Phase III trial comparing docetaxel and cisplatin combination chemotherapy with mitomycin, vindesine, and cisplatin combination chemotherapy with concurrent thoracic radiotherapy in locally advanced non-small-cell lung cancer: OLCSG 0007

Yoshihiko Segawa, Katsuyuki Kiura, Nagio Takigawa, Haruhito Kamei, Shingo Harita, Shunkichi Hiraki, Yoichi Watanabe, Keisuke Sugimoto, Takuo Shibayama, Toshiro Yonei, Hiroshi Ueoka, Mitsuhiro Takemoto, Susumu Kanazawa, Ichiro Takata, Naoyuki Nogami, Katsuyuki Hotta, Akio Hiraki, Masahiro Tabata, Keitaro Matsuo, Mitsune Tanimoto

Research output: Contribution to journalArticle

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Abstract

Purpose: To demonstrate the efficacy of docetaxel and cisplatin (DP) chemotherapy with concurrent thoracic radiotherapy (TRT) for patients with locally advanced non-small-cell lung cancer (LA-NSCLC). Patients and Methods: Patients age 75 years or younger with LA-NSCLC, stratified by performance status, stage, and institution, were randomly assigned to two arms consisting of DP (docetaxel 40 mg/m2 and cisplatin 40 mg/m2 on days 1, 8, 29, and 36) or mitomycin, vindesine, and cisplatin (MVP) chemotherapy with concurrent TRT. Results: Between July 2000 and July 2005, 200 patients were allocated into either the DP or MVP arm. The survival time at 2 years, a primary end point, was favorable to the DP arm (P = .059 by a stratified log-rank test as a planned analysis and P = .044 by an early-period, weighted log-rank as an unplanned analysis). There was a trend toward improved response rate, 2-year survival rate, median progression-free time, and median survival in the DP arm (78.8%, 60.3%,13.4 months, and 26.8 months, respectively) compared with the MVP arm (70.3%, 48.1%, 10.5 months, and 23.7 months, respectively), which was not statistically significant (P > .05). Grade 3 febrile neutropenia occurred more often in the MVP arm than in the DP arm (39% v 22%, respectively; P = .012), and grade 3 to 4 radiation esophagitis was likely to be more common in the DP arm than in the MVP arm (14% v 6%, P = .056). Conclusion: DP chemotherapy combined with concurrent TRT is an alternative to MVP chemotherapy for patients with LA-NSCLC.

Original languageEnglish
Pages (from-to)3299-3306
Number of pages8
JournalJournal of Clinical Oncology
Volume28
Issue number20
DOIs
Publication statusPublished - Jul 10 2010
Externally publishedYes

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docetaxel
Vindesine
Mitomycin
Combination Drug Therapy
Non-Small Cell Lung Carcinoma
Cisplatin
Radiotherapy
Thorax
Drug Therapy
Febrile Neutropenia
Survival
Esophagitis
Survival Rate
Radiation

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Phase III trial comparing docetaxel and cisplatin combination chemotherapy with mitomycin, vindesine, and cisplatin combination chemotherapy with concurrent thoracic radiotherapy in locally advanced non-small-cell lung cancer : OLCSG 0007. / Segawa, Yoshihiko; Kiura, Katsuyuki; Takigawa, Nagio; Kamei, Haruhito; Harita, Shingo; Hiraki, Shunkichi; Watanabe, Yoichi; Sugimoto, Keisuke; Shibayama, Takuo; Yonei, Toshiro; Ueoka, Hiroshi; Takemoto, Mitsuhiro; Kanazawa, Susumu; Takata, Ichiro; Nogami, Naoyuki; Hotta, Katsuyuki; Hiraki, Akio; Tabata, Masahiro; Matsuo, Keitaro; Tanimoto, Mitsune.

In: Journal of Clinical Oncology, Vol. 28, No. 20, 10.07.2010, p. 3299-3306.

