Phase III trial of thoracic irradiation with or without cisplatin for locally advanced unresectable non-small-cell lung cancer

A Hoosier Oncology Group Protocol

C. Blanke, R. Ansari, R. Mantravadi, R. Gonin, R. Tokars, W. Fisher, K. Pennington, T. O'Connor, S. Rynard, M. Miller, Lawrence Einhorn

Research output: Contribution to journalArticle

135 Citations (Scopus)

Abstract

Purpose: Here we report the results of a phase III study, to evaluate whether the addition of cisplatin to radiation therapy (XRT) would improve progression-free survival or overall survival for patients with locally advanced unresectable non-small-cell lung cancer (NSCLC). Patients and Methods: Two hundred forty patients with biopsy-proven unresectable NSCLC without distant metastases or lower-stage medically inoperable patients were randomized to one of two treatment arms. Arm A consisted of thoracic XRT alone, 60 to 65 Gy total tumor dose in daily fractions of 1.80 to 2.00 Gy; and arm B consisted of identical XRT with the addition of cisplatin 70 mg/m2 every 3 weeks for three cycles beginning on the first day of irradiation. Results: Two hundred fifteen patients were eligible and assessable. The overall response rate was 50% on the combination arm versus 38% on the XRT- alone arm (P = .076). The median progression-free survival time was 23 versus 22 weeks, respectively (P = .0537). The median survival time was 43 weeks on the combination arm versus 46 weeks on the XRT arm (P(overall) = .3469). The 1-, 2-, and 5-year survival rates were 43%, 18%, and 5% on the combination arm versus 45% 13%, and 2% on the XRT arm, respectively. Conclusion: Cisplatin, administered every 3 weeks, does not significantly improve response rate, progression-free survival, or overall survival when added to thoracic XRT for locally advanced unresectable NSCLC.

Original languageEnglish (US)
Pages (from-to)1425-1429
Number of pages5
JournalJournal of Clinical Oncology
Volume13
Issue number6
StatePublished - 1995

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Non-Small Cell Lung Carcinoma
Cisplatin
Thorax
Disease-Free Survival
Survival
Radiotherapy
Survival Rate
Neoplasm Metastasis
Biopsy
Neoplasms
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase III trial of thoracic irradiation with or without cisplatin for locally advanced unresectable non-small-cell lung cancer : A Hoosier Oncology Group Protocol. / Blanke, C.; Ansari, R.; Mantravadi, R.; Gonin, R.; Tokars, R.; Fisher, W.; Pennington, K.; O'Connor, T.; Rynard, S.; Miller, M.; Einhorn, Lawrence.

In: Journal of Clinical Oncology, Vol. 13, No. 6, 1995, p. 1425-1429.

Research output: Contribution to journalArticle

Blanke, C, Ansari, R, Mantravadi, R, Gonin, R, Tokars, R, Fisher, W, Pennington, K, O'Connor, T, Rynard, S, Miller, M & Einhorn, L 1995, 'Phase III trial of thoracic irradiation with or without cisplatin for locally advanced unresectable non-small-cell lung cancer: A Hoosier Oncology Group Protocol', Journal of Clinical Oncology, vol. 13, no. 6, pp. 1425-1429.
Blanke, C. ; Ansari, R. ; Mantravadi, R. ; Gonin, R. ; Tokars, R. ; Fisher, W. ; Pennington, K. ; O'Connor, T. ; Rynard, S. ; Miller, M. ; Einhorn, Lawrence. / Phase III trial of thoracic irradiation with or without cisplatin for locally advanced unresectable non-small-cell lung cancer : A Hoosier Oncology Group Protocol. In: Journal of Clinical Oncology. 1995 ; Vol. 13, No. 6. pp. 1425-1429.
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abstract = "Purpose: Here we report the results of a phase III study, to evaluate whether the addition of cisplatin to radiation therapy (XRT) would improve progression-free survival or overall survival for patients with locally advanced unresectable non-small-cell lung cancer (NSCLC). Patients and Methods: Two hundred forty patients with biopsy-proven unresectable NSCLC without distant metastases or lower-stage medically inoperable patients were randomized to one of two treatment arms. Arm A consisted of thoracic XRT alone, 60 to 65 Gy total tumor dose in daily fractions of 1.80 to 2.00 Gy; and arm B consisted of identical XRT with the addition of cisplatin 70 mg/m2 every 3 weeks for three cycles beginning on the first day of irradiation. Results: Two hundred fifteen patients were eligible and assessable. The overall response rate was 50{\%} on the combination arm versus 38{\%} on the XRT- alone arm (P = .076). The median progression-free survival time was 23 versus 22 weeks, respectively (P = .0537). The median survival time was 43 weeks on the combination arm versus 46 weeks on the XRT arm (P(overall) = .3469). The 1-, 2-, and 5-year survival rates were 43{\%}, 18{\%}, and 5{\%} on the combination arm versus 45{\%} 13{\%}, and 2{\%} on the XRT arm, respectively. Conclusion: Cisplatin, administered every 3 weeks, does not significantly improve response rate, progression-free survival, or overall survival when added to thoracic XRT for locally advanced unresectable NSCLC.",
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T1 - Phase III trial of thoracic irradiation with or without cisplatin for locally advanced unresectable non-small-cell lung cancer

