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The addition of cisplatin to cyclophosphamide-doxorubicin-etoposide combination chemotherapy in the treatment of patients with small cell lung carcinoma : A randomized study of 457 patients

✍ Scribed by Thierry Urban; Claude Chastang; François-Xavier Lebas; Jean-Paul Duhamel; Guy Adam; Jacqueline Darse; Jeanne-Marie Bréchot; Bernard Lebeau

Publisher
John Wiley and Sons
Year
1999
Tongue
English
Weight
94 KB
Volume
86
Category
Article
ISSN
0008-543X

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✦ Synopsis

BACKGROUND.

To assess whether the addition of cisplatin (100 mg/m 2 administered intravenously on Day 1) to CDE (cyclophosphamide [1000 mg/m 2 on Day 1], doxorubicin [45 mg/m 2 on Day 1], and etoposide [150 mg/m 2 on Days 1 and 2] combination is useful in the treatment of patients with small cell lung carcinoma (SCLC).

METHODS.

In a multicenter clinical trial, 457 patients were randomized from May 1988 to March 1993 to receive either CDE (n ϭ 228) or cisplatin-CDE (PCDE, n ϭ 229) chemotherapy every 4 weeks for 6 cycles. As patients with limited SCLC were included in a concomitant trial assessing thoracic radiotherapy, the current study mainly included patients with extensive stage (79%) or limited stage disease and a contraindication for thoracic radiotherapy.

RESULTS. The objective response rate was higher in the cisplatin-CDE group (72%) than in the CDE group (53%) (P ϭ 0.0001). The median overall survival was similar for the groups that received CDE (266 days) and PCDE (271 days) (P ϭ 0.93, log rank test). A higher fatal neutropenia rate was observed in the PCDE group (n ϭ 23) than in the CDE group (n ϭ 4) (P Ͻ 0.001, log rank test), mainly for patients with extensive disease (n ϭ 26; P ϭ 0.015, log rank test).

CONCLUSIONS.

The addition of cisplatin to a CDE regimen is toxic to patients with extensive SCLC and does not improve overall survival. The PCDE combination must be avoided for patients with extensive SCLC; CDE or cisplatin-etoposide combinations remain standard chemotherapy for these patients. The PCDE combination associated with granulocyte-colony stimulating factors could only be assessed in patients with good prognoses.

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