Paclitaxel (Taxol) and carboplatin followed by concomitant paclitaxel, cisplatin and radiotherapy for inoperable stage III NSCLC.

We assessed the efficacy and toxicity of low-dose paclitaxel (Taxol) given combined with carboplatin before radiotherapy, and with cisplatin concomitantly with radiotherapy, in 27 patients with previously untreated inoperable stage IIA/IIIB non-small cell lung cancer. The induction chemotherapy consisted of paclitaxel 135 mg/m2 given over 1 h on day 1 and carboplatin 200 mg/m2 on day 2 repeated every 3 weeks for three cycles. Patients free of progression after induction chemotherapy received megavoltage radiation (56 Gy, 2 Gy/fraction) along with paclitaxel (30 mg/m2/1 h) and cisplatin (30 mg/m2/1 h) given 2-4 h before irradiation on days, 1, 2, 3, 22, 23 and 24. A combination of antero-posterior and oblique treatment fields was used to limit the dose to the spinal cord and to the left side of the heart to 36 Gy. The overall response rate was 78% (complete response, 19%). With a median follow-up of 19 months the median survival is 12 months, the estimated 2-year survival rate is 36%, and all patients with a complete response survived for at least 12 months after starting treatment. A total of 17 deaths occurred with metastases predominantly in the brain. Major acute toxicities (> grade 3) during induction chemotherapy included leuko-/neutropenia (n = 5/27, 19%), and during chemoradiotherapy leuko-/neutropenia (n = 10/23, 43%), thrombocytopenia (n = 1, 4%), oesophagitis (n = 3, 13%) and pneumonitis (n = 7, 30%). No toxic deaths occurred. Marked renal toxicity was not observed. We conclude that this chemoradiotherapy regimen is effective and well-tolerated, and should be further evaluated in a randomised phase III trial.