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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
  1. RT: radiotherapy; IMRT: intensity-modulated radiotherapy; CTx: chemotherapy; KPS: Karnofsky performance status; ECOG: Eastern Cooperative Oncology Group performance status; WHO: World Health Organisation performance status; FEV1: forced expiratory volume 1; V20: lung volume receiving 20 Gy; ENI: elective nodal irradiation; Cetuximab SR: standard regimen with 400 mg/m2 given i.v. on day 1 and 250 mg/m2 on days 8, 15, 22, 29, 36 and 43; OS: overall survival; PFS: progression-free survival; PR and CR: partial and complete remission as per RECIST criteria; NR: not reported; PET: positron emission tomography
  2. * all results relate to the cetuximab arm of the study