Research output: Contribution to journalArticle

Segawa, Yoshihiko ; Kiura, Katsuyuki ; Takigawa, Nagio ; Kamei, Haruhito ; Harita, Shingo ; Hiraki, Shunkichi ; Watanabe, Yoichi ; Sugimoto, Keisuke ; Shibayama, Takuo ; Yonei, Toshiro ; Ueoka, Hiroshi ; Takemoto, Mitsuhiro ; Kanazawa, Susumu ; Takata, Ichiro ; Nogami, Naoyuki ; Hotta, Katsuyuki ; Hiraki, Akio ; Tabata, Masahiro ; Matsuo, Keitaro ; Tanimoto, Mitsune. / Phase III trial comparing docetaxel and cisplatin combination chemotherapy with mitomycin, vindesine, and cisplatin combination chemotherapy with concurrent thoracic radiotherapy in locally advanced non-small-cell lung cancer : OLCSG 0007. In: Journal of Clinical Oncology. 2010 ; Vol. 28, No. 20. pp. 3299-3306.
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title = "Phase III trial comparing docetaxel and cisplatin combination chemotherapy with mitomycin, vindesine, and cisplatin combination chemotherapy with concurrent thoracic radiotherapy in locally advanced non-small-cell lung cancer: OLCSG 0007",
abstract = "Purpose: To demonstrate the efficacy of docetaxel and cisplatin (DP) chemotherapy with concurrent thoracic radiotherapy (TRT) for patients with locally advanced non-small-cell lung cancer (LA-NSCLC). Patients and Methods: Patients age 75 years or younger with LA-NSCLC, stratified by performance status, stage, and institution, were randomly assigned to two arms consisting of DP (docetaxel 40 mg/m2 and cisplatin 40 mg/m2 on days 1, 8, 29, and 36) or mitomycin, vindesine, and cisplatin (MVP) chemotherapy with concurrent TRT. Results: Between July 2000 and July 2005, 200 patients were allocated into either the DP or MVP arm. The survival time at 2 years, a primary end point, was favorable to the DP arm (P = .059 by a stratified log-rank test as a planned analysis and P = .044 by an early-period, weighted log-rank as an unplanned analysis). There was a trend toward improved response rate, 2-year survival rate, median progression-free time, and median survival in the DP arm (78.8{\%}, 60.3{\%},13.4 months, and 26.8 months, respectively) compared with the MVP arm (70.3{\%}, 48.1{\%}, 10.5 months, and 23.7 months, respectively), which was not statistically significant (P > .05). Grade 3 febrile neutropenia occurred more often in the MVP arm than in the DP arm (39{\%} v 22{\%}, respectively; P = .012), and grade 3 to 4 radiation esophagitis was likely to be more common in the DP arm than in the MVP arm (14{\%} v 6{\%}, P = .056). Conclusion: DP chemotherapy combined with concurrent TRT is an alternative to MVP chemotherapy for patients with LA-NSCLC.",
author = "Yoshihiko Segawa and Katsuyuki Kiura and Nagio Takigawa and Haruhito Kamei and Shingo Harita and Shunkichi Hiraki and Yoichi Watanabe and Keisuke Sugimoto and Takuo Shibayama and Toshiro Yonei and Hiroshi Ueoka and Mitsuhiro Takemoto and Susumu Kanazawa and Ichiro Takata and Naoyuki Nogami and Katsuyuki Hotta and Akio Hiraki and Masahiro Tabata and Keitaro Matsuo and Mitsune Tanimoto",
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TY - JOUR

T1 - Phase III trial comparing docetaxel and cisplatin combination chemotherapy with mitomycin, vindesine, and cisplatin combination chemotherapy with concurrent thoracic radiotherapy in locally advanced non-small-cell lung cancer

