Phase II study of twice-daily high-dose thoracic radiotherapy alternating with cisplatin and vindesine for unresectable stage III non-small-cell lung cancer: Japan Clinical Oncology Group Study 9306

Ikuo Sekine, Yutaka Nishiwaki, Takashi Ogino, Akira Yokoyama, Mari Saito, Kiyoshi Mori, Iwao Tsukiyama, Satoshi Tsuchiya, Kazushige Hayakawa, Kimio Yoshimura, Naoki Ishizuka, Nagahiro Saijo

Research output: Contribution to journalArticle

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Abstract

Purpose: To evaluate the efficacy and toxicity of high-dose thoracic radiotherapy (TRT) alternating with chemotherapy (CH) for unresectable stage III non-small-cell lung cancer (NSCLC). Patients and Methods: Forty-one patients received TRT with 1.5 Gy twice daily, 5 days a week, on weeks 1, 2, 5, 6, and 9, up to a total dose of 66 to 72 Gy, alternating with cisplatin 80 mg/m2 on day 1 and vindesine 3 mg/m2 on days 1 and 8, repeated every 4 weeks, for two or three courses beginning on week 3. Results: The median (range) total dose of TRT and number of CH courses were 72 Gy (16.5 to 72 Gy) and three (zero to three), respectively. Delay in TRT ≥ 5 days was observed in 24 (75%) of 32 patients who completed the projected treatment, due to leukopenia in 12, esophagitis in seven, infection in two, and other causes in three patients. Partial responses were obtained in 36 patients (88%). The median survival time and 3- and 5-year survival rates were 18.4 months, 24%, and 10%, respectively. Grade 3 or 4 leukopenia and esophagitis developed in 32 and seven patients, respectively. Grade 3 or 4 late esophageal toxicity developed in two patients. Conclusion: Alternating high-dose TRT and CH for stage III NSCLC produced a high response rate with median and long-term survival comparable to prior trials utilizing standard approaches in this population. Acute and late esophageal toxicity was observed and interruption of TRT was required in most of the patients.

Original languageEnglish
Pages (from-to)797-803
Number of pages7
JournalJournal of Clinical Oncology
Volume20
Issue number3
DOIs
Publication statusPublished - 2002 Feb 1
Externally publishedYes

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Vindesine
Medical Oncology
Non-Small Cell Lung Carcinoma
Cisplatin
Japan
Radiotherapy
Thorax
Esophagitis
Leukopenia
Drug Therapy
Survival
Survival Rate

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase II study of twice-daily high-dose thoracic radiotherapy alternating with cisplatin and vindesine for unresectable stage III non-small-cell lung cancer : Japan Clinical Oncology Group Study 9306. / Sekine, Ikuo; Nishiwaki, Yutaka; Ogino, Takashi; Yokoyama, Akira; Saito, Mari; Mori, Kiyoshi; Tsukiyama, Iwao; Tsuchiya, Satoshi; Hayakawa, Kazushige; Yoshimura, Kimio; Ishizuka, Naoki; Saijo, Nagahiro.

In: Journal of Clinical Oncology, Vol. 20, No. 3, 01.02.2002, p. 797-803.

Research output: Contribution to journalArticle

Sekine, Ikuo ; Nishiwaki, Yutaka ; Ogino, Takashi ; Yokoyama, Akira ; Saito, Mari ; Mori, Kiyoshi ; Tsukiyama, Iwao ; Tsuchiya, Satoshi ; Hayakawa, Kazushige ; Yoshimura, Kimio ; Ishizuka, Naoki ; Saijo, Nagahiro. / Phase II study of twice-daily high-dose thoracic radiotherapy alternating with cisplatin and vindesine for unresectable stage III non-small-cell lung cancer : Japan Clinical Oncology Group Study 9306. In: Journal of Clinical Oncology. 2002 ; Vol. 20, No. 3. pp. 797-803.
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abstract = "Purpose: To evaluate the efficacy and toxicity of high-dose thoracic radiotherapy (TRT) alternating with chemotherapy (CH) for unresectable stage III non-small-cell lung cancer (NSCLC). Patients and Methods: Forty-one patients received TRT with 1.5 Gy twice daily, 5 days a week, on weeks 1, 2, 5, 6, and 9, up to a total dose of 66 to 72 Gy, alternating with cisplatin 80 mg/m2 on day 1 and vindesine 3 mg/m2 on days 1 and 8, repeated every 4 weeks, for two or three courses beginning on week 3. Results: The median (range) total dose of TRT and number of CH courses were 72 Gy (16.5 to 72 Gy) and three (zero to three), respectively. Delay in TRT ≥ 5 days was observed in 24 (75{\%}) of 32 patients who completed the projected treatment, due to leukopenia in 12, esophagitis in seven, infection in two, and other causes in three patients. Partial responses were obtained in 36 patients (88{\%}). The median survival time and 3- and 5-year survival rates were 18.4 months, 24{\%}, and 10{\%}, respectively. Grade 3 or 4 leukopenia and esophagitis developed in 32 and seven patients, respectively. Grade 3 or 4 late esophageal toxicity developed in two patients. Conclusion: Alternating high-dose TRT and CH for stage III NSCLC produced a high response rate with median and long-term survival comparable to prior trials utilizing standard approaches in this population. Acute and late esophageal toxicity was observed and interruption of TRT was required in most of the patients.",
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T1 - Phase II study of twice-daily high-dose thoracic radiotherapy alternating with cisplatin and vindesine for unresectable stage III non-small-cell lung cancer

