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Masahiko Kusumoto
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MTE 14 - Imaging of Lung Cancer (Sign Up Required) (ID 563)
- Event: WCLC 2017
- Type: Meet the Expert
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 07:00 - 08:00, F205 + F206 (Annex Hall)
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MTE 14.01 - Computed Tomographic Features of Small Pulmonary Nodules: A Follow-Up Study (ID 7794)
07:00 - 07:30 | Presenting Author(s): Masahiko Kusumoto
- Abstract
- Presentation
Abstract:
A ground-glass nodule (GGN) is a morphologic description of pulmonary nodule category on thin-section chest computed tomography (CT). Pure GGNs are defined as focal nodular areas of increased pulmonary attenuation through which pulmonary parenchymal structures, such as pulmonary vessels or bronchial structures, can be observed. Part solid nodules present with ground-glass and solid components, in which the underlying pulmonary architecture cannot be visualized, whereas solid nodules are without ground-glass components. These nodules differ in pathological condition and natural history by type, and management corresponding to these differences is required. Transient GGNs, which disappear after 3 months in repeated CT, are likely due to inflammation or infection. If many small GGNs are present, these are more likely to represent atypical adenomatous hyperplasia (AAH), and follow-up with annual CT scans is advised. The majority of persistent solitary pure GGNs are pathologically atypical adenomatous hyperplasia, adenocarcinoma in situ (AIS), and minimally invasive adenocarcinoma (MIA); these nodules do not grow, or progress very slowly. Pure GGNs less than 15 mm in diameter are followed up after 3 months, 1 year, and 2 years with CT. In the meantime, when the GGN increases in size, or if solid components appear in the nodule, a definite diagnosis is made, although such cases are extremely rare. Even when a solid component appears inside the GGN, there are options for further follow-up as long as the diameter of the solid component remains less than 5 mm. A solitary pure GGN that is unchanged for 5 years could remain unchanged even after 10 years. Of solitary pure GGNs 5 mm or less in diameter, approximately 10% will grow, with 1% developing into invasive adenocarcinomas or MIAs. Therefore, it is recommended that solitary pure GGNs smaller than 5 mm be rescanned after 3 to 5 years, in order to look for development of a solid component. In cases of part solid nodules, which present with both ground-glass and solid components, the underlying pulmonary structures cannot be observed. These nodules are more suspicious than pure ground-glass nodules and thus require more aggressive management if they persist. Persistent part solid nodules usually represent lepidic predominant adenocarcinomas or MIAs. In particular, if the margin of a part solid nodule is well-defined on thin-section CT, it is often dianogsed as lepidic predominant adenocarcinoma or MIA. Some inflammatory lesions show part solid nodules on CT; if the nodules do not disappear or decrease in size on CT after 3 months, they are highly likely to be adenocarcinomas. Usually, a lung adenocarcinoma showing part solid nodules on CT does not grow rapidly in 3 months. Therefore, a 3-month CT follow-up is effective for diagnosing a partly solid nodule (which is difficult to diagnose). Small solid nodules are most commonly observed, although few are malignant. These nodules are easily detected on CT, but it is difficult to diagnose their malignancy. Nodules over 10 mm in diameter are suspicious for malignancy, and an attempt should be made to obtain a definitive diagnosis. Solid nodules with a maximum diameter of 5 to 10 mm in smokers should be followed up until after 3 months, 6 months, 1 year, and 2 years on CT. In non-smokers, however, intervals of follow-up could be longer. Solitary nodules less than 5 mm in diameter are very rarely malignant and only require annual follow-up if patients have risk factors such as smoking. The reasons why intervals of follow-up differ between smokers and non-smokers are because smokers have a higher risk of lung cancer, and the tumor doubling time is shorter in the case of lung cancer in smokers. If the size of a nodule increases during follow-up, a definitive diagnosis is needed. If the size of a solid nodule is unchanged for 2 years, the possibility of lung cancer is extremely low, and follow-up observation may be completed; however, in smokers, emphysema is often complicated, and the diagnosis is more difficult as the shape and margin of the nodule also vary. In the case of small cell carcinoma, hilar and mediastinal lymph node metastasis may occur 3 months after nodule detection, and the early diagnosis of small cell lung cancer is extremely difficult. In the present lecture, the outcomes of follow-up of these various small pulmonary nodules will be illustrated. Figure 1CT image at detection Figure 210 years later
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P1.03 - Chemotherapy/Targeted Therapy (ID 689)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-008 - Analysis of Data on Interstitial Lung Disease Onset and Its Risk Following Treatment of ALK-positive NSCLC with Xalkori (ID 9146)
09:30 - 09:30 | Author(s): Masahiko Kusumoto
- Abstract
Background:
Incidence and potential risk factors of interstitial lung disease (ILD) were evaluated in patients with ALK-positive non-small cell lung cancer (NSCLC) enrolled for all-case surveillance of Xalkori.
