Therapie mit Docetaxel und Carboplatin bei Patienten mit fortgeschrittenem nicht-kleinzelligen Bronchialkarzinom (NSCLC) in der klinischen Praxis

Zusammenfassung

Ziel der Studie war die Untersuchung der Wirksamkeit und Toxizität einer Kombination aus Docetaxel und Carboplatin als First- und Second-line-Chemotherapie bei Patienten mit fortgeschrittenem nicht-kleinzelligen Bronchialkarzinom in der täglichen klinischen Routine. Zwischen 10/1996 und 5/2001 erhielten 38 Patienten (10 Frauen, 28 Männer; medianes Alter 62 Jahre) mit histologisch bestätigtem nicht-kleinzelligen Bronchialkarzinom im Stadium III B (n = 9) und Stadium IV (n = 29) und einem Allgemeinzustand Grad 0 - 2 nach ECOG (Grad 0: n = 2; Grad 1: n = 27; Grad 2: n = 9) eine Kombinationschemotherapie aus Docetaxel und Carboplatin. Den ersten 12 Patienten wurden alle drei Wochen 100 mg/m² Docetaxel, kombiniert mit Carboplatin 300 mg/m², verabreicht. Die folgenden 26 Patienten erhielten alle drei Wochen 75 mg/m² Docetaxel zusammen mit Carboplatin AUC 5. Für 32 Patienten (84,2 %) war es eine First-line-Chemotherapie. 5 Patienten wurden im Rahmen einer Second-line-Chemotherapie behandelt und ein Patient erhielt die Behandlung als Fourth-line-Chemotherapie. Insgesamt wurden 164 Zyklen verabreicht, im Median 4 Zyklen pro Patient. Histologisch lagen 17 Adenokarzinome (44,8 %), 12 Plattenepithelkarzinome (31,6 %), ein großzelliges Karzinom (2,6 %) und 8 nicht weiter differenzierbare nicht-kleinzellige Bronchialkarzinome (21 %) vor. Drei Patienten (7,9 %) wiesen eine partielle Remission (PR) auf. Ein stabiler Erkrankungszustand (SD) war bei 32 Patienten (84,2 %) zu verzeichnen. Drei Patienten (7,9 %) wiesen eine Progression (PD) auf. Gegenwärtig leben noch 7 Patienten. Die 1- und 2-JahresÜberlebensraten betragen 34,2 % bzw. 7,9 %. Das mediane Überleben liegt bei 237 Tagen (95 %-CI 228-434) und die mediane Zeit bis zur Progression beträgt 138 Tage (95 %-CI 144-318). Eine Leukozytopenie Grad 4 lag bei 7 Patienten (18,4 %) und Grad 3 bei 14 Patienten (36,8 %) vor. Es trat kein therapiebedingter Todesfall auf. Die Kombination aus Docetaxel (75 mg/m²) und Carboplatin (AUC 5) ist auch außerhalb von klinisch kontrollierten Studien eine wirksame und verträgliche First- und Second-line-Chemotherapie bei Patienten mit fortgeschrittenem nicht-kleinzelligen Bronchialkarzinom.

Abstract

The activity and toxicity of the combination of Docetaxel and Carboplatin as first- and second-line chemotherapy for advanced non-small cell lung cancer (NSCLC) were studied in daily clinical routine. Between 10/1996 and 05/2001, 38 patients (10 females, 28 males; median age 62 years) with histologically confirmed stage III B (n = 9) and IV (n = 29) NSCLC and with an ECOG performance status of PS 0 - 2 (PS 0: n = 2; PS 1: n = 27; PS 2: n = 9) were treated. The first 12 patients received Docetaxel (100 mg/m²) plus Carboplatin (300 mg/m²) and the following patients Docetaxel (75 mg/m²) plus Carboplatin (AUC 5). 32 patients (84.2 %) were treated with first-line chemotherapy, 5 patients with second- and one patient with fourth-line therapy. Cycles were repeated every three weeks to a maximum of 6 cycles. A total of 164 cycles was delivered with a median of 4 cycles per patient. Tumor histology was adenocarcinoma (17; 44.8 %), squamous cell (12; 31.6 %), large cell (1; 2.6 %) and other undifferentiated NSCLC (8; 21 %). Partial response (PR) was observed in three patients (7.9 %), stable disease (SD) in 32 patients (84.2 %) and progressive disease (PD) in three patients (7.9 %). 7 patients are still alive. Median survival was 237 days (228 - 434 days, 95 % CI), and median time to progression was 138 days (144 - 318 days, 95 % CI). The 1- and 2-year survival was 34.2 % and 7.9 %, respectively. Leucopenia grade 4 was observed in 7 patients (18.4 %), grade 3 in 15 patients (36.8 %). There was no treatment-related death. These results demonstrate that the combination chemotherapy with Docetaxel (75 mg/m²) and Carboplatin (AUC 5) is an active and feasible regimen as first- and second-line treatment of advanced NSCLC outside controlled clinical trials.

Fortgeschrittenes nicht-kleinzelliges Bronchialkarzinom - Docetaxel und Carboplatin - First-line-Therapie - Second-line-Therapie - Klinische Praxis

Advanced non small cell lung cancer - Docetaxel and Carboplatin combination chemotherapy - First- and second-line chemotherapy - Daily clinical routine

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