T2 - Japan Clinical Oncology Group Study 9306

AU - Sekine, Ikuo

AU - Nishiwaki, Yutaka

AU - Ogino, Takashi

AU - Yokoyama, Akira

AU - Saito, Mari

AU - Mori, Kiyoshi

AU - Tsukiyama, Iwao

AU - Tsuchiya, Satoshi

AU - Hayakawa, Kazushige

AU - Yoshimura, Kimio

AU - Ishizuka, Naoki

AU - Saijo, Nagahiro

PY - 2002/2/1

Y1 - 2002/2/1

N2 - Purpose: To evaluate the efficacy and toxicity of high-dose thoracic radiotherapy (TRT) alternating with chemotherapy (CH) for unresectable stage III non-small-cell lung cancer (NSCLC). Patients and Methods: Forty-one patients received TRT with 1.5 Gy twice daily, 5 days a week, on weeks 1, 2, 5, 6, and 9, up to a total dose of 66 to 72 Gy, alternating with cisplatin 80 mg/m2 on day 1 and vindesine 3 mg/m2 on days 1 and 8, repeated every 4 weeks, for two or three courses beginning on week 3. Results: The median (range) total dose of TRT and number of CH courses were 72 Gy (16.5 to 72 Gy) and three (zero to three), respectively. Delay in TRT ≥ 5 days was observed in 24 (75%) of 32 patients who completed the projected treatment, due to leukopenia in 12, esophagitis in seven, infection in two, and other causes in three patients. Partial responses were obtained in 36 patients (88%). The median survival time and 3- and 5-year survival rates were 18.4 months, 24%, and 10%, respectively. Grade 3 or 4 leukopenia and esophagitis developed in 32 and seven patients, respectively. Grade 3 or 4 late esophageal toxicity developed in two patients. Conclusion: Alternating high-dose TRT and CH for stage III NSCLC produced a high response rate with median and long-term survival comparable to prior trials utilizing standard approaches in this population. Acute and late esophageal toxicity was observed and interruption of TRT was required in most of the patients.

AB - Purpose: To evaluate the efficacy and toxicity of high-dose thoracic radiotherapy (TRT) alternating with chemotherapy (CH) for unresectable stage III non-small-cell lung cancer (NSCLC). Patients and Methods: Forty-one patients received TRT with 1.5 Gy twice daily, 5 days a week, on weeks 1, 2, 5, 6, and 9, up to a total dose of 66 to 72 Gy, alternating with cisplatin 80 mg/m2 on day 1 and vindesine 3 mg/m2 on days 1 and 8, repeated every 4 weeks, for two or three courses beginning on week 3. Results: The median (range) total dose of TRT and number of CH courses were 72 Gy (16.5 to 72 Gy) and three (zero to three), respectively. Delay in TRT ≥ 5 days was observed in 24 (75%) of 32 patients who completed the projected treatment, due to leukopenia in 12, esophagitis in seven, infection in two, and other causes in three patients. Partial responses were obtained in 36 patients (88%). The median survival time and 3- and 5-year survival rates were 18.4 months, 24%, and 10%, respectively. Grade 3 or 4 leukopenia and esophagitis developed in 32 and seven patients, respectively. Grade 3 or 4 late esophageal toxicity developed in two patients. Conclusion: Alternating high-dose TRT and CH for stage III NSCLC produced a high response rate with median and long-term survival comparable to prior trials utilizing standard approaches in this population. Acute and late esophageal toxicity was observed and interruption of TRT was required in most of the patients.

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