Chapter 085. Neoplasms of the Lung (Part 13) Table 85-5 Randomized Studies of Adjuvant Chemotherapy in NSCLC Stu dy Treatment Nu mber of Patients 5- Year Survival (%) M edian Survival Ha zard Ratio (95% CI) p Value EC OG 3590 (II–IIIA) Surgery →RT vs. Surge ry + post- op concurrent RT + cis/etoposide 242 246 3 9% 3 3% 39 months vs. 38 months 0.9 3 (0.74– 1.18) 0 .56 AL PI (I–IIIA) Surgery alone vs. Surgery + post-op 603 606 5 1% N R 0.9 6 (0.8– 0 .59 mitomycin/vindesin e/cisplatin 4 3% 1.1) Big Lung Trial (I–IIIB) Surgery alone vs. Surgery + post-op chemotherapy a 189 192 33 months 34 months 1.0 2 (0.77– 1.35) 0 .90 IAL TIB–IIIA Surgery alone vs. Surgery + post- op Cis + VP16/vinca 405 361 4 0% 4 4.5% N R 0.8 6 (0.76– 0.98) < 0.03 UF TIA–IB Surgery alone vs. Surgery + post-op UFT 488 469 8 5% 8 8% — 0.7 1 (0.52– 0.98) 0 .04 CA LGB IB Surgery alone vs. Surgery + 172 5 78 0.8 0 (0.60– 0 (ASCO 06) post-op carbo/paclitaxel 172 7% 5 9% months 95 months 1.07) .10 NC I-CIB–II Surgery alone vs. Surgery + post-op Cis/vinorelbine 241 241 5 4% 6 9% 73 months 94 months 0.6 9 (0.52– 0.91) 0 .04 AN ITA IB, II, IIIA Surgery alone vs. Surgery + post-op Cis/vinorelbine 433 407 4 3% 5 1% 44 months 66 months 0.7 9 (50– 88.5) 0 .017 a Chemotherapy allowed: mitomycin, cisplatin, ifosfamide; mitomycin, vinblastine, cisplatin; cisplatin, vindesine; cisplatin, vinorelbine. Note: RT, radiation therapy; NR, not reported; UFT, tegafur and uracil. The role of adjuvant chemotherapy for stage IB disease is undefined. Subset analysis of all the randomized studies showed no benefit in patients with stage IB. In addition, one clinical trial focusing solely on IB disease and using carboplatin and paclitaxel (one of the most commonly used regimens for advanced disease) found a hazard ratio of 0.80 (20% reduction in death with adjuvant chemotherapy) that was not statistically significant. Thus, patients with stage IB NSCLC are not routinely given adjuvant therapy. Adjuvant Radiotherapy for NSCLC Stages I–II After apparent complete resection, postoperative adjuvant radiation therapy does not improve survival and may actually be detrimental to survival in N0 and N1 disease. . Chapter 085. Neoplasms of the Lung (Part 13) Table 85-5 Randomized Studies of Adjuvant Chemotherapy in NSCLC Stu dy Treatment Nu mber of Patients 5- Year Survival. therapy; NR, not reported; UFT, tegafur and uracil. The role of adjuvant chemotherapy for stage IB disease is undefined. Subset analysis of all the randomized studies showed no benefit in patients. carboplatin and paclitaxel (one of the most commonly used regimens for advanced disease) found a hazard ratio of 0.80 (20% reduction in death with adjuvant chemotherapy) that was not statistically