The most effective treatment for early-stage (I–IIIA) non–small-cell lung cancer (NSCLC) is surgical resection. Despite optimal surgical techniques employed for the resections, a substantial percentage of patients with stage I–IIIA NSCLC subsequently relapse and die from their lung cancer.1 Studies that suggested adjuvant chemotherapy could prolong survival for some patients with early-stage lung cancer began to emerge. A number of trials have since documented that the use of chemotherapy in both the preoperative (neoadjuvant) and postoperative (adjuvant) settings can prolong survival. This chapter summarizes the evidence showing the benefit from adjuvant and neoadjuvant therapy for specific subgroups of patients with early-stage NSCLC.
Randomized trials including 29 to 841 patients with early-stage NSCLC performed over the last 30 years were jointly analyzed in an individual patient data meta-analysis published by the Non-Small Cell Lung Cancer Collaborative Group (NSCLCCG) in 1995.2 This analysis, involving more than 4300 patients, showed a strong trend toward improved survival of approximately 5% at 5 years for patients with surgically resected early-stage NSCLC treated with adjuvant cisplatin-based chemotherapy compared with those on observation alone (hazard ratio [HR] = 0.87; 95% confidence interval [CI], 0.74 to 1.02; p = 0.08). These results prompted a new generation of larger randomized controlled trials to attempt to validate the observations made in the meta-analysis. The patient, treatment, and outcome information from the studies enrolling more than 300 patients and comparing surgery alone to surgery followed by chemotherapy is presented in Table 89-1. This chapter does not address the use of postoperative tegafur and uracil (UFT). Although Japanese trials have demonstrated a survival benefit with adjuvant UFT, there have been no confirmatory trials in Western populations, and this agent is not presently available in the United States so is not included in this chapter.9
Table 89-1Overview of the Adjuvant Chemotherapy Trials Enrolling More Than 300 Patients, Published After the 1995 Non–Small-Cell Lung Cancer Meta-Analysis |Favorite Table|Download (.pdf) Table 89-1Overview of the Adjuvant Chemotherapy Trials Enrolling More Than 300 Patients, Published After the 1995 Non–Small-Cell Lung Cancer Meta-Analysis
| ||ALPI3 ||IALT4 ||BLT5 ||JBR.106 ||CALGB 96337 ||ANITA8 |
|Study dates ||1994–1999 ||1995–2000 ||1995–2001 ||1994—2001 ||1996–2003 ||1994–2000 |
|No. of patients ||1088 ||1867 ||381 ||482 ||344 ||840 |
|Stage eligibility ||I–IIIA ||I–III ||I–III ||IB–II ||IB ||IB–IIIA |
|Chemotherapy regimen ||Mitomycin, vindesine and cisplatin ||Cisplatin plus a vinca alkaloid or etoposide ||Cisplatin-baseda ||Cisplatin and vinorelbine ||Carboplatin and paclitaxel ||Cisplatin and vinorelbine |
|No. of cycles planned ||3 ||3 or 4 ||3 ||4 ||4 ||4 |
|Pneumonectomy, no. (%) ||274 (25%) ||648 (35%) ||NA ||114 (24%) ||37 (11%) ||310 (37%) |
|Postoperative radiotherapy ||Optional ||Optional ||Optional ||None ||None ||Optional |
|Median follow-up, years ||5.4 ||4.7 ||NA ||5.1 ||6.2 ||6.3 |
|Hazard ratio for death ||0.96 ||0.86 ||1.02 ||0.69 ||0.83 ||0.8 |
|95% confidence interval ||0.81–1.13 ||0.76–0.98 ||0.77–1.35 ||0.52–0.91 ||0.64–1.08 ||0.66–0.96 |
|p-value ||0.589 ||<0.03 ||0.9 ||0.04 ||0.125 ||0.017...|
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