A Multicenter Randomized Controlled Study of Paclitaxel plus Carboplatin versus Oral Uracil-Tegafur as the Adjuvant Chemotherapy in Resected Non–Small Cell Lung Cancer

Shinichi Toyooka, Norihito Okumura, Hiroshige Nakamura, Masao Nakata, Motohiro Yamashita, Hirohito Tada, Shinsuke Kajiwara, Naoki Watanabe, Morihito Okada, Junichi Sakamoto, Motoi Aoe, Junichi Sou, Shinichiro Miyoshi, Katsuyuki Hotta, Keitaro Matsuo, Hiroshi Date

Research output: Contribution to journalArticle

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Abstract

Introduction: We conducted a randomized controlled study to compare the survival benefit of paclitaxel plus carboplatin and oral uracil-tegafur (UFT) as adjuvant chemotherapy in resected NSCLC. Methods: In an open-label multicenter trial, patients with pathological stage IB to IIIA NSCLC were randomized into a group receiving paclitaxel (175 mg/m2) plus carboplatin (area under the curve 5) every 3 weeks for four cycles (arm A) or a group receiving orally administered UFT (250 mg/m2) daily for 2 years (arm B). The primary and secondary end points were overall survival and relapse-free survival and toxicity, respectively. Results: Between November 2004 and November 2010, 402 patients from 40 institutions were included (201 in each arm). The median follow-up period was 6.5 years. The 5-year overall survival rate was 70% (95% confidential interval [CI]: 63–76] in arm A versus 73% (95% CI: 66–78) in arm B (hazard ratio = 0.92, 95% CI: 0.55–1.41, p = 0.69). There was no significant difference in the 5-year relapse-free survival rate between arms A and B (56% versus 57% [hazard ratio = 0.92, 95% CI: 0.63–1.34, p = 0.50]). Toxicities were well tolerated and there was no treatment-related death. Toxicities of any grade or grade 4 were significantly more frequent in the paclitaxel plus carboplatin group (95.7% and 22.1%, respectively) than in the UFT group (76.5% and 1.0%, respectively [p < 0.0001 in both]). Conclusions: As adjuvant chemotherapy, paclitaxel plus carboplatin was no better than UFT in terms of survival among patients with stage IB to IIIA NSCLC tumors who underwent complete resection (UMIN000000810).

Original languageEnglish
Pages (from-to)699-706
Number of pages8
JournalJournal of Thoracic Oncology
Volume13
Issue number5
DOIs
Publication statusPublished - May 1 2018

Fingerprint

Tegafur
Uracil
Carboplatin
Adjuvant Chemotherapy
Paclitaxel
Non-Small Cell Lung Carcinoma
Survival
Survival Rate
Recurrence
Multicenter Studies
Area Under Curve
Neoplasms

Keywords

  • adjuvant chemotherapy
  • carboplatin
  • Non–small cell lung cancer
  • paclitaxel
  • uracil-tegafur

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

A Multicenter Randomized Controlled Study of Paclitaxel plus Carboplatin versus Oral Uracil-Tegafur as the Adjuvant Chemotherapy in Resected Non–Small Cell Lung Cancer. / Toyooka, Shinichi; Okumura, Norihito; Nakamura, Hiroshige; Nakata, Masao; Yamashita, Motohiro; Tada, Hirohito; Kajiwara, Shinsuke; Watanabe, Naoki; Okada, Morihito; Sakamoto, Junichi; Aoe, Motoi; Sou, Junichi; Miyoshi, Shinichiro; Hotta, Katsuyuki; Matsuo, Keitaro; Date, Hiroshi.

In: Journal of Thoracic Oncology, Vol. 13, No. 5, 01.05.2018, p. 699-706.

