Weekly docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer: A Phase I/II study with 5 years' follow-up

Paal F. Brunsvig, Reidulv Hatlevoll, Randi Berg, Grethe Lauvvang, Kristin Øwre, Mari Wang, Steinar Aamdal

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

This Phase I/II study investigated weekly docetaxel (Taxotere ®) with concurrent radiotherapy in 42 patients with untreated stage III non-small cell lung cancer (NSCLC). All patients were treated with chest irradiation: 2 Gy administered 5 days/week for 5 weeks, to a total of 50 Gy. Docetaxel (1-h infusion) was administered on days 1, 8, 22, and 29 ≤2 h before radiation fractions 1, 6, 16, and 21 (i.e. every week excluding the third week of treatment). In the Phase I study (n = 12), docetaxel was started at 20 mg/m2 per week (n = 3) and escalated in 10 mg/m2 increments (30 mg/m2, n = 3; 40 mg/m2, n = 6). Dose-limiting toxicity (grade 3-4 esophagitis) occurred with docetaxel 40 mg/m2. The Phase II study (n = 30), therefore, evaluated docetaxel 30 mg/m2 (considered recommended dose). All patients except one experienced asymptomatic grade 3-4 lymphopenia; four patients (9.5%) had grade 3-4 esophagitis. The overall response rate was 45.5%, with eight (24.2%) complete responses. The median time to progression at the recommended dose of 30 mg/m2 (n = 33) was 12.0 months and the median survival time was 13.6 months. The 1-year survival rate was 60.6%. Five patients (one from Phase I and four from Phase II) were alive after >5 years. In conclusion, weekly docetaxel 30 mg/m2 plus radiotherapy is active and well tolerated in stage III NSCLC.

Original languageEnglish (US)
Pages (from-to)97-105
Number of pages9
JournalLung Cancer
Volume50
Issue number1
DOIs
StatePublished - Jan 1 2005

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docetaxel
Non-Small Cell Lung Carcinoma
Radiotherapy
Esophagitis
Lymphopenia
Thorax
Survival Rate

Keywords

  • Chemotherapy
  • Concurrent chemoradiotherapy
  • Non-small cell lung cancer
  • Phase I/II
  • Stage III
  • Weekly docetaxel

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Weekly docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer : A Phase I/II study with 5 years' follow-up. / Brunsvig, Paal F.; Hatlevoll, Reidulv; Berg, Randi; Lauvvang, Grethe; Øwre, Kristin; Wang, Mari; Aamdal, Steinar.

In: Lung Cancer, Vol. 50, No. 1, 01.01.2005, p. 97-105.

Research output: Contribution to journalArticle

Brunsvig, Paal F. ; Hatlevoll, Reidulv ; Berg, Randi ; Lauvvang, Grethe ; Øwre, Kristin ; Wang, Mari ; Aamdal, Steinar. / Weekly docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer : A Phase I/II study with 5 years' follow-up. In: Lung Cancer. 2005 ; Vol. 50, No. 1. pp. 97-105.
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abstract = "This Phase I/II study investigated weekly docetaxel (Taxotere {\circledR}) with concurrent radiotherapy in 42 patients with untreated stage III non-small cell lung cancer (NSCLC). All patients were treated with chest irradiation: 2 Gy administered 5 days/week for 5 weeks, to a total of 50 Gy. Docetaxel (1-h infusion) was administered on days 1, 8, 22, and 29 ≤2 h before radiation fractions 1, 6, 16, and 21 (i.e. every week excluding the third week of treatment). In the Phase I study (n = 12), docetaxel was started at 20 mg/m2 per week (n = 3) and escalated in 10 mg/m2 increments (30 mg/m2, n = 3; 40 mg/m2, n = 6). Dose-limiting toxicity (grade 3-4 esophagitis) occurred with docetaxel 40 mg/m2. The Phase II study (n = 30), therefore, evaluated docetaxel 30 mg/m2 (considered recommended dose). All patients except one experienced asymptomatic grade 3-4 lymphopenia; four patients (9.5{\%}) had grade 3-4 esophagitis. The overall response rate was 45.5{\%}, with eight (24.2{\%}) complete responses. The median time to progression at the recommended dose of 30 mg/m2 (n = 33) was 12.0 months and the median survival time was 13.6 months. The 1-year survival rate was 60.6{\%}. Five patients (one from Phase I and four from Phase II) were alive after >5 years. In conclusion, weekly docetaxel 30 mg/m2 plus radiotherapy is active and well tolerated in stage III NSCLC.",
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