A phase III study of adjuvant chemotherapy in patients with completely resected, node-negative non–small cell lung cancer (JCOG 0707)Central MessagePerspective
Objective: To evaluate efficacy of S-1 (tegafur/gimeracil/oteracil), an active novel fluoropyrimidine, as compared to UFT (tegafur/uracil) as a postoperative adjuvant therapy in patients with node-negative non–small cell lung cancer (NSCLC). Methods: Eligible patients had undergone complete resectio...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2020-12-01
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| Series: | JTCVS Open |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666273620300826 |
| _version_ | 1818393349109841920 |
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| author | Hideo Kunitoh, MD Masahiro Tsuboi, MD Masashi Wakabayashi, MSc Morihito Okada, MD Kenji Suzuki, MD Shun-ichi Watanabe, MD Hisao Asamura, MD H. Fukuda T. Shibata T. Kazato T. Mizutani J. Eba |
| author_facet | Hideo Kunitoh, MD Masahiro Tsuboi, MD Masashi Wakabayashi, MSc Morihito Okada, MD Kenji Suzuki, MD Shun-ichi Watanabe, MD Hisao Asamura, MD H. Fukuda T. Shibata T. Kazato T. Mizutani J. Eba |
| author_sort | Hideo Kunitoh, MD |
| collection | DOAJ |
| description | Objective: To evaluate efficacy of S-1 (tegafur/gimeracil/oteracil), an active novel fluoropyrimidine, as compared to UFT (tegafur/uracil) as a postoperative adjuvant therapy in patients with node-negative non–small cell lung cancer (NSCLC). Methods: Eligible patients had undergone complete resection of p-stage I (T1 with tumor diameter >2 cm or T2-N0M0 by 5th edition Union for International Cancer Control TNM) NSCLC, and were randomized to receive oral UFT 250 mg/m2/day for 2 years (Arm A) or oral S-1 80 mg/m2/day for 2 weeks with a 1-week rest period, for 1 year (Arm B). The primary end point was relapse-free survival (RFS), with 80% power and a one-sided type I error of 0.05. Results: From November 2008 to December 2013, 963 patients were enrolled (Arm A: 482, Arm B: 481). Toxicities (hematologic/nonhematologic) of grade 3 or more were observed in 15.9 (1.5/14.7)% in Arm A, and in 14.9 (3.6/12.1)% in Arm B, respectively. At data cut-off in December 2018, the hazard ratio for RFS was 1.06 (95% confidence interval, 0.82-1.36), showing no superiority of S-1 over UFT. The hazard ratio of overall survival (OS) was 1.10 (95% confidence interval, 0.81-1.50). The 5-year RFS/OS were 79.4%/88.8% in Arm A and 79.5%/89.7% in Arm B, respectively. The original NSCLC accounted for 58%/53%, respectively, of the Arm A/Arm B OS events. Secondary malignancies were observed in 85 (17.8%) and 84 (17.8%) individuals in Arm A and Arm B, respectively. Conclusions: S-1 was not superior to UFT as postoperative adjuvant therapy in node-negative NSCLC. Future investigation should incorporate identification of high-risk populations for recurrence. |
| first_indexed | 2024-12-14T05:43:54Z |
| format | Article |
| id | doaj.art-273289350fd7427fb3520e617a0f763d |
| institution | Directory Open Access Journal |
| issn | 2666-2736 |
| language | English |
| last_indexed | 2024-12-14T05:43:54Z |
| publishDate | 2020-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JTCVS Open |
| spelling | doaj.art-273289350fd7427fb3520e617a0f763d2022-12-21T23:14:55ZengElsevierJTCVS Open2666-27362020-12-01490102A phase III study of adjuvant chemotherapy in patients with completely resected, node-negative non–small cell lung cancer (JCOG 0707)Central MessagePerspectiveHideo Kunitoh, MD0Masahiro Tsuboi, MD1Masashi Wakabayashi, MSc2Morihito Okada, MD3Kenji Suzuki, MD4Shun-ichi Watanabe, MD5Hisao Asamura, MD6H. FukudaT. ShibataT. KazatoT. MizutaniJ. EbaJapanese Red Cross Medical Center, Tokyo, Japan; Address for reprints: Hideo Kunitoh, MD, Department of Medical Oncology, Japanese Red Cross Medical Center, 4-1-22 Hiro-o, Shibuya-ku, Tokyo 150-8935, Japan.National