Phase III comparison of twice-daily split-course irradiation versus once-daily irradiation for patients with limited stage small-cell lung carcinoma

James A. Bonner, Jeff A Sloan, Thomas G. Shanahan, Burke J. Brooks, Randolph Stuart Marks, James E. Krook, James B. Gerstner, Andrew Maksymiuk, Ralph Levitt, James A. Mailliard, Henry D. Tazelaar, Shauna Hillman, James R. Jett

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171 Citations (Scopus)

Abstract

Purpose: Because small-cell lung cancer is a rapidly proliferating tumor, it was hypothesized that it may be more responsive to thoracic irradiation (TI) given twice-daily than once-daily. This hypothesis was tested in a phase III trial. Patients and Methods: Patients with limited- stage small-cell lung cancer were entered onto a phase III trial, and all patients initially received three cycles of etoposide (130 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). Subsequently, patients who did not have progression to a distant site (other than brain) were randomized to twice- daily thoracic irradiation (TDTI) versus once-daily thoracic irradiation (ODTI) given concomitantly with two additional cycles of etoposide (100 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). The irradiation doses were TDTI, 48 Gy in 32 fractions, with a 2.5-week break after the initial 24 Gy, and ODTI, 50.4 Gy in 28 fractions. After thoracic irradiation, the patients received a sixth cycle of etoposide/cisplatin, followed by prophylactic cranial irradiation (30 Gy/15 fractions) if they had a complete response. Results: Of 311 assessable patients enrolled in the trial, 262 underwent randomization to TDTI or ODTI. There were no differences between the two treatments with respect to local-only progression rates, overall progression rates, or overall survival. The patients who received TDTI had greater esophagitis (≥ grade 3) than those who received ODTI (12.3% v 5.3%; P=.05). Although patients received thoracic irradiation encompassing the postchemotherapy volumes, only seven of 90 local failures were out of the portal of irradiation. Conclusion: When TI is delayed until the fourth cycle of chemotherapy, TDTI does not result in improvement in local control or survival compared with ODTI.

Original languageEnglish (US)
Pages (from-to)2681-2691
Number of pages11
JournalJournal of Clinical Oncology
Volume17
Issue number9
StatePublished - Sep 1999

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Small Cell Lung Carcinoma
Thorax
Etoposide
Cisplatin
Cranial Irradiation
Survival
Esophagitis
Random Allocation

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III comparison of twice-daily split-course irradiation versus once-daily irradiation for patients with limited stage small-cell lung carcinoma. / Bonner, James A.; Sloan, Jeff A; Shanahan, Thomas G.; Brooks, Burke J.; Marks, Randolph Stuart; Krook, James E.; Gerstner, James B.; Maksymiuk, Andrew; Levitt, Ralph; Mailliard, James A.; Tazelaar, Henry D.; Hillman, Shauna; Jett, James R.

In: Journal of Clinical Oncology, Vol. 17, No. 9, 09.1999, p. 2681-2691.

Research output: Contribution to journalArticle

Bonner, JA, Sloan, JA, Shanahan, TG, Brooks, BJ, Marks, RS, Krook, JE, Gerstner, JB, Maksymiuk, A, Levitt, R, Mailliard, JA, Tazelaar, HD, Hillman, S & Jett, JR 1999, 'Phase III comparison of twice-daily split-course irradiation versus once-daily irradiation for patients with limited stage small-cell lung carcinoma', Journal of Clinical Oncology, vol. 17, no. 9, pp. 2681-2691.
Bonner, James A. ; Sloan, Jeff A ; Shanahan, Thomas G. ; Brooks, Burke J. ; Marks, Randolph Stuart ; Krook, James E. ; Gerstner, James B. ; Maksymiuk, Andrew ; Levitt, Ralph ; Mailliard, James A. ; Tazelaar, Henry D. ; Hillman, Shauna ; Jett, James R. / Phase III comparison of twice-daily split-course irradiation versus once-daily irradiation for patients with limited stage small-cell lung carcinoma. In: Journal of Clinical Oncology. 1999 ; Vol. 17, No. 9. pp. 2681-2691.
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abstract = "Purpose: Because small-cell lung cancer is a rapidly proliferating tumor, it was hypothesized that it may be more responsive to thoracic irradiation (TI) given twice-daily than once-daily. This hypothesis was tested in a phase III trial. Patients and Methods: Patients with limited- stage small-cell lung cancer were entered onto a phase III trial, and all patients initially received three cycles of etoposide (130 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). Subsequently, patients who did not have progression to a distant site (other than brain) were randomized to twice- daily thoracic irradiation (TDTI) versus once-daily thoracic irradiation (ODTI) given concomitantly with two additional cycles of etoposide (100 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). The irradiation doses were TDTI, 48 Gy in 32 fractions, with a 2.5-week break after the initial 24 Gy, and ODTI, 50.4 Gy in 28 fractions. After thoracic irradiation, the patients received a sixth cycle of etoposide/cisplatin, followed by prophylactic cranial irradiation (30 Gy/15 fractions) if they had a complete response. Results: Of 311 assessable patients enrolled in the trial, 262 underwent randomization to TDTI or ODTI. There were no differences between the two treatments with respect to local-only progression rates, overall progression rates, or overall survival. The patients who received TDTI had greater esophagitis (≥ grade 3) than those who received ODTI (12.3{\%} v 5.3{\%}; P=.05). Although patients received thoracic irradiation encompassing the postchemotherapy volumes, only seven of 90 local failures were out of the portal of irradiation. Conclusion: When TI is delayed until the fourth cycle of chemotherapy, TDTI does not result in improvement in local control or survival compared with ODTI.",
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T1 - Phase III comparison of twice-daily split-course irradiation versus once-daily irradiation for patients with limited stage small-cell lung carcinoma

