ILD. This study evaluated the toxicity and efficacy of carbon ion radiotherapy (CIRT) in patients with non-small cell lung cancer (NSCLC) and ILD. METHODS: Between June 2004 and November 2014, 29 patients diagnosed with NSCLC and ILD were treated with CIRT. No patient was eligible for curative surgery or conventional radiotherapy secondary to ILD. Owing to prior symptomology, radiation pneumonitis (RP) and symptom progression pre- and post-treatment were evaluated. The relationships between RP and clinical factors were investigated. RESULTS: Twenty-eight men and one woman, aged 62 to 90 years old, were followed for 2.7-77.1 months (median: 22.8 months). Single-grade symptomatic progression (grade 2-3) was observed in 4 patients, while 1 patient experiencedtwo-grade progression. Two patients experienced radiation-induced acute exacerbation. Local control at 3 years was 63.3% (72.2% for stage I disease); survival at 3 years was 46.3% (57.2% for stage I disease). Eighteen patients had died by the time of this writing, 10 of lung cancer progression. Radiation pneumonitis post-treatment progression correlated with dosimetric factors of the lungs (V5, V10) and a low pre-treatment serum surfactant protein-D. CONCLUSIONS: We found that CIRT may be useful as a low-risk, curative option for NSCLC patients with ILD, a population that is typically ineligible for conventional therapy. The DVH analysis showed that minimizing the low-dose region is important for reducing the risk of severe RP. TRIAL REGISTRATION: NIRS-9404 . Registered 1 March 1994.

A Dose Escalation Clinical Trial of Single-Fraction Carbon Ion Radiotherapy for Peripheral Stage I Non-Small Cell Lung Cancer.

OBJECTIVES: Our objective was to report initial results of a dose escalation trial of single-fraction carbon ion radiotherapy for peripheral stage I NSCLC. METHODS: Between April 2003 and February 2012, a total of 218 patients were treated. The total dose was raised from 28 to 50 Gy (relative biological effectiveness [RBE]). There were 157 male and 61 female patients, with a median age of 75 years. Of the tumors, 123 were stage T1 and 95 were stage T2. A total of 134 patients (61.5%) were medically inoperable. By histological type, there were 146 adenocarcinomas, 68 squamous cell carcinomas, three large cell carcinomas, and one mucoepidermoid carcinoma. RESULTS: The median follow-up was 57.8 months (range 1.6-160.7). The overall survival rate at 5 years was 49.4%. The local control (LC) rate was 72.7%. A statistically significant difference in LC rate (p = 0.0001, log-rank test) was seen between patients receiving 36 Gy (RBE) or more and those receiving less than 36 Gy (RBE). In 20 patients irradiated with 48 to 50 Gy (RBE), the LC rate at 5 years was 95.0%, the overall survival rate was 69.2%, and the progression-free survival rate was 60.0% (median follow-up was 58.6 months). With dose escalation, LC tended to improve. As for adverse lung and skin reactions, there were no patients with grade 3 or higher reactions, and less than 2% had a grade 2 reaction. Regarding chest wall pain, only one patient had grade 3 late toxicity. CONCLUSIONS: We have reported the outcome of a dose escalation study of single-fraction carbon ion radiotherapy for stage I NSCLC, showing the feasibility of obtaining excellent results comparable to those with previous fractionated regimens.

Single-Fraction Carbon-Ion Radiation Therapy for Patients 80 Years of Age and Older With Stage I Non-Small Cell Lung Cancer.

