Phase I study of hypofractionated dose-escalated thoracic radiotherapy for limited-stage small-cell lung cancer

Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):466-73. doi: 10.1016/j.ijrobp.2005.12.013. Epub 2006 Mar 24.

Abstract

Purpose: To determine the maximal tolerated dose of hypofractionated thoracic radiotherapy with concurrent chemotherapy for limited-stage small-cell lung cancer patients.

Methods and materials: Three radiotherapy regimens were used. Radiotherapy was given in two phases: patients initially received 20 Gy in 10 fractions to gross tumor plus uninvolved mediastinal nodes, followed by a boost to gross disease of 30, 38, or 42 Gy in 15 fractions. Radiotherapy was planned with conformal techniques. All patients received four cycles of cisplatin (25 mg/m2) and etoposide (100 mg/m2) chemotherapy. Radiotherapy commenced with Day 1 of Cycle 2 of chemotherapy. All complete/near-complete responders were offered prophylactic cranial irradiation. The maximal tolerated dose of radiotherapy was based on the dose that caused unacceptably high rates of radiotherapy-related toxicity.

Results: Thirteen patients were accrued. All patients who commenced radiotherapy received all prescribed chemo- and radiotherapy. There were no treatment-related deaths. There was one Grade 3 acute nonhematologic toxicity in the 50-Gy group. Of the 6 patients given 58 Gy, 3 experienced acute Grade 3 esophagitis. With a median follow-up of 7 months, median overall survival was 9.5 months.

Conclusions: The maximal tolerated dose of thoracic radiotherapy with concurrent chemotherapy on this trial was 50 Gy in 25 daily fractions.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Carcinoma, Small Cell / drug therapy
  • Carcinoma, Small Cell / pathology
  • Carcinoma, Small Cell / radiotherapy*
  • Cisplatin / administration & dosage
  • Combined Modality Therapy
  • Dose Fractionation, Radiation
  • Etoposide / administration & dosage
  • Female
  • Humans
  • Lung Neoplasms / drug therapy
  • Lung Neoplasms / pathology
  • Lung Neoplasms / radiotherapy*
  • Male
  • Maximum Tolerated Dose*
  • Middle Aged
  • Radiotherapy, Conformal / adverse effects
  • Radiotherapy, Conformal / methods
  • Treatment Outcome

Substances

  • Etoposide
  • Cisplatin