ADJUVANT RADIOTHERAPY VERSUS COMBINED SEQUENTIAL CHEMOTHERAPY FOLLOWED BY RADIOTHERAPY IN THE TREATMENT OF RESECTED NONSMALL CELL LUNG-CARCINOMA - A RANDOMIZED TRIAL OF 267 PATIENTS

Background. The effect of adjuvant chemotherapy after resection of non small cell lung cancer (NSCLC) remains an unresolved question. Methods . From October, 1982, to November, 1986, 267 patients with resected NS CLC were included in a randomized trial. The adjuvant allocated treatm ents were either postoperative radiotherapy, 60 Gy in 6 weeks (radioth erapy group = 129 patients), or three courses of postoperative COPAC ( cyclophosphamide, doxorubicin, cisplatin, vincristine, lomustine) chem otherapy followed by a similar radiotherapy schedule (chemotherapy/rad iotherapy group = 138 patients). Results. The sex ratio (M:F) was 19/1 ; mean age was 57 +/- 9 years. According to postoperative staging, 8 p atients were Stage I, 70 were Stage II, and 189 were Stage m. The hist ologic type was squamous cell carcinoma in 175 patients, adenocarcinom a in 57, and large cell carcinoma in 35. The minimum follow-up was 6 y ears. Four patients were lost to follow-up. Death was recorded in 233 patients. No significant difference was observed in terms of disease f ree interval (P = 0.47, log-rank test), or overall survival (P = 0.68, log-rank test). With respect to the first site of relapse, distant me tastasis occurred more frequently in the radiotherapy group (P = 0.09, log-rank test) whereas local relapse occurred similarly in both group s (P = 0.27). An interaction was observed between lymph node involveme nt and treatment in terms of overall survival. Conclusions. The COPAC chemotherapy as postoperative treatment failed to improve overall surv ival in patients with resected NSCLC receiving postoperative radiother apy but decreased the pattern of metastatic progression, mainly in the N2 patients.