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T. Sawa
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MS 18 - Advocacy Snapshots (ID 36)
- Event: WCLC 2015
- Type: Mini Symposium
- Track: Advocacy
- Presentations: 1
- Moderators:P. Mondragon, K. Norris
- Coordinates: 9/08/2015, 14:15 - 15:45, 703
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MS18.02 - Advocates Making a Responsible Case for High-Risk Screening (ID 1927)
14:35 - 14:50 | Author(s): T. Sawa
- Abstract
- Presentation
Abstract:
Purpose: The purpose is to discuss how to advocate to make a Responsible Case for the Screening of lung cancer high risk group. Background and fact: Screening is looking for cancer at an early stage before a person has any symptoms. For the better screening, efficiency is determined as well as sensitivity and specificity. In these forty years, three screening tests have been studied to find if they decrease the risk of dying from lung cancer. Chest X-rays were evaluated at the earliest time in the lung cancer screening history while it is no longer recommended for screening.. Sputum cytology is a procedure in which a sample of sputum is viewed under a microscope to check for cancer cells, so it is required to good mucus that is coughed up from the lungs. Now, it is used as a non-invasive examination of a patient with a sputum symptoms rather than screening. Low-dose spiral CT (LDCT) scan is a special kind of x-ray that takes many pictures as you lie on a table that slides in and out of the machine. A computer then combines these pictures into a detailed picture of a slice of your body. In this procedure, low-dose radiation is used to make a series of very detailed pictures of areas inside the body with reduction of radiation exposure.. The National Lung Screening Trial (NLST) provided the first evidence that lung screening can reduce cancer deaths, when data from the study was published in 2011. The National Lung Screening Trial began in 2002 and enrolled more than 53,000 participants who were current or former heavy smokers, ages 55 to 74. The trial randomly assigned people to receive lung screening either by low-dose helical CT scans or chest X-rays. The trial was sponsored by the National Cancer Institute, and the University of Michigan was one of 33 places across the country to take part. U-M enrolled 850 participants. The study found that screening individuals with low-dose CT scans could reduce lung cancer mortality by 20 percent compared to chest x-ray. Now, it is concluded that the only recommended screening test for lung cancer is LD-CT, which result Medicare's decision to cover lung cancer screening in US. However, the evidence at the present time in LD-CT screening is only one report from US, the results of additional studies from Europe (NELSON) and Japan (Sagawa team) is awaited. Discussion: To raise up the efficiency of screening, It is important who is suitable as subjects. According to “ the Lung Cancer Screening Guidelines and Recommendations” by CDC, many organizations in US definite that lung cancer screening with LDCT is recommended for people of age 55 to 74 years with ≥ 30 pack year smoking history, who either currently smoke or have quit within the past 15 years while some difference of subjects who are in relatively good health or age 55 to 80 years across organizations. However, major obstacles are lying that smokers are lack of awareness or information for risks and benefits with attention to the specifics of each person making a decision about screening as well as the risk of lung cancer, in order to operate LD-CT screening effectively. GLCC poll in 2013 showed that in Australia and Great Britain current smokers are less aware of the symptoms of lung cancer than former smokers and people who have never smoked regularly. Even if screening system was developed, the risk of death due to lung cancer can not be reduced unless the people of high risk group do not visit to appropriate screening service that has been ensurring quality. In addition, Assessment of smoking and the provision of smoking cessation services must be part of any lung cancer screening program. Advocate movement based on research is urgently needed to develop approaches that will maximize cessation rates among smokers undergoing screening. Even more, it is required to enlightenment for smokers in cooperation with the international community by utilizing a variety of public relations means. In November 2014, lung cancer awareness month, Japan Lung Cancer Society approved the Kyoto Declaration. This declaration has been included that the tackle in the prevention of lung cancer and development of effective treatment by alliance with lung cancer Society, lung cancer patient, government, people, medical personnel, advocacy organizations, and healthcare industry. While the evidence from the NLST supports the implementation of lung cancer screening for high-risk individuals via LDCT, the experience to date also must validates the prior recommendations around institutional approaches to lung cancer screening, including the need for the availability of multidisciplinary clinical teams. In order to advocate making responsible case, several ways should be developed like a “Shared Decision-Making” toolkit(s) by the Lung Association that would act as a “consumers’ guide” for those considering lung cancer screening. After examine such a tool, it is also one of the ideas to take advantage according to the circumstances of each country.
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ORAL 01 - Chemotherapy Developments for Lung Cancer (ID 88)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:G. Blumenschein, S. Lee
- Coordinates: 9/07/2015, 10:45 - 12:15, 401-404
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ORAL01.01 - Randomized Phase III Study of Nedaplatin plus Docetaxel versus Cisplatin plus Docetaxel for Advanced Squamous Cell Lung Cancer (WJOG5208L) (ID 621)
10:45 - 10:56 | Author(s): T. Sawa
- Abstract
- Presentation
Background:
Nedaplatin (N) is a second-generation platinum compound with lower nausea/vomiting and nephrotoxicity than cisplatin (C). Nedaplatin plus docetaxel (ND) showed a promising efficacy with acceptable toxicity for advanced squamous cell lung cancer (SqLC) in the previous phase II study.
