ABSTRACT
This phase II study was conducted to assess tolerance and efficacy of concurrent weekly paclitaxel and carboplatin with split course thoracic irradiation in patients with locally advanced unresectable non-small cell lung cancer [NSCLC]. Patients with histologically confirmed unresectable stage IIIA/IIIB NSCLC with Karnofsky performance status of >/ 70 and weight loss /<5% with no palpable supraclavicular lymph nodes were treated with thoracic irradiation, 2 Gy daily, 5 days/week for three weeks [total dose of 30 Gy], followed by 10 days rest and the dose was repeated for a total dose of 60 Gy. Concurrently with radiation, patients received weekly paclitaxel 45 mg/m2 and carboplatin 100 mg/m2 given on days 1, 8, 15, 30, 37 and 44. Response was assessed by chest CT scan 2 months after treatment was completed and survival was calculated from the time of start of treatment. Between October 1999 and August 2000, 29 patients were treated. The median age was 56 years, there were 22 males [75.9%] and 7 females [24.1%]. Ten patients [34.5%] had stage IIIA disease and 19 patients [65.5%] with stage IIIB. Regarding acute toxicity, only 1 patient [3.4%] suffered from grade 4 toxicity [neutropenia]. Grade 3 esophagitis, pneumonitis and neutropenia were reported in 17.2%, 20.7% and 17.2%, respectively. The overall response rate was 69% with 6.9% complete response and 62.1% partial response. The median overall survival was 16.8 mon., with 1 and 2 year survival rates of 58.6% and 31%, respectively. The recorded 1 year and 2 year progression free survival rates were 48.3% and 27.6%, respectively, with a median time of progression of 11 months. The study concluded that this treatment regimen produces high response and survival rates with modest toxicity in patients with locally advanced unresectable NSCLC and it must be compared either alone or preceded by induction chemotherapy with the standard cisplatin based chemoradiation treatment