Method:
The survey was conducted on all patients treated with XALKORI[®] 200mg/250mg capsules. The observation period was 52 weeks from the initiation of treatment with Xalkori, or time from treatment commencement until treatment discontinuation in patients who discontinued treatment prematurely. Investigator-reported cases of ILD were assessed by the ILD independent review committee consisting of external experts to evaluate background risk factors potentially associated with the onset of ILD.
Result:
Among 2059 patients enrolled for this survey from May 2012 to October 2014, 1972 were included in a safety analysis. Among 139 reported cases of patients developing ILD following Xalkori treatment, 116 patients were confirmed to have ILD (incidence rate of 5.9%). The breakdown of these cases was mainly as follows: 63 (54%) patients were male, 52 (45%) were female, 57 (49%) were aged at least 65 years, 3 (2.6%) had a previous history of ILD, and 63 (54%) had smoking history, including former smokers. Giving the breakdown by Grade, 46 patients had Grade 2 or lower ILD, and 70 patients had Grade 3 or higher, including 22 with Grade 5 (mortality rate of 1.1%). Ninety-one patients (78.4%) developed ILD within 12 weeks after treatment commencement. The background factors with statistically significant differences among patients included age, body surface area, Eastern Cooperative Oncology Group Performance Status (ECOG PS) and smoking history. Also the multivariate analysis revealed that aging, poor ECOG PS, former smokers and previous history or complications of ILD were correlated with the occurrence of ILD.
Conclusion:
The onset time, the incidence of ILD and risk factors obtained from this surveillance didn’t seem to be significant difference with those of EGFR TKIs reported previously.
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P3.04 - Clinical Design, Statistics and Clinical Trials (ID 720)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.04-002 - A Randomized Phase II Study of Carboplatin plus Nab-Paclitaxel with or Without Nintedanib for NSCLC with IPF (J-SONIC): Trial in Progress (ID 9627)
09:30 - 09:30 | Author(s): Masahiko Kusumoto
- Abstract
Background:
Idiopathic pulmonary fibrosis (IPF) is a fatal lung disease characterized by worsening dyspnea and progressive loss of lung function. Acute exacerbation of IPF is associated with high morbidity and mortality. Several studies have provided evidence of an association between lung cancer and IPF, with a prevalence of lung cancer in IPF patients ranging from 9.8% to 38%. Although the efficacy of nintedanib for IPF has been demonstrated, it has remained unknown whether this agent also reduces the risk of chemotherapy-induced acute exacerbation of IPF. Patients with interstitial pneumonia have been excluded from most prospective clinical trials for NSCLC because of the risk of acute exacerbation, with only two prospective single-arm phase II studies having been reported. In addition, it has been difficult to perform a randomized prospective clinical trial for patients with advanced NSCLC and IPF because of their rarity. The optimal chemotherapy regimen for advanced NSCLC with IPF has thus remained unclear.
Method:
Chemotherapy-naïve patients with advanced NSCLC associated with IPF (enrollment target of n = 170) are randomized at a 1:1 ratio to receive four cycles of carboplatin (AUC 6 on day 1) plus nab-paclitaxel (100 mg/m[2] on days 1, 8, and 15) administered every 3 weeks either without (arm A) or with (arm B) nintedanib (150 mg b.i.d., daily), to be followed in arm B by single-agent administration of nintedanib (150 mg b.i.d., daily). The primary end point of the study is time to acute exacerbation of IPF.Figure 1
Result:
Section not applicable
Conclusion:
J-SONIC is the first randomized controlled study for treatment of NSCLC associated with IPF. The goal of the study is to demonstrate that nintedanib in combination with carboplatin plus nab-paclitaxel prolongs time to acute exacerbation of IPF compared with carboplatin plus nab-paclitaxel alone. Study enrollment began in May 2017 and is to continue for 3 years.
