Multicenter observational cohort study of post-operative treatment for completely resected non-small-cell lung cancer of pathological Stage I (T1 >2 cm and T2 in TNM classification version 6).
Post-operative adjuvant chemotherapy has been considered an effective strategy to reduce cancer recurrence and improve survival for resected non-small-cell lung cancer. The Japan Clinical Oncology Group has completed patient accrual for a randomized Phase III study (JCOG0707), which compares the survival benefit of UFT and S-1 for completely resected pathological Stage I (T1 >2 cm and T2 in TNM classification version 6) non-small-cell lung cancer. However, there is a growing concern that those who participated in clinical trials are highly selected patients and do not represent the 'real-world' population. This multicenter observational cohort study aims to analyze the backgrounds, pattern of care and outcomes of the patients who were excluded from the JCOG0707 study during the accrual period. The results of this cohort study will be useful for external validity of the results of clinical trial such as JCOG0707.
Department of Thoracic Surgery, National Cancer Center Hospital East, Chiba thishida@nifty.com.
Tomoyuki
T
Hishida
Department of Thoracic Surgery, National Cancer Center Hospital East, Chiba.
Masahiro
M
Tsuboi
Department of Respiratory Medicine, Juntendo University School of Medicine, Tokyo.
Takehito
T
Shukuya
Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo.
Kazuya
K
Takamochi
Department of Thoracic Surgery, National Cancer Center Hospital, Tokyo.
Hiroyuki
H
Sakurai
Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba.
Kiyotaka
K
Yoh
Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo.
Yasuo
Y
Ohashi
Department of Chemotherapy, Japanese Red Cross Medical Center, Tokyo, Japan.
Hideo
H
Kunitoh
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology* / Q000517:prevention & control / Q000601:surgery / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D015331:Cohort Studies; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000473:pathology* / Q000517:prevention & control / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D018579:Patient Selection; D011184:Postoperative Period; D011355:Prodrugs / Q000008:administration & dosage; D016016:Proportional Hazards Models; D005641:Tegafur / Q000008:administration & dosage; D014498:Uracil / Q000008:administration & dosage
D004338:Drug Combinations; D011355:Prodrugs; C079198:S 1 (combination); D005641:Tegafur; D014498:Uracil; D010094:Oxonic Acid; D005472:Fluorouracil
early stage; non-small-cell lung cancer; observational cohort study; post-operative adjuvant chemotherapy; randomized Phase III study