A phase II trial, feasibility of combination of daily cisplatinum and accelerated radiotherapy via concomitant boost in stage III non-small cell lung cancer

Lung Cancer. 1998 Apr;20(1):37-46. doi: 10.1016/s0169-5002(98)00003-8.

Abstract

Purpose: A prospective phase II trial was conducted by the Institute of Oncology, Istanbul University in December 1994 on patients with locally-advanced non-small cell lung cancer to assess acute toxicity and the feasibility of a combination of radiosensitizer and accelerated radiotherapy with concomitant boost.

Materials and methods: Patients were irradiated using 'large' fields (primary tumour and locoregional lymph nodes) with 1.8 Gy per fraction, five fractions a week. Reduced 'boost' fields (primary and involved nodes only) were also irradiated twice-weekly 1.8 Gy per fraction in ten fractions concomitantly 6 h after the administration of large field. Total radiation dose was 63 Gy in 5 weeks (45 Gy 'large' fields and 18 Gy 'boost'). The maximum allowed dose to the spinal cord was 3750 cGy. Cisplatinum, 6 mg/m2 was given daily just before 'large' field irradiation.

Results: As of January 1997, 15 patients were evaluated (median follow-up of 12.5 months with a range of 5.5-23 months). The overall acute toxicity rate was 38% and Grade 3 acute toxicity was 8%. Grade 4 or greater acute toxicities were not observed. The overall rate of cisplatinum-induced nausea and vomiting was 80% (severe in 60%), but all were easily treated with antiemetics. Complete response rate (clinical and radiological) was 40% and an overall response rate was 73%. Median survival was 16 months and progression-free survival was 5.5 months (range of 2.5-21 months).

Conclusions: Toxicity was well tolerated and no treatment-related death occurred with this combined treatment regimen. Although it appears that better local control rates can be achieved, additional phase II/III studies are needed.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy
  • Carcinoma, Non-Small-Cell Lung / radiotherapy*
  • Cisplatin / adverse effects
  • Cisplatin / therapeutic use*
  • Combined Modality Therapy / adverse effects
  • Confidence Intervals
  • Dose Fractionation, Radiation
  • Female
  • Humans
  • Lung Neoplasms / drug therapy
  • Lung Neoplasms / radiotherapy*
  • Male
  • Middle Aged
  • Prospective Studies
  • Radiation-Sensitizing Agents / adverse effects
  • Radiation-Sensitizing Agents / therapeutic use*
  • Radiotherapy / adverse effects
  • Radiotherapy / methods
  • Survival Analysis

Substances

  • Antineoplastic Agents
  • Radiation-Sensitizing Agents
  • Cisplatin