AU - Bonner, James A.

AU - Sloan, Jeff A

AU - Shanahan, Thomas G.

AU - Brooks, Burke J.

AU - Marks, Randolph Stuart

AU - Krook, James E.

AU - Gerstner, James B.

AU - Maksymiuk, Andrew

AU - Levitt, Ralph

AU - Mailliard, James A.

AU - Tazelaar, Henry D.

AU - Hillman, Shauna

AU - Jett, James R.

PY - 1999/9

Y1 - 1999/9

N2 - Purpose: Because small-cell lung cancer is a rapidly proliferating tumor, it was hypothesized that it may be more responsive to thoracic irradiation (TI) given twice-daily than once-daily. This hypothesis was tested in a phase III trial. Patients and Methods: Patients with limited- stage small-cell lung cancer were entered onto a phase III trial, and all patients initially received three cycles of etoposide (130 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). Subsequently, patients who did not have progression to a distant site (other than brain) were randomized to twice- daily thoracic irradiation (TDTI) versus once-daily thoracic irradiation (ODTI) given concomitantly with two additional cycles of etoposide (100 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). The irradiation doses were TDTI, 48 Gy in 32 fractions, with a 2.5-week break after the initial 24 Gy, and ODTI, 50.4 Gy in 28 fractions. After thoracic irradiation, the patients received a sixth cycle of etoposide/cisplatin, followed by prophylactic cranial irradiation (30 Gy/15 fractions) if they had a complete response. Results: Of 311 assessable patients enrolled in the trial, 262 underwent randomization to TDTI or ODTI. There were no differences between the two treatments with respect to local-only progression rates, overall progression rates, or overall survival. The patients who received TDTI had greater esophagitis (≥ grade 3) than those who received ODTI (12.3% v 5.3%; P=.05). Although patients received thoracic irradiation encompassing the postchemotherapy volumes, only seven of 90 local failures were out of the portal of irradiation. Conclusion: When TI is delayed until the fourth cycle of chemotherapy, TDTI does not result in improvement in local control or survival compared with ODTI.

AB - Purpose: Because small-cell lung cancer is a rapidly proliferating tumor, it was hypothesized that it may be more responsive to thoracic irradiation (TI) given twice-daily than once-daily. This hypothesis was tested in a phase III trial. Patients and Methods: Patients with limited- stage small-cell lung cancer were entered onto a phase III trial, and all patients initially received three cycles of etoposide (130 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). Subsequently, patients who did not have progression to a distant site (other than brain) were randomized to twice- daily thoracic irradiation (TDTI) versus once-daily thoracic irradiation (ODTI) given concomitantly with two additional cycles of etoposide (100 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). The irradiation doses were TDTI, 48 Gy in 32 fractions, with a 2.5-week break after the initial 24 Gy, and ODTI, 50.4 Gy in 28 fractions. After thoracic irradiation, the patients received a sixth cycle of etoposide/cisplatin, followed by prophylactic cranial irradiation (30 Gy/15 fractions) if they had a complete response. Results: Of 311 assessable patients enrolled in the trial, 262 underwent randomization to TDTI or ODTI. There were no differences between the two treatments with respect to local-only progression rates, overall progression rates, or overall survival. The patients who received TDTI had greater esophagitis (≥ grade 3) than those who received ODTI (12.3% v 5.3%; P=.05). Although patients received thoracic irradiation encompassing the postchemotherapy volumes, only seven of 90 local failures were out of the portal of irradiation. Conclusion: When TI is delayed until the fourth cycle of chemotherapy, TDTI does not result in improvement in local control or survival compared with ODTI.

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