T2 - A Hoosier Oncology Group Protocol

AU - Blanke, C.

AU - Ansari, R.

AU - Mantravadi, R.

AU - Gonin, R.

AU - Tokars, R.

AU - Fisher, W.

AU - Pennington, K.

AU - O'Connor, T.

AU - Rynard, S.

AU - Miller, M.

AU - Einhorn, Lawrence

PY - 1995

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N2 - Purpose: Here we report the results of a phase III study, to evaluate whether the addition of cisplatin to radiation therapy (XRT) would improve progression-free survival or overall survival for patients with locally advanced unresectable non-small-cell lung cancer (NSCLC). Patients and Methods: Two hundred forty patients with biopsy-proven unresectable NSCLC without distant metastases or lower-stage medically inoperable patients were randomized to one of two treatment arms. Arm A consisted of thoracic XRT alone, 60 to 65 Gy total tumor dose in daily fractions of 1.80 to 2.00 Gy; and arm B consisted of identical XRT with the addition of cisplatin 70 mg/m2 every 3 weeks for three cycles beginning on the first day of irradiation. Results: Two hundred fifteen patients were eligible and assessable. The overall response rate was 50% on the combination arm versus 38% on the XRT- alone arm (P = .076). The median progression-free survival time was 23 versus 22 weeks, respectively (P = .0537). The median survival time was 43 weeks on the combination arm versus 46 weeks on the XRT arm (P(overall) = .3469). The 1-, 2-, and 5-year survival rates were 43%, 18%, and 5% on the combination arm versus 45% 13%, and 2% on the XRT arm, respectively. Conclusion: Cisplatin, administered every 3 weeks, does not significantly improve response rate, progression-free survival, or overall survival when added to thoracic XRT for locally advanced unresectable NSCLC.

AB - Purpose: Here we report the results of a phase III study, to evaluate whether the addition of cisplatin to radiation therapy (XRT) would improve progression-free survival or overall survival for patients with locally advanced unresectable non-small-cell lung cancer (NSCLC). Patients and Methods: Two hundred forty patients with biopsy-proven unresectable NSCLC without distant metastases or lower-stage medically inoperable patients were randomized to one of two treatment arms. Arm A consisted of thoracic XRT alone, 60 to 65 Gy total tumor dose in daily fractions of 1.80 to 2.00 Gy; and arm B consisted of identical XRT with the addition of cisplatin 70 mg/m2 every 3 weeks for three cycles beginning on the first day of irradiation. Results: Two hundred fifteen patients were eligible and assessable. The overall response rate was 50% on the combination arm versus 38% on the XRT- alone arm (P = .076). The median progression-free survival time was 23 versus 22 weeks, respectively (P = .0537). The median survival time was 43 weeks on the combination arm versus 46 weeks on the XRT arm (P(overall) = .3469). The 1-, 2-, and 5-year survival rates were 43%, 18%, and 5% on the combination arm versus 45% 13%, and 2% on the XRT arm, respectively. Conclusion: Cisplatin, administered every 3 weeks, does not significantly improve response rate, progression-free survival, or overall survival when added to thoracic XRT for locally advanced unresectable NSCLC.

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