Efficacy and tolerability of a weekly schedule of docetaxel-cisplatin as first-line treatment for advanced non-small cell lung cancer (NSCLC)

Abstract

18159 Background: Docetaxel-cisplatin, administered every 3 weeks, is an effective first-line chemotherapy for locally advanced or metastatic NSCLC. However, this regimen is commonly associated with neutropenia and neutropenic infections. Moreover, the extensive hydration required with cisplatin given every 3 or 4 weeks makes outpatient treatment difficult. We assessed the efficacy and tolerability of weekly docetaxel-cisplatin, which may be better tolerated than the standard regimen. Methods: Patients (pts) with histologically confirmed stage UICC IIIB (malignant effusion) or IV NSCLC were treated with docetaxel (35 mg/m2, 30 min. infusion) and cisplatin (25 mg/m2, 30-min. infusion) on Days 1, 8, and 15, every 4 weeks for 4–6 cycles. Pts received ondansetron 8 mg iv and dexamethasone 8 mg iv preceding every day of chemotherapy and oral dexamethasone 2 x 4 mg daily from the day before until the day after chemotherapy. NK1-antagonists were given at the investigator’s discretion. On each day of therapy, 2750 mL of fluid was infused over 3.5 h. Most pts were treated in an outpatient department. Safety was assessed using CTCAE v3.0. The primary endpoint was response rate (RECIST). Results: 45 pts were enrolled; efficacy and tolerability data were available for 43 pts. 12/45 pts achieved an objective response (11 partial; 1 complete; ITT response rate 27%). Median time to progression was 3.9 months. Pts received a median of 3 full cycles. 4 pts (9%) required dose reductions. No cases of neutropenic fever/infections or grade 2–4 thrombocytopenia were observed. Only 2 pts (5%) had grade 3 neutropenia. One pt (2%) experienced grade 3–4 nausea/vomiting. 5 pts died during therapy for reasons not unequivocally attributable to tumor progression (bacterial meningitis with normal neutrophil counts [n=1], pneumonia with normal neutrophil counts [n=1], pulmonary arterial embolism [n=1], unknown [n=2]). Conclusions: Docetaxel-cisplatin administered weekly was well tolerated. Hematologic toxicity and neutropenic fever were uncommon. Docetaxel-cisplatin can be safely administered with relatively low hydration volumes in an outpatient setting. Survival data will be presented. No significant financial relationships to disclose.