Research output: Contribution to journalArticle

Toyooka, S, Okumura, N, Nakamura, H, Nakata, M, Yamashita, M, Tada, H, Kajiwara, S, Watanabe, N, Okada, M, Sakamoto, J, Aoe, M, Sou, J, Miyoshi, S, Hotta, K, Matsuo, K & Date, H 2018, 'A Multicenter Randomized Controlled Study of Paclitaxel plus Carboplatin versus Oral Uracil-Tegafur as the Adjuvant Chemotherapy in Resected Non–Small Cell Lung Cancer', Journal of Thoracic Oncology, vol. 13, no. 5, pp. 699-706. https://doi.org/10.1016/j.jtho.2018.02.015
Toyooka, Shinichi ; Okumura, Norihito ; Nakamura, Hiroshige ; Nakata, Masao ; Yamashita, Motohiro ; Tada, Hirohito ; Kajiwara, Shinsuke ; Watanabe, Naoki ; Okada, Morihito ; Sakamoto, Junichi ; Aoe, Motoi ; Sou, Junichi ; Miyoshi, Shinichiro ; Hotta, Katsuyuki ; Matsuo, Keitaro ; Date, Hiroshi. / A Multicenter Randomized Controlled Study of Paclitaxel plus Carboplatin versus Oral Uracil-Tegafur as the Adjuvant Chemotherapy in Resected Non–Small Cell Lung Cancer. In: Journal of Thoracic Oncology. 2018 ; Vol. 13, No. 5. pp. 699-706.
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abstract = "Introduction: We conducted a randomized controlled study to compare the survival benefit of paclitaxel plus carboplatin and oral uracil-tegafur (UFT) as adjuvant chemotherapy in resected NSCLC. Methods: In an open-label multicenter trial, patients with pathological stage IB to IIIA NSCLC were randomized into a group receiving paclitaxel (175 mg/m2) plus carboplatin (area under the curve 5) every 3 weeks for four cycles (arm A) or a group receiving orally administered UFT (250 mg/m2) daily for 2 years (arm B). The primary and secondary end points were overall survival and relapse-free survival and toxicity, respectively. Results: Between November 2004 and November 2010, 402 patients from 40 institutions were included (201 in each arm). The median follow-up period was 6.5 years. The 5-year overall survival rate was 70{\%} (95{\%} confidential interval [CI]: 63–76] in arm A versus 73{\%} (95{\%} CI: 66–78) in arm B (hazard ratio = 0.92, 95{\%} CI: 0.55–1.41, p = 0.69). There was no significant difference in the 5-year relapse-free survival rate between arms A and B (56{\%} versus 57{\%} [hazard ratio = 0.92, 95{\%} CI: 0.63–1.34, p = 0.50]). Toxicities were well tolerated and there was no treatment-related death. Toxicities of any grade or grade 4 were significantly more frequent in the paclitaxel plus carboplatin group (95.7{\%} and 22.1{\%}, respectively) than in the UFT group (76.5{\%} and 1.0{\%}, respectively [p < 0.0001 in both]). Conclusions: As adjuvant chemotherapy, paclitaxel plus carboplatin was no better than UFT in terms of survival among patients with stage IB to IIIA NSCLC tumors who underwent complete resection (UMIN000000810).",
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AU - Toyooka, Shinichi

AU - Okumura, Norihito

AU - Nakamura, Hiroshige

AU - Nakata, Masao

AU - Yamashita, Motohiro

AU - Tada, Hirohito

AU - Kajiwara, Shinsuke

AU - Watanabe, Naoki

AU - Okada, Morihito

AU - Sakamoto, Junichi

AU - Aoe, Motoi

AU - Sou, Junichi

AU - Miyoshi, Shinichiro

AU - Hotta, Katsuyuki

AU - Matsuo, Keitaro

AU - Date, Hiroshi

PY - 2018/5/1

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N2 - Introduction: We conducted a randomized controlled study to compare the survival benefit of paclitaxel plus carboplatin and oral uracil-tegafur (UFT) as adjuvant chemotherapy in resected NSCLC. Methods: In an open-label multicenter trial, patients with pathological stage IB to IIIA NSCLC were randomized into a group receiving paclitaxel (175 mg/m2) plus carboplatin (area under the curve 5) every 3 weeks for four cycles (arm A) or a group receiving orally administered UFT (250 mg/m2) daily for 2 years (arm B). The primary and secondary end points were overall survival and relapse-free survival and toxicity, respectively. Results: Between November 2004 and November 2010, 402 patients from 40 institutions were included (201 in each arm). The median follow-up period was 6.5 years. The 5-year overall survival rate was 70% (95% confidential interval [CI]: 63–76] in arm A versus 73% (95% CI: 66–78) in arm B (hazard ratio = 0.92, 95% CI: 0.55–1.41, p = 0.69). There was no significant difference in the 5-year relapse-free survival rate between arms A and B (56% versus 57% [hazard ratio = 0.92, 95% CI: 0.63–1.34, p = 0.50]). Toxicities were well tolerated and there was no treatment-related death. Toxicities of any grade or grade 4 were significantly more frequent in the paclitaxel plus carboplatin group (95.7% and 22.1%, respectively) than in the UFT group (76.5% and 1.0%, respectively [p < 0.0001 in both]). Conclusions: As adjuvant chemotherapy, paclitaxel plus carboplatin was no better than UFT in terms of survival among patients with stage IB to IIIA NSCLC tumors who underwent complete resection (UMIN000000810).

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KW - carboplatin

KW - Non–small cell lung cancer

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KW - uracil-tegafur

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