T2 - OLCSG 0007

AU - Segawa, Yoshihiko

AU - Kiura, Katsuyuki

AU - Takigawa, Nagio

AU - Kamei, Haruhito

AU - Harita, Shingo

AU - Hiraki, Shunkichi

AU - Watanabe, Yoichi

AU - Sugimoto, Keisuke

AU - Shibayama, Takuo

AU - Yonei, Toshiro

AU - Ueoka, Hiroshi

AU - Takemoto, Mitsuhiro

AU - Kanazawa, Susumu

AU - Takata, Ichiro

AU - Nogami, Naoyuki

AU - Hotta, Katsuyuki

AU - Hiraki, Akio

AU - Tabata, Masahiro

AU - Matsuo, Keitaro

AU - Tanimoto, Mitsune

PY - 2010/7/10

Y1 - 2010/7/10

N2 - Purpose: To demonstrate the efficacy of docetaxel and cisplatin (DP) chemotherapy with concurrent thoracic radiotherapy (TRT) for patients with locally advanced non-small-cell lung cancer (LA-NSCLC). Patients and Methods: Patients age 75 years or younger with LA-NSCLC, stratified by performance status, stage, and institution, were randomly assigned to two arms consisting of DP (docetaxel 40 mg/m2 and cisplatin 40 mg/m2 on days 1, 8, 29, and 36) or mitomycin, vindesine, and cisplatin (MVP) chemotherapy with concurrent TRT. Results: Between July 2000 and July 2005, 200 patients were allocated into either the DP or MVP arm. The survival time at 2 years, a primary end point, was favorable to the DP arm (P = .059 by a stratified log-rank test as a planned analysis and P = .044 by an early-period, weighted log-rank as an unplanned analysis). There was a trend toward improved response rate, 2-year survival rate, median progression-free time, and median survival in the DP arm (78.8%, 60.3%,13.4 months, and 26.8 months, respectively) compared with the MVP arm (70.3%, 48.1%, 10.5 months, and 23.7 months, respectively), which was not statistically significant (P > .05). Grade 3 febrile neutropenia occurred more often in the MVP arm than in the DP arm (39% v 22%, respectively; P = .012), and grade 3 to 4 radiation esophagitis was likely to be more common in the DP arm than in the MVP arm (14% v 6%, P = .056). Conclusion: DP chemotherapy combined with concurrent TRT is an alternative to MVP chemotherapy for patients with LA-NSCLC.

AB - Purpose: To demonstrate the efficacy of docetaxel and cisplatin (DP) chemotherapy with concurrent thoracic radiotherapy (TRT) for patients with locally advanced non-small-cell lung cancer (LA-NSCLC). Patients and Methods: Patients age 75 years or younger with LA-NSCLC, stratified by performance status, stage, and institution, were randomly assigned to two arms consisting of DP (docetaxel 40 mg/m2 and cisplatin 40 mg/m2 on days 1, 8, 29, and 36) or mitomycin, vindesine, and cisplatin (MVP) chemotherapy with concurrent TRT. Results: Between July 2000 and July 2005, 200 patients were allocated into either the DP or MVP arm. The survival time at 2 years, a primary end point, was favorable to the DP arm (P = .059 by a stratified log-rank test as a planned analysis and P = .044 by an early-period, weighted log-rank as an unplanned analysis). There was a trend toward improved response rate, 2-year survival rate, median progression-free time, and median survival in the DP arm (78.8%, 60.3%,13.4 months, and 26.8 months, respectively) compared with the MVP arm (70.3%, 48.1%, 10.5 months, and 23.7 months, respectively), which was not statistically significant (P > .05). Grade 3 febrile neutropenia occurred more often in the MVP arm than in the DP arm (39% v 22%, respectively; P = .012), and grade 3 to 4 radiation esophagitis was likely to be more common in the DP arm than in the MVP arm (14% v 6%, P = .056). Conclusion: DP chemotherapy combined with concurrent TRT is an alternative to MVP chemotherapy for patients with LA-NSCLC.

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