Table 1 Study design and efficacy
From: A review of clinical trials of cetuximab combined with radiotherapy for non-small cell lung cancer
Reference | Study type | Patients | Other criteria | RT schedule | Systemic therapy | Follow-up | Results |
|---|---|---|---|---|---|---|---|
Jensen et al. [16] | Single institution phase II, Germany, n = 30 | Not candidates for concomitant chemoradiation (or refused), KPS at least 70, one of two trials with mandatory PET | Stage IIIA or B, no malignant pleural effusion, FEV1 ≥ 1.5 l or 40% of norm value, weight loss < 5% | Only IMRT trial, 66 Gy in 33 daily fractions of 2 Gy, ENI to 50 Gy (or 40 depending on lung dose, target volume NR) | Cetuximab SR followed by 13 weekly consolidation cycles | Median 19 mo | Median OS 19.6 mo, median PFS 8.5 mo, 63% PR, no CR, patterns of failure NR, survival not influenced by histology |
Jatoi et al. [15] | Multi-centre phase II, US, n = 58 | Not candidates for concomitant chemoradiation, either age ≥ 65 years with ECOG 0-2 or younger but ECOG 2 | Stage III A or B, no pleural effusion, FEV1 ≥ 1 l, haemoglobin ≥ 9 g/dl, V20 not exceeding 40% | 60 Gy in 30 daily fractions of 2 Gy, ENI to ipsilateral hilar and mediastinal nodes (44 Gy) | Cetuximab SR | Median 17 mo | Median OS 15.1 mo, median PFS 7.2 mo, 26% PR, no CR, patterns of failure and impact of histology NR |
Hallqvist et al. [19] | Multi-centre phase II, Sweden, n = 71 | Medically inoperable or unresectable, WHO 0-1 | Stage IIIA or B, no pleural effusion with positive cytology, FEV1 ≥ 1 l or 40% of expected volume | 68 Gy in 34 daily fractions of 2 Gy, no ENI | 2 cycles of induction cisplatin/docetaxel, cetuximab SR starting one week before RT | Median 39 mo | Median OS 17 mo, PFS NR, 16% PR and 7% CR at 12 months (NR at earlier time points), patterns of failure: 31% distant only, 23% local only, 7% regional only, 11% combinations of these, survival not influenced by histology |
Hughes et al. [20] | Dual centre phase II, UK, n = 12 | Inoperable, WHO 0-1 | Stage IIIA or B, no pleural effusion | 64 Gy in 32 fractions of 2 Gy, in 4 cases ENI to ipsilateral hilar and mediastinal nodes (50 Gy) | Up to 4 cycles (median 3) of platinum-based induction CTx, cetuximab SR starting one week before RT | Median 10 mo | Median OS NR, PFS NR, 58% PR, no CR, patterns of failure and impact of histology NR |
Blumenschein et al. [21] | Multi-centre phase II, US, n = 87 | Inoperable, Zubrod 0-1 | Stage IIIA or B, weight loss < 5%, FEV1 ≥ 1,2 l | 63 Gy in 35 fractions of 1.8 Gy, ENI to ipsilateral hilar and mediastinal nodes (45 Gy) | Cetuximab SR week 1-17, weekly carboplatin/paclitaxel during RT followed by 2 cycles consolidation carboplatin/paclitaxel | Median 22 mo | Median OS 22.7 mo, median time to progression around 14-15 mo, 29% CR, 33% PR, patterns of failure and impact of histology NR |
Govindan et al. [23] | Multi-centre phase II, randomised, US, n = 101 | Inoperable, ECOG 0-1, one of two trials with mandatory PET | Stage IIIA or B, no pleural effusion, weight loss ≤ 10% | 70 Gy in 35 fractions of 2 Gy, no ENI | Cetuximab SR (7 weeks) plus 4 cycles carboplatin/pemetrexed vs. same CTx without cetuximab (n = 48), afterwards 4 cycles of pemetrexed | Median 32 mo | Median OS 25.2 mo*, median failure-free survival 12.3 mo, 4% CR, 68% PR, patterns of failure NR, survival not influenced by histology |