TABLE I.
Studies selected for inclusion
| Reference | Design | Target sample size | Follow-up (months) |
|---|---|---|---|
| Albain et al., 200910 (Intergroup 0139) | ▪ Phase III RCT | 510 (484 eligible), | 22.5 |
| ▪ Closed early | randomized before induction | (range: 0.9–125.1) | |
| Inclusion criteria: | Potentially resectable stage IIIA (pN2) disease: T1–3 primary NSCLC with pathology proof of N2 involvement | ||
| Comparison: | (A) Concurrent induction CTx (cisplatin–etoposide) plus RT (45 Gy) and continued RT if no progression; consolidation CTx (cisplatin–etoposide) given | ||
| (B) Concurrent induction CTx (cisplatin–etoposide) plus RT (45 Gy) and resected if no progression; consolidation CTx (cisplatin–etoposide) given | |||
| Patients analyzed: | (A) 213 randomized; 19 excluded in analysis; 50 did not complete consolidation CTx | ||
| (B) 216 randomized; 14 excluded in analysis; 91 did not complete consolidation cCTx | |||
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| Sorensen et al., 20139 (Nordic, abstract) | ▪ Phase III RCT | 406 | Not reported |
| ▪ Closed early | |||
| Inclusion criteria: | Previously untreated, histologically verified NSCLC, stages T1–3N2M0 | ||
| Comparison: | (A) Sequential CTx (paclitaxel–carboplatin) followed by RT (60 Gy) | ||
| (B) CTx (paclitaxel–carboplatin), followed by surgery, followed by RT (60 Gy) | |||
| Patients analyzed: | (A) 171 randomized | ||
| (B) 170 randomized; 132 underwent surgery | |||
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| Eberhardt et al., 20158 (ESPATUE) | ▪ Phase III RCT | 300, | Median: |
| ▪ Closed early | randomized after induction | 78 | |
| Inclusion criteria: | Potentially resectable stage IIIA (N2) or select stage IIIB NSCLC with pathology proof of N2 involvement; select stage IIIB patients included those with N3 disease with contralateral mediastinal nodes and proven T4 disease with involvement of the pulmonary artery, carina, left atrium, vena cava, or mediastinum | ||
| Comparison: | (A) Induction CTx (cisplatin–paclitaxel), then concurrent CTx (cisplatin–vinorelbine) plus RT (45 Gy), and chemoRT boost, risk-adapted to between 65 Gy and 71 Gy | ||
| (B) Induction CTx (cisplatin–paclitaxel), then concurrent CTx (cisplatin–vinorelbine) plus RT (45 Gy), and resected | |||
| Patients analyzed: | (A) 80 randomized; 76 received chemoRT boost | ||
| (B) 81 randomized; 70 underwent surgery | |||
RCT = randomized controlled trial; NSCLC = non-small-cell lung cancer; CTx = chemotherapy; RT = radiation therapy; chemoRT = chemoradiotherapy.