TY - JOUR
T1 - Pattern of care in adjuvant therapy for resected Stage I non-small cell lung cancer
T2 - Real-world data from Japan
AU - Yoh, Kiyotaka
AU - Takamochi, Kazuya
AU - Shukuya, Takehito
AU - Hishida, Tomoyuki
AU - Tsuboi, Masahiro
AU - Sakurai, Hiroyuki
AU - Goto, Yasushi
AU - Yoshida, Koichi
AU - Ohde, Yasuhisa
AU - Okumura, Sakae
AU - Ohashi, Yasuo
AU - Kunitoh, Hideo
N1 - Funding Information:
This work was supported by funding from Taiho Pharmaceutical under study contract. The Comprehensive Support Project for Oncology Research of the Public Health Research Foundation, in Japan, conducted this study. Taiho Pharmaceutical had no role in the design of the study. The company did not participate in the collection, management, analysis, or interpretation of the data; the preparation, review or approval of the manuscript; or the decision to submit the manuscript for publication.
Publisher Copyright:
© The Author(s) 2018. Published by Oxford University Press. All rights reserved.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - Background: Adjuvant tegafur/uracil (UFT) chemotherapy is recommended for patients with completely resected Stage I non-small cell lung cancer (NSCLC) in Japan. A Phase III trial, the Japan Clinical Oncology Group (JCOG) 0707, comparing the survival benefit of UFT and S-1 (tegafur/gimeracil/oteracil) for this population is being conducted. However, the selection of patients in the randomized clinical trial (RCT) may not represent the real-world population. The present study aimed to investigate the pattern of care for patients receiving adjuvant chemotherapy for completely resected NSCLC. Methods: Patients with completely resected pathological Stage I (T1 > 2 cm and T2 in 6th TNM edition) NSCLC eligible for the JCOG0707 trial but excluded from it during the enrollment period (2008–13) were eligible for this study. Physicians from institutions that participated in the JCOG0707 retrospectively assessed the medical records of each patient. Results: This study enrolled 5006 patients, 85% of those initially considered for participation in the JCOG0707 trial (5006 of 5923 patients). Among them, 2389 were ineligible for the trial and 2617 had not been enrolled despite being eligible. The most frequent reason for non-enrollment despite eligibility was the decline in patients’ participation, and the major reasons for trial ineligibility were concomitant malignancy and comorbidities. Of all the patients enrolled in our study, 1659 received adjuvant chemotherapy, mainly UFT. Conclusions: Our study indicates that only 15% of the real-world patients with completely resected NSCLC were enrolled into the adjuvant chemotherapy RCT, and among those not participating in the trial, one-third received adjuvant chemotherapy.
AB - Background: Adjuvant tegafur/uracil (UFT) chemotherapy is recommended for patients with completely resected Stage I non-small cell lung cancer (NSCLC) in Japan. A Phase III trial, the Japan Clinical Oncology Group (JCOG) 0707, comparing the survival benefit of UFT and S-1 (tegafur/gimeracil/oteracil) for this population is being conducted. However, the selection of patients in the randomized clinical trial (RCT) may not represent the real-world population. The present study aimed to investigate the pattern of care for patients receiving adjuvant chemotherapy for completely resected NSCLC. Methods: Patients with completely resected pathological Stage I (T1 > 2 cm and T2 in 6th TNM edition) NSCLC eligible for the JCOG0707 trial but excluded from it during the enrollment period (2008–13) were eligible for this study. Physicians from institutions that participated in the JCOG0707 retrospectively assessed the medical records of each patient. Results: This study enrolled 5006 patients, 85% of those initially considered for participation in the JCOG0707 trial (5006 of 5923 patients). Among them, 2389 were ineligible for the trial and 2617 had not been enrolled despite being eligible. The most frequent reason for non-enrollment despite eligibility was the decline in patients’ participation, and the major reasons for trial ineligibility were concomitant malignancy and comorbidities. Of all the patients enrolled in our study, 1659 received adjuvant chemotherapy, mainly UFT. Conclusions: Our study indicates that only 15% of the real-world patients with completely resected NSCLC were enrolled into the adjuvant chemotherapy RCT, and among those not participating in the trial, one-third received adjuvant chemotherapy.
KW - Adjuvant chemotherapy
KW - Non-small cell lung cancer
KW - Randomized clinical trial
KW - Real-world study
KW - Surgery
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U2 - 10.1093/jjco/hyy165
DO - 10.1093/jjco/hyy165
M3 - Article
C2 - 30452719
AN - SCOPUS:85059495672
SN - 0368-2811
VL - 49
SP - 63
EP - 68
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
IS - 1
ER -
