[A random study on taxol and concomitant radiotherapy vs sequential combined modality in treatment of advanced non-small cell lung cancer].

BACKGROUND

To evaluate the results of taxol and concomitant radiotherapy and those of sequential combined modality chemotherapy with taxol plus cisplatin ( DDP) and radiotherapy in treatment of locally advanced non small cell lung cancer ( NSCLC) .

METHODS

From January 1998 through August 1999, 36 patients ( 24 male, 12 female; 18 squamous cell carcinoma, 14 adenocarcinoma, 4 others; 24 initially treated, 12 retreated) with locally advanced NSCLC were enrolled in this study and were randomized into 2 groups. The median age of the patients was 58. The majority of patients had a performance status of 0 or 1. In concomitant group, the patients received radiation therapy at 2 Gy given on Monday to Friday of each week for 6 to 7 consecutive weeks. The total planned radiation dose was 60 to 65 Gy. At twenty-four hours before radiotherapy, taxol 40 mg / m² was administered on Sunday of each week for 6 consecutive weeks. In sequential group, the patients received induction chemotherapy with taxol 175 mg/ m² and cisplatin 100mg/ m² every 3 weeks for two cycles followed by conventional radiation therapy.

RESULTS

The overall response rate was 66. 7% ( 12/ 18) in concomitant group and 50%( 9/ 18) in sequential group. The local control rate was 83. 3%( 15/ 18) in concomitant group and 50% ( 9/ 18) in sequential group. The main toxicity in concomitant group was esophagitis ( 72. 2%, 13/ 18) . The hematological tox icity and other nonhematological toxicity were mild in concomitant group. The main toxicities in sequential group were leukocytopenia ( 94. 4% , 17/ 18; grade 3/ 4 in 7 patients) , nausea and vomiting ( 94. 4%, 17/ 18; grade 3/ 4 in 5 patients) , alopecia ( grade 3/ 4 in 8 patients) , neurotoxicity ( grade 1/ 2 in 14 patients) and nephrotoxicity ( grade 1/ 2 in 5 patients) . One year survival rate in concomitant group was 50% ( 9/ 18) and in sequential group was 44. 4% ( 8/ 18) . The median survival period was 12 months in concomitant group and 11 months in sequential group.

CONCLUSIONS

Weekly taxol and concomitant radiotherapy is as effective as sequential combined modality in patients with locally advanced NSCLC and concomitant chemoradiotherapy has higher local control rate and lower tox icity except for esophagitis.