A prospective randomized study of adjuvant chemotherapy in completely resected stage IIIA-N2 non-small cell lung cancer / 中国肺癌杂志

ABSTRACT

<p><b>BACKGROUND</b>Recently, results from IALT, JBR10 and CALGB9633 showed that postoperative adjuvant chemotherapy improved survival rate of patients with non-small cell lung cancer (NSCLC) after complete resection. The aim of this study is to evaluate the effect of postoperative adjuvant chemotherapy on survival after complete resection for stage IIIA-N2 NSCLC.</p><p><b>METHODS</b>From Jan 1999 to Dec 2003, one-hundred and fifty patients with stage IIIA-N2 NSCLC were randomly divided into two groups. The chemotherapy group received four cycles of chemotherapy with navelbine or paclitaxel plus carboplatin, while the observation group did not receive chemotherapy after operation.</p><p><b>RESULTS</b>In the chemotherapy group, 86.1% (68/79) of patients finished 4 cycles of chemotherapy, and no one died of toxic effects of chemotherapy; 25% of patients had grade III-IV leukopenia, 2% of patients had febrile leukopenia. The median survival time for the entire 150 patients was 879 days, and 1-, 2- and 3-year survival rate was 81%, 59% and 43%. There was no significant difference in median survival between the chemotherapy and observation groups (P= 0.0527), but there was significant difference in the 1- and 2-year survival rate (94.71% and 76.28% vs 88.24% and 60.13%, P < 0.05). The most common site of recurrence was the brain. Twenty-six percent (39/150) of patients recurred in the brain as their first site of failure, and 22.8% (18/79) for the chemotherapy group, 29.6% (21/71) for the observation group. The median survival time for patients who developed brain metastasis was not significantly different between the chemotherapy and observation groups (812 days vs 512 days, P=0.122), but there was significant difference in the 2-year survival rate (66.7% vs 37.6%, P < 0.01). The median survival was 190 days for the patients since brain metastasis appeared.</p><p><b>CONCLUSIONS</b>Postoperative adjuvant chemotherapy dose not significantly improve median survival among patients with completely resected stage IIIA-N2 NSCLC, but significantly improves the 1- and 2-year survival rate. It also dose not decrease the incidence of brain metastasis but puts off the time of brain metastasis.</p>