A phase I/II study of docetaxel, etoposide, and carboplatin before concurrent chemoradiotherapy with cisplatin and etoposide in limited-stage small cell lung cancer

Invest New Drugs. 2006 May;24(3):213-21. doi: 10.1007/s10637-005-3669-3.

Abstract

Limited stage small cell lung cancer (LS-SCLC) is an infrequent but aggressive tumor. No major advances in the treatment of this disease have been achieved in recent years. This study was conducted to determine the maximum-tolerated dose (MTD) and efficacy of docetaxel, etoposide, and carboplatin (DEC) given before definitive chest radiotherapy with concurrent cisplatin and etoposide. Seventeen untreated LS-SCLC patients received docetaxel 50 mg/m2, etoposide 50-80 mg/m2, and carboplatin AUC = 5-6, intravenously on day 1 followed by etoposide 100-160 mg/m2 orally on days 2 and 3 every 21 days for two cycles followed by once daily radiotherapy to a total dose of 50 Gy given concurrently with cisplatin (60 mg/m2, d1) and etoposide (120 mg/m2, d1 and 240 mg/m2 day 2-3) for 2 cycles. All patients were assessable for toxicity and 15 for response. The most frequent toxicity was grade 3 and 4 neutropenia in 41% of patients during DEC and in 57% with chemoradiation. The MTD for DEC was docetaxel 50 mg/m2 plus carboplatin AUC = 5 and etoposide 50/100 mg/m2 with growth factor support. Significant nonhematologic toxicities were primarily radiation-related esophagitis (43%). One patient (6%) died from toxicity. The overall response rate was 82% with 10 patients (59%) achieving a complete response. The median survival was 12.1 months (95% CI, 6.4-17.8 months) and the 1-year survival rate was 47%. This novel approach produced similar efficacy results to current two drug regimens but was associated with significant neutropenia. Alternative strategies to increase complete response rates and survival are needed.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carboplatin / administration & dosage
  • Carboplatin / adverse effects
  • Carcinoma, Small Cell / drug therapy*
  • Carcinoma, Small Cell / radiotherapy*
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Combined Modality Therapy
  • Docetaxel
  • Etoposide / administration & dosage
  • Etoposide / adverse effects
  • Female
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / radiotherapy*
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neutropenia / chemically induced
  • Taxoids / administration & dosage
  • Taxoids / adverse effects
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • Taxoids
  • Docetaxel
  • Etoposide
  • Carboplatin
  • Cisplatin