Methods:
Eligible patients (pts) were those with pathologically proven SqLC with stage IIIB/IV or postoperative recurrence, aged 20-74 years and ECOG PS 0-1. Pts were randomized 1:1 to ND (N 100 mg/m[2] and docetaxel (D) 60mg/m[2] iv, q3w, up to 6 cycles) or C plus D (CD) (C 80 mg/m[2] and D 60mg/m[2] iv, q3w, up to 6 cycles) according to stage, gender and institution. The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), response rate (RR) and adverse events (AEs). Target sample size of 350 provided 90% statistical power to detect a hazard ratio of 0.71 with one-sided type I error of 0.05.
Results:
Between July 2009 and July 2012, 355 pts were randomized. Of 349 for efficacy analysis (ND 177; CD 172), baseline characteristics were well-balanced between two arms. ND had a significantly longer OS (p=0.037, one-sided stratified log-rank test). The OS HR was 0.81 (90%CI, 0.67-0.98) with a median OS of 13.6 months [m] for ND and 11.4 for CD. ND had a longer PFS (p=0.050) with a HR of 0.83 (0.69-1.00) and a median PFS of 4.9 m in ND and 4.5 in CD. RR was 54.5% in ND vs 52.9% in CD (p=0.829). Grade 3 or higher AEs of nausea (4.0% vs 14.3%), fatigue (3.4% vs 10.9%), hyponatremia (13.6% vs 30.3%) and hypokalemia (2.3% vs 8.6%) are more frequent in CD. Grade 3 or higher AEs of neutrophils (82.5% vs 70.3%) and platelets (9.0% vs 0.0%) are more frequent in ND, but there was no difference in grade 3 or higher febrile neutropenia (13.6% vs 15.4%). Treatment related deaths occurred in 4 and 3 pts in ND and CD, respectively.
Conclusion:
ND showed a significantly longer OS as compared to CD with different toxicity profile. ND will be considered as a new standard treatment for advanced or relapsed SqLC. Clinical trial information: UMIN000002015.
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P1.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 212)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.03-015 - Safety and Effectiveness of Chemo-Radiotherapy with Weekly Nab Paclitaxel plus Carboplatin in Locally Advanced Non-Small Cell Lung Cancer (ID 2956)
09:30 - 09:30 | Author(s): T. Sawa
- Abstract
Background:
Combination therapy of carboplatin (CBDCA) and nab-PTX is a useful choice for first-line therapy of patients with advanced non-small cell lung cancer (NSCLC). The efficacy and safety of weekly albumin-bound paclitaxel (nab-PTX) and carboplatin (CBDCA) with concurrent radiotherapy for unresectable locally advanced non-small cell lung cancer was evaluated as a multicenter phase II study of Gifu thoracic oncology group.
Methods:
Patients with stage III NSCLC and an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible. Concurrent chemoradiotherapy consisted of weekly administration of nab-PTX (40 mg/m[2]) plus CBDCA (area under the plasma concentration time curve (AUC) 2) and thoracic radiotherapy (60 Gy/30 fractions) for a total of 6 weeks. The primary tumor and involved nodal disease received 60 Gy in 2-Gy fractions over 6 weeks. A three dimensional treatment planning system was used in every institute. After concurrent chemoradiotherapy, patients received an additional two cycles of consolidation phase chemotherapy that consisted of 4-week cycles of nab-PTX (100 mg/m[2] on days 1, 8, and 15)/CBDCA (AUC 5 mg/ml/min on day 1). Response was evaluated in accordance with the RECIST. Progression-free and overall survival were estimated using the Kaplan Meier method. Toxicity was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events.
Results:
The study became way canceled for serious adverse events, when the 10 cases were enrolled in this trial between September 2013 and January 2014 from 3 institutes. Patient characteristics are summarized as follow. The median age was 73 years. The ECOG performance status was 0 for 30% of patients and 1 for 70% of patients. Of these patients, 5 cases had squamous cell carcinoma and 5 cases had adenocarcinoma. The overall response rate was 40.0% and the median progression-free survival was 6.7 months. total of 7 patients were unable to complete the consolidation phase chemotherapy because of toxicities (pneumonitis, lung infection, or heart failure), poor PS, or patient preference. The most common grade 3/4 hematological toxicity was leukopenia (8 patients, 80%). Other grade 3/4 hematological toxicities were neutropenia (5 patients, 50%) and anemia (1 patient, 10%). Other grade 3 or worse severe toxicities were anorexia (3 patients, 30%), nausea (2 patients, 20%), diarrhea (1 patient, 10%), pneumonitis (2 patients, 20%), heart failure (2 patients, 20%), and lung infection (1 patient, 10%). Treatment-related death occurred in two patients. Grade 2 or worse severe pneumonitis was observed in all 3 patients that had volume of lung receiving at least 20 Gy (V20) >30%.
Conclusion:
The results of this study indicate that no further investigation is warranted into nab-PTX and CBDCA with concurrent thoracic radiation using three dimensional treatment planning system for stage III NSCLC with V20 >30% due to severe toxicity.
