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Y. Nakanishi
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MINI 07 - ChemoRT and Translational Science (ID 110)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:D. Raben, B. Kavanagh
- Coordinates: 9/07/2015, 16:45 - 18:15, 201+203
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MINI07.01 - A Randomized Phase II Study of S-1 and Cisplatin vs Vinorelbine and Cisplatin with Concurrent Radiotherapy for Locally Advanced NSCLC: WJOG5008L (ID 544)
16:45 - 18:15 | Author(s): Y. Nakanishi
- Abstract
- Presentation
Background:
Cisplatin-based chemotherapy and concurrent radiotherapy is the standard treatments for locally advanced non-small cell lung cancer ( LA-NSCLC). This trial evaluated two experimental regimens of chemotherapy with concurrent radiotherapy.
Methods:
Eligible patients (pts) with unresectable stage III NSCLC, 20 to 74 years of age, and ECOG PS of 0–1 were randomized to either Arm SP, S-1 (40 mg/m[2]/dose per oral, b.i.d, on days 1-14) and cisplatin (60 mg/m[2] on day 1) repeated every 4 weeks or Arm VP, vinorelbine ( 20mg/m[2] on day 1, 8) and cisplatin (80 mg/m[2] on day) repeated every 4 weeks with early concurrent thoracic radiotherapy of 60Gy at 2 Gy per daily fraction. The primary endpoint was overall survival rate at 2-year (2yr-OS). A pick-the-winner design was used to identify the treatment regimen most likely to be superior. The planned sample size was 55 patients per arm, assuming in each arm that the null hypothesis for 2yr- OS was 50% versus an alternative hypothesis for 65% with one-sided alpha of 0.10 and power of 80%. All the radiation treatment plans were reviewed at quality assurance committee meetings. (Study ID: UMIN000002420)
Results:
One hundred eleven patients were registered between Sep 2009 and Sep 2012. Of 108 patients for efficacy analysis, the 2yr-OS was 76% (95% CI, 62-85%) for SP and 69% (95% CI, 54-79%) for VP. The hazard ratio (HR) of death between the two arms was 0.85 (0.48-1.49). The median progression-free survival (PFS) was 14.8 months for SP and 12.3 months for VP with a HR of 0.92 (0.58-1.44). 80% and 48% of pts completed the protocol treatment in SP and VP, respectively. Common grade 3-4 toxicities of both SP and VP were neutropenia 33%, 75%, platelets 9%, 4%, hemoglobin 26%, 28%, febrile neutropenia 9%, 17%, diarrhea 6%, 0% respectively. There were 4 and 5 treatment-related deaths in Arms SP and VP, respectively. The quality assurance committee judged that 74% of radiation treatment plans had no deviation and 24% had a minor deviation.
Conclusion:
Both arms rejected the null hypothesis for 2yr-OS. In this study Arm SP was declared the winner in terms of 2yr-OS, PFS, treatment completion, and toxicity.
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MINI 10 - ALK and EGFR (ID 105)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:T. Yap, T. Li
- Coordinates: 9/07/2015, 16:45 - 18:15, Mile High Ballroom 1a-1f
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MINI10.10 - A Multicenter Prospective Biomarker Study in Afatinib-Treated Patients with EGFR-Mutation Positive Non-Small Cell Lung Cancer (ID 472)
16:45 - 18:15 | Author(s): Y. Nakanishi
- Abstract
- Presentation
Background:
Afatinib is an oral, irreversible ErbB family blocker and one of the key drugs for patients with EGFR mutation positive advanced non-small cell lung cancer (NSCLC). Although treatment with afatinib has a clinical benefit for these patients, such individuals inevitably develop drug resistance as with other TKIs. This is a multicenter prospective biomarker study to inform the usefulness of noninvasive liquid biopsy in the treatment of EGFR-tyrosine kinase inhibitors (EGFR-TKIs) and explore the molecular mechanism of acquired-resistance against afatinib.
