PURPOSE: To assess efficacy and toxicity of weekly low-dose paclitaxel given combined with four weekly carboplatin concomitantly with radiotherapy in locally advanced NSCLC patients (pts). To evaluate response rate, time to progression and median survival time.
METHODS: Prospective phase II study. 18 pts (17 male/1 female) involved, median age 63 years (46-71) with newly diagnosed NSCLC, clinical stage IIIA/IIIB (6/12), PS 0-1 (11/7). Chemotherapy naive pts received four cycles of paclitaxel 100 mg/m2 (reduced to 50 mg/m2 during radiation) on day 1, 8, and 15 and carboplatin AUC 6 in day 1, in 28 days cycles. Concomitant normofractionated external beam irradiation to primary tumor and regional lymph nodes (65,0-71,0 Gy/fraction 1,8-2,0 Gy/5 fraction/week) was administred in patients free of progression since the third cycle.
RESULTS: The median number of paclitaxel infusions administered per pts was 12 (3-12) and 4 infusions of carboplatin (1-4). 15 pts received radiotherapy. The most frequent hematological toxicities were neutropenia and leukopenia (grade 3/4 both in 17% of pts) and anemia (11% of pts). Grade 3/4 esophagitis occured in 3 (17%) and pneumonitis in 2 (11%) of pts. No toxic death occurred. 13 pts had partial response (72%), 3 stable (17%) and 2 progressive disease (11%). Median progression free survival was 35 weeks (6-57), median survival time was 60 weeks, 1-year survival 55% with a median follow-up 18 months.
CONCLUSION: Weekly low-dose paclitaxel combined with four weekly carboplatin chemotherapy administered concomitantly with radiotherapy is an effective treatment in locally advanced NSCLC. The toxicity of this regimen is very low.
CLINICAL IMPLICATIONS: This combined modality treatment is a reasonable option for pts with locally advanced inoperable NSCLC in PS 0-1.
DISCLOSURE: Irena Spasova, None.