Carboplatin + epirubicin +VP-16 + lenograstim followed by radiotherapy + carboplatin as radiosensitizer in limited small cell lung cancer. A multicenter phase II study.

Abstract

UNLABELLED:

A phase II trial was undertaken to test the activity and toxicity of carboplatin (300 mg/m2, i.v. day 1) + epirubicin (75 mg/m2, i.v. day 1) + VP-16 (100 mg/m2, i.v. days 1 to 3) + lenograstim (5 mcg/kg, s.c. days 6 to 15) administered every 3 weeks for 4 cycles and subsequent chest irradiation (50 Gy) + daily carboplatin (25 mg/m2) in the first-line treatment of adults affected by limited small cell lung cancer (SCLC).

PATIENTS AND METHODS:

A single-stage phase II design was used; the complete response (CR) rate after chest radiotherapy was the primary end-point. Twenty-three CRs were required out of 38 patients to consider the treatment worthy of further study. Prophylactic cranial irradiation (PCI) was planned in case of CR. Patients aged < or = 70 were eligible if they had limited SCLC, a performance status not worse than 2 by the ECOG scale and no prior chemotherapy or radiotherapy.

RESULTS:

From January 1995 to April 1999, 33 patients were enrolled; the median age was 60 years. All the patients started chemotherapy; 23 patients received chest irradiation and concurrent daily carboplatin; 11 patients also received PCI. Toxicity was generally mild. Sixteen CRs (48.5%, 95% CI: 30.8-66.5) were recorded; the objective response rate was 72.7% (95% CI: 54.5-86.7). The median time-to-progression was 7.9 months (95% CI: 6.5-10.4). The median-survival was 10.7 months (95% CI: 9.2-16.1).

CONCLUSION:

Induction chemotherapy with carboplatin + epirubicin + VP-16 followed by chest irradiation plus concurrent daily carboplatin is well-tolerated but not sufficiently active to warrant further study in the treatment of patients with limited SCLC.

• Authors: C Gridelli, C Curcio, R V Iaffaioli, L Brancaccio, M D'Aprile, V Gebbia, A Rossi, A Tortoriello, E Veltri, P Maione, A Barbarisi, C Gallo, C Guida, F Perrone
• Journal: Anticancer research (Anticancer Res) 2001 Nov-Dec Vol. 21 Issue 6A Pg. 4179-83 ISSN: 0250-7005 [Print] Greece
• PMID: 11911315 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Radiation-Sensitizing Agents
• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• Epirubicin
• Etoposide
• Lenograstim
• Carboplatin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carboplatin (administration & dosage, adverse effects)
• Carcinoma, Small Cell (drug therapy, radiotherapy)
• Combined Modality Therapy
• Epirubicin (administration & dosage, adverse effects)
• Etoposide (administration & dosage, adverse effects)
• Female
• Granulocyte Colony-Stimulating Factor (administration & dosage, adverse effects)
• Humans
• Lenograstim
• Lung Neoplasms (drug therapy, radiotherapy)
• Male
• Middle Aged
• Radiation-Sensitizing Agents (administration & dosage, adverse effects)
• Recombinant Proteins (administration & dosage, adverse effects)