PURPOSE: In an aging society, many senior citizens want less invasive treatment because of potential medical complications. The National Institute of Radiological Sciences has started to treat stage I lung cancer with single-fraction carbon-ion radiation therapy (CIRT) as a dose escalation prospective phase 1/2 trial. We evaluated the efficacy and safety of CIRT for patients 80 years of age and older, undergoing single-fraction CIRT. METHODS AND MATERIALS: Peripheral non-small cell lung cancer patients who were treated with single-fraction CIRT were prospectively followed. We analyzed the data from among these patients 80 years of age and older. RESULTS: There were 70 patients. Median age was 83 years (range: 80-89) and median follow-up period was 42.7 months (range: 12-128 months). Three-year local control, cause-specific survival, and overall survival rates were 88.0%, 81.6%, and 72.4%, respectively. Five-year local control, cause-specific survival, and overall survival rates were 85.8%, 64.9%, and 39.7%, respectively. There were no adverse effects higher than grade 2 either in the acute or late phase in terms of skin and lung. Analgesic agents were necessary for only 5 patients (7.1%), to relieve muscular or rib fracture pain caused by irradiation. CONCLUSIONS: Single-fraction CIRT was low-risk and effective, even for the elderly.

Salvage surgery for local recurrence after carbon ion radiotherapy for patients with lung cancer.

OBJECTIVES: Carbon ion radiotherapy (CIRT) has been expected to be an alternative for surgery for early-stage non-small-cell lung cancer (NSCLC) and adopted as the second-best choice even in operable patients although local recurrence after CIRT is sometimes experienced. The purpose of this study was to investigate the demographic data, perioperative courses and therapeutic outcomes of patients who underwent salvage resection for local recurrence after CIRT. METHODS: From November 1994 to February 2012, CIRT was applied for 602 c-T1/T2/T3N0M0 NSCLC lesions of 599 patients at the National Institute of Radiological Science. A total of 95 (16%) patients were diagnosed as having local recurrence, of whom 12 underwent salvage surgeries. The medical records were retrospectively reviewed. RESULTS: There were 7 men and 5 women (mean age, 63 ± 7.4 years). The clinical stages upon initial presentation with NSCLC were as follows: 4 IA, 7 IB and 1 IIB. All the patients were operable, but refused surgery and underwent CIRT. The median progression-free survival time after CIRT was 20 months (range, 7.1-77 months), and salvage surgery was performed at a median of 24 months (range, 9-78 months) after CIRT. All surgeries were successfully performed without any significant CIRT-related adhesions during the surgery, resulting in no mortality or Clavien-Dindo grade 3-4 postoperative complications. However, the distribution of pathological stages was as follows: 4 IA, 3 IB, 2 IIB, 2 IIIA and 1 IV, which included 6 upstages from the clinical stages before CIRT. The Kaplan-Meier estimate of overall survival after the salvage surgery showed that the 3-year survival rate was 82%. CONCLUSIONS: The dose intensity of CIRT spared the hilum of the lungs and parietal pleura, none of the patients developed adhesions outside of the radiation field, such that the salvage surgeries for local recurrence after CIRT were safe and feasible.

[Corrigendum] Aberrant methylation of CXCL12 in non-small cell lung cancer is associated with an unfavorable prognosis.

The PCR panels presented in Figs. 1 and 2 are incorrect. The authors provide the correct figures below. These changes do not affect the interpretation or conclusions of this work. The authors regret this error. [the original article was published in the International Journal of Oncology 33: 113-119, 2008 DOI: 10.3892/ijo.33.1.113]

A prospective nonrandomized phase I/II study of carbon ion radiotherapy in a favorable subset of locally advanced non-small cell lung cancer (NSCLC).

