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High-Dose Once-Daily Thoracic Radiotherapy in Limited-Stage Small-Cell Lung Cancer: CALGB 30610 (Alliance)/RTOG 0538.

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Increasing thoracic radiotherapy dose for limited-stage small-cell lung cancer did not improve overall survival. The standard 45-Gy twice-daily regimen remains effective and well-tolerated, offering similar outcomes to higher-dose once-daily schedules.

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Area of Science:

  • Oncology
  • Radiation Oncology
  • Thoracic Oncology

Background:

  • Limited-stage small-cell lung cancer (SCLC) treatment often involves thoracic radiotherapy.
  • Level 1 evidence supports 45-Gy twice-daily radiotherapy as standard care.
  • Clinical practice frequently deviates, using higher-dose once-daily regimens.

Purpose of the Study:

  • To prospectively compare the efficacy of standard 45-Gy twice-daily radiotherapy versus higher-dose once-daily regimens in limited-stage SCLC.
  • To determine if escalating radiotherapy dose improves overall survival (OS).

Main Methods:

  • Phase III trial (CALGB 30610/RTOG 0538) involving patients with limited-stage SCLC.
  • Random assignment to 45-Gy twice-daily or 70-Gy once-daily radiotherapy, concurrent with chemotherapy.
  • Primary endpoint: overall survival (OS) in the intention-to-treat population.

Main Results:

  • A total of 638 patients were analyzed (313 in the twice-daily arm, 325 in the once-daily arm).
  • After a median follow-up of 4.7 years, no significant improvement in OS was observed with the 70-Gy once-daily regimen (HR, 0.94; P = .594).
  • Median survival was 28.5 months (twice-daily) vs. 30.1 months (once-daily); 5-year OS was 29% vs. 32%, respectively. Treatment was tolerable with similar severe adverse event rates.

Conclusions:

  • The 45-Gy twice-daily thoracic radiotherapy regimen remains the standard of care for limited-stage SCLC.
  • This study provides robust evidence that higher-dose once-daily radiotherapy does not improve survival outcomes.
  • The findings help guide the selection of thoracic radiotherapy regimens in this patient population.