Cancer Center Hospital East, Kashiwa, JapanJapan Clinical Oncology Group Data Center, National Cancer Center Hospital, Tokyo, JapanHiroshima University Hospital, Hiroshima City Minamiku, JapanJuntendo University, Tokyo, JapanNational Cancer Center Hospital, Tokyo, JapanKeio University, Tokyo, JapanObjective: To evaluate efficacy of S-1 (tegafur/gimeracil/oteracil), an active novel fluoropyrimidine, as compared to UFT (tegafur/uracil) as a postoperative adjuvant therapy in patients with node-negative non–small cell lung cancer (NSCLC). Methods: Eligible patients had undergone complete resection of p-stage I (T1 with tumor diameter >2 cm or T2-N0M0 by 5th edition Union for International Cancer Control TNM) NSCLC, and were randomized to receive oral UFT 250 mg/m2/day for 2 years (Arm A) or oral S-1 80 mg/m2/day for 2 weeks with a 1-week rest period, for 1 year (Arm B). The primary end point was relapse-free survival (RFS), with 80% power and a one-sided type I error of 0.05. Results: From November 2008 to December 2013, 963 patients were enrolled (Arm A: 482, Arm B: 481). Toxicities (hematologic/nonhematologic) of grade 3 or more were observed in 15.9 (1.5/14.7)% in Arm A, and in 14.9 (3.6/12.1)% in Arm B, respectively. At data cut-off in December 2018, the hazard ratio for RFS was 1.06 (95% confidence interval, 0.82-1.36), showing no superiority of S-1 over UFT. The hazard ratio of overall survival (OS) was 1.10 (95% confidence interval, 0.81-1.50). The 5-year RFS/OS were 79.4%/88.8% in Arm A and 79.5%/89.7% in Arm B, respectively. The original NSCLC accounted for 58%/53%, respectively, of the Arm A/Arm B OS events. Secondary malignancies were observed in 85 (17.8%) and 84 (17.8%) individuals in Arm A and Arm B, respectively. Conclusions: S-1 was not superior to UFT as postoperative adjuvant therapy in node-negative NSCLC. Future investigation should incorporate identification of high-risk populations for recurrence.http://www.sciencedirect.com/science/article/pii/S2666273620300826non–small cell lung cancernode-negativeadjuvant chemotherapytegafur/uraciltegafur/gimeracil/oteracil |
| spellingShingle | Hideo Kunitoh, MD Masahiro Tsuboi, MD Masashi Wakabayashi, MSc Morihito Okada, MD Kenji Suzuki, MD Shun-ichi Watanabe, MD Hisao Asamura, MD H. Fukuda T. Shibata T. Kazato T. Mizutani J. Eba A phase III study of adjuvant chemotherapy in patients with completely resected, node-negative non–small cell lung cancer (JCOG 0707)Central MessagePerspective JTCVS Open non–small cell lung cancer node-negative adjuvant chemotherapy tegafur/uracil tegafur/gimeracil/oteracil |
| title | A phase III study of adjuvant chemotherapy in patients with completely resected, node-negative non–small cell lung cancer (JCOG 0707)Central MessagePerspective |
| title_full | A phase III study of adjuvant chemotherapy in patients with completely resected, node-negative non–small cell lung cancer (JCOG 0707)Central MessagePerspective |
| title_fullStr | A phase III study of adjuvant chemotherapy in patients with completely resected, node-negative non–small cell lung cancer (JCOG 0707)Central MessagePerspective |
| title_full_unstemmed | A phase III study of adjuvant chemotherapy in patients with completely resected, node-negative non–small cell lung cancer (JCOG 0707)Central MessagePerspective |
| title_short | A phase III study of adjuvant chemotherapy in patients with completely resected, node-negative non–small cell lung cancer (JCOG 0707)Central MessagePerspective |
| title_sort | phase iii study of adjuvant chemotherapy in patients with completely resected node negative non small cell lung cancer jcog 0707 central messageperspective |
| topic | non–small cell lung cancer node-negative adjuvant chemotherapy tegafur/uracil tegafur/gimeracil/oteracil |
| url | http://www.sciencedirect.com/science/article/pii/S2666273620300826 |
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