BACKGROUND: Although concurrent chemoradiotherapy (CCRT) has become the standard approach for unresectable locally advanced non-small cell lung cancer (LA-NSCLC), most patients are not candidates for this treatment because of comorbidities. We evaluated the safety and efficacy of carbon ion radiotherapy (CIRT) in LA-NSCLC patients. METHODS: Patients with stage IIA to IIIA (UICC 7th edition) LA-NSCLC were enrolled in a sequential phase I/II trial. For a phase I dose escalation study, the total prescribed dose was increased by 4 Gray equivalents (GyE) in 2 steps, from 68 to 72 GyE and then to 76 GyE, using 16 fractions over 4 weeks. After determining the recommended dose, the phase II trial was started in an expanded cohort. RESULTS: Of the 36 patients treated in phase I, 2 grade 3 adverse events (radiation pneumonitis and tracheoesophageal fistula) were observed in the 76 GyE group. Accordingly, for phase II, the next consecutive 26 patients were treated with 72 GyE, with no grade 3 to 5 toxicities resulting. A total of 62 eligible patients were recruited. The majority of patients (49 of 62) were N0 or N1 patients, and the rest (13 of 62) were single-station N2 patients. The median follow-up period was 25.2 months. The 2-year local control rate (LCR) and overall survival (OS) for the entire cohort were 93.1% and 51.9%, respectively. In particular, patients with cT3-4N0 had an excellent prognosis; the 2-year OS and LCR were 69.3% and 100%, respectively. CONCLUSIONS: Short-course CIRT monotherapy shows promise as an effective nonsurgical treatment for inoperable LA-NSCLC.

Surveillance of chronic obstructive pulmonary disease in high-risk individuals by using regional lung cancer mass screening.

BACKGROUND AND OBJECTIVE: Patients with chronic obstructive pulmonary disease (COPD) are at risk for lung cancer; the diseases have common etiologies, including cigarette smoking. We aimed to clarify the effectiveness of COPD detection using a regional mass-screening program for lung cancer. MATERIALS AND METHODS: A total of 7,067 residents of Togane, Chiba, Japan received lung cancer screening between May and July, 2011. We defined four groups of possible COPD candidates: group A (n=358), positive smoking history, positive chronic respiratory symptoms; group B (n=766), positive smoking history, positive lifestyle-related disease; group C (n=75), passive smoking history, positive chronic respiratory symptoms; and group D (n=301), passive smoking history, positive lifestyle-related disease. Candidates underwent on-site pulmonary function testing (PFT). RESULTS: The criteria for COPD candidates were fulfilled in 1,686 of 7,067 individuals (23.9%); 1,500 participants underwent PFT (89%), and 171 (11.4%) were diagnosed with COPD. The overall COPD detection rate was 2.4%. The frequency of COPD was significantly higher in groups A and B than in groups C and D (P=0.048); however, the distribution of COPD grades was similar among the groups (P=0.372). Multiple logistic regression analysis identified male sex, age 60 years or greater, and positive smoking history as risk factors for COPD. CONCLUSION: COPD screening using a community-based lung cancer-screening program may be effective for disease detection. Individuals who are 60 years of age or older with a positive smoking history should undergo PFT to detect COPD.

Detection of chronic obstructive pulmonary disease in community-based annual lung cancer screening: Chiba Chronic Obstructive Pulmonary Disease Lung Cancer Screening Study Group.

BACKGROUND AND OBJECTIVE: Detection of chronic obstructive pulmonary disease (COPD) is crucial in the management of COPD. The aim of this study was to establish the utility of a community-based lung cancer screening for detecting COPD. METHODS: In Japan, community-based lung cancer screening for residents who are 40 years or older using chest radiography is well established. A screening system in Chiba City, Japan, was used to detect COPD. The criteria to consider COPD at screening included age of 60 years or older, a smoking history and chronic respiratory symptoms. Participants fulfilling these criteria were referred for diagnostic evaluation consisting of pulmonary function testing (PFT) and chest computed tomography (CT). RESULTS: Of 89,100 Chiba City residents who underwent lung cancer screening, 72,653 residents were 60 years or older. Among them, 878 (1.0%) were identified with suspected COPD and referred for further evaluation. Of those identified, a total of 567 residents (64.6%, 567/878) underwent further evaluations, and 161 (28.4%) were reported to have COPD, with 38.5% of them requiring COPD treatment. To verify the diagnoses from the secondary evaluation centres, PFT and CT data were collected from 228 study participants, and 24.9% were diagnosed with COPD. CT findings classified according to the Goddard classification revealed that 20.1% of these participants had moderate to severe emphysema. CONCLUSIONS: COPD screening added to a community-based lung cancer screening programme may be effective in the detection of patients with COPD.