[A randomized clinical trial of preoperative neoadjuvant chemotherapy followed by surgery in the treatment of stage III non-small cell lung cancer].

BACKGROUND

To explore the feasibility and toxicity of preoperative neoadjuvant chemotherapy followed by surgery in the treatment of stage III NSCLC and to evaluate its effects on tumor response, resection rate, tumor downstaging, and survival rate.

METHODS

From Jan. 1990 to Jan. 2001, 624 patients were randomly devided into group A ( preoperative neoadjuvant chemotherapy group) and group B ( control group, without neoadjuvant chemotherapy) . Group A had 314 patients and group B had 310 cases. The patients in group A were give 2 cycles of neoadjuvant chemotherapy, and operations were performed in 4 weeks after finishing the last chemotherapy. Twenty-one patients were given bronchial artery intervensional chemotherapy. The other 293 cases were given intravenous chemotherapy. The regimens included MVP in 68 cases, CAP in 36 cases, EP in 67 cases, VIP in 20 cases, Gem+ DDP in 30 cases, NVB+ DDP in 32 cases, Taxol+ NVB in 30 cases, and Taxol+ DDP in 10 cases. The patients in group B were firstly operated. Thoracic radiation therapy of 50-55 Gy was g iven in the patients with N1 and N2 disease both in group A and group B.

RESULTS

The tumor response to induction chemotherapy was 73. 57%( 231/ 314) in group A. The tumor downstaging was 43. 63%( 137/ 314) . The histological complete response was 15. 92%( 50/ 314) . The resection rate was 97. 69% in group A, and 91. 94% in group B. No significant differences of blood loss, operative complications and mortality were observed between the group A and group B. The 1-, 3-, 5- and 10-year survival rates were 89. 35%, 67. 46% , 34. 39% and 29. 34% in group A, and 87. 53%, 51. 54%, 24. 19% and 21. 64% in group B respectively. The long-term survival rate in group A was remarkably higher than that in group B ( P < 0. 01) .

CONCLUSIONS

The results demonstrate that the preoperative neoadjuvant chemotherapy is safe and effective. It is helpful to decrease the tumor staging , to increase the resection rate of the tumor, and to improve the long-term survival rate and life qualities of patients with stage III NSCLC.