2 SEQUENTIAL PHASE-II TRIALS USING DIFFERENT DOSE INTENSITIES - PACLITAXEL, CARBOPLATIN, AND EXTENDED-SCHEDULE ORAL ETOPOSIDE FOR SMALL-CELL LUNG-CANCER

We evaluated the feasibility and efficacy of combination paclitaxel (T axol) (via I-hour infusion) carboplatin (Paraplatin), and oral etoposi de (VePesid) in the first-line treatment of patients with small-cell l ung cancer. Between June 1993 and July 1996, 117 patients with small-c ell lung cancer were treated in two sequential phase II studies. The f irst 38 patients received a lower-dose regimen: paclitaxel 135 mg/m(2) , via I-hour infusion; carboplatin dosed to an area under the concentr ation-time curve (AUG) of 5.0, and oral etoposide 50 mg alternating wi th 100 mg on days I through 10. Based on a very favorable toxicity pro file, the paclitaxel and carboplatin doses were increased in the subse quent cohort of 79 patients (paclitaxel 200 mg/m(2) by I-hour infusion ; carboplatin target AUC increased to 6.0). Thoracic radiation therapy (1.8 Gy/day; total dose, 45 Gy) was administered concurrently with co urses 3 and 4 of chemotherapy in patients with limited-stage small-cel l lung cancer, The combination of paclitaxel 200 mg/m(2), carboplatin to an AUC of 6.0, and extended-schedule oral etoposide 50 or 200 mg al ternating days 1 through 10 is highly active and well tolerated in pat ients with small-cell ling cancer, The regimen can be administered con currently with radiation therapy with no unusual side effects, althoug h a minority of patients develop esophagitis, Median survival rates in patients with both extensive-and limited-stage disease compare favora bly with other reported regimens.