Methods:
Eligible patients were EGFR-TKIs naïve and had histologically and cytologically confirmed stage IIIB/IV adenocarcinoma of the lung with activating EGFR mutations. Patients remained on afatinib treatment until disease progression or unacceptable toxicity. Tumor samples were collected upon before afatinib treatment and after disease progression. Plasma samples were collected upon before and during afatinib treatment (4 and 24 weeks after initiation) and after disease progression. DNA derived both from tumors and plasma was analyzed using Scorpion-ARMS (ARMS), digital PCR (dPCR) and next generation sequencing (NGS). We used a nanofluidic dPCR system (BioMark HD System; Fluidigm) with a digital chip to detect activating or resistance mutations of EGFR in a quantitative and highly sensitive manner. NGS on an Ion Torrent PGM device (Thermo Fisher Scientific) was applied to detect target molecules which contribute to the survival and growth of lung cancer cells. We compared the sensitivity of these methods in detection of EGFR activating mutations in plasma DNA.
Results:
A total of 35 EGFR mutation positive NSCLC patients were enrolled. Twenty one patients harbored a deletion in exon 19 and fourteen patients had an L858R missense mutation in exon 21. Twenty seven (77.1%) patients had an objective response. In plasma DNA obtained before afatinib treatment, dPCR and NGS detected EGFR activating mutations more sensitively compared with ARMS (83.9% v 58.1%; p <0.005, 74.2% v 58.1%; p =0.059, respectively). Concordance of EGFR activating mutations detected by dPCR and NGS was 26/31 (84%) (kappa value: 0.52). All of the mutation type detected by NGS on plasma DNA completely corresponded to that found in matching tumor tissue by NGS. As of March 2015, serial plasma DNA was analyzed in 9 patients. The copy number of activating mutation was markedly decreased in 5 of 9 patients.
Conclusion:
EGFR activating mutations in plasma DNA were frequently detected by dPCR or NGS. We will present the detailed data for monitoring mutation load in plasma DNA during the afatinib treatment.
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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)
14:15 - 15:45 | Author(s): Y. Nakanishi
- 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 - 12:15 | Author(s): Y. Nakanishi
- 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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P2.11 - Poster Session/ Palliative and Supportive Care (ID 230)
- Event: WCLC 2015
- Type: Poster
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.11-004 - Assessment of Pain Management in Cancer Outpatients Who Receive Chemotherapy (ID 1389)
09:30 - 17:00 | Author(s): Y. Nakanishi
- Abstract
Background:
Pain is one of the most frequent and burdensome symptoms in cancer patients. In addition, inadequate pain management may limit anti-cancer active treatment in these patients and impair their quality of life. Chemotherapy in the outpatient settings has become common in Japan in the last decade. However, the adequacy of pain management in patients who receive outpatient chemotherapy is not yet well-known. The primary objective of this study was to assess pain prevalence and intensity in these patients. The secondary objective was to assess the pain management status using the pain management index (PMI).
Methods:
Cancer patients with solid tumors or hematologic malignancies who received chemotherapy in the outpatient setting were enrolled. The PMI scores were calculated using the patient-rated pain score and the analgesic score. The PMI was evaluated twice in each patient on the first day and 3 to 5 weeks later when patients received chemotherapy at Outpatient Chemotherapy Administration Unit, Kyushu University Hospital, Japan. Patients were required to complete questionnaires including Japanese Brief Pain Inventory and the Distress Thermometer and Impact Thermometer.
Results:
Of 740 patients enrolled, 524 patients (71%) who completed the questionnaires at both baseline and follow-up were applied to the statistical analysis. 54% patients experienced any pain and 14% patients had moderate or severe pain. 286 patients (55%) received adequate pain management at both baseline and follow-up, while 238 patients (45%) received inadequate pain management at baseline and/or follow-up. Multivariable analysis revealed that major depression had the most impact on adequacy of pain management.
Conclusion:
Patients who receive outpatient chemotherapy have a high prevalence of pain. The PMI is available to evaluate the pain management status of cancer patients in outpatient setting. Pain management for cancer patients needs to be assessed regularly even though